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CPD

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Introduction

Humans have evolved structures and mechanisms to provide protection against harm from exogenous substances.¹ In the same way that medicines overcome these to achieve therapeutic effects, poisoning occurs when a substance evades or utilises this protection and reaches a site where it causes adverse effects.¹

Paracelsus’s maxim – ‘all substances are poisons, there is none that is not a poison; the right dose differentiates a poison from a remedy’– is helpful to appreciate the potential toxicity of pharmaceuticals.¹

Learning objectives

After successful completion of this CPD activity, pharmacists should be able to:

Recognise the pharmaceutical substances that are commonly associated with poisoning in Australia
Identify the appropriate course of action in suspected poisoning with pharmaceuticals
Recognise doses of registered pharmaceuticals that are likely to cause adverse effects in poisonings.

Competency standards (2016) addressed: 1.1, 1.3, 1.4, 1.5, 2.2, 3.1

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.

Toxicity occurs when the dose of a pharmaceutical passes a point above which it causes adverse effects.¹ These adverse effects may occur on a predictable continuum (e.g. respiratory depression increases with opioid dose increase), or occur only once a threshold has been passed (e.g. liver toxicity with paracetamol overdose).¹

The major toxicity from a given pharmaceutical is usually seen in only one or two target organs, which may not necessarily be the site of initial exposure or highest concentration.^1,2 Some pharmaceuticals are only toxic when they have been transformed to chemically reactive entities as part of normal metabolic activity.^1,2

Pharmaceutical poisoning in Australia

This article focuses on poisoning by pharmaceuticals to provide specific information to pharmacists about substances they are likely to deal with in their usual practice.

In Australia, Poisons Information Centres (PICs) receive calls from the public and health professionals seeking advice about exposure to poisons. They are physically located in New South Wales, Queensland, Victoria and Western Australia, and use a referral system to provide a national 24-hour service (see Figure 1).³

[caption id="attachment_14518" align="alignright" width="250"]

Figure 1 – National poisons information hotline. Reference: NSW Poisons Information Centre4[/caption]

In 2015 Australian PICs received calls related to nearly 165,000 poisoning exposure events involving more than 1,800 different substances.³ Although not all poisonings result in a call to a PIC, these calls include both actual and suspected poisoning, and broadly indicate the pharmaceuticals that are commonly involved in poisoning.^3,5

Six of the 10 most frequent classes of substances reported to PICs in 2015 across all age groups were pharmaceuticals. These, along with the most common substance reported in each class, are listed in Table 1.³ A similar list is seen in more recent annual reports from the individual state PICs.^6–9

In 2015, 64.4% of reported exposures to PICs were unintentional, 18.1% were related to medication errors, and 10.7% involved deliberate self-poisoning. The circumstances of exposure varied across age groups (see Table 2).

Table 1 – Frequently reported pharmaceuticals to Poisons Information Centres in 2015

Pharmaceutical classes involved in calls to PICs (% of total exposures)	Most common substance(s) in this class (% of exposures within each class)
Paracetamol-containing analgesics (10.2)	Paracetamol (80.4)
Antidepressants (4.2)	Sertraline (15.0)
NSAIDs (3.9)	Ibuprofen (72.7)
Cardiovascular agents (3.4)	Beta-blockers (22.1), including metoprolol (7.4)
Sedatives (2.9)	Benzodiazepines (83.2), including diazepam (45.5)
Antipsychotics (.27)	Quetiapine (54.2)

PICs = Poisons Information Centres References: Huynh, et al³

The number of deaths (1,391 in the 12 months to 30 June 2017) associated with poisoning by pharmaceuticals in Australia is small compared to the number of calls received by PICs (more than 16,000).^10–12 The majority of these involved narcotics and hallucinogens (see Table 3).^11,13

Many of these deaths involved more than one of these substances. Most people (about 73%) who died from unintentional poisoning by pharmaceuticals were 30–54 years old.¹¹

In the same time period there were 3,039 deaths by suicide in Australia, of which 401 (around 13%) involved poisoning with ‘drugs, medicaments or biological substances’ (see Table 3).¹¹ The most common pharmaceuticals involved include benzodiazepines and antidepressants. Non-opioid analgesics, including paracetamol and NSAIDs, were also implicated (see Table 3).¹¹

Consideration of the different circumstances and substances involved in pharmaceutical poisoning in different populations can help pharmacists provide tailored advice regarding safe use of medicines for individuals.¹⁴ Further information about individual pharmaceuticals commonly associated with poisoning is described below. The treatments mentioned are intended as summaries of key points which may be of interest to pharmacists. The referenced source material should be consulted for details.

Table 2 – Circumstances of exposures across age groups

Age groups (years)	Circumstance of exposure
Children (0–14)	Mostly unintentional
Adolescents (15–19)	Mostly deliberate self-poisoning
Adults (20–74)	Medication errors, unintentional and deliberate self-poisoning
Older adults (>74)	Medication errors

References: Huynh, et al,³ Huynh, et al⁵

Paracetamol

Paracetamol is one of the most common drugs involved in poisoning worldwide, in part due to its perceived safety, widespread use and accessibility.^15–17 It is commonly involved in both unintentional and intentional poisonings for all age groups and is the most common cause of acute liver failure in Australia.^{3,5,11,15–17} Hospitalisations for paracetamol overdose have risen over the past two decades.^15–17

At therapeutic doses, paracetamol is metabolised in the liver and generally eliminated without causing toxicity. In overdose however, the relative contribution of a usually minor CYP1A2 pathway increases, where paracetamol is oxidised to the electrophilic N-acetyl-p-benzoquinone imine (NAPQI) intermediate, which is then conjugated with glutathione and eliminated.¹ If glutathione becomes depleted, NAPQI accumulates and binds to cellular proteins causing centrilobular necrosis and liver damage.¹

Signs and symptoms of paracetamol poisoning include abdominal pain, nausea and vomiting from acute liver injury, kidney impairment and mild coagulopathy. In more severe cases, hypoglycaemia, severe coagulopathy, metabolic acidosis and hepatic encephalopathy from liver failure and death can occur.^17–20

In acute poisoning, the toxic dose is 10 g (or 200 mg/kg if under 50 kg) as a single dose of either immediate or modified-release formulations.^17–20

In repeated dose poisoning (supratherapeutic dosing), the toxic dose is 10 g (or 200 mg/kg if under 50 kg) over 24 hours, or 12 g (or 300 mg/kg if under 40 kg) or more over 48 hours.^17–20

Therapeutic doses of 60 mg/kg (up to 4 g) daily over several days can be toxic in some circumstances, especially in people with reduced glutathione stores.^17,18 Contributing factors include dehydration, advanced age, comorbidities affecting liver function, alcohol use, poor nutritional status, concurrent medications (especially CYP1A2 inducers) and genetic predisposition.^17,18

All people with suspected acute intentional paracetamol poisoning or suspected ingestion of a toxic dose of paracetamol should be referred to hospital for assessment.¹⁸

The antidote acetylcysteine (or N-acetylcysteine, NAC) is effective when given promptly, preventing hepatotoxicity in most cases if given within 8 hours of an acute ingestion.¹⁸ There are well-established hospital treatment protocols for intravenous NAC administration, which vary depending on time since ingestion, acute versus repeated supratherapeutic ingestion, and immediate versus modified-release preparations. Serum paracetamol and serum ALT are measured to determine the need for and duration of treatment.^17–20

Activated charcoal is sometimes given to remove unabsorbed solid-dose paracetamol after recent (2–4 hours) ingestion of immediate-release formulations, or within 4 hours of ingestion of modified-release preparations.¹⁸

Table 3 – Deaths and associated pharmaceuticals

Reason for exposure	Pharmaceutical	Number of deaths
Unintentional poisoning	*Narcotics and hallucinogens*
	Heroin*	399
	Methadone	212
	Other opioids	402
	*Other pharmaceuticals*
	Benzodiazepines	581
	Antidepressants	337
Intentional poisoning	*Drugs, medicaments or biological substances*
	Benzodiazepines	196
	Antidepressants	182
	Non-opioid analgesics (e.g. paracetamol, NSAIDs)	92

*Heroin is classified as a pharmaceutical in the International Statistical Classification of Diseases and Related Health Problems, Revision10 References: AIHW,¹¹ WHO¹³

NSAIDs

NSAIDs, particularly ibuprofen, are commonly associated with poisoning in children and adolescents.^3,5,11 NSAID poisoning rarely causes hospitalisation or death; most poisonings are asymptomatic and resolve spontaneously without requiring supportive treatment.^21,22Aspirin poisoning is treated separately as salicylate poisoning.^21,23

Toxicity is a consequence of excessive inhibition of the COX-1 enzyme.²¹ Most exposures result in mild gastrointestinal symptoms, such as nausea, vomiting and epigastric discomfort.^21,22 Large exposures can result in severe toxicity, including acute renal impairment and subsequent metabolic acidosis, seizures (associated with mefenamic acid), neurological symptoms (e.g. drowsiness, confusion, nystagmus, blurred vision, diplopia, headache and tinnitus), and coma.^21,22 Acute renal impairment can be exacerbated by existing renal and cardiovascular disease, or hypovolemia from vomiting or concurrent alcohol ingestion.²²

Acute doses of ibuprofen less than 100 mg/kg are likely to be asymptomatic.²¹ Severe toxicity is generally seen at doses more than 400 mg/kg.^22,24,25

There is no antidote for NSAID poisoning. Treatment is primarily observation and support for specific symptoms if they occur.^22,24,25 Activated charcoal is sometimes given after recent (2 hours) massive overdoses.²²

Quetiapine

Quetiapine is commonly involved in poisoning in adolescents and adults.^3,5,11It is approved in Australia for treating schizophrenia and bipolar disorder. Quetiapine is also prescribed off-label for other psychiatric conditions, such as treatment-resistant depression and generalised anxiety disorder, which are associated with an increased risk of intentional poisoning.²⁶

Quetiapine is an atypical antipsychotic, antagonising serotonin receptors and to a lesser extent dopaminergic, histaminic, muscarinic and peripheral alpha1-adrenoreceptors.^27,28 The features of poisoning include anticholinergic activity (tachycardia, delirium, urinary retention), peripheral vasodilation and hypotension, increased QT interval, CNS and respiratory depression with loss of airway protection and rarely seizures.^27–29

In children, 25 mg may be toxic and doses greater than 100 mg may be associated with severe toxicity.^27,28

In adults, acute doses of 10 mg/kg are significant, and more than 2 g of immediate-release quetiapine increases risk of toxicity, especially coma.^27-29Doses of more than 3 g are associated with significant CNS depression and hypotension.^27-29

The toxic dose for modified-release quetiapine is not known. Symptoms have delayed onset (up to 12 hours, compared to up to 6 hours for immediate-release preparations) and are prolonged (up to 72 hours).^27-29

There is no specific antidote and treatment is supportive, as required, depending on the symptoms. Supportive care includes intubation, ventilation and intravenous fluid resuscitation.^27–29

Activated charcoal is sometimes given to remove unabsorbed quetiapine after recent (2 hours) ingestion of immediate-release formulations, or within 4 hours of ingestion of modified-release preparations.²⁷

Benzodiazepines

Diazepam and temazepam are commonly associated with both intentional and unintentional self-poisoning in adolescents and adults, and are commonly involved in accidental and suicide poisoning deaths.^3,5,11,30 Intentional poisoning often involves other pharmaceuticals and/or alcohol.^3,5,11,30

When taken alone in overdose, usually only mild to moderate CNS and respiratory depression occurs, with a ceiling on the CNS effect despite increased exposure.^30–32 Features of toxicity include drowsiness, ataxia and slurred speech. Large overdoses may cause hypotension, bradycardia and hypothermia.^30–32 When taken with other CNS depressants, deep coma, significant respiratory depression and death may occur.^30–32

The toxic dose varies widely due to tolerance. Acute doses of 1–4 times the maximum daily dose may cause significant CNS depression in benzodiazepine-naive patients, whereas dependent patients may have few adverse effects with 10–50 times the daily dose.³⁰ Co-ingestion with other CNS depressants significantly amplifies toxicity and is a common scenario leading to death.^30–32

Treatment is usually supportive, including airway protection, intubation and ventilation if required. Decontamination with activated charcoal is not indicated because of the rapid onset of sedation in poisoning.^30–32

The antidote flumazenil is not commonly used as it can precipitate withdrawal in dependent people, cause seizures and unmask arrhythmias.^30–32

Treatment of toxicity from co-ingested substances is also important.^31,32

SSRIs

Antidepressants are commonly associated with intentional and unintentional poisoning.^3,5,11 The most common antidepressants reported in poisoning exposures to PICs are SSRIs, specifically fluoxetine in children and adolescents, and sertraline in adults.^3,5

SSRI poisoning is usually benign, sometimes with nausea, vomiting and drowsiness.^34,35 A more serious acute serotonergic toxidrome (i.e. serotonin syndrome) may occasionally occur in massive overdoses, or if taken in combination with other serotonergic substances, with symptoms of neuromuscular excitation, hyperthermia and altered conscious state.^33–35

Acute doses greater than 300 mg of escitalopram or 600 mg of citalopram are associated with QT interval prolongation.^33,34 Doses of 50 times the daily dose of other SSRIs have been reported to cause no severe adverse effects.^33–35

Treatment is supportive, with specific treatment for hypotension, serotonergic toxidrome and arrhythmias if they occur.^33–35 Activated charcoal may be used for toxic doses of citalopram and escitalopram within 4 hours of ingestion, and for massive overdoses of other SSRIs if ingestion is recent (2 hours).³³

Cardiovascular agents

Cardiovascular agents are a large group of medicines with a wide range of mechanisms of action and toxicity. Poisoning is mainly reported in adults (20–74 years) and older adults (>74 years).^3,5

The most commonly reported cardiovascular agents involved in poisoning are beta-blockers; the most common among these is metoprolol.^3,5

Different beta-blockers have different toxicities, and metoprolol is considered relatively less toxic than propranolol and sotalol.^36,37

The effects of beta-blocker poisoning are related to their action on beta-receptors, including bradycardia, hypotension, heart block, bronchospasm and hypo- or hyperglycaemia.^36,37 Toxicity is increased if an individual has reduced cardiovascular reserve.³⁶ Ingestion with other cardiovascular agents can increase the risk of cardiac toxicity.^36,37 Further, propranolol can cause QRS widening, and sotalol can cause QT-interval prolongation, both of which can cause life-threatening cardiovascular toxicity.^36,37

Ingestion of more than 2 g of propranolol is associated with seizures, delirium and coma due to its lipophilicity.^36,37 Modified-release metoprolol may cause delayed toxicity.^36,37

Treatment of beta-blocker poisoning may require intubation and ventilation, especially if cardiac function is unstable or consciousness is reduced.^36,37 Activated charcoal is sometimes given after recent (2 hours) ingestion of immediate-release formulations, or within 4 hours of ingestion of modified-release metoprolol.^36,37 Intravenous fluid resuscitation, atropine, adrenaline or isoprenaline, and high-dose insulin euglycaemia therapy, may be used to restore circulation.^36,37 Intravenous glucose can be used for seizure control, which is presumed to be caused by intracellular glucose depletion.^36,37

Opioids

Opioids, mainly heroin and methadone, are the most common cause of unintentional drug-related death in Australia, often in combination with other substances.^11,38 Oxycodone is the most common opioid reported in calls to PICs, mostly in adults and older adults.^3,5,11 Opioids are also commonly associated with poisoning-related suicide deaths.¹¹

Poisoning causes respiratory and CNS depression by agonising mu2-receptors.^38–40 Methadone, oxycodone and loperamide poisoning can also cause QT-interval prolongation and torsades de pointes.^38,39 Nausea, vomiting and constipation can also occur.^38–40

Toxic effects are dose-dependent but vary widely due to tolerance.^38,39 Opioid-naive people may experience toxic effects with small doses, especially if co-ingested with other sedating substances. Long-acting opioids can cause delayed and prolonged toxicity.^38,39 Methadone can be fatal to children in small amounts.^38,39

Treatment includes airway and breathing support and use of the antidote naloxone. Activated charcoal may be used within 2 hours if immediate-release formulations have been ingested or 6 hours where modified-release formulations are involved.^38–40

Naloxone is a competitive opioid receptor antagonist used to reverse hypoventilation and increase a person’s ability to protect their airway.^38–41 Protocols exist for intramuscular or intranasal administration by non-medically trained people in the community (e.g. friends and family) and for intravenous administration in hospital.^38–42 Pilot programs are currently underway in some Australian states to assess the benefits of supplying free naloxone to people at high risk of opioid overdose, and to people likely to witness an overdose.^41,43

Knowledge to practice

Pharmacists in many practice settings can respond to reports and questions about poisoning, especially by using and promoting the services of PICs.

Pharmacists should promote the safe use of pharmaceuticals as a core part of their practice. Consideration should be given to populations, circumstances and specific medicines associated with increased risk of accidental and deliberate poisoning.

Pharmacists may use key aspects of pharmacy practice to reduce the risk of poisoning by pharmaceuticals, including⁵:

education of patients and caregivers on the correct use of high-risk medicines
education of patients and caregivers on the appropriate storage of high-risk medicines
consideration of less-toxic alternatives to, or ceasing, high-risk medicines as appropriate
minimisation of the quantity of high-risk medicines available to people at risk of poisoning through the use of small pack sizes, supervised dosing or staged supply.

Conclusion

Pharmacists are the custodians of medicines and have an important role in ensuring their safe and appropriate use. Knowledge of the substances and populations most likely to be associated with poisoning, either intentional or unintentional, can help to provide individualised information and support to minimise the risk of harms.

Key points:

All suspected poisonings should be reported to a Poisons Information Centre, where advice should be sought.
Paracetamol is the most common pharmaceutical involved in calls to Poisons Information Centres in Australia.
SSRIs, ibuprofen, cardiovascular agents, diazepam and quetiapine are other common pharmaceuticals involved in poisonings.
Opioids, especially heroin and methadone, are the pharmaceuticals most commonly involved in poisoning deaths in Australia, followed by benzodiazepines and antidepressants.
Timely assessment of poisonings in hospital can be lifesaving and is important to determine the supportive and specific treatment requirements.

References

Klaassen CD, Watkins JB. Casarett & Doull’s Essentials of Toxicology. 3rd ed. McGraw Hill. 2015.
National Institutes of Health. Environmental Health and Toxicology Information. ToxTutor. 2018. At: https://toxtutor.nlm.nih.gov/02-004.html
Huynh A, Cairns R, Brown JA, et al. Patterns of poisoning exposure at different ages: the 2015 annual report of the Australian Poisons Information Centres. Med J Aust 2018;209:74–9.
NSW Poisons Information Centre. 2021. At: www.poisonsinfo.nsw.gov.au/
Huynh A, Cairns R, Brown JA, et al. Patterns of poisoning exposure at different ages: the 2015 annual report of the Australian Poisons Information Centres. Med J Aust 2018;209:74–9. Appendix.
New South Wales Poisons Information Centre. 2013 Annual Report. At: www.poisonsinfo.nsw.gov.au/site/files/ul/data_text12/4918535-NSWPIC_Annual_Report_2013.pdf
Queensland Poisons Information Centre. Annual Report 2019. At: www.childrens.health.qld.gov.au/wp-content/uploads/PDF/poisons/annual-reports/2019.pdf
Victorian Poisons Information Centre. Annual Report 2018. At: www.austin.org.au/Assets/Files/VPIC%20Annual%20Report%202018.pdf
Western Australian Poisons Information Centre. Annual Report 2018. At: www.scgh.health.wa.gov.au/en/Our-Services/Service-directory/~/media/C4F4785903EF491A9846217DCC8EADE3.ashx
AIHW. Injury in Australia: accidental poisoning. 2021. At: www.aihw.gov.au/reports/injury/accidental-poisoning
AIHW 2019: Henley GE & Harrison JE. Trends in injury deaths, Australia, 1999–00 to 2016–17. Injury research and statistics series no. 127. Cat. no. INJCAT 207. Canberra: AIHW.
AIHW 2016: Pointer S. Poisoning in children and young people 2012–13. Injury research and statistics series no. 97. Cat. no. INJCAT 173. Canberra: AIHW.
WHO. International Statistical Classification of Diseases and Related Health Problems 10th Revision. At: https://icd.who.int/browse10/2010/en
Sansom LN, ed. Managing poisoning. Australian pharmaceutical formulary and handbook online. 2021. At: https://apf.psa.org.au/health-information/poisoning/managing-poisoning
Cairns R, Brown JA, Wylie CE et al. Paracetamol poisoning-related hospital admissions and deaths in Australia, 2004–2017. Med J Aust 2019;211(5):218–223.
NPS. Rates of paracetamol overdose continue to rise in Australia. 2019. At: www.nps.org.au/news/paracetamol-overdoses-rise
Chiew AL, Reith D, Pommerlau A et al. Updated guidelines for the management of paracetamol poisoning in Australia and New Zealand. Med J Aust Guideline Summary 2019;1–9.
Paracetamol Poisoning. In eTG complete online. Melbourne: Therapeutic Guidelines; 2020. At: https://tgldcdp.tg.org.au/viewTopic?topicfile=toxicology-paracetamol-primary-care
Perth Children’s Hospital. Poisoning – Paracetamol. 2018. At: https://pch.health.wa.gov.au/For-health-professionals/Emergency-Department-Guidelines/Poisoning-Paracetamol
The Royal Children’s Hospital Melbourne. Paracetamol poisoning. 2021. At: www.rch.org.au/clinicalguide/guideline_index/Paracetamol_poisoning/
Hunter LJ, Wood DM, Dargan PI. The patterns of toxicity and management of acute nonsteroidal anti-inflammatory drug (NSAID) overdose. Open Access Emerg Med 2011;3:39–48.
Nonsteroidal anti-inflammatory drug (NSAID) poisoning. In eTG complete online. Melbourne: Therapeutic Guidelines; 2020. At: https://tgldcdp.tg.org.au/viewTopic?topicfile=toxicology-NSAID
Perth Children’s Hospital. Poisoning – Salicylate. 2018. At: https://pch.health.wa.gov.au/For-health-professionals/Emergency-Department-Guidelines/Poisoning-Salicylate
The Royal Children’s Hospital Melbourne. Nonsteroidal anti-inflammatory drug NSAID poisoning. 2019. At: www.rch.org.au/clinicalguide/guideline_index/Nonsteroidal_Anti-inflammatory_Drug_NSAID_poisoning/
Austin Health. Clinical toxicology guidelines: Non-steroidal anti-inflammatory drugs (NSAIDs). 2019. At: www.austin.org.au/Assets/Files/NSAIDs%20guideline_SG%20final.pdf
Rossi S, ed. Quetiapine. Australian medicines handbook online. Adelaide: Australian Medicines Handbook; 2021. At: https://amhonline.amh.net.au/chapters/psychotropic-drugs/antipsychotics/quetiapine
Quetiapine poisoning. In eTG complete online. Melbourne: Therapeutic Guidelines; 2020. At: https://tgldcdp.tg.org.au/viewTopic?topicfile=toxicology-quetiapine
The Royal Children’s Hospital Melbourne. Quetiapine Poisoning. 2019. At: www.rch.org.au/clinicalguide/guideline_index/Quetiapine_Poisoning/
Austin Health. Clinical toxicology guidelines: Quetiapine. 2019. At: www.austin.org.au/Assets/Files/Quetiapine%20guideline%202019%20SG%20Final.pdf
Benzodiazepine poisoning. In eTG complete online. Melbourne: Therapeutic Guideline; 2020. At: https://tgldcdp.tg.org.au/viewTopic?topicfile=toxicology-benzodiazepine
The Royal Children’s Hospital Melbourne. Benzodiazepine poisoning. 2019. At: www.rch.org.au/clinicalguide/guideline_index/Benzodiazepine_poisoning/
Austin Health. Clinical toxicology guidelines: Benzodiazepines and the “Z drugs”. 2019. At: www.austin.org.au/Assets/Files/Benzodiazepines_V2_FINAL.pdf
Selective serotonin reuptake inhibitor (SSRI) poisoning. In eTG complete online. Melbourne: Therapeutic Guidelines; 2020. At: https://tgldcdp.tg.org.au/viewTopic?topicfile=toxicology-SSRI
Austin Health. Clinical toxicology guidelines: Selective serotonin reuptake inhibitors (SSRIs). 2020. At: www.austin.org.au/Assets/Files/SSRI%20guideline%20Final%202020[1].pdf
The Royal Children’s Hospital Melbourne. Selective serotonin re-uptake inhibitors SSRIs poisoning. 2017. At: www.rch.org.au/clinicalguide/guideline_index/Selective_serotonin_re-uptake_inhibitors_SSRIs_poisoning/
Beta-blocker poisoning. In eTG complete online. Melbourne: Therapeutic Guidelines; 2020. At: https://tgldcdp.tg.org.au/viewTopic?topicfile=toxicology-beta-blocker
Austin Health. Clinical toxicology guidelines: Beta blockers. 2018. At: www.austin.org.au/Assets/Files/Beta%20Blockers%20guideline_ZK%20revision_July%202018.pdf
Opioid poisoning: general management. In eTG complete online. Melbourne: Therapeutic Guidelines; 2020. At: https://tgldcdp.tg.org.au/viewTopic?topicfile=toxicology-opioid-general
Austin Health. Clinical toxicology guidelines: Opioids (not including tramadol & tapentadol). 2020. At: www.austin.org.au/Assets/Files/Opioids%20(not%20including%20Tramadol%20&%20Tapendatol)%20Guideline_Final%20SG%202020.pdf
The Royal Children’s Hospital Melbourne. Management of the paediatric patient receiving opioids. 2018. At: www.rch.org.au/rchcpg/hospital_clinical_guideline_index/Management_of_the_paediatric_patient_receiving_opioids/
NPS. Naloxone spray (Nyxoid) for opioid overdose. 2020. At: www.nps.org.au/radar/articles/naloxone-nasal-spray-nyxoid-for-opioid-overdose
The Penington Institute. COPE – Overdose first aid. 2019. At: www.penington.org.au/cope-overdose-first-aid/
Australian Government Department of Health. Take home naloxone pilot. At: www.health.gov.au/initiatives-and-programs/take-home-naloxone-pilot

BEN GILBERT BPharm, GradCertHigherEd, GradDipTox, MPS is a community pharmacist with experience in pharmacy business ownership, university teaching and research, and working with developing countries to strengthen their medical supply chains.

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Poisoning with common pharmaceuticals

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Case scenario

One of your regular patients, Angela, 43, comes to see you. She has just seen her doctor about some redness and cracking at the corners of her mouth, which has been present for 3–4 days. Her doctor has told her that it is called ‘angular cheilitis’ and that she should buy some antifungal cream to treat it.

You are aware that Angela is taking iron supplements and also has coeliac disease. She is not taking any other medicines, has no other medical conditions, and is not pregnant or breastfeeding.

Learning objectives

After successful completion of this CPD activity, pharmacists should be able to:

Describe the presenting symptoms and management of angular cheilitis
Discuss differential diagnoses and when referral is required
Explain how pharmacists can translate knowledge into practice when managing patients with angular cheilitis.

Competency standards (2016) addressed: 1.1, 1.3, 1.5, 2.3, 3.2, 3.5

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.

Introduction

Angular cheilitis is a common condition that presents as redness or maceration at the corners of the mouth.^1,2 It is an inflammatory condition, and often has a fungal and/or bacterial cause.^1–3 Angular cheilitis may also be known as angular stomatitis, angulus infectiosus, cheilosis or perleche (perlèche).^2,4 As primary healthcare professionals, pharmacists are often asked about different dermatological conditions.⁵ Pharmacists need to be able to diagnose angular cheilitis, advise patients on causes and treat and/or refer as appropriate.

What are the causes?

Angular cheilitis often has an infectious cause. Infective organisms include Candida albicans, Staphylococcus aureus and Streptococcus.^3,6 It is also often associated with intra-oral candidiasis.³

A number of factors may contribute to angular cheilitis, although it may also occur spontaneously (see Box 1).⁴ It is more common in elderly patients due to an overhanging upper lip. This causes skin folds, which allows saliva to accumulate, leading to a constant moist environment and skin irritation from the saliva.⁷ A receding jawline and poorly fitting dentures may also cause angular cheilitis and promote secondary bacterial or candida infections.⁷

What are the risk factors?

Angular cheilitis is common and affects both children and adults (although it is more common in the elderly).^2,7 While it may develop spontaneously, it is more common in those who wear dentures or other oral appliances.⁶ Small children who dribble excessively, suck their thumbs, lick their lips, bite the corners of their mouth or use dummies can also develop the condition.^6,10 People with other medical conditions and who have poor health in general are at higher risk of angular cheilitis.² See Box 2 for risk factors for angular cheilitis.

There have been a number of case reports of angular cheilitis occurring in patients with COVID-19.¹² Angular cheilitis has also been seen in healthcare workers during the COVID-19 pandemic due to increased use of personal protective equipment.¹²

Box 1 – Causes of angular cheilitis

Dermatitis
Poor-fitting dentures
Vitamin B deficiency (B₂, B₃, B₆, B₉ or B₁₂)
Iron or zinc deficiency
Excessive saliva causing eczematous cheilitis (a type of contact irritant dermatitis)
Reduced saliva production causing cracking and desquamation
Dry, chapped lips
Excessive licking of lips
Overgrowth of bacteria, yeasts or viruses
Overhanging upper lip causing skin folds
Contact allergies.

References: Rossi,¹ Oakley,²Lugović-Mihić,⁴ Devani,⁶ Bear,⁷ Stoopler,⁸ Mowad⁹

What are the symptoms?

Angular cheilitis is an inflammatory condition. It often presents as irritation, redness and skin maceration at the corners of the mouth, usually bilaterally.^1,6–9,13Dry lips are often present.⁶ There may be cracks, skin fissures, ulcers or blisters, which can be painful.^2,6 Patients may describe a burning sensation in the area where the lesions are.⁶ Bleeding, oozing or crusting of the sores may also occur.^2,8 Crusting may suggest a bacterial infection with Staphylococcus aureus.¹

Angular cheilitis may last for several days or be an ongoing condition depending on the cause.² It may be recurrent, particularly in older patients.⁷ Fungal or bacterial infection may potentially progress to cause more widespread infection on nearby skin or elsewhere in the body.² Licking the lips worsens symptoms.²

The severity of pain with angular cheilitis can range from no pain to severe discomfort.⁸ Pruritis may also be present.⁸

How is it diagnosed?

In the majority of cases, diagnosis is based on clinical examination and taking a patient history.^6,8 Patient history should include^4,6:

symptom duration and any previous treatments tried
dental status (e.g. use of dentures or other oral appliances)
oral hygiene practices
whether the patient has a tendency to lick or bite their lips/corners of their mouth
any change to saliva production (e.g. amount of saliva produced)
other medical conditions (e.g. anaemia, conditions causing immunodeficiency, other dermatological and allergic conditions such as eczema)
any medicines the patient is taking
smoking status
lifestyle habits (e.g. chewing tobacco, alcohol consumption)
exposure to cold, hot, windy or dry weather conditions
occupation.

Patients with angular cheilitis caused by Candida should also be assessed for oral candidiasis, as these two conditions may co-present. Symptoms of oral candidiasis include white patches in the mouth, redness, soreness, burning in the mouth and loss of taste.^8,14

Patients using dentures or other oral appliances are more likely to be colonised with Candida, while patients who regularly use face masks are more likely to have Staphylococcus aureus colonisation.⁶ Swabs taken from angular cheilitis may identify any infectious causes (e.g. Candida albicans, Staphylococcus aureus, herpes simplex).² Skin biopsies are not usually required.²

Box 2 – Risk factors for angular cheilitis

Oral thrush (e.g. in infants and the elderly, those using corticosteroids or antibiotics)
Dentures (especially if they are ill-fitting and there is gum recession)
Poor oral hygiene
Smoking
Using face masks regularly (e.g. for work)
Nutritional deficiencies (e.g. coeliac disease, iron deficiency, riboflavin, vitamin B12 or zinc deficiencies)
Other medical conditions (e.g. ulcerative colitis, Crohn’s disease, malignancies, bulimia, anorexia nervosa, Sjögren syndrome)
Skin sensitivity (e.g. atopic dermatitis)
Down syndrome
Medicines (e.g. isotretinoin, acitretin, antiretroviral medicines, inhaled corticosteroids)
Immunosuppression (e.g. chemotherapy treatment, diabetes, patients living with HIV)
Children who frequently lick their lips and suck their thumbs
Frequent mouth washing and flossing teeth roughly
Older age
Winter months

HIV = human immunodeficiency virus References: Oakley,² eTG,³ Lugović-Mihić,⁴ Devani,⁶ Bear,⁷ College of Dental Hygienists of Ontario¹¹

Differential diagnoses

Most cases of angular cheilitis can be easily identified, however some cases may present similarly to other conditions.⁶Other conditions to exclude include herpes labialis, secondary syphilis, erosive lichen planus, contact dermatitis and actinic cheilitis.^4,6,8 Taking a detailed history of the condition, including symptom duration, any previous treatment used, and whether symptoms are recurring, will assist in differentiating angular cheilitis from other conditions.⁶

When to refer

Patients should be referred when a definitive diagnosis cannot be made by the pharmacist, when the patient is unresponsive to treatment, or where a prescription medicine is indicated.^3,8 Patients with underlying medical conditions that may contribute to angular cheilitis should also be referred. ^3,6,8

If a dental cause is suspected (e.g. poorly fitting dentures), patients should be referred for a dental review.³

How is it managed?

Treatment of angular cheilitis will depend on the cause. In many cases, it is a self-limiting condition and will resolve on its own; however, in other cases, prolonged treatment may be required.^2,7 Treatments used may include²:

lip balm or other emollient ointment

lopical antiseptics
lopical or oral antibiotics
lopical or oral antifungal medicines
lopical corticosteroid ointment
nutritional supplements
filter injections or implants
botulinum toxin to clear lines/wrinkles.

For idiopathic causes, using a barrier ointment may be sufficient to resolve the condition.⁶ If a bacterial or fungal infection is suspected, the causative infectious organism should be confirmed to ensure the most appropriate treatment.⁴ If there are any precipitating factors causing the condition (e.g. hypersalivation, poorly fitting dentures, dry mouth), these should be treated and managed.^4,9

Antifungal treatment

Topical azole antifungals are the recommended initial treatment for angular cheilitis with a fungal cause. Recommended treatments are³:

First-line – clotrimazole 1% cream applied topically to the corners of the mouth twice daily for at least 14 days. Treatment should be continued for at least 14 days after symptoms clear.
Second-line – miconazole 2% cream applied topically to the corners of the mouth, twice daily for at least 14 days. Treatment should be continued for at least 14 days after symptoms clear.

[caption id="attachment_14475" align="alignright" width="207"]

Images: DermNet NZ[/caption]

Topical clotrimazole and miconazole are generally well tolerated.¹ They may infrequently cause burning, stinging, itching or redness, and rarely allergic contact dermatitis.¹ Patients should be counselled that for the treatment to be successful, it needs to be applied regularly.¹ Topical azoles will generally not cause drug interactions; however, occasionally topical miconazole may be absorbed in a sufficient amount to interact with other drugs.¹ Azoles inhibit CYP3A4, and miconazole also inhibits CYP2C9.¹ Azoles may reduce the metabolism of warfarin and increase its anticoagulant effect and bleeding risk. If this combination is used, INR should be monitored and warfarin dose reduced where needed.¹ The Australian Medicines Handbook advises that this interaction can occur with the use of topical products such as miconazole or econazole.¹ The product information for miconazole oral gel contraindicates its use in combination with warfarin.¹⁵

To relieve any inflammation, hydrocortisone 1% cream may be applied, in addition to topical azole antifungals, twice daily to the corners of the mouth until the inflammation clears.³ If a combination product containing both an antifungal and corticosteroid is used, this should only be used until the inflammation clears. Treatment should then continue with a topical antifungal alone for 14 days after symptoms clear.³

Adverse effects associated with topical corticosteroids include folliculitis, skin atrophy, striae, depigmentation, acneiform eruptions, and infrequently allergic contact dermatitis.¹

If oral candidiasis is also present, this should be treated with appropriate antifungal treatment (see ‘Oral candidiasis’, Australian Pharmacist, September 2021).

Antibacterial treatment

If Staphylococcus aureus infection is present, topical treatment with mupirocin applied to the corners of the mouth may be used.⁶ Hydrocortisone cream 1% may also be used in addition to mupirocin to treat the inflammation.⁶

Mupirocin cream is indicated for infected small skin lesions.¹ It is generally applied three times a day for a maximum of 10 days.¹ Mupirocin may cause localised skin reactions, such as itch, burning, erythema, stinging, pain or swelling.¹Avoid contact with eyes and mouth.¹

The Australian Medicines Handbook recommends avoiding the use of topical sodium fusidate as its oral form is effective against methicillin-resistant Staphylococcus aureus (MRSA). Using sodium fusidate topically can promote antimicrobial resistance.¹ It may however be prescribed for staphylococcal skin infections if other options are unsuitable.¹ It is applied 2–3 times a day for 7 days. Infrequently, a rash, contact dermatitis, itch, burning or irritation may occur with its use.¹ Contact with eyes should be avoided.¹

Other management strategies

Strategies to limit saliva coming into contact with the skin should be recommended. Using lip balms during the day and petroleum jelly or another barrier cream at night can protect the skin.^7,9A hydrocortisone ointment in conjunction with an antifungal cream may reduce recurrence.⁷ If dentures are worn, they should be kept clean and removed at night.⁷

Patients should use a new toothbrush once treatment has commenced for an infectious cause to avoid re-infection.⁸If patients do not respond to treatment, further investigations should be undertaken to identify any underlying causes.⁶ This includes haematological screening to measure haemoglobin, mean corpuscular volume, folate, vitamin B₁₂, iron, ferritin, transferase, and fasting blood glucose levels.⁶ A dental review is important if dental or denture-related causes are contributing to angular cheilitis.³ Any predisposing factors (e.g. other medical conditions, nutritional deficiencies) should also be identified and managed.³

What is the prognosis?

The prognosis of angular cheilitis is usually positive. In most cases, the condition will respond to appropriate treatment. However, recurrence is common if the underlying cause(s) are not identified and appropriately managed.⁷

How can it be prevented?

Preventing further recurrences of angular cheilitis should focus on addressing and managing underlying or contributing factors (e.g. malnutrition, diabetes).⁷Patients using inhaled corticosteroids should ensure they rinse their mouth out with water afterwards to remove any residual medicine.⁶ Other strategies to reduce recurrence include ensuring properly fitting dentures, avoiding irritants, ensuring proper salivation and addressing any structural abnormalities.⁶ Good oral hygiene should also be encouraged.⁶

Knowledge to practice

Pharmacists can support patients with suspected or confirmed angular cheilitis by taking a thorough patient history. Based on these responses, pharmacists can advise patients on appropriate management and treatment, strategies to prevent recurrence, or refer for further medical review as required. Supporting patients with potential underlying causes by ensuring adherence to medicines and supplements, and by providing lifestyle advice for chronic conditions, is also important.

Conclusion

Angular cheilitis is a common condition that can occur in people of all ages, although it is most commonly seen in older people. It usually presents as redness and skin maceration at the corners of the mouth, and cracks, fissures, ulcers or blisters can develop. A number of factors can increase the risk of developing angular cheilitis, including poor oral hygiene, poorly fitting dentures, nutritional deficiencies, other medical conditions and skin sensitivity. Management focuses on treating any infectious cause (fungal or bacterial) and addressing any underlying causes. Pharmacists should advise patients on available treatments and refer where required.

Case scenario continued

You recommend clotrimazole 1% cream to be applied twice a day to the corners of her mouth. You advise that it must be used regularly to be effective, and continued for 2 weeks after the symptoms clear. She can also use a lip balm for her lips and corners of her mouth to protect from excess moisture.

Angela mentions that the doctor has referred her for a blood test to check her iron and other blood levels. You advise her that nutritional deficiencies can increase the risk of developing angular cheilitis, and reinforce the importance of having the blood tests and seeing her doctor for the results afterwards.

Key points:

Angular cheilitis, an inflammatory condition, presents as irritation, erythema and skin maceration at the corners of the mouth; cracks, ulcers or blisters may also be present.
Potential causes or risk factors of angular cheilitis include oral thrush, poorly fitting dentures, nutritional deficiencies, immunosuppression and using face masks regularly.
Diagnosis is based on clinical examination and taking a patient history.
Management of angular cheilitis is multifaceted depending on potential causes or underlying medical condition.

Further information

Therapeutic Guidelines: Oral and Dental has information on the management of angular cheilitis: www.tg.org.au

DermNet NZ: Angular cheilitis provides an overview of angular cheilitis, including causes and potential treatment options, and also has photos of how angular cheilitis may present: https://dermnetnz.org/topics/angular-cheilitis/

References

Rossi S, ed. Australian medicines handbook. Adelaide: Australian Medicines Handbook; 2021.
Oakley A. Angular cheilitis. 2010. At: https://dermnetnz.org/topics/angular-cheilitis/
eTG Complete. Melbourne: Therapeutic Guidelines; 2021.
Lugović-Mihić L, Pilpović K, Crnarić I, et al. Differential diagnosis of cheilitis – how to classify cheilitis? Acta Clin Croat 2018;57(2):342–51.
Tucker R. Community pharmacists’ perceptions of the skin conditions they encounter and how they view their role in dermatological care. Int J Pharm Pract 2012;20(5):344–6.
Devani A, Barankin B. Dermacase. Angular cheilitis. Can Fam Physician 2007;53(6):1022–3.
Bear L. Angular cheilitis. 2016. At: www.dermcoll.edu.au/atoz/angular-cheilitis/
Stoopler ET, Nadeau C, Sollecito TP. How do I manage a patient with angular cheilitis? J Can Den Assoc 2013;79:d68.
Mowad C. Cheilitis. 2021. At: www.uptodate.com/contents/cheilitis
Atlanta Women’s Obstetrics & Gynecology. Angular cheilitis. 2020. At: https://awog.org/womens-health/health-library/?DOCHWID=sta123239
College of Dental Hygienists of Ontario. Angular cheilitis. 2014. At: www.cdho.org/Advisories/CDHO_Factsheet_Angular_Cheilitis.pdf
Riad A, Kassem I, Issa J, et al. Angular cheilitis of COVID-19 patients: a case-series and literature review. Oral Dis 2020;10.1111/odi.13675.
Gupta S. Mucosal candidiasis clinical presentation. 2020. At: https://emedicine.medscape.com/article/1075227-clinical
Centers for Disease Control and Prevention. Candida infections of the mouth, throat, and esophagus. 2021. At: www.cdc.gov/fungal/diseases/candidiasis/thrush/index.html
Johnson & Johnson Pacific. Product information – Daktarin oral gel. Ultimo: Johnson & Johnson Pacific; 2020.

NAOMI WEIER BPharm(Hons), GradCertPharmPract, GradDipClinEd, MClinPharm, CertIV TAE, AACPA, MPS is a pharmacist and PhD candidate. She has experience working in community pharmacy, private hospitals, undertaking Home Medicines Reviews, and has previously worked as a pharmacist in PSA’s Knowledge Development team. Naomi currently works in Aboriginal health and as a tutor for the University of Tasmania’s School of Pharmacy and Pharmacology.

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Angular cheilitis

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Case scenario

Frederick, 64, has type 2 diabetes and hypertension. He requests treatment for worsening reflux and mentions he has been drinking more lately. You agree that alcohol can cause and worsen reflux symptoms, and you obtain his consent to ask a few questions about his alcohol use.

Frederick tells you he drinks 2–4 cans of beer on most days and more on Friday nights. He doesn’t describe any withdrawal effects when he doesn’t drink, nor are there any red flags associated with his reflux symptoms. When you ask him how he feels about his alcohol use, he tells you it has increased more than he would like, especially during lockdown.

Learning objectives

After successful completion of this CPD activity, pharmacists should be able to:

Define alcohol dependence
Explain the management options of alcohol dependence
Explain the pharmacist’s role when managing patients with alcohol dependence

Competency standards (2016) addressed: 1.1, 1.4. 1.5, 2.2, 3.1, 3.5

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.

Introduction

Alcohol is the drug most commonly used by Australians, with 1 in 4 Australians aged 14 or older drinking at harmful levels at least monthly.¹ More than 2%, or 1 in 50 Australians are estimated to be alcohol dependent, making alcohol dependence the most common drug problem in Australia.²

So what is alcohol dependence? There are various classification systems and terms used to define alcohol dependence. According to the World Health Organization’s International Classification of Diseases, now in its 11th revision (the ICD-11), alcohol dependence is ‘a disorder of regulation of alcohol use arising from repeated or continuous use of alcohol’, with the characteristic feature being a strong drive to use alcohol.³

The US Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), uses similar concepts but defines a spectrum of alcohol use disorder from mild to severe depending on the number of symptoms, defined as ‘a problematic pattern of alcohol use leading to clinically significant impairment or distress’.

Tolerance is defined as needing to drink a larger amount for the same effect, or the same amount having a lesser effect.⁴ Alcohol tolerance is associated with an upregulation of the enzymes that break down alcohol, the alcohol dehydrogenases.⁵

Epidemiology and risk factors for alcohol dependence

Like all substance use disorders, alcohol dependence is frequently a chronic remitting and relapsing health condition, though often those with less severe disorders will resolve their alcohol dependence without formal help.⁶ There are genetic, psychological, social and environmental contributors to developing alcohol dependence, and chronic alcohol use can also lead to changes in the brain that make cessation challenging.⁷ Risk factors for developing alcohol dependence include drinking larger amounts over a long period of time, alcohol consumption from an early age, family history, mental health problems, a history of trauma and other social factors that may promote alcohol consumption.^4,8

Alcohol withdrawal severity can range from mild (headache, anxiety, agitation, tremor, disturbed sleep, palpitations and sweating), to severe and potentially life threatening (seizures, persistent vomiting, extreme agitation, autonomic instability, confusion, paranoia and delirium), making careful assessment and planning for withdrawal critical.⁹ Patients should be advised not to cease alcohol suddenly without medical support if they have been drinking larger quantities for a long period of time, especially if they describe tolerance and withdrawal symptoms.⁴

The onset of withdrawal symptoms can begin within 6–24 hours from the last drink, peaking after 2–3 days and subsiding after around 1 week.^10,11

Box 1 – Audit-C questionnaire

1 How often do you have a drink containing alcohol?

A Never (0)

B Monthly or less (1)

C 2–4 times a month (2)

D 2–3 times a week (3)

E 4 or more times a week (4)

2 How many standard drinks containing alcohol do you have on a typical day?

A 1 or 2 (0)

B 3 or 4 (1)

C 5 or 6 (2)

D 7 to 9 (3)

E 10 or more (4)

3 How often do you have six or more drinks on a single occasion?

A Never (0)

B Less than monthly (1)

C Monthly (2)

D Weekly (3)

E Daily or almost daily (4)

A score of 4 or more for men and 3 or more for women indicates risky drinking, with a higher score considered to indicate higher-risk drinking.

Diagnosis and assessment

To meet the criteria for ICD-11 alcohol dependence, there are three broad features, which are usually evident over a period of at least 12 months; however, if alcohol use is continuous over at least 3 months, a diagnosis may be made.^3,12 The three broad features are (1) impaired control over use, (2) alcohol becoming an increasing priority in life (over other responsibilities or personal care, or despite harm), and (3) physiological features of tolerance, withdrawal, and continued use despite harm.^3,12

The DSM-5 criterion for alcohol use disorder is the presence of at least two of the following symptoms occurring within a 12-month period: craving; persistent desire to cut down; use in larger amounts than intended; use leading to a failure to fulfil role obligations; considerable time spent obtaining, using or recovering from alcohol; continued use despite persistent physical or psychological problems; or continued use despite alcohol exacerbating social or interpersonal problems.

The DSM-5 alcohol use disorder diagnosis has sub-classifications of mild, moderate and severe, depending on the symptoms score: 2–3 is mild, 4–5 is moderate, ≥6 is severe.

In practice, these concepts are often simplified to conceptualise dependence or ‘addiction’ to the ‘Four Cs’: Compulsive use, Craving, Continued use despite harm, and loss of Control over use.

To identify likely alcohol dependence in the pharmacy setting, there are a number of brief screening tools that have been validated against these diagnostic criteria. One of the most widely used tools is the Alcohol Use Disorders Identification Test (AUDIT), which can identify hazardous and harmful alcohol use as well as possible dependence.¹³ This brief 10-item tool provides a score out of a possible 40, with a score of 8–15 indicating hazardous use, warranting simple advice focusing on reducing hazardous drinking; a score of 16–19 suggests the need for brief counselling combined with ongoing monitoring of alcohol use and harms; and a score of 20 or higher indicates the need for referral for further diagnostic assessment of dependence. The AUDIT test can be accessed at www.drugabuse.gov/sites/default/files/audit.pdf.

A briefer, 3-question, yet reliable tool is the AUDIT-C (See Box 1).^14,15 Answers are allocated a score according to response, and these are added up to give a result out of 12. Scores of 4 or more in men and 3 or more in women are considered a positive screen for risky or hazardous use. This should trigger a review of recent alcohol use patterns to evaluate the likelihood of more severe dependence requiring medical assessment and management. Where the three questions indicate hazardous use, using the full AUDIT may help determine the need for referral.

Another common screening approach is to use the CAGE tool,⁹ which comprises four yes/no questions (see Box 2). Two or more ‘yes’ answers are likely to indicate alcohol dependence, and a need for referral for assessment and possible treatment.

The AUDIT, AUDIT-C and the CAGE are well validated screening tools used in primary care settings.^17–19

There are good reasons for pharmacists to ask about alcohol use. We now know that alcohol use contributes to cancer, with greater consumption associated with greater risk.^20,21 This is in addition to increased risks of injury and falls, effects on mental health, and the development of other medical conditions. For these reasons, the National Health and Medical Research Council guidelines now recommend drinking no more than 10 standard drinks a week, and no more than 4 standard drinks on any one occasion.²⁰ There is no safe level of alcohol consumption during pregnancy, nor in those under 18 years of age.²⁰ Additionally, alcohol use can contribute to poor sleep, anxiety and gastritis, all of which may lead to presentations in the pharmacy and requests for non-prescription medicines.

These risks are in addition to pharmacodynamic and pharmacokinetic interactions that influence the absorption, distribution, metabolism and excretion of medicines and/or alcohol.²²These interactions can increase the likelihood of adverse effects with commonly used medicines such as nonsteroidal anti-inflammatories, increase the risk of liver toxicity with paracetamol, increase the risk of sedation with opioids and increase the risk of falls. Acute alcohol use can also increase availability of warfarin, risking haemorrhage, and enhance the effects of insulin, risking hypoglycaemia. These are just a few examples of how alcohol can complicate management of a range of chronic conditions that make discussions on alcohol use in the pharmacy a key part of pharmacy practice.

Long-term alcohol dependence can result in severe and persistent effects on cognition through direct effects on the brain (e.g. negative effects on the brain and memory) and indirect effects (e.g. thiamine deficiency). Severe cases of thiamine deficiency can cause Wernicke–Korsakoff syndrome, which affects coordination, memory, and can cause psychoses.²³

Liver dysfunction, including cirrhosis, is another common long-term effect of alcohol dependence.²⁴ In people with regular alcohol use and dependence, type-2 diabetes, cardiovascular disease and neurological problems are also common.²⁰ Compared with the general population, people with alcohol use disorders have substantially increased risk of death. A systematic review showed a more than 10-fold risk for death from liver cirrhosis and mental disorders, a 7-fold risk for a fatal injury, and double the risk for cardiovascular and cancer deaths.²⁵

Box 2 – CAGE questionnaire

1 Have you ever felt you should Cut down on your drinking?

2 Have people Annoyed you by criticising your drinking?

3 Have you ever felt bad or Guilty about your drinking?

4 Have you ever had a drink first thing in the morning to steady your nerves or get rid of a hangover (Eye-opener)?

Management

Treatment for alcohol dependence often involves management of acute withdrawal symptoms in the short term and pharmacotherapies to support abstinence or reduced drinking in the longer term.

Often the first step in treating alcohol dependence is medically managed alcohol withdrawal. Alcohol withdrawal can be managed in a range of settings, with a careful clinical assessment required to determine the optimal setting.

Many patients with mild to moderate alcohol withdrawal symptoms can be managed in an outpatient setting. However, some patients will require inpatient management. This includes patients with a history of withdrawal seizures, severe symptoms of withdrawal delirium, and other substance-dependent or medical comorbidities that may complicate withdrawal management.⁴ Additionally, patients without a safe and supportive home environment should be managed in an inpatient setting.⁴

Benzodiazepines are the first-line treatment for alcohol withdrawal, and when commenced early can prevent severe complications, such as seizures and withdrawal delirium.²⁶ When benzodiazepines for alcohol withdrawal are required in an outpatient setting, patient safety concerns need to be considered. For this reason, staged supply (e.g. daily dispensing) is often used to help prevent overuse and over-sedation if taken in combination with alcohol. Staged supply is often used in combination with daily assessment of alcohol intoxication and withdrawal symptoms to mitigate risks.

Many services have their own policies and procedures for the management and treatment of alcohol withdrawal, including the use of the Alcohol Withdrawal Scale (AWS) and the Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar)²⁷to assess withdrawal symptoms, and a protocol for either fixed-dose benzodiazepines or symptom-triggered dosing.

Other features of complex alcohol withdrawal include psychotic symptoms, agitation, delirium and dehydration.²⁸

As long-term alcohol use often results in thiamine depletion, intravenous thiamine is often initiated at the same time (200–900 mg intravenously or intramuscularly daily for 3–5 days; the required dose is dependent on risk factors and symptoms; these will also determine the duration), with longer-term oral thiamine (100–300 mg daily) also recommended.^28,29

Acamprosate and naltrexone can be used following acute withdrawal to support abstinence. Acamprosate and naltrexone reduce alcohol craving and disrupt the reward pathways.²⁸ Naltrexone, an opioid antagonist, should not be used in people who are opioid dependent or use opioids for pain relief.²⁸

Disulfiram, an aversive medicine, causes flushing, nausea and vomiting when alcohol is consumed, by blocking aldehyde dehydrogenase. Disulfiram is used second-line in relapse prevention.²⁸ There are various safety considerations with disulfiram, including ensuring alcohol withdrawal is complete before commencing, and consideration of liver toxicity. Disulfiram is commonly used with supervised administration, as the evidence for effectiveness outside supervised dosing is limited.²⁸

Where there is suspected nutritional deficiency, supplementation with multivitamins, zinc and magnesium may be considered.²⁸ Magnesium supplementation may assist with muscle rigidity and cramping if there is magnesium deficiency.

In addition to pharmacological management, there are various important psychosocial aspects to consider. Individual psychological approaches such as CBT to address behavioural and thinking patterns that might contribute to ongoing alcohol use are effective, in addition to developing strategies to manage triggers and cravings.³⁰ Group approaches such as smart recovery and peer support groups can also provide crucial support to people in the long term, and assist patients after any acute management of alcohol withdrawal is complete.³¹

Knowledge to practice

When talking to patients, one way to raise alcohol use is to discuss its relevance to the management of other chronic diseases. For example, alcohol use can complicate the clinical outcomes for common conditions such as diabetes and cardiovascular disease.^32,33 When responding to requests for non-prescription medicines such as proton pump inhibitors or medicines for insomnia or anxiety, it may also be useful to consider if alcohol use is contributing to the symptoms. Use of techniques like motivational interviewing to explore the patient’s potential reasons for change and support them in making these changes is recommended.

Brief interventions are appropriate for people with risky alcohol use, but are not effective or appropriate on their own for alcohol dependence. Motivational interviewing techniques can still play a role in supporting patients to make changes and follow up on referrals. Where you suspect a patient has developed tolerance and alcohol dependence, a referral for assessment and appropriate follow-up care is required.

When asking about alcohol use, use the 5 As approach of Ask, Assess, Advise, Assist and Arrange³⁴:

Ask if the patient would like to discuss alcohol use, and raise the topic in a way that normalises alcohol use. For example: ‘We now ask everyone about alcohol use, as it can have important effects on other aspects of your health. Would you mind if I ask you a few questions about your alcohol use?’
Assess using one of the validated tools described above.
Advise on the level of risk associated with current alcohol use.
Assist using motivational interviewing approaches to understand the patient’s reasons for change, and increase readiness to make those changes.
Arrange appropriate follow-up, whether that is a referral to a GP, or a plan to check in again with progress if there is no evidence of dependence. For low-risk drinking, simple advice such as being aware of risky drinking limits and suggesting strategies to reduce or quit can lead to meaningful reductions in alcohol use. At any point, if the patient indicates they do not want to talk about alcohol, it is important to respect their wish, yet welcome them to bring it up at any point in the future and make clear that you remain available to support them if they change their mind. Patient leaflets may assist in helping patients identify reasons for change.

Further information and a diagrammatic representation of this approach can be accessed at www.monash.edu/medicine/sphpm/general-practice/research-projects/reach.

If patients want to seek resources themselves, www.counsellingonline.org.au provides free 24-hour support (either online or via state-based telephone services though the site). This can enable patients to confidentially and anonymously seek advice, self-assessment, support and referral options, and to access online or telephone counselling.

Substance use, including alcohol dependence, carries an enormous stigma. Patients experience problematic alcohol use for an average of 18 years before seeking help.³⁵Often multiple supportive conversations are needed over time to develop readiness to access care. An individual interaction may not result in immediate change, yet the long-term and population-level effects of brief interventions are important. Pharmacists can play a crucial role by having regular conversations about alcohol use in a non-judgemental way and encouraging patients to access help sooner, reducing the potential severity of their dependence and health consequences.

Conclusion

Pharmacists can identify risky alcohol use and alcohol dependence, and facilitate patients to seek treatment. Discussing alcohol can be made relevant for patients in the context of common drug interactions, management of chronic conditions, broader health benefits of reducing alcohol, or in association with requests for non-prescription medicines. Uncomplicated alcohol withdrawal can be managed in outpatient settings, and a range of pharmacotherapy options are available to support patients in maintaining abstinence following withdrawal treatment.

Case scenario continued

Frederick’s AUDIT-C score indicates he is drinking at risky levels, but he is not likely to be dependent. You discuss the current NHMRC guideline recommendations and ask him what might help him cut down. Frederick feels that ‘grabbing a beer’ has become habitual, and he suggests going for a walk, substituting tea in the evenings, or stopping at one beer as possible strategies to break the habit. You discuss that alcohol is probably contributing to his reflux and may also be complicating his diabetes management. Frederick recognises the potential benefits of decreased alcohol use and agrees to check in with you next week.

Key points:

Alcohol dependence is a disorder of regulation of alcohol use arising from repeated and continuous use of alcohol.
1 in 4 Australians drink at risky levels at least once a month, and 1 in 50 are estimated to be alcohol dependent.
Management of alcohol withdrawal commonly involves benzodiazepines, and a range of pharmacotherapies including acamprosate, naltrexone and disulfiram are available to support longer-term relapse prevention.
Developing skills in motivational interviewing and experience in delivering brief interventions using the 5 As framework will support effective conversations to reduce harm around alcohol.

[cpd_submit_answer_button] References

Australian Institute of Health and Welfare. Alcohol, tobacco & other drugs in Australia. 2020. At: www.aihw.gov.au/reports/alcohol/alcohol-tobacco-other-drugs-australia/contents/drug-types/alcohol#consumption
Slade T, Johnston A, Teesson M, et al. The mental health of Australians 2. Report on the 2007 National Survey of Mental Health and Wellbeing. In: Department of Health and Ageing, ed. Canberra, 2009.
Saunders JB, Degenhardt L, Reed GM, et al. Alcohol use disorders in ICD-11: past, present, and future. Alcohol Clin Exp Res 2019;43(8):1617–31.
Drummond C. Alcohol-use disorder. BMJ Best Practice 2018.
Miller P. Biological research on addiction. Academic Press 2013.
Cunningham JA, McCambridge J. Is alcohol dependence best viewed as a chronic relapsing disorder? Addiction 2012;107(1):6–12.
Moussas G, Christodoulou C, Douzenis A. A short review on the aetiology and pathophysiology of alcoholism. Ann Gen Psychiatry 2009;8:10.
Tetrault JM, O’Connor PG. Risky drinking and alcohol use disorder: epidemiology, pathogenesis, clinical manifestations, course, assessment, and diagnosis. 2021. At: www.uptodate.com/contents/risky-drinking-and-alcohol-use-disorder-epidemiology-pathogenesis-clinical-manifestations-course-assessment-and-diagnosis
Weinhouse GL, Hoffman RS. Management of moderate and severe alcohol withdrawal syndromes. 2021. At: www.uptodate.com/contents/management-of-moderate-and-severe-alcohol-withdrawal-syndromes
Rossi S, ed. Australian medicines handbook. Adelaide: Australian Medicines Handbook; 2021.
Holt SR, Tetraut JM. Ambulatory management of alcohol withdrawal. 2020. At: www.uptodate.com/contents/ambulatory-management-of-alcohol-withdrawal
World Health Organization. International classification of diseases for mortality and morbidity statistics, 11th revision. 2019. At: https://icd.who.int/en
Babor T, Higgins-Biddle J, Saunders J, et al. The Alcohol Use Disorders Identification Test: guidelines for use in primary care, 2nd ed. World Health Organization, 2001.
Bradley KA, DeBenedetti AF, Volk RJ, et al. AUDIT-C as a brief screen for alcohol misuse in primary care. Alcohol Clin Exp Res 2007;31(7):1208–17.
Dawson DA, Grant BF, Stinson FS, et al. Effectiveness of the derived Alcohol Use Disorders Identification Test (AUDIT-C) in screening for alcohol use disorders and risk drinking in the US general population. Alcohol Clin Exp Res 2005;29(5):844–54.
Ewing JA. Detecting alcoholism: The CAGE questionnaire. JAMA 1984;252(14):1905–7.
Fiellin DA, Reid MC, O’Connor PG. Screening for alcohol problems in primary care: a systematic review. Arch Intern Med 2000;160(13):1977–89.
Bush K, Kivlahan DR, McDonell MB, et al. The AUDIT Alcohol Consumption Questions (AUDIT-C): An effective brief screening test for problem drinking. Arch Intern Med 1998;158(16):1789–95.
Bradley KA, DeBenedetti AF, Volk RJ, et al. AUDIT-C as a brief screen for alcohol misuse in primary care. Alcohol Clin Exp Res 2007;31(7):1208–17.
Australian Government. Australian guidelines to reduce health risks from drinking alcohol. National Health and Medical Research Council, Australian Research Council and Universities Australia. Commonwealth of Australia, Canberra, 2020.
Winstanley MH, Pratt IS, Chapman K, et al. Alcohol and cancer: a position statement from Cancer Council Australia. Med J Aust 2011;194(9): 479–82.
Johnson BA, Seneviratne C. Chapter 31 – Alcohol–medical drug interactions. In: Sullivan EV, ed. Handbook of Clinical Neurology: Elsevier 2014:543–59.
Zahr NM, Pfefferbaum A. Alcohol’s effects on the brain: neuroimaging results in humans and animal models. Alcohol Res 2017;38(2):183–206.
Osna NA, Donohue TM, Jr, Kharbanda KK. Alcoholic liver disease: pathogenesis and current management. Alcohol Res 2017;38(2):147–61.
Roerecke M, Rehm J. Cause-specific mortality risk in alcohol use disorder treatment patients: a systematic review and meta-analysis. Int J Epidemiol 2014;43(3):906–19.
Mayo-Smith MF. Pharmacological management of alcohol withdrawal: a meta-analysis and evidence-based practice guideline. JAMA 1997;278(2):144–51.
Sullivan JT, Sykora K, Schneiderman J, et al. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict 1989;84(11):1353–7.
Manning V, Arunogiri S, Frei M, et al. Alcohol and other drug withdrawal: practice guidelines, 3rd ed. Richmond: Turning Point, 2018.
Alcohol and other drug problems [Published 2013]. In: eTG complete. Melbourne: Therapeutic Guidelines; 2021.
WHO Mental Health Gap Action Programme. Psychosocial interventions for management of alcohol dependence. In: World Health Organization, ed, 2015.
Kelly JF, Humphreys K, Ferri M. Alcoholics Anonymous and other 12-step programs for alcohol use disorder. Cochrane Database of Systematic Reviews 2020. Issue 3.
Engler PA, Ramsey SE, Smith RJ. Alcohol use of diabetes patients: the need for assessment and intervention. Acta Diabetol 2013;50(2):93–9.
Mostofsky E, Chahal HS, Mukamal KJ, et al. Alcohol and immediate risk of cardiovascular events: a systematic review and dose-response meta-analysis. Circulation 2016;133(10):979–87.
Enliven Health Literacy Services. Alcohol and your health, 2020.
Chapman C, Slade T, Hunt C, et al. Delay to first treatment contact for alcohol use disorder. Drug Alcohol Depend 2015;147:116–21.

A/Prof SUZANNE NIELSEN BPharm, BPharmSc(Hons), PhD, MPS is the Deputy Director of the Monash Addiction Research Centre, and a registered pharmacist with extensive experience in addiction treatment and research, including working in community and specialist drug treatment services.

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Alcohol dependence

Because of the extremely poor taste of sodium benzoate, pharmacists are integral in compounding this oral liquid to improve its palatability.

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Introduction

Urea cycle disorders (UCD) are rare inherited metabolic disorders with an incidence estimated to be 1:35,000 births.¹ UCDs are caused by the dysfunction of any of the six enzymes (namely, carbamoyl phosphate synthetase I, N-acetylglutamate synthetase, ornithine transcarbamylase, argininosuccinic acid synthetase, argininosuccinate lyase, and arginase) or the two transport proteins (ornithine translocase and aspartate/glutamate carrier) involved in urea biosynthesis.^2,3The urea cycle converts the highly toxic ammonia produced from amino acid catabolism into urea, for excretion via the kidneys. A defect in urea synthesis results in hyperammonemia.²

Learning objectives

After successful completion of this CPD activity, pharmacists should be able to:

Explain the role of sodium benzoate in the management of urea cycle disorders
Explain the process required to compound sodium benzoate oral liquid
Describe the legal requirements for labelling of compounded medicines.

Competency standards (2016) addressed: 1.3, 1.4, 1.5, 3.4, 3.5

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.

UCDs are usually diagnosed in early childhood, however partial enzyme deficiencies can remain silent, until rare episodes of protein overload or increased catabolism can result in hyperammonemia.¹ Hyperammonemia risk is also increased in cases of prolonged fasting, surgery, trauma, pregnancy, or episodes of increased catabolism in infections such as gastroenteritis.¹ UCDs account for approximately 23% of acute hyperammonemia in critically ill children.⁴ For hyperammonemia caused by UCDs or increased ammonia plasma levels due to acute liver failure, the nitrogen (ammonia) scavengers, such as sodium phenylacetate and sodium benzoate, are key medicines for bypassing the urea cycle.^{3, 4}Phenylacetate (or its precursor, phenylbutyrate) binds with glutamine to generate phenylacetylglutamine, and sodium benzoate binds with glycine to form hippurate (Figure 1).³ These conjugates are then excreted in urine, thereby reducing ammonia plasma levels.^3-5

Preparation

Active pharmaceutical ingredient (API)

Sodium benzoate (C₆H₅.CO₂Na, molecular weight (MW) = 144.1 g/mol) (Figure 2), is a white or almost white, slightly hygroscopic, crystalline or granular powder. It is soluble in the following solvents: 1 in 2 of water, 1 in 75 of alcohol, and 1 in 50 of alcohol (90%).⁵

Soluble 1 in 50 means 1 g of solute (drug) will dissolve in 50 mL of solvent.

Sodium benzoate is well known as a preservative in pharmaceutical formulations, including oral preparations, due to its antibacterial and antifungal properties.⁵ The benzoates are also used as preservatives in foods, and are present naturally in some foods, and in cosmetics.⁵ The antimicrobial activity of sodium benzoate is due to the un-dissociated sodium benzoate and is pH-dependent, where it is relatively inactive above a pH of 5, due to the presence of the benzoate anion, which is unable to penetrate the bacterial cell wall (Figure 2).⁵

Sodium benzoate, for the treatment of UCDs, is not marketed in Australia but may be available through the Special Access Scheme.⁶ This active pharmaceutical ingredient (API) can therefore be sourced as pure powder and is suitable for preparation as an oral liquid, since it is absorbed from the gastrointestinal tract and rapidly excreted in the urine.⁵

Stability and palatability of sodium benzoate oral liquid

A 250 mg/mL sodium benzoate (API) oral liquid prepared with ORA-Sweet was shown to be stable (API above 96%) for 90 days, when stored in amber plastic prescription bottles at room temperature (23–25 °C).⁷ There were no detectable physical changes in the oral liquid throughout the 90-day study period.⁷ Similar stability results (94.5%, 93.0% and 93.7% of the initial API concentration remaining after 96 days) were achieved when sodium benzoate was dissolved in 40 mL of water, with and without the addition of 1 mL of flavour (no flavour, cherry, mint) and made up to volume with syrup (to 100 mL), to achieve a concentration of 200 mg/mL.⁸

Patient adherence often presents a challenge due to the odour and taste of sodium benzoate. Maines et al ⁸ prepared five differently flavoured oral solutions: cherry, cacao, vanilla, berries and mint. Mint was preferred by both adults and paediatric patients. This study also included a long-term follow-up of two paediatric patients with UCDs treated with the mint-flavoured formulation; both patients demonstrated good metabolic control and tolerability during the follow-up period.⁸

Excipients

ORA-Sweet was one of the original commercial vehicles available to pharmacists for preparing oral liquids. The formula for ORA-Sweet is available in the United States Pharmacopeia–National Formulary (USP–NF) as Vehicle for Oral Solution NF, and the ingredients are described in the latest edition of the Australian Pharmaceutical Formulary (APF 25), which states the pH of this vehicle is between 4–5.⁹

ORA-Sweet contains sucrose, glycerol, sorbitol, dibasic sodium phosphate, citric acid, potassium sorbate, methyl paraben and purified water.⁹ Due to the solubility of sodium benzoate in water,⁵ a suspending agent was not required. A number of commercial vehicles are available for pharmacists, such as Suspendit from the Professional Compounding Pharmacists of Australia (PCCA),¹⁰ Oral Mix from Medisca,¹¹ and the SyrSpend range from Fagron.¹² Contact your local supplier for appropriate vehicle options.

Formula, method and stability

The formula and method of preparation for sodium benzoate oral liquid (250 mg/mL) shown in Figure 3 is adapted from Atkins et al,⁷ which is prepared with pure API in ORA-Sweet and reported to be stable for 90 days, when stored in low-light conditions in amber, plastic prescription bottles at room temperature (23–25° C).

Figure 3 – Formula and method of preparation

SODIUM BENZOATE (250 mg/mL)

ORAL LIQUID (100 mL)

Sterile water (solvent) 50 mL

Sodium benzoate powder USP 25 g

ORA-Sweet (vehicle) to 100 mL

METHOD

Rinse all glassware and the final container with sterile water.
Weigh the API into a beaker of appropriate size.
Add the sterile water and mix until dissolved.
Transfer to a tared, child-resistant, amber prescription bottle.
Make up to the final volume with ORA-Sweet.
Shake well and label.

Packaging, storage and labelling

Compounded products must be prepared and dispensed in a manner that complies with legislative standards and ensures their quality, safety and efficacy.⁹ The APF provides a brief overview of compounded preparations, including references for important standards and guidelines.⁹ Pharmacists must use professional judgment to assess the potential risks to staff and the patient associated with preparing and dispensing a compounded product. The Professional Practice Standards has a compounding decision support and risk assessment tool for assessing risk that is available online (Appendix 7).¹³ Compounded products must be labelled in accordance with the relevant state or territory legislation, and should include the approved pharmacopoeial or APF name (where applicable), the name and quantity/concentration of all APIs and any preservatives used, the expiry date, storage details, directions for use and cautionary advisory labels.⁹ Pharmacists should use a systematic approach for quality assurance of compounding activities, using principles of good compounding practice. Processes and procedures should be reviewed regularly to identify areas for improvement and the resulting actions should be documented.⁹

Since the formula should be protected from light, amber prescription bottles with child-resistant caps are recommended. Contact your local supplier for packaging options. Oral syringes may be more suitable for infants and young children, whereas measuring cups are appropriate for older children.⁶ It is important that patients and carers are counselled on correct use, storage and appropriate disposal.⁹ The preparation should be stored out of reach of children and pets.

Box 2 – Cautionary advisory labels used for this preparation

Counselling for patients

In the preparation of compounded products, the pharmacist is guided by the professional standards and guidelines,⁹the prescriber and the needs of the carer and patient. Patient counselling and education may be adapted from CMIs available for commercial products,¹⁴or patient support groups such as Medicines for Children¹⁵ or the National Urea Cycle Disorders Foundation.¹⁶

Essential information should include:

Practice points, patient advice and counselling

Advice should be sought from a paediatric metabolic specialist.⁶ Dosing guidelines for acute hyperammonaemia and maintenance treatment provided in the AMH Children’s Dosing Companion are based on clinical experience and consensus opinion.⁶
Ensure adequate monitoring for adverse effects including hypokalaemia and nausea and vomiting.^{5, 6}
The risk of hyperbilirubinaemia may be increased in neonates,⁶ since benzoates can displace bound bilirubin from albumin.⁵
Due to the high sodium content, the preparation should be used with caution in children with heart failure, sodium-retention oedema or severe renal or hepatic impairment.⁶

Directions for use

Shake well before each use to ensure an accurate dose.⁹
Use the measuring device supplied (e.g. spoon, oral syringe, cup or dropper) to accurately measure the required dose. Do not use kitchen teaspoons to measure medicine as they are inaccurate and increase the risk of under‑ or overdosing.⁶
The oral liquid should be taken with or soon after food.^{6, 9} NPS MedicineWise produces a useful online resource for advice on how to use oral syringes –measuring liquid medicines for children (https://resources.amh.net.au/public/measuring-liquid-medicines.pdf).¹⁷
The preparation should be stored protected from light in a cool place, and kept away from children and pets.

Conclusion

A variety of medicines are commonly compounded by pharmacists in Australia. Compounding of a medicine is appropriate when there is no suitable and available commercial product or therapeutic alternative. In addition in the case of sodium benzoate oral liquid, because of the extremely poor taste of sodium benzoate, pharmacists have been integral in compounding this oral liquid to improve its palatability, to improve adherence in paediatric patients.⁸

Pharmacists involved in the compounding of medicines must ensure they comply with all relevant and applicable legislative requirements and ensure professional obligations are met.

Key points:

Urea cycle disorders are rare inherited metabolic disorders caused by an enzyme dysfunction.
Sodium benzoate is an ammonia scavenger and is a key medicine used to bypass the urea cycle and reduce ammonia plasma levels.
Sodium benzoate oral liquid may be compounded by pharmacists to meet specific patient needs where commercial products are not available or marketed in Australia.
Pharmacists should provide advice to patients about appropriate packaging and storage to ensure the stability of the sodium benzoate oral liquid.

[cpd_submit_answer_button] References

Silfverberg T, Sahlander F, Enlund M, et al. Late onset hyperornithinemia-hyperammonemia-homocitrullinuria syndrome – how web searching by the family solved unexplained unconsciousness: a case report. J Med Case Rep 2018;12(1):274.
Wang FS, Goh DLM, Ong HT. Urea cycle disorder presenting as bilateral mesial temporal sclerosis – an unusual cause of seizures: a case report and review of the literature. J Med Case Rep 2018;12(1):208.
Haberle J, Boddaert N, Burlina A, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet J Rare Dis 2012;7:32.
Savy N, Brossier D, Brunel-Guitton C, et al. Acute pediatric hyperammonemia: current diagnosis and management strategies. Hepat Med 2018;10:105–115.
Martindale: The complete drug reference (electronic resource). London: Pharmaceutical Press; 2021.
AMH. Australian Medicines Handbook Children’s Dosing Companion online. Adelaide: Australian Medicines Handbook Pty Ltd; 2021.
Atkins JR, Lull ME, Decker AS, et al. Stability of extemporaneously prepared sodium benzoate oral suspension. Int J Pharm Compd 2018;22(4):326–8.
Maines E, Urru SAM, Burri E, et al. Formulation and clinical evaluation of sodium benzoate oral solution for the treatment of urea cycle disorders in pediatric patients. AAPS PharmSciTech 2020;21(3):100.
Sansom L. N. ed. Australian pharmaceutical formulary and handbook, 25th ed. Canberra: Pharmaceutical Society of Australia; 2021.
PCCA SUSPENDIT. At: www.pccarx.com/products/PCCA-SUSPENDIT%C2%AE/30-4825/PROPRIETARYBASES
Medisca ORAL MIX. At: www.medisca.com.au/Pages/ProductDetails.aspx?StockCode=2512&C=B&C2=110
Fagron SyrSpend SF. At: https://au.fagron.com/en-au/concept/syrspendtm-sf
Pharmaceutical Society of Australia. Professional Practice Standards, Version 5, 2017. At: https://my.psa.org.au/s/article/Professional-Practice-Standards
AMMONUL. At: www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf
Medicines for Children. Sodium benzoate for urea cycle disorders. At: www.medicinesforchildren.org.uk/sodium-benzoate-urea-cycle-disorders
National Urea Cycle Disorders Foundation. Treatment options. At: www.nucdf.org/ucd_treatment.htm
NPS MedicineWise. Measuring liquid medicines for children. At: www.amh.net.au/resources/public/measuring-liquid-medicines.pdf

Dr ALISON HAYWOOD MPS is a Senior Lecturer at Griffith University’s School of Pharmacy and Medical Sciences.

Professor BEVERLEY GLASS FPS is a Professor of Pharmacy at James Cook University’s College of Medicine and Dentistry.

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Compounding sodium benzoate oral liquid for urea cycle disorders

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Introduction

Oral candidiasis, also known as oral candidosis or oral thrush, is an opportunistic infection of the oral cavity caused by the Candida species.¹ It is a common fungal infection of the oral cavity.² There are a variety of clinical presentations. It is often regarded as the ‘disease of the diseased’,^3–5 highlighting the opportunistic nature of the infection. Management is with antifungal medicines, however addressing any underlying or contributing factors is key to best care.

Learning objectives

After successful completion of this CPD activity, pharmacists should be able to:

Describe the presenting symptoms and management of oral candidiasis
Discuss differential diagnoses and when referral is required for presentations of oral candidiasis
Explain how pharmacists can translate knowledge into practice when managing patients with oral candidiasis.

Competency standards (2016) addressed: 1.1, 1.3, 1.5, 2.3, 3.2, 3.5

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.

The Candida spp. are the most common fungal pathogens isolated from the oral cavity and can be found in a large percentage of the population.⁶ C. albicans is isolated most frequently.⁶ Oral carriage of Candida spp. is generally asymptomatic and occurs in 35–80% of healthy individuals.⁷ Those with active carious lesions involving their dentition and people who smoke have been found to have higher carriage of oral Candida.¹⁰The presence of Candida alone is not indicative of pathology.¹⁰

Opportunistic infections can result in the presence of an underlying condition.¹⁰ This transition from harmless colonisation to pathogenic microorganisms is the result of the upset between the balance of host immune defences and fungal virulence factors.¹¹ While strain-specific phenotypic characteristics may give specific Candida strains advantages, it is the host’s immune competence that determines the outcome (i.e. clearance, colonisation or infection).^8,11 The prevalence of oral candidiasis is impacted by age and is more commonly seen in the very young or old.¹³There is no gender predilection.⁹ Superficial C. albicans infections are non-lethal (compared to systemic infections, which can be fatal).¹³

Oral candidiasis should be managed with antifungal therapy.¹⁶ Topical preparations are available as Pharmacist Only medicines. In moderate to severe cases, or if unresponsive to topical treatment, systemic antifungals may be necessary.¹⁶ It is important that there is treatment and proper management of any predisposing cause; recalcitrant cases should be referred to an oral medicine specialist (i.e. specialist dentist) or the patient’s general practitioner (GP) in a timely manner. Pharmacists need to provide advice on the appropriate use of antifungal medicines, identify potential drug interactions, and support patients in optimising their health.

Causes and risk factors

Of the Candida spp., the dimorphic yeast C. albicans is the most common and is generally regarded as the most virulent.⁶ Other members of the Candida genus (C. tropicalis, C. glabrata, C. parapsilosis, C stellatoidea, C. krusei and C. kyfer) are more frequently seen in people who are immunosuppressed, such as patients living with HIV/AIDS.⁶

Morphological changes (such as changing from budding yeast to filamentous forms) under different environmental conditions, and the ability for Candida to adhere to epithelial cells of human tissues, impact the organism’s virulence.⁴ Other pathogenic mechanisms that increase virulence include the expression of adhesins and invasins on the cell surface, thigmotropism, the formation of biofilms, phenotypic switching and the secretion of hydrolytic enzymes.¹³ The virulence factors of C. albicans underscore its ability to infect diverse host niches.^4,13

Risk factors

Risk factors for the development of oral candidiasis are numerous. Examples of local predisposing factors include poor oral hygiene, use of a prosthesis such as dentures, endogenous epithelial changes (e.g. from smoking), changes in the normal oral flora, and qualitative and quantitative salivary changes (e.g. hyposalivation).¹ Systemic risk factors include extremes of age, primary and secondary immunodeficiencies, nutritional deficiencies (e.g. iron, vitamin B6, magnesium), endocrine conditions (e.g. diabetes) and chemotherapy and radiotherapy.³ Other risk factors for candidiasis may include use of inhaled corticosteroids and oral medicines such as antibiotics.^14,16 Optimal management of predisposing factors is imperative for the management of candidiasis.¹

Figure 1 – Group I: primary oral candidiasis conditions

[caption id="attachment_14274" align="alignnone" width="1000"]

Images courtesy of Dr Amanda Phoon Nguyen[/caption]

Clinical presentation

Oral candidiasis can present in a number of ways. A proposed classification for oral candidiasis lesions divides the condition into two main groups^5,17:

Group I, or primary oral candidiasis refers to lesions localised to the oral cavity with no involvement of skin or other mucosae.
Group II, or secondary oral candidiasis, occurs when the lesions are present in the oral cavity as well as extraoral sites such as skin.

Primary oral candidiasis

This broadly, includes pseudomembranous (acute and chronic), erythematous (acute and chronic) and chronic hyperplastic candidiasis (see Figure 1).¹⁹

Candida-associated lesions under this classification include angular cheilitis, median rhomboid glossitis, denture-associated erythematous stomatitis (DAES) and linear gingival erythema.¹⁹

Secondary oral candidiasis

This includes chronic mucocutaneous candidiasis, a heterogenous group of syndromes. White plaques may be seen intraorally which become widespread, thick and adherent.²⁰

Acute pseudomembranous candidiasis presents as white flecks, plaques or nodules, which will usually wipe off with gauze. These are typically semi-adherent, leaving a red erythematous base when removed. Lesions are usually asymptomatic, though patients may sometimes complain of burning and dysphagia. It can occur anywhere on the oral mucosa.¹⁵

Chronic hyperplastic candidiasis may present as an adherent white plaque of variable thickness, usually asymptomatic, with an irregular surface texture. The most common sites include the buccal mucosa and tongue. Hyperplastic candidiasis may be associated with endocrinopathies and hairy leukoplakia. Chronic hyperplastic candidiasis may be potentially malignant and associated with a higher degree of dysplasia and malignancy, and a biopsy is usually mandatory.²¹

Erythematous candidiasis presents as raw-appearing lesions of the oral mucosa. Erythematous candidiasis, especially in the acute form, may occasionally be painful.³

Some conditions, such as denture stomatitis and median rhomboid glossitis,³ are known as Candida-associated conditions rather than an oral candidiasis, and Candida is not the only causative agent.⁵ These conditions are linked to the Candida species as well as other causes. Candida-associated conditions include³:

angular cheilitis, which are ulcerations and/or redness around the labial commissures. Painful cracks or fissures are seen at the corners of the lips, and these may be ulcerated, erythematous or bleeding
median rhomboid glossitis, which presents as an erythematous, diamond-shaped patch involving the mid-dorsal tongue
denture-associated erythematous stomatitis, which presents as inflammation in the denture-bearing area of the hard palate
linear gingival erythema, where there is erythema involving the marginal gingiva.

Angular cheilitis is a common condition. This is a multifactorial, inflammatory condition, commonly with an infectious origin, affecting the oral commissures for variable durations. It is estimated to affect up to 1% of the population. It affects both adults and children, with no gender predilection. The condition may be prevalent in groups where anaemia is a factor.⁵ Infectious organisms involved include Candida albicans, Staphylococcus aureus and Beta-haemolytic streptococci.²²

Figure 2 – An oral mucosal biopsy with Periodic acid-Schiff (PAS) stain showing the presence of candidal hyphae.

Diagnosis

Broadly, the diagnosis of oral candidiasis is generally based on clinical signs and symptoms, in conjunction with a thorough medical history and examination.³ Currently, there is no convincing evidence of a single test or method able to identify the transition from candidal colonisation to pathogenicity.²² A number of techniques can be used to isolate Candida within the oral cavity. These include the use of a smear, a plain swab, an imprint culture, collection of saliva, the concentrated oral rinse, and mucosal biopsy (see Figure 2).²³

The morphological changes of Candida under different environmental conditions may help explain some of the confusion surrounding the clinical utility of methods used to detect and confirm candidal infection in the oral cavity. The use of swabs for culture and microscopy is not necessarily able to discriminate the transition between candidal carriage and invasiveness in the oral cavity.²² The most correct methods of sampling and detection will therefore depend on the nature of the lesion being investigated.

Differential diagnosis

There are numerous other conditions that may be associated with oral symptoms similar to those of oral candidiasis. These should be considered as differential diagnoses and include:

traumatic causes, such as damage to tongue papillae. This may be because of mucosal disease, damage secondary to salivary gland hypofunction (such as radiotherapy, saliva problems, eating disorders, gastro-oesophageal reflux and dehydration)
conditions secondary to salivary gland disorders or immune-mediated conditions affecting the salivary glands, such as Sjogren’s syndrome
oral mucosal diseases, such as oral lichen planus
metabolic issues, such as nutritional deficiencies, diabetes, thyroid problems or hormone changes
medication-related adverse effects. For example, ACE inhibitors can cause oral burning
allergies, including reaction to dental materials or dentures
oral galvanism
systemic haematinic disorders, including vitamin B, iron or folate deficiency.

Referral

Pharmacists should refer patients with suspected chronic mucocutaneous candidiasis, if there is uncertainty of the diagnosis or if unable to exclude other differential diagnoses such as oral mucosal disease. They should also refer patients whose presentation persists beyond initial therapy, or if there is recalcitrant/recurrent disease.

Should there be failure of initial therapy, additional laboratory testing should be undertaken by the specialist, with careful consideration of any underlying systemic risk factors and potential for drug-resistant Candida strains.²⁵

Pharmacists should also refer patients who have underlying medical conditions contributing to oral candidiasis that are not being optimally managed.

TABLE 1 – Antifungal medicines for primary oral candidiasis

MEDICINE	DOSE	COMMENT
First line Miconazole 2% oral gel	Adults and children ≥2 years: 2.5 mL is topically applied, then swallowed, 4 times a day, after food, for 7–14 days Neonates and children <2 years: 1.25 mL is topically applied, then swallowed, 4 times a day, after feeding, for 7–14 days. Apply at the front of the mouth in small amounts to avoid choking Treatment should continue for 7 days after resolution of symptoms	Patients should be advised to place gel on the tongue and hold in the mouth for as long as possible before swallowing As the primary reservoir for oral Candida carriage, the tongue dorsum is often the initiating point of infection⁹
Second-line Amphotericin B lozenges	Adults and children ≥2 years: 10 mg lozenge is sucked, then swallowed, after food, for 7–14 days. Treatment should continue for 2–3 days after resolution of symptoms	Use with caution in patients with salivary gland hypofunction, as it is difficult to dissolve and the sucking action may further irritate the oral mucosa
Third-line Nystatin oral liquid 100,000 units/mL	Adults and children ≥2 years: 1 mL is topically applied, then swallowed, 4 times a day, after food, for 7–14 days. Treatment should continue for 2–3 days after resolution of symptoms Neonates and children <2 years: 1 mL is topically applied, then swallowed, 4 times a day, after feeding, for 7–14 days. Treatment should continue for 2–3 days after resolution of symptoms	Nystatin liquid contains sucrose. There may be a risk of dental caries The patient must not eat or drink directly after application as successful treatment requires an adequate contact time between the drug and oral mucosa

References: Vila,⁴ eTG¹⁶

Management

Management of an oral candidal infection is based on the differentiation of candidal lesions from other similar clinical presentations. The choice of antifungal treatment depends on the patient’s immunological status, presenting symptoms and anticipated adherence with the selected treatment.²⁵

Antifungal agents such as nystatin, amphotericin B or azoles are commonly used in the pharmacological management of oral candidiasis. They work by targeting ergosterol biosynthesis which interferes with cell wall permeability, leading to cell death.¹⁸ Azoles are fungistatic drugs, and this has led to the emergence of resistance.⁴ See Table 1 for treatment options.

Oral candidiasis should be managed with antifungal therapy¹⁶; there is a scarcity of robust evidence for complementary treatment options. Anti-Candida diets have been proposed. While high Candida abundance has been associated with the recent consumption of carbohydrates, there is a lack of supporting evidence for patients to be encouraged to adopt these diets.²⁴

Patients must be reminded to remove any prosthesis such as dentures when using topical antifungal therapy. Miconazole or nystatin are the treatments of choice for people with dentures.¹⁶ Miconazole oral gel may be applied directly to the fitting surface of dentures and should be used at least twice a day.¹⁶ Denture hygiene, such as removing nightly and appropriate cleaning, must also be reinforced.¹⁶Patients should be instructed to store dentures in a dry area overnight to reduce the risk of fungal colonisation.¹⁶ Nystatin contains sucrose, and should be used with caution in dentate patients with oral candidiasis, particularly for those with a history of radiation therapy, salivary gland hypofunction and/or a high caries risk.

For angular cheilitis, a Candida-associated condition, management includes assessment and management of any causative factors.¹⁶ A topical antifungal cream should be applied to the corners of the mouth; treatment should continue for 14 days after symptoms resolve.¹⁶ Recommended treatments include¹⁶:

clotrimazole 1% cream applied twice daily for at least 14 days
miconazole 2% cream applied twice daily for at least 14 days.

Topical application of 1% hydrocortisone cream can be used in addition to the antifungal cream until inflammation subsides.¹⁶ The patient may need to see their dentist for review of potential dental-related causes of angular cheilitis.¹⁶

Adverse effects

Adverse effects associated with nystatin include nausea, vomiting and diarrhoea, although these are generally more severe with higher doses.¹² Amphotericin B lozenges may infrequently cause mild nausea, vomiting or diarrhoea, while miconazole oral gel can cause mild gastrointestinal disturbances.¹²

Nystatin oral drops and miconazole oral gel are pregnancy category A and are considered safe to use in breastfeeding.¹² Amphotericin B is pregnancy category B3, and its risks and benefits should be considered. There is likely to be minimal infant exposure if amphotericin B lozenges are used in breastfeeding.¹²

Potential interactions

Both nystatin and amphotericin B are poorly absorbed through the oral mucosa, so drug interactions are rare.

Oral miconazole can be absorbed systemically through the oral mucosa and may cause clinically relevant drug interactions.¹² Miconazole inhibits CYP3A⁴ and CYP2C.⁹ The manufacturer of miconazole oral gel contraindicates its use with many drugs, including warfarin, medicines that prolong the QT interval (e.g. cisapride, quinidine, terfenadine), ergot alkaloids, HMG-CoA reductase inhibitors (e.g. simvastatin, lovastatin), triazolam and oral midazolam.¹²Pharmacists should check the product information to identify potential interactions and recommended management strategies accordingly.

Prevention

Preventive measures include encouraging the patient to have a healthy diet (including limiting sugar intake), reinforcing proper oral and denture hygiene, ensuring adequate hydration and rinsing the mouth out with water after using corticosteroid inhalers.¹⁶ It is also important that patients ensure they are using antifungal medicines correctly to properly treat any infection.

Knowledge to practice

Pharmacists can support patients with oral candidiasis by identifying cases and providing treatment where appropriate, or referring to another health professional for further review. Pharmacists also have an important role in educating patients, including counselling on the appropriate use of antifungal medicines, providing advice on preventing future episodes, and supporting patients in managing underlying medical conditions.

Further information

Therapeutic Guidelines: Oral and Dental contains information on oral candidiasis and treatment options. At: www.tg.org.au
www.healthdirect.gov.au/oral-thrush
www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-01809-3&d=202105031016933
www.aspenpharma.com.au/wp-content/uploads/PICMI/PI/PI_ MycostatinOralDrops.pdf

Conclusion

Oral candidiasis is a common fungal infection of the oral cavity. Diagnosis is typically through clinical examination and patient history. There are a variety of clinical presentations; diagnosis may be confusing. Oral candidiasis is often regarded as the ‘disease of the diseased’, highlighting the opportunistic nature of the infection. Careful consideration of any underlying or systemic contributors is imperative. Antifungals, with consideration to adverse effects and drug interactions, in addition to appropriate counselling from the pharmacist, are used to manage the condition. Pharmacists must also recognise when referral is required.

Key points:

Oral candidiasis is a common, opportunistic fungal infection of the oral cavity.
Oral candidiasis is more common in the very young or very old.
Miconazole, amphotericin B and nystatin are indicated for 7–14 days.

[cpd_submit_answer_button] References

Regezi JA, Sciubba JJ, Jordan RCK. Oral pathology: clinical pathologic correlations, 7th ed. Missouri: Elsevier; 2017.
Akpan A, Morgan R. Oral candidiasis. Postgrad Med J 2002;78(922):455–9.
Regezi JA, Sciubba JJ, Jordan RCK. Oral pathology: clinical pathologic correlations, 7th ed. Missouri: Elsevier; 2017.
Patil S, Rao RS, Majumdar B, et al. Clinical appearance of oral candida infections and therapeutic strategies. Front Microbiol 2015;6:1391.
Vila T, Sultan AS, Montelongo-Jauregui D, et al. Oral candidiasis: a disease of opportunity. J Fungi (Basel) 2020;6(1):15.
Samaranayake LP. Superficial oral fungal infections. Curr Opin Dent 1991;1(4):415–22.
McCullough MJ, Savage NW. Oral candidosis and the therapeutic use of antifungal agents in dentistry. Aust Dent J 2005;50(4 Suppl 2):S36–9.
Lewis M, Williams D. Diagnosis and management of oral candidosis. Br Dent J 2017;223:675–81.
Cannon RD, Holmes AR, Mason AB, at al. Oral candida: clearance, colonization, or candidiasis. J Dent Res 1995;74(5):1152–61.
Taylor M, Raja A. Oral candidiasis. StatPearls 2021. At: www.ncbi.nlm.nih.gov/books/NBK545282
Mun M, Yap T, Alnuaimi AD, et al. Oral candidal carriage in asymptomatic patients. Aust Dent J 2016;61(2):190–5.
Qin Y, Zhang L, Xu Z, et al. Innate immune cell response upon Candida albicans infection. Virulence 2016;7(5):512–26.
Rossi S, ed. Australian medicines handbook. Adelaide: Australian Medicines Handbook. At: amhonline.amh.net.au
Mayer FL, Wilson D, Hube B. Candida albicans pathogenicity mechanisms. Virulence 2013;4(2):119–28.
Campisi G, Panzarella V, Matranga D, et al. Risk factors of oral candidosis: a two-fold approach of study by fuzzy logic and traditional statistic. Arch Oral Biol 2008;53(4):388–97.
Mortazavi H, Safi Y, Baharvand M, et al. Oral white lesions: an updated clinical diagnostic decision tree. Dent J (Basel) 2019;7(1):15.
eTG Complete. Melbourne: Therapeutic Guidelines; 2021.
Axéll T, Samaranayake LP, Reichart PA, et al. A proposal for reclassification of oral candidosis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1997;84(2):111–2.
Lakhani P, Patil A, Majumdar S, et al. Challenges in the polyene- and azole-based pharmacotherapy of ocular fungal infections. J Ocul Pharmacol Ther 2019;35(1):6–22.
Singh A, Verma R, Murari A, et al. Oral candidiasis: an overview. J Oral Maxillofac Pathol 2014;18(Suppl 1):S81–S85.
Antachopoulos C, Walsh TJ, Roilides E. Fungal infections in primary immunodeficiencies. Eur J Pediatr 2007;166:1099–1117.
McCullough M, Jaber M, Barrett AW, et al. Oral yeast carriage correlates with presence of oral epithelial dysplasia. Oral Oncol 2002;38(4):391–3.
Manfredi M, Polonelli L, Aguirre-Urizar JM, et al. Urban legends series: oral candidosis. Oral Dis 2013;19(3):245–61.
Byadaahally Raju S, Rajappa S. Isolation and identification of Candida from the oral cavity. ISRN Dent 2011;2011:487921.
Hoffmann C, Dollive S, Grunberg S, et al. Archaea and fungi of the human gut microbiome: correlations with diet and bacterial residents. PLoS One 2013;8(6):e66019.
Farah CS, Lynch N, McCullough, MJ. Oral fungal infections: an update for the general practitioner. Aust Dent J 2010;55(Suppl 1):48–54.
Medical Director. AusDI. 2021. At: https://ausdi.hcn.com.au/drugInteractions.hcn#
Lewis, MAO, Williams DW. Diagnosis and management of oral candidosis Br Dent J 2017;223(9):675–81.

Dr AMANDA PHOON NGUYEN BDSc, MRACDS (GDP), DClinDent (OralMed), MRACDS (OralMed), Cert ADL, FOMAA, FPFA, FICD is an Oral Medicine Specialist in Perth, Western Australia. She is also a PhD candidate, Adjunct Senior Lecturer at University of Western Australia, and Consultant at Perth Children’s Hospital. Her expertise includes oral mucosal disease, orofacial pain, temporomandibular disorders, dental sleep medicine and paediatric oral medicine.

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Oral candidiasis

People

Valerie Constable is the joint recipient of the 2021 PSA Symbion Lifetime Achievement Award

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Over a combined 103 years, the joint recipients of this year’s Lifetime Achievement Award, Valerie Constable and the late John Ware, helped progress the pharmacy profession for the next generation.

The Pharmacists Support Service (PSS) recorded an 80% jump in calls last year, its team of volunteers speaking to pharmacists, interns and students seeking a listening ear during a particularly challenging time.

But if a distressed pharmacist rang the helpline 26 years ago, it would have been Valerie Constable’s voice on the end of the line.

It was 1995 when PSA’s Victorian branch received a letter from the Doctors’ Health Advisory Service (DHAS) saying it had been contacted by pharmacists asking for help, including one who ultimately died by suicide. While substance abuse was a big issue for doctors, pharmacists in Victoria were experiencing frequent robberies, and DHAS suggested PSA establish its own targeted support service.

Ms Constable, PSA’s first female President in Victoria, immediately saw the need for a helpline run by pharmacists, for pharmacists.

‘I felt quite strongly about it,’ she says of the initiative, the highlight of her career. ‘My family had experienced suicide and I knew what it did to people. So I put my hand up and said if anybody should do it, it should be PSA, because they represent all pharmacists. I took the calls for the first 2 years. It was seat-of-the-pants stuff, as there wasn’t another organisation in Australia to follow. Similar outfits in the UK and US were just getting started.'

Ms Constable proved there was demand for the service, and PSA Victoria provided ongoing funding. Over time, PSS expanded nationally, taking on more volunteers, developing a formal training program with Lifeline and bringing on Kay Dunkley FPS as CEO (its first paid employee). From 20 calls a year initially, PSS now handles about 10 calls a week and provides valuable, non-judgmental support to those in need.

In addition to leadership roles with PSA and establishing PSS, Ms Constable’s career was dedicated to community pharmacy. She met her husband Bob at the Victorian College of Pharmacy in the early 1950s, and spent 36 years living above their pharmacy in a former drapery store in Pascoe Vale South, about 10 kilometres north of Melbourne’s CBD.

Times are changing

Ms Constable says she would find pharmacy ‘very hard’ now. ‘I love being a pharmacist and have never wished to be anything else ... [But] it has become very stressful with lots of pressure, even more so in this pandemic,’ she says.

‘The main thing I always practiced and tried to teach our trainees was that every patient who leaves your pharmacy must feel you have done your very best to help them.’

‘I hope I have given something back to the profession I love.’

While PSS issues have changed over the years – bullying has become more prevalent, but there are fewer holdups – the service is just as relevant.

‘A big aim of the PSS is to alleviate stress and find a way around it. And having a pharmacist answer the phone each time is important, because they understand the situation – they’ve been there, done that,’ Ms Constable says.

‘I am confident that PSS will achieve even more in the future and I am proud of what has already been achieved. I hope I have given back something to the profession I love.’

What change in pharmacy in the past 2 years were you most excited about?

The change which most excited me was that Commonwealth and State governments publicly recognised the value of pharmacists’ expertise, experience and accessibility.

This is witnessed by the use of community pharmacists as vaccinators during the present COVID-19 pandemic.

What action in PSA’s Pharmacists in 2023 is the most important?

Action 4: Facilitate pharmacist prescribing within a collaborative care model. This will benefit pharmacists as well as the public and the government.

Lifetime Achievement Award joint recipient John Ware OAM

A community pharmacist for 40 years, John Ware FPS OAM posthumously received a Lifetime Achievement Award. He died in December 2020 aged 92.

[caption id="attachment_14340" align="alignright" width="254"]

John Ware OAM[/caption]

After graduating from the Victorian College of Pharmacy in 1950, Mr Ware operated pharmacies in Melbourne and rural Australia and served as PSA’s National President and President of the Victorian Branch, as well as President of the Western Pacific Pharmaceutical Forum and the International Pharmaceutical Federation (FIP) Foundation.

After his OAM in 2002, in 2006, Mr Ware became one of a small number of Australians to receive a Fellowship of the FIP and in 2014 received the FIP Distinguished Service Award.

He was remembered fondly by Professor Arthur Christopoulos, Dean of Monash University’s Faculty of Pharmacy and Pharmaceutical Sciences, and Victorian PSA President John Jackson.

‘He epitomised the professional pharmacist, improving care especially through education, collaboration and commitment to pharmacy organisations such as PSA and FIP,’ said Prof Christopoulos.

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How PSA’s 2021 joint Lifetime Achievement Award recipients led the way

Linda Badewitz-Dodd MPS is the Symbion PSA Pharmacist of the year

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From producing the world’s first comprehensive guide to drugs in sport to supporting her community through bushfires, and now the pandemic, Linda Badewitz-Dodd MPS is always willing to step up to the challenge.

A coal-face pharmacist who practices what she preaches. A pioneer. A community leader. These are just a few of the ways Ms Badewitz-Dodd’s peers describe her, and it’s easy to see why.

Her pharmacy in Merimbula on the New South Wales south coast, which she co-owns with business partner Tania Dwyer, provides a wide range of professional services with a focus on personalised support and care. During the 2019–20 bushfires, the pharmacy remained open, supplying face masks, essential medicines and emergency support to the community, while Ms Badewitz-Dodd dealt with the threat of fire to her own home in nearby Tathra.

‘When you live in a small town, your friends become your family,’ she says. ‘Ensuring the pharmacy stayed open and getting things for the community when it needed them was very rewarding. Helping people and accepting help (when you are accustomed to giving it) – that’s what defines community to me.’

A clinical start

Ms Badewitz-Dodd didn’t always aspire to life as a community pharmacist. After graduating from the University of Sydney in 1985, she did a post graduate diploma in hospital pharmacy as it ‘offered an avenue for specialties and to see closer at hand your knowledge being applied’.

She went on to work as a clinical pharmacist at Sydney’s Royal Prince Alfred Hospital, doing ward rounds with doctors and spending time in the intensive care, neurosurgery and neurosurgical intensive care units.

‘That was an amazing experience. It’s when I realised that we’re all here together for one purpose, and that’s looking after the patient … It shaped my belief in pharmacists being part of a team and able to contribute meaningfully.’

Drugs in sport

Before the 1990 Commonwealth Games in Auckland, Ms Badewitz-Dodd, by then Managing Editor of MIMS, wanted to include a`Permitted in Sport’ or `Not Permitted in Sport’ symbol in MIMS Bi-Monthly that clearly identified products that could be taken by athletes.

‘If you have an opinion, voice it. don’t be afraid to be wrong or to have the discussion – and know when not to accept a simple “no”.’

From then producing a handbook for athletes, coaches and sport management staff was a logical progression and resulted in the first edition of Drugs in Sport in 1990, she recalls.

‘A similar publication was produced for MIMS UK. Then the world was becoming digital and internationally there were “Live Drug Databases” which were the precursors to the Current Global DRO – a collaboration between numerous countries including the United States, Canada, the United Kingdom, Australia, Switzerland, New Zealand, Japan and others.’

Ms Badewitz-Dodd and the other pharmacists in the group manage the ingredients and she additionally manages the brands for Australia, Canada and New Zealand.

A seachange

Having her first child meant, sadly, stepping away from MIMS as, ‘nothing compared to being a mum’.

Ms Badewitz-Dodd continued her drugs in sport consultancy work, joined PSA’s NSW Branch Committee and presented Insight, a PSA education program (‘on cassettes!’).

Meanwhile, her husband David Dodd was working hard in his pharmacy at Eastwood, in Sydney’s north-west.

The long hours took its toll on the young family (the couple had children aged 2 and 4 at this point). They spent a few months travelling before moving to Tathra where they began working for local pharmacist Warren Seeto, who had been Ms Badewitz-Dodd’s first (and last) boss.

And while she continued to raise their children, Mr Seeto and Mr Dodd went into partnership – until his tragic death in 2013 when he was hit by a car.

‘When my husband was killed I inherited his half of the business, so I had to set up and become a community pharmacist,’ Ms Badewitz-Dodd says.

‘I was doing a bit of relieving around the place, but it was never my passion. It is now though,’ she says. ‘I think whatever you choose to do, if you don’t do it with passion, people can tell.’

Her advice for others is to be brave. ‘If you have an opinion, voice it. Don’t be afraid to be wrong or to have the discussion – and know when not to accept a simple “no”.'

What change in pharmacy in the past 2 years were you most excited about?

The drive to empower pharmacists to practice to their scope of practice is a game changer for me professionally. Recognition that pharmacists can and do provide services to our community, such as vaccinations and administration of IM and SC medicines, is well overdue. I am excited to see where this will take us.

What action in PSA’s Pharmacists in 2023 is the most important?

That is a difficult question as so many of the actions go hand in hand. But Action 4: Facilitate pharmacist prescribing within a collaborative care model has the most scope for our profession. For example with flu vaccinations, we already prescribe – we make the clinical judgment as to whether it is beneficial for a particular patient and then act accordingly. There are so many other things we can do – let’s just do it.

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Linda Badewitz-Dodd MPS is PSA’s 2021 Pharmacist of the Year

Aged care innovator Maria Berbecaru MPS is the 2021 Symbion PSA ECP of the year

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Just 3 years out of university, Maria Berbecaru MPS made history by implementing an Australian-first aged care pharmacy service. She hopes her experience will inspire others and help make embedding pharmacists in aged care the norm.

A 2016 graduate of the University of Tasmania, Maria Berbecaru credits two experiences during her intern year at Swansea Pharmacy, on Tasmania’s east coast, with igniting her interest in aged care.

The first was assisting nursing staff during medicine administration rounds at a local residential aged care facility (RACF), where she answered questions about the crushability of medicines and the correct administration techniques of eye preparations and inhalers.

A few months later, Ms Berbecaru shadowed the visiting consultant pharmacist who conducted medication reviews at the RACF, helping with patient interviews and sitting in on discussions about drug-related problems with the pharmacist and local GP.

‘I was intrigued by how well-received the medicine suggestions were by the GP and the beneficial impact the pharmacist had on residents’ overall health,’ she says.

‘Witnessing first-hand the significant impact pharmacists could have on the well-being of individuals is what sparked an interest for me to pursue a pathway into aged care.’

Finishing her internship, Ms Berbecaru began working at Lindisfarne Amcal Pharmacy in Hobart and gained her accreditation. Since then, she has not only pursued aged care but has been a pioneer – implementing Australia’s first integrated community pharmacy delivered medicine supply and on-site clinical service model at an RACF. The service began in a single RACF in January 2019 and expanded to a second location this year, providing care to approximately 250 residents.

Although there have been similar models trialled in Australia, most have relied on dedicated grants. Ms Berbecaru’s model, on the other hand, was established in collaboration with the RACFs, which help fund her employment at the Lindisfarne pharmacy.

Real-time results

From daily ward visits, helping nurses with patient admissions, assisting visiting GPs with rounds, to performing residential medication management reviews (RMMRs), Ms Berbecaru’s duties at the RACFs vary depending on the day.

‘My goal is to promote and elevate the embedded pharmacists in aged care model.’

It’s this variety that she enjoys most. ‘Every day is different and presents different challenges that keep me on my toes,’ she says. ‘I also enjoy the interprofessional collaboration, where everyone works towards improving delivery of care for the residents.

‘For example, [if I identified] a resident was experiencing pain despite using pain medicines [I would] discuss the pain in further detail with the resident and communicate this to the GP via phone or email. The GP either reviews the resident’s pain during their next visit to the facility or accepts the medicine recommendation [I have] put forward.’

She also does 3-monthly psychotropic reviews, which have had a measurable impact.

The use of antipsychotics at the first RACF to adopt the resident aged care pharmacist is now less than 6% of residents, down from almost 20% when Ms Berbecaru started.

Looking ahead

Ms Berbecaru says being recognised so early in her career is an honour and a reminder that the work she does matters, but that it is a ‘collective win’.

‘I wouldn’t have achieved what I have without the individuals who supported me, taught me and tolerated me … Together we are treading on new territory and illustrating the importance of pharmacists within aged care.’

When she isn’t exploring new hiking tracks with friends or increasing her heart rate by skydiving or aquatic parasailing, she hopes to inspire other pharmacists to become involved in aged care.

‘My goal is to promote and elevate the embedded pharmacists in aged care model … Additionally, [I’d like] to assist with solidifying a sustainable funding model, so that this unique role becomes widely adopted across other residential aged care facilities in Australia.

‘I believe with the right opportunities, guidance and a sustainable funding model in place, embedded residential clinical pharmacists will become the norm.

'They will be pivotal members of the care team, promoting safe prescribing, appropriate use and administration of medicines and optimising resident care,’ she believes.

What change in pharmacy in the past 2 years were you most excited about?

The expanding scope of pharmacists’ practice and recognised need for them within healthcare teams. For example, pharmacists practicing within GP clinics, immunising pharmacists (and their increased vaccination scope) and embedded residential clinical pharmacists has increased public awareness and understanding of pharmacists’ significant impact within care teams and the health system overall.’

What action in PSA’s Pharmacists in 2023 is the most important?

I believe all 11 actions are equally important, but if we draw attention to Action 3, embedding pharmacists within healthcare teams, it will be both a short-term and long-term solution to reduce the burden on Australia’s strained healthcare system. Pharmacists are the 'cogs' of the healthcare machine.

The PSA Early Career Pharmacist of the Year Award is proudly sponsored by Symbion. [post_title] => Aged care innovator is PSA's 2021 ECP of the Year [post_excerpt] => Just 3 years out of university, Maria Berbecaru MPS made history by implementing an Australian-first aged care pharmacy service. She hopes her experience will inspire others and help make embedding pharmacists in aged care the norm. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => 2021-early-career-pharmacist-of-the-year [to_ping] => [pinged] => [post_modified] => 2021-10-13 12:44:04 [post_modified_gmt] => 2021-10-13 01:44:04 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.australianpharmacist.com.au/?p=14326 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [title_attribute] => Aged care innovator is PSA’s 2021 ECP of the Year [title] => Aged care innovator is PSA’s 2021 ECP of the Year [href] => https://www.australianpharmacist.com.au/2021-early-career-pharmacist-of-the-year/ [module_atts:td_module:private] => Array ( ) [td_review:protected] => Array ( ) [is_review:protected] => [post_thumb_id:protected] => 14327 )

Aged care innovator is PSA’s 2021 ECP of the Year

Erin Cooper MPS is PSA's 2021 Intern of the Year

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While most interns were focused on simply surviving their first year of practice during a pandemic, Erin Cooper MPS found time to give back to her peers.

The start of Ms Cooper’s professional career was quite literally a baptism by fire, as she arrived in Canberra to begin her internship at Capital Chemist Wanniassa just days before the Black Summer bushfires reached the ACT.

She had come from Orange, about 270 kilometres away in New South Wales, where she worked in a local community pharmacy, attended Charles Sturt University and was President of the National Australian Pharmacy Students’ Association (NAPSA).

‘I remember being at my friend’s house on New Year’s Eve. I was starting work the next day and we were sitting outside on the deck, when suddenly we got engulfed in smoke,’ Ms Cooper says of her arrival in Canberra.

‘I had to hit the ground running from the minute I started. People were coming [into the pharmacy] wanting masks and Ventolin, and we could only have one of the doors open because there was so much smoke coming in.’

And then came the pandemic. The Wanniassa pharmacy team was split into two groups to reduce the risk of infection, and Ms Cooper ended up on the opposite side to her preceptor.

‘That was difficult, but I formed such great connections with everyone else that I felt like I had a whole team of mentors, not just one … I feel quite confident in my role having come out of that.’

A graduate’s guide

While finding her feet during the first half of her internship, Ms Cooper was also responsible for leading her peers through a time of great uncertainty as NAPSA President.

University campuses were closed and students were worried they wouldn’t be able to do their placement hours and finish their courses. On top of this, they needed to start thinking about life after university.

‘I don’t think you’ll get anywhere if you don’t get involved.’

Before getting her internship in Wanniassa, Ms Cooper tried to gather as much information as possible, but found it hard to keep track of all the different requirements. In a bid to help others, and inspired by a previous NAPSA publication, she decided to create a guide to internships for the graduating class of 2020.

‘When you’re applying for internships, you have an enormous list of things to do and you need to make sure you do them all by the right date. I found it really difficult. My lecturers were super helpful, but even then there were still things that were quite ambiguous,’ she says.

After contacting ‘everyone I could think of who is involved in the intern process’, and many hours of edits, NAPSA’s Intern Guide for 2020 Pharmacy Graduates was born – helping pharmacy students across the country prepare for one of the most important years of their career.

Pursuing passions

With the pressure of her intern year now behind her, Ms Cooper is currently enjoying life as a community pharmacist and the relationships she has developed with patients. It also leaves her with enough time to indulge in another passion – teaching ballet.

She says her biggest piece of advice for others is to get involved, whether through PSA’s Communities of Specialty Interest, Early Career Pharmacists groups or with NAPSA.

‘If I hadn’t gotten involved I wouldn’t know all the people I do now, my best friends who I met through NAPSA and now live all across Australia, who I still talk to almost daily. I don’t think you’ll get anywhere if you don’t get involved.’

What change in pharmacy in the past 2 years were you most excited about?

The expansion in pharmacists’ scope of practice, particularly in vaccinations. I know this varies state by state, but at the beginning of my intern year pharmacists in the ACT could only administer vaccines for whooping cough and the flu to those over 16 years. Now I can vaccinate anyone over 10 with the flu shot and provide Boostrix, MMR and COVID vaccines in the pharmacy.

What action in PSA’s Pharmacists in 2023 is the most important?

Action 7: Equip the pharmacist workforce through practitioner development to address Australia’s existing and emerging health challenges is important to further the profession. As seen through the COVID-19 pandemic, pharmacists can play a huge role. This is reflected through our ever-expanding scope of practice allowing us to provide services not previously available in the pharmacy.

The PSA Intern of the Year Award is proudly sponsored by MIMS. [post_title] => Erin Cooper MPS is PSA's 2021 Intern of the Year [post_excerpt] => While most interns were focused on simply surviving their first year of practice during a pandemic, Erin Cooper MPS found time to give back to her peers. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => 2021-intern-of-the-year [to_ping] => [pinged] => [post_modified] => 2021-09-24 18:14:35 [post_modified_gmt] => 2021-09-24 08:14:35 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.australianpharmacist.com.au/?p=14321 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [title_attribute] => Erin Cooper MPS is PSA’s 2021 Intern of the Year [title] => Erin Cooper MPS is PSA’s 2021 Intern of the Year [href] => https://www.australianpharmacist.com.au/2021-intern-of-the-year/ [module_atts:td_module:private] => Array ( ) [td_review:protected] => Array ( ) [is_review:protected] => [post_thumb_id:protected] => 14322 )

Erin Cooper MPS is PSA’s 2021 Intern of the Year

The COVID-era pharmacist

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SYMPTOM	CAUSE	VALVE LESION
Fatigue Dizziness, blackouts	Inadequate cardiac output	Stenosis
Shortness of breath, cough Swelling of ankles and feet Abdominal swelling	Congestion	Regurgitation Heart failure
Chest pain	Increased workload	Aortic stenosis
Palpitations	Enlargement of heart chambers	Regurgitation (esp. mitral) Mitral stenosis
Stroke	Blood clots	Mitral

‘Freedom Day’ yet to come

The hotspot pharmacist

Vaccinating through the crisis

End of lockdown looms for Canberra

Pharmacy students hopeful for the future

Moderna booster queries on the rise

ATAGI advice

Remain vigilant

Large-scale myocarditis study

Must know Spikevax advice for pharmacists

Preventing use by non-smokers

Supporting pharmacists

Pharmacist leading the charge

Clinic set up

Pharmacists best for the job

Combatting hesitancy

Tips for community pharmacists

Anaphylaxis management and pharmacists

Parents’ perspectives

A key resource

Anaphylaxis support

What is chemical restraint?

When psychotropic medicines are used to manage behavioural and psychological symptoms of dementia is this chemical restraint?

Are hypnotics such as temazepam chemical restraint?

What do providers need to do when a chemical restraint is proposed or used?

Inappropriate antimicrobial prescribing

A positive COVID effect

Cautionary label for antibiotics remains important

Practical tips for pharmacists

Hidden symptoms of valvular heart disease

Greater awareness of valvular heart disease needed

Introduction

Learning objectives

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.

Pharmaceutical poisoning in Australia

Knowledge to practice

Conclusion

Key points:

Case scenario

Learning objectives

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Introduction

What are the causes?

What are the risk factors?

What are the symptoms?

How is it diagnosed?

When to refer

How is it managed?

What is the prognosis?

How can it be prevented?

Knowledge to practice

Conclusion

Case scenario continued

Key points:

Further information

Case scenario

Learning objectives

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.

Introduction

Epidemiology and risk factors for alcohol dependence

Diagnosis and assessment

Management

Knowledge to practice

Conclusion

Case scenario continued

Key points:

Introduction

Learning objectives

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.

Preparation

Counselling for patients

Conclusion

Key points:

Introduction

Learning objectives

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.

Causes and risk factors

Clinical presentation

Diagnosis

Management