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CPD

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Case scenario
Mary, 34 years old, is seeking your assistance with ‘something embarrassing’. After waking up, she noticed some pain and itchiness around her anus, and upon inspection, a sore, discoloured bulge that ‘definitely wasn’t there last week’.

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

Describe the causes and symptoms associated with haemorrhoids and anal fissures
Summarise over-the-counter treatment options for haemorrhoids and anal fissures
Discuss potential interactions, adverse effects and precautions of treatment options
Recognise when referral to a doctor is required

Competency standards addressed (2016): 1.1, 2.1, 2.2, 2.3, 2.4, 3.1, 3.5

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.
What are haemorrhoids?
Symptomatic haemorrhoids, also known as ‘piles’, are characterised by enlargement, swelling, prolapse and/or thrombosis of swollen blood vessels.¹

Haemorrhoids are a normal part of the rectal anatomy, being vascular cushions in the distal (lower) rectal mucosa. They provide a significant proportion of resting anal pressure, around 15–20% , contributing to the complete closure of the anal canal.¹ Haemorrhoids are either internal or external (see Figure 1).²

Swelling of the haemorrhoids in the lower rectum can present internally, originating from the superior haemorrhoidal cushion, externally, originating from the inferior haemorrhoidal cushion, or a combination of both, as depicted in Figure 1. Symptomatic internal and external haemorrhoids present themselves with different symptom profiles due to placement and differences in innervation.²

In this article, ‘symptomatic haemorrhoids’ or ‘disease of the haemorrhoids’ will now be termed ‘haemorrhoids’.
FIGURE 1 – Internal and external haemorrhoids

What are the symptoms of haemorrhoids?
Internal and external haemorrhoids may present with varying symptomology as a result of differences in location, with around 40% of people with haemorrhoids having no symptoms at all.²
Common symptoms of haemorrhoids include²:

passing of fresh blood when defaecating – will usually coat the stool or drip into the toilet, and may be exacerbated by straining
painful, external, palpable lump (thrombosed external haemorrhoids)
anal pruritis (itching) and irritation
mild faecal incontinence
mucous and wetness
sensation of fullness in the perianal area.

Thrombosed, external haemorrhoids are more likely to result in pain, often excruciating, due to significant somatic innervation of the area, and associated distension and inflammation. Internal haemorrhoids are viscerally innervated, and are therefore not sensitive to pain, touch or temperature.²
Who gets haemorrhoids?
Estimating the true prevalence of haemorrhoids is difficult as discomfort in the anorectal region is often, and perhaps incorrectly, diagnosed as haemorrhoids.² A 2011 study revealed a prevalence of 39% of haemorrhoids in adults, with approximately 45% of those adults experiencing symptoms.³ Haemorrhoids before age 20 are considered unusual.²

Haemorrhoid risk factors include^2,4,5:

ageing
chronic constipation or diarrheoa – check medicine usage, e.g. use of opioid analgesics
pregnancy, as a result of hormonal changes (follicle stimulating hormone, prolactin and steroids), pressure from the growing uterus, changes in blood flow and constipation (see Box 1)
pelvic tumours
long periods of sitting on the toilet
straining when defaecating.

BOX 1 – HAEMORRHOIDS IN PREGNANCY

It is estimated that 25–35% of women experience haemorrhoids during pregnancy, most commonly during the second and third trimesters, with some reports of up to 85% in some populations during the third trimester. For most women, haemorrhoids resolve without intervention following childbirth.

References: Aust Government Department of Health⁶; Staroselsky et al⁷
What conditions may be confused for haemorrhoids?
Key symptoms associated with haemorrhoids, particularly anal itching and bleeding, are also associated with other conditions and disease states (Table 1), and may require referral for further investigation if haemorrhoids are not suspected.²
TABLE 1– Differential diagnoses of haemorrhoids

BLEEDING OR PRESENCE OF BRIGHT RED BLOOD
ANAL PRURITIS

Anal fissures (discussed in this article)
Solitary rectal ulcer syndrome
Polyps
Rectal prolapse
Colorectal and anal cancer
Proctitis

Anal abscess
Anal fissures
Fistula
Anal squamous cell carcinoma
Other skin diseases
Infection of anal canal lining (anoderm), e.g. bacterial, fungal or viral

Reference: UpToDate²
How can haemorrhoids be diagnosed?
In the community pharmacy setting, history taking and symptom description will assist in making a diagnosis. If a physical examination is required, refer the patient to a general practitioner.

The presence of bright, red blood, anal pruritis and/or acute onset of perianal pain can be used to diagnose haemorrhoids. Painful defaecation is usually not a symptom of haemorrhoids, unless they are thrombosed.²
What treatments are available to manage haemorrhoids?
A number of treatments are available over the counter to assist patients with symptomatic relief of haemorrhoids. Often, they will resolve on their own after several days, but can become chronic, requiring surgical intervention.^2,8

Over-the-counter treatments can include oral or topical analgesics, topical agents, including corticosteroids, to reduce swelling, therapies to reduce sphincter spasm, and venoactive agents to increase venous tone of haemorrhoidal tissues.² Some of these therapies are not available in Australia. Table 2 outlines over-the-counter therapies available in Australia.
TABLE 2 – Current over-the-counter therapies available in Australia for the management of haemorrhoids and anal fissures

MEDICATION COMBINATION
MECHANISM OF ACTION
DOSE
COMMON ADVERSE EFFECTS
INTERACTIONS
PREGNANCY AND BREASTFEEDING
NOTES

Hydrocortisone/ cinchocaine hydrochloride ointment (external and internal) and suppositories

Proctosedyl
Corticosteroid to reduce inflammation and itch

Local anaesthetic
Apply/insert up to three times daily

Stinging of the skin, sensitisation of skin, exacerbation of local infection, skin atrophy.
Used externally, systemic absorption risk is low.

Rectal absorption may occur when used internally.

Check for potential interactions if being used for internal haemorrhoids.
Safe Category A
Apply/insert after a bowel motion. Wash and dry anal area before application.

Nozzle available for internal use of ointment.

Limit use to <7 days.

Zinc oxide 300 mg, Peru balsam 50 mg, benzyl benzoate 33 mg suppositories and ointment

Anusol
Astringent and ingredients purported to have benefits that may lack evidence
Suppositories: one suppository morning and night, and after each bowel movement

Ointment: apply twice daily, ensuring area is completely covered.

Safe Category B2
Suppositories for internal use only

Ointment useful for both external and internal haemorrhoids (applicator included)

Limit use to <7 days.

Zinc oxide/cinchocaine hydrochloride ointment

Rectinol
Astringent and analgesic
Apply three times a day, after a bowel movement.
Sensitisation of skin
Safe
Indicated for both external and internal haemorrhoids (applicator included)

Limit use to <7 days.

Lidocaine/ allantoin/ hamamelis liquid extract/ zinc oxide ointment

Hemocane
Astringent and analgesic
Apply around the anus morning and night, after each bowel movement.
Sensitisation of skin
Safe
Indicated for both external and internal haemorrhoids (applicator included)

Limit use to <7 days.

Lidocaine/hydrocortisone cream

SOOV IT
Corticosteroid to reduce inflammation and itch

Local anaesthetic
Apply three times a day, and after a bowel movement.
Stinging of the skin, sensitisation of skin, exacerbation of local infection, skin atrophy.
Safe
Indicated for both external and internal haemorrhoids (applicator included).

Limit use to <7 days.

Glyceryl trinitrate ointment

Rectogesic

Not indicated for use in haemorrhoids
Release of nitric oxide relaxes internal anal sphincter, reducing anal pressure and increasing blood flow
Insert 1–1.5cm strip of ointment into anal canal up to three times a day for at least two weeks.

Anal fissures may require up to four weeks of treatment.
Headache, dizziness
Do not use if currently using sildenafil, vardenafil, tadalafil or other PDE5 inhibitors.
Category B2

Should be safe to use in breastfeeding – apply a small amount after breastfeeding.
Indicated for anal fissures and relief of pain and discomfort following haemorrhoid surgery. Not for haemorrhoids

Ensure patients have a 12-hour period per day where they are not using this treatment as tolerance can develop.

PDE5 = phosphodiesterase-5
References: AMH,⁹ Mothersafe,¹⁰ NPS MedicineWise,^11-13 Anusol,¹⁴ Altomare et al,¹⁵ Havlickova B,¹⁶ MIMSOnline^17,18
What non-pharmacological approaches can patients take to help with symptom relief?
Diet and lifestyle modifications can be very helpful in reducing symptom severity and reducing haemorrhoid occurrence^2,10,20,21:

Increase fibre intake to 25–35 grams per day and drink 1.5–2 litres of water each day (ensure patient isn’t fluid restricted). Staying hydrated and adequate fibre intake is necessary to produce passable stools with minimal straining. The benefits of increased fibre intake can take up to six weeks to be fully realised. Advise patients not to take in too much fibre, as this can lead to diarrhoea, which can irritate haemorrhoids.
Restrain from straining or lingering when defecating, e.g. reading on the toilet. Paying close attention to the body’s signals, such as the urge to pass a stool, can reduce the risk of constipation.
Use of a moist towel or baby wipe instead of dry toilet paper after passing a stool can reduce irritation.
Engage in regular physical exercise. Patients should avoid rigorous exercise during an episode as this may irritate the haemorrhoids.
Limit fatty foods and alcohol as they can exacerbate constipation.
Warm water (sitz) baths. Soap can irritate haemorrhoids and therefore should be avoided. A gentle cleanser may be more appropriate for maintaining hygiene.
Ice packs applied to external haemorrhoids can help reduce pain and swelling.

When should patients be referred?
Changes in bowel habits or consistency of stools, or other symptoms, such as fever, night sweats and abdominal pain, are not associated with haemorrhoids and should be immediately referred for further investigation.²

Patients with haemorrhoids that are unresponsive to over-the-counter treatments should also be referred for further investigation and management.
What is an anal fissure and how is it caused?
An anal fissure occurs when the skin in the anal canal splits below the dentate line, forming a longitudinal tear. Due to delayed healing, anal fissures can become chronic, resulting in ulcer formation and spasming of the anal sphincter muscle.^22,23

Fissures affect males and females equally. They are more common in younger adults, with a median age of onset of approximately 40 years. Whilst less common, they do occur in the elderly and children.²⁴

The underlying pathophysiology of anal fissures is not clear, although factors such as pain, internal sphincter pressure and spasm, poor healing as a result of local ischaemia and reduced blood flow may all contribute to the development of anal fissures.^23-25

Primary causes of anal fissures may include:^23-25

chronic or prolonged diarrhoea
constipation and hard stools
vaginal delivery
injury to the area
penetration
anorectal surgery.

Other causes of anal fissures may include HIV/AIDS, Crohn’s disease, ulcerative colitis, anal cancer, tuberculosis, herpes, leukemia and syphilis.²⁴
What are the symptoms of anal fissures?
The most common symptom of anal fissures is pain, with approximately 91% of patients experiencing this as a primary symptom. The sensation is often described as sharp and tearing during defaecation, and may persist in the minutes to hours following.²⁴

Other symptoms may include^24,26:

bleeding – bright, red blood on the stool or toilet paper after defaecation
small lump or skin tag near the fissure (more common with chronic fissures).

How are anal fissures diagnosed?
Anal fissures can usually be diagnosed based on the patient’s history and symptoms.²⁴

Patients may believe that their symptoms are due to haemorrhoids and be reluctant to accept a possible diagnosis of anal fissures. Education and counselling can help patients understand the difference between the two conditions.²⁴
What over-the-counter management options are available for patients with anal fissures?
Non-pharmacological management is very effective in helping patients manage the symptoms of anal fissures and are very similar to those used in the management of haemorrhoids.

Managing anal fissures involves considering three components of the condition²⁴:

resolving the underlying cause of anal fissures, e.g. relieving constipation and straining, or avoidance of other forms of anal trauma
relaxation of the internal sphincter to improve blood flow and healing
relief of pain associated with the fissure.

Conservative management alone can result in resolution in up to 50–70% of patients with anal fissures. These approaches include^23,24:

increased fibre intake
warm (sitz) baths. Baths of 40°C have been shown to significantly reduce resting anal canal pressures via the somato-anal reflex, compared to immersion in cooler temperatures.

Patients can also use glyceryl trinitrate ointment (Pharmacist Only Medicine, see Table 2 and Box 2) as a topical treatment for anal fissures. Hydrocortisone and lignocaine products have also been used but, in terms of healing rates, have been shown to be inferior to warm baths and increased fibre.²³

BOX 2 – GLYCERYL TRINITRATE – MECHANISM OF ACTION

Glyceryl trinitrate works by releasing nitric oxide, the predominant non-adrenergic, non-cholinergic neurotransmitter in the internal anal sphincter. This results in relaxation of the internal anal sphincter and vasodilatation to improve blood flow to the fissure and promote healing.²⁴

When to refer
Patients with chronic anal fissures should be referred to their doctor. A physical examination can confirm the presence of an anal fissure and rule out other causes.²⁴

Other treatments such as calcium-channel blockers, botulinum toxin and surgery may be required for patients unresponsive to conservative, over-the-counter treatments. Referral to the patient’s general practitioner is required in these cases for further investigation and management.²⁴

Case scenario continued
After taking Mary’s history, it appears she is suffering from a thrombosed, external haemorrhoid due to the presence of acute pain and Mary‘s description of a discoloured lump that appeared in a very short period of time. She had been prescribed paracetamol with low-dose codeine by her doctor 2 weeks ago for tooth pain, which has likely resulted in constipation, leading to straining.

You recommend a topical ointment to be applied externally up to 3 times a day, as well as a stool softener to assist with constipation. You also advise Mary to increase her fibre and fluid intake to reduce the risk of constipation in the future.

Conclusion
The pharmacist can play an important role in the diagnosis and management of acute haemorrhoids and anal fissures with a range of over-the-counter treatments and nonpharmacological measures. Ensuring patients who have chronic or complex haemorrhoids and anal fissures seek referral is important, as well as identifying any potential red flags that may be suggestive of other, more serious conditions.
Key points

Symptomatic haemorrhoids are a common condition, characterised by enlargement, swelling, prolapse and/or thrombosis of the haemorrhoids – the vascular cushion in the distal rectal mucosa. They can be either internal or external.
Management of haemorrhoids involves lifestyle modifications, such as increased fibre and water intake, as well as topical treatments available over the counter to reduce pain, itchiness and inflammation.
Patients experiencing symptoms not associated with haemorrhoids, such as abdominal pain or changes in bowel habits, should be referred for further investigation.
An anal fissure is a longitudinal tear in the anal sphincter. Due to delayed healing, anal fissures can become chronic, resulting in ulcer formation and spasming of the anal sphincter muscle.
Treatment of anal fissures involves increased fibre intake, warm baths and topical treatments, including glyceryl trinitrate ointment.
Patients with chronic anal fissures should be referred for further investigation and management.

[cpd_submit_answer_button]

References

Gallo G, Sacco R, Sammarco G. Epidemiology of hemorrhoidal disease. Epidemiology of Hemorrhoidal Disease. In: Ratto C, Parello A, Litta F, eds. Hemorrhoids. Coloproctology. Springer, Cham 2018. At: https://link.springer.com/referenceworkentry/10.1007%2F978-3-319-51989-0_1-1
Bleday R, Breen E. Hemorrhoids: clinical manifestations and diagnosis. 2020. At: uptodate.com/contents/hemorrhoids-clinical-manifestations-and-diagnosis
Riss S, Weiser FA, Schwameis K, et al. The prevalence of hemorrhoids in adults. Int J Colorectal Dis 2012;27(2):215– 220. At: https://www.ncbi.nlm.nih.gov/pubmed/21932016
Colorectal Surgical Society of Australia and New Zealand. Haemorrhoids. 2013. At: cssanz.org/index.php/patients/haemorrhoids
Quiljano E, Abalos E. Conservative management of symptomatic and/or complicated haemorrhoids in pregnancy and the puerperium. Cochrane Database of Systematic Reviews 2012, Issue 2. At: https://www.ncbi.nlm.nih.gov/pubmed/16034920
Australian Government Department of Health. Pregnancy care guidelines: haemorrhoids. 2019. At: https://www.health.gov.au/resources/pregnancy-care-guidelines/part-i-common-conditions-during-pregnancy/haemorrhoids
Staroselsky A, Nava-Ocampo AA, Vohra S, et al. Hemorrhoids in pregnancy. Can Fam Physician 2008;54(2):189–190. At: https://www.ncbi.nlm.nih.gov/pubmed/18272631
Haemorrhoids. 2019. At: www.healthdirect.gov.au/haemorrhoids-piles#treated
Rossi S, ed. Australian medicines handbook. Adelaide: Australian Medicines Handbook; 2020. At: https://amhonline.amh.net.au/
The Royal Hospital for Women. Haemorrhoids in pregnancy and breastfeeding. 2019. At: seslhd.health.nsw.gov.au/sites/default/files/groups/Royal_Hospital_for_Women/Mothersafe/documents/HaemorrhoidspandbupdateSept19.pdf
NPS MedicineWise. Consumer medicine information – Proctosedyl. 2018. At: nps.org.au/medicine-finder/proctosedyl-ointment
NPS MedicineWise. Consumer medicine information – SOOV IT. 2018. At: nps.org.au/medicine-finder/soov-it-ointment
NPS MedicineWise. Consumer medicine information – Rectogesic. 2015. At: nps.org.au/medicine-finder/rectogesic-ointment
Anusol suppositories. At: https://anusol.com.au/Anusol-Suppositories
Altomare DF, Giannini I. Pharmacological treatment of hemorrhoids: a narrative review. Expert Opin Pharmacother 2013;14(17):2343–2349. At: https://www.ncbi.nlm.nih.gov/pubmed/24024752
Havlickova B. Topical corticosteroid therapy in proctology indications. Aliment Pharmacol Ther 2010;31:19–32. At: https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1365-2036.2010.04278.x
eMIMs cloud. Proctosedyl – full product information. 2018. At: emims.com.au/Australia/drug/info/Proctosedyl%20Ointment/Proctosedyl?type=full
The Royal Women’s Hospital. Glyceryl trinitrate. 2020. At: https://thewomenspbmg.org.au/medicines/glyceryltrinitrate/
Pray W, Pray G. Counseling patients with hemorrhoids. US Pharm 2011;36(12):12–15. At: https://www.uspharmacist.com/article/counseling-patients-with-hemorrhoids
Mott T, Latimer K, Edwards C. Hemorrhoids: Diagnosis and Treatment Options. Am Fam Physician 2018;97(3):172–179. At: https://www.ncbi.nlm.nih.gov/pubmed/29431977
Institute for Quality and Efficiency in Health Care. Enlarged hemorrhoids: how can you relieve the symptoms yourself? 2006. At: ncbi.nlm.nih.gov/books/NBK65083/
Colorectal Surgical Society of Australia and New Zealand. Anal fissure. 2013. At: https://cssanz.org/index.php/patients/anal-fissure
Schlichtemeier S, Engel A. Anal fissure. Aust Prescr 2016;39(1):14–17. At: https://www.ncbi.nlm.nih.gov/pubmed/27041801
Beaty JS, Shashidharan M. Anal Fissure. Clin Colon Rectal Surg 2016;29(1):30–37. At: https://www.ncbi.nlm.nih.gov/pubmed/26929749
Lund JN, Scholefield JH. Aetiology and treatment of anal fissure. Br J Surg 1996;83(10):1335–1344. At: https://www.ncbi.nlm.nih.gov/pubmed/8944447
American Society of Colon and Rectal Surgeons. Anal fissure. At: https://fascrs.org/patients/diseases-and-conditions/a-z/anal-fissure

Dr GLEN SWINBURNE BPharm (Hons), PhD, GCPharmPrac, GCMgmt, MPS is an early-career pharmacist, clinical educator and medical writer with over nine years’ experience in pharmacy practice. He specialises in pharmacy education and health literacy. [/vc_column_text][/vc_column][vc_column width="1/3"][/vc_column][/vc_row]
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Managing haemorrhoids and anal fissures in community pharmacy

td_module_mega_menu Object ( [authorType] => [post] => WP_Post Object ( [ID] => 10248 [post_author] => 1891 [post_date] => 2020-05-20 15:37:03 [post_date_gmt] => 2020-05-20 05:37:03 [post_content] => [vc_row][vc_column width="2/3"][vc_column_text] Not all individuals respond identically to the same dose of the same drug. These variations can be pharmacokinetic (where the same dose results in a different plasma concentration) and/or pharmacodynamic (where the same plasma concentration causes a different drug response) in origin.

Learning objectives

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

Explain how dosing is affected by pharmacokinetic and pharmacodynamic properties of a drug.
Discuss the importance of pharmacokinetic and pharmacodynamic drug properties in clinical practice.
Explain how individual variations (e.g. age, weight) and disease states can affect dosing regimens and drug therapy.

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

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

This article discusses the impact renal function, age, body weight and genetics can have on the pharmacokinetics (PK) and pharmacodynamics (PD) of drugs and therefore their dosing.

Renal function

Most drugs (and their active metabolites) are renally excreted, so when renal function is impaired, there is potential for drug accumulation and toxicity in the absence of dosage adjustment, particularly for those drugs with a low therapeutic index (e.g. lithium, digoxin).^1,2 Renal drug excretion is facilitated by glomerular filtration and renal tubular secretion; renal tubular reabsorption can impact drug concentration. These three processes are dependent on renal blood flow (volume of blood delivered to the kidneys per unit time). A change in any one of the three processes will impact drug concentration. Pharmacists should generally calculate appropriate dose adjustments for adults taking these drugs using the Cockcroft-Gault equation. The equation incorporates the individual’s weight, age, gender and serum creatinine (see Box 1). The 2020 AMH reminds pharmacists to ‘be aware that the estimate of glomerular filtration rate (eGFR) automatically reported with electrolyte test results is not equivalent to CrCl, that there is little evidence that it is suitable for adjusting drug doses in people with renal impairment.⁴

Age – paediatrics

Calculating safe and appropriate drug doses for children (see Table 1) is critically important. Children are not simply small adults and therefore should not be dosed as small adults. Differences in anatomy, physiology, immunology and biochemistry can impact the PK processes of absorption, distribution, metabolism and excretion (ADME):

Absorption Distribution Metabolism Elimination

Absorption

From birth to approximately 2 weeks, gastric pH is neutral and so acid labile drugs (e.g. erythromycin base) are absorbed to a greater extent during this period of development. As gastric pH increases, absorption of acid labile drugs decrease as a result of drug degradation.⁵ Compared with adults, infants and children have a shorter intestinal transit time, which may reduce the amount of drug absorbed (particularly poorly soluble drugs). Neonates, young infants and children have a larger surface area to body-mass ratio and thinner stratum corneum, increasing the risk of toxicity with percutaneously administered drugs.⁶

TABLE 1 – Paediatric age classes

Preterm newborn	Born before 37 completed weeks of gestation
Neonate	50%
Infant	75%
Toddler	87.5%
Preschool child	93.75%
School age child	96.89%
Adolescent	98.44%

Distribution

Total body water of newborns is approximately 80%, and this reduces to adult levels (60%) in the first year of life.⁷ Total body water influences the volume of distribution (Vd) of drugs. Hydrophilic drugs (e.g. aminoglycosides, β-lactams) administered using a weight-based dose will have a larger Vd (and lower plasma concentration) in neonates and infants when compared with adults. In newborns, alpha-1-acid glycoprotein (AGP), a plasma protein involved in the binding and transport of many drugs, is reduced by half. Albumin stores are also lower in newborns so drugs that are highly protein bound are in a higher proportion of unbound or free drug and hence available to interact with molecular drug targets and distribute into extravascular compartments.

Metabolism

Newborns have difficulty metabolising many drugs because metabolic enzyme systems are underdeveloped at birth.¹⁰ Therefore, when doses are adjusted for body weight, newborns can require proportionately lower dosages of a drug when compared to a healthy adult. While each individual enzyme has a unique maturation pathway, most hepatic enzymes have matured after the first year of life. Metabolism of drugs in children is not straightforward. In children, drugs metabolised by CYP2C9 may need to be given at doses 50–100% higher than those given to adults to achieve therapeutic concentrations.¹¹

Excretion

Glomerular filtration rate (GFR) is proportionately ≈25% of adult levels at birth and rises to adult levels by about 2 years of age. This reduced clearance of renally excreted drugs in neonates and infants can result in toxic accumulation.

Pharmacodynamics

Differences in paediatric physiology can affect pharmacodynamics, drug efficacy and toxicity.⁸ When determining the appropriate dosage of a drug for a child, pharmacists should refer to a specialist paediatric reference such as the AMH Children’s Dosing Companion, or contact the nearest Medicines Information Centre.⁹ For more information on dosing in children, refer to The Australian Pharmaceutical Formulary and Handbook 24th edition (APF24).¹⁰

TABLE 2 – Examples of physiological differences in children that influence the pharmacokinetic characteristics of some medicines

Age – elderly

Absorption

There is an increase in gastric pH and reduction in gastric emptying rate, however oral drug absorption across the digestive tract wall is not significantly affected.¹² As people age, the skin undergoes many structural and functional changes.¹³Structural changes to the stratum corneum decreases transcutaneous absorption of water-soluble drugs. Reduction in blood flow to the skin (40%)¹⁴ decreases transcutaneous drug absorption (skin patches, subcutaneous injections).

Distribution

With advancing age, lean body mass (particularly skeletal muscle mass) and total body water decline. There is a resultant proportional increase in total body fat. This impacts the Vd of drugs.¹⁵ Lipophilic drugs (eg benzodiazepines) tend to have an increased Vd (and increased half-life) and water-soluble drugs (e.g. lithium, gentamicin, digoxin, theophylline, and cimetidine) have a reduced Vd.¹⁶

Metabolism

The anatomy and physiology of the liver can change dramatically as part of the ageing process. There is a reduction in both liver mass (17–36%) and hepatic blood flow (20–40%). However, based on PK studies, these changes do not appear to significantly impact the metabolic clearance of most drugs.¹⁷

Excretion

Renal function declines with age.¹⁸ Renal impairment should be closely monitored in the elderly and individuals should be dosed according to their renal function.

Body weight

In adults, a normal or healthy weight range is a body mass index (BMI) of 18.5–24.99 kg/m2. A BMI <18.5 kg/m2 indicates an individual is underweight. A BMI of 25–29.99 is overweight while obesity is defined as a BMI ≥30 kg/m2. Being either underweight or obese is associated with many pathophysiological changes, which can potentially alter the PK/PD of many drugs.

Body size descriptors

In general, drugs are dosed using one of three approaches: fixed dosing, weight-based dosing, or body surface area (BSA)-based dosing. Different body size descriptors include total body weight (TBW), lean body weight (LBW), ideal body weight (IBW), and adjusted body weight (ABW). Total body weight TBW is an individual’s actual body weight. Drug dosing recommendations are in general based on TBW. This is appropriate for normal weight individuals when TBW, LBW and IBW are comparable. In people who are obese, adipose tissue and LBW do not increase proportionally. When calculating drug doses using TBW, one is assuming that drug clearance and /or distribution is linearly scalable for normal weight through to extremely obese individuals. For example, would you use a dosage of 10 mg/kg/day in a 65 kg versus a 130 kg individual? Does a 130 kg individual eliminate a drug twice as fast as a 65 kg individual? The answer is clearly ‘no’. If we give the 130 kg individual double the drug, (based on their total body weight), the result may (dependent on the drug and its properties) be an overdose or toxicity.^19,20 Lean body weight LBW reflects the weight of all non-fat body mass components (i.e. organs, bone, muscle and extracellular fluid). Adipose tissue does little to influence drug clearance, while non-adipose tissue (LBW) is responsible for up to 99% of drug clearance.²¹ Therefore, using LBW is a more scientific approach to weight-based dosing.22 LBW calculators are available online, e.g. Therapeutic Guidelines.²² Ideal body weight IBW describes the best possible weight associated with maximum life-expectancy for a given height and gender.23 It does not consider body composition and usually results in individuals of the same height and gender being given the same drug dosage. For example, a 59 kg adult female with a height of 163 cm (IBW = 55.4 kg), will be given the same dose of drug as a 78 kg adult female with a height of 163 cm (IBW = 55.4 kg). Unlike the Therapeutic Guidelines, the Australian Medicines Handbook states to use the IBW (if less than TBW) when calculating creatinine clearance.4 Adjusted body weight Using adjusted body weight applies a dosing weight correction factor (e.g. 0.4 for aminoglycosides, hydrophilic drugs)²⁴ that typically remain in the extracellular fluid and their Vd correlates with lean mass. Body surface area Body surface area (BSA) is the body size descriptor used for dosing some antineoplastic drugs. It is not commonly used to calculate doses of other drugs. Like IBW, it does not take into consideration body composition.²⁵ Failure to modify drug doses in obese patients can result in toxicity (particularly when using drugs with a narrow therapeutic window) or inadequate drug therapy.

TABLE 3 – Body size formula

Absorption

Obesity is associated with significantly higher splanchnic blood flow, accelerated gastric emptying time and higher cardiac output, all of which may alter the rate and extent of oral drug absorption. The few studies that have evaluated the impact of obesity on oral drug absorption, have generally reported no significant differences in the rate and extent of absorption of the studied drugs in obese compared to non-obese individuals. The systemic absorption of drugs administered via intramuscular, transdermal and subcutaneous routes can be affected when there is a significant increase in subcutaneous fat, However, data is limited. Sanderink, et al, examined the rate and extent of absorption of subcutaneous enoxaparin in obese and non-obese individuals. The study found the time to reach Cmax (maximum concentraton) was 1 hour longer in obese individuals when compared to non-obese individuals.²⁹ However, no difference in the bioavailability was observed.

Distribution

Individuals who are obese have a higher fat mass. Generally, the Vd of lipophilic drugs (phenytoin, midazolam, propofol, voriconazole) tends to be higher in obese individuals compared to hydrophilic drugs (e.g aminoglycosides, acyclovir, beta-lactams, low molecular weight heparins). For example, thiopental and diazepam have a higher Vd in obese individuals, while hydrophilic drugs such as gentamicin and tobramycin, generally have lower Vd in obese individuals.³⁰ Note, however, that cyclosporine and digoxin (both lipophilic drugs) have a decreased Vd in obese individuals when dose is calculated using TBW. Therefore, lipophilicity alone cannot predict a change in Vd. Studies have reported that albumin protein concentrations are unaltered in obese individuals³¹ and drugs such as thiopental and phenytoin (which are bound mainly by albumin) show no signifi cant changes in Vd.^32,33 Studies of α1-acid glycoprotein (AAG) bound drugs have reported both increased and decreased concentrations in obesity.³¹

Metabolism

Existing literature suggests that metabolism, specifically hepatic metabolism, is variably affected by body weight. The impact of obesity on phase 1 metabolism is isozyme specific.³⁴ For example, the activity of CYP450 2E1, 1A2, 2C9 and possibly 2C19 and 2D6 seems to be higher (induced) and CYP450 3A4 seems to be lower (inhibited) in obese individuals. Obesity also alters various phase 2 metabolic pathways in different patterns and to different levels. However, these alterations are usually not clinically significant.

Excretion

Obesity is associated with a higher GFR initially (hyperfiltration)³⁵ but this may reduce over time due to other obesity- related comorbidities, such as chronic kidney disease.

Genetic variability

Differences in CYP450 enzyme expression genetic polymorphism) can influence the response to commonly prescribed drugs. For example, the hepatic enzyme CYP2D6 metabolises approximately 25% of all prescribed drugs, including many antidepressants, carvedilol, metoprolol, ondansetron and codeine.12 When codeine is metabolised by the enzyme CYP2D6 it is converted into its active metabolite morphine. Individuals who carry one or two inactive copies of the CYP2D6 gene are classified as poor metabolisers, and they will likely experience inadequate pain relief when prescribed codeine. In contrast, individuals who carry more than two copies of the CYP2D6 gene are known as ultrarapid metabolisers and are at risk of developing adverse effects of opioid toxicity, even at the prescribed dose. Such individuals convert codeine to morphine rapidly, resulting in higher than expected morphine plasma concentrations.

Therapeutic drug monitoring

Individual variations and disease states have an impact on drug PK and PD. To optimise safe and effective drug dosing, countering for individual variations, therapeutic drug monitoring (TDM) can be used. TDM involves the measurement of drug concentrations (e.g. plasma drug concentrations) usually at designated intervals. Drugs that may require TDM include those with a4,36:

narrow therapeutic index (e.g. digoxin or lithium)
clearly defined therapeutic range
marked PK variability
non-linear (zero order) PK
clear relationship between plasma concentration and effectiveness or toxicity of the drug
serious outcome when there is therapeutic failure (e.g. may be life-threatening seizures, transplant rejection). Commonly monitored drugs include carbamazepine, phenytoin, lithium, valproate, digoxin, cyclosporin, sirolimus, tacrolimus.

Conclusion

Pharmacokinetic and pharmacodynamic drug properties can be dependent on individual variability and can impact drug dosing and adverse drug effects. Using their expert knowledge and through these principles, pharmacists can ensure the quality use of medicines that result in optimal patient outcomes.

Key points

Pharmacokinetic and pharmacodynamic drug properties are affected by individual variability including disease state. Not all individuals respond identically to the same dose of the same drug.
Pharmacokinetic and pharmacodynamic drug properties must be considered to ensure best patient outcome.
Drug absorption, distribution, metabolism and elimination (ADME) are affected by pharmacokinetic and pharmacodynamic drug properties, impacting on drug dosing.

[cpd_submit_answer_button] References

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Dr MARY BUSHELL BPharm (Hons), PhD, GCTLHE, AFACP, AACPA, MPS is the Clinical Assistant Professor in Pharmacy. LYN TODD BPharm MPS is a Senior Lecturer at the University of Canberra. Dr ZAHID HUSSAIN PharmD, MClinPharm, PhD is a Lecturer in Pharmacy at the University of Canberra. ANGELA ADAMS BPharm GCAP is a Hospital Pharmacist with a specialty in hospital in the home and outpatient infusion services at Wagga Wagga Health Services. [/vc_column_text][/vc_column][vc_column width="1/3"][/vc_column][/vc_row] [post_title] => Impact of individual variations and disease states on drug therapy [post_excerpt] => Not all individuals respond identically to the same dose of the same drug. These variations can be pharmacokinetic and/or pharmacodynamic in origin. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => impact-of-individual-variations-and-disease-states-on-drug-therapy-cpd [to_ping] => [pinged] => [post_modified] => 2020-05-22 14:24:57 [post_modified_gmt] => 2020-05-22 04:24:57 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.australianpharmacist.com.au/?p=10248 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [title_attribute] => Impact of individual variations and disease states on drug therapy [title] => Impact of individual variations and disease states on drug therapy [href] => https://www.australianpharmacist.com.au/impact-of-individual-variations-and-disease-states-on-drug-therapy-cpd/ [module_atts:td_module:private] => Array ( ) [td_review:protected] => Array ( [td_post_template] => single_template_4 ) [is_review:protected] => [post_thumb_id:protected] => 10249 )

Impact of individual variations and disease states on drug therapy

General principles of pharmacokinetics and pharmacodynamics

Upper respiratory tract infections, commonly known as colds and flu, are the most common medical conditions affecting humans.

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Case scenario 1

Louisa, 27, a public relations executive visits the pharmacy and requests something for a sore throat; her job requires her to be able to talk to her team and clients frequently during the day. Louisa has had a sore, scratchy and painful throat for 2 days which is now affecting her ability to swallow and is causing discomfort when she speaks. Louisa is otherwise healthy and has no allergies. She occasionally takes antihistamines and has made an appointment with her GP to get antibiotics. In the meantime, she has asked you for advice on products that would provide symptomatic relief.

Learning objectives

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

Recognise the issues resulting from antimicrobial resistance
Discuss current recommendations for the management of upper respiratory tract infections.
Summarise the symptomatic management of upper respiratory tract infections and the role of the pharmacist in both non-prescription and non-pharmacological treatment options.
Assess customers’ symptoms and circumstances that may require referral.

Competency standards addressed (2016): 1.1, 1.4, 1.5, 2.2, 2.4, 3.2, 3.5, 3.6

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This article is produced in partnership with Reckitt Benckiser.[/caption]

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Case scenario 1 continued

Utilising the 1,2,3 GRIP strategy for symptomatic treatment you:

1. Address patient’s concerns: identify the main/most troublesome symptom, duration and impact. Ask about treatments used.

Louisa confirms her throat has been sore for the past 2 days and she has had some hot honey and lemon drinks to soothe it.

2. Be vigilant – Assess severity: identify risk factors, co-morbidities, other medical conditions/medicines being taken; ask about red flag symptoms and determine whether referral is necessary.

With no other worrying symptoms or health issues, Louisa believes that after 2 days of a sore throat, antibiotics will help minimise the risk of passing her cold to a workmate or family.

‘I’ve had antibiotics for my sore throat in the past,’ she points out.

You explain to Louisa that antibiotics will not provide her with the relief that she is after, but there are treatments that will help with the pain and the difficulty in swallowing.

Sore throats are very often caused by viruses, so antibiotics are of no benefit. In the minority of cases when cold symptoms are caused by bacteria, there is little benefit from taking antibiotics, but there is the risk of adverse effects and increased resistance.

Some treatments can rapidly address the sore throat pain and difficulty swallowing.

3. Counsel on effective self-management: determine what the patient needs for symptomatic relief; recommend appropriate products, taking into account individual preferences; advise when a doctor’s visit might be needed.

Louisa states she would like something to act rapidly.

‘I want something that acts fast, and I need to be able to talk and swallow without pain.’

You recommend flurbiprofen lozenges and mention self-care strategies – maintenance of hydration, adequate rest and hygiene measures like the use of antiseptic hand gels – to prevent symptom development and infection spread.

You explain the normal duration of a sore throat is around 7 days. If symptoms extend beyond this or new symptoms develop, Louisa should return to the pharmacy for assessment.

Introduction

Antimicrobial resistance (AMR) is a worldwide challenge. It is a real and immediate threat. More than 20 years ago the World Health Organization (WHO) identified the increasing problem of AMR; and now lists it as one of the most pressing global threats to human health.¹ With few innovative and new antimicrobials in the drug development pipeline, the WHO describes a future of a post-antibiotic world that will eliminate the advances in healthcare made over the past 100 years. Simple infections may become unmanageable and potentially fatal.² England’s Chief Medical Officer, Dame Sally Davies, warned last year that AMR poses a catastrophic threat. ’Antimicrobial resistance could soon kill at least 10 million people per year and wipe out humanity before climate change does.’³ Less than a generation after his 1928 chance observation of the effects of the Penicillium notatum mould triggered the beginning of the antibiotic era, Alexander Fleming warned ‘the ignorant man may easily under dose himself and by exposing his microbes to nonlethal quantities of the drug, make them resistant’.⁴ Of course, under-dosing is not the only predisposing factor to resistance. Antimicrobial resistance is a natural process of random mutation that allows a pathogen to survive and proliferate; inappropriate use of antimicrobials will hasten the process of resistance.¹

Antibiotic prescribing in Australia

There is good evidence that the overall rates of antibiotic resistance correlate with the total quantity of antibiotics used, as determined by the number of individuals treated, prior exposure and the average duration of each treatment course.⁵ In developing countries, lack of surveillance on the development of resistance, poor quality of available antibiotics, clinical misuse and easy accessibility of antibiotics contribute to antibiotic resistance. In the developed world, antibiotic resistance is attributable to poor antibiotic regulation and excessive antibiotic use in food processing.^6,7 In Australia, rates of prescribing of antibiotics are high. In 2014 more than 30 million antibiotics were provided to Australians through the PBS/RPBS and nearly half the Australian population were prescribed at least one course of antibiotics.⁸ Most antibiotics are prescribed by general practitioners (88%) with other primary care providers (e.g. dentists, optometrists, midwives and nurse practitioners) issuing a small proportion of the total.⁸ Although antibiotic stewardships have resulted in an overall reduction in antibiotic use by 22–36%, antibiotic prescriptions dispensed in Australia each year is still well above the Organisation for Economic Co-operation and Development per capita average.⁸ A point prevalence survey, published in Australian Prescriber in November 2019, showed that, on the day of the survey, almost 10% of 20,000 aged care residents were prescribed an antimicrobial; nearly two-thirds of recently prescribed antimicrobials were for residents who had no documented signs or symptoms of infection; and over a quarter of antimicrobials had been prescribed for longer than 6 months.⁹ Antibiotic resistance is an issue in both hospital and community settings.¹⁰ Patients may present with antimicrobial-resistant tuberculosis (see Box 1), gonorrhoea, typhoid fever and group B streptococcus.¹¹ Infection with antibiotic-resistant bacteria may cause severe illness, increased mortality rates, an increased risk of complications and admission to hospital, often resulting in higher treatment costs.¹²

BOX 1 - THE DIFFERENCE BETWEEN ANTIBIOTIC RESISTANCE AND ANTIMICROBIAL RESISTANCE.

The term antibiotic resistance is used to specifically describe resistance to antibiotics that occurs in common infection-causing bacteria. ‘Antimicrobial resistance more broadly encompasses resistance to drugs used to treat infections caused by other microbes as well, such as parasites (e.g. malaria), viruses (e.g. HIV) and fungi (e.g. Candida).’

Reference: WHO¹⁴

Antibiotic resistance – the patients’ understanding

A 5-year-long antibiotic awareness campaign was initiated by NPS MedicineWise in 2012. A preliminary survey undertaken at that time revealed that misconceptions and uncertainties regarding the role of antibiotics existed among patients and primary care physicians. For example, it showed that only 50% of patients are conscious of the development of antibiotic resistance, with even fewer (40%) aware that antibiotics are ineffective against viruses.¹³ European research has shown similar results, reporting that around half of patients believed antibiotics were effective in treating viruses, colds and flu.¹⁵ Further NPS MedicineWise research, conducted during September 2014 and released during Antibiotic Awareness week in November that year, showed that 20% of surveyed consumers indicated they would expect antibiotics for a cold or flu, and 17% said they would ask a doctor to prescribe an antibiotic. Patient expectations are cited as the main reason for inappropriate prescribing.¹³ Australian data presented at the Heath Technology Assessment international conference in 2019 showed that between 2012 and 2017, GP antibiotic PBS prescriptions reduced by 18.4%. Antibiotic defined daily doses (DDDs) per 1,000 inhabitants reduced from 23.7 in 2012 to 18.4 in 2016, similar to Norway (18.6 in 2016) and the UK (18.7). Time series modelling estimated 24.8% fewer GP antibiotic prescriptions for upper respiratory tract infections (URTIs) by 2017 versus no awareness program.¹⁶ Consumer survey results indicated increased awareness of antibiotic resistance (50% in 2011, 74% in 2017) and that the minority expect antibiotics for URTIs (22% in 2017).¹⁶ Primary care physicians say they often feel under pressure from patients to prescribe antibiotics.¹⁷ Some studies report that patients strongly influence the antibiotic prescribing of GPs by using a number of different behaviours, such as, ‘I’m going on holidays tomorrow’ or ‘I got antibiotics for this infection last time and they worked’.¹⁸ Other studies report that only a small proportion of patients explicitly expect a prescription,¹⁹ and even if they do, their primary concern is to find symptomatic relief.¹⁴ In a Dutch survey, patients who, prior to the consultation, indicated a desire for an antibiotic, were equally satisfied with the consultation afterwards irrespective of whether they received an antibiotic or not. Furthermore, a clear explanation about the expected course and duration of disease and a proper physical examination correlated more to patient satisfaction than a prescription.²⁰ These studies were supported by a survey undertaken in Australia as long ago as 2004, which indicated almost all GPs believe patients come with at least some expectation of receiving antibiotics for cold and flu symptoms; however, patients place the most importance on examination and an explanation of treatments and recovery time.²¹

Recommendations for the symptomatic management of upper respiratory tract infections

URTIs, commonly known as colds and flu, are the most common medical conditions affecting humans, with adults suffering 2–4 colds each year and schoolchildren 5–10 colds each year.⁵ As antibiotics are often prescribed inappropriately to treat URTIs, it’s important to seek a more rational approach to URTI treatment, one in which the community pharmacist and pharmacy staff can play a pivotal role. The Global Respiratory Infection Partnership (GRIP) has developed such a framework.⁶

Therapeutic Guidelines for treatment of respiratory tract infections

In April 2019, the Therapeutic Guidelines for the use of antibiotics were extensively revised and updated. The guidelines state: ‘Antibiotics that are overused in primary care include amoxicillin+clavulanate, cefalexin, cefaclor, roxithromycin and erythromycin.’ Symptomatic treatment is the recommended first-line therapy for acute pharyngitis/tonsillitis, acute rhinosinusitis, acute otitis media and acute bronchitis. Specifically, with regard to acute pharyngitis/tonsillitis, the guidelines state that ‘most cases are viral (see Box 2). Even if infection is bacterial, antibiotic treatment is not required unless the patient is at increased risk of rheumatic fever (e.g. Aboriginal and Torres Strait Islander Australians or patients with scarlet fever)’.²² In addition to individual and community-acquired resistance from inappropriate use, there is increasing evidence that overuse of antibiotics can have the unintended consequence of also reducing or removing resident bacteria that are important for gut health. Use of broad-spectrum antibiotics has been observed to have several impacts on gut health, including: reducing microbial diversity in the gut,²³ reducing protective species such as Bifidobacterium spp²⁴ and promoting the colonisation of opportunistic pathogens such as Clostridium difficile that can cause pseudomembranous colitis.²⁵ In infants and young children, antibiotic use has also been linked to an increased risk of asthma and weight gain.²³

BOX 2 – THE UNDERLYING CAUSE OF URTIs

More than 200 viruses are known to be responsible for URTIs. The most common associated with the common cold are:

Rhinoviruses 30–50%
Coronaviruses 10–15%
Influenza viruses 5–15%

85–95% of sore throats in adults are caused by viruses

References: Eccles R,²⁷ Schulman ST²⁸

Case scenario 2

Martin, 40, a surveyor, brings to the pharmacy a repeat prescription for roxithromycin, the original of which had been dispensed some six months previously to treat a chest infection. He presents with aches and pains and yellow nasal discharge. He has no medical conditions or allergies. Utilising the 1,2,3 GRIP strategy for symptomatic treatment you:

1. Address patient’s concerns: identify the most troublesome symptom, duration and impact and ask about treatments used. Martin explains his mild aches and pains, but the most annoying symptoms are painful sinuses, slight nasal congestion and a yellow nasal discharge. ‘I had a bit of a cold with a sore throat a week or so ago. I thought I was over it, but now with this muck coming from my nose I reckon I need these antibiotics.’

Martin has taken paracetamol, ‘a couple of tablets, two or three times a day for the pain; it’s helped a bit’.

2. Be vigilant – Assess severity: identify risk factors, co-morbidities, other medical conditions/medicines being taken; ask about red flag symptoms and determine whether referral is necessary.

Martin has type 2 diabetes, diagnosed a year ago and currently controlled. He is taking metformin in accordance with prescribed directions. He admits to being about 10 kg overweight and now goes to the gym twice a week but, not feeling very well, hasn’t been this week.

Martin has no other medical conditions or allergies. He takes a daily multivitamin when he remembers. No red flag symptoms are apparent. You reassure Martin that coloured mucus is not an indication of a bacterial infection, but simply a normal inflammatory response to what is almost certainly a cold virus. Antibiotics would be of little value, adverse effects are possible and increased resistance is likely.

You discuss a range of symptomatic treatment options including nasal decongestants, sinus rinses and anti-inflammatory analgesics (the combination ibuprofen/paracetamol). Martin chooses the saline nasal spray (‘the sinus rinse is a step too far’) and ibuprofen/pseudoephedrine cold tablets.

You explain the normal duration of various common cold symptoms and provide Martin with the Colds and Flu PSA Self Care card and highlight self-management strategies.

You also stress that if the symptoms worsen or do not improve in 7 days, he should return for reassessment.

The GRIP approach to colds and flu

The Global Respiratory Partnership (GRIP) is a multi-disciplinary group of international experts, comprising of primary care and hospital physicians, microbiologists, researchers and pharmacists. GRIP members were selected due to their existing interest and work in the field of antibiotic use and resistance. All members are focused on implementing change in antibiotic use and the treatment of non-serious infections, such as URTIs, in primary care. The Partnership is committed to addressing antibiotic overuse-related problems, using evidence-based studies to support suitable rationale for antibiotic use and promote antibiotic stewardship among healthcare professionals.⁶ All GRIP materials were sponsored and developed in partnership with RB Healthcare. The views expressed in the materials are those of the Partnership. GRIP has created a simple three-step approach for pharmacists to address URTIs⁶:

Step 1 – address specific concerns of patients
Step 2 – be vigilant
Step 3 – counsel on effective self-management of symptoms.

Address patient concerns Pharmacists can determine the patient’s main or most troublesome symptoms. Many patients have a poor understanding of the normal duration of URTI symptoms and need to be reassured about the typical duration and severity of their illness. The average durations of respiratory tract infections are²⁶:

acute otitis media: 4 days
acute sore throat/acute pharyngitis/acute tonsillitis: 1 week
runny or blocked nose: 1–3 weeks
common cold: 10–14 days
acute rhinosinusitis: 2–3 weeks
acute cough/acute bronchitis: 3 weeks.

Pharmacists should discuss antibiotic resistance and explain why antibiotics are rarely needed: most URTIs are caused by viruses, antibiotics will provide no benefit, and can sometimes cause unpleasant adverse effects (e.g. allergy, thrush, vomiting and diarrhoea) and will increase the likelihood of resistance in the individual and in the community. Pharmacists should check what medicines have already been used; and determine what therapies will be most helpful. Be vigilant, assess severity Before recommending non-prescription therapy, we should assess the extent and severity of the symptoms, identify possible red flag symptoms and check for other medical conditions/high risk patients and refer if necessary. Patients for whom sore throat symptoms persist without improvement for more than one week, or get progressively worse, may need referral (see Figure 1).

FIGURE 1 – Red flag symptoms and high-risk categories

Symptoms that persist without improvement for more than one week (for sore throat), or appear to be getting progressively worse may need doctor consultation. Any of the following red flag symptoms also require further investigation:

Coughing up blood
Shortness of breath
Neck swelling on one side of the neck, unrelated to the lymph nodes
Great difficulty swallowing, e.g. unable to swallow food
Very high temperature (>390C) or night sweats
Drooling or muffled voice
Wheezing sounds when breathing.

Be alert to those patients at increased risk of complications:

Elderly patients aged >65 years or young children <2 years of age or born prematurely
Immunocompromised patients
Pre-existing conditions such as diabetes, cystic fibrosis, chronic lung disease and those with HIV
Specific local populations, such as Aboriginals or Torres Strait Islanders in Australia, American Indians or Indigenous Alaskans
Patients who show signs of being severely unwell.

Adapted with permission from GRIP Resources; 1,2,3 Resources. Discussion Guide. At: www.grip-initiative.org/media/1403/rb1619-grip-discussion-guide-a3-241018.pdf Counsel on effective self-management Reassurance (see Figure 2) and non-prescription medicines can be provided for symptomatic relief in the absence of red flag symptoms and in patients who are not at increased risk of complications (see Figure 1).

FIGURE 2 – Advice and counselling

Symptomatic treatments of choice

Sore throat, often the first indicator of an URTI, is caused by the inflammatory response to viral or bacterial infections.²⁹ This inflammatory response is the result of a complex mix of inflammatory mediators, but the dominant mediators are bradykinin and prostaglandins.³⁰ Bradykinin is a potent stimulant of pain nerve fibres and also causes vasodilation and increased capillary permeability resulting in tissue swelling.³¹ Topical anti-inflammatory medicines (benzydamine and flurbiprofen) are available as lozenges, sprays or gargles; and can be recommended for symptomatic relief of sore throat. Gargles only deliver the active ingredients to the anterior oral cavity and not the palatine tonsils or the pharynx.³² Medicated throat lozenges have the added advantage over sprays and gargles of being slow releasing and therefore delivering the active ingredients to the affected areas of the throat over a prolonged period of time.³³ An Australian study (n=320), comparing flurbiprofen lozenges to placebo, has shown flurbiprofen lozenges to be significantly superior to placebo in reducing throat soreness and swollen throat for up to 4 hours. The study evaluated subjective ratings for pain relief, throat soreness and swollen throat.³⁴ As prostaglandins play an important role in the generation of inflammation and pain, the systemic NSAID analgesics, such as ibuprofen, could be recommended.²⁹ Ibuprofen or paracetamol (or the more recently marketed ibuprofen/paracetamol combination) will also be useful if the URTI symptoms include headache, earache or sinus pain. When nasal congestion is problematic, the options include oral pseudoephedrine or phenylephrine. A topical decongestant such as oxymetazoline, tramazoline or xylometazoline – with appropriate warnings about prolonged use – can also be recommended. Ipratroprium bromide (or the combined ipratroprium bromide/ xylometazoline hydrochloride) nasal spray can be used when rhinorrhoea is a troublesome symptom.³⁵ Cold and flu symptoms can be multiple and varied. Multi-ingredient combination products are aggressively promoted and widely used. Specifically targeting the most troublesome symptoms with individual ingredient products would seem to be the most desirable therapy and result in the best resolution of symptoms.³⁶ However, a study conducted at The Common Cold Centre in Cardiff, United Kingdom, in 2014, showed that, when used as directed, the multi-ingredient combination products provided a safe, convenient, effective and cost-effective way of treating multiple symptoms of cold and flu.³⁶ The choice of product is dependent on presenting symptoms and patient preference. Pharmacists can assist in recommending the appropriate product. In addition to pharmacotherapy, it is important to recommend self-care strategies, such as: maintenance of hydration, steam inhalation, adequate rest, home hygiene, regular, healthy meals and avoidance of cigarette smoke or other airborne pollutants. It may also be useful to promote vaccination and provide consumers with a PSA Self Care Card (titles include Colds and Flu, Coughs and Sinus Problems) or an NPS MedicineWise ‘Respiratory Tract Infections Action Plan’ leaflet (downloadable from the NPS website).³⁷

Key points

Antimicrobial resistance is a threat to human health and presents a worldwide challenge.
Symptomatic treatment, in most cases, is the recommended first-line therapy for acute pharyngitis and tonsillitis.
Pharmacists can help manage the consumer’s main or most troublesome symptoms and refer when required.

To test what you have learned, complete the below questionnaire:

[cpd_submit_answer_button] References

World Health Organization. Fact Sheet No: 194 Antimicrobial resistance. At: www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
World Health Organization. The evolving threat of antimicrobial resistance – options for action. At: apps.who.int/iris/handle/10665/44812
Hajibagheri S. Exclusive. Antibiotic resistance could kill us before climate change, warns country’s top medical officer. Sky News. 2019. At: news.sky.com/story/antibiotic-resistance-could-kill-us-before-climate-change-warns-countrys-top-medical-officer-11796884
Zellweger RM, Carrique-Mas J, Limmathurotsakul D, et al. A current perspective on antimicrobial resistance in Southeast Asia. J Antimicrob Chemother 2017;72(11):2963– At: www.ncbi.nlm.nih.gov/pubmed/28961709
Australian Government Department of Health. Cold and flu statistics. 2018. At: healthdirect.gov.au/colds-and-flu-statistics
Global Respiratory Infection Partnership. GRIP’s pentagonal framework for a global change in antibiotic resistance. At: grip-initiative.org
Llor C, Bjerrum L. Antimicrobial resistance: risk associated with antibiotic overuse and initiatives to reduce the problem. Ther Adv Drug Saf 2014;5(6):229– At: www.ncbi.nlm.nih.gov/pmc/articles/PMC4232501/
Australian Commission on the Safety and Quality of Health Care, AURA report. 2016. At: www.safetyandquality.gov.au/publications-and-resources/resource-library/aura-2016-first-australian-report-antimicrobial-use-and-resistance-human-health-full-report
Dowson L, Rajkhowa A, Bulsing K, et al. The 2018 aged care national antimicrobial prescribing survey: results show room for improvement. Aust Prescr 2019;42(6):200– At: www.nps.org.au/australian-prescriber/articles/the-2018-aged-care-national-antimicrobial-prescribing-survey-results-show-room-for-improvement
National Collaborating Centre for Infectious Diseases. Proceedings of community-acquired antimicrobial resistance consultation notes. Winnipeg, Canada. February 2010. At: www.nps.org.au/media-centre/media-releases/
Center for Disease Control and Prevention (CDC). Disease/ pathogens associated with antimicrobial resistance. 2012. At: www.cdc.gov/drugresistance/DiseasesConnectedAR
Livermore DM. Current epidemiology and growing resistance of gram-negative pathogens. Korean J Intern Med 2012;27:128– At: www.ncbi.nlm.nih.gov/pmc/articles/PMC3372794/
National Prescribing Service. Media Release November 2014. Antibiotic awareness week 2014 – could your individual prescribing decisions be contributing to antibiotic resistance. At: www.nps.org.au/media-centre/
World Health Organization. What is the difference between antibiotic and antimicrobial resistance? 2020. At: www.emro.who.int/health-topics/drug-resistance/what-is-the-difference-between-antibiotic-and-antimicrobial-resistance.html
TNS Opinion & Social. Special Eurobarometer 338: Antimicrobial resistance. Directorate-General for Health and Consumers 2010. At: http://ec.europa.eu/health/antimicrobial_resistance/docs/ebs_338_en.pdf
Health Technology Assessment international meeting Cologne 2019. At: https://htai.org/wp-content/uploads/2019/08/htai_AM19_abstracts_20190812.pdf
Van Driel ML, De Sutter A, Deveugele M, et al. Are sore throat patients who hope for antibiotics actually asking for pain relief? Ann Fam Med 2006;4:494– At: www.ncbi.nlm.nih.gov/pubmed/17148626
Scott JG, Cohen D, DiCicco-Bloom B, et al. Antibiotic use in acute respiratory infections and the ways patients pressure physicians for a prescription. J Fam Pract 2001;50:853– Erratum in: J Fam Pract 2001;50:1077. At: www.ncbi.nlm.nih.gov/pubmed/11674887
Altiner A, Haag H, Schraven C, et al. Acute cough: what do patients expect? Z Allg Med 2002;78: 9–
Welschen I, Kuyvenhoven M, Hoes A, al. Antibiotics for acute respiratory tract symptoms: patients’ expectations, GPs’ management and patient satisfaction. Fam Pract 2004;21:234– At: www.ncbi.nlm.nih.gov/pubmed/15128681
van der Velden A, Duerden MG, Bell J, et al. Prescriber and patient responsibilities in treatment of acute respiratory tract infections – essential for conservation of antibiotics. Antibiotics 2013;2:316– At: www.ncbi.nlm.nih.gov/pmc/articles/PMC4790342/
Antibiotic prescribing in primary care: Therapeutic Guidelines summary table 2019. https://tgldcdp.tg.org.au/fulltext/quicklinks/GPSummary_v11.pdf
Korpela K, Salonen A, Virta LJ, et al. Intestinal microbiome is related to lifetime antibiotic use in Finnish pre-school children. Nat Commun 2016;26(7):10410. At: www.ncbi.nlm.nih.gov/pubmed/26811868
Rashid M et al. Determining the long-term effect of antibiotic administration on the human normal intestinal microbiota using culture and pyrosequencing methods Clin Infect Dis 2015;60(suppl 2)S77– At: www.ncbi.nlm.nih.gov/pubmed/25922405
Britton RA, Young VB. Role of the intestinal microbiota in resistance to colonization by Clostridium difficile. Gastroenterology 2014; 146(6):1547– At: www.ncbi.nlm.nih.gov/pubmed/24503131
National Institute for Health and Care Excellence. NICE Clinical Guideline 69. 2008. At: nice.org.uk/guidance/cg69
Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis 2005;5(11):718– At: www.ncbi.nlm.nih.gov/pubmed/16253889
Shulman ST, Bisno AL, Clegg HW et al. Clinical practice guideline for the diagnosis and management of group A streptococcal pharayngitis: 2012 update by the Infectious Diseases Society of America 2012;55(10):1279– At: www.ncbi.nlm.nih.gov/pubmed/23091044
Bathala S, Eccles R. A review on the mechanism of sore throat in tonsillitis. J Laryngol Otol 2013;127(3):227– At: www.ncbi.nlm.nih.gov/pubmed/23317998
Enna SJ, Steranka LR. Receptors and the common cold. Trend Pharmacol Sci 1989;10(10): 387– At: www.ncbi.nlm.nih.gov/pubmed/2694535
Steranka LR, Manning DC, De Haas CJ, et al. Bradykinin as a pain mediator: receptors are localised to sensory neurons and antagonists have analgesic actions. Proc Natl Acad Sci 1988;85(9):3245– At: www.jstor.org/stable/31982
Becker W, Naumann HH, Pfaltz CR. Ear, nose and throat diseases: a pocket reference. Thieme-Stratton Corp. New York. 1989. At: www.amazon.com/Ear-Nose-Throat-Diseases-Reference/dp/3136712013
Church A, Evans P. Pickford M, et al. Scintigraphy: an appropriate methodology to assess the effectiveness of medication formats in providing local delivery to the mouth and throat. Poster presented at the Annual Scientific Meeting of the British Pain Society, Glasgow, UK.24–27 April 2007.
Schachtel B, Aspley S, Shephard A, et al. Onset of action of a lozenge containing flurbiprofen 8.75 mg: a randomized, double-blind, placebo-controlled trial with a new method for measuring onset of analgesic activity. Pain 2014;155(2):422– At: www.ncbi.nlm.nih.gov/pubmed/24231654
Respiratory Expert Group. Therapeutic Guidelines. Respiratory. Version 5. Melbourne. Therapeutic Guidelines Limited 2015. At: www.clinicalguidelines.gov.au/register/therapeutic-guidelines-respiratory-version-5
Eccles R, Fietze I, Rose UB. Rationale for treatment of common cold and flu with multi-ingredient combination products for multi-symptom relief in adults. Open J Resp Dis 2014;4:73≠ DOI: 10.4236/ojrd.2014.43011 At: https://file.scirp.org/pdf/OJRD_2014080414262518.pdf
NPS MedicineWise. Respiratory tract infections action plan. At: https://cdn0.scrvt.com/08ab3606b0b7a8ea53fd0b40b1c44f86/fc2723c4a3fcdec8/31e4936adc6c/NPS-MedicineWise-RTI-Action-Plan--1-.pdf

JOHN BELL AM, BPharm, FPS, FRPharmS, FACPP, FFIP, FCPA, MSHP is a Practitioner/Teacher in Primary Health Care and Professional Services at the Graduate School of Health, University of Technology Sydney. Conflicts of interest – John Bell is a member of the International Global Respiratory Infection Partnership (GRIP) and Chair of GRIP Australia. GRIP is supported by an unrestricted educational grant from RB Healthcare. [post_title] => Upper respiratory tract infections – symptomatic management [post_excerpt] => URTIs, commonly known as colds and flu, are the most common medical conditions affecting humans, with adults suffering 2–4 colds each year and schoolchildren 5–10 colds each year. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => upper-respiratory-tract-infections-symptomatic-management-cpd [to_ping] => [pinged] => [post_modified] => 2020-04-16 08:40:14 [post_modified_gmt] => 2020-04-15 22:40:14 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.australianpharmacist.com.au/?p=9932 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [title_attribute] => Upper respiratory tract infections – symptomatic management [title] => Upper respiratory tract infections – symptomatic management [href] => https://www.australianpharmacist.com.au/upper-respiratory-tract-infections-symptomatic-management-cpd/ [module_atts:td_module:private] => Array ( ) [td_review:protected] => Array ( [td_post_template] => single_template_4 ) [is_review:protected] => [post_thumb_id:protected] => 9935 )

Upper respiratory tract infections – symptomatic management

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Case scenario
Cara has noted an increase in consumers in her pharmacy who have been requesting sleep apnoea supplies and decides to look into providing a range of sleep apnoea products to match this demand. Rather than relying on guesswork, Cara researches the key requirements for the effective treatment of sleep apnoea and selects a range of products that will meet these requirements and also meet Australian standards for quality, such as registration with the Therapeutic Goods Administration.

Cara undertakes training in the use of these products to ensure she can advise consumers correctly on their use and provide reliable advice to clients who require assistance in selecting sleep apnoea devices, such as replacement masks.

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

Define the term clinical governance and identify its importance to pharmacy practice
Discuss how pharmacists can apply clinical governance principles in practice.

Competency standards addressed (2016): 1.1, 1.2, 1.3, 1.6, 3.5, 4.7

Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.
Introduction
In corporate terms, governance is the application of oversight to an organisation to ensure consistency and stability in activities performed for the benefit of the organisation, accountability of staff and management in performing those activities, in a manner that minimises or manages undesirable risk.¹

Governance tends to guide the “why” of an organisation. This is distinct from day to day management of an organisation, which tends to deliver the “what” of an organisation. For instance, the management of a mining company focuses on the staffing, investment, and acquisition of natural resources, while the governance of a mining company may guide the way these activities are delivered in order to minimise environmental impact and risk of injury to employees. Compliance, risk management and ethics are all components of governance.¹

Clinical governance is a concept that has evolved from corporate governance, with a specific focus on health service delivery. The need for clinical governance within health services was first recognised in the UK and has since been adopted in Australia and other countries. It is akin to corporate governance in that it focuses on how health services are delivered, to enable continual assessment and improvement of services.²

The purpose of clinical governance is to ensure that health services are delivered to all recipients of care aimed to the same standard. Effective application of clinical governance in any context should result in the same services delivered by different organisations at the same level of quality and efficacy.
Clinical governance and pharmacy practice
The concept of clinical governance seeks to ensure acceptable quality of delivery of health services, through maintenance of standards, review of outcomes and continual improvement. This is represented in the following seven core principles that can be applied across any health service, regardless of size. Many industries and organisations will expand on these principles based on their specific needs; for instance, aged care services may have additional principles related to falls or chemical restraint.
Standards of training and education
For any service or health intervention, there is an expectation that the practitioners will be appropriately trained, including reaccreditation where necessary. This principle includes the understanding that as new research develops, training and education is updated to incorporate new learnings.
Research and development
Research and development is a key part of any health intervention – just as practitioners are expected to maintain competence in their field over time, research is required to ensure a health intervention remains appropriate as new developments emerge.
Record keeping
Keeping records about health services delivered, education and training of practitioners, and individual client interventions is of critical importance to the governance of any health service. Central to this is the ability to retrieve records in a contextually relevant manner – for instance, the recording of Clinical Interventions under the 6th Community Pharmacy Agreement is meaningless if this intervention cannot be seen and understood the next time a consumer presents to the pharmacy.
Risk management
Risk management involves the identification and mitigation of any risks associated with the health service, whether it be adverse outcomes, loss of funding, impacts on public perceptions of the service delivery organisation, or opportunity cost in delivering a specific service. Of the principles of clinical governance, risk management has the greatest in common with the principles of corporate governance.

It is important to note that risk cannot be eliminated; therefore a risk management strategy involves the identification of all potential risks, to which a weighting system is applied that highlights those risks that will have the greatest impact on the service or the clientele to which it is delivered. Addressing risk is therefore contextual to different periods of time based on both internal and external factors as circumstances change.

Case scenario continued
Cara has been providing sleep apnoea products in her pharmacy for a few months. She has become more interested in the condition, how it impacts a person’s quality of life, comorbidities, and risk factors for other conditions. Cara is enthusiastic about providing a case-finding service (see Box 1) for people who have existing risk factors for sleep apnoea but wants to ensure that the service is fit for purpose – and is delivered in a high-quality manner.

Cara researches sleep apnoea services offered to community pharmacy by third parties, but decides that the decision requires a better understanding of service delivery from an independent source. She accesses the PSA document Practice Guidelines for the Provision of Sleep Apnoea Services within Pharmacy.⁴ After familiarising herself with the guidelines, Cara decides that it is important to undertake accredited training in this area. She decides to research this training before implementing a sleep apnoea case-finding service in her pharmacy. Cara, meanwhile, continues to provide sleep apnoea devices to consumers who have been referred to her pharmacy.

BOX 1 – Case-finding defined

Case-finding is a risk stratification process by which resources are targeted at individual groups suspected to be at risk of a particular disease. Rather than waiting for signs and symptoms of active disease, case-finding involves systematically seeking at risk people.

Reference: HealthKnowledge²
Efficacy
The principle of efficacy in clinical governance is the most disparate principle from corporate governance. While a corporation may exist for the purposes of generating profits for its investors, a health service is delivered for the purposes of addressing a specific health need. The efficacy of health service delivery requires ongoing review to ensure that it is delivering the intended outcome. The concept of clinical governance arose in the United Kingdom due to similar services in different hospitals resulting in very different outcomes.⁵

Audit and review

A key principle of clinical governance is accountability. To deliver a health service in a manner that is responsive to the needs of the intended recipients, there must be an integrated method of assessing the impact, efficacy, cost effectiveness, and clinical relevance of that service. Reviews are a method of delivering on accountability by those who are delivering the service, while audits are ideally provided by an external assessor who is impartial. From a pharmacy perspective, the Quality Care Pharmacy Program (QCPP) is an example of an external audit that results in accreditation.

Openness

The concept of openness from a governance perspective addresses the cultural issues associated with errors and blame. The delivery of a health service will result in errors and near misses even in the most efficient of settings – openness is crucial to ensuring that these errors and near misses are identified and strategies implemented that can reduce future risk.

Openness among practitioners who are delivering the health service needs to be fostered so that these errors and near misses aren’t seen as a personal failing, but rather a result of the services’ structure and delivery method. When errors and near misses are seen as a natural consequence of service delivery instead of an individual’s failings, they can be identified and addressed appropriately.

Another key aspect to openness in the clinical setting is the concept of co-designed services. The development of any health service must include input from the people who would want to access that service. Without a basis of co-design, services may be unfit for purpose, difficult to access, or unappealing to the target audience.

Case scenario continued
Cara discusses her intention to develop a sleep apnoea service with consumers who have been purchasing sleep apnoea devices from her pharmacy; the discussion focuses on whether they see a need for a case-finding service, and whether they would be comfortable with this service provided by the pharmacy. The general attitude of acceptance of the proposed service model from existing consumers gives Cara confidence to proceed.

Cara undertakes accredited training in sleep apnoea, and is now confident to implement a case-finding service within her pharmacy (several obstructive sleep apnoea questionnaires can be found in Appendix 1 of PSA’s Practice Guidelines for the Provision of Sleep Apnoea Services within Pharmacy).³ After entering into an agreement with a sleep service provider, they communicate the new service to staff within the pharmacy, as well as local health services. Cara implements training for staff who will be delivering the service directly or indirectly (such as referring consumers to the pharmacist). They also ensure that they include sleep apnoea within their scope of practice on their Continuing Education Learning Plan and include the service design and review process in their Quality Care Pharmacy Program (QCPP) manual.

Clinical governance in different practice settings
Community pharmacy

In community pharmacy practice pharmacists often practice alone or with a small number of colleagues within the same setting. Despite this, there is a clear need for clinical governance for services that are delivered in community pharmacies to ensure consistency of service delivery.

Pharmacists who are considering the introduction of a new service into their practice can use the principle of clinical governance to assist in design and implementation. The PSA’s document Clinical Governance Principles for Pharmacy Services⁶ translates the principles of clinical governance into a format that is directly applicable to community pharmacy practice.

Pharmacists will still require a commitment to implement these standards in a manner that delivers on the clinical governance concept. This includes integrating the audit and review process in to QCPP accreditation cycles; working with the local community and other service providers in the development of the service offer; formulating an appropriate training and re-training plan; and undertaking a risk assessment to determine the impact (positive and negative) of the service.

General practice setting

As greater numbers of pharmacists work in the general practice setting, they will be exposed to the role of clinical governance within a small multidisciplinary team.

The PSA’s document Guidelines for General Practice Pharmacists7 provides essential resources to assist pharmacists to work within a clinical governance model of service delivery, allowing the pharmacist to integrate into existing services and develop new services based on community need and scope of practice.

Aged care facility setting

Pharmacists are beginning to take on roles within aged care facilities, providing fertile ground for new service design. Clinical governance principles are being utilised to strengthen communication pathways between community pharmacy and general practice in relation to the care of residents. At transitions of care, the aged care pharmacist is able to implement medication reconciliation services through a clinical governance model that draws in hospital providers, general practitioners, community pharmacists and facility staff.

Hospital pharmacy

Clinical governance within a hospital setting has the benefit of a wider infrastructure and a well-established culture of clinical governance frameworks that draw on the diversity of professions present in this setting. Clinical governance principles have led to the wider acceptance of proven models of care that utilise pharmacist expertise, such as pharmacists providing medication reconciliation services during emergency presentations and discharge.

Clinical governance in practice

The application of a clinical governance model in practice may seem daunting the first time it is implemented, but the process is designed to create stability and reproducibility to services across the sector. From the first idea through to delivery of the first service, following the principles of clinical governance provides a structured method of service design that can be applied to any service.

Applying a clinical governance model highlights the training required by staff, documentation requirements, health provider consultation, monitoring, communication, and the demand from the community for the service being developed. By starting with a clinical governance model, false starts and lacklustre service uptake can be avoided.

Case scenario continued
Cara has now been delivering a Sleep Apnoea Screening Service for a number of years. She and her staff have found the service rewarding, both for the increased service they have been able to provide to their clientele, and for the increased collaboration with health providers in the area who have referred people for sleep apnoea screening.

Despite this, Cara is mindful that all services require review and quality improvement to remain safe and relevant to those people who would benefit from the service. Cara undertakes a review of the service delivery, and while she is satisfied the service model implemented in the pharmacy remains the most appropriate for the setting, she notes it has been some years since she undertook training, and that a refresher course would be appropriate. At the same time, Cara decides to update training for the pharmacy assistants and the new intern pharmacist, ensuring they are all familiar with the service and the newer masks that have become available recently.

Key points

Clinical governance ensures continual assessment and improvement of health services. It encompasses compliance, risk management and ethics.
The seven core clinical governance principles that can be applied across any health service are: standards of training and education; research and development; audit and review; record keeping, risk management, efficacy, and transparency.

[cpd_submit_answer_button]

References

Governance Institute of Australia. What is governance? At: governanceinstitute.com.au/resources/what-is-governance/
Differences between screening and diagnostic tests and case finding. 2008. At: www.healthknowledge.org.uk/public-health-textbook/disease-causation-diagnostic/2c-diagnosis-screening/screening-diagnostic-case-finding
Australian Commission on Safety and Quality in Health Care. National model clinical governance framework. Sydney: ACSQHC; 2017. At: www.safetyandquality.gov.au/sites/default/files/migrated/National-Model-Clinical-Governance-Framework.pdf
Pharmaceutical Society of Australia. Practice guidelines for the provision of sleep apnoea services within pharmacy. 2015. At: https://my.psa.org.au/s/article/Sleep-Apnoea-Guidelines
Scally G, Donaldson LJ. The NHS’s 50 anniversary. Clinical governance and the drive for quality improvement in the new NHS in England. BMJ 1998;317(7150):61–5. At: www.ncbi.nlm.nih.gov/pubmed/9651278
Pharmaceutical Society of Australia. Clinical governance principles for pharmacy services. 2018. At: my.psa.org.au/s/article/Clinical-Governance-Principles-for-Pharmacy-Services
Pharmaceutical Society of Australia. Guidelines for general practice pharmacists. 2019. At: my.psa.org.au/s/article/Guidelines-for-general-practice-pharmacists

JARROD MCMAUGH BPharm, MPS is a PSA Project Pharmacist in the Victorian Office.[/vc_column_text][/vc_column][vc_column width="1/3"][/vc_column][/vc_row]
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Clinical governance

People

Minimising harm, building trust

Pharmacist of all trades

If catastrophe calls, include these ‘musts’ in your plan

Rural pharmacy resource advocate

Diversity is the word

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NUMBER OF t_½	STEADY-STATE LEVEL
1	50%
2	75%
3	87.5%
4	93.75%
5	96.89%
6	98.44%
7	99.22%
8	99.61%
9	99.80%

Pharmacists and smoking cessation

Searching for a vaccine

Help is at hand

What started you on the road to community pharmacy?

What insights can you bring to pharmacists after your many years in the profession?

How has the role of the pharmacist changed until your recent retirement?

What have the changing qualifications and language meant to the profession?

What do you think are your greatest achievements in harm minimisation?

What are your plans in retirement?

What has changed?

Starting conversations

Resources for pharmacists

A gap in the literature

Improving adherence

Symptom differentiation

Allergic rhinitis management

Drugs under investigation

Hydroxychloroquine for prevention

Other treatments

Unsafe practices

Case scenario

Learning objectives

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

What are haemorrhoids?

FIGURE 1 – Internal and external haemorrhoids

What are the symptoms of haemorrhoids?

Common symptoms of haemorrhoids include2:

Who gets haemorrhoids?

BOX 1 – HAEMORRHOIDS IN PREGNANCY

What conditions may be confused for haemorrhoids?

TABLE 1– Differential diagnoses of haemorrhoids

How can haemorrhoids be diagnosed?

What treatments are available to manage haemorrhoids?

TABLE 2 – Current over-the-counter therapies available in Australia for the management of haemorrhoids and anal fissures

What non-pharmacological approaches can patients take to help with symptom relief?

When should patients be referred?

What is an anal fissure and how is it caused?

What are the symptoms of anal fissures?

How are anal fissures diagnosed?

What over-the-counter management options are available for patients with anal fissures?

BOX 2 – GLYCERYL TRINITRATE – MECHANISM OF ACTION

When to refer

Case scenario continued

Conclusion

Key points

Learning objectives

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

Renal function

Age – paediatrics

Absorption

TABLE 1 – Paediatric age classes

Distribution

Metabolism

Excretion

Pharmacodynamics

TABLE 2 – Examples of physiological differences in children that influence the pharmacokinetic characteristics of some medicines

Age – elderly

Absorption

Distribution

Metabolism

Excretion

Body weight

Body size descriptors

TABLE 3 – Body size formula

Absorption

Distribution

Metabolism

Excretion

Genetic variability

Therapeutic drug monitoring

Conclusion

Key points

Case scenario

Learning objectives

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

Introduction

Pharmacokinetics and pharmacodynamics

Onset and duration of action

Volume of Distribution (Vd)

Clearance (Cl)

Common symptoms of haemorrhoids include²:

Volume of Distribution (V_d)

Steady-state concentration (C_ss)

BOX 3 – ORGANIC ANION-TRANSPORTING POLYPEPTIDES^13,14