Introduction to Minor Ailment and Self-Care Prescribing

Historical Context, 2010

The Pharmacy Act, 1996 was amended effective September 1, 2003 giving pharmacists authority to prescribe drugs. At that time pharmacist prescribing was limited to emergency contraception. On March 3, 2010 the Saskatchewan Minister of Health announced his intention to approve regulations and bylaws expanding this authority to other drugs. In the meantime, an Advisory Working Group made up of stakeholders from various areas of drug management (e.g. physicians, nurses, dentists, pharmacists, etc.) developed policies for pharmacist prescribing. The Saskatchewan College of Pharmacists Council approved these policies and drafted corresponding regulations and bylaws. Ministerial approval for enhanced authority for pharmacist prescribing was subsequently granted.

Level 1 of enhanced prescribing authority for pharmacists includes the provision for pharmacists to prescribe Schedule 1 drugs for the treatment of minor, self-limiting and self-diagnosed ailments such as rashes, cold sores and hay fever. Similar minor ailment models have been piloted and implemented in Great Britain within the past decade. Preliminary data from Great Britain suggests that these programs have increased access for the public to healthcare for minor ailments, increased access to physicians for patients with more serious conditions and reduced costs to the national healthcare system. In Nova Scotia, legislation approving expanded prescribing authority for pharmacists including prescribing for minor ailments has just been passed. Similar programs are being considered in many other Canadian provinces.

In a minor ailment program, the pharmacist is the first point of contact for the patient. The patient approaches the pharmacist for advice about treatment of a self-diagnosed condition. If the self-diagnosis is reasonable based on the pharmacist’s assessment and the best treatment option in the pharmacist’s judgement is a Schedule 1 drug, the pharmacist can initiate a prescription. If the pharmacist is unable to confirm the patient’s diagnosis and / or the patient’s symptoms are severe, the pharmacist will refer the patient to a physician or other appropriate healthcare provider. The prescribed drug must be (1) listed in minor ailment guidelines and (2) have an approved indication for the patient’s self-diagnosed condition. The pharmacist is required to record the prescription with the Pharmaceutical Information Program and to notify the patient’s physician of the prescription. Physician or other practitioner authorization is required for repeat or maintenance therapy for most conditions.

The Saskatchewan Drug Information Service (now medSask) was contracted by the Saskatchewan College of Pharmacists to prepare the Minor Ailment guidelines. The first step involved reviewing the literature and consultation with other Canadian pharmacy organizations. From this information, a list of conditions that could potentially qualify as minor ailments and a list of prescription drugs that might be suitable for patient self-care of these conditions were compiled. The next step was consultation with Saskatchewan community pharmacists through nominal group meetings; the first in Saskatoon, Jan. 5th, 2010 and the second in Regina. Jan. 12th, 2010. The groups were asked to (1) select criteria to define minor ailments and prescription drugs appropriate for pharmacists to prescribe for these conditions and (2) to apply these criteria to select specific conditions and drugs to be included in Saskatchewan minor ailment program. The results from the group meetings are summarized below.

Suggested criteria for Minor Ailment conditions

• Can be reliably self-diagnosed by patient
• Self-limiting condition
• Laboratory tests are not required for diagnosis
• Treatment will not mask underlying conditions
• Medical and medication histories can reliably differentiate more serious conditions
• Only minimal or short-term follow-up needed

Suggested criteria for prescription drugs suitable for pharmacist prescribing for patient minor ailments

• Has an official indication for the self-care condition 
• Has valid evidence of efficacy for the self-care condition
• Has wide safety margin
• Not subject to abuse
• Dosage regimen for treatment of self-care conditions is not complicated

 Using these criteria, the conditions and Schedule I drugs listed in Table 1 were considered appropriate for the Minor Ailment program.

TABLE 1: Schedule I drugs appropriate for prescription by pharmacists for specified minor ailment or self-care conditions

System	Condition	Drug Class	Specific Rx Drug
CNS	Headache and Migraine	NSAIDs	ibuprofen all strengths naproxen all strengths diclofenac
		Triptans (Appropriate for self-diagnosis of recurrences but initial diagnosis should be made by physician)	almotriptan naratriptan rizatriptan sumatriptan zolmitriptan eletriptan (non-formulary) frovatriptan (non-formulary)
Eyes, Ears, Oral	Cold sore	Antivirals (topical, oral)	acyclovir cr/oint/oral famciclovir  valacyclovir
	Mouth ulceration (mild)	Corticosteroids (dental)	triamcinolone dental paste
	Oral thrush	Antifungals (oral)	nystatin drops
Dermatology	Acne (mild – mod.)	Benzoyl peroxide	benzoyl peroxide (BP) up to 10 %
		Antibiotics (topical)	clindamycin phosphate clindamycin / BP clindamycin / tretinoin erythromycin / BP erythromycin / ethyl alcohol /avobenzone/octinoxate   erythromycin / tretinoin
		Retinoids	adapalene cr 0.1%, 0.3%; gel 0.1% adapalene 0.1%/BP 2.5% tazarotene 0.05%,0.1% cr or gel tretinoin cr or gel all strengths  tretinoin/avobenzone/octinoxate cr all strengths
	Atopic dermatitis (mild – moderate)	Corticosteroids, low  - moderate potency (topical)	hydrocortisone cream 1 %, 2.5 % desonide 0.05 % betamethasone valerate clobetasal butyrate diflucortolone valerate hydrocortisone valerate mometasone furoate triamcinolone acetate
	Diaper rash	Antifungal / corticosteroids (topical)	clotrimazole hydrocortisone 1 % cr / oint
	Insect bites	Mild corticosteroids	hydrocortisone 1 % cr/oint
	Skin infections (bacterial)	Antibiotics (topical)	fucidic acid cr/oint mupirocin cr/oint
	Tinea infections (athlete’s foot, jock itch, ringworm)	Antifungal (topical)	terbinafine 1 % cr ketoconazole 2 % cr
Gastrointestinal	Dyspepsia / GERD	H2 Receptor antagonists	cimetidine 300, 400, 600 mg famotidine 40 mg nizatadine 150, 300 mg ranitidine 150, 300 mg
		PPIs	esomeprazole 20, 40 mg lansoprazole 15, 30 mg omeprazole 10, 20 mg pantoprazole 40 mg rabeprazole 10, 20 mg
	Hemorrhoids	Corticosteroid combinations (rectal)	HC / zinc sulphate HC /  zinc sulfate, pramoxine
Genitourinary	Dysmenorrhea	NSAIDs	celecoxib diclofenac ketoprofen mefenamic acid naproxen sodium
Musculoskeletal	Pain	NSAIDS	diclofenac diclofenac/misoprostol naproxen
		Cox-2 Inhibitors	celecoxib meloxicam
Respiratory	Allergic rhinitis	Intranasal antihistamine	levocabastine
		Intranasal corticosteroids	beclomethasone mometasone furoate fluticasone proprionate

TABLE 2: Schedule I drugs appropriate for pharmacists to prescribe under the circumstances described below:
NOTE: SASKATCHEWAN PHARMACISTS ARE NOT CURRENTLY AUTHORIZED TO PRESCRIBE FOR PHARYNGITIS ALTHOUGH THIS CONDITION HAS BEEN APPROVED IN PRINICIPLE BY THE SASKATCHEWAN COLLEGE OF PHARMACY PROFESSIONALS COUNCIL

a) Self-diagnosed recurrences of specified conditions after initial diagnosis or assesment for underlying conditions by physician or nurse practitioner

• Conditions
  • Uncomplicated acute cystitis
  • Erectile dysfunction (ED)
  • Onychomycosis
• Patient history of previous medical diagnosis of condition and assessment of risk factors is a requirement before pharmacists can prescribe for these conditions, otherwise the patient must be referred to a medical doctor or nurse practitioner (or podiatrist in case of onychomycosis) for initial evaluation and diagnosis.
• There is limited information on the length of time a prior diagnosis or assessment would be valid, so this will be left up to the judgement of the pharmacist. (For example, anecdotal reports suggest women who have had a previously confirmed episode of cystitis would be able to recognize symptoms of a recurrence many years after the initial occurrence.)
• Check PIP and/or pharmacy records for medication used to treat previous episodes.
• Check eHR Viewer if lab tests, culture results are relevant to prescribing.

b)  Pharmacists have access to additional training on assessment and prescribing criteria for these conditions

• Conditions
  • Pharyngitis
  • Influenza
  • Conjunctivitis
  • Shingles
• Training on throat swab technique and analysis, relevant physical assessment and antimicrobial stewardship prescribing guidelines for these conditions will be provided for pharmacists.
• Pharmacist prescribing of oral antiviral agents will be authorized ONLY during an epidemic or pandemic declared by the Chief Medical Health officer for Saskatchewan

 c) Health promotion / wellness services

• Conditions
  • Contraception, ongoing: hormonal contraceptives (HC)
  • Emergency contraception (EC)
  • Obesity
  • Smoking cessation
• Comprehensive training on assessment, prescribing and monitoring of HCs, providing EC and family planning counselling (including long acting reversible and permanent contraceptive options) will be provided for pharmacists. When non-hormonal contraception is the most appropriate or preferred option, the patient will be referred to a medical doctor or nurse practitioner.
• Prescribing for smoking cessation or obesity should be part of an overall lifestyle change program for smoking cessation (e.g., PACT) or weight loss whenever possible to increase the likelihood of successful therapy.

Condition	Drug Class	Specific Rx Drug	Comments
Conjunctivitis, allergic	Antihistamines, mast cell stabilizers (Ophth)	ketotifen drops olapatadine drops lodoxamide drops nedocromil drops	Concern about patient ability to differentiate between bacterial and allergic conjunctivitis
Conjunctivitis, bacterial	Antibiotics (Ophth)	erythromycin oint. trimethoprim-polymixin drops tobramycin oint., drops	As above. Anecdotal reports of resistance to gentamicin ophthalmic drops.
Contraception, emergency		levonorgestrel ulipristal acetate
Contraception, ongoing	Hormonal contraceptives	combined estrogen/progestin: oral, dermal patch, vaginal Progestin-only oral
Erectile dysfunction	PDE inhibitors	sildenafil tadenafil vardenafil	Concerns about recreational use, abuse.
Herpes zoster (Shingles)	Antivirals (oral)	acyclovir famciclovir  valacyclovir	Suggested as possibly appropriate. No precedent found in the literature
Influenza treatment / prophylaxis	Antivirals	oseltamavir zanamavir	Concerns about inappropriate use, resistance
Obesity	Lipase inhibitor	orlistat	Obesity not considered a self-limiting condition
Onychomycosis	Antifungal, topical	efinaconazole	Medical guidelines recommend microscopy of nail scrapings to diagnose and culture if uncertainty
Pharyngitis (Sore throat)	Local analgesics Antibiotics	benzydamine penicillin V amoxicillin cephalexin clindamycin clarithromycin azithromycin	Concern regarding masking strep throat
Acute, uncomplicated cystitis	Antibiotics	co-trimoxazole fosfomycin tromethamine nitrofurantoin trimethoprim	Appropriate for self-diagnosis of recurrences but initial diagnosis should be made by physician.

Participants in the group meetings suggested that the following information should be included in the guidelines:

• Information used by physicians for diagnosis
• Time frame for follow-up with patients
• When to refer patients to family physician
• Comparisons of drug efficacy, side effects, etc. to help in choice of drug to prescribe
• Age restrictions
• Drug dosage protocols
• Limitations on quantity of drug prescribed / duration of treatment

The purpose of the guidelines is to provide community pharmacists with tools to facilitate the decision-making and documentation processes of prescribing for minor ailments self-diagnosed by patients. Each guideline consists of three documents; (1) an overview of pathophysiology, patient assessment and treatment for each condition (2) a treatment algorithm and (3) an assessment and treatment checklist.

The medSask Guidelines for Prescribing for Minor Ailments and Patient Self-Care (the “Guidelines”) are intended to be used as a tool to aid decision-making when prescribing for certain minor ailments or self-care conditions. The Guidelines are intended solely for educational and informational purposes and are not to be used for diagnostic purposes, and do not replace personal skill, professional judgment, and care of a pharmacist or other healthcare professionals.

1. Overview

• Brief description of pathophysiology and epidemiology of condition
• Common symptoms - to assess patient self-diagnosis.
• Differential diagnosis / when to refer – alternative diagnoses, patient characteristics (e.g. age, concurrent medical conditions), red flag symptoms that could indicate more serious conditions 
• Non-pharmacological treatment
• Over-the-counter drug options
• Schedule 1 drug options appropriate for pharmacist prescribing – points to consider in choosing which agent to prescribe
• Advice/Monitoring parameters  - special directions for use, onset of effect, when to follow-up with patient, when to refer to physician, advice on prevention, etc.

2. Algorithm

• Visual treatment decision tree for quick reference

3.  Pharmacist Assessment / Treatment Checklist

• Checkbox list of criteria for diagnosis confirmation, physician referral and choice of treatment (recommendations and / or prescription)
• Can be printed to fax to primary care provider
• Can serve as documentation of patient intervention

Document prepared by Karen Jensen MSc, BSP
Manager, medSask
Updated  Oct 31, 2018