National Pharmacy Association
Pharmacy name and addressSOP prepared by (full name and role)SOP reviewed by (full name and role)SignatureSignatureDate SOP preparedSOP reviewed dateSOP version numberSOP version numberThe information contained within this document is in line with the current Data Protection Act (DPA) requirements. This information may be subject to change upon implementation of the General Data Protection Regulations (GDPR) on 25th May 2018.ScopeThis SOP sets out the process for selling medicines, including pseudoephedrine and ephedrine-containing productsGuidanceIMPORTANT: The RP must be signed in when making any sales of medicinesRefer to the “delegation of responsibilities” notes to ensure that for each action/activity to be delegated, it takes into account the competency of the relevant team member to carry out that action/activityReferral to the pharmacistCertain categories of requests / symptoms / conditions (as listed in Table 1 below – this is not an exhaustive list) should always be referred to the pharmacist for assessment before making any supply. Table 1: Referral to the pharmacist prior to an OTC sale (amend as required)Reason for referralExamples of where the referral can be madeChild requesting an OTC medicineChild experiencing severe pain Child in distress Child under 16 years of age requesting a supply of EHCAlarm symptoms Loss of appetitePersistent symptomsSevere painUnexplained bleedingUnexplained weight loss Visual disturbancesVomiting (when not associated with an acute viral condition)If longer than normally expected for the conditionExisting conditions Underlying conditions such as asthma, cancer, diabetes, epilepsy Potential interactionsInteractions with prescribed medicines, OTC medicines and/or herbal products“At-risk” groupsChildrenBreastfeeding or pregnantElderly or frail Medicines with the potential for abuseCodeineCyclizineLaxativesPhenergan?Pseudoephedrine / ephedrineSedating antihistaminesLarge/ multiple requestsFor different members of family Going away on holiday Regular requestsProducts only to be sold by a pharmacistEmergency hormonal contraceptivesP medicines stored in the dispensary Cyclizine tablets 50mgPOM to P reclassificationsImigran? Recovery tablets 50mg Phenergan elixir or tabletsParacetamol effervescent tablets 500mg, pack size 100Patient assessment before OTC saleUse WWHAM mnemonic for patient assessment as appropriateWho is the medicine for?What are the symptoms?How long have symptoms been present?Actions taken already?Medicines been taken?Sale of medicines within licensed indications A medicinal product can only be sold over-the-counter (OTC) in accordance with its marketing authorisation. This information can be found within the product’s Summary of Product Characteristics (SPC) listed on the electronic Medicines Compendium website (.uk/emc/), or from the Medicines & Healthcare products Regulatory Agency (MHRA) website (.uk/pil-spc)Sale of medicines to children There is no legal minimum age limit for OTC sales to children – pharmacy staff should refer to the pharmacist Maximum and multiple pack sizes of medicines for OTC saleThere are legal restriction on certain medicines in terms of the maximum amount that can be supplied as an OTC sale, as listed below in table 2.Table 2: Maximum and multiple pack sizes of medicines for OTC saleMedicineGuidanceAspirin and paracetamolMaximum of 100 capsules/ tablets, including soluble tablets If the product being sold falls under the British Pharmacopoeia definition of an effervescent tablet, this restriction does not applyCodeine and dihydrocodeine Maximum pack size of 32 tablets/capsules Codeine or dihydrocodeine are licensed for short-term use only – customers requiring treatment periods in excess of three days should be referred to their doctor Additional MHRA restrictions are in place for codeine, for example, it should not be recommended for children between the ages of 12 and 18 with breathing problems – refer to the MHRA section of the GOV.UK website Pseudoephedrine and ephedrineMaximum of 720mg pseudoephedrine or 180mg ephedrine Pharmacists may use professional discretion, in exceptional circumstances, to supply multiple packs of pseudoephedrine or ephedrine-containing products if the request is for different members of a household, as long as the total quantity sold is below the set limitsCannot sell pseudoephedrine-containing products at the same time as ephedrine-containing products, irrespective of strength or total quantity of the active ingredientsNo suitable medicine for sale or if referral to RP is requiredSuitable medicine for sale and no referral neededNoYesNot competentIndividual presents with minor ailment and/or OTC product requestConsider use of consultation room and/or need for chaperone to be presentCompetent individual Is it possible to speak to patient representative/carer/ parent/ guardian?Use WWHAM mnemonic as appropriate to consider action to take, even if request is for a particular medicineRefer to the pharmacist - PMake sale and offer appropriate advice Offer appropriate advice and/or signpost for referral or RP recommends the sale of a medicine – P (if required)Refer to relevant self-care and signposting SOP ................
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