Pharmacy (P) Medicines Past Paper PDF
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Uploaded by NobleSage1736
University of Sunderland
2024
John Sherwood MRPharmS
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Summary
This document is a set of lecture notes or study materials for a pharmacy class regarding the sale and supply of medicines. The document covers various aspects of pharmacy practice relevant to P medicines, such as learning outcomes, legal regulations, professional guidelines, and examples of questions. It references the University of Sunderland.
Full Transcript
WEEK 18 Sale and supply of medicines – Part 2 Pharmacy (P) Medicines John Sherwood MRPharmS 27th November 2024 Slide 1 of 24 OSPAP MPHM15 Sale and Supply...
WEEK 18 Sale and supply of medicines – Part 2 Pharmacy (P) Medicines John Sherwood MRPharmS 27th November 2024 Slide 1 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Learning outcomes Explain the circumstances which must be fulfilled for a P to be lawfully sold or supplied Define ‘supervision’ legally and be able to relate it to pharmacy scenarios Understand why the legal definition is likely to change in the future and explain the reasons for this Know the classification of paracetamol and aspirin products and how many multiple packs may be sold in one transaction List the restrictions on OTC pseudo/ephedrine products and describe how they may be legally sold List the restrictions on OTC codeine/DHC products and describe how they may be legally sold Explain the difference between professional and legal requirements for the sale of P medicines in relation to requests for large quantities Explain the rationale for where these medicines are merchandised in the pharmacy and be aware of GPhC requirements regarding this Slide 2 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Pharmacy (P) medicines (1) There is no definitive list of Pharmacy medicines P medicines are medicinal products which are not POM or GSL or which are classified by the manufacturer as P in their marketing authorisation Medicines made in a pharmacy for retail sale under the exemptions from licensing are all P medicines How can you tell if a medicine is a P medicine? Be careful not to describe P medicines as ‘Pharmacy only medicines’ (as these products are legally classified as GSL (see GSL lecture)) Slide 3 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Pharmacy (P) medicines (2) Some POMs are P when they are sold in smaller pack sizes, or strengths, or for certain indications, or in a certain pharmaceutical forms Strength and pharmaceutical form e.g., hydrocortisone – 1% cream 15g (P) For a specific indication e.g., Naproxen 250mg – primary dysmenorrhea in women aged between 15 and 50 years (P) Some controlled drugs at low strengths e.g., codeine, dihydrocodeine and morphine are exempt from POM status when in preparations containing only one of the controlled drugs below a stated strength Slide 4 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Selling paracetamol tablets 500mg Which of these is an illegal sale of paracetamol tablets 500mg (non- soluble) in a single transaction to the same purchaser? A. 1 box of 16 from a newsagent B. 2 boxes of 16 from a newsagent C. 3 boxes of 16 from a newsagent D. 1 box of 32 from a pharmacy E. 2 boxes of 32 from a pharmacy F. 3 boxes of 32 from a pharmacy Slide 5 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Schedule 15 Products Aspirin, ibuprofen and paracetamol Paracetamol tablets 500mg (non-soluble) Pack size of 16 – GSL Pack size of 32 – P It is illegal to sell a quantity of > 100 tablets over the counter (NB Packs of 100 are classified as POM) In a pharmacy, multiple packs of paracetamol can be sold to the same patient up to the POM limit but this is at the professional discretion of the pharmacist, who should authorise the sale. NB Paracetamol tablets soluble 500mg – no legal maximum, use professional discretion (same for liquids, powders, granules) See MEP (online) for further information Slide 6 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Sale of Pharmacy (P) medicines May not be sold by any person unless: They are lawfully conducting a pharmacy business The premises is a registered pharmacy They are a pharmacist or, if they are not, they are acting under the supervision of a pharmacist The above does not apply to the supply of a medicinal product in the event or anticipation of pandemic disease where a protocol has been approved by a Government Minister Sale must comply with GPhC Standards for Pharmacy Professionals and any related GPhC guidance relating to pharmacy staff and premises Slide 7 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Definition of supervision (1) Sales of P medicines must be done by the pharmacist or by a member of staff acting under the supervision of a pharmacist Interpretation of this term has been provided during a criminal court case The legal definition of supervision is: The pharmacist must be aware of the sale and be in a position to intervene where necessary Sale or supply of a medicine cannot be said to be supervised when the pharmacist is absent from the pharmacy, no matter for how short a period Can a pharmacist be present in the pharmacy premises and not be in a position to supervise the sale of P medicines? Slide 8 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Definition of supervision (2) But this legal definition was made in a case involving the sale of a part 1 poison in 1943 (which also had to be sold ‘by or under the supervision of a pharmacist’ – Pharmacy and Poisons Act 1933) The same term is used in the Medicines Act 1968 regarding the sale of a P medicine The assumption is that the same definition would apply but this has never been tested in the Courts for the sale of P medicines Pharmacy practice has moved on since 1968 and there are real practical difficulties in ensuring P medicines are supervised even when the pharmacist is in physical close proximity to the medicines counter (e.g. in the consultation room) Slide 9 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Sales of P medicines whilst the pharmacist is in the consultation room This is the issue which causes most concern The pharmacist is likely to be near the P medicines counter but they are in a sound-proofed room The GPhC have advised that the sale of P medicines can still take place if the pharmacist is in the consultation room providing that: the pharmacy has robust standard operating procedures (SOPs) in place which detail when pharmacist intervention would be required in the sale of P- Medicines and staff members have ensured that they have followed those procedures and are happy to make the sale, and the pharmacist is happy for sales to take place when they are in the consultation room, as they will be responsible for any sales of P-Medicines that take place If staff members are unsure about anything or have any questions, they must be able to speak to the pharmacist before any sale is made This is GPhC (good practice advice) – the legal definition still applies Slide 10 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Supervision of P medicines - Update In 2022, various pharmacy organisations came together to form ‘The Pharmacy Supervision Practice Group’ In August 2023 they produced a report, ‘Supervision in Community Pharmacy’ The report makes recommendations to reframe legislation, regulation and professional standards and guidance around the future of supervision in community pharmacy The report says ‘…whilst the pharmacist should be present in the pharmacy and accessible to patients and the public, primary and secondary legislation should be clarified to reflect that “supervision” should no longer be interpreted to mean supervising individual transactions. A clarifying statement or direction in legislation or regulatory rules and standards to remove the case law precedent would be a helpful step forward.’ The report has been passed to the DoHSC and the GPhC The report does not change any information on the previous slides – all the information on the previous slides still applies now The key concern here is patient safety Slide 11 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 RPS Professional Guidance (1) The RPS produced professional guidance regarding the supply of all OTC medicines (i.e. GSL and P) Patient experience and patient-centred care Patients are supported in their decision-making about medicines Patients are treated with dignity and respect by pharmacy staff The pharmacy team respect privacy and confidentiality and are empathic to patient sensitivities The views of patients and carers are actively sought in the development and delivery of pharmacy services Patients have access to high quality information and support in order to make informed choices about the use of medicines in a manner they can easily understand Pharmacists support the provision of clear, understandable information about medicines Patients can ask to discuss their medicines with a pharmacist Slide 12 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 RPS Professional Guidance (2) Safe and effective use of medicines and medicines expertise Medicines recommended are chosen to maximise safety, effectiveness and adherence to treatment The pharmacy team provides expertise and advice to support the safe and effective use of medicines by patients The pharmacy team are aware when referral to the pharmacist or other healthcare professional is necessary Pharmacists are readily accessible to provide advice for other pharmacy staff and patients Pharmacists support optimisation of treatment with their expertise in medicines Pharmacy medicines must not be accessible to the public by self-selection Workforce The pharmacy team have the right skill mix and the capability and capacity to develop and provide quality services to patients Induction and ongoing learning and development are provided for all members of the pharmacy team The pharmacy workforce is planned and appropriately resourced in order to support service quality, productivity and safety. Slide 13 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 RPS Professional Guidance (3) Pharmacists need to be particularly careful when selling medicines where the pack sizes are restricted by law or for any requests for large quantities Always need to consider legal restrictions on pack sizes which may be GSL or P in small packs but POM in larger packs Medicines sold OTC are mostly intended to treat acute conditions (with a few exceptions) A request for an excessive quantity may indicate abuse, misuse or inappropriate self-treatment There is always the option to sell a smaller quantity of medicine or refuse the sale (with explanation and appropriate signposting) Welfare and safety of the patient must be the prime concern Slide 14 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Location of P medicines in the pharmacy (1) The law does not state where in the pharmacy P medicines should be merchandised Traditionally, P medicines are stored behind the pharmacy counter (which is usually near the dispensary where sales can easily be supervised) Such a location reminds staff of the legal classification of these medicines as well as helping to preventing unauthorised sales when the pharmacist is not in a position to supervise the sale It was always a professional/good practice requirement that P medicines should not be placed on self-selection shelves Slide 15 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Location of P medicines in the pharmacy (2) Some pharmacies place empty boxes of P medicines on self- selection shelves so that patients can read the information on the box before deciding whether to purchase it (and exchange it for a ‘real’ pack at the pharmacy counter after suitable checks for suitability have been made) Another option is to place P medicines in front of the medicine counter but behind glass or plastic lockable doors so that patients are able to read information on the box In both cases above, the safety of patients buying P medicines should be paramount Pharmacy staff should ask appropriate questions to ensure the medicine is suitable for the patient, especially where a request is based on advertising or a recommendation from someone else Slide 16 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 P medicines available on open display or on self-selection (1) The GPhC does allow P medicines to be on open display or on ‘facilitated self-selection’ providing that the pharmacy has ‘key safeguards in place’ The GPhC say that ‘key safeguards’ could include technological solutions to prevent inappropriate sales being completed, or safeguards relating to staff roles, responsibilities and training as well as ongoing team learning. For example, the tills may be programmed to recognise P-medicines and prevent sales being made either by unqualified staff or in an unregistered part of the premises. The pharmacy must have done a risk assessment before they make P medicines available on open display/facilitated self-selection Slide 17 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 P medicines available on open display or on self-selection (2) The GPhC acknowledges that some P medicines may not be suitable for open display/facilitated self-selection. This could include those liable to misuse or abuse, those that are at higher risk of theft/shoplifting. Examples might include codeine-containing products, recent POM to P switches, sleep aid medicines or any high value medicines. The risk assessment should describe the action(s) the pharmacy has taken to minimise or avoid the risks identified. For example, the products may be kept out of sight, or in a locked display cabinet. Particular care must be taken to ensure that if there is no pharmacist available on the premises then these medicines are not sold. This may be harder to enforce if the medicines are on open display Refusal of the sale of a P medicine could be more difficult if the patient has already selected the medicine. Any refusal should include the explanation for the refusal and any advice for the patient to see further care or help Slide 18 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Ephedrine / Pseudoephedrine Used as decongestants and all medicines containing them are P Due to their potential for misuse, there are legal restrictions on the quantities that can be sold or supplied OTC MHRA were considering making these products POM. Instead, they decided to limit the quantity that may be sold and asked pharmacy to monitor sales Legal maximum quantity that can be sold in any transaction 720mg pseudoephedrine 180mg ephedrine Unlawful to sell a pseudoephedrine-containing product at the same time as an ephedrine-containing product RPS advise that the sale should be made by a pharmacist or by a trained member of staff acting under the supervision of a pharmacist Even a lawful request should be refused if there are grounds for misuse Suspicions can be reported to the local GPhC inspector, local CD liaison police officer or accountable officer See MEP (online) for signs of possible misuse and RPS Quick Reference Guide Slide 19 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Codeine / Dihydrocodeine P medicines, in low strengths, used as analgesics Risk of overuse and addiction so the sale is restricted as below: Indication: short term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone. No longer recommended for cold, flu, cough, sore throats and minor pain Pack sizes: Maximum pack size of 32 dose units (all formulations, including effervescent)(> 32 are POM) PILs and labels: The warning ‘Can cause addiction. For three days use only’ must appear on the pack. Also, a warning on the pack and PIL that the medicine can cause addiction or overuse headache if used continuously for more than 3 days. The PIL must also contain information about the warning signs of addiction. RPS recommends a maximum of one pack to be sold per transaction In September 2020, the MHRA required that warnings in PILs of all opiate containing products (POM and P) must be strengthened in terms of the risk of dependence and addiction if used for a long period of time. Slide 20 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 PROMOTION OF MEDICINES Slide 21 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Promotion of Medicines The sale of medicines in a pharmacy is a professional activity Medicine prices are not ‘fixed’ and to try and prevent competition on price is unlawful Promotions that include free ‘gifts’ of medicines are deemed unacceptable by the MHRA Promotions that aim to sell higher quantities of medicines that patients need are unprofessional and could have patient safety consequences Price promotions may encourage the stock piling of medicines by patients and subsequent use for too long a duration or use beyond the expiry date Most medicines available OTC are for the short-term relief of acute conditions (with the occasional exception) – continual use should be questioned Promotions of medicines encourages patients to think of them as just another commodity for sale and pharmacy needs to try and emphasise that this is not the case There is a key issue here about ensuring public safety and the appropriate use of medicines – this is especially important when they are sold from a pharmacy Slide 22 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 Further resources RPS resources Pseudoephedrine and ephedrine: Look, Listen and Report Interim statement of professional standard for OTC medicines The role of registered technicians to supervise the sale and supply of medicines Slide 23 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines WEEK 18 P medicines: True or False? 1) When a pharmacist is in the stock room upstairs the sale of P medicines can still legally take place 2) A pharmacist may delegate the supervision of P medicines to the pre-registration pharmacist when he is away from the premises 3) A pharmacist can exercise supervision when away from the pharmacy so long as he is contactable on a mobile phone 4) A pharmacist may decide to sell recently switched POM to P medicines personally 5) It is a legal requirement that P medicines should not be available for patients to pick up themselves 6) A suitably trained member of staff may legally sell the ‘morning after pill’ 7) It is a legal requirement to record the dispensing of a P medicine on a private prescription 8) It is legally permitted to sell two boxes of 32 co-codamol 8/500 in one transaction 9) A P medicine for sale in a supermarket pharmacy may be added to a patient’s other shopping in a basket and purchased with other goods at any till in the supermarket 10) It is a legal requirement that pharmacies have protocols in place for selling P medicines Slide 24 of 24 OSPAP MPHM15 Sale and Supply of Medicines - P medicines