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Which of the following statements is TRUE regarding the sale of Paracetamol tablets soluble 500mg?
Which of the following statements is TRUE regarding the sale of Paracetamol tablets soluble 500mg?
What is the legal definition of the pharmacist's supervision during the sale of P medicines?
What is the legal definition of the pharmacist's supervision during the sale of P medicines?
Which of these scenarios would be considered a violation of the legal definition of supervision during the sale of P medicines?
Which of these scenarios would be considered a violation of the legal definition of supervision during the sale of P medicines?
In what situation would the sale of a P medicine be permitted even if a pharmacist is not present on the premises?
In what situation would the sale of a P medicine be permitted even if a pharmacist is not present on the premises?
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A pharmacist is preparing a prescription order while a member of staff is selling a P medicine. The pharmacist is aware of the sale but is busy attending to other tasks. Is this situation considered a violation of the legal definition of supervision?
A pharmacist is preparing a prescription order while a member of staff is selling a P medicine. The pharmacist is aware of the sale but is busy attending to other tasks. Is this situation considered a violation of the legal definition of supervision?
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What is the legal maximum quantity of ephedrine that can be sold in any single transaction?
What is the legal maximum quantity of ephedrine that can be sold in any single transaction?
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Which of the following is NOT a valid reason to refuse a lawful request for a pseudoephedrine-containing product?
Which of the following is NOT a valid reason to refuse a lawful request for a pseudoephedrine-containing product?
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What is the maximum pack size for codeine-containing P medicines?
What is the maximum pack size for codeine-containing P medicines?
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Which of the following is NOT a recommended warning that must appear on the packaging and Patient Information Leaflet (PIL) of codeine-containing P medicines?
Which of the following is NOT a recommended warning that must appear on the packaging and Patient Information Leaflet (PIL) of codeine-containing P medicines?
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What is the maximum number of codeine-containing P medicine packs that RPS recommends to be sold in one transaction?
What is the maximum number of codeine-containing P medicine packs that RPS recommends to be sold in one transaction?
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What is the recommended indication for the use of codeine-containing P medicines?
What is the recommended indication for the use of codeine-containing P medicines?
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What is the minimum training requirement for someone to sell pseudoephedrine-containing products?
What is the minimum training requirement for someone to sell pseudoephedrine-containing products?
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What is the recommendation regarding the sale of pseudoephedrine-containing products and ephedrine-containing products in the same transaction?
What is the recommendation regarding the sale of pseudoephedrine-containing products and ephedrine-containing products in the same transaction?
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Which of the following promotional practices is specifically deemed unacceptable by the MHRA?
Which of the following promotional practices is specifically deemed unacceptable by the MHRA?
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What is a major concern regarding price promotions for over-the-counter (OTC) medicines?
What is a major concern regarding price promotions for over-the-counter (OTC) medicines?
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Why is it crucial for pharmacists to emphasize that OTC medicines are not just commodities?
Why is it crucial for pharmacists to emphasize that OTC medicines are not just commodities?
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Which of the following scenarios is NOT a concern related to promotion of medicines in pharmacies?
Which of the following scenarios is NOT a concern related to promotion of medicines in pharmacies?
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Which of the following statements BEST reflects the overarching message regarding medicine promotion?
Which of the following statements BEST reflects the overarching message regarding medicine promotion?
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Which of the following statements is TRUE regarding Pharmacy (P) medicines?
Which of the following statements is TRUE regarding Pharmacy (P) medicines?
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Which of the following scenarios would classify as a P medicine?
Which of the following scenarios would classify as a P medicine?
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What is the most likely reason for the legal definition of 'supervision' regarding P medicines to change in the future?
What is the most likely reason for the legal definition of 'supervision' regarding P medicines to change in the future?
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Which of the following is NOT a learning outcome related to Pharmacy (P) medicines mentioned in the document?
Which of the following is NOT a learning outcome related to Pharmacy (P) medicines mentioned in the document?
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Based on the information provided, what is the most likely reason for the specific merchandising placement of P medicines within a pharmacy?
Based on the information provided, what is the most likely reason for the specific merchandising placement of P medicines within a pharmacy?
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What is the main reason for the need for clarifying statements or directions in legislation or regulatory rules and standards?
What is the main reason for the need for clarifying statements or directions in legislation or regulatory rules and standards?
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What is the RPS's primary concern in relation to their professional guidance on the supply of OTC medicines?
What is the RPS's primary concern in relation to their professional guidance on the supply of OTC medicines?
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Which of the following principles BEST reflects the core focus of RPS professional guidance on patient experience and patient-centered care?
Which of the following principles BEST reflects the core focus of RPS professional guidance on patient experience and patient-centered care?
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Which of the following is NOT a key element of the RPS professional guidance related to the safe and effective use of medicines?
Which of the following is NOT a key element of the RPS professional guidance related to the safe and effective use of medicines?
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What is the purpose of the statement "Pharmacy medicines must not be accessible to the public by self-selection" within the RPS professional guidance?
What is the purpose of the statement "Pharmacy medicines must not be accessible to the public by self-selection" within the RPS professional guidance?
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What is the key takeaway regarding the workforce in the RPS professional guidance on P medicines?
What is the key takeaway regarding the workforce in the RPS professional guidance on P medicines?
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The RPS professional guidance is a key part of ensuring patient safety and effective use of medicines. Which of the following statements best reflects the underlying principle of this guidance?
The RPS professional guidance is a key part of ensuring patient safety and effective use of medicines. Which of the following statements best reflects the underlying principle of this guidance?
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This RPS professional guidance is designed to achieve several outcomes. Which of the following is NOT an anticipated outcome of the guidance?
This RPS professional guidance is designed to achieve several outcomes. Which of the following is NOT an anticipated outcome of the guidance?
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Which of the following accurately describes the legal definition of 'supervision' as it applies to P medicines?
Which of the following accurately describes the legal definition of 'supervision' as it applies to P medicines?
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What is the central concern regarding the sale of P medicines when the pharmacist is in the consultation room?
What is the central concern regarding the sale of P medicines when the pharmacist is in the consultation room?
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According to the GPhC, what conditions must be met for the sale of P medicines while the pharmacist is in the consultation room?
According to the GPhC, what conditions must be met for the sale of P medicines while the pharmacist is in the consultation room?
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What is the key recommendation made by 'The Pharmacy Supervision Practice Group' regarding 'supervision' in community pharmacy?
What is the key recommendation made by 'The Pharmacy Supervision Practice Group' regarding 'supervision' in community pharmacy?
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What is the primary purpose of the 'Pharmacy Supervision Practice Group' report?
What is the primary purpose of the 'Pharmacy Supervision Practice Group' report?
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Which of the following statements accurately reflects the contemporary approach to 'supervision' of P medicines in community pharmacies?
Which of the following statements accurately reflects the contemporary approach to 'supervision' of P medicines in community pharmacies?
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What is the most significant challenge presented by the current legal definition of 'supervision' in relation to P medicine sales?
What is the most significant challenge presented by the current legal definition of 'supervision' in relation to P medicine sales?
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What is the potential impact of the 'Pharmacy Supervision Practice Group' report on the future of P medicine sales in community pharmacies?
What is the potential impact of the 'Pharmacy Supervision Practice Group' report on the future of P medicine sales in community pharmacies?
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Which of the following is NOT mentioned as a challenge associated with ensuring supervision of P medicines in a community pharmacy?
Which of the following is NOT mentioned as a challenge associated with ensuring supervision of P medicines in a community pharmacy?
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What is the significance of the 'Pharmacy Supervision Practice Group' report's recommendation to clarify the legal definition of 'supervision'?
What is the significance of the 'Pharmacy Supervision Practice Group' report's recommendation to clarify the legal definition of 'supervision'?
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Study Notes
OSPAP Programme: Sale and Supply of Medicines - Part 2
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Learning Outcomes:
- Explain circumstances for lawful P medicine sale/supply.
- Define "supervision" in pharmacy contexts and future changes.
- Explain paracetamol/aspirin product classification and limitations.
- List OTC pseudo/ephedrine and codeine/dihydrocodeine product restrictions and legal sale.
- Explain professional and legal aspects for large quantities.
- Explain the rationale for pharmacy merchandising of these medicines.
- Understand GPhC requirements.
Pharmacy (P) Medicines (1)
- No definitive list of P medicines.
- P medicines are not POM or GSL, or classified by manufacturers as P.
- Medicines made in a pharmacy for retail sale under exemptions are P.
- Caution: Do not call P medicines "Pharmacy only medicines". They are legally GSL under certain classifications.
Pharmacy (P) Medicines (2)
- Some POMs become P when sold in smaller sizes/strengths or for specific uses/indications.
- Example: 1% hydrocortisone 15g cream is (P).
- Example: Naproxen 250mg for primary dysmenorrhea in women aged 15–50 years is (P).
- Certain controlled drugs in low strengths (e.g., codeine, dihydrocodeine, morphine) are exempt from POM status in preparations with only one controlled drug under the designated strength.
Selling Paracetamol Tablets 500mg
- Selling more than 100 tablets of paracetamol over the counter is illegal. (Note: Packs of 100 are classified as POM)
- Pack size of 16 is GSL.
- Pack size of 32 is P.
- A pharmacy can sell more than one pack of paracetamol to the same customer, up to the POM limit, at the discretion of the pharmacist.
Schedule 15 Products
- Paracetamol, aspirin, ibuprofen are examples of Schedule 15 products.
- Pack size of 16 is GSL.
- Pack size of 32 is P.
- It is illegal to sell more than 100 tablets of paracetamol in a single transaction.
- Paracetamol soluble 500mg has no legal maximum, pharmacist discretion.
Sale of Pharmacy (P) Medicines
- P medicines cannot be sold by anyone unless they are operating a legitimate pharmacy and an employee is a pharmacist or an employee acting under the pharmacist's supervision.
- This does not apply to situations where pandemic protocols are activated, specifically those approved by governmental ministers.
- The sale of these medicines must adhere to the GPhC standards for Pharmacy Professionals and related GPhC guidelines for pharmacy staff and premises.
Definition of Supervision (1)
- P medicine sales must involve the pharmacist or staff under their supervision.
- Legal definition of supervision: The pharmacist must be aware of the sale and be in a position to intervene, if needed.
- Sale is not considered supervised if the pharmacist is absent, regardless of duration.
Definition of Supervision (2)
- The legal definition was based on a 1943 case regarding Part 1 poisons.
- The same definition is used in the 1968 Medicines Act.
- Practical difficulties exist in ensuring supervision when the pharmacist is present but not immediately at the counter.
Sales of P medicines whilst the pharmacist is in the consultation room
- Pharmacists are typically near the P medicine counter but in a soundproofed area.
- SOPs (Standard Operating Procedures) are needed for sales under the supervision of a pharmacist when they are in the consultation room.
- Staff familiar with SOPs can make sales.
- Pharmacist must be capable of acting on any question from staff, and has responsibility for the sales.
Supervision of P Medicines - Update
- (2022) A report on supervision in community pharmacies was produced.
- The report emphasizes that supervision should not be solely related to individual transactions.
- The report suggests clarification or direction in legislation for removing precedent related to supervision in legal and regulatory standards.
- Patient safety is the primary concern.
RPS Professional Guidance (1)
- Professional guidance regarding the supply of all OTC (over the counter) medicines has been provided.
- Supportive decision making of the patient related to medication is encouraged.
- Dignity, respects, privacy, confidentiality, and empathy are key concepts. Patient and carer views are sought in the delivery of pharmacy services.
- Clear and accessible information is vital for appropriate use of medication.
RPS Professional Guidance (2)
- Medicines expertise is key for safe, effective, adherence with suitable treatment.
- Pharmacy teams must follow safe and effective use guidelines of medication by patients.
- Members of the team are aware of referral protocols to a pharmacist or other healthcare professionals.
- Pharmacists provide knowledge for other staff and for patients. Pharmacists support treatment optimization.
- Pharmacies do not need public access by self-selection to pharmacy medicines (P medicines).
- Staff development and capacity includes a right skill mix, and quality service to the patient. Pharmacy workforces are planned and appropriately resourced for maintaining service quality, productivity, and safety.
RPS Professional Guidance (3)
- Pharmacists must take care when selling P medicines with size/quantity restrictions.
- Restrictions on the size of a medicine pack might be GSL or P in smaller packages but are POM in large ones.
- Medicines bought on the counter are primarily for short-term use (exceptions possible).
- Excessive product purchases may indicate misuse, inappropriate use, or abuse.
- If unsafe, sale refusal is allowed with explanation and appropriate signposting of suitable alternatives.
- Patient safety and welfare remain paramount concerns.
Location of P Medicines in the Pharmacy (1)
- Laws do not specify specific locations for P medicines in pharmacies.
- Typically, P medicines are stored behind the counter near the dispensary.
- This location prompts adherence to the legal classification of P medicines, making it hard to make unauthorized sales when a pharmacist is not present to supervise the transaction.
- Professional/good practice dictates that P medicines must not be placed on self-selection shelves.
Location of P Medicines in the Pharmacy (2)
- Some pharmacies place medicine information boxes on self-selection shelves.
- Patients learn about a medication before purchasing a full package at the front counter.
- P medicines are behind glass or locked doors, making unauthorized sales difficult.
- Staff should provide adequate, patient-based information and safety guidelines when handling P medicines and recommendations.
P Medicines Available on Open Display / Self Selection (1)
- The GPhC allows P medicines on open display or self-selection systems, with adequate safety regulations in place.
- Technological solutions and staff training can prevent unsafe/inappropriate sales.
- Risk assessment is a prerequisite.
P Medicines Available on Open Display / Self Selection (2)
- Some P medicines may not be suitable for open display or self-selection.
- Risk of misuse, abuse, theft, or inappropriate use is considered.
- This is important for products like cough suppressants, sleep aids, or high-value items.
- Risk assessment should be documented for medicines that may be subject to misuse, abuse, or theft.
- Pharmacies must have a policy in place when a pharmacist is not present.
- Refusal of the sale must include explanation and directions.
Ephedrine/Pseudoephedrine
- Used in decongestants.
- Subject to limited sales to prevent misuse (maximum sale amounts).
- Legal restrictions on OTC sales of these products.
- Pharmacies must monitor and track the sale of these products.
Codeine/Dihydrocodeine
- Low strengths used as analgesics.
- Selling is limited for risk of overuse and addiction.
- Short-term use and moderate pain relief are indicated.
- Packaged sizes are limited.
- Patient information leaflets (PILs) must include warnings about addiction.
Promotion of Medicines
- Medicine sales are a professional activity.
- Price fixing is unlawful.
- Free gifts/promotions are not allowed.
- Excessive purchases are discouraged.
- Promoting inappropriate use is unprofessional.
- Short-term relief medicine promotion should be properly managed.
Further Resources
- RPS resources for pseudoephedrine/ephedrine (Look, Listen and Report).
- Interim statement of professional standards for OTC medicines.
- Role of registered technicians for supervising medication sales.
P medicines: True or False?
- Review of 10 true/false statements related to P medicine sales. (Detailed answers omitted here as they require precise, context-specific answers, not suitable for simple study notes unless the details are further categorized.)
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Description
Test your knowledge on the legal regulations surrounding the sale of P medicines, including the roles of pharmacists, supervision requirements, and specific drug limitations. This quiz covers essential scenarios and rules that govern pharmacy practice.