Pharmacy Regulations Quiz
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Questions and Answers

Which of the following statements is TRUE regarding the sale of Paracetamol tablets soluble 500mg?

  • A pharmacist must be present on the premises to supervise the sale, but the sale can be done by a non-pharmacist. (correct)
  • The sale can be conducted by a non-pharmacist, as long as the pharmacist is on-site and has a written protocol approved by a Government Minister.
  • The sale can be conducted by a non-pharmacist without the supervision of a pharmacist, as long as the premises is a registered pharmacy.
  • The sale of Paracetamol tablets soluble 500mg is not regulated by GPhC Standards for Pharmacy Professionals and any related guidance.
  • What is the legal definition of the pharmacist's supervision during the sale of P medicines?

  • The pharmacist must be aware of the sale and be in a position to intervene if necessary. (correct)
  • The pharmacist must be 'virtually' present, meaning they can be in another location, but readily available to provide oversight.
  • The pharmacist must be physically present on the premises, but is not required to be directly involved in the sale.
  • The pharmacist needs to be physically present on the premises and actively involved in the sale process, observing the transaction directly.
  • Which of these scenarios would be considered a violation of the legal definition of supervision during the sale of P medicines?

  • The pharmacist is in a nearby office, able to hear the sale being made but is not visually observing it. (correct)
  • The pharmacist is present in the pharmacy and is visually observing the sale happening but is not directly involved.
  • The pharmacist is briefly absent from the pharmacy for a short period, but another pharmacist on site is overseeing the sale.
  • The pharmacist is present in the pharmacy, but is busy preparing a prescription for another patient. (correct)
  • In what situation would the sale of a P medicine be permitted even if a pharmacist is not present on the premises?

    <p>During a pandemic, when a protocol has been approved by a government minister. (C)</p> Signup and view all the answers

    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?

    <p>Yes, as the pharmacist is distracted and unable to intervene immediately if required. (C)</p> Signup and view all the answers

    What is the legal maximum quantity of ephedrine that can be sold in any single transaction?

    <p>180mg (C)</p> Signup and view all the answers

    Which of the following is NOT a valid reason to refuse a lawful request for a pseudoephedrine-containing product?

    <p>The customer is requesting the product to be sold at a reduced price. (E)</p> Signup and view all the answers

    What is the maximum pack size for codeine-containing P medicines?

    <p>32 dose units (D)</p> Signup and view all the answers

    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?

    <p>Consult a doctor if symptoms persist or worsen (C)</p> Signup and view all the answers

    What is the maximum number of codeine-containing P medicine packs that RPS recommends to be sold in one transaction?

    <p>One (C)</p> Signup and view all the answers

    What is the recommended indication for the use of codeine-containing P medicines?

    <p>Short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen, or aspirin alone (B)</p> Signup and view all the answers

    What is the minimum training requirement for someone to sell pseudoephedrine-containing products?

    <p>The sale must be conducted by a trained member of pharmacy staff, acting under the supervision of a pharmacist. (B)</p> Signup and view all the answers

    What is the recommendation regarding the sale of pseudoephedrine-containing products and ephedrine-containing products in the same transaction?

    <p>It is illegal to sell pseudoephedrine-containing products and ephedrine-containing products at the same time. (C)</p> Signup and view all the answers

    Which of the following promotional practices is specifically deemed unacceptable by the MHRA?

    <p>Bundling a free gift with the purchase of an over-the-counter medicine. (A)</p> Signup and view all the answers

    What is a major concern regarding price promotions for over-the-counter (OTC) medicines?

    <p>Price promotions may lead to the stockpiling of medicines by patients, potentially resulting in misuse or expiration. (A)</p> Signup and view all the answers

    Why is it crucial for pharmacists to emphasize that OTC medicines are not just commodities?

    <p>To increase patient trust and professionalism in the pharmacy setting. (D)</p> Signup and view all the answers

    Which of the following scenarios is NOT a concern related to promotion of medicines in pharmacies?

    <p>Promotions that increase pharmacy revenue, potentially leading to a decline in patient care. (B)</p> Signup and view all the answers

    Which of the following statements BEST reflects the overarching message regarding medicine promotion?

    <p>The primary concern in promoting medicines is ensuring public safety by promoting appropriate medicine use. (F)</p> Signup and view all the answers

    Which of the following statements is TRUE regarding Pharmacy (P) medicines?

    <p>Medicines made in a pharmacy for retail sale under the exemption from licensing can be classified as P medicines, but only if they are not POM or GSL. (B)</p> Signup and view all the answers

    Which of the following scenarios would classify as a P medicine?

    <p>A medicine that is made in a pharmacy under the exemption from licensing and is intended for retail sale. (D)</p> Signup and view all the answers

    What is the most likely reason for the legal definition of 'supervision' regarding P medicines to change in the future?

    <p>To enhance patient safety by ensuring closer monitoring of P medicine sales by pharmacists. (A)</p> Signup and view all the answers

    Which of the following is NOT a learning outcome related to Pharmacy (P) medicines mentioned in the document?

    <p>Explain the historical evolution of P medicine regulations and their impact on current practices. (D)</p> Signup and view all the answers

    Based on the information provided, what is the most likely reason for the specific merchandising placement of P medicines within a pharmacy?

    <p>To comply with specific GPhC requirements regarding the physical placement of P medicines in a pharmacy. (A)</p> Signup and view all the answers

    What is the main reason for the need for clarifying statements or directions in legislation or regulatory rules and standards?

    <p>To remove ambiguities and inconsistent interpretations of existing legal precedents. (C)</p> Signup and view all the answers

    What is the RPS's primary concern in relation to their professional guidance on the supply of OTC medicines?

    <p>Maximizing the safety and effectiveness of medicine use by patients. (B)</p> Signup and view all the answers

    Which of the following principles BEST reflects the core focus of RPS professional guidance on patient experience and patient-centered care?

    <p>Empowering patients to make informed decisions about their medicines. (D)</p> Signup and view all the answers

    Which of the following is NOT a key element of the RPS professional guidance related to the safe and effective use of medicines?

    <p>Pharmacists should actively promote the use of complementary and alternative therapies. (D)</p> Signup and view all the answers

    What is the purpose of the statement "Pharmacy medicines must not be accessible to the public by self-selection" within the RPS professional guidance?

    <p>To reduce the risk of medication errors and misuse. (A)</p> Signup and view all the answers

    What is the key takeaway regarding the workforce in the RPS professional guidance on P medicines?

    <p>The pharmacy team should be adequately trained and resourced to provide quality services to patients. (B)</p> Signup and view all the answers

    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?

    <p>The RPS professional guidance emphasizes the importance of the pharmacist as a professional expert in medication management and patient care. (B)</p> Signup and view all the answers

    This RPS professional guidance is designed to achieve several outcomes. Which of the following is NOT an anticipated outcome of the guidance?

    <p>Reduced reliance on the healthcare system by promoting self-treatment with OTC medicines. (B)</p> Signup and view all the answers

    Which of the following accurately describes the legal definition of 'supervision' as it applies to P medicines?

    <p>It requires the pharmacist to be physically present in the pharmacy, but it may not explicitly mean overseeing each transaction. (C)</p> Signup and view all the answers

    What is the central concern regarding the sale of P medicines when the pharmacist is in the consultation room?

    <p>The inability to visually supervise the transaction due to the consultation room's soundproofing. (C)</p> Signup and view all the answers

    According to the GPhC, what conditions must be met for the sale of P medicines while the pharmacist is in the consultation room?

    <p>The staff members must be able to communicate directly with the pharmacist about any sales of P medicines. (A)</p> Signup and view all the answers

    What is the key recommendation made by 'The Pharmacy Supervision Practice Group' regarding 'supervision' in community pharmacy?

    <p>The legal definition of 'supervision' should be revised to focus on the pharmacist's overall presence and accessibility rather than direct transaction oversight. (A)</p> Signup and view all the answers

    What is the primary purpose of the 'Pharmacy Supervision Practice Group' report?

    <p>To redefine the legal definition of 'supervision' to ensure that it is more aligned with current pharmacy practice and the evolving nature of P medicines. (D)</p> Signup and view all the answers

    Which of the following statements accurately reflects the contemporary approach to 'supervision' of P medicines in community pharmacies?

    <p>The pharmacist must be physically present within the pharmacy, but they may supervise P medicine sales indirectly, as long as clear SOPs and communication channels are in place. (B)</p> Signup and view all the answers

    What is the most significant challenge presented by the current legal definition of 'supervision' in relation to P medicine sales?

    <p>The difficulty in reconciling the definition with the practical realities of modern pharmacy practices, particularly in situations where the pharmacist is not directly observing the transaction. (C)</p> Signup and view all the answers

    What is the potential impact of the 'Pharmacy Supervision Practice Group' report on the future of P medicine sales in community pharmacies?

    <p>It could lead to a more flexible approach to 'supervision' that acknowledges the pharmacist's overall accessibility and communication channels, rather than strict physical oversight. (A)</p> Signup and view all the answers

    Which of the following is NOT mentioned as a challenge associated with ensuring supervision of P medicines in a community pharmacy?

    <p>Patients may be intimidated by the presence of a supervising pharmacist and may be reluctant to seek advice about their medication. (C)</p> Signup and view all the answers

    What is the significance of the 'Pharmacy Supervision Practice Group' report's recommendation to clarify the legal definition of 'supervision'?

    <p>It seeks to align the legal definition with the evolving practices and challenges of modern community pharmacy, ensuring a more relevant and practical approach. (A)</p> Signup and view all the answers

    Study Notes

    OSPAP Programme: Sale and Supply of Medicines - Part 2

    • 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.

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