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HMR 2012 Sale & Supply of Medicinal Products

Page 1: Overview

  • Title: HMR 2012 Sale & Supply of Medicinal Products 1 - OTC Medicines

  • Focus: Pharmacy and General Sale Law relating to pharmacy MPharm.

Page 2: Intended Learning Outcomes

  • Understand legal classifications in HMR 2012:

    • Pharmacy (P) medicines

    • General Sale (GSL) medicines

  • Understand specific legal and professional requirements for sale and supply.

  • Understand the concept of deregulation in pharmacy law.

Page 3: Legal Classification of Medicines

  • POM (Prescription Only Medicine)

    • Available on prescription (with exemptions to be discussed).

  • P medicines

    • Available in registered pharmacy without a prescription but under pharmacy supervision.

  • GS(L) (General Sale Medicines)

    • Available for general sale and can be sold in retail outlets without pharmacist supervision.

Page 4: Definition of P Medicines

  • A pharmacy medicine is:

    • Not a POM

    • Not GSL

    • Subject to authorization for sale only from a pharmacy.

    • Referenced in HMR 2012 Schedule 1 Part 2.

Page 5: Examples of Pharmacy Medicines

  • Common P medicines include:

    • Night Nurse preparations

    • Contac capsules

    • Tyrozets lozenges

    • Chloramphenicol eye drops

  • Location in pharmacy: P medicines are typically found behind the pharmacy counter.

Page 6: Selling P Medicines

  • Premises: Must be a GPhC registered pharmacy.

  • Responsible Pharmacist: Must ensure safe and effective operation of the pharmacy.

  • Seller/Supplier: Must be either a pharmacist or working under the direct supervision of a pharmacist (who is physically present).

Page 7: Medicines Available Only from Pharmacy

  • Specific products that must be sold from a pharmacy:

    • Anthelmintics (anti-parasitic)

    • Parenterals (injectable medications)

    • Enemas (specific uses for irrigation)

    • Aloxiprin or aspirin for administration to children.

Page 8: Counter Prescribed Medicines

  • Pharmacists may create products for treating customers upon request.

  • The need for the product must be established through pharmacist's judgment.

  • Person must be present in the pharmacy for counter prescribed medicines.

  • Such medications are treated as P medicines, even if all ingredients are GSL.

  • Important: POMs cannot be counter prescribed.

Page 9: Professional & Legal Issues - P Medicines MEP Guidance

  • Guidance includes:

    • Pseudoephedrine and Ephedrine (MEP 3.2.1)

    • Oral Emergency Hormonal Contraception (EHC) (MEP 3.2.2)

    • Codeine and Dihydrocodeine (MEP 3.2.4)

    • Paracetamol and Aspirin (MEP 3.2.3)

Page 10: Pharmacy Medicines and Dispensing

  • P medicines can be prescribed by both private and NHS services.

  • All prescriptions for P medicines need to be dispensed by a pharmacist or under their supervision.

  • In terms of dispensing, all GSL products are considered P medicines.