Pharmacy Law and Legal Classifications Notes

SESSION OUTLINE

  • Understand pharmacy law
  • Discuss law relating to medicines and poisons
  • Review legal classifications of medicines and their prescription requirements

IMPORTANCE OF PHARMACY LAW

  • Access to medicines involves licensing and classification
  • Supply of medicines includes sale and dispensing processes
  • Management of poisons and oversight of drug misuse laws
  • Adhering to standards of practice to ensure health and safety
  • Understanding employment law and control of waste
  • Knowledge of Information Governance, GDPR, and safeguarding practices

DEVELOPMENT OF PHARMACY LAW

  • Before the mid-19th century: No legal restrictions on sale of poisons/drugs
  • Pharmacy Act 1852: Established framework for pharmaceutical society, giving power to hold exams, issue certificates, and regulate use of the title "pharmaceutical chemist"
  • 2010 Transition: Pharmaceutical society replaced by GPhC (General Pharmaceutical Council) and RPS (Royal Pharmaceutical Society)

MEDICINES ACT 1968

  • Covers:
    • Licensing of medicines
    • Sales promotion
    • Regulation of retail pharmacy business
    • Legal classification of medicines
    • Wholesale dealing
  • Includes herbal, homeopathic, and veterinary products

LEGAL CLASSIFICATION OF MEDICINES

  • Established to regulate safe supply of medicines
  • Marketing Authorization: Mandatory for product safety and quality, issued by MHRA (Medicines Healthcare Regulatory Agency)

THREE LEGAL MEDICINE CLASSES

  • POM (Prescription Only Medication): Requires prescription
  • P (Pharmacy Only Medication): Available in pharmacies but not for general sale
  • GSL (General Sales List): Available to the public without prescription
  • Change in legal status must follow an application process

EXAMPLES OF POM TO P SWITCHES

  • Hana 75 microgram film-coated tablets (Daily contraceptive)
  • Sumatriptan (Migraine relief, 50mg tablets)
  • Sildenafil (Viagra Connect, 50mg tablets)
  • Levonorgestrel Initial Tablets for emergency contraception

LEGAL CLASSIFICATION DEPENDENCIES

  • Classification is product-based, not solely on active substance
  • Use cases can influence legal class
  • Example: Chloramphenicol eye drops vs. Chloramphenicol IV

PARACETAMOL CLASSIFICATION

  • Varies with pack size:
    • GSL for pack size of 16
    • P for pack size of 32
    • POM for pack size of 100
  • Legal restriction: No more than 100 non-effervescent tablets can be sold at one time unless clearly under professional judgement

ASPIRIN CLASSIFICATION

  • Similar to Paracetamol:
    • GSL for pack size of 16
    • P for pack size of 32
    • POM for pack size of 100

CODEINE AND DIHYDROCODEINE

  • Introduced tighter controls to minimize addiction risks in 2009
  • Usage indication: Short-term treatment of acute moderate pain
  • Must be prescribed as POM if containing over 32 dose units

PSEUDOEPHEDRINE AND EPHEDRINE

  • Specific legal restrictions (Human Medicines Regulations 2012):
    • Only 720mg of Pseudoephedrine or 180mg of Ephedrine can be sold without prescription
    • Must verify sales with trained pharmacy staff

EMERGENCY HORMONAL CONTRACEPTION

  • Requires clinical suitability assessment by pharmacists before dispensing
  • Legal class for Levonorgestrel and Ulipristal acetate is P

LEGAL CLASS AND PRODUCT CLASSIFICATION

  • Legally determined by marketing authorization, not merely by the substance
  • Various formulations like Ibuprofen can also vary in legal designation

HOW TO FIND LEGAL CLASSIFICATION

  • Packaging labels indicate classifications
  • British National Formulary (BNF) annotations
  • Manufacturer’s Summary of Product Characteristics (SPC) documents

LEGISLATIVE CHANGES IN PHARMACY

  • Health Act 1999: Strengthened regulation of healthcare professionals
  • Human Medicines Regulations 2012: Allowed pharmacists to use professional judgement on labels
  • Amended rules on labelling and dispensing practices

CONTROLLED DRUGS (CDs)

  • Governed by the Misuse of Drugs Act 1971
  • Must comply with specific legal requirements for prescriptions depending on the schedule of the drugs

PRESCRIPTION LEGAL REQUIREMENTS

  • Must include necessary information (e.g., patient details, prescriber details)
  • Specific format required to ensure legality

LABEL REQUIREMENTS

  • Must contain patient’s name, pharmacy address, and directions for use
  • Good practice recommendations include safety warnings in labels

POISONS ACT

  • Revised classification and regulation of poisons
  • Pharmacists need to report suspicious transactions and manage records accordingly

FURTHER READING ON PHARMACY REGULATIONS

  • Access pharmacy resources via RPS and other pharmaceutical law guides.