Medicinal Product Classifications Quiz

Medicines Regulations I

• This presentation covers medicines regulations, focusing on the pharmacy profession and practice.

Medicines Regulations Lecture Set Overview

• The lecture covers five key areas: medication classification, prescriptions, dispensing and collection of medicines, private prescriptions, and controlled drugs.

GPhC Standards

• GPhC stands for General Pharmaceutical Council.
• GPhC standards emphasize person-centered care, leadership, and collaboration.
• Key standards include speaking up about concerns, effective communication, confidentiality and privacy, professional behavior and judgement; professional knowledge and skills, and partnership working.

Intended Learning Outcomes

• Students will be able to define a medicinal product by the end of the session.
• Students can list the three legal classifications of medicines.
• Students will be able to describe the conditions for sale and supply of the three legal classifications of medicines within the UK.
• Students will be able to identify the quantities of paracetamol that can be legally sold in different shopping outlets.

Definition

• Medicinal products are defined by the Human Medicines Regulations (HMR) 2012.
• A medicinal product can be any substance, or combination of substances presented as having properties for preventing or treating diseases in human beings, or any substance or combination that may be used or administered to human beings for: Restoring, correcting, or modifying a physiological function via pharmacological, immunological, or metabolic action, or for making a medical diagnosis.

Legal Classifications

• HMR 2012 divides medicinal products into three legal classes: Prescription Only Medicines (POM), Pharmacy Medicines (P), and General Sales List Medicines (GSL).
• Controlled drugs are a type of POM that require a prescription to obtain. They are classified by schedules 1 to 5 and are governed by the Misuse of Drugs Regulations 2001.

Prescription Only Medicines (POM)

• POMs are typically dispensed only upon receiving a prescription from a qualified prescriber (doctor, dentist, or supplementary/independent prescribers).
• There are exemptions, where POMs can be supplied without a prescription under certain circumstances
• Exemptions involve Maximum strengths, Maximum quantities, Certain routes of administration, Use in specified persons, and Use for a specific purpose. Examples include: Codeine (maximum strength 20mg), Paracetamol (up to 100 tablets), Diclofenac (topical preparation), Sildenafil (for erectile dysfunction in males), and Chloramphenicol eye drops (for bacterial conjunctivitis)

Pharmacy Medicines (P)

• Pharmacy medicines can only be sold from registered pharmacies.
• Sales require pharmacist supervision.
• These medicines are not accessible for self-selection by the public, though this is not a legal requirement anymore.
• There's no definitive list of P medicines. Some medicines are only sold in pharmacies.

P Medicines – specific examples

• Aspirin and Paracetamol (non-effervescent) are classified as a P, if their pack size and quantity is below certain thresholds.
• Examples of P medicines that must be on prescription except size limits: Pseudoephedrine salts or Ephedrine base, even with a marketing authorization.
• Codeine and dihydrocodeine must be in packs of 32 tablets or capsules, maximum

Paracetamol – labels and packaging

• Labelling must include "paracetamol" for easy identification.
• Directions for safe use should be present.
• Overdosing should be reported immediately to a doctor.

Paracetamol – labels and packaging (Additional info)

• Do not take other paracetamol while taking this paracetamol product (Over 12yrs old)
• If for children, do not give other paracetamol products.

Pharmacy Medicines (P) - specific examples

• Pseudoephedrine or Ephedrine, even with marketing authorization as a P or GSL medicine are available only with a prescription, unless the product contains a maximum dose of 720mg of Pseudoephedrine salts or 180mg of Ephedrine base salts.
• Codeine and dihydrocodeine are limited to packs of 32 tablets or capsules (effervescent included) and are for short-term treatment of moderate pain when not relieved by other pain relievers, such as paracetamol, ibuprofen, or aspirin.

P Medicines – why have restrictions?

• Restrictions are in place to prevent addiction, overdoses, misuse, delays in diagnosis, risks to certain patient groups, side effects, and additional counseling needed.

Signs of possible misuse

• Warning signs such as nervous behaviour, lack of symptoms, rehearsed answers, aggressive behaviour, opportunistic behaviour (especially in busy times or inexperienced staff), requesting specific products or large quantities can indicate misuse.

Pharmacy Medicines

• Pharmacists (and assistants) must obtain sufficient information and provide advice on the use of products, which should involve WWHAM questions.
• Intervention is possible when needed, especially with specific medicinal products.
• Particular care is needed when dealing with children, the elderly, and other vulnerable social groups.
• Pharmacists should be personally involved. WWHAM protocol is essential in obtaining relevant information.

General Sales List (GSL)

• GSL medicines are products not categorized as POMs or Ps.
• They can be sold without pharmacist supervision with reasonable safety concerns.
• GSL medicines are usually available at pharmacies and other locations, such as stores, where access to the public can be limited.
• Pack sizes for GSL medicines are typically limited to avoid unsupervised use.

General Sales List (additional info)

• Examples of the largest pack sizes for paracetamol and ibuprofen are 16 tablets
• These are available in shops without a pharmacist.

Reclassification or Switching

• Medicines can change drug classes or fall within more than one, which can result from changes requested by the manufacturer.
• Examples include: Desogestrel 75mcg (oral contraceptive), Gina 10mcg (vaginal tablets for HRT), Proton pump inhibitors (esomeprazole 20mg, pantoprazole 20mg), and Fexofenadine 120 mg (Allevia tablets)

Test Your Understanding

• Questions are presented addressing whether or not a post office and pharmacy can sell specific numbers of tablets/packs of tablets for paracetamol

Further Reading

• Listed are references for additional information on medicine regulation related content.

Recommended Reading

• Includes references related to the study material provided.

Thank You

• An contact address and website information is provided