Medicinal Product Classifications Quiz

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Questions and Answers

What qualifies a product to be classified as a 'medicinal product'?

A combination of substances only used for cosmetic purposes

Any substance claiming to prevent or treat disease (correct)

A substance that has no effect on physiological functions

Any substance used exclusively for veterinary purposes

What are the three legal classifications of medicines under HMR 2012?

Prescription medicines, dietary supplements, and herbal remedies

Prescription Only Medicines, Pharmacy medicines, and General Sales Medicines (correct)

Controlled medications, generic medications, and branded medications

Dosage medications, over-the-counter medications, and prescription medications

Which of the following best describes a Prescription Only Medicine (POM)?

Can be purchased without any restrictions

Must be obtained with a prescription from an authorized prescriber (correct)

Available only in pharmacies and requires no prescription

Medications that do not require any regulatory oversight

What is a characteristic of Controlled Drugs (CDs) in the UK?

They are subject to strict regulations due to their potential for abuse Signup and view all the answers

Which of the following statements about the sale of Paracetamol is correct?

There are legal restrictions on the quantity sold in various outlets Signup and view all the answers

Which of the following is NOT considered an appropriate prescriber for Prescription Only Medicines (POMs)?

Pharmacists Signup and view all the answers

What is the maximum strength of codeine that can be sold without a prescription?

20 mg Signup and view all the answers

Which of the following medicines requires a prescription due to being classified as a Controlled Drug (CD)?

Diclofenac Signup and view all the answers

Under what condition can Paracetamol in non-effervescent tablets be classified as a pharmacy medicine?

Pack size does not exceed 32 and total quantity does not exceed 96 Signup and view all the answers

Which route of administration is specifically limited for Diclofenac?

Topical preparations only Signup and view all the answers

What is a requirement for P Medicines sold in a pharmacy?

They can only be sold under the supervision of a pharmacist. Signup and view all the answers

Which of the following is true regarding Chloramphenicol eye drops?

They are prescribed for bacterial conjunctivitis. Signup and view all the answers

What should be indicated on the packaging of a Paracetamol product?

The product name must include ‘paracetamol’. Signup and view all the answers

Why should a doctor be consulted if too much paracetamol is taken?

It may lead to delayed serious liver damage. Signup and view all the answers

What is the maximum pack size for codeine and dihydrocodeine?

32 tablets or capsules. Signup and view all the answers

What warning must be included on the labels for codeine and dihydrocodeine?

Can cause addiction: For three days use only. Signup and view all the answers

What is a requirement when selling P or GSL medicines containing pseudoephedrine or ephedrine?

Only one product containing them can be sold at a time. Signup and view all the answers

One indication for the short-term treatment of pain that codeine may be prescribed for is?

Acute, moderate pain not relieved by other common analgesics. Signup and view all the answers

What is a common sign of possible misuse of medications?

Nervous or guilty behavior. Signup and view all the answers

What should pharmacists do when asked for treatment advice?

Obtain sufficient information about the patient and situation. Signup and view all the answers

Why are there restrictions on P Medicines?

To address addiction, overdose, and misuse concerns. Signup and view all the answers

What is the maximum number of paracetamol tablets a pharmacy can legally sell in a single transaction?

100 tablets Signup and view all the answers

Which classification applies to a pack size of 16 paracetamol tablets when sold by a post office?

P medicine Signup and view all the answers

What is a possible legal selling condition for paracetamol at a pharmacy?

Up to two packs of 32 tablets Signup and view all the answers

Which of the following statements is true regarding pharmacies selling paracetamol tablets?

Pharmacies can only sell up to 100 tablets. Signup and view all the answers

What happens if the pack size exceeds 16 tablets in a post office?

It becomes a prescription-only medicine. Signup and view all the answers

What is the recommended reading for understanding medicines law in the UK?

Dale and Applebe’s Pharmacy and Medicines Law Signup and view all the answers

Which entity is responsible for regulating medicines in the UK?

Medicines and Healthcare products Regulatory Agency Signup and view all the answers

What classification of medicines pertains to items like paracetamol sold in packs of specific sizes?

P Medicine Signup and view all the answers

What is the main purpose of WWHAM questions in a pharmacy setting?

To provide advice on the use of products Signup and view all the answers

Which of the following statements regarding General Sales List (GSL) medications is true?

They can be sold without supervision in registered pharmacies Signup and view all the answers

What is the maximum pack size of non-effervescent paracetamol that can be sold without pharmacist supervision?

16 tablets Signup and view all the answers

Which type of medication can be switched from POM to GSL?

Fexofenadine – Allevia 120mg tablets Signup and view all the answers

In what scenario must pharmacists personally intervene during a product sale?

When asked for a product by name Signup and view all the answers

What does a 'P to GSL switch' refer to in pharmaceutical practice?

A product changing from prescription only to over-the-counter status Signup and view all the answers

What is a requirement for pharmacies in selling certain GSL medications?

They must ensure that the customer understands how to use the product Signup and view all the answers

What is the maximum number of paracetamol tablets a post office can sell in one transaction?

1 pack of 16 tablets Signup and view all the answers

Study Notes

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

Thank You

An contact address and website information is provided

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Description

Test your knowledge on the classifications of medicinal products, including Prescription Only Medicines and Controlled Drugs in the UK. This quiz covers legal requirements, characteristics, and specific conditions related to various medicines. Ideal for students and professionals in the healthcare field.