Pharmacy Law and Ethics

• The lecture discusses Pharmacy Law and Ethics.

Learning Objectives

• Outline how the public can access P medicines.
• Explain the regulations for Pharmacy supply of P medicines.
• Describe what constitutes a Prescription Only Medicine (POM).
• Explain how POMs are supplied to the public.
• Describe who is authorized to write a prescription.
• Summarize the regulations related to the administration of POMs.

Core Texts

• Key texts include Chapter 8 on both P medicines and POMs from "Dale and Appelbe's Pharmacy and Medicines Law," Tenth Edition, by Gordon E Appelbe and Joy Wingfield.
• "Medicines, Ethics and Practice" published by the Royal Pharmaceutical Society, is also another key text

Sale and Supply of Medicinal Products

• The Human Medicines Regulations 2012 categorize Medicinal Products into three classes: General Sale List (GSL), Pharmacy Medicines (P), and Prescription Only Medicines (POM).
• The sale of Medicinal Products (MP) is restricted to ensure safe and appropriate use.

Pharmacy Supply of P Medicines

• A 'pharmacy medicine' or 'P Medicine' can be sold from registered pharmacy premises by a pharmacist or someone under their supervision.
• GSL medicines and P medicines are collectively called over-the-counter (OTC) or non-prescription medicines.

Pharmacy Medicines (P) Classification

• Medicinal Products needing more stringent control than GSL are classified as P.
• There is no definitive list of P medicines.
• A product in GSL can be classified as a P medicine if sold:
  • In larger quantities than allowed by GSL.
  • At higher concentrations than specified by GSL.
  • At higher dosages than in GSL.
• POMs may be exempt as P medicines based on:
  • Dose
  • Concentration (Strength)
  • Route of administration
  • Use
• A product not on either GSL or POM lists, or if made up in a pharmacy and is not a POM can be classified as a P medicine.

Supply of P Medicines Regulations

• P medicines can only be sold or supplied by retail if the sale is conducted under certain conditions.
• These conditions include the person lawfully conducting a retail pharmacy business, the sale occurring from a registered pharmacy, or the transaction being supervised by a pharmacist.
• The Retail Pharmacy Business must be under the personal control of a Responsible Pharmacist for the sale of Medicinal Products, including GSL products, as per the Health Act 2006, ss.27-29.

Pharmacist Supervision

• Supervision generally means the Pharmacist must know what is happening and be able to intervene.
• Supervision can exist even without physical presence.
• Supervision has been considered by the High Court and is subject to guidance from the GPhC.

Medicine Counter Assistants (MCAs)

• The GPhC requires all pharmacies to have a written protocol outlining procedures for when medicines are supplied and when treatment advice is requested.
• All medicines counter staff must complete or be undertaking an approved training course.

Ethical Considerations for Medicine Sales

• There is very little Statute Law regarding the sale of medicines by Pharmacists
• Professional obligations and responsibilities are imposed by the Standards for pharmacy professionals.
• A key professional responsibility is to ensure the health, safety, and wellbeing of patients and the public.
• This includes controlling excessive and unnecessary purchases of medicines.
• The GPhC can take disciplinary action against pharmacists.

Reclassification of Medicines (POM to P)

• Manufacturers can apply for reclassification.
• Altered licensing may be needed, including age limits, condition specifications, treatment duration, or diagnostic requirements.
• Other considerations include reduced pack sizes and new packaging/PIL.

POM-P Reclassification: Major vs. Simple

• Major reclassification involves new therapeutic categories and/or new target population for an existing product.
• Major reclassification factors include product information, clinical overview, a risk management plan (RMP).
• Simple reclassification of a product already holding a Marketing Authorisation (MA) needs to be marketable in the UK.
• Simple reclassification must have the same active ingredient, route of administration and use; the same or higher strength; the same or higher dosage.

Examples of POM to P Reclassification

• Eumovate cream containing clobetasone butyrate 0.05%:
  • POM version is available in 30g or 100g for eczema and dermatitis, used for maintenance between courses of more potent corticosteroids.
  • P version is available in 15g for short-term treatment of eczema and dermatitis (not seborrheic), for adults and children over 12 years.
• Recent switches from POM to P include Viagra Connect (Sildenafil 50 mg) tablets for erectile dysfunction.
• Nasacort (Triamcinolone acetonide) nasal spray is available for nasal allergies.
• Maloff Protect (atovaquone/proguanil HCL) tablets are available as malaria prophylaxis

P to POM Reclassification

• Domperidone tablets, initially switched to P in 1998 for nausea, bloating and fullness, were later reclassified to POM.
• Pharmacovigilance showed cardiac effects, including serious ventricular arrhythmia or sudden cardiac death.
• The reclassification particularly affected people older than 60 years of age taking oral domperidone doses of more than 30mg per day.
• Community pharmacists were given 48 hours to remove this medicine on 3 September 2014.
• MHRA reclassified the product to a POM medicine.

POM Definition

• A prescription-only medicine (POM) requires a prescription from an appropriate practitioner to be sold or supplied.
• There are exemptions to requiring a prescription in some cases.
• Medicines can be classified under more than one category depending on formulation, strength, quantity, indication, or marketing authorization.
• Defined in Human Medicines Regulations (HMR Reg.5) include medicines that:
  • Is covered by an authorization requiring it to be available only on prescription.
  • Is covered by an EU marketing authorisation and is classified as a prescription only medicine.
  • Is a prescription only medicine by virtue of Part 1 of Schedule 1 of HMR.
  • Results from assembly or reformulation of a medicinal product that is a POM.

How To Obtain a POM

• A professional person can obtain POMs by wholesale from a pharmacy or wholesaler.
• Members of the public can obtain POMs with a valid prescription from a practitioner.
• Members of the public can obtain POMs in an emergency supply at the request of a doctor or designated prescriber.
• Members of the public can obtain POMs in an emergency supply at the request of the patient.
• Members of the public can obtain POMs by means of a Patient Group Direction (PGD).

Criteria for POM Classification (MHRA/HMR)

• Direct or indirect danger to human health exists, even when used correctly, without medical supervision.
• The classification is marked through toxicity or by jeopardising the health of the community.
• There is frequently incorrect use possibly leading to direct or indirect danger to human health, or psychological dependence.
• The classification is marked through the Further investigation of activity and/or side-effects that is required.
• The product is normally prescribed for parenteral administration(by injection).

Schedule 1 - Human Medicines Regulations

• The following medicinal products should only be available on prescription:
  • A product for parenteral administration.
  • A product that is a controlled drug, unless it is covered by a marketing authorisation that classifies it as a pharmacy medicine.
  • Cyanogenic substances, other than preparations for external use.
  • Medicinal substances that emit or contain radiation on administration.

POM order exemptions

• Exemptions are listed in Schedule of the regulations.
• Products containing aloxiprin, aspirin, and paracetamol are exempt from POM control if the quantity does not exceed 100 tablets or capsules (HMR Reg 2.36).

Pseudoephedrine Products Regulation

• Products containing pseudoephedrine salts or ephedrine base or salts are POMs.
• They are exempt from POM regulation if a product containing pseudoephedrine is not sold with other products containing ephedrine base.
• The total amount to one person is 720mg of pseudoephedrine or 180mg of ephedrine.
• These products must be sold by a pharmacist or trained pharmacy staff.
• Sale can be refused with reasonable suspicion of abuse

Regulations Governing New Medicinal Products

• New medicinal products (MPs) are POM for 5 years after first licensing unless there is existing evidence of safety.
• The POM Order is updated to include the products before the expiry of this 5-year period.

Supply of a POM Main Route

• The main route to sell or supply a POM is under the authority of a prescription from an appropriate practitioner or via an exemption(HMR Reg 2.14).

Appropriate POM Practitioners

• Appropriate practitioners include registered medical practitioners (doctors), dentists, supplementary prescribers, nurse independent prescribers.
• Appropriate practitioners include pharmacist independent prescribers, EEA, Swiss doctors, dentists, prescribing pharmacists and nurses.

Other Appropriate Practitioners

• Community practitioner nurse prescribers, optometrist independent prescribers are also appropriate.
• Podiatrist independent prescribers, physiotherapist independent prescribers, and therapeutic radiographer independent prescribers are also appropriate.

Prescriptions: Signatures

• Signatures on prescriptions must be signed in indelible ink by an appropriate practitioner in their own name.

Prescriptions: Electronic Prescriptions

• Electronic prescriptions must be created in electronic form, signed by an advanced electronic signature.
• Electronic prescriptions should be sent to the person by whom it is dispensed.
• An advanced electronic signature must be uniquely linked to the signatory, capable of identifying them, and created using means over which the signatory maintains sole control.
• Changes to the data must be detectable through linked software.

Prescriptions: Dates

• Prescriptions must include the date they were signed.
• In general prescriptions are valid for up to six months from the appropriate date.
• The appropriate date is the later of either the date on which the prescription was signed, or a date indicated by the practitioner.
• Prescriptions for Controlled drugs have shorter dates.

Prescriptions: Particulars

• Prescriptions require particulars that indicate the type of appropriate practitioner.
• This includes doctor, dentist, supplementary prescriber, nurse independent prescriber, and pharmacist independent prescriber.
• EEA and Swiss doctors and dentists, community practitioner nurses (for a limited selection of POMs), and optometrist independent prescribers (not for CDs or parenetral medicines) are also included.

Prescriptions: Patient Name and Address

• A patient's name is required on the prescription.
• An address is needed, a fixed abode is acceptable, and it is not required on EEA or Swiss prescriptions.

Prescriptions: Patient Age

• If the patient is under 12, their age is required.
• The date of birth is now required on Swiss / EEA prescriptions.
• The Date of Birth is often printed on NHS prescriptions for payment purposes, but this is not a legal requirement for adults.

Prescriptions: Details of Medication

• Details of the medicinal product are NOT legal requirements for prescriptions for POMs, with the exception of controlled drugs.
• It's important to know what to supply for prescription pricing and remuneration purposes.
• Appropriate steps to take when an incomplete prescription is received is available in the Guidance on prescribing section at the start of the British National Formulary (www.bnf.org).

Further Reading

• Post lecture reading includes MEP Section 3.2.
• Post Lecture Reading focuses on limits on sale of Paracetamol and Aspirin.
• Post Lecture Reading focuses on Codeine and Dihydrocodeine, and Pseudoephedrine salts and ephedrine.
• Further reading includes making notes and remembering all post lecture CPD is examinable.
• Further reading includes review of MEP Section 3.1