Medicines Regulations 1 PDF

Medicines Regulations I PHARMACY PROFESSION AND PRACTICE AMBER TIDMARSH Medicines Regulations Lecture Set Overview 1. Medication classification 2. Prescriptions 3. Dispensing and collection of medicines 4. Private Prescriptions 5. Controlled Drugs GPhC Standards https://www.pha...

Medicines Regulations I PHARMACY PROFESSION AND PRACTICE AMBER TIDMARSH Medicines Regulations Lecture Set Overview 1. Medication classification 2. Prescriptions 3. Dispensing and collection of medicines 4. Private Prescriptions 5. Controlled Drugs GPhC Standards https://www.pharmacyregulation.org/standards/standards-for-pharmacy-professionals Intended Learning Outcomes By the end of this session you should be able to: ❖ Define a ‘medicinal product’ ❖ List the 3 legal classifications of medicines ❖ Describe conditions for sale and supply of the 3 legal classifications of medicines in the UK ❖ Identify quantities of paracetamol that can legally be sold in different shopping outlets Definition ‘Medicinal products’ are defined by Human Medicines Regulations (HMR) 2012 as: (a) Any substance or combination of substances presented as having properties of preventing or treating disease in human beings Or… Definition continued… (b) Any substance or combination of substances that may be used by or administered to human beings with a view to: o Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or o Making a medical diagnosis Legal Classifications HMR 2012 groups medicinal products into 3 legal classes: o Prescription Only Medicines (POM) o Pharmacy medicines (P) o General Sales Medicines (GSL) o Controlled drugs (CDs)** Prescription Only Medicines (POM) POMs generally can only be supplied when in receipt of a prescription from an appropriate prescriber. Appropriate prescribers include: oDoctors oDentists oSupplementary / Independent prescribers However there are circumstances where POMs can be supplied without a prescription Prescription only medicine exemptions o Maximum strengths to be sold o Maximum quantities to be sold o Certain routes of administration o Use in specified persons o Use for a specific purpose Prescription only medicine exemptions o Maximum strengths to be sold: Codeine max strength 20 mg o Maximum quantities to be sold: Paracetamol up to 100 tablets o Certain routes of administration Diclofenac only available as topical preparation (gel/cream) o Use in specified persons: Sildenafil for erectile dysfunction in males o Use for a specific purpose: Chloramphenicol eye drops for bacterial conjunctivitis Controlled Drugs (CDs) CD medicines are a type of POM medication which require a prescription to obtain them. They are governed by the Misuse of Drugs Regulations 2001. They are classified by schedules 1 to 5. Pharmacy Medicines o Can only be sold from a registered pharmacy premises o Can only be sold under the supervision of a pharmacist o Must not be accessible to the public for self-selection (most pharmacies although GPhC no longer prohibit this) o There is no definitive list of P medicines but there are some medicines which can only be sold in a pharmacy P Medicines – specific examples Aspirin or Paracetamol in the form of non-effervescent tablets or capsules, even with a P or GSL marketing authorisation, must be prescribed unless they have reduced pack size and quantities Preparations of Aspirin and Paracetamol in the form of non- effervescent tablets or capsules Medicinal product Pharmacy medicine if… Aspirin - Pack size doesn’t exceed 32 - Total quantity of max 96 sold to a person at one time 300mg Aspirin - Pack size doesn’t exceed 100 - Total quantity of max 100 sold to a person at one time 75mg Paracetamol - Pack size doesn’t exceed 32 - Total quantity of max 96 sold to a person at one time 500mg Paracetamol – labels and packaging o Contains paracetamol Unless the product name contains the word ‘paracetamol’ on the outer and immediate packaging o Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor This must appear adjacent to the directions or recommended dosage o Do not take anything else containing paracetamol while taking this medicine o Talk to a doctor at once if you take too much of this medicine, even if you feel well This is because too much paracetamol can cause delayed serious liver damage Paracetamol – labels and packaging o If for persons over 12 years: o Do not take anything else containing paracetamol while taking this medicine o If for children 12 years and younger o Do not give anything else containing paracetamol while giving this medicine Paracetamol – labels and packaging P Medicines – specific examples Pseudoephedrine salts or Ephedrine base even with a marketing authorisation, as a P or GSL medicine, must be on a prescription EXCEPT if: o No more than one product containing any of the above is sold at any one time o The product sold to a person at any one time does not contain more than: o 720mg Pseudoephedrine salts (12 x 60mg tablets) o 180mg Ephedrine base salts P Medicines – specific examples Codeine and dihydrocodeine limited to a pack size of maximum of 32 tablets or capsules (including effervescent) Requirements for sale: INDICATIONS – short-term treatment of acute, moderate pain not relieved by paracetamol, ibuprofen or aspirin alone PILS & LABELS – need to state indication and warning ‘Can cause addiction: For three days use only’ P Medicines – why have restrictions? o Addiction o Overdose o Overuse o Delay in diagnosing a condition which may require different treatment o Risk to certain patient groups o Side effects o Abuse - not being used for the intentional indication o Additional counselling and information required May be more you have thought of The above also applies when considering prescribing practice Signs of possible misuse o Nervous or guilty behaviouravoiding eye o Lack of symptoms o Rehearsed answers o Impatient or aggressive o Opportunistic – busy times or inexperienced staff o Specific products o Paraphernalia o Large quantities or frequent requests Need to be cautious of unconscious bias Pharmacy Medicines o When asked for advice on treatment pharmacists (and assistants) must: o Obtain sufficient information (e.g. WWHAM questions) o Provide advice on the use of products o When asked for a product by name procedures must allow intervention when needed o Particular care is needed for children, elderly and other social groups o Pharmacists must be personally involved where appropriate General Sales List (GSL) o A product that is not a POM or P medicine o Can, with reasonable safety, be sold or supplied without the supervision of a pharmacist o From registered pharmacies and other places that can ‘close to exclude the public’ General Sales List Some medicines are classified as GSL because of restrictions in pack size Largest pack size of: o paracetamol (non-effervescent) o ibuprofen 200mg tablets that shops without a pharmacist working in them can sell is 16 tablets Reclassification or switching Sometimes medicines change drug classes or fall within more than one. This can be requested by the manufacturer with supporting evidence POM to P switches Desogestrel 75mcg, an oral contraceptive – Hana, Lovima Gina 10mcg vaginal tablets for HRT P to GSL switches Proton pump inhibitors – esomeprazole 20mg , pantoprazole 20mg POM to GSL switch Fexofenadine – Allevia 120mg tablets Test your understanding Can a post- office sell 16 tabs? Can a post Can a post- office sell 4 office sell 1 packs of 16 pack of 32 tabs tabs Paracetamol 500 mg Tablets… Can a Can a pharmacy pharmacy sell 2 packs sell 1 pack of of 32 tabs 100 tabs Can a pharmacy sell 4 packs of 32 tabs Test your understanding Yes Can a post- office sell 16 tabs? Yes – legally Can a post Can a post- No – pack size of office sell 4 office sell 1 but not good packs of 16 pack of 32 over 16 becomes a practice tabs tabs P medicine Paracetamol 500 mg Tablets… No – pack size of Can a Can a pharmacy pharmacy 100 or more is a sell 2 packs sell 1 pack of of 32 tabs 100 tabs POM Yes Can a pharmacy sell 4 packs of 32 tabs No – pharmacies can only legally sell UP TO 100 tablets Royal Pharmaceutical Society FREE membership https://www.rpharms.com/rps-membership/students Recommended Reading o Royal Pharmaceutical Society, 2023, Medicines Ethics and Practice, July 2023, Edition 46 or the RPS website https://www.rpharms.com/rps- membership/why-join-rps/students o Reissner D, Langley C, Dale J – Dale and Applebe’s Pharmacy and Medicines Law, 12th Edition, London, Pharmaceutical Press 2021 o Access can be found using Medicines Complete using your Keele Institution credentials Intended Learning Outcomes You should now be able to: o Define a ‘medicinal product’ o List the 3 legal classifications of medicines o Describe conditions for sale and supply of the 3 legal classifications of medicines in the UK o Identify quantities of paracetamol that can legally be sold in different shopping outlets Further Reading o Medicines and Healthcare products Regulatory Agency (MHRA), 2019, About us. Available at http://www.mhra.gov.uk/Aboutus/Whoweare/index.htm o Human Medicines Regulations 2012 http://www.legislation.gov.uk/uksi/2012/1916/contents/made o Reclassification of medicines – Gov UK Available at https://www.gov.uk/guidance/medicines-reclassify-your-product Thank you Keele University Newcastle-under-Lyme Staffordshire ST5 5BG [email protected] +44 (0)1782 732000