Human Medicines Regulation 2012

What changes were made in 2016 Non-medical prescribing What changes were made in 2017 External products and schools to administer epipens What changes were made in 2018 and 2019 The supply of potassium iodide in the event of a radioactive event and paramedic prescribing rights How many parts and schedules are there in the human medicines regulations? 17 Parts with 35 schedules Medicinal products, manufacturing and wholesale dealing marketing, authorisations, homeopathic, medicine, products, What does the human medicines regula- traditional herbal registrations, phartions define or classify? macovigilance, dealings with medicinal products, packaging leaflets, advertising, BP: enforcement and miscellaneous provisions What would medicinal products classify Legal classification and definition of what a medicinal product is Manufacturing and wholesale dealing Licences and rules for inspections and enforcement. As well as the requirements for manufacturers to have a qualified person employed Marketing authorisations Formally known as product licences how applications are made and enforced and how marketing authorisations are rewarded Pharmacovigilance Discuss the oversight of the use of medicinal products and the legislation strengthens and clarifies roles with regards to pharmacovigilance Dealings with medicinal products Umbrella term for how medicines are sold and supplied and any exemptions to regulations Packaging and leaflets 1/9 Minimum requirements for each level of packaging and leaflets required. Could be braille. Also labelling required Advertisements Regulations prohibit advertisements of certain medicinal products and also controls the claims that can be made about medicinal products BP Enforcement - discussion of how inspections take place and their process Miscellaneous - offences under the regulations Main changes affecting pharmacy Most prominent - NMP What is a medicinal product Any substance or combination of substances presented as having properties of preventing or treating disease in human beings or modifies and controls physiological functions by exerting a pharmacological, immunological or metabolic action or diagnosis Medicine that is available on prescription where the product has a UK marketing What is a prescription only medicine? authorisation and is categorised as a POM or European MA and is classified as a pom within that MA The POM order - any injectable for parenteral administration - All CD except schedule 5 - any cyanogenic Which medicines schedule one part one - all radioactives can only be prescription any medicines? - aspirin or paracetamol tabs/caps which are not effervescent are POM except special circumstances - pseudoephedrine/ephedrine are POM except specific pack sizes - any drug without and MA but assem2/9 bled (specials) - small batch meds Regulation 214 medications cannot be Which regulation governs the sale and supplied, except in accordance with a supply of prescription only medications prescription from an appropriate practitioner Regulation 215, which requires a clinical management plan to be in place when Which legislation governs, supplementhe medicine is prescribed and when it's tary prescribers administered - access to health records also Community practitioner, nurse preWho does regulation 215 not apply to scribers as they already have a formulary to work from Which schedule requires a clinical management plan to be in place for supplementary prescribers Schedule 14 - must include patient name, illness or condition, date plan was written and date for review. - Drugs included in the CMP which will be the list of which drugs the supplementary What must be included in a clinical man- prescriber can prescribe from. agement plan? - Restrictions and limitations on any of the drugs, including fix doses, or strength or set period of time. - Allergies and safety measures to take action I'm event of ADR. - Must be a referral plan Which regulation governs the general requirements for prescriptions Regulation, 217 What are the legal requirements for a prescription? Address of the prescriber name of the prescriber, prescribers qualification, name of patient, address of patient written in indelible ink start date for the pre3/9 scription, age if under 12, signature, within 6 months Which regulation covers the requirements for prescriptions by EEA professionals? Regulation, 218 What needs to be available for a EEA prescription Additional - DoB - Prescriber contact details - email number - work address - does not have to be in English Which regulation governs electronic prescriptions Regulation, 219 Specific form Advanced electronic signature - must link What do electronic prescriptions require to prescriber Sent to spine or electronically What legislation governs P meds Regulation 220 What is a pharmacy medicine? Medical products that cannot be sold without the supervison of a pharmacist in a premises that is registered as a pharmacy. A pharmacist is required to be able to intervene in any sale Eye ointment Vitamin a products over 70/500 international units or 220050 units of retinol Which products can only be P medicines Vitamin d max daily dose over 400 units on the schedule one part two Meds for worms Enema Irrigation Which regulation governs general sales list medicines Regulation, 221 Which regulation governs the sale of GSL medicines from automated machines Regulation, 222 4/9 What conditions are required for gsl - lockable premises - manufactured ready for sale - unopened Which schedule restricts pack sizes for aspirin, aloxiprin, paracetamol and ibuprofen Schedule 15 What are the restrictions on paracetamol GSL - 100ml = no more than 20 doses suspensions? P - 200ml = more than 20 doses What are GSL medicines? Any medicine which is not a p or a pom medicine and has a UK marketing authorisation that allows it to be sold as a GSl medicine or EU What is governed by regulation, 223 Allowing doctors and dentists to sell/supply P&GSL medicines to their patients who are the person caring for that patient What does regulation 223 permit The sale or supply in the course of business of a hospital or health centre or by a registered midwife Which regulation controls emergency supply at the request of a prescriber Regulation 224 Which regulation covers emergency supply at patients request Regulation 225 Which regulation controls records of emergency supply sales Regulation, 253 Which schedule stipulates the requirements for the record of emergency supply Schedule 23 Date of supply, name, quantity, form, and What needs to be recorded in the book strength of drug, name and address of for emergency supply at the request of a prescriber, name and address of patient, prescriber date written on prescription, date prescription receibed What needs to be recorded in the book Date, name, strength, quantity, form, pafor an emergency supply at the request tients details and reasons for supply of a patient 5/9 Regulation 226 Which regulation governs the exemption for sale in hospitals Regulation 227 What does regulation 227 mean Ward charts can be used in place of prescriptions - they allow for pom p and gsl to be administered to patients. Also allows supplementary prescribers to prescribe or order drugs for patients as long as they comply with the CMP Which regulation covers PGD Regulation 230-234 WHERE CAN A PGD BE USED? - 229 primary care (CCG) - 231 hospital (NHS) - 232 dental practice - 233 community pharmacy (private or ccg) - 234 police What is wholesale dealing Regulations which remove medicines act exemption and state that a wholesale dealers authorisation is required or it is an offence to supply by wholesale What would a pharmacy need to supply They would need a wholesale dealers liwholesale medicines cense or a wholesale dealers gsl licence They will not take action - small quantity What does the mhra say about occasionand med is for individual patient need. al supply between pharmacies Also no profit made from supply What documents would have to be formed Pharmacy would have to write a signed order to request med and pharmacy supplying would have to make an entry in prescription register to be retained for 2 years Date, name, quantity, strength and form, name and address, trade, business and What criteria must be Met for supply for profession, why supplied and CD entry if occasional needs necessary Price charts to demonstrate no profit 6/9 Statement that med was needed for individual patient Product name - non proprietary name Formulation Quantity of product What should be recorded on a label for a Strength manufactured medicinal product Active excipients Route of administration KEEP OUT OF REACH OF CHILDREN What should be including on box Handling conditions Storage conditions Expiry date Warnings by the marketing authorisations How to dispose of safely Name and address of licence holder (PL/MA) MA or PL number Batch number Instructions on how to take if self medicating What should be on blister pack medicines Product name Name of MA holder Expiry date Batch number both must be embossed If there are 3 active ingredients, names must be on the foil Product name + form and strength Method of administration; How should a small container like an eye Quantity of product drop bottle be labelled Batch number Expiry date Outer packaging must contain full info Regulation 260 - one is required Regulation 269 - one is not supplied OFFENCE Which regulation covers PIL 7/9 Identification of medicinal product Therapeutic indications Side effects Necessary instructions for use Side effects What to do in an emergency Reference to expiry date Date of last revision What should be included in a PIL "Contains paracetamol" must also carry the words "do not take more that the label tells you to. If you do not get better, talk to What is the exception to the requirement your doctor" - if under 12, word is "give" for a MA to state warnings for products Requirement under schedule 25 and what schedule is it under Under schedule 27 there is a requirement to provide info in PIL - talk to doctor at once if you take too much even if you feel well What colour must aspirin and paraceta- Tablets must be white to prevent appeal mol be to kids Which schedule lists who can buy medicines and under which circumstances Schedule 22 Which schedule provides the parameters for sale of medicines to universities and HEIs Schedule 17 POM without prescription Which regulation allows manufacturers to sell products direct to persons who are entitled to purchase medicines directly by wholesale Regulation 249 Why may wfi be supplied Provision of drug treatment services Under which schedule are pharmacists allowed to directly supply water for injection to a patient for drug treatment services Schedule 17 What is maximum sale of wfi 5ml Dry powder should be prescribed If powder and water on same prescrip8/9 tion - 1 charge as water is needed If separate - 2 charges Which schedule covers medicines optimisation Schedule 25 part 1 Pharmacists are legally allowed to amend dispensing labels to improve What can pharmacists do under schedchance of patient taking med, change diule 25 part 1 rections, warnings, brand name, patient friendly language, What are child resistant containers needed for Regulated medicine such as paracetamol, aspirin, iron - regulation 272 Not required to be in CRC as they go off when exposed to air, must be in so much What's the rule for effervescent tablets fluid that the chance of being misused is small What is the rule for medications for export They do not need to be in CRCs If not practicably reasonable to use a CRC because size too big or if a patient What are the exemptions under reg 274 over 16 specifically requests a normal container (low dexterity) 9/9