PPM the Human Medicines Regulations

- nullifies and replaces part of the Mediwhat was the humans medicines regula- cines act 1968 tions made from - why?: so that the regulations can be found in one place - EU pharmaceutical law no longer applies to UK - laws derived from the EU still remain - introduced medicines and medical dewhat was the impact of leaving the EU on vices act 2021: ministers can now amend the pharmaceutical law or supplement laws relating to human medicines, vet medicines and medical devices and the regulations made must be for the purpose of safeguarding public health give an overview of the human medicines regulation 2012 - medicines can only be supplied to public from pharmacist with exception of GSL - HMR covers: labelling, containers of medicines and how they are advertised - doesn't apply to medical devices or vet medicines - manufacture, import, distribution, sale and supply, labelling, advertising, pharmacovigilance is all regulated important regulations - part 1: general provisions - part 4: requirement for authorisation - part 5: marketing authorisations - part 6: certification of homeopathic medicinal products - part 7: traditional herbal registrations - part 9: borderline products - part 10: reception to requirements for MA - part 11: pharmacovigilance - part 12: dealings with medicinal products - part 13: packaging and leaflets 1 / 11 what is a medicinal product - any substance or combination of substances presented as having properties of preventing or treating disease in humans and or - any substance or combinations of substances that may be used by or administered to humans with a view to restore, correct, modify a physiological function by exerting a pharmacological, immunological, metabolic action or making a medical diagnosis what is a marketing authorisation - having a MA shows that the product has been approved by a regulatory body which has seen evidence of their safety, quality and efficacy - reg 46: before meds can be marketed, sold, supplied, imported it must have MA (product license) who issues marketing authorisations and how long do they last - medicines and healthcare products regulatory agency (MHRA) - granted for 5 years or less that it is safe in terms of - direct effects on patient - risks to person administering what do the MHRA mean by safety when - danger to community giving a MA - extent to which the product may interfere with treatment - diagnosis or preventing of disease - does the medicine do what it claims to do what does the MHRA mean by efficacy - an MA can't be refused if there is in terms of giving an MA already another product available with greater efficacy - they assess whether medicine can be what does the MHRA mean by quality in produced with sufficient quality assurterms of giving an MA ance 2 / 11 - medicines already with MAs unaffected by brexit - centrally authorised product (CAPs) were converted into UK MAs what is the impact of leaving the EU for - MHRA has taken over role EU agencies the licensing of human medicines had with respect to pharmacovigilance - pharmacies don't have to comply with the falsified medicines directive - national medicines verification system can no longer be used what is the electronic medicines compendium - document containing up to date, easily accessible info about medicines licensed for use in the UK - has 14,000+ documents - contains SmPC and PILs what are SmPC - summary of product characteristics - tell healthcare professional how to prescribe and use medicine correctly - info based on clinical trials what are PILs - patient information leaflet - is included in the pack with a medicines - is a summary of the SmPC written for patients what are centrally authorised products -product with community marketing authorisation - grandfathering: the process of CAPs granted before brexit automatically becoming UK MAs after brexit what is an unlicensed medicine - medicine which doesn't have a valid MA in the UK - when it has license or authorisation in another country. it can be imported for a specific patient - a med which ahs been manufactured against a specific Rx for a specific patient, known as 'specials' - med which has had its form altered 3 / 11 - a mixture of two or more meds before administration when can unlicensed medicines be pre- - med from a licensed UK manufacturer scribed to patients which is awaiting an MA or has had MA suspended (for a specific patient) - new med undergoing clinical trials - prescriber has to make judgment whether the medicine is necessary for a specific patient how is it decided to use an unlicensed medicine 1. establish the optimal treatment for the patient 2. understand the patients experience what are the 5 principles of the procure- and make a shared decision ment and supply of specials 3. identify a preparation and supplier 4. monitor the patient and review the need for a special 5. ensure effective governance is in place - effort must be made to identify a UK licensed med instead explain 5 principles of the procurement - specials only supplied with the full and supply of specials : establish the knowledge of prescriber and patient optimal treatment for the patient - professional judgement made to assess risks and benefits explain 5 principles of the procurement and supply of specials: understand the patient's experience and make a shared decision - patients needs, values, preferences are discusses to ensure that the implications and practicalities of supplying/using specials are understood -pharmacists must ensure patients reexplain 5 principles of the procurement ceive meds that are appropriate: quality, and supply of specials: identify a prepa- for patients conditions, for patients perration and a supplier sonal circumstances, with minimal clinical risks explain 5 principles of the procurement - the appropriateness of continued preand supply of specials: monitor the pa- scribing of specials is reviewed ensuring tient and review the need for a special it remains the best option what does an "off-label" mean 4 / 11 - a medicine that is being used in a different way than described in the MA when can an "off-label" medicine be used - when there are multiply uses for the meds but the manufacturer may not have included them in the MA - when using the meds in an age group not specific in the MA - when using meds at a higher dose than specified in the MA what are the main things that an MA includes - indications for the meds - dosage of meds - patient population (age,gender, medical status) - route of administration what healthcare professional can prescribe an unlicensed med - doctors - dentists - independent nurse - pharmacist prescribers -supplementary prescriber who can prescribe a licensed medicine "off-label" - doctors - dentists - independent nurse - pharmacist prescribers -supplementary prescriber - nurse independent prescriber - pharmacist independent prescriber - optometrist - independent prescriber what must prescribers pay particular attention to when prescribing unlicensed or off label meds - adverse reactions - product quality - discrepant product info or labeling what is a generic medicinal product - product that has same qualitative/quantitative composition in active substances, same pharmaceutical form, and have biochemical similarities with the reference medicinal product (RMP) 5 / 11 - branded generics: generic drugs which have a brand name what is a proprietary product - branded product - more expensive than generic product what are borderline products - product where the status of the product is queries what is an orphan drug - drug developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance what is the early access to medicines scheme - a scheme aiming to give patients with life threatening or debilitating conditions access to meds that do not have an MA yet what is a parallel import - a med authorised in European Economic Area (EEA) member state that is allowed to be marketed in the UK as long as the imported product has no therapeutic difference from the cross-referenced UK product what is manufacturer license - a license that is required if you want to manufacture, assemble or import human medicines other than from an approved country for import what is a wholesale dealer's license - regulation 18 states without a WDL a person must not: - distribute a medicinal product by way of wholesale dealing or - posses a medicinal product for the purpose of such distribution what is wholesale dealing - selling, supplying, procuring, holding, exporting med product for the purpose of sale or supply - sale of supply of a medicinal product to a person who is not the end user 6 / 11 what is pharmacovigilance - the monitoring of medicines throughout their marketed life involves: - monitoring use of meds in everyday practice to find adverse effects of changed in patterns of adverse effects - assessing risks and benefits of emds to see if action is necessary to improve their safe use - providing into to healthcare prof and patients to optimise safe and effective use of medicines - monitoring impact of any action take what is the yellow card scheme - mechanisms by which anybody can voluntarily report any suspected adverse reactions or side effects to a drugs what is a traditional herbal medicine, herbal preparation, herbal substance - a medicinal product whose only active ingredients are herbal substances or herbal preparations - preparation: a preparation obtained by subjecting herbal substances to processes - substance: a plant or part of a plant, algae, fungi, lichen, or an unprocessed exude of a plant - MA?: have to either have a full MA or a what are the laws surrounding traditional traditional herbal registration - traditional herbal registration: registraherbal medicines tion granted by the licensing authority - Samuel Hahnemann in 18th century - a holistic complementary and alternative therapy based on the concept of what is homeopathy and who created it "like treats like" and involves the administration of dilute products prepared according to methods given in homeopathic pharmacopoeias 7 / 11 explain the licensing of homeopathic remedies - remedies are regulated by certificates of registration granted under part 6 of regulations - MHRA does not require applicants to prove that the remedy is effective by they do have to demonstrate product quality and safety - homeopathic: plants, minerals, animal, what are homeopathic and herbal prod- synthetic materials uct made from - herbal: naturally occurring plants, part of plants or extracts of plants - homeopathic: serial dilutions and succussion (shaking) are critical in ensuring the efficacy. the more succussion that how are homeopathic and herbal prod- takes place, the more energy is imparted uct made and the more efficacious the product - herbal: prepared using either extracts of the herbal material or through use of crude drug itself - homeopathic: extensive dilution is used or very small amount of the starting material is used. they believe that the how does homeopathic and herbal prodgreater the dilution the more potent and uct dosage affect the efficacy of the prodefficacious it becomes uct - increasing the dose will increase the effect and or increase the risk of adverse reactions are homeopathic and herbal products safe - homeopathic: considered non-toxic and safe for administration - cannot be regarded as safe as they have unwanted effects - homeopathic: suitable for use but are homeopathic and herbal product should be done under guidance of qualisafe during pregnancy and breast feed- fied homeopath ing - herbal:certain herbal ingredients should be avoided or used with caution 8 / 11 - homeopathic: no evidence of interacwill homeopathic and herbal products intions teract with prescription meds - herbal: can interact - homeopathic: no sound scientific evidence to explain. no evidence to support efficacy is it known that homeopathic and herbal - herbal: effects of the active ingredients products work and is there evidence for in a herbal product can be shown to have efficacy pharmacological actions. there is scientific evidence to support the efficacy of a limited number of herbal products in specific conditions - general sale: considered safe to be sole.supplied without pharm supervision - pharmacy: can only be sold or supplied what are the legal classes of medicines from a pharmacy under the supervision of a pharm - prescription only: can only be sold or supplied against a valid prescription who sets the legal classes for medicines - the MHRA - place selling it must be capable of being closed to exclude public - medicine must have been packed elsewhere what conditions also need to be met to - the packaging must not have been sell GSL opened (no split packs) - sales of pain relief should be restricted to a a max of two packs in any one transaction - doctors - dentists - supplementary prescribers - nurse independent prescribers - pharm independent prescribers who can write a POM prescription 1. signature of prescriber 2. address of prescriber 3. date 9 / 11 what needs to be included to make a prescription legal 4. particulars of the prescriber 5. name of patients 6. address of patient 7. age/dob what prescriptions can be repeatable - private prescriptions - is there is no number indicating the number of repeats it can only be repeated once - first dispensing must be made within 6 months of the appropriate date - a standard NHS prescriptions is not repeatable - prescriber produces a repeatable prescription and a set of identical 'batch' forms, one for each time the Rx is repeated explain repeat dispensing for NHS pre- batch forms retained for safekeeping by scriptions pharmacy - repeats can be dispensed at regular intervals or as determined by the pharmacist what is the electronic prescription service - EPS used to issue electronic Rx - benefits patients who receive regular meds how does the EPS (phase 4) work 1. gp decides to issue and Rx 2. a 'non-nominated; EPS R2 Rx can be issued if no nomination is present and a paper Rx is not required by the patient 3. medication is added to the central NHS soinse 4. spine hold the Rx ready for pulling down once the patient presents their token to their chosen pharmacy 5. patient takes their paper token to their chosen pharm 6. pharm scans token, then dispenses the meds, and may discuss whether an EPS nomination could be set 10 / 11 7. patient collects the Rx from the pharmacy explain the record keeping for POMs - POM register - reg 253 requires a record to be made of every sale or supply of a POM from a pharm except: 1. NHS Rx 2. oral contraceptives 3. supplies of controlled drugs which are recorded elsewhere 4. wholesale supplies - its good practice to record NHS POMs and the record must be kept for 2 years from last entry - for private Rx: record must be kept for 2 years from dispensing - date of supply - date on Rx - name and address of patient what are the POM register requriements - name and address of prescriber - details of the medicine supplied (name, quantity, form, strength) 11 / 11