Human Medicines Regulations 2012 - Study Materials

1. how can POM medicines be - on receipt of a valid prescription supplied? - from an appropriate practitioner 2. what medicines are exempt - products below a certain strength from POM status? - product in a. specified form - product sold in a specific quantity 3. pharmacy medicines (P) - purchased w/out prescription - only be purchased from a registered pharmacy - only sold under supervision of a pharmacist 4. GSL medicines restrictions - sold from any lockable premises or vending for sale machines - must be sold in original packaging - quantities strictly controlled 5. does pharmacist need to be no present for sale of GSL? 6. what are PO (Pharmacy GSL medicines Only) medicines legally under the human Medicines Regulations 2012? 7. how can pharmacy only medicines be sold? - no supervision required - available for self selection - MA stipulates they can only be sold in a pharmacy 8. 1/8 who can write prescriptions? 9. what are the legal requirements for both private and NHS prescriptions? appropriate practitioners - medical prescribers, non-medical prescribers and Swiss + EEA doctors and dentists - prescription must be written in ink indelible - signed w/ ink by practitioner w/ their own name - Name + address of patient and practitioner - indication of prescriber qualification - Valid date within 6 months - Age if under 12 10. what is the legal requirements of prescriptions if more than one? formulation and strength 11. what information isn't re- patient titles - mrs, mr etc quired for prescriptions under Human Medicines Regu- - patient postcode lations 2012? - practitioners name in a addition to signature 12. what must a label for a dis- - name of medicine pensed drug LEGALLY con- - name of patient tain? - form - strength - quantity - dose + frequency - Cautions - children warning 13. what must a children warn- keep out of reach of children ing say on the label? 14. 2/8 what are pharmacists al- name of product lowed to change on a label? - directions for use - precautions relating to use 15. how long must private pre- 2 years scriptions be kept for? 16. legally requirements for reg- - a record must be maintained for each private ister entries? supply of a POM medicine - private prescriptions must be kept in pharmacy for 2 years after dispensed 17. what must manufacturers do under the human medicines regulations 2012? - manufacture medicines using methods complying w/ MA - maintain and demonstrate quality standards - label products to a specified standard - provide PILs 18. Marketing Authorisation li- - previously called product licences cence - MHRA must consider safety, quality and efficacy before issuing a MA 19. Manufacturers/ Importers Licence (MIA) - manufacture or package medicinal products - trade licensed medicinal products imported from non EEA countries or wholesale 20. what is required when issuing Manufacturer's/ Importers licence? - premises, equipment and processes - equipment - storage conditions 3/8 - Skills of manufacturing ppl 21. Parallel Import Licences (PI) - those wishing to import medicines to UK from EU REQUIRE A PI - products MUST have a MA in another EU state 22. what 3 categories are par- - simple allel import licences divided into? -standard - complex 23. Manufacturers 'specials' li- - allows holder to manufacture unlicensed cence (MS) medicines - these medicines are known as specials - allows import of unlicensed medicines from outside EEA 24. example of companies with Martindale and BCM an MS licence 25. example of a company with IDIS an MS that allows import of unlicensed medicines from EEA? 26. what can holders of - buy and sell wholesale P, POM and GSL wholesale dealing licences medicines and some herbals (WL/WDL) do? 27. how does the human med- - ensure safe, handling, storage and distribuicines regulations 2012 en- tion sure quality assurance? - maintaining staff, premises and equipment effectively 4/8 - quality control and qualified persons 28. how must a good phar- comply w/ good manufacturing practice maceutical company uphold the Human Medicines Regu- - undertake qualitative and quantitative analylations 2012? sis of products 29. what information must a medicine have? - product name - formulation - quantity - strength - admin route - keep out of reach of children 30. what conditions must a - handling medicine be labelled with ? - storage 31. what date must a medicine expiry date box be labelled with? 32. additional information that a - how to dispose of safely medicine must be labelled with? - MA or PL number - Batch number - Warnings by MA - Name and address of licence holder 33. what information must blis- - product name ter packed medicines contain? - expiry date 5/8 - batch number - name of holder of MA 34. what should be done if a - an abbreviated label may be used - which container is too small to la- should contain the information next card bel? 35. how must small containers - product name like eye drop bottle be labelled? - method of admin - quantity of product - batch number - expiry date 36. what should patient information leaflets contain? - identification of medicinal product - therapeutic indications - necessary instructions for use - side effects - what to do in emergency 37. what date must PILs contain? date of last revision 38. what is supervision under the HMR 2012? - sale or supply of POM or P medicines that is supervised by a pharmacist 39. examples of case law of su- - Roberts v little woods (1943) pervision - RPSGB v Boots (1953) 40. 6/8 when are POMs reclassified - medicine not likely to be dangerous to health to P? if used correctly - medicine not likely to be dangerous to health if used incorrectly - used as POM w/out unusual side effects required to be investigate by MHRA or EMEA 41. what types of POMs can't be injections reclassified to P? 42. what happens when a med- - manufacturer submits all data held by then to icine is switched from POM MHRA to P? - MHRA assessed proposed product against range of standards - consultation to determine if product is necessary 43. when does MHRA grant a li- information provided satisfactory - this licence cence of P to a POM medi- state strict conditions to allow product to be cine? sold as P 44. why are pom to p switches - pharmacists can supply genuinely effective important? treatments OTC - enable epjharmavists to remain competent and updated - errors by pharmacists and staff amplified 45. medicines switched from POM to P - ibuprofen - 1983 - hydrocortisone 1% - 1987 - domperidone - 2000 - levonorgestrel - 2001 7/8 46. what must happen before a - minister for health under guidance from P medicines is reclassified MHRA must be satisfied as a GSL? - medicine is safe for public - can be sold w/out need of pharmacist supervision and advice 47. example of a medicine that acyclovir - 2004 has switched from P to GSL 48. offences under the human - improper use of restricted titles medicines regulations 2012 - failure to correctly label a medicine - failure to provide PIL - loaning POMs - sell medicinal product not of quality demanded - adulterating medicines 49. more offences under human - failure to identify responsible pharmacist medicines regulations 2012 - sale and supply of unlicensed medicines - purchasing medicines from unlicensed wholesalers 8/8