PASP Class Notes

1. What does part 1 of ' Ministers define Medicines and Ads' HMR include? /MAD - highlighting the role of ministers '- definition of medicinal product - advertisement 2. What does part 2 of 'advisory bodies engaged in regulation' HMR include? advisory bodies = CHM/ BPC (commission on Human Medicines/British Pharmacopeia Commission) regulation = They regulate in medicine 3. What does part 3 of 'MAW License' = Manufacturing, importing, Whole HMR include? dealing activities that require a License - sets out rules for manufacturing/importing/wholesaling dealing of medicinal products and active substances, all of which must be licensed activities. 4. What does part 4 of requirement for authorisation HMR include? - "Product Approval Options: MA, HC, THR" HC = Homeopathic certificate of registration 5. What does part 5 of 'Application guidelines for MAs' HMR include? - emphasising the detailed requirements for MA + specific provisions for generic + biological medicinal products, as well as new combinations of active substances. 6. What does part 6 of certification of homeopathic medicinal products: HMR include? - describes the homeopathic medicinal products and sets out the information that must be supplied with an application for a certificate of registration 1 / 15 7. What does the part 7 traditional herbal registrations: of HMR include? - describes the traditional herbal medicinal products to which it applies- sets the information that must be supplied with an application for a traditional herbal registration 8. What does part 9 of 'Regulation process for borderline products' HMR include? - determining the regulatory status of unlicensed products - allowing suppliers to make written and oral representations if the licensing authority provisionally deems a product to be a medicinal product. 9. What does part 10 of EASE PT 'Exceptional access, special access' - unliHMR include? censed medicinal products that can be supplied under certain conditions PT 'Parallel import license' + exemptions for advanced therapy medicinal products + response to Toxic substances / nuclear radiation 10. What does part 11 of 'SAFETY-O' HMR include? - SAFETY = ensure safety through monitoring (pharmacovigilance) - O = Obligations on authorisation holders + licensing authority in relation to pharmacovilgilance 11. What does part 12 of 'CSP - HP' = Classification, Sale, and Provision with HMR include? Hospital Exemptions - related to the sale, supply, and administration of medicinal products, including their classification and exemption for hospitals and supply under PGD 12. 2 / 15 What does part 13 of 'PRB - HH' = Packaging and leaflet requirements with HMR include? specific rules of Radionuclides, Braille, Herbal + Homeopathic products 13. What does part 14 of 'PAID-SMH'- = Prohibitions, Advertisement InformaHMR include? tion, Sampling, Medical Sales Representatives, and Hospitality at meetings 14. What does part 15 of BP: HMR include? - provides for the publication of the BP and related documents 15. What does part 16 of 'SGM - Inspect' = Secretary of state, GPhC, MHRA HMR include? responsibilities, and inspector powers ( provide the inspector with power to enter + search premises) 16. What is pharmacovigilance? - monitoring the safety of medicines in clinical use + and taking appropriate action to minimise risk 17. Can you explain - explain how use + prescribe a medicine what the SmPC is in relation to moni- - it includes important info like composition and phartoring the safety of macological prop. medicines 18. Can you explain refers to the automatic conversion of CAP to UK MA what grandfathering unless the holders of these products opted out. means in the context of the UK leaving the EU and centrally authorised products? 19. Can you explain It is an act that brought changes to regulations related what the Medicines to medicines + medical devices in the UK and Medical Devices Act 2021 introduced when the UK left the EU? 3 / 15 20. Can you describe what the conditions are for traditional herbal medicine to be licensed in the UK? - the product must have been in medicinal use for a continuous period of at least 30 years (at least 15 in the UK/ another listed country by the MHRA) - Additionally, the traditional use of the product should not be harmful - the pharmacological effects should be plausible - meet equivalent quality + safety standards 21. Key conditions for licensing traditional herbal medicines MNEMONICS: 'OLD SAFE HERBS' O - Old ( been in medicinal use for at least 30 years) L - Long (at least 15 years in UK) D- Drug ( traditional use not harmful) S- Safety ( pharmacological effects plausible) H -Herbal ( meet equivalent quality + safety standards ) 22. Can you explain - 'like cures like' what the 2 main - 'diluting a substance makes it more potent' principles of homeopathy are? 23. Who is responsible The Medicines and Healthcare products Regulatory for issuing MA in Agency (MHRA) UK? 24. Can you explain human blood components what is not included in the HMR definition of a medicinal product? 25. What is Medicinal product: S.P..A.T Substance/ combination of substances, Presented as having prop for preventing/ Treating disease in human being 4 / 15 26. Can you explain It allows them to potentially benefit from new treatwhy it is imporments that have not completed the full regulatory aptant for patients with proval process yet. life-threatening conditions to have access to new medicines that do not yet have an MA? 27. What can be used as a evidence that a legally valid prescription exists? Fax - can be relevant when making an emergency supply 28. What important in- - allergies formation should be - previous ADR included in an SCR? - acute medications - current/ discontinued repeats 29. What are the re- ensure the safe + effective running of the pharmacy sponsibilities of the whenever it is open + operating RP? - maintaining SOPs 30. What activities can still happen with the RP absent but a second pharmacist present? A Good Pharmacist Always Loves Selling POMs 31. Can you explain why it is important for an RP to ensure that there are procedures in place for identifying which members of staff are competent to perform certain - it helps to maintain safe + effective handling of medicinal products Assembly process (counting tablets), generating labels, GSL sale, accuracy checking, labeling containers, Selling P medicines, Supplying POM - by identifying staff who are competent to perform specific tasks, the RP can minimise the risk of errors, ensure quality service to patients 5 / 15 tasks in a pharmacy setting? 32. What is a retail phar- Includes the retail sale of medicinal products that are macy business? not subject to general sale. 33. What should a retail pharmacy business be owned / conducted by? - a registered pharmacist - a partnership of pharmacists in England / Wales - a body corporate such as Boots/Lloyds - a representative of a deceased/bankrupt pharmacisr. 34. What are the bene- - principles of good practice are followed fits of SOPs? - fully utilise the expertise of all members of the pharmacy team - provide guidance to locums and part-time staff - contribute to the audit process 'PUCC' = principles followed, utilise expertise, clear guidance, contribute to audits 35. What are the cons of - voluminous and expensive SOPs? - substitute for professionalism - replacement for thinking - an excuse for not doing something extra that is required VRET = Voluminous, Replacement, Excuse, Thinking 36. What regulations - the medicines act 1968 cover the registra- - HMR 2012 tion and ownership - pharmacy order 2010 of retail pharmacy business? 37. What arrangements - ensure medicinal products are ordered, stored, premust be in place for pared, and supplied in a safe manner when RP is absent? - ensure there are procedures to deal with circumstances when a member of staff who is not a pharmacist may give advice about medicinal products - ensure there are procedures in place for identifying 6 / 15 which members of staff are competent to perform certain task 38. What must SOP's cover as a minimum? - supply of medicines - medicine delivery outside the pharmacy - record-keeping - the circumstance in which a non-pharmacist gives advice on medicinal products -arrangement for if RP is absent - a complaints/ incident procedure - how changes to SOPs are communicated to staff 39. What SOP covers (mnemonic)? 'SMR-AAC' - supply - medicine delivery - records - advice by non-pharmacist - absent RP aarangements - complaints procedure / SOP communication 40. What are seriused in event of a serious shortage of a medicine to ous shortage proto- allow community pharmacists to manage shortages cols? without needing to refer patients back to prescribers 41. When can SSP's - an alternative quantity/strength/formulation of POM provide authority to - a generic/therapeutic equivalent supply under the supervision of a pharmacist? 42. What is the penal- up to 7 years in prison ty for possession of class A drugs? 43. Describe Sch 1 drugs: - most tightly controlled - includes hallucinogenic drugs - most have no therapeutic use - home office may grant licenses for these to be possessed for research purposes 7 / 15 44. Describe Sch 2 drugs: - includes opiates - have medicinal uses as well as a significant potential for misuse - additional prescription requirements, need to maintain registers, control on their destruction 45. Describe Sch 3 drugs: - includes minor stimulants - potential for misuse but less harmful than Sch 2 - don't need to be recorded in CD register + no special destruction requirements 46. Describe Sch 4 drugs: - contains most of the benzodiazepines - not subject to special prescription requirements - majority not recorded in CD register 47. 'not subject to special prescription requirements' means? They can generally be prescribed and dispensed like regular medications without the need for additional restrictions or special prescribing conditions. 48. Describe Sch 5 drugs: - preparations that contain small amounts of CD - examples include codeine linctus / co-codamol - exempt from most of the CD requirements 49. What schedules of Sch 4 (the first dispensing process must be within 28 CD can have redays of date) peatable private prescriptions? Sch 5 50. Who cannot prescribe CD? community practioner nurse prescriber 51. Who can prescribe - doctor CD's for addiction? - dentists 52. What are the emer- - patients who are unable to speak English gency situations - confused patients where SCRs can - patients in care home settigs be emergency accessed? 8 / 15 53. What requirements - gain explicit consent must any health- must not coerce patients care professional - must be involved in the patient's care that wants to access to patients SCR satisfy? 54. What are the condi- - immediate need for the medicine tions for an emer- - not practical for the patient to obtain a prescription gency supply? - the patient has previously been prescribed the medicine - the dose is appropriate for the patient's needs - max 30 days supply / 5 days for CD - label attached that include the words 'emergency supply' 55. When should the within 72 hours of the supply prescriber provide the pharmacist with a prescription by for an emergency supply? 56. How long must a pharmacy record be kept for and what must it include? the owner of the pharmacy must provide a pharmacy record for the RP to enter their details, which must be kept for 5 years + available to appropriate people for inspection 57. What does a RP have to display? - a notice to the public stating their name - their GPhC registration number - the fact that they are in charge of the pharmacy at that moment in time 58. Who can become RP? any registered pharmacist with no additional training, as long as they are competent 59. What should the - name + registration number pharmacy record for - date + time they become + stop being RP RP show? 9 / 15 - the date + time of any absences from the pharmacy (reason for absence is good practice) 60. What is an audit? Is a quality improvement process that seeks to improve patient care + outcomes through a systematic review of care against explicit criteria 61. Why are audits done? - to establish whether SOPs recommendations in place are being followed in practice - enables you to identify areas of improvement + provide more training to staff 62. What must be mea- the outcome of change must be measured and current sured in an audit? practice must be measured against standard practice 63. What are the main stages of audit MNEMONIC SACAPIA 64. What are the main stages involved in audit? - selecting the area you would like to audit - agreeing the standards of best practice - collecting the data - analysing the data against the standards - providing feedback on the results obtained - implementing agreed changes - allowing time for the changes to be applied, before re-auditing - collecting data - analyse the data - provide feedback on results obtained - discussing whether the practice has improved S = select A = agree C = collect A = analyse P= provide feedback I = implement changes A = allow time 65. 10 / 15 What is the purpose It is designed to determine how well a service is workof a service evalua- ing + if it is achieving the intended aims. tion? It ensures the service supports an evidence-based approach to practice delivery + benefits the patients. 66. What are SOPs? tools which are used to help ensure the safe + effective management of a pharmacy a comprehensive written guide on how to correctly perform a task 67. What does a SOP detail? - what is to be done - when should be done - who should be doing it - where it should be done - how should be done WWWWH 68. Why do we need SOP's? - to ensure quality + consistency - to ensure good practice is delivered - provide an audit tool - assist with staff training + development - ensure that laws that relate to the manufacture of medicines are correctly implemented 69. What are the Caldicott principles? - are a set of guidelines that apply to all data collected for the provision of health + social care services where patient service users can be identified JEDI J = justify purpose E = ensure it's necessary D = don't use confidential info unless its necessary I = information is handled with care + kept secure 70. JUNA - CD 11 / 15 What are the differ- J= justify the purpose for using confidential info ent Caldicott princi- U = use confidential info when necessary / min necesples? sary N = (access to confidential info should be on a strict) need-to-know basis A = (everyone with access to confidential info) aware of their responsibilities C = comply with the law D = duty to share info important as to protect patient confidentiality - inform patients and service users about how their confidential info is used 71. What is the key as- CFDL pect of clinical governance? C = consider what could go wrong F = find methods of preventing errors D = document facts when something does go wrong L = learn from any mistakes 72. What does PIDA protect from negative treatment / unfair dismissal if they protect whistleblow- have disclosed certain info in public interest ers from? 73. What does LFPSE stand for? Learning From Patient Safety Events 74. How does LFPSE - allow them to record patient safety incidents and allow help organisations, providers to access data about recorded patient safety staff and patients? events 75. What does clinical healthcare professionals are required to have in place governance mean? procedures for minimising risk + harm to patients 76. 12 / 15 What are the different headings that clinical governance can be considered under? - audit - clinical effectiveness - CPD - involving people who use your services - staff/risk management - GPDR and data protection 77. How can people who use your services be involved? LEAF 78. What does staff management involve? - each member of staff who joins the team must have an induction when they start L = leaflet about pharmacy services E = ensure display of notices A = address complaints + feedback F = foster approp consideration - must also receive ongoing support with training + development - clear procedures in place for managing poor staff peformance 79. What are the categories of concern that the GPhC will investigate? - serious unprofessional/inappropriate behaviour - dishonesty - criminal conduct - dispensing errors - working under the influence 80. What are the steps that the GPhC advises that pharmacy professionals should follow when reporting a concern? - report without delay - report to the immediate supervisor - report to another person in authority, when not possible to report to the supervisor - keep a record - maintain confidentiality 81. What are the disclo- 'COMDD' sures protected un- C=commission of a criminal offence der the PIDA? O= obligation breach 13 / 15 M= miscarriage of justice D = danger to health and safety D= damage to the environment 82. When may a pharmacy professional disclose confidential info? when it is in the public interest e.g. it is required to prevent a serious crime, harm to pa person / serious risk to public health 83. What does the inupholds, regulates + prosecutes breaches of the DPA formation commissioner's office do? 84. What are the 7 prin- 'FDA -ISAC' ciples of the GDPR? F = (lawfulness) fairness + transparency D = data minimisation A = accuracy I = integrity S = storage limitation A = accountability C = confidentiality 85. What does confi- electronic + hard copy data personal details dential info include? - info about a person's medication + medical history 86. What does confidential info not include? - anonymous info - pseudonymised info - info that is already legitimately in the public domain 87. Name circumstances where it is appropriate to disclose confidential info: - have the consent of the person - have to disclose by law - should do so in the public interest - must do so in the vital interests of a person receiving care 88. What is SCR? a secure, electronic patient record that contains key info derived from patients detailed GP records 14 / 15 89. When are SCRs ac- In emergency + unplanned care scenarios, where such cessed? info would otherwise be unavailable 90. What does an SCR - medicines contain? - allergies - ADRs 91. What other situations where SCRs are accessed ( other than emergency supply )? - private services - locally commissioned services - patient queries - responding to symptoms OTC 92. What is the national - patient safety incident reports reporting and learn- - need to record all errors, including near misses ing system(NRLS)? 93. What are some ways - physical separation to reduce selection - visual warnings errors? - shelf edgers - prompts on PMR system to alert staff as to whether the correct item has been selected 94. What are the 5 NRLS - no harm ) either a prevented patient safety incident/no categories for the harm incident) degree of harm to the patient? - low harm ( required extra observation + caused minimal harm) - moderate harm (resulted in further treatment, etc.) - severe harm (permanent/long-term harm) - death 95. What are the steps to reduce risk and manage dispensing errors? - reporting - investigating - planning -sharing 15 / 15