PASP Part I

1. Who were preparers of medicine held in high re- priests gard with? 2. What was Hippocrates theory? Illness + disease was caused by an imbalance in the 4 humours (blood, black bile, yellow bile + phlegm) 3. What did medicines in the 19th century contain that made them toxic? - Pb - mercury - antimony 4. Who was pharmacy trade under in medieval Lon- Company of Grocers don? 5. Why did apothecaries break away from the Com- to ensure the purity of pany of Grocers? products being sold 6. When apothecaries broke away from the Compa- The Worshipful Sociny of Grocers, what was formed? ety of the Art and Mystery of the Apothecaries 7. When apothecaries took on the role of prescribing Chemists + Druggists and dispensing, who filled the gaps in the market? 8. Why did chemists and druggists form a problem they were unregulatfor apothecaries? ed (have no qualifications) 9. What is the British Pharmacopoeia's role? - protect public health by providing quality standard for UK pharmaceutical substances + medicinal products 10. What did the Apothecaries Act 1815 make a requirement? apprenticeship + training 1 / 20 11. What led to the development of the Pharmaceuti- failed attempts by cal Society in 1841? apothecaries to prevent chemists + druggists dispensing meds 12. When did the Pharmacist title begin? after chemists + druggists were phased out in 1953 13. How do you qualify as a pharmacist? - 4 year MPharm degree - 52 week of foundation training year with enhanced supervision + support 14. What is Miller's triangle? shows level of competance - knows = knowledge - knows how = competence - shows how = performance - does = action 15. What are the 4 domains of study? 1) person centred care + collaboration 2) professional practice 3) leadership & management 4) education + research 16. What does a Pharmacy Technician do? prepare, dispense, supply + issue a wide range of meds 2 / 20 17. What does an Accredited Checking Technician do? focus on service provision, medicines management + optimisation 18. What does a Dispensing Assistant do? - check all medicines that are dispensed to prevent error - also prepare + administer meds 19. What is primary care? first point of contact e.g. GP, pharmacist + dentist 20. What is secondary care? hospitals, can be planned/emergency/urgent 21. What is tertiary care? specialised care e.g. neurosurgery 22. What is Royal Pharmaceutical Society (RPS)? - professional body representing the interests of its membersxa - not compulsory to join 23. What is the General Pharmaceutical Council (GPhC)? - independent regulator for pharmacists + pharmacy technicians - council members (14) are appointed 24. What are the 9 GPhC standards for pharmacy professionals? 1) person centred care 2) partnership working 3) effective communication 4) professional knowledge + skills 3 / 20 5) professional judgement 6) professional behaviour 7) confidentiality + privacy 8) speak up about concerns 9) effective leadership 25. Define fitness to practice: a person has the skills, knowledge, health + character to practise safely + effectively 26. What is Duty of Candour? open + honest when things go wrong 27. What are the core principles the NHS was founded - meets the needs of on? everyone - free at the point of delivery - based on clinical need, not ability to pay 28. What is Integrated Care Systems? (ICS) composed of 2 parts: 1) integrated care boards (ICB) 2) integrated care partnerships 29. What do Integrated Care Boards do? decide on how the NHS budget is spent 30. What do Integrated Care Partnerships do? bring NHS together with other key partners to address broader health 31. What does the Health Care Act 2022 do? 4 / 20 makes it easier for organisations to deliver joined up care for those reliant on many different services, PCNS 32. What is a Primary Care Network (PCNs)? group of GP practices in partnership with other health care services (e.g. pharmacy, mental health & social care) 33. What should all regulatory bodies have? a reporting system so anyone can report unprofessional behaviour 34. What percentage of the NHS budget goes to drug 15% bills? 35. What is the first known drug standard? Salerno Medict Edict of 1240 36. How did legislation develop before WWII? in an unplanned manner 37. What was thalidomide used for back then + now? morning sickness but is now used for: skin diseases in leprosy, some AIDS - related conditions + a target cancer drug 38. What was regulation before the thalidomide dis- purpose was controlaster based on? ling sales of poisons 39. What symptoms did thalidomide cause in offspring? 5 / 20 impairments like limb difference + loss sights 40. What symptoms did thalidomide cause in adults? nerve damage in hands + feet 41. What changes in regulation did the thalidomide disaster cause? 1) drugs no longer approved on just animal basis ( human trials needed ) 2) must provide evidence drug is safe for use in pregnancy 42. What does the Medicines Act 1968 do? control safety, quality + efficiency of medical products + devices 43. What does the Committee for Medicinal Products play a vital role in aufor Human Use (CHMP) do? thorisation of medications 44. What does Medicines and Healthcare Products Regulatory Agency (MHRA) do? regulates medications and devices + also regulate blood components for transfusion 45. What does the Misuse of Drugs Act 1971 do? controls use of harmful drugs 46. What did the Health Act 2006 do? - prohibit smoking in certain areas - amended min age people can buy tobacco 47. What does the Health & Social Care Act 2012 do? supports collaboration + partnership-working 6 / 20 to better health care for patients 48. What does the Equality Act 2010 do? legally protects people from discrimination in the workplace 49. What did the Pharmacy Order 2010 do? established the GPhC as a independent regulatory body so they can make rules & orders in relevant areas 50. What does the Trade Desription Act 1968 do? makes it an offence for people to sell products/services based off of misinformation 51. What does the Consumer Protection Act 1987 make companies liable for? damaged cause to consumers from defective products 52. Which of these: England, Scotland and Wales, share the same legal system? - England and Wales (scotland doesn't) 53. What does statute law consist of? primary + secondary legislation 54. What is primary legislation? main laws passed by Acts of Parliament (legislative bodies of the UK) 55. What does it mean by Parliament is a 'sovereign'? supreme legal authority in the UK that can end/create any law (courts of law cannot overturn an Act of Parliament) 7 / 20 56. What happens when there's disputes on how an - decisions is based Act of Parliament is interpeted in court? on Parliaments intention not on subjective opinion - decisions reached in court then become precedent = 'followed in future cases' 57. What is secondary legislation? Law created by ministers/other bodies given to them by Act of Parliament; in form of regulation 58. Which legislation occurs faster: primary/secondary? Secondary legislation occurs faster unlike Primary legislation that takes months to pass through parliamentary processes 59. What is the first step in creating a new law? green paper 60. What is green paper? - consultation doc put together by government department that anyone can comment on - stimulates discussion 61. What is white paper? document explaining government's preferred future policy on the subject before introducing legislation 8 / 20 62. Why is white paper good before presenting a bill? allows government to test public opinion + gather feedback 63. How does the parliamentary stage begin? with the monarch's speech 64. What is the Monarch's speech? done every year at opening of Parliament + sets out Government proposals for legislation 65. What is a Bill? a new proposed law presented to Parliament 66. What is common law (case law)? body of law built up overtime, based on judicial precedent 67. What is judicial precedent? decision made by a judge in court is used in later cases where the facts are the same/similiar 68. What is criminal law? crimes are created by the government 69. Why are intentions important in criminal law? it can break crimes into: - criminal act - criminal intent 70. What is strict liability? offender is liable despite whether or not they intended to do something; e.g. speeding 9 / 20 71. Who is criminal law enforced by? the state, e.g. the police 72. Who prosecutes criminal laws? Crown Prosecution Services (CPS) 73. When does the state actually prosecute in crimi- 1) if there's sufficient nal law? evidence so there's a reasonable chance of winning 2) public interest to do so 74. What is the standard of proof? degree to which a party must prove its case to succeed 75. What is the burden of proof? requirement to satisfy that the standard of proof 76. What is beyond reasonable doubt (criminal law)? Standard of proof required in criminal court, no other explanation can be deduced from the facts + evidence except that the offender did the crime 77. What is the outcome of a criminal law case? court sentences offender with suitable sanction e.g. prison/fine 78. What is civil law? regulated human relationships, protects individual rights + provides compensation 10 / 20 79. Who is the burden + standard of proof rest with in - in civil law this is up civil law compared to criminal law? to the claimant - in criminal law that is up to the prosecution 80. What must be proved in the court of civil law? balance of probabilities 81. What must be proved in the court of criminal law? beyond a reasonable doubt 82. What are civil law actions designed to do? correct problems, not punish/deter 83. What does 'tort' mean? civil wrong 84. What is the most common tort? negligence 85. Define duty of care: take reasonable care to avoid acts that you can forsee will hurt your people directly affected by your actions 86. What 4 things need to have been done for a claim 1) defendant must've of negligence to be successful under law? owed a duty of care to the claimant 2) defendant breached duty of care 3) claimant must've suffered loss/injury due to the breach 4) quantify the claim for compensation/damages 87. What is the Bolam Test? if majority of professionals didn't do 11 / 20 a specific counselling but a minority did, they majority aren't found negligent 88. How is the Bolam Test overrided? safeguard was introduced in 1998 to allow courts to override the bolam test if it did not hold up to logical scrutiny 89. What is apportioned? liability is shared between defendants 90. What is administrative law? part of civil law that creates + regulates public bodies e.g. NHS + their activities 91. What does administrative law do? sets out public bodies e.g. NHS, responsiblility + gives them the authority they need to take on more responsibility 92. What is professional law? gives regulatory bodies e.g.GPhC the power to register + discipline relevant health professionals 93. Where are criminal cases heard? - magistrates court for less serious cases = has a lower maximum penalty - crown court for more serious cases 12 / 20 94. Where are civil cases heard? - initially heard in a county/family court - more serious cases are passed to high court 95. Where a criminal and civil court cases appealed? court of appeal 96. What is the European Convention on Human Rights? (ECHR) - international human rights treaty between 47 states (members of the council of Europe) - that represents a legal commitment to guaranty certain fundamental freedoms to protect the rule of law + promote democracy in EU countries 97. Define ethics: science of morals 98. define law: system of rules 99. What 4 principles are used when considering - beneficence ethical principles of professional-patient relation- - non-maleficience ships? - respect for autonomy - justice 100. What is beneficience? - balancing benefits of treatment against risks + costs - healthcare professional should act in a way that benefits the patient 101. What is non-maleficence? 13 / 20 avoiding causing harm - harm should not be disproportionate to the benefits of treatment 102. What is respect for autonomy? respecting the decision-making of autonomous persons - enabling individuals to make reasoned INFORMED choices 103. What is the justice moral concept? - distributing benefits, risks + costs fairly - patients in similiar positions should be treated in a similiar manner 104. Define professional judgement: use of accumulated knowledge + experience in order to make an informed decision 105. What does the Human Medicines Regulation mainly relate to? registration + conduct of pharmacies 106. What was the impact of leaving the EU on the UK? EU pharmaceutical law no longer applies to the UK 107. Define medicinal product: any substance / combination of substances presented as having prop of prevent14 / 20 ing/treating disease in human beings 108. What must a medicinal product have before it can MA be marketed, sold, supplied or imported? 109. Who is responsible for issuing MA? Medicines & Healthcare Regulator Agency (MHRA) 110. When we left the EU, what impact did this have on if the human medihuman medicines in the UK? cines already had a UK MA, it's unaffected by our departure 111. When we left the EU, what impact did this have on medicines approved by European Medicines Agency (EMA)? - medicines approved by EMA's centralised route were converted into UK MA's - are still authorised unless the CAP (centralised authorised products) holder opted out 112. What do pharmacies not have to comply with? falsified medicines directive 113. How long is an MA granted? a period of 5 years / less if specified 114. Since, no medicines are completely safe, what do consider the risks of the MHRA consider? meds + balance them against the benefits (risk/benefits ratio) 115. What 2 documents are produced when applying - summary of prodfor an MA? uct characteristics (SmPC) 15 / 20 - patient information leaflet (PIL) 116. What is CAP? decentralised system where an MA granted in an individual member state would only apply to that member state 117. What are proprietary products also referred to as? branded product 118. What are prescribers encourage to prescribe in- generic product as it's stead of proprietary products? And why? less expensive 119. Define bordeline products status of the product is queried 120. What is early access to medicines scheme (EAMS)? helps give people with life threatening conditions to new meds that do not yet have a MA 121. Define parallel import: import original medicine from one EU country, repackaging & reselling it a low price in EU countries 122. When is a Manufacturers License required? If you wish to manufacture, assemble/import human medicines other than from an approved country 123. What can't wholesale dealing be done without? - MA - certificate of registration - THR 16 / 20 124. What do herbal remedies need to have either of? either a full MA based upon safety, quality + efficacy / THR 125. What conditions need to be met for a THR? - product has been in medicinal use for a continuous period of at least 30 years (must've been in the UK / another country listed by the MHRA) - establish traditional use isn't harmful + efficacy of product is plausible based on long-standing use & experience 126. Define homeopathy: - no real evidence of efficacy, however there's evidence of a strong placebo effect 127. What does the MHRA require/not require of a homeopathic remedy? - doesn't require applicants to prove remedy is effective - but have to demonstrate the products quality + safety 128. Why are homeopathic remedies not considered to does not contain any have a direct safety issue? active substances 129. What do the 3 legal classes dictate? controls on their retail supply 130. How can medicines be moved from one 1 legal class to another? by making an application to the MHRA 17 / 20 131. Define GSM: safe enough to be sold/supplied without supervision of a pharmacist; available as self-selection 132. Define pharmacy medicines: only sold/supplied from a pharmacy under the supervision of a pharmacist 133. Define POM: only sold/supplied against a valid prescription under direct supervision of a pharmacist 134. What colour is the standard NHS prescription? green 135. What is the definition of faxes in the context of prescriptions? Not a legally valid prescription but can be used as evidence that a legally valid prescription. 136. Why are faxes relevant when making an emergency supply? Faxes are relevant when making an emergency supply because they can serve as evidence of a legally valid prescription. 137. What does it mean when a prescriber doesn't - 2 supplies in total write a number on repeat prescription? State the - in an oral contracepdifference in oral contraceptive tive it means it can repeated 5 times 138. When must first dispensing be made? 18 / 20 within 6 months of approp date, after that no legal time limits for remaining repeats 139. What is Electronic Prescription Service (EPS)? enables prescriptions to be sent electronically from prescriber to the pharmacy, then to NHSBSA for payment 140. What happened to prescriptions prior to EPS phase 4? prescription could only be issued when patient has a nominated pharmacy / another dispenser 141. When are paper prescriptions used? - if patients request it from GP - meds being prescribed are not listed in the NHS list of meds 142. What happens if patient has a nomination (under prescription is sent EPS Phase 4) what happens? electronically to their dispenser 143. What happens if patient doesn't have a nomina- prescription is sent to tion (under EPS phase 4) what happens? spine & GP prints token, which patient gives in to the pharmacy 144. What do pharmacists need to do once patient gives them a token? use a smartcard + pin to access NHS spine 145. Where are records of Prescribed Only Medicines POM register kept? 146. How long do POM records need to be kept? 147. When must the prescriber record a POM? 19 / 20 2 years from last entry on the day it's supplied / if not practicable then following next day 148. What 4 POM don't need be recorded? 20 / 20 - NHS prescriptions - oral contraceptives - wholesale supplies - supplies of CD which are recorded elsewhere