PPM - Supplying Medicines and Poisons

1. what are general GSL - drugs sold or supplied from any retail outlet that can sale drugs be closed so as to exclude the public. e.g ibuprofen 2. what are pharma- P - drugs only sold or supplied from a pharmacy under the cy drugs supervision of a pharmacist e.g levonelle one step 3. what are prescription only medicines POM - drugs only sold or supplied in accordance with a valid prescription from an appropriate practitioner e.g flucloxacillin 4. what are the - protect public and assure safe, effective care when using roles of the GPhC pharmacy services - set standards for pharm and pharmacies - promote professionalism, support continuous improvement, assure quality and safety of pharmacy - due to pharm order 2010: GPhC can set standards and issue guidance 5. what titles are re- - pharmacist and pharm technician stricted - restricted by pharm order 2010 - offence to use titles if not registered - an offence to practise as pharm or tech without being registered 6. what is the ex- pharm students emption to prac- - can work as pharm dispensers without completion of tising as a phar- dispensing course macist when not registered 7. what does it mean to practise without being registered - doing any work, giving advise in relation to prep, assemble, dispensing, sale, supply of medicines, science of medicines 8. what are the - responsible pharm roles of a regis- - superintendent pharm tered pharmacist - pharm independent prescriber - pharm supplementary prescriber 1 / 12 - prescriber writing prescriptions for certain vet medicines - owning registered pharmacy 9. what are the ac- - responsible for safe custody and direct supervision of tivities of a regis- controlled drugs tered pharmacist - authorising supply of certain vet medicines - responsible for sale of medicinal products from registered pharmacy - responsible for supply of medicinal products from prescription 10. what can be done - sale and supply of pharmacy and POM medicines by or under the - assembly, prep or dispensing of medicines supervision of a - sale of poisons registered pharmacist 11. what are the legal requirements needed to register as a pharmacist 1. complete MPharm degree 2. complete 1 yr pre-reg training. 3. complete GPhC registration exam 4. meeting fitness to practice requirements 12. what happens on trainees build portfolio of evidence and demonstrate their pre-reg training competence whilst being observed year 13. what is needed to 1. must renew registration each year keep registration 2. must undergo annual revalidation 3. comply with standards for pharmacy professions issued by GPhC 14. What is a retail pharmacy business - business which consists of or includes retail sale of medicinal products that aren't subject to general sale - pharms in shops, supermarket, gps: community 15. who is the per- - owner or person who employs pharmacist working there son who lawfully not the employee conducts a retail 2 / 12 pharmacy business 16. who can lawfully own or conduct a retail pharmacy business - registered pharmacist - partnership of pharmacists where every partner is a pharmacist - body corporate - representative of deceased or bankrupt pharmacist or pharmacist that's lost mental capacity 17. do pharmacy - yes. must be registered with GPhC premises have to - offence to use title pharmacy if not registered be registered - owner responsible for reg and renewal each year - owner and superintendent pharmacist jointly responsible for ensuring pharmacy meets GPhC standards 18. what is the medicines (pharmacies) (responsible pharmacist) regulations 2008 - introduced role of responsible pharm with respect to lawfully conducting retail pharm business - owners must appoint responsible registered pharm to oversee pharmacy - no additional training required for pharm to be in charge - reg pharm can only be in charge on one pharm at a time 19. what are the duties of the responsible pharmacist - secure the safe & effective running of pharmacy - establishing and maintain standard operating procedures - make records of who is the responsible pharm -expected to be present during operating hours of pharm 20. what is a respon- - members of public have to know who RP is sible pharmacist - RP required to display notice stating they are the RP at notice that time 21. what does the RP - name of RP notice need to - their GPhC reg number contain - the fact that the RP is in charge of the pharm at that time 22. what is a pharma- - record identifies responsible pharm at any particular date cy record and time owner must provide pharm record for RP to enter their 3 / 12 details - owner responsible for ensuring that record is kept for five years and available for inspection 23. what does the RP need to put on the pharmacy record - name and reg number - date and time they became RP - date and time they stop being RP - date and time of any absences from pharm 24. how long can - max two hours the RP be absent - if absent for more, another RP must be appointed from the pharm 25. what needs to be - arrangements ensuring medicinal products are ordered, in place before stored, prepared, sold, supplied, delivered and disposed the RP is absent in safe effective manner - procedures that deal with circumstances when a pharm member who is not a pharmacist may give advice about medicinal products - procedures for identifying which members of staff 26. What must RP do - only leave if they judge pharm can continue to operate when they are ab- safely and effectively in their absence sent - record date of absence, their leaving and time of return - remain contactable by other pharm staff - if they can't be contacted they may arrange for another pharm to be contactable to provide advice - return reasonable promptly if they feel it becomes necessary 27. what activities can happen under the supervision of a pharmacist and the supervising pharmacist physically present - professional check of an Rx - sale/supply of P and POM meds - supply of meds under a patient group direction - wholesale of medicines - emergency supply of a medicine at the request of a patient or healthcare professional 28. 4 / 12 what activities can happen under the supervision of a pharmacist and the supervising pharmacist may not need to be physically present at the pharmacy the assembly process - generating a dispensing label - taking meds off the dispensary shelves - assembly of the item - labelling of containers with the dispensing label - accuracy checking 29. what are standard operating procedures - step-by-step instructions for performing a particular task - risk management and harm minimisation strategy - states what must be done, when, where, how, by whom - compulsory in pharmacy - came into use in 2005 30. what do sops helps with - ensure good practice followed at all times - provide opportunity to fully utilise expertise of all members - enable pharms to delegate tasks appropriately - help avoid confusion on roles - provide advice to locum - contributes to audit process - provide assurances that procedure comply with the law and professional standards 31. what do critics say about sops are: - voluminous & complex - substitute for professionalism - replacement for thinking - excuse for not doing something extra that is required 32. how often are sops reviewed every 2 years - RP can review more often in necessary 33. what must the sops cover - arrangements for safe effective ordering, storage, prep, disposal of medicines - supply of medicines - medicine delivery outside of pharm 5 / 12 - recording of all ^ - outlines circumstances where non-pharm can give advice about medicinal products - identifying staff who can do certain tasks - arrangements for when the RP is absent - steps to be taken when RP is changed - complaints procedure - incident proceudre 34. what is a superin- - pharmacist responsible for managing company pharmatendent pharma- cy in terms of keeping, preparing, dispensing p or pom cist medicines - don't have any legal duties or responsibilities 35. who can be - any pharm who has sufficient knowledge and experience a superintendent to be competent in the role pharmacist - can only be superintendent for one company at a time - name and reg number must be notified to GPhC 36. what are serious - exemption of rule that POMs can only be sold/supplied shortage proto- in accordance with a valid prescription cols (SSPs) 37. What do SSP's give authority to sell/supply under the supervision of a pharm - alternative quantity of POM to control supply of product to ensure patients in particular need will be provided for - alternative strength of POM when one strength is in shortage - alternative formulation of POM e.g tablet form in shortage so capsules given - generic equivalent - therapeutic equivalent 38. what conditions - change must be in accordance with what is stipulated in are subject to the SSP supply of SSPs - sale/supply is by or under supervision of pharm - pharm believes that the substitution is reasonable and appropriate 39. explain an emer- - pharm can make emergency supply of POM meds at gency supply at request of prescriber 6 / 12 the request of a prescriber 40. what conditions must be satisfied for the emergency supply at the request of a prescriber to be lawful - relevant prescriber: pharm must be satified that request is from a relevant prescriber - emergency: satisfied that it is an emergency - 72 hrs: prescriber must provide pharm with prescription within 72 hrs of supply 0 directions: must be supplied in accordance with directions of prescriber - record: record to be made in POM register on date of supply 41. what needs to be written on the POM register for an emergency supply of POM at request of prescriber -date of supply - name, address of prescriber - name and quantity of meds supplied - name, address of patient - date which prescription is received - date on prescription 42. explain emerwhen patient requests emergency supply of POM gency supply at request of patient 43. what does the pharmacist need to do when a patient requestes emergency POM medication interview patient and satisfy themselves that: - there is immediate need for medicine - it is not practical for patient to obtain a prescription - patient has previously been prescribed medicine by relevant prescriber - dose is appropriate for patient's needs 44. what is the max 30 days supply amount of medicine that can be supplied in emergency 45. 7 / 12 what are the exemptions to the 30 day max amount of medicine in emergecy - insulin, inhaler for asthma, ointment: smallest available pack - oral contraceptive: quantity sufficient for one treatment cycle - antibiotic for oral administration in liquid form: enough for full course of treatment only - controlled drug: 5 days treatment 46. explain emergency supply records for emergency supply of POM at the request of a patient - an entry must be made in the prescription only medicines register, on the day that the suplly is made or (if not practical) the day after must include - date of supply - name and quantity of meds supplied - name and address of the patient - info about the nature of the emergency, why they need the POM and why it is impracticable for them to get an Rx 47. what happens - RPS advises pharmacists to use their professional judgement and consider the best interest of the patient when it is not possible for the pharmacist to interview the patient requesting an emergency supply 48. is it legal for a pharmacist to make an emergency supply when doctor's surgery is open - legislation does not prevent a pharm from making an emergency supply when a doctor's surgery is open 49. what is different the label must include words: emergency supply to the labelling of emergency medicines 50. 8 / 12 how are emergency supply medicines paid for - payment is up to the pharmacists. they decide whether to charge the patient and if so how much 51. what is a sum- electronic record containing key clinical info about pamary care record tient (SCR) - patient can opt out of it - patients can view and add things to it at gp 52. what info does - allergies the SCR include - previous adverse drug reactions - acute meds - current repeats - discontinued repeats - patient name, address, dob, NHS number 53. why are SCR use- - reduce need to call GP to resolve prescription queries ful - improve response to patient queries - make for better informed patient consultations - help identify prescribing errors - reduce patient waiting times - improve healthcare for patients 54. how can health- - must get consent from patient care profession- - have to have legit relationship with patient als access a patients SCR 55. when is it appro- - hospital pharmacies: using them as part of the medicines priate to use an reconciliation process SCR - community pharmacies: - emergency supply -adverse reaction - self care- providing vaccinations and other services 56. what is the community pharmacy consolation service (CPCS) - takes referrals from NHS 111, 999, and intergraded urgent care clinical assessment services to relive pressure on NHS by connecting patients with pharmacists - launched 29 oct 2019 9 / 12 57. what are the labelling requirements - must be on outer package and on the immediate packaging - must be legible, comprehensive and indelible - can include pictures, pictograms or diagrams 58. explain labelling for blind and partially sighted patients - product name must appear in braille format on the outer packaging and the MA holder must ensure that they are able to provide the patient info leaflet in suitable formats for these patients 59. explain what compulsory: needs to be on a - patient name label - name and address of pharmacy supplying the product - date medicine was dispensed unless, when exercising their professional skill and judgement, the pharmacist believes its inclusion is inappropriate the following items are also required: - product name - direction for use - precautions relating to use of the product - other particulars as specified by prescriber RPS recommends: - 'keep out of reach and sight of children' - 'use this medicine only on your skin' where applicable 60. what is a pa- the SmPC in patient friendly terms tient information - compulsory to supply it with every medicine leaflet - it must be legible, clear and easy to use 61. can pharmacies - yes but public must have valid home office licence to buy sell poisons and the item and pharmacists must check that it is valid chemicals - if licence is not needed the pharm must judge if request is sus or not 62. what are regulat- - chemicals that may be used to cause harm but have legit ed substances everyday uses in home or hobbies - sale to general public is restricted 10 / 12 63. how can the pub- - have to apply to home office for licence to acquire, lic buy regulated possess and use substance (EPP licence) substances - is illegal to supply without licence 64. what must a pharmacists do before supplying regulated substances to public check EPP licence for: - validity - it its in date - unaltered - photo id - that substance and quantity requested match licence - record transaction on licence 65. when does a - when supplying regulated non-medicinal poisons record have to be made when supplying regulated substances 66. if a non-medicinal product is being supplied to a private individual what needs to be included on the record - date of supply - name address prescriber - name and quantity of registered poison supplied - purpose of supply - signature of purchaser 67. if a non-medicinal poison is supplied for use in a trade, business or profession what needs to be included on the record - date of supply - name address of trade, business, profession - name and quantity of regulated poison supplied - purpose of supply - signature 68. how should reg- - separately from other items especially food and drink ulated and reportable poisons be stored 11 / 12 69. what is prescrip- - medicine that can only be prescribed by a vet tion only medicine veterinarian POM-V 70. what is a prescription only medicine - veterinarian, pharmacist, SQP POM-VPS - medicine which can be prescribed by any RQP - RQP: vets, pharmacists, suitably qualified persons - clinical assessment doesn't have to be carried out when prescribing - RQP must have sufficient info about the animal, the condition to be treated to enable them to prescribe and supply 71. what is the - an NFA-VPS medicine doesn't have to be prescribed non-food anibut it may only be supplied by an RQP, provided the mal- veterinarian, requirements for supply are followed pharmacist, SQP NFA-VPS 72. what is an autho- - there are no legal restriction on the retail supply of rised veterinary veterinary medicines classified as AVM-GSL medicine - general sales list AVM-GSL 73. what is are exempt medicines under schedule 6 of the veterinary medicines regulaions - exemptions for small pet animals (SAES) - an unlicensed medicine that does not require an MA because it meets the requirements of schedule 6 of the veterinary medicines regulations - exemption for small pet animals 74. what are unauthorised veterinary medicines - an unlicensed med that does not have an MA and is not eligible for exemption through the SAEs - it can only be prescribed by a vet under the cascade 12 / 12