Medicines and Poisons

1. How do you find out the legal class of a medicine? What do you look for?: SmPC (summary of product characteristics) 2. Where can you find the SmPC of a medicine?: EMC (Electronic medicines compendium) 3. What do the GPhC do? What are the 5 main roles?: - Investigate concerns - Set standards for education and training of Pharmacists, Pharmacy technicians and Pharmacy team - Inspecting Pharmacies - Registering and listing Pharmacies and Pharmacists - Requiring Pharmacists and technicians to carry out revalidation activities annually 4. What is the definition of a retail pharmacy business?: 'a business (other than a professional practice carried on by a doctor or dentist) which consists of or includes the retail sale of medicinal products that are not subject to general sale'. 5. What defines lawfully conducting a retail pharmacy business?: 'A person who carries on a retail pharmacy business is the owner or person who employs the pharmacist working there NOT the employee or e.g. the locum pharmacist.' - Not an employee, but the OWNER 6. Who can own a retail pharmacy business?: - A registered pharmacist - A partnership of pharmacists in England or Wales, every partner must be a registered pharmacist - A public limited company/body corporate: like BOOTS, Lloyds, The Co-opertive etc (they must appoint a superintendent pharmacist). - A representative of a pharmacist who has: lost mental capacity, gone bankrupt, is deceased. - In SCOTLAND ONLY; a partnership where only one partner minimum needs to be a pharmacist. 7. The title "pharmacy" can only be used with registered pharmacies, and the pharmaceutical department of...: Hospital or health centre 8. Which people in regard to a pharmacy, are jointly responsible for ensuring the pharmacy meets GPhC standards?: Superintendent pharmacist and the owner 9. Who is responsible for the registration, and renewal of the pharmacy?: The pharmacy owner 10. What three things is the responsible pharmacist obliged to display?: GPhC registration number - The name of the given responsible pharmacist - The fact the responsible pharmacist is in charge of the pharmacy at the given time. 1/6 11. Every pharmacy when open, must have how many responsible pharmacists on duty?: One (only one) 12. What is a "responsible pharmacist"?: The pharmacist appointed by the owner of the pharmacy to be in charge of the pharmacy, in relation to the sale and supply of medicines, and safe running of the pharmacy. 13. What additional training is required for a pharmacist to become a responsible pharmacist?: None 14. How many pharmacies can a pharmacist be the "responsible pharmacist" for?: One 15. The responsible pharmacist must complete a record, showing what?: Name and reg. number - The date and time(s) they start/stop being a responsible pharmacist - Date and times of absences from pharmacy 16. How long can a responsible pharmacist be absent for during business hours?: Maximum of two hours 17. Generally, a responsible pharmacist shouldn't be absent from the pharmacy, but can be if WHAT 3 areas are covered?: - Arrangements are in place to ensure that medicinal products are ordered, stored, prepared, sold, supplied, delivered and disposed of in a safe and effective manner. - There are procedures that deal with circumstances when a pharmacy member of staff who is not a pharmacist may give advice about medicinal products. - There's procedures in place to identify who the responsible pharmacist wants to take on certain tasks. 18. What things need the supervision of a pharmacist and supervising pharmacist? (they need to be physically present, responsible pharmacist is in charge still).: - Sale or supply of P and POM's - Supply of medicines under a patient group direction (PGD) - Wholesale of medicines - Emergency supply of medicines - Professional check of prescription 19. What things don't require the supervision of a supervising pharmacist, but require the supervision of a pharmacist? (responsible pharmacist is in charge still): The assembly process, meaning: - Generating a dispensing label - Taking medicines off dispensary shelves - Assembling items (like counting tablets) - Labelling containers with the dispensing label - Accuracy checking 2/6 20. What things don't require the supervision of a pharmacist? (responsible pharmacist is still in charge): - Sale of GSM (general sale medicines) - Processing waste stock medicines or patient returned medicines 21. What activities can take place WITHOUT a responsible pharmacist, but require the support staff carrying them out to be trained properly?: - Ordering stock from pharmaceutical wholesalers - Receiving stock from pharmaceutical wholesalers - Putting away stock received onto shelves - Date checking - Stocking pharmacy with consumables - Cleaning the pharmacy - Responding to enquiries (about medicine issues) - Accessing PMR (patient medication records) - Receiving prescription from EPS - Processing prescription forms that have been dispensed - Receiving patient returned medicines - Delivery persons conveying medicines to patients 22. When should SOP's be reviewed?: At least every 2 years 23. Some advantages of SOP's?: - Role clarification (tells who what to do) - Provides advice to part time staff - Enables pharmacies to delegate tasks (frees up time) - Helps ensure good practice is followed - Contributes to audit process 24. When did SOP's come into general use, becoming mandatory?: 2005 (courtesy of Royal Pharmaceutical Society) 25. SSP's (serious shortage protocols), are protocols that allow certain powers to pharmacists in the event of a medicine shortage. What are these powers?: They can prescribe (in the event of a shortage): - An alternative quantity of a POM, to control the supply, ensuring patients in particular need get it. - An alternative strength of a POM, if one particular strength is in shortage. - An alternative formulation of a POM, if the other formulation is in shortage. - A generic or therapeutic equivalent. 26. Must the sale and supply of anything SSP be under the supervision of a pharmacist?: Absolutely 27. Only "relevant prescribers" can request an emergency supply, who counts as as this?: - A doctor - A dentist 3/6 - A supplementary prescriber - A nurse independent prescriber - A pharmacist independent prescriber - A community practitioner nurse prescriber - A physiotherapist independent prescriber - A podiatrist independent prescriber - A therapeutic radiographer independent prescriber - An optometrist independent prescriber - An EEA or Swiss health professional - A paramedic independent prescriber 28. In case of an emergency supply, under what time frame must the prescriber provide the pharmacist with a prescription?: Within 72 hours 29. If a patient requests an emergency supply of a prescription, what 4 criteria must be satisfied?: - There is immediate need for the medicine - It is not possible/practical for patient to obtain the prescription - The patient has previously prescribed the medicine - The dose is appropriate for the patients needs 30. Emergency supply at the request of the patient should usually include the pharmacist interviewing the patient (Regulation 225 Human Medicines Regulations 2012), if this isn't possible, what should the pharmacist do?: The RPS advises pharmacists to use their professional judgement and consider the best interest of the patient 31. Is it legal for a pharmacist to make an emergency supply when a doctor's surgery is open?: Yes 32. For emergency supply records a record must be made on the POM register, containing what?: - Date of supply - Name and quantity of medicine - Name and address of patient - Nature of emergency, why they need the POM, why it isn't practical for them to get the prescription 33. The label attached to an emergency supply must say what?: 'Emergency supply' 34. Will the NHS reimburse an emergency prescription?: No 35. For emergency supplies of controlled drugs, it is illegal to prescribe from schedules 2 and 3, unless it is...: Phenobarbital or phenobarbital sodium 36. The SCR (Summary Care Record), contains key clinical informations on patients. It can be accessed via NHS's SPINE. What as minimum does an SCR include?: - Allergies - ADR's (adverse drug reactions) 4/6 - Acute meds - Current repeats - Discontinued repeats - Patients name, address, DOB, NHS number 37. In order to access a SCR, what must you have?: Consent of patient, and genuine involvement in their care 38. When may you not need patient consent for accessing SCR?: - If patient is unconscious / emergency situation - People who can't speak English - For confused patients/care home patients 39. Three main scenarios in accessing SCR?: - Emergency supply - Checking for ADR's (adverse reactions) - Providing vaccinations or flu services 40. Where should dispensing labels be placed?: Outer and inner packaging 41. What is a legal requirement for ALL medicine labels?: "Keep out of reach of children" 42. In what two situations can a pharmacist not prescribe with a child resistant container?: - Not reasonably practical - User over 16 requests, as they find them difficult to open 43. Certain poisons and chemicals can be sold from a pharmacy, however they are controlled as they can do great harm to people. What license is needed by a member of the public for certain poisons/chemicals?: EPP (explosives precursors and poisons) 44. The regulations (Control of Poisons and Explosives Precursors Regulations 2015) have 4 parts, splitting up the substances. What are the 4 parts split into?: Regulated substances (parts 1+2) and Reportable substances (parts 3+4) 45. Regulated substances are split into part one and part two, what are these parts?: Part 1 - Regulated explosive precursors (hydrogen peroxide greater than 12%) Part 2 - Regulated non-medical poisons (arsenic and its compounds, hydrogen cyanide, mercury etc) 46. Before supplying a regulated substance, what is needed?: - EPP license - Check if license is valid - Check substance and quantity match what is on the license - Record transaction on license 47. You must make a record of Part 2 regulated substances (Regulated non-medical poisons). What must you include?: The covers patient and business records: - Date of supply 5/6 - Name and address of individual or business - Name and quantity of regulated poison supplied - The purpose for which it is required - Signature of purchaser, or person doing trade for business 48. Reportable substances (part 3+4) don't need a _____ from the public?: EPP License 49. For an emergency supply medicine, what max amount of insulin, inhaler, ointment or cream can be prescribed?: Smallest pack available 50. For an emergency supply medicine, what max amount of oral contraceptive can be prescribed?: Enough for one cycle 51. For an emergency supply medicine, what max amount of a controlled drug within Schedule 4 or 5 of the Misuse of Drugs Regulations 2001 can be prescribed?: 5 days treatment 6/6