Law Exam Information PDF

All Law topics in a word document What are the 2 main legislation that affect pharmacy? 1. Medicines Act 1968 2. Human Medicines Regulations What is the Licencing body for pharmacy? Medicines and Healthcare products Regulatory Agency (MHRA) What is a license required for? The sale, s...

All Law topics in a word document What are the 2 main legislation that affect pharmacy? 1. Medicines Act 1968 2. Human Medicines Regulations What is the Licencing body for pharmacy? Medicines and Healthcare products Regulatory Agency (MHRA) What is a license required for? The sale, supply and adminstration of medicines and medical devices for human use. What is the definition of a medicinal products according to D&A? A medicinal product is: Any substance or combination of substances intended to prevent or treat disease in humans, or Any substance or combination of substances that can be administered to humans with the purpose of: Restoring, correcting, or modifying a physiological function through pharmacological, immunological, or metabolic action, or Assisting in making a medical diagnosis. Note: Whole human blood and its components are excluded from this definition. What is the name given to licence with regulatory approval? The Marketing Authorisation (MA) How are medicines classified in the UK? It is controlled by the Human Medicines Regulations 2012 and consists of three different classes: General sale list (GSL), Pharmacy medicines (P) and prescription-only medicines (POM) Can GSL products be sold without the pahramcist being present? Yes What are the 3 conditions for GSL sale? 1. The place where the medicines are sold or supplied must be able to close to exclude the public- so not a stall 2. Has a UK marketing authorisation (or equivalent for herbal or homoeopathic) 3. Must have been made up in a container elsewhere and not altered. What MA makes a product a GSL medicine? If it is a P or a POM medicine What is a P medicine? A medicine that is not classified as a POM or GSL What are the resistrictions on sale and supply and this means that the product may not be sold, supplied or offered fpr the same of supply unless? 1. The product is lawfully conducting a retail pharmacy business 2. The product is sold, offered or exposed for sale, or supplied on the premises which are a registered pharmacy. 3. The person is, or acts under the supervision of a pharmacist. Hence a person shouldn't be able to grab them by themselves How do you identify a P medicine? It must have a 'P' on the box of the manufactureres orginal packaging. All Law topics in a word document What does an OTC medicine mean? A medicine that is either a GSL or P What are the Pack size limits? Aspirin and Paracetamol tablets (Non- Effervescent) or capsules: MAX The maximum pack size 16 GSL, 32 P Maximum quantity= 100 (96) in reality Effervescent with no aspirin or 325mg but 12= 160mL Liquid Paracetamol can be repeated 5 times (so a total of 6 times) Which schedule drugs can you not repeat on a private repeat Rx? Schedules 2 and 3 Can you repeat prescriptions in the NHS? (I.e. can you use the same prescription to dispense the same medicine over and over again?) No - only a repeat dispensing scheme So if an NHS prescription says repeat 2x, you cant use the same prescription to get the same med again - you have to use the repeat dispensing scheme Example of a repeatable private prescription: Common Law Exam Q: How many times is a repeatable prescription legal if it has all of these things and if the time frame is ok. A record of every supply of a POM must be kept unless... (hint: there's 4) 1. It is an NHS prescription - private ones have to keep a record 2. It is a prescription for an oral contraceptive (but good practise to still record in POR) (prescription only register) 3. A separate record has been made in the CD register (but good practise to still record in POR) All Law topics in a word document 4. Supply is by wholesale and the signed order or invoice relating to the sale is retained for 2 years (more in endocrine module) For a private prescription of a POM, when does the record need to be made? On the same day (unless not practical then the next day is fine) What details need to be recorded on a private prescription record? (Of a POM) Essentially, everything you see on the prescription plus: Date of supply Reference number Price charged How long is the private prescription record(POR) kept for? For 2 years from date of supply (or date of last supply for repeatable prescriptions) How long is the private prescription kept for? 2 years from date of dispensing (unless repeats remain) After dispensing, where are NHS prescriptions sent to? Sent to NHS prescription services (part of the NHSBSA) (NHS business services authority) - electronic and paper submissions (monthly) This is so the pharmacy can get paid for the amount of drugs they've sold After dispensing, where are private prescriptions sent to? Kept for 2 years after final dispensing Make POR record for each dispensing If repeatable, can return the prescription to the patient between repeats if they wish (mark details of supply made) What are the main 2 peices of legislation that regualte controlled drugs? 1. Misuse of drugs act 1971 (PRIMARY) 2. Misuse of drugs regualtions 2001 (SECONADARY) How does it achieve this? Prohibiting possession, supply, manufacture, import or export, except... As allowed by Regulations or a licence from the Secretary of State All Law topics in a word document Advisory Council on Misuse of Drugs Recommends drug classifications based on harmfulness and determines.Class determines penalties for drug offences under the Act Class A Drugs Includes heroin(diamorphine), cocaine, ecstasy; LSD, Methadone- used to use opiod addiction Possession Penalty Class A Up to 7 years imprisonment or unlimited fine. Supply Penalty Class AUp to life imprisonment or unlimited fine. Class B Drugs Includes cannabis, amphetamines, barbiturates, codeine Possession Penalty Class B Up to 5 years imprisonment or unlimited fine. Supply Penalty Class BUp to 14 years imprisonment or unlimited fine. Class C Drugs Includes anabolic steroids; lesser penalties. Possession Penalty Class C Up to 2 years imprisonment or unlimited fine. Supply Penalty Class C Up to 14 years imprisonment or unlimited fine. Misuse of Drugs Regulations 2001 Controls for legitimate use of controlled drugs. Levels of control on the controlled drugs Schedule 1 = CD Lic Schedule 2 = CD POM Schedule 3 = CD No Register POM Schedule 4 (part 1) = CD Benz POM (part 2) = CD Anab POM Schedule 5 = CD Inv P or CD Inv POM Schedules recommended by ACMD Schedule 1 Drugs Includes hallucinogenic drugs (e.g. LSD), ecstasy-type substances, raw opium Strictly controlled, little therapeutic use, research only. (Although can't strictly controlled) Hospital pharmacists make take possession from a patient to destroy or hand over to police Schedule 2 Drugs Includes strong opioids (e.g. diamorphine, morphine, methadone, oxycodone, pethidine), major stimulants (e.g. amfetamines), quinalbarbitone, ketamine What are the full control relation to in terms of Sch 2 Full controls relating to: prescription requirements safe custody record-keeping of supplies Schedule 3 Drugs Includes minor stimulates, moderate opioids, gabapentinoids, and strong benzodiazepines (such as buprenorphine, tramadol, temazepam, midazolam, gabapentin and pregabalin) All Law topics in a word document What are the full control relation to in terms of Sch 3 Controls less stringent than for schedule 2 Prescription requirements Safe custody - but numerous exemptions (see later) CD register entries NOT required ('No Reg') Invoices retained for 2 years Licences required for import / export Schedule 4 Drugs pt1 Part I: CD Benz contains most benzodiazepines (e.g. diazepam), z-drugs (e.g. zopiclone), and Sativex (cannabinoid oromucosal spray) - 28 DAYS TO DISPENSE THE PRESCRIPTION c Part II: CD Anab contains anabolic and androgenic steroids, and growth hormones What are the full control relation to in terms of Sch 4 -No safe custody, no prescription requirements (except validity) or records to be kept -Import / export licence required (but not for CD Anab for personal use) Schedule 5 Drugs Low strength preparations of certain CDs e.g. codeine, co-codamol (paracetamol & codeine), dihydrocodeine, morphine sulfate oral solution 10mg/5ml (currently) What are descriptors of Sch 5? P or POM Negligible risk of abuse (?) Does not include preparations for injections Invoices retained for 2 years What are the rules associated with possession of controlled drugs. Unlawful to be in possession of CDs (other than in Schedule 5) unless permitted by: a.Home Office licence b.Member of group specified by the Home Office c.Member of a class of person specified in the Regulations e.g. practitioners, pharmacists d.Regulations provide that possession of a drug/group of drugs is lawful e.Legally prescribed (who can prescribe in Y2 and Y3) What are the Safe Custody Regulations? All Schedule 2 & 3 CDs must be kept in locked safe, cabinet or room -The Misuse of Drugs (Safe Custody) Regulations 1973 What drugs have a safe-custody exemption? Schedule 2 - quinalbarbitone Schedule 3 - many drugs exempt, easier to remember those for which it does apply! E.g. Temazepam All Law topics in a word document Buprenorphine- patches and tablets What records must be kept and required? Records of CDs received or supplied Must be kept for all schedule 1 and 2 CDs Can be an electronic or hand-written register Separate page for every drug class, strength, form (and brand) For controlled drugs received what must be documented? Date received Name & address from whom received Quantity received What is in Controlled drugs registers ? Date supplied Name & address of recipient Details of authority to possess - prescriber or licence holder's details Quantity supplied Details of person collecting - patient, patient's representative or health care professional (if HCP need to record name and address) Whether proof of identity was requested from collector Whether proof of identity was provided What is in Controlled drugs registers MUST HAVES? Separate page for every drug class, strength, form (and brand) → E.g. morphine sulfate (Sevredol) 10mg tablets Entered chronologically Entered promptly - same or next day Indelible Unaltered Rules for corrections Kept at premises Kept for 2 years following date of last entry Inspected What is a key practice to maintain stock accuracy? Maintain a running balance. How often should regular stock checks be undertaken, and what should be done with discrepancies?Weekly; discrepancies should be recorded, signed, and dated. What are two common issues with liquid medications? Overage and spillage. All Law topics in a word document How can running balance checks be facilitated for different brands? Use a separate page for each brand. Who is responsible for maintaining running balances? Pharmacists, but they can delegate tasks to competent staff. What are the precription requirements-Schedule 2 and 3 Signature - signed and familiar (or satisfied genuine) Appropriate Date (applies to Sch 2, 3 & 4) - 28 days validity Prescriber's address - UK only Name of CD Form Strength Dose - legally acceptable Total quantity - words and figures Quantity prescribed (professional requirement not legal) - 30 days Dental prescriptions - 'for dental treatment only' Instalment directions (Y3) What type of amendment can be made if the prescriber's intentions are clear? A technical amendment for spelling mistakes. Can pharmacists correct missing or incorrect information like date, dose, form, or strength? No, these cannot be corrected. Can amendments be authorised by a separate letter from the prescriber? No, amendments cannot be authorised this way. What ethical dilemma might arise from correcting a prescription? Corrections can cause delays for patients in severe pain or at the end of life. What is the legal requirement for Schedule 2 medicines regarding collection? Determine who is collecting: patient, representative, or healthcare professional. Why is it important to determine who is collecting Schedule 2 medicines? Different actions are required depending on the collector (refer to MEP Table 16). For Schedule 2 and 3 medicines, what is a good practice during collection? Obtain a signature from the person collecting. What is important to consider when delivering Schedule 2 and 3 medicines? Follow good practice and document the delivery process. What should be performed after each dispensing? A visual balance check. Controlled Drugs Registers Records of CDs received or supplied, maintained for 2 years. All Law topics in a word document What is OST: Opioid substation therapy Who is OST initiated and managed by? By specialist prescribers in addiction - can be part of another role e.g. GP - doctor, nurse, IP/SP, pharmacist IP/SP Give 2 of the most common OSTs Mathadone (CD sch 2) - usually liquid Buprenorphine (CD sch 3) - sublingual tablets What is required from the home office to prescribe: cocaine, diamorphine, dipipanone A special license form home office Only by medical prescribers (doctors) No special license required to prescribe for other illnesses or injury At what interval is a patient usually prescribed OST? Daily or every few days = instalments Why is it prescribed in instalments? Helps patient control use Reduces risk of overdose Improves adherence Reduces risk of diversion / theft Enables supervised consumption (Clinical 6) What prescription type is used for instalment prescriptions? FP10MDA almost always used Can be normal FP10 if instalments not needed, but this is rarely seen FP10MDA prescription requirements: MEP 3.6.7 All usual POM and CD prescription requirements apply - look at: Y2 CVS CD Lecture All Law topics in a word document Y1 FUN L&E Basis 2 Lecture PLUS: - Amount of medicine to be supplied per instalment (in addition to the dose) - Interval between each time the medicine can be supplied - Must have both a dose and instalment amount specified separately FP10MDA prescription requirements? Additionally 1. Amount of medicine to be supplied per instalment (in addition to dose) 2. Interval between each time the medicine can be supplied 3. Both a dose and instalment amount must be specified separately. For the FP10MDA prescription to be valid, what is the max number of days of treatment allowed? 14 days - this must be specified on the prescription For the FP10MDA prescription to be valid, the 1st instalment should be supplied within how many days of appropriate date? Within 28 days - this must be specified on the prescription Example of an FP10MDA prescription form: Home-office Approved wording for instalment prescribing: Dispensing instalments due on days when pharmacy is closed on a prior suitable day Dispensing remaining instalment amount when patient has missed collection day and instalment covered more than one day's dose Consulting prescriber if 3 or more consecutive days missed Supervising consumption on collection days Dispensing daily doses in separate containers Why must the approved wordings be present? Approved wording must be present for pharmacy to make a supply in ways above wording permits - Will not have legal protection otherwise Instalment collection by a representative: All Law topics in a word document What must the patient provide so that a representative can collect it? MEP 3.6.8 A letter from the patient - authorising and naming the representative (including when in police custody) How many letters does the patient need to send? Separate dated letter for each collection What should the representative bring? An ID What should you record in the CD register when supplying to a representative? Details of the representative If directions for the OST states: 'supervised consumption', who must be contacted? The prescriber (follow rules within service specifications), unless in police custody FP10MDA prescription processing: Endorse RHS of prescription form (as seen earlier - look at the prescription picture) Make a separate CD register entry for each instalment supply Submit to NHSBSA after all instalments supplied (or beyond due date) What is nalaxone? An opioid antagonist How does nalaxone work? Completely/partially reverses CNS depression (esp. respiratory depression) caused by opioids What is the licensed indication for nalaxone? For treatment of acute opioid overdose (POM) What does the HMR 2012 say about administration of parenteral POMs? HMR 2012 exemption list of parenteral POMs which may be administered by anyone to save a life in an emergency (without the directions of an appropriate practitioner) HMRs also permit staff to do what? HMRs also permit staff providing 'lawful drug treatment services' to obtain naloxone from a wholesaler and make direct supplies to patients without a prescription, PGD or PSD Includes community pharmacies providing drug treatment services - Supervised consumption of OST / needle and syringe programmes (Clinical 6) - Take-home naloxone scheme may be as part of above or separate service OTC opioids and the risk of addiction: What is the max pack size of Low dose codeine/dihydrocodeine combined with another analgesic (paracetamol, ibuprofen, aspirin)? MEP 3.2.4 codeine and dihydrocodeine All Law topics in a word document ** in notes Problems with repeat purchasing due to opioid dependence or addiction: Deaths from OTC opioid overuse Coroner's report https://www.judiciary.uk/wp-content/uploads/2019/12/Deborah-Headspeath- 2019-0387.pdf Supplies from online pharmacies under close scrutiny from GPhC What is the MHRA labelling requirement on the front of a pack of OTC opioids regarding the risk of addiction? Can cause addiction For three days use only What should PILs contain in regard to risk of addiction? Warnings of addiction, dependence More info: New MHRA advice to healthcare professionals Sept 2020: "HCPs should discuss warnings about the risk of dependence and addiction with any patient taking or planning to take an opioid medicine" MHRA safety leaflet for patients available February 2024: MHRA reclassified codeine linctus 15mg/5ml from Pharmacy (P) to prescription only (POM) - MEP 3.1.4 What are the most common cannabinoids? Tetrahydrocannabinol (THC) - psychoactive Cannabidiol (CBD) - non-psychoactive Info on CBD oil products: Marketed as food supplements classed as 'novel foods' Not licensed medicines Regulated by the Food Standards Agency, enforced by local trading authorities Products need to assessed for safety, authorised and approved before being placed on the market If medicinal claims made - medicines legislation applies All Law topics in a word document Must not contain THC (but difficult to fully isolate) Cannabis-based products for medical use: Epidyolex® CD Sch 5 Highly purified CBD liquid Treatment of seizures associated with Lennox-Gastaut Syndrome or Dravets Syndrome Sativex® CD Sch 4 Spray containing cannabis extracts CBD and THC Moderate to severe spasticity in MS Record keeping required - Home Office advises using a CD register More Cannabis-based products for medical use: Nabilone CD Sch 2 Synthetic non-natural cannabinoid capsules N&V caused by cytotoxic chemotherapy unresponsive to convention treatments Dronabinol CD Sch 2 Synthetic, nature-identical, version of THC Unlicensed in UK (available as a special - FDA approved in USA) Loss of appetite in AIDS / severe N&V caused by cancer chemotherapy unresponsive to conventional treatments Initiated by a specialist prescriber (clinician on the GMC specialist register) only Other suitably competent prescribers (including pharmacist IPs) may continue prescribing New psychoactive substances (NPS) All Law topics in a word document Define psychoactive substances - what does it do? What are the 3 exempted psychoactive substances? MEP 3.7.14 Defined in the Psychoactive Substances Act (PSA ) 2016 "Substances capable of producing a psychoactive effect" Stimulates or suppresses the CNS, affects mental functioning or emotional state Substances not controlled under MDA Exempted substances include alcohol, caffeine, nicotine Criminal offence regarding NSPs: Criminal offence to: Import (e.g. purchase online from a foreign website) Possess with intent to supply Possess within custodial institutions Unregulated production of NSP: No quality assurance May contain unclaimed Sch 1 and 2 substances What you need to be aware of with NSPs as a pharmacist: Need to be aware of: - Potential for interactions with POMs, including unclaimed active ingredients (some guidance available) - need to report - Usually used in addition to traditional drugs of abuse - high risk of synergistic or additive pharmacological effects - Includes some OTC P medicines when used recreationally e.g. travel sickness tablets As awareness of use and harms increases, substances often become regulated under the MDA/MDR e.g. - NO - Sch 5 CD (November 2023) - Nitazenes (synthetic opioids) - Sch 1 CD (March 2024) Who can prescribe CDs? 3.3.14 (MEP) INF 1 - non-medical prescirbers lecture All Law topics in a word document Not all prescribers, some prescirbers limited to certain CDs Don't need to memorise this: - supply and administration of CDs against PGDs depending on schedule: Sch 2: Diamorphine and morphine - pharmacists and nurses only (MEP 3.3.10) Ketamine Immediate and necessary treatment only Sch 3: Midazolam Sch 4: All except anabolic steroids and injectables for treating addiction Sch 5: No restrictions For a schedule 2 and 3 CDs, what kind of prescription do you get? A standardised prescription form The prescription requirements for schedule 2/3 CDs are the same as normal NHS prescriptions What are the prescription requirements for schedule 2/3 CDs? 28 days validity (also sch 4) Total quantity in words and figures Dosage instructions PLUS - must state prescribers private CD prescribing ID number - prescription submitted to relevant NHS agency (NHSBSA) after dispensing and copy retained in the pharmacy for 2 years Remember - other human private prescriptions are just retained in the pharmacy for 2 years All Law topics in a word document Are repeats allowed for sch 2/3? No Can sch 4/5 be repeated? Can be repeated if first dispensing occurs within period of validity (28 days/6 months) Private CD form: FP10PCD Pink form Recap from inf 2 lecture on veterinary medicines: And an update since INF 2 lecture: Also private (as per all veterinary prescriptions) (all vet prescription = private) Regulations as for human medicines but: - Not required to use standardised form - Prescriber declaration - 'prescribed for treatment of an animal or herd under my care' - RCVS registration number of prescriber - Retain prescription for 5 years - Not required to submit prescriptions to NHSBSA Update since INF2 Lecture: - Good practice up to 30 days' of treatment only (now same as human prescriptions) CD requisitions: Standardised requisition form for Sch 2 and 3 FP10CDF (original - no copies) Must be used if written in the community or presented to CP - Primary care HCPs, veterinary surgeons, hospital to CP → cannot be any ordinary form Hospitals exempt if requisition from within same hospital trust Hospices and prisons exempt Reminder for all other POMs (requisitions) Requisitions from HCPs can be verbal or written (aka signed order) All Law topics in a word document Supplies to schools require signed order from headteacher / principal Record keeping requirements determine information needed Covered in Y2 ENDO Wholesale Supply Lecture (need to know) Image of an FP10CDF prescription form: MEP 3.6.6 Legal requirements for a CD requisition If the form is completed in full, the requirements will have been met CD requisitions processing requirements for sch 2/3: Sch 2 - record supply in CD register Sch 3 - record supply in POR (as for all supplies of POMs which are not NHS prescriptions) Send original form to relevant NHS agency (NHSBSA) Keep a copy in the pharmacy for 2 years Emergency requisitions: not examined, but need to know the law around this: Rarely seen but permitted Doctor or dentist can be supplied with a Sch 2 or 3 CD without first providing the approved form (FP10CDF) in an emergency (e.g. to save a life, severe accident) Must provide the requisition within 24 hours Midwife supply order (MSO) - not examined Rarely seen Registered Midwife can request, possess and administer diamorphine, morphine and pethidine for a specific patient Request made by MSO (not standardised CD requisition form) Rules on what order must contain MEP 3.6.6 (don't need to know details) MSO needs authorising signature from appropriate medical officer (in writing) All Law topics in a word document Records of supply in CD register Retain MSO for 2 years Submissions to NHSBSA: All CDs in Sch 2 and 3 prescribed for humans or purchased (via requisition) in the community NHS FP10, FP10D, FP10MDA, Private FP10PCD, Requisition FP10CDF Only exemptions are private veterinary prescriptions and MSO Allows the use of CDs to be monitored Standardised FP10PCD and FP10CDF forms and submission a result of Shipman enquiry - submission needed to allow monitoring of CD prescriptions and administrations Rules for correcting CD register errors: MEP 3.6.11 Entries must not be cancelled, obliterated or altered - No crossing out / correction fluid Corrections made by dated notes in margin or footnote Register marked to show who made amendment - Name / initials / signature, GPhC number if applicable - Correct running balance if affected (as above) Private CD prescriptions / requisitions - POR - Sch 2 - POR entry not legally required (due to CD entry) - Sch 3, 4 & 5 - POR entry is a legal requirement Example of correcting an error in a CD register: Investigating running balance discrepancies: Conduct a thorough review of the controlled drug - Double check stock level (colleague second check): - CD cabinet All Law topics in a word document - Uncollected prescriptions / requisitions - Prescriptions / requisitions waiting to be checked - Review all stock received and supplied since last check Most likely cause: - Missed entry / duplicate entry / entry made on incorrect page of register - Correct register as appropriate Other possible causes: - Dispensing error - contact relevant patients to check - Missing invoice or delivery error - contact wholesaler to check Unaccounted missing stock / overstock / dispensing error: - Inform pharmacy Superintendent/CD Lead or Hospital Trust CDAO (more later) - Complete incident form Destruction of CDs : MEP 3.6.10 All CDs in schedules 2, 3, 4 (Part 1 Benz) must be denatured before disposal - rendered unuseable. Includes out-of-date stock and patient returned medicines Denaturing = rendered irretrievable See MEP Table 18 dosage forms and methods Keep Sch 2 under safe custody before denaturing and 24 hours after Place in container with other medicines waste Destruction of CDs:MEP 3.6.10 What are the rules for disposal of medicines? Liquids, sharps, tabs/caps are treated differently See Y1 DIG Regulation of Pharmacies Lecture and MEP 3.7.2 (need to know) Destruction of CDs: patient returns: MEP 3.6.10 Schedules 2, 3, 4 (Part 1) may be destroyed in pharmacy without authorised witness Good practice to document (but not in CD register) and ask staff member to witness All Law topics in a word document Destroy as soon as possible Destruction of CDs: out of date pharmacy stock Schedule 2: - Must be destroyed in presence of authorised witness - Record in CD register (maintain running balance) Schedule 3: - No authorised witness required - Good practice to ask staff member to witness Authorised witnesses: Various individuals and classes of person can be authorised to witness CD destruction Includes: - Police constables - GPhC inspectors - Anyone appointed by an CD Accountable Officer (often senior pharmacy managers) Cannot be anyone involved in day-to-day management of the CDs Cannot be an Accountable Officer CD accountable officer (CDAO) Responsible for ensuring safe and appropriate use of CDs within an organisation - E.g. NHS hospital Trust, NHS England Region (several ICBs) Oversees rather than directly manages Monitors use, concerns, incidents Liaises with national network of CDAO Rights to: - Inspect any premises with CDs - Investigate concerns All Law topics in a word document - Appoint authorised witnesses for CD destruction GPs, dental practices and community pharmacies have an appointed 'CD lead' within their organisation - report to Regional CDAO It is unlawful to be in possession of CDs (other than schedule 5s - cos you can get these over the counter), unless permitted by which 5 things? (hint: some/most of these were seen in part 1) A home office license B member of group specified by the home office C member of a class of persons specified in the regulations e.g. practitioners, pharmacists D regulations provide that possessions of a drug/group of drugs is lawful E legally prescribed (who an prescribe will be taught in year 3) All schedule 2 and 3 CDs must be kept in safe custody. What does this mean? They must be kept locked away in e.g. a safe, or a locked room when not being used - misuse of drugs (safe Custody) regulations 1973 Which schedule 2 drug is an exception to the safe custody rule? Quinalbarbitone - this isnt rlly seen being used that often any more, but it wont hurt to put it in the safe There are loads of schedule 3 drugs that are exempt from the safe custody rule, so it's easier to remember the 2 most commonly dispensed schedule 3's that are NOT exempt. What are they? Temazepam buprenorphine (we'll come across this again in the pain module) Record keeping: which 2 schedules must you keep records of at all times? Schedules 1 and 2 Can the records be hand written, electronic or both? Both What is particular about the drug class, strength, form (and brand) of each record? Separate page for every drug class, strength, form and brand All Law topics in a word document For any CD received from e.g. the wholesaler, which 3 bits of info must be recorded? Date supply received name and address from whom received quantity received For any CDs supplied, which 7 bits of info need to be recorded? Date supplied name and address of recipient details of authority to possess - prescriber or licence holder's details quantity supplied details of person collecting schedule 2 CD - patient, patient's representatives or healthcare representatives (if the latter, also record their name and address) whether proof of identity was requested of the person collecting whether proof of identity was provided *these are the minimum fields of info that must be recorded; additional relevant info can be added* This is an example of a layout of a typical controlled drug register: CD register writing rules: Separate page for every drug class, strength, form (and brand) - E.g. morphine sulfate (Sevredol) 10mg tablets Entered chronologically Entered promptly - same or next day Indelible (if on paper) - cannot be rubbed out All Law topics in a word document Unaltered - if you make a mistake, you cant scribble it out, Tipp-ex Rules for corrections - you cant scribble/write corrections beside the mistake - corrections must be made in a footnote Kept at premises Kept for 2 years following date of last entry Inspected - as part of GPHC inspections e.g. Is it a legal requirement to keep running balances? No - its good practise tho Running balances in a pharmacy refer to the continuous tracking of the quantity of medications or other inventory items. This involves updating the stock levels in real-time as items are dispensed to patients or received from suppliers. Usually, how often are running balances, which includes regular stock checks and investigating discrepancies, undertaken? Usually every week these are recorded, signed and dated How are liquid balances checked? Liquid balances should be checked visually with periodic volume checks, and checks to confirm the balance on completion of a bottle. Stock checks should be recorded, signed and dated by the healthcare professional carrying out the check and if possible, two people should carry out stock checks. what are the prescription requirements for a schedule 2 and 3 CD? (hint: a lot of these are normal requirements for normal prescriptions) Signature - signed and familiar (or satisfied genuine) Appropriate Date (applies to Sch 2, 3 & 4) - 28 days validity All Law topics in a word document Prescriber's address - UK only Name of CD Form Strength Dose - legally acceptable Total quantity - words and figures Quantity prescribed (professional requirement not legal) - max quantity of schedule 2/3 usually 30 days, but can be more. If you have concerns, talk to the prescriber Dental prescriptions - 'for dental treatment only' Instalment directions (Y3) This is an example of a schedule 2/3 drug prescription: What is the error in both of these prescriptions? Answer on the next card Answers from previous card: For the first one: - bd is illegal on a CD prescription - you need to specify how many bd For the second one: - remember that the total quantity must be written in both words and figures - so the "5 patches" needs to have FIVE on it too - you dont have to return this one to the prescriber - words and figures are "technical amendments" that you can change in the pharmacy - to change it: - write the figure/words, then your name, then your GPHC registration number, then the current date All Law topics in a word document Do you have the right to change spelling mistakes on a CD prescription if the prescriber's intentions are clear? Yes - only if their intentions are clear Can you correct any other missing or incorrect information e.g. date, dose, form, strength on the prescription? No Amendments cannot be authorised by a separate letter from the prescriber. How do they have to be amended? They must be amended via another prescription. For a schedule 2 drug, what is the requirement for collections? Legal requirement to determine who is collecting - there are loads of rules, and these are in the MEP table 16 For schedule 2 and 3 , who should be collecting the signature from the patient if it is being delivered, and what can the delivery driver not do? The person delivering must get a signature from the patient before leaving - this is not a law but is a good practise requirement the person delivering cannot put the drug through the letterbox or whatever. This sticker must be on all prescription bags: