Prescribing and dispensing controlled drugs.pdf

Prescribing & dispensing in veterinary practice: Responsibilities & controlled drugs CP3.14 Supporting the patient Pat Pawson1 1 Intended Learning Outcomes Year ILOs • CP3036 – • Explain the current guidelines and legislative requirements that apply when stocking, prescribing, dispensing a...

Prescribing & dispensing in veterinary practice: Responsibilities & controlled drugs CP3.14 Supporting the patient Pat Pawson1 1 Intended Learning Outcomes Year ILOs • CP3036 – • Explain the current guidelines and legislative requirements that apply when stocking, prescribing, dispensing and disposing of drugs used in veterinary medicine, including cytotoxic & controlled drugs. CP3039 – Judge courses of action against current guidelines and legislative frameworks to ensure safe working practices and protect personnel. Lecture content ILOs 1. 2. 3. 4. 5. Evaluate dispensary practice, in relation to current guidelines and legislative frameworks Recognise a Suspected Adverse Event (SAE), describe how to report a SAE and explain the importance of doing so Describe the basic requirements when stocking, prescribing, dispensing and destroying controlled drugs List the Schedules of controlled drugs and give examples List the requirements for a controlled drug written prescription 2 2 Prescribing & dispensing • Need to review … – Module 12 week 3: Principles of Drug Legislation 3 Prescribing & dispensing: Responsibilities & controlled drugs Lecture overview • Part 1: Dispensary practice • Part 2: Controlled drugs – Legislation & Schedules • Part 3: Controlled drugs – Practicalities of prescribing & dispensing CDs 4 The dispensary 5 5 The dispensary • Vet can only supply vet medicines from a premises (VPP) registered with RCVS • Regular inspections assess compliance with legislation – RCVS inspect premises for Practice Standards Scheme (PSS) – VMD inspect non-PSS premises • Aspects considered – – – – – – Security Prescription and supply of medicines Storage of medicines Health & safety Record keeping Controlled drugs 6 6 Health & safety precautions • Control of Substances Hazardous to Health • COSHH risk assessments • Standard operating procedures (SOPs) – Spillages • Personal protective equipment (PPE) • Manual handling 7 7 8 Health & safety precautions • Control of Substances Hazardous to Health • COSHH risk assessments • Standard operating procedures (SOPs) – Spillages • Personal protective equipment (PPE) • Manual handling 9 9 10 10 Health & safety precautions • Control of Substances Hazardous to Health • COSHH risk assessments • Standard operating procedures (SOPs) – Spillages • Personal protective equipment (PPE) • Manual handling 11 11 The dispensary • Inspection report • VMD classifies deficiencies as minor, major or critical – Critical: » Significant risk to human/animal health or the environment » Significant deviation from VMR • Enforcement: – Improvement notices – Seizure notices – Prosecution & removal from register of VPP 12 12 The mobile dispensary 13 13 The mobile dispensary 14 14 The mobile dispensary • Problems associated with keeping drugs in vehicles – Temperature » Min-max thermometer » Data logger preferred » Portable refrigeration unit – Public access – Stock rotation – Drug waste • Remove drugs from vehicles when not in use 15 15 Public access • Vehicle is a “public place” • CDs, firearms etc. are not deemed to be secure in a locked vehicle • A lockable bag, box or case or a lockable glove compartment is acceptable for transport but not “long term” storage • Vehicles require a “fixed” lockable box or safe to meet safe custody requirements – Bolted to the floor or chassis (metal cable) 16 16 Mailing medicines • Prescription medicines may be sent via Royal Mail • Check current details on Prohibited Goods using Royal Mail website • CDs should NOT be sent through the post • In exceptional circumstances use recorded delivery or ‘signed for’ courier delivery – For e.g. a client unable to travel to practice & unable to send a representative 17 17 Suspected adverse events • Report problems with animal medicines to the VMD in the UK – On-line via website – Improves safe & effective use of veterinary medicines 18 18 What to report? • Suspected adverse reactions AND lack of efficacy • Reactions to authorised veterinary medicines AND human medicines • Reactions in animals AND also people handling drugs 19 19 Controlled Drugs 20 Legislation 1. Misuse of Drugs Act 1971 • • • Controls availability of drugs considered “dangerous or otherwise harmful” Defines unlawful activities with respect to CD Vets can prescribe, administer or supply CD in the course of their work 2. Misuse of Drugs (Safe Custody) Regs 1973 • Describes the requirements for storage • Governs use of CDs in (veterinary) medicine 3. Misuse of Drugs Regulations 2001 21 Useful resources • Veterinary Medicines Directorate: Product information database & Veterinary Medicines Guidance Notes – https://www.gov.uk/government/organisations/veterina ry-medicines-directorate • BSAVA Guide to the Use of Veterinary Medicines – https://www.bsavalibrary.com/content/chapter/10.222 33/9781905319862.app2 • RCVS Guidance on Controlled Drugs – https://www.rcvs.org.uk/setting-standards/advice-andguidance/controlled-drugs-guidance-a-to-z/ 22 Classification of CDs • Drugs controlled under MoD Act are divided in to Classes • Classes are used to define penalties for illegal possession/use DRUGS MAXIMUM PENALTIES CLASS A Crack cocaine, cocaine, ecstasy, heroin, LSD, magic mushrooms, methadone, methamphetamine Possession: 7 years in prison and/or fine Supply: life imprisonment and/or fine CLASS B Amphetamines, barbiturates, cannabis, codeine, ketamine, methylphenidate, synthetic cannabinoids, synthetic cathinones Possession: 5 years in prison and/or fine Supply: 14 years imprisonment and/or fine CLASS C Anabolic steroids, benzodiazepines, gamma hydroxybutyrate (GHB), gamma butyrolactone (GBL), piperazines (BZP), khat Possession: 2 years in prison and/or fine Supply: 14 years in prison and/or fine 23 Schedules CDs • MoD Regulations divide CDs into Schedules 1-5 – Scheduling depends on therapeutic benefit vs harm » Schedule 1 risk of harm >> benefit » Schedule 5 risk of harm << benefit – Dictates the degree to which drug use is regulated 24 Schedule 1 CDs • Greatest potential harm • No significant therapeutic value • Most strictly controlled – E.g. Cannabis, lysergic acid diethylamide (LSD) 25 Cannabis-based products for medicinal use • Cannabinoids derived from cannabis – Tetrahydrocannabinol (THC) – Cannabidiol (CBD) » If pure, this is NOT a controlled drug • Rescheduling in November 2018 allows some products to be prescribed • Indications: – Chronic pain – Resistant forms of epilepsy – Chemotherapy-related nausea and vomiting • Non-medicinal synthetic cannabinoids remain in Schedule 1 26 Schedule 2 CDs       Must be stored in a fixed locked receptacle (safe custody) Additional information required on prescriptions Prescriptions valid for only 28 days Use must be recorded in a register, signed by vet Destruction must be authorised & witnessed Invoices must be retained for a minimum of two years • Examples include: – Pethidine – Morphine – Methadone – Fentanyl – Quinalbarbitone – Ketamine 27 Schedule 2 CDs EXCEPTIONS: • Quinalbarbitone – Exempt from safe custody requirements 28 Schedule 3 CDs X   X X  Must be stored in a fixed locked receptacle (safe custody) Additional information required on prescriptions Prescriptions valid for only 28 days Use must be recorded in a register, signed by vet Destruction must be authorised & witnessed Invoices must be retained for a minimum of two years • Examples: – Pentobarbitone – Phenobarbitone – Midazolam – Buprenorphine – Tramadol • • • • • Exempt from safe custody requirements (exceptions!) Subject to same prescription requirements as Schedule 2 CDs No legal requirement to record transactions in a CD register Requirements relating to destruction do not apply Invoices must be retained for a minimum of two years 29 Schedule 3 CDs EXCEPTIONS: • Buprenorphine is a Schedule 3 CD in all respects, except … – It is NOT exempt from safe custody requirements and should be stored in a fixed locked receptacle 30 Recent additions to Schedule 3 • Tramadol re-classified in 2014 • Gabapentin (& pregabalin) reclassified in 2019 • Both are typical Schedule 3 drugs – Exempt from safe custody requirements – But must be requisitioned & prescribed as a CD 31 Schedule 4 CDs X X  X X  Must be stored in a fixed locked receptacle (safe custody) Additional information required on prescriptions Prescriptions valid for only 28 days Use must be recorded in a register, signed by vet Destruction must be authorised & witnessed Invoices must be retained for a minimum of two years • Examples: – Part 1: benzodiazepines (except midazolam - Schedule 3) – Part 2: anabolic and androgenic steroids Are exempt from safe custody requirements Some CD prescription-writing requirements apply CD registers do not need to be kept Requirements relating to destruction do not apply Invoices must be retained for a minimum of two years 32 Schedule 5 CDs X X X X X  Must be stored in a fixed locked receptacle (safe custody) Additional information required on prescriptions Prescriptions valid for only 28 days Use must be recorded in a register, signed by vet Destruction must be authorised & witnessed Invoices must be retained for a minimum of two years • Examples: preparations containing low concentrations of controlled drugs, including codeine and morphine Are exempt from safe custody requirements Some CD prescription-writing requirements apply CD registers do not need to be kept Requirements relating to destruction do not apply Invoices must be retained for a minimum of two years 33 Summary of schedules REQUIREMENTS Safe custody Extra prescription requirements Prescription valid for … SCHEDULE 2 SCHEDULE 3 SCHEDULE 4 SCHEDULE 5 * X* X X   X X 28 days 28 days 28 days 6 months CD register  X X X Extra requirements for disposal  X X X Invoices kept for 2 years     * Exceptions apply 34 Managing use of CDs Standard Operating Procedures (SOPs) • Unambiguous document • Description of a procedure to be followed • Working document & subject to regular review – Will be different for each practice • Forms the basis of an audit 35 Standard Operating Procedures SOPs should cover the following: • Who has access to CDs • Where CDs are stored • How to dispense CDs • How to destroy & dispose of CDs • What records need to be kept • Who to alert and what to do if complications arise Taken from DH ‘Safer Management for Controlled Drugs’ 36 Safe custody: CD cabinet Misuse of Drugs (Safe Custody) Regulations 1973 Must be bolted to wall or floor Preferably double locked Must be locked when not in use Lock must be different to any other lock on ward • Keys must only be available to authorised members of staff • Cupboard should be reserved solely for the storage of CDs • • • • 37 Keyholders • Any responsible person within the practice • Good practice would suggest a VS or qualified VN • Acceptable to have multiple keyholders identified • Not acceptable to allow unknown persons access to the CD cabinet 38 Prescriptions • Can be hand written; typed or computerised BUT must be signed IN INK by the prescriber • It is an offence to supply against a faxed or emailed prescription (but the drug can be prepared for issue) • Prescriptions for Schedule 2, 3 & 4 are only valid for 28 days • Repeats on the same prescription are NOT allowed for Schedule 2 & 3 • Only 28 days worth of medication should be prescribed (unless longterm meds) Computer generated prescriptions are considered ‘good practice’ as they generate an easy to follow audit trail 39 Prescription requirements In addition to general prescription requirements, Schedule 2 & 3 CD prescriptions must also state: • Declaration that CD is prescribed for an animal or herd under the veterinarian’s care • Name & address of owner, plus name of animal to whom the CD is to be administered • Name & form of drug • Amount of product prescribed in both words & numbers – For example: Twenty (20) capsules • Strength of preparation • Dose to be administered and the route (take as directed or take as required is not acceptable) • Prescribing vet’s MRCVS registration number 40 CDs register • Bound or electronic • Individual sections for each CD • Record receipt – Date, name & address of supplier & amount – Running balance – Signed by VS or VN • Record supply – Date, name & address of patient (or case number) & amount – Running balance – Prescribers MRCVS number – Signed by VS • Auditable • Kept for 2 years (minimum) 41 Checking the balance • Check & sign at regular intervals • E.g. in SAH, balance is checked at least once daily • Aim to identify discrepancies ASAP as easier to deal with • Good practice for 2 people to initial balance 42 Register errors • Errors should NOT be obliterated with tippex, crossed or scrubbed out • Incorrect entries must be readable • Bracket error & asterix* • Use footnote to record reason for error • On a new line, write correct entry with new balance • If possible, countersign error 43 Register discrepancies • Consult SOP in event of register discrepancy • Once resolved, include footnote in register correcting discrepancy in balance • Advisable to keep appropriate records of action taken when discrepancies arise • If source of discrepancy cannot be identified, a formal internal investigation must be undertaken 44 Destruction of out-of-date Schedule 2 CDs • Keep segregated & clearly marked in CD cabinet • Two step process: – Must be denatured (rendered irretrievable) » Commercial denaturing kit or cat litter/sawdust – Disposed of as pharmaceutical waste • Must be recorded in register & balance adjusted – Don’t sign out until destroyed • Witnessed by: – Vet independent of practice – Police (Controlled Drugs Liaison Officer) – VMD inspector or Practice Standards Scheme assessor • Try to avoid by practising good stock rotation 45 Waste Schedule 2 CDs Smashed ampoules • Some breakages are inevitable • Clear up using an appropriate spill kit – SOP • Dispose of waste in appropriate containers – Pharmaceutical waste • Record in register that ampoule has been broken • Counter sign 46 Destruction of residual CDs “Residual drug” is drug remaining in vial/ampoule or remaining in a syringe • Must first be denatured – Commercial denaturation kit or cat litter • Then disposed of as pharmaceutical waste • Must be recorded – Residual in vial signed out in CD register – Residual in syringe has already been signed out to patient • No legal requirement to witness destruction 47 Destruction of returned CDs • Must be denatured • Then disposed of as pharmaceutical waste • No need to record – But good practice to record & have destruction witnessed 48 Methadone (Comfortan) • • Methadone is authorised for veterinary use (POM-V CD) But it is a multi-dose bottle • • • • Variation in amount in bottle Additional drug in needle hub of each syringe filled Discrepancy at end of bottle Abuse potential increased? 49