B1. Controlled drugs Flashcards
controlled drugs are regulated and classified by what 2 main pieces of legalisation?
-misuse of drugs, act 1971
-misuse of drugs, regulations 2001
Describe the misuse of drugs act 1971
-Primary purpose is to prevent the misuse of ‘controlled drugs’ (i.e. those listed in the Act) by:
-Prohibiting possession, supply, manufacture, import or export, except…
-As allowed by Regulations or a licence from the Secretary of State
Describe Advisory Council on Misuse of Drugs (ACMD)
-Recommend classifications according to their potential harmfulness:
Class A, B, or C
-Class determines penalties for drug offences under the Act
Penalties for drug offences?
ONE NOTE
Describe misuse of drugs regulations 2001
-Controls applied for legitimate use
-Classified on the basis of several factors, including:
extent of use in medical practice
need to prevent misuse
-5 schedules provide different levels of control (MEP 3.6.2)
what are the 5 schedules?
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
Describe schedule 1 (CD Lic)
-Includes hallucinogenic drugs (e.g. LSD), ecstasy-type substances, raw opium, cannabis (except specific licensed medicinal)
-Most strictly controlled group
-Little or no therapeutic use
-Limited to research and other special purposes
-Licence needed from the Home Secretary in order to possess, produce, supply, etc.
-Hospital pharmacists make take possession from a patient to destroy or hand over to police
Describe schedule 2 (CD POM)
-Includes strong opioids (e.g. diamorphine, morphine, methadone, oxycodone, pethidine), major stimulants (e.g. amfetamines), quinalbarbitone, ketamine
-Full controls relating to:
prescription requirements
safe custody
record-keeping of supplies
-Licences required for import/export
Describe schedule 3 (CD No Reg POM)
-Includes minor stimulants, moderate opioids (e.g. buprenorphine, tramadol), gabapentinoids (gabapentin and pregabalin, and strong benzodiazepines (such as temazepam, midazolam,)
-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
Describe schedule 4 (CD Benz POM or CD Anab POM)
Schedule split into two parts:
Part I: CD Benz contains most benzodiazepines (e.g. diazepam), z-drugs (e.g. zopiclone), and Sativex (cannabinoid oromucosal spray)
Part II: CD Anab contains anabolic and androgenic steroids, and growth hormones
-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)
Describe schedule 5 (CD Inv P or CD Inv POM)
Low strength preparations of certain CDs e.g. codeine, co-codamol (paracetamol & codeine), dihydrocodeine, morphine sulfate oral solution 10mg/5ml (currently)
-P or POM
-Negligible risk of abuse
-Does not include preparations for injections
-Invoices retained for 2 years
Unlawful to be in possession of CDs (other than in Schedule 5) unless permitted by:
-Home Office licence
-Member of group specified by the Home Office
-Member of a class of person specified in the Regulations e.g. practitioners, pharmacists
-Regulations provide that possession of a drug/group of drugs is lawful
-Legally prescribed (who can prescribe in Y2 and Y3)
Describe safe custody of CDs
-All Schedule 2 & 3 CDs must be kept in locked safe, cabinet or room
-The Misuse of Drugs (Safe Custody) Regulations 1973
what are the drugs exempt from safe-custody?
-Schedule 2 - quinalbarbitone
-Schedule 3 - many drugs exempt, easier to remember those for which it does apply! (e.g. temazepam, buprenorphine)
Describe record keeping (Controlled Drugs Registers)
-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)
what details should be kept for controlled drugs RECEIVED?
-Date received
-Name & address from whom received
-Quantity received
What details should be kept for controlled drugs SUPPLIED?
-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
Describe controlled drugs registers
-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 making corrections
-Kept at premises
-Kept for 2 years following date of last entry
-Inspected
Describe running balances
-Good Practice (but not legal requirement) to maintain a running balance
-Perform a visual balance check after each dispensing
-Undertake regular stock checks and investigate discrepancies (usually once a week) – recorded, signed, dated
-Liquids – issues with overage, spillage
-Separate page for each brand facilitates running balance checks
-Pharmacists have responsibility for maintain running balances but can delegate tasks to competent staff
What are the prescription errors for schedules 2 and 3?
-Signature – signed and familiar (or satisfied genuine)
-Appropriate Date (for Sch 2, 3 & 4) – 28 days validity
-Prescriber’s address – UK only
-Name of CD
-Form
-Strength
-Dose – must be legally acceptable
-Total quantity – words and figures
-Quantity prescribed – professional requirement (not legal) up to 30 days
-Dental prescriptions – ‘for dental treatment only’ (dental prescribing Y2)
-Instalment directions (instalments in Y3)
Prescription errors- technical errors?
Total quantity in either words or figures missing
Spelling mistakes - if prescriber’s intentions are clear
ONE NOTE
Other prescription errors?
-Cannot correct any other missing or incorrect information e.g. date, dose, form, strength
-Amendments cannot be authorised by a separate letter from the prescriber
-Creates an ethical dilemma when correction causes delay for a patient in severe pain / end of life
Describe collection of schedule 2 CDs
-Schedule 2:
Legal requirement to determine who is collecting
Patient or representative?
Healthcare professional (on patient’s behalf)?
Different actions required for each – MEP Table 16
-Schedule 2 and 3:
Good practice to obtain signature from person collecting
Deliveries
ONE NOTE
