B1 Controlled drugs Flashcards
what 2 main pieces of legislation regulate and classify controlled drugs?
- Misuse of Drugs Act 1971
- Misuse of Drugs Regulations 2001
what is the primary purpose of the Misuse of Drugs Act 1971 and how is this achieved?
purpose is to prevent the misuse of ‘controlled drugs’ by:
- prohibiting possession, supply, manufacture, import or export, except…
- …as allowed by Regulations or a license from the Secretary of State
what does the Advisory Council on Misuse of Drugs (ACMD) do and what does this determine?
- recommend classifications of controlled drugs according to their potential harmfulness (class A, B or C)
- class determines penalties for drug offences under the Act
examples of class A drugs
- heroin (diamorphine)
- cocaine
- ecstasy
- LSD
- methadone
punishment for possession of class A drugs
up to 7 years in prison, an unlimited fine or both
examples of class B drugs
- amphetamines
- barbiturates
- cannabis
- codeine
punishment for supply of class A drugs
up to life in prison, unlimited fine or both
punishment for possession of class B drugs
up to 5 years in prison, unlimited fine or both
punishment for supply of class B drugs
up to 14 years in prison, unlimited fine or both
examples of class C drugs
- anabolic steroids
- benzodiazepines (diazepam)
- nitrous oxide
punishment for possession of class C drugs, what is the exception?
- up to 2 years in prison, unlimited fine or both
- anabolic steroids are not an offence to possess if they are for personal use
punishment for supply of class C drugs
up to 14 years in prison, unlimited fine or both
what does the Misuse of Drugs Regulations 2001 apply?
- applies controls for legitimate use
what are drugs classified on the basis of in the Misuse of Drugs Regulations 2001?
several factors including:
- extent of use in medical practice
- need to prevent misuse
what is the Misuse of Drugs Regulations 2001 split into?
5 schedules that provide different levels of control
- schedule 1: CD Lic (License)
- schedule 2: CD POM
- schedule 3: CD No Register POM
- schedule 4 part 1: CD Benz POM
- schedule 4 part 2: CD Anab POM
- schedule 5: CD Inv P or CD Inv POM
who recommended the schedules of the Misuse of Drugs Regulations 2001?
ACMD
what drugs are included in schedule 1 (CD Lic) of the Misuse of Drugs Regulations 2001?
- hallucinogenic drugs eg. LSD
- ecstasy-type substances
- raw opium
- cannabis (except specific licensed medicinal)
describe schedule 1 (CD Lic) of the Misuse of Drugs Regulations 2001
- most strictly controlled group
- little or no therapeutic use
- limited to research and other special purposes
- license needed form the Home Secretary in order to possess, produce, supply etc.
- hospital pharmacists may take possession from a patient to destroy or hand over to police
what drugs are included in schedule 2 (CD POM) of the Misuse of Drugs Regulations 2001?
- strong opioids (eg. heroin, morphine, methadone, oxycodone)
- major stimulants (eg. amphetamines)
- quinalbarbitone
- ketamine
schedule 2 (CD POM) of the Misuse of Drugs Regulations 2001 contains full controls relating to what 3 things?
- prescription requirements
- safe custody
- record-keeping of supplies
what is required for import or export of drugs listed in schedule 2 (CD POM) of the Misuse of Drugs Regulations 2001?
a license
what drugs are included in schedule 3 (CD No Reg POM) of the Misuse of Drugs Regulations 2001?
- minor stimulants
- moderate opioids (eg. buprenorphine, tramadol)
- gabapentinoids (gabapentin and pregabalin)
- strong benzodiazepines (eg. temazepam, midazolam)
compare the controls of schedule 2 and 3 of the Misuse of Drugs Regulations 2001
- controls are less stringent in schedule 3 than schedule 2
what does schedule 3 of the Misuse of Drugs Regulations 2001 have controls for?
- prescription requirements
- safe custody (but numerous exceptions)
- CD register entries not required
- invoices retained for 2 years
- licenses required for import / export
what drugs are included in schedule 4 part 1 (CD Benz) of the Misuse of Drugs Regulations 2001?
- most benzodiazepines (eg. diazepam)
- z-drugs (eg, zopiclone)
- Sativex (cannabinoid oromucosal spray)
what drugs are included in schedule 4 part 2 (CD Anab) of the Misuse of Drugs Regulations 2001?
- anabolic and androgenic steroids
- growth hormones
what controls that are detailed in schedule 2 and 3 of the Misuse of Drugs Regulations 2001 are not detailed in schedule 4?
- no safe custody
- no prescription requirements (except validity)
- no records to be kept
is a license required for drugs in either part of schedule 4 of the Misuse of Drugs Regulations 2001? state the exception
- yes
- required for import / export
- not required for CD Anab for personal use
what drugs are included in schedule 5 (CD Inv P or CD Inv POM) of the Misuse of Drugs Regulations 2001?
- low strength preparations of certain CDs (eg. codeine, co-codamol)
- dihydrocodeine
- morphine sulphate oral solution 10mg/5ml (currently schedule 5, there is a higher strength version in schedule 2)
describe the drugs included in schedule 5 of the Misuse of Drugs Regulations 2001 and why
- P or POM
- negligible risk of abuse
- doesn’t include preparations for injection
how long are invoices retained for of drugs in schedule 5 of the Misuse of Drugs Regulations 2001?
2 years
it is unlawful to be in possession of controlled drugs (other than those in schedule 5) unless permitted by what?
- Home Office license
- member of group specified by the Home Office
- member of group specified in the Regulations eg. practitioners, pharmacists
- regulations provide that possession of a drug / group of drugs is lawful
- legally prescribed
which schedules of drugs in the Misuse of Drugs Regulations 2001 must be kept in safe custody?
schedule 2 and 3 unless they have a safe-custody exemption
what is considered safe custody?
locked safe, cabinet or room
what drug in schedule 2 of the Misuse of Drugs Regulations 2001 has safe custody exemptions?
quinalbarbitone
give 2 examples of drugs in schedule 3 of the Misuse of Drugs Regulations 2001 that are NOT exempt from safe custody?
- many drugs are exempt
- 2 examples of those that are NOT exempt are temazepam and buprenorphine
what schedules of drugs in the Misuse of Drugs Regulations 2001 must controlled drug registers be kept for?
all schedule 1 and 2 CDs
describe controlled drug registers
- can be electronic or hand-written
- separate page for every drug class, strength, form (and brand)
what information must be recorded in controlled drug registers for controlled drugs RECEIVED?
- date received
- name and address from whom received
- quantity received
what information must be recorded in controlled drug registers for controlled drugs SUPPLIED?
- date supplied
- name and address of recipient
- details of authority to possess - prescriber or license holder’s details
- quantity supplied
- details of person collecting (patient, patient’s representative or healthcare professional)
- whether proof of identity was requested from collector
- whether proof of identity was provided
describe how information must be inputted into controlled drug registers and what must be done after a page is completed
- separate page for every drug class, strength, form (and brand)
- 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
is it illegal to not keep a running balance in controlled drug registers?
- no
- it is good practice to do so but not a legal requirement
how should CD balances be checked and when?
- perform a visual balance check after each dispensing
- undertake regular stock checks and investigate discrepancies (usually once a week)
who in a pharmacy has responsibility for maintaining running balances and who must do them?
pharmacist is responsible but can delegate tasks to competent staff
prescription requirements for drugs in schedule 2 and 3 of the Misuse of Drugs Regulations 2001
- signature (signed and familiar - or satisfied genuine)
- appropriate date
- prescriber’s address
- name of CD
- form
- strength
- dose
- total quantity (words and numbers)
- quantity prescribed
- ‘for dental treatment only’ (if on dental prescription)
- instalment directions
how long are prescriptions for schedule 2, 3 and 4 drugs valid after the appropriate date?
28 days
what is the professional requirement for quantity of CDs prescribed?
up to 30 days, however, not illegal to prescribe more
what are technical errors on prescriptions?
errors that pharmacist can amend indelibly to make prescription comply with law if the intentions of the prescription are clear
give 2 examples of technical prescription errors
- total quantity in either words or figures missing
- spelling mistakes (if prescriber’s intentions are clear)
what information cannot be changed or added by the pharmacist on CD prescriptions like in technical errors? what do these issues cause?
- date, dose, form, strength
- these missing infos cause ethical dilemma when correction time causes delay for patient in severe pain / end of life
describe the requirements for collection of schedule 2 CDs specifically
- legal requirement to determine who is collecting (patient or HCP?)
- different actions are required depending on who collects
describe the requirements for collection of schedule 2 and 3 CDs
good practice to obtain signature from person collecting
