controlled drugs Flashcards
(33 cards)
Legislation
The Misuse of Drugs Act 1971
Misuse of Drugs Regulations 2001
Misuse of Drugs (Safe Custody) Regulations 1973
The Health Act 2006
Controlled Drugs (Supervision of Management and Use) Regulations 2013
The Misuse of Drugs Act 1971
Designates the term ‘Controlled Drug’ to a range of harmful and dangerous drugs
Imposes a total prohibition on possession, supply or manufacture, import & export of these drugs except when allowed by Regulation
Misuse of Drugs Regulations 2001 permits the use of Controlled Drugs in medicine
Classification
2001 Regulations classify CDs into 5 schedules according to the different levels of control attributed to each (Schedule 1 having most control)
Schedule 1 (CD Lic POM)
Schedule 2 (CD POM)
Schedule 3 (CD No Register POM)
Schedule 4 (CD Benz POM and CD Anab POM)
Schedule 5 (CD INV P and CD INV POM)
Schedule 1
Annotated (CD Lic) in MEP
Controlled Drugs with no medicinal purpose
Production and possession limited to research and other special purposes in the public interest
Must have a licence from the Secretary of State
Includes hallucinogenic drugs (e.g. ‘LSD’) ecstasy-type substances and raw opium
Pharmacists
Can only possess Schedule 1 drugs to enable destruction or to hand to a police officer
Seek advice from Home Office for means of destruction
Schedule 2
Annotated (CD POM) in MEP or CD2 in BNF
Contains opiates (e.g. diamorphine, morphine, methadone) major stimulants (e.g. amfetamines), quinalbarbitone and ketamine
Pharmacists and other classes of persons named in 2001 Regulations have a general authority to prescribe, process, supply and procure Schedule 2 CDs when acting in that capacity (role)they require:
Safe custody (except quinalbarbitone)
Record keeping
Restrictions on destruction apply
Invoices do not need to be kept (CD entry made)
Schedule 3
Annotated ‘CD No Register POM’ in MEP or CD3 in BNF
Includes minor stimulants and other drugs (e.g. buprenorphine, temazepam, tramadol, midazolam, phenobarbital, gabapentin and pregabalin). Others as well
Similar controls to Schedule 2
Register entries not required
No safe custody requirements (except temazepam and buprenorphine)
Authorised witness not required for destruction
Invoices must be kept for two years.
Schedule 4
Split into
Part I ‘CD Benz POM’ in MEP or CD4-1 in BNF
Part II ‘CD Anab POM’ in MEP or CD4-2 in BNF
CD4-1 contains most benzodiazepines, non-benzodiazepine hypnotics and Sativex
CD4-2 contains most anabolic and androgenic steroids, clenbuterol
No restriction on possession of Part II if as part of a medicinal product
Schedule 5
Annotated (CD Inv P) or (CD Inv POM) in MEP
CD5 in BNF
Contains preparations of Controlled Drugs which present negligible (little) risk of abuse due to low strength in compound preparations (e.g. codeine, pholcodeine)
No restrictions on import, no register requirements & no safe custody
Invoices must be kept for two years
The Misuse of Drugs Act (safe custody) 1973
Stipulates that controlled drugs should be stored in line with the Safe custody regulations
Detail storage and safe custody requirements of controlled drugs
All Schedule 2 and some Schedule 3 drugs
Enforcement body
Home office via the police
Approved CD cabinets
Should be stored in a cabinet or safe locked with a key
Made of metal with suitable hinges and stuck to the wall or floor with bolts that are not accessible outside the cabinet
Cabinet must be on the internal wall
Key = responsible pharmacist
Other members of staff must ask the pharmacist each time
Sometimes its by a smart card, records can be automatically kept electronically
Possession & Supply
Unlawful to possess or supply any controlled drug UNLESS the individual has a licence, is a member of a specified group, or regulation specifies that possession is lawful.
A person can only supply those classes they can legally possess
Supply is always subject to the HMR 2012
Class A, B and C CDs
Misuse of Drugs Act (MDA) 1971 divides CDs into three classes for the purposes of imposing penalties in criminal law convictions.
The class of drug reflects the relative harm when misused in descending order of severity from A - C
Psychoactive substances
Include substances such as nitrous oxide (‘laughing gas’).
A fine or prison sentence may be given if someone
carries a psychoactive substance and intends to supply it
makes a psychoactive substance
sells, deals or share a psychoactive substance (also called supplying)
Prescription Requirements
what do they apply for
what are the requirements
Prescription requirements apply for Sch 2 & 3 CDs
For both NHS & private Rxs
The requirements for a valid prescription are
Name and address of patient
Name, form and strength of drug
The dose
Quantity in words & figures
Signature of prescriber
Address of prescriber (in UK)
Particulars of what type of prescriber they are
Date
Also,
For dental prescriptions, the words ‘for dental treatment only’ must be present
For instalment Rxs, a valid instalment direction & where appropriate the instalment wording
Technical errors on Sch 2 & 3 CD Rxs
Technical error
Minor typographical error or spelling mistake
Total quantity is missing in either words or figures – not both
Ensure the Rx is genuine
Pharmacists can amend the Rx indelibly, so it meets the Rx writing requirements
Include the amendment/addition
Name of pharmacist
GPhC number
Signature of pharmacist
Date
Rx must be made legal before it can be dispensed
Collection
Sch 2 & 3
Collector to sign (good practice)
Do not have supply if
Not signed
Not satisfied as to identity
HCP: need
Name & Address
Instalments- just one signature
Prescription requirements
owings and quantity prescribed
Owings
Validity – 28 days after the appropriate date for Sch 2, 3 & 4 CDs
Quantity prescribed
DoH recommends max. of 30 days’ supply for Sch 2, 3 & 4 CDs
Prescribers should be able to justify greater quantities
You have a duty to ask why
Controlled drugs register
All healthcare professionals holding CDs
Must keep a CD register
Personal responsibility to ensure it is accurate and up-to-date
A separate register is required for each brand, strength & form
Wards & hospital departments (found here)
GPs
Nursing homes
Out-of-hours
The controlled drugs register must be kept
The register must be kept
on the premises to which the register applies
2-years from the date of the last entry
In its original form or copied & kept in an approved computerised format
Available for inspection to authorised persons (e.g. a GPhC inspector or CD liaison officer) on request
Records kept in the CD register must be kept of both receipts & supplies of Sch 2 CDs
Entries must be chronological
Entered promptly (on the same day)
In ink or indelible
Unaltered
Electronic CD registers
Safeguards must be incorporated into software to ensure all the following:
Author of each entry is identifiable
Entries cannot be altered at a later date
Log of all data entered is kept and can be recalled for audit purposes
Access control systems in place to minimise risk of unauthorised or unnecessary access to data
Adequate backups are made
Register can be seen by inspectors with minimum disruption to dispensing process
Amending CD register entries
Entries must not be cancelled, obliterated or altered
Corrections are made using marginal notes or footnotes
Notes must show who the amendments are attributable to
Name, signature, GPhC number & date
Rxs for substance misusers – FP10MDA
Medicines for substance misuse can be prescribed on an FP10
FP10MDA Rx forms are used where instalments are required
Instalment Rxs are the most common Rx type used for substance misusers
FP10MDAs - how long can we supply them for
FP10MDAs are only available in paper form
The following can be prescribed on an FP10MDA
Any Sch 2 CD
Buprenorphine (Sch 3)
Buprenorphine/naloxone (Sch 3)
Diazepam (Sch 4)
Diluents
Water for injection
A maximum of 14-days’ supply can be prescribed on an FP10MDA
Missed doses - ON FP10 MDA
Less than 3 days ‘ missed treatment, follow prescriber instructions relating to supply
If instructions do not allow supply, inform pt and explain the next steps
Missing 3 days’ treatment -> risk of lost tolerance -> cause overdose
Discuss with prescriber as referral may be required
If less than 3 days is missed, the Rx must be endorsed accordingly
‘Not dispensed’ in both the ‘item’ & ‘quantity supplied’ boxes or putting a line through them
‘ND’, ‘DNA’ or ‘N/C’ is not acceptable
