Regulation of Controlled Drugs Flashcards
Legislative Framework for Controlled Drugs
- The Misuse of Drugs Act 1971
- The Misuse of Drugs Regulations 2001 as amended
- The Misuse of Drugs (Safe Custody) Regulations 1973 as amended (herein referred to as ‘Safe Custody Regulations’)
- The Health Act 2006
- Controlled Drugs (Supervision of Management and Use) Regulations 2013 which affect England and Scotland.
Human Medicines Regulations 2012
- Sets out comprehensive regime for the authorisation of medicinal products
- Allows certain exemptions from the general restriction
- Allows midwives to supply or administer morphine, diamorphine, pethidine or pentazocine
Misuse of drugs act 1971
- CD drugs subject to misuse
- Controls and prohibits possession, import, manufacture, supply and export
- Except where permitted in regulations 2012
- Divided into classes A. B and C, depending on harmfulness when misused, determine max penalty that can be imposed
The Misuse of Drugs (Safe Custody) Regulations 1973 as amended
Detail the storage and safe custody requirements for CDs
Requirements of a CD cupboard
Imposes controls on storage of CDs
- Lockable
- Made of Metal
- Fixed to wall or floor
- Nominated Key Holder has Responsibility
The Health Act 2006
- Introduced the concept of an ‘accountable officer’
- Requires healthcare organisations, and those providing services to healthcare organisations, to have SOPs in place for using and managing CDs.
Accountable Officer
Responsible for supervising and managing the use of CDs in their organisation or setting:
- Overseeing the monitoring and auditing of the management, prescribing and use of CDs
- Ensuring the systems recording concerns and incidents involving CDs are in place
- Attendance at local intelligence network meetings
- Occurence Reports
- Authorised witness for CD destruction
The 2001 Regulations classify CDs into five Schedules according to the different levels of control attributed to each:
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 (CD LIC POM)
- Most have no therapeutic use
- Must hold a home office licence for production, possession or supply
Schedule 1 examples
LSD, raw opium, cannabis
Schedule 2 (CD POM)
- CD register
- Safe custody (except quinalbarbitone) apply
- Destruction by appropriately authorised person with authorised witness and keep record
Schedule 2 examples
- diamorphine
- morphine
- methadone
- oxycodone
- major stimulants (amphetamines)
- ketamine
Schedule 3 (No reg)
- No register
- Most are exempt from safe custody requirements (except temazepam and buprenorphine)
- emergency supply is not allowed (except for phenobarbital for epilepsy)
Schedule 3 examples
Minor stimulants and others
- Buprenorphine
- Midazolam
- Phenobarbital
- Temazepam
- Tramadol
- Gabapentin
- Pregabalin
Schedule 4
- Exempt from safe custody and CD entry
- Repeat prescriptions are allowed
- Emergency supplies are allowed (max 5 days)
Schedule 4 (CD BENZ POM) examples
Part I
- Contains most of bdz (diazepam)
- Non-bdz (Zolpidem)
- Sativex (Cannabinoid oral spray)
Schedule 4 (CD ANAB POM) examples
Part II:
- Contains anabolic and androgenic steroids (testosterone) and growth hormones
Schedule 5
- contains schedule 2 CD in low strengths which are exempt from full control
- Some are available OTC
Schedule 5 examples
Contains preps of certain CDs:
- Codeine
- Pholcodine
- Morphine
that are exempt from full control when present in medicinal products of specifically low strengths.
How long are CD prescriptions valid for?
- 28 days
- except Sch 5: 6 months
Which CD Rx are repeatable?
All except Sch 2 and 3
Which CD can be given as emergency supply
Sch 4 + 5
No Sch2
No Sch 3 except phenobarbital for epilepsy
Which CD invoices need to be retained for 2 years?
Sch3 + 5
Which CDs require a requisition?
Sch 2 + 3
Quantity Supplies
- quantity prescribed should be appropriate for clinical need of patient
- Schedule 2, 3, 4 should be limited to 30 days
- This is good practice and not legal requirement but use your professional judgement, but prescribers should justify why ore than 30 days is needed in all cases
Possession of Sch 1 CD
- Home Office licence is required
- However, pharmacists can take for purpose of destruction or to hand over to police officer.
Import, export of CDs
- Licence needed: Schedule 1, 2, 3 and 4 (Part I) CDs.
- Licence needed: Schedule 4 (Part II) CDs, unless the substance is imported or exported by a person for self-administration.
- No restrictions on the import or export of Schedule 5 CDs
Travelling with CDs
- Personal licence not required if travelling with less than 3 months supply
- Advised: covering letter signed by prescriber
What should the covering letter from the prescriber contain?
- Name of the patient
- Travel plans
- Name of the prescribed CDs
- Total quantities and dose.
CD Destruction
- Pharmacy contractors must have appropriate arrangements in place for the safe disposal of CD
- home office advises that all schedule 2, 3, 4, should be denatured before being placed into waste containers
- Pharmacists should use CD denaturing kits to denature CDs wherever possible
Persons authorised to witness the denaturing of CDs
- Where there is a requirement to make a CD register entry, legislation also requires to have their destruction witnessed
- Typically Schedule 2 CDs
Destruction of patient-returned CDs
The destruction of patient-returned CDs, whether they require denaturing or not, does not require witnessing by an authorised person.
Patient Returns
- can accept CD from patients from their own home or care homes
- Cannot accept waste medicine from care homes which provide nursing care
- A record should be made (not in CD register) for patient returned Schedule 2
- No legal requirement to destroy them in the presence of an authorised witness, but is good practice to do so
Date Expired Stock
- For expired, unwanted Schedule 2 stock, destruction required it to be witness by an authorised person
- For schedule 3, it would be good practice to have staff witness the denaturing
- accountable officers can authorise people or groups of people to witness the destruction
List of aspects that must be recorded in CD register
- Date of Destruction
- Name, strength, form and quantity of drug
- Signature of authorised witness
- signature of professional destroying it
CD denaturing kits
- Pharmacists are responsible for using a kit that has been obtained from a reputable source
- Use kits in accordance with the manufacturers’ instructions
Destructions of CD: Solid dosage forms, e.g. capsules and tablets
- Grind or crush
- Add to the CD denaturing
- Ensure that whole tablets or capsules are not retrievable.
Destructions of CD: Liquid dosage forms
- Pour into an appropriately-sized CD denaturing kit.
- Bottle can be rinsed out and the liquid disposed using the denaturing kit
Destructions of CD: Ampoules and vials
- Liquid: open the ampoule and empty the contents into a CD denaturing kit. Dispose of the ampoule as sharps pharmaceutical waste.
- Powder: open ampoule, add water. The resulting mixture can be poured into the CD denaturing kit and the ampoule disposed of as sharps pharmaceutical waste.
Destructions of CD: Patches
- Remove the backing and fold the patch over on itself.
- Place into a waste disposal bin or a CD denaturing kit.
Destructions of CD: Aerosol formulations
- Expel into water and dispose of the resulting liquid in denaturing kit
