Regulation of Controlled Drugs

Question 1

Legislative Framework for Controlled Drugs

Answer 1

• 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.

Question 2

Human Medicines Regulations 2012

Answer 2

• 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

Question 3

Misuse of drugs act 1971

Answer 3

• 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

Question 4

The Misuse of Drugs (Safe Custody) Regulations 1973 as amended

Answer 4

Detail the storage and safe custody requirements for CDs

Question 5

Requirements of a CD cupboard

Answer 5

Imposes controls on storage of CDs

• Lockable
• Made of Metal
• Fixed to wall or floor
• Nominated Key Holder has Responsibility

Question 6

The Health Act 2006

Answer 6

• 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.

Question 7

Accountable Officer

Answer 7

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

Question 8

The 2001 Regulations classify CDs into five Schedules according to the different levels of control attributed to each:

Answer 8

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).

Question 9

Schedule 1 (CD LIC POM)

Answer 9

• Most have no therapeutic use
• Must hold a home office licence for production, possession or supply

Question 10

Schedule 1 examples

Answer 10

LSD, raw opium, cannabis

Question 11

Schedule 2 (CD POM)

Answer 11

• CD register
• Safe custody (except quinalbarbitone) apply
• Destruction by appropriately authorised person with authorised witness and keep record

Question 12

Schedule 2 examples

Answer 12

• diamorphine
• morphine
• methadone
• oxycodone
• major stimulants (amphetamines)
• ketamine

Question 13

Schedule 3 (No reg)

Answer 13

• No register
• Most are exempt from safe custody requirements (except temazepam and buprenorphine)
• emergency supply is not allowed (except for phenobarbital for epilepsy)

Question 14

Schedule 3 examples

Answer 14

Minor stimulants and others
- Buprenorphine
- Midazolam
- Phenobarbital
- Temazepam
- Tramadol
- Gabapentin
- Pregabalin

Question 15

Schedule 4

Answer 15

• Exempt from safe custody and CD entry
• Repeat prescriptions are allowed
• Emergency supplies are allowed (max 5 days)

Question 16

Schedule 4 (CD BENZ POM) examples

Answer 16

Part I
- Contains most of bdz (diazepam)
- Non-bdz (Zolpidem)
- Sativex (Cannabinoid oral spray)

Question 17

Schedule 4 (CD ANAB POM) examples

Answer 17

Part II:
- Contains anabolic and androgenic steroids (testosterone) and growth hormones

Question 18

Schedule 5

Answer 18

• contains schedule 2 CD in low strengths which are exempt from full control
• Some are available OTC

Question 19

Schedule 5 examples

Answer 19

Contains preps of certain CDs:
- Codeine
- Pholcodine
- Morphine

that are exempt from full control when present in medicinal products of specifically low strengths.

Question 20

How long are CD prescriptions valid for?

Answer 20

• 28 days
• except Sch 5: 6 months

Question 21

Which CD Rx are repeatable?

Answer 21

All except Sch 2 and 3

Question 22

Which CD can be given as emergency supply

Answer 22

Sch 4 + 5
No Sch2
No Sch 3 except phenobarbital for epilepsy

Question 23

Which CD invoices need to be retained for 2 years?

Answer 23

Sch3 + 5

Question 24

Which CDs require a requisition?

Answer 24

Sch 2 + 3

Question 25

Quantity Supplies

Answer 25

- 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

Question 26

Possession of Sch 1 CD

Answer 26

- Home Office licence is required - However, pharmacists can take for purpose of destruction or to hand over to police officer.

Question 27

Import, export of CDs

Answer 27

- 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

Question 28

Travelling with CDs

Answer 28

- Personal licence not required if travelling with less than 3 months supply - Advised: covering letter signed by prescriber

Question 29

What should the covering letter from the prescriber contain?

Answer 29

- Name of the patient - Travel plans - Name of the prescribed CDs - Total quantities and dose.

Question 30

CD Destruction

Answer 30

- 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

Question 31

Persons authorised to witness the denaturing of CDs

Answer 31

- Where there is a requirement to make a CD register entry, legislation also requires to have their destruction witnessed - Typically Schedule 2 CDs

Question 32

Destruction of patient-returned CDs

Answer 32

The destruction of patient-returned CDs, whether they require denaturing or not, does not require witnessing by an authorised person.

Question 33

Patient Returns

Answer 33

- 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

Question 34

Date Expired Stock

Answer 34

- 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

Question 35

List of aspects that must be recorded in CD register

Answer 35

- Date of Destruction - Name, strength, form and quantity of drug - Signature of authorised witness - signature of professional destroying it

Question 36

CD denaturing kits

Answer 36

- Pharmacists are responsible for using a kit that has been obtained from a reputable source - Use kits in accordance with the manufacturers’ instructions

Question 37

Destructions of CD: Solid dosage forms, e.g. capsules and tablets

Answer 37

- Grind or crush - Add to the CD denaturing - Ensure that whole tablets or capsules are not retrievable.

Question 38

Destructions of CD: Liquid dosage forms

Answer 38

- Pour into an appropriately-sized CD denaturing kit. - Bottle can be rinsed out and the liquid disposed using the denaturing kit

Question 39

Destructions of CD: Ampoules and vials

Answer 39

- 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.

Question 40

Destructions of CD: Patches

Answer 40

- Remove the backing and fold the patch over on itself. - Place into a waste disposal bin or a CD denaturing kit.

Question 41

Destructions of CD: Aerosol formulations

Answer 41

- Expel into water and dispose of the resulting liquid in denaturing kit