Yazdan (Controlled drugs)

Question 1

Controlled drugs are classified in 2 ways

Answer 1

1. Misuse of drugs act 1971
2. Misuse of drugs regulations 2001

1971- imposing a complete ban on the possession, supply, manufacture, import and export of controlled drugs except as allowed by license from the Secretary of State.

2001- allow for the lawful possession and supply of controlled drugs for legitimate purposes. They cover prescribing, administering, safe custody, dispensing, record keeping, destruction, disposal of CDs to prevent diversion for misuse.

Question 2

Classes of CDs

Answer 2

Drugs are classified according to their potential harmfulness
- Class A- cocaine, heroin, ecstasy
- Class B- amphetamine, cannabis
- Class C- anabolic steroid, Benzo diazepam
The class determines penalties for drug offences under the Act

Question 3

MDR 2001

Answer 3

Controls applied to their legitimate use
5 schedules- different levels of control
- Schedule 1- CD Lic
- 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 or CD Inv POM

Question 4

Schedule 1 (CD Lic

Answer 4

May not be used for medicinal purposes, their production and possession being limited to purpose of research.
Includes hallucinogenic drugs (e.g. LSD), raw opium, cannabis.

• Most strictly controlled group
• Little to no therapeutic use
• Limited to research and other special purposes
• Licence needed from the Home Secretary in order to possess, produce, supply, etc.

Pharmacist can take possession under two circumstances
- when possession is taken for the purpose of destruction
- when possession happened for the purpose of handing over to police officer

Question 5

Schedule 2 (CD POM)

Answer 5

Includes opiates (e.g. morphine, methadone, oxycodone, diamorphine), major stimulants (e.g. amphetamines), quinalbarbitone (used for sedation before surgery).

Full controls relating to:
- prescription requirements (must write amount in number and words)
- safe custody
- record keeping (e.g. CD register entries)

Licences required for import/export.
When you receive CDs you have to keep record of what drug, amount, date, total, When you hand out you write date, patient name, number of tablets, which prescriber, updated total.

Question 6

Schedule 3 (CD No Reg POM)

Answer 6

Includes barbiturates, buprenorphine, temazepam, gabapentin, and pregabalin.

Rules are more relaxed than for schedule 2
- Prescription requirements (must write amount in number and words)
- Safe custody
- CD register entries NOT required
- Invoices retained for 2 years
- Licences required for import/export

Question 7

Schedule 4 (CD Benz POM and CD Anabolic POM)

Answer 7

Schedule split into 2 parts:
- Part 1: CD Benz e.g. benzodiazepines (Diazepam), Sativex (cannabis extract)
- Part 2: CD Anabolic e.g. anabolic steroids, growth hormones

No safe custody
No prescription requirements
No records must be kept
Import/export licence (but not for CD Anabolic for personal use)

Question 8

Schedule 5 (CD Inv P or CD Inv POM))

Answer 8

Low strength preparations of certain CDs e.g. co-codamol (paracetamol and codeine)

P or POM
Negligible risk of abuse
Does not include preparations for injections
Invoices retained for 2 years

Question 9

Prescribing

Answer 9

Prescribers- doctors, dentists, pharmacists, nurse independent prescriber.
Supplementary prescriber- acting in accordance with clinical management plan.
To prescribe cocaine, diamorphine or dipipanone for treating addiction the prescriber needs a licence from the home office. Licence is not needed for treating injury.

Question 10

Safe custody

Answer 10

Schedules 2 and 3 must be kept in a locked safe, cabinet or room.

Exemptions
- Schedule 2: quinalbarbitone
- Schedule 3: many exemptions. Applies to temazepam, diethylpropion, buprenorphine

The cabinet must comply with the requirement specified in the safe custody regulation.
You can apply for exemption certificate from police.
If the CD is kept out they must be under the direct personal supervision of pharmacist.
Some companies want to keep non-safety medication in the cupboard which they can do but it has to be stated in their protocol or relevant policy details.
A key log could be used to audit who had access to the keys, including overnight, storage in the pharmacy (e.g. locum pharmacists).

Question 11

Prescription requirements for Schedule2 & 3 drugs

Answer 11

Prescriber’s signature
Date
Address (UK)
Name of CD, form, strength
Dose (PRN is not acceptable, needs to say one PRN)
Total quantity (needs words and figures, if one is missed the pharmacist can amend the prescription indelibly so it becomes compliant. Rx then marked to show amendment- name, date, signature, GPhC no.).
Quantity prescribed
If dental Rx, then the words ‘for dental treatment only’

CD prescriptions are only valid for 28 days.

Question 12

What needs to be corrected by original prescriber?

Answer 12

Missing date
Incorrect dose
Form
Strength

Question 13

CDs on blue prescription

Answer 13

If patient hasn’t had medication for 3 days there is a risk that they will have lost tolerance. The usual dose may cause overdose so the prescriber must be contacted.

Question 14

Representative collecting CD medication

Answer 14

Obtain a letter from the drug misuser that authorises and names the representative.
Separate letter each time the representative sends someone.
A pharmacist must be satisfied that the letter is genuine.
Good practice to insist unseeing the patient in person at least once a week unless this is known not to be possible.

Question 15

Private CD prescriptions

Answer 15

Standardised prescription form for Schedule 2 & 3 CDs
Must state prescribers private CD prescribing number
Prescription submitted to PPD (prescribing pricing division) after dispensing and a copy retained in the pharmacy.

Question 16

Collection of Schedule 2 & 3 CDs

Answer 16

Schedule 2
- Legal requirement to ascertain who is collecting
- Patient or representative
- Healthcare professional on pt behalf

Schedule 2 & 3
- Good practice to obtain signature from person collecting
- Instalment prescription only needs to be signed once
- Representative can sign on behalf of the patient but an audit trial should be available to confirm delivery of the medicine to the patient

Question 17

Legal requirements for CD requisition

Answer 17

Signature of the recipient.
Name of the recipient.
Address of the recipient.
Profession or occupation.
Total quantity of the drug.
Purpose of the drug.

Question 18

Controlled Drugs Registers

Answer 18

Different part of register for each class, strength, and formulation.
Entered chronologically and promptly.
Indelible.
Kept at premises for 2 years following last entry.

When CD received (white area of register):
- Date
- Name and address from supplier
- Quantity received

When supplied (grey area of register)::
- Date
- Name and address of recipient
- Details of authority to possess- prescriber or licence holder’s details
- Quantity supplies
- Details of person collecting- patient, patient representative, healthcare professional
- Whether proof of identity was requested from collector
- Whether proof of identity was provided

Question 19

Destruction of controlled drugs

Answer 19

When patient returns CDs, they need to be denatured. A witness is not required but it is preferable to have another member of staff there to witness. Needs to be recorded in a separate book not the CD register.

When a CD is expired they need to be denatured. A witness is required for CD2 and preferable for CD3. Record needs to be made in CD register- contain date of destruction, quantity destroyed, signature of witness.

Witness:
- Police
- Authorised by Home secretary
- Authorised by Secretary of State for health
- Accountable officer- cannot be a witness but has the power to authorise other persons to be witnesses