Regulations of Controlled Drugs 1- legislation

Question 1

describe the legislative framework for the regulation of controlled drugs

Answer 1

1) the medicines act 1968
2) the misuse of drugs act 1971
- Misuse of Drugs and Misuse of Drugs (Safe Custody) 2007
- Misuse of Drugs (Supply to Addicts) Regulations 1997
3) the health act 2006: The Controlled Drugs (Supervision and Management of Use)

Question 2

what did the Medicines Act 1968 contain?

Answer 2

1) Sale , supply, administration
2) The Human Medicines Regulations 2012- Replacing most of the Medicines Act 1968
3) Allows certain exemptions from the general restrictions : allow midwives to supply and/or administer morphine, diamorphine, pethidine or pentazocine.

Question 3

outline the Misuse of Drugs Act 1971

Answer 3

controls and prohibits dangerous or otherwise harmful drug:

1) possession
2) export, import
3) manufacture
4) supply
- Drugs subject to the control of MDA and listed within it are termed ‘Controlled Drugs. Divided into Classes A, B and C for establishing the maximum penalty that can be imposed.

Question 4

List 4 class A, B and C drugs

Answer 4

1) class A: cocaine, heroin, lysergide (LSD), methadone, opium
2) Class B: barbiturates, cannabis, ketamine, codeine, pholcodine
3) Class C: buprenorphine, mazindol, tramadol, zopiclone, most benzodiazepines

Question 5

outline the regulations with regards to the supply of CD’s to addicts . Misuse of Drugs Regulations 1997

Answer 5

1) Doctors needed Home Office licence to prescribe, administer or supply diamorphine, cocaine or dipipanone for the treatment of addiction or suspected addiction
2) 2007 – A general licence has been issued to cover doctors approved by the Department of Health.

Question 6

outline the The Health Act 2006

Answer 6

1) All designated bodies required to appoint an Accountable Officer
2) A duty of collaboration placed on responsible bodies to share intelligence on controlled drug issues.
3) Have up-to-date SOPs in place
4) Give power to police and other nominated people to enter premises and inspect stocks and records of CDs.

Question 7

outline the The Controlled Drugs (Supervision of Management and Use) Regulations 2006

Answer 7

1) Certain NHS and independent healthcare bodies - Accountable Officer to improve the safe management and use of CDs
2) Bodies to co-operate with each other e.g. sharing information and concerns about CD uses and its management.
3) 2013 version – The Regulations amended to reflect the new NHS architecture (but only apply to England and Scotland)

Question 8

according to the Misuse of Drugs (Safe Custody) Regulations 1973 where should CD’s be stored?

Answer 8

Bolted CD cabinet

Question 9

outline the Misuse of Drugs and Misuse of Drugs (Safe Custody) (amendment) Regulations 2007

Answer 9

1) Accountable officers: nominate persons or groups to witness the destruction of CDs
2) Allow operating department practitioners to order, possess and supply CDs
3) Remove the requirement to maintain a Controlled Drug Register in a prescribed format
4) Change the record keeping requirements for CDs
5) Reschedule Midazolam from Schedule 4 to Schedule 3

Question 10

Outline the Misuse of Drugs Regulations 2001

Answer 10

1) Divides CDs into 5 Schedules. Depends upon its therapeutic benefit against its harm when misused:
2) Schedule 1 CDs – highest level of control
3) Schedule 5 CDs – lowest level of control

Question 11

outline what schedule 1 drugs are and give some examples

Answer 11

1) LSD, ecstasy, mescaline, cannabis
2) The majority of drugs in Schedule 1 have no recognised therapeutic use.
3) Generally limited to research – must hold a Home Office licence.
4) Practitioners may not lawfully possess these except under licence from the Home Office.

Question 12

can pharmacists take possession of schedule 1 drugs?

Answer 12

Pharmacists cannot take possession of the material except:

1) for the purpose of destruction
2) for the purpose of handing over to police.
3) Under NO circumstances return Sch 1 drugs to a patient at discharge.

Question 13

outline what schedule 2 drugs are and give some examples

Answer 13

1) Includes diamorphine, morphine, methadone, amphetamines and some barbiturates, and ketamine
2) CD prescription requirements apply
3) Supply is restricted to licensed wholesalers, practitioners, hospitals and registered pharmacies.
4) A licence is required to import or export.
5) CD register for supplies and obtained Sch 2
6) Safe custody (except quinalbarbitone). Including patient returns.
7) Destruction - by appropriately authorised person with authorised witness and keep record.

Question 14

how long are schedule 2 drugs valid on a prescription and can emergency supplied be handed out?

Answer 14

1) Prescription valid for 28 days.
2) Emergency supplies NOT allowed
3) Repeat prescribing NOT allowed

Question 15

outline what schedule 3 drugs are and give some examples

- (CD no register POM)

Answer 15

1) buprenorphine, midazolam, phenobarbitone and temazepam.
2) CD prescription writing requirements
3) Exempt from safe custody requirements (except temazepam, buprenorphine and diethylpropion).
4) No statutory requirements to record the supply.
5) The requirements relating to destruction do not apply.
6) Invoices must be retained for 2 years.
7) Subjected to full import and export control.

Question 16

how long are schedule 3 drugs valid on a prescription and can emergency supplied be handed out?

Answer 16

1) Emergency supply is not allowed except phenobarbitone for treatment of epilepsy.
2) Repeat prescribing is not permitted.
3) Script is valid for 28 days.

Question 17

outline what schedule 4 drugs are and give some examples

Answer 17

1) Prescription writing as per POM requirements
2) Exempt from safe custody and CD entry recording
3) Script is valid for 28 days
4) Cannot possess without an appropriate prescription.
5) Possession by practitioners and pharmacists acting in their professional capacities is authorised.
6) Subjected to full import and export control.

Question 18

schedule 4 drugs are split into two parts outline these parts and give examples of drugs within each part

Answer 18

1) Part 1, which contains most of the benzodiazepines and other drugs including zolpidem
2) Part 2 which contains anabolic and androgenic steroids including testosterone, clenbuterol and also growth hormones

Question 19

outline what schedule 5 drugs are and give some examples

Answer 19

1) Schedule 5 includes some Schedule 2 controlled drugs, such as codeine, pholcodine, and morphine, which are exempt from Schedule 2 requirements because they are in low strength formulations.
2) Invoices must be kept for two years.
3) A practitioner, pharmacist or a person holding an appropriate licence may manufacture or compound any Schedule 5 substances.
5) Some are available OTC - caution when supply.

Question 20

What class do the following drugs belong to:

1) Tramadol
2) Lisdexamfetamine
3) Zopiclone
4) Zaleplon

Answer 20

1) Tramadol – Schedule 3 CD No Register POM (exempt from safe custody)
2) Lisdexamfetamine – Schedule 2
3) Zopiclone – Schedule 4 Part 1
4) Zaleplon – Schedule 4 Part 1

Question 21

which schedule of drug does the pharmacist have to check ID for?

Answer 21

schedule 2

Question 22

what is the maximum duration that should be supplied for schedule 1-4 drugs ?

Answer 22

30 days as good practice