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Ama - Pharmacy Law and Ethics > Regulation of Controlled Drugs > Flashcards

Regulation of Controlled Drugs Flashcards

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1
Q

Legislative Framework for Controlled Drugs

A
  • 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.
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2
Q

Human Medicines Regulations 2012

A
  • 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
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3
Q

Misuse of drugs act 1971

A
  • CD drugs subject to misuse
  • Controls and prohibits manufacture, possession, supply, import 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
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4
Q

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

A

Detail the storage and safe custody requirements for CDs

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5
Q

Requirements of a CD cupboard

A

Imposes controls on storage of CDs

  • Lockable
  • Made of Metal
  • Fixed to wall or floor
  • Nominated Key Holder has Responsibility
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6
Q

The Health Act 2006

A
  • 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.
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7
Q

Accountable Officer

A

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
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8
Q

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

A

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).

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9
Q

Schedule 1 (CD LIC POM)

A
  • Most have no therapeutic use
  • Must hold a home office licence for production, possession or supply
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10
Q

Schedule 1 examples

A

LSD, raw opium, cannabis

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11
Q

Schedule 2 (CD POM)

A
  • CD register
  • Safe custody (except quinalbarbitone) apply
  • Destruction by appropriately authorised person with authorised witness and keep record
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12
Q

Schedule 2 examples

A
  • diamorphine
  • morphine
  • methadone
  • oxycodone
  • major stimulants (amphetamines)
  • ketamine
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13
Q

Schedule 3 (No reg)

A
  • No register
  • Most are exempt from safe custody requirements (except temazepam and buprenorphine)
  • emergency supply is not allowed (except for phenobarbital for epilepsy)
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14
Q

Schedule 3 examples

A

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

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15
Q

Schedule 4

A
  • Exempt from safe custody and CD entry
  • Repeat prescriptions are allowed
  • Emergency supplies are allowed (max 5 days)
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16
Q

Schedule 4 (CD BENZ POM) examples

A

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

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17
Q

Schedule 4 (CD ANAB POM) examples

A

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

18
Q

Schedule 5

A
  • contains schedule 2 CD in low strengths which are exempt from full control
  • Some are available OTC
19
Q

Schedule 5 examples

A

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

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

20
Q

How long are CD prescriptions valid for?

A
  • 28 days
  • except Sch 5: 6 months
21
Q

Which CD Rx are repeatable?

A

All except Sch 2 and 3

22
Q

Which CD can be given as emergency supply

A

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

23
Q

Which CD invoices need to be retained for 2 years?

A

Sch3 + 5

24
Q

Which CDs require a requisition?

A

Sch 2 + 3

25
Q

Quantity Supplies

A
  • quantity prescribed should be appropriate for clinical needs of patient
  • Schedules 2, 3, and 4 should be limited to 30 days
  • This is good practice and not a legal requirement, but use your professional judgement.
  • Prescribers should justify why more than 30 days is needed in all cases
26
Q

Possession of Sch 1 CD

A
  • Home Office licence is required
  • However, pharmacists can take for purpose of destruction or to hand over to police officer.
27
Q

Import, export of CDs

A
  • 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
28
Q

Travelling with CDs

A
  • Personal licence not required if travelling with less than 3 months supply
  • Advised: covering letter signed by prescriber
29
Q

What should the covering letter from the prescriber contain?

A
  • Name of the patient
  • Travel plans
  • Name of the prescribed CDs
  • Total quantities and dose.
30
Q

CD Destruction

A
  • 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
31
Q

Persons authorised to witness the denaturing of CDs

A
  • Where there is a requirement to make a CD register entry, legislation also requires to have their destruction witnessed
  • Typically Schedule 2 CDs
32
Q

Destruction of patient-returned CDs

A

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

33
Q

Patient Returns

A
  • 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
34
Q

Date Expired Stock

A
  • 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
35
Q

List of aspects that must be recorded in CD register

A
  • Date of Destruction
  • Name, strength, form and quantity of drug
  • Signature of authorised witness
  • signature of professional destroying it
36
Q

CD denaturing kits

A
  • Pharmacists are responsible for using a kit that has been obtained from a reputable source
  • Use kits in accordance with the manufacturers’ instructions
37
Q

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

A
  • Grind or crush
  • Add to the CD denaturing
  • Ensure that whole tablets or capsules are not retrievable.
38
Q

Destructions of CD: Liquid dosage forms

A
  • Pour into an appropriately-sized CD denaturing kit.
  • Bottle can be rinsed out and the liquid disposed using the denaturing kit
39
Q

Destructions of CD: Ampoules and vials

A
  • 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.
40
Q

Destructions of CD: Patches

A
  • Remove the backing and fold the patch over on itself.
  • Place into a waste disposal bin or a CD denaturing kit.
41
Q

Destructions of CD: Aerosol formulations

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

Ama - Pharmacy Law and Ethics (36 decks)

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