Controlled Drugs (CDs)

Question 1

When can Schedule 1 CDs be administered or prescribed?

Answer 1

Under a Home office licence

Question 2

Who can administer Schedule 2, 3, 4 CDs to patients?

Answer 2

• A doctor, dentist, independent prescriber or independent nurse prescriber
• A supplementary prescriber acting in accordance with clinical management plan
• A person acting in accordance with the direction of a prescriber entitled to prescribe CDs (e.g. pharmacists)

Question 3

1) What is needed for a pharmacy to import or export Schedule 1, 2, 3, 4 Part I CDs?
2) What about Schedule 4 Part II?

Answer 3

1) A licence

2) Licence also needed, UNLESS it is for self-administration

Question 4

Would a person travelling with < 3 months supply of a CD need a personal licence?

Answer 4

No - but it would be advised to carry a signed letter from the prescriber, highlighting the indication, patient name, travel plans, doses and quantities

Question 5

What are the legal requirements for a CD requisition form?

Answer 5

1) Signature of recipient
2) Name of recipient
3) Address of recipient
4) Profession/occupation
5) Total quantity of drug
6) Purpose of requisition

Question 6

Can supply be made against a faxed/photocopied requisition form?

Answer 6

No

Question 7

1) Must a written requisition form be obtained BEFORE delivery of any Sch 2 or 3 CDs?
2) Are there any premises where this is NOT a requirement?
3) Are there any circumstances where this is NOT a requirement?

Answer 7

1) Yes
2) Yes - GPhC registered pharmacies, although Home Office advised the sending of a written form when one pharmacy is supplying another
3) In an emergency, provided form is sent within 24h. Failure to do so would be an offence by the doctor etc

Question 8

Can midwifes obtain CDs? which CDs?

Answer 8

Yes - registered midwifes can use a Midwife Supply Order to obtain the following:

• Diamorphine
• Morphine
• Pethidine

Question 9

What information MUST a Midwife Supply Order contain?

Answer 9

1) Midwife name and occupation
2) Name of person the CD is supplied for
3) Purpose for which CD is required
4) Total quantity of CD
5) Signature of appropriate medical officer - a Doctor or person responsible for supervising midwifes in the area

Question 10

What are the Safe Custody Regulations?

Answer 10

Refers to physical security of certain CDs. Requires HCPs to keep them in a ‘locked safe’, cabinet or room

Question 11

Examples of CDs requiring Safe Custody?

Answer 11

• Sch 1
• Sch 2, except some liquid formulations and Quinalbarbitone
• Sch 3, except the following: Gabapentin, Mazindol, Meprobamate, Midazolam, Pentazocine, Phentermine, Phenobarbital, Pregabalin, Tramadol

Question 12

What must be ensured when CDs requiring Safe Custody storage are not in the CD cabinet?

Answer 12

They require the ‘direct personal supervision’ of a registered pharmacist

Question 13

Does Safe Custody still apply to patient-returned CDs?

Answer 13

Yes - they should be segregated from the other stock in the cabinet to avoid supply to future patients

Question 14

When disposing of returned/ expired/ obsolete stock, Which CDs require denaturing?

Answer 14

Schedule 2, 3 or 4 (Part I)

Question 15

1) When patients return CDs, is an authorised witness required for denaturation?
2) What record must be kept?

Answer 15

1) No, however it is preferable for it to be witnessed by another member of staff familiar with CDs
2) Record should NOT be made in the CD register, but patient-returned Sch 2 drugs and their destruction should be recorded in a separate record

Question 16

How should solid dosage forms be denatured?

Answer 16

• Grind or crush before adding to denaturing kit, using small amount of water to avoid release of particles into air
• Where a denature kit is not available, crushed drug is added to warm soapy water and mixed to dissolve. Mixture is poured into a suitable product and placed in pharma waste container and sent for incineration

Question 17

1) When expired/ obsolete/ unwanted stock is denatured, is a witness required?
2) What record must be kept?

Answer 17

1) Yes, IF Sch 2. For Sch 3, it would be GOOD PRACTICE to have another member of staff witness denaturing
2) Entry should be made in CD register for Sch 2 CDs

Question 18

How should liquid dosage forms be denatured?

Answer 18

• Pour into an appropriately sized denaturing kit
• Where one is not available, pour liquid into a suitable product (diluent) and pour into an appropriate waste disposal bin
• Bottles can be rinsed using denaturing kit liquid and then recycled appropriately

Question 19

How should ampoules or vials be denatured?

Answer 19

• For liquid containing ampoules- open ampoule and pour into denaturing kit and then same as a liquid formulation
• For powder containing ampoules- open ampoule and add water to dissolve powder inside. Resulting mixture can be poured into denaturing kit

Question 20

How should patches be denatured?

Answer 20

• Remove backing and fold the patch over itself

- Place into waste disposal bin or denaturing kit

Question 21

Prescription requirements for CD Rx?

Answer 21

1) Patient details - name and address
2) CD drug details - name, form strength, dose, quantity (in WORDS AND FIGURES)
3) Date (Valid for 28 days)
4) Prescriber signature and details - address

Question 22

Who may collect Sch 2 CDs from the pharmacy?

Answer 22

• Patient or patient’s representative