CDs

Question 1

Following the Shipman Inquiry, accountable officers were introduced with responsibility for supervising and managing the use of CDs. What do these responsibilities involve? (5)

Answer 1

1. Oversight of the monitoring and auditing of the management, prescribing and use of CDs.
2. Ensuring that systems are in place for recording concerns and incidents involving CDs and the operation of these systems
3. Attendance of Local intelligence Network meetings
4. Submission of occurrence reports which describe the details of any concerns the organisation has regarding the management of CDs.
5. The appointment of authorised witnesses for the destruction of CDs

Question 2

Which legislation are applicable to CDs and pharmacy? (5)

Answer 2

1. The Misuse of drugs Act 1971
2. The misuse of drugs regulations 2001
3. The misuse of drugs (safe custody) Regulations 1973
4. The health act 2006
5. Controlled Drugs Regulations 2013

Question 3

CDs are classified by the 2001 Regulations into different levels of control. Explain each Schedule and give examples.

Answer 3

Schedule 1 - most have no therapeutic use and a license is generally required for their possession or supply. e.g hallucinogenic drugs (LSD), raw opium and cannabis

Schedule 2 - pharmacists can handle these drugs if they are named in the 2001 regulations. e.g. opiates (diamorphine, morphine, methadone, oxycodone), major stimulants (amphetamine), quinalbarbitone and ketamine.

Sch 3 - minor stimulants and other drugs such as temazepam, tramadol, midazolam and phenobarbital - these are less likely to be misused/less harmful

Sch 4 - split into two parts.
Part 1 - CD Benz POM - contains most benzodiazepines (diazepam), non-benzo hypnotics (zopiclone) and Sativex (cannabinoid oromucosal mouth spray)

Part 2 - CD anab POM - contains most of the anabolic and androgenic steroids together with clenbuterol (an adrenoceptor stimulant) and growth hormones.

Sch 5 - preparations of certain CDs such as codeine, pholcodine and morphine, that are exempt from full control when present in low strengths.

Question 4

What are the other mechanisms of lawful possession of CDs? (5)

Answer 4

1. Home Office Licence
2. Home Office Group Authority - covered by this can possess and supply
3. Legislation: Class of person e.g. those named in
   2001 regulation - acting within their capacity - Dr, registered practising midwife
4. Legislation: class of drug - possessing certain drugs is lawful e.g Sch 4 part 2 when contained in medicinal products and Sch 5
5. Patients - they have been prescribed by a suitable prescriber

Question 5

A home office license is required to possess a Sch 1 drug such as cannabis. When would a pharmacist be exempt from this requirement? (2)

Answer 5

1. Possession is taken with the purpose of destruction

2. Purpose of handing it over to the police

Question 6

Who can administer or prescribe a Sch 1 drug?

Answer 6

Only those with a Home Office License

Question 7

Who can administer or prescribe a Sch 2, 3 or 4 drug?

Answer 7

1. doctor, dentist, pharmacist independent prescriber or
   nurse independent prescriber acting in their own right
2. A supplementary prescriber (including a pharmacist
   supplementary prescriber) acting in accordance with
   a clinical management plan
3. A person acting in accordance with the directions of a prescriber entitled to prescribe CDs
   (including pharmacist independent prescribers).

Question 8

Is a licence needed to export or import Sch 1, 2, 3 or 4 part 1 drugs?

How about Sch 4 part 2 drugs or Sch 5?

Answer 8

Yes

Part 2 drugs - yes unless they are for self - administration.
No restrictions for Sch 5

Question 9

In prisons, a requisition form is needed to obtain Sch 1,2 and 3 CDs. What are the requirements for a requisition. (6)

Answer 9

1. Signature of recipient
2. Name of recipient
3. Address of recipient
4. Profession or Occupation
5. Total Quantity of drug
6. Purpose of requisition

Question 10

Can supplies be made against a faxed or photocopied requisition?

Answer 10

No

Question 11

Discuss the practice issues with a requisition

Answer 11

1. In an emergency, a doctor or dentist can be supplied Sch 2 and 3 CDs with the requsition to be supplied within 24 hours. Failure to do so - offence on the Dr or dentist part
2. Where stock is collected by a messanger on behalf of the purchaser - written authorisationr required and pharmacist must be satisfied and keep it for 2 yrs
3. Pharmacists are not able to requisition a Sch 1 drug.
4. Legislation requires that a requisition in writing must be obtained by supplies before delivery of any Sch 2 or 3

Question 12

What are the processing requirements of a requisition for a Sch 1, 2 or 3 CD? (3)

Answer 12

1. Mark the requisition indelibly with supplier’s name and address (the pharmacy), if a pharmacy stamp is used must be clear and legible.
2. Send the original copy to the relevant NHS agency.

Good practice - pharmacy to keep a copy for 2 years from date of supply

Question 13

When do these processing requirements not apply for requisitions? (3)

Answer 13

1. By a person responsible for the dispensing and
   supply of medicines at a hospital, care home,
   hospice, prison or organisation providing
   ambulance services who must mark and retain
   the original requisition for two years
2. By pharmaceutical manufactures or wholesalers
3. Against veterinary requisitions (the original
   requisition should be retained for five years).

Question 14

A midwife can order which specific CD drugs? (3)

Answer 14

1. Diamorphine
2. Morphine
3. Pethidine

Question 15

What must be on a midwife CD supply order form?

Answer 15

1. Name of midwife
2. Occupation of the midwife
3. Name of person to be supplied/administered with CD
4. Purpose of CD
5. Total quantity
6. Signature of appropriate medical officer - Dr authorised by the local supervising authority

Question 16

What are the (NHS and Private) prescription requirements for a Sch 2 or 3 drug? (10 + 2 if appropriate)

Answer 16

1. Patient Name
2. Patient Address
3. Dose (must be stated clearly - NOT PRN, as directed ect )
4. Formulation (abbreviations are acceptable)
5. Strength (if there is more than 1 strength available)
6. Total Quantity (must be written in words and figures)
7. Quantity prescribed
8. Signature of prescriber
9. Date (within 28 days)
10. Address of prescriber (must be within UK)
11. Dental wording where appropriate
12. Instalment wording where appropriate

Question 17

What does an instalment direction for Sch 2/3 drugs tell you?

Answer 17

1. Amount of med per instalment

2. Interval between each time the med can be supplied

Question 18

What risk is there if a patient misses 3 or more doses of a CD?

Answer 18

risk that patient has lost tolerance to the drug and the usual dose may cause overdose.

Question 19

What CAN and CAN’T a pharmacist change on a CD prescription?

Answer 19

Minor typographical errors or spelling mistakes, or where either the words or figures (but not both) of the total quantity has been omitted. The pharmacist can amend the prescription indelibly and endorse it with their name, date, signature and GPhC number.

CANNOT correct things like missing date, incorrect dose, form or strength. These need to be done by prescriber.

In an emergency another prescriber authorised to prescribe CDs.

Amendments CANNOT be made by a covering letter.

Question 20

What are the additional private prescription requirements for Sch 2 and 3?

Answer 20

1. Standardised forms - england FP10PCD
   if not on standardised form - cannot be accepted unless its a vet prescription.
   Must also be on the form if it is to be dispensed in a hospital where it was not issued. If it was issued and dispensed in the same hospital then the form is not required.
2. Prescriber Identification Number - different to professional registration number e.g. GMC.
   It is a number issued by the relevant NHS agency
3. Submission -pharmacies must submit original private prescriptions to NHS Business Services Authority. This requires an identifying code assigned to the pharmacy.

Question 21

What are the additional requirements for Private Vet prescriptions for CDs, if any?

Answer 21

1. Do not need to be written on standardised forms
2. Do not need to be submitted to the relevant NHS agency
3. Forms to be retained for 5 years.

Question 22

What action is required when someone collects a Sch 2 CD?

Answer 22

Patient - request evidence of person’s identity unless already known to pharmacist

Patient’s Rep - request evidence of person’s identity unless already known to pharmacist

Healthcare professional acting on behalf of patient - Unless already known to pharmacist. Need:
Name and Address of healthcare prof. Also request evidence of identity

Question 23

Which CDs should be kept under safe custody?

Answer 23

1. Sch 1 drugs
2. Sch 2 drugs except some liquids and quinalbarbitone
3. Sch 3 drugs unless exempted under the Misuse of Drugs Regulations 1973 - e.g. phenobarbital, mazindol, tramadol.

Some that NEED it - temazepam and buprenorphine

Question 24

Which CDs need to be denatured before disposal?

Answer 24

Sch 2, 3 and 4 part 1

Question 25

What are requirements of denaturing and witnessing of patient returned CDs?

Answer 25

Denaturing req -Sch 2, 3 and 4 part 1

No need for an authorised witness

Record keeping - no need for CD register but for Sch2 needs to be recorded in a separate record for this purpose.

Question 26

What are requirements of denaturing and witnessing of expired/unwanted stock of CDs?

Answer 26

Denaturing req -Sch 2, 3 and 4 part 1

Authorised witness needed for Sch 2. Good practice for Sch 3.

Entry should be made in CD register for Sch 2

Question 27

How should CDs be disposed of?

Answer 27

All Controlled Drugs in Schedule 2, 3 and 4 (part 1) should be destroyed by being denatured and rendered irretrievable
before being placed into pharmaceutical waste containers and sent for incineration.

Should NOT be disposed into sewerage system

Question 28

What is the method of destruction of Solid Dosage forms - tabs and caps

Answer 28

1. Grind or crush the solid dose formulation before adding to the CD denaturing kit to ensure that whole tablets or capsules are not retrievable.
2. The use of a small amount of water whilst grinding or crushing may
   assist in minimising particles of dust being released into the air

Question 29

What would you do if a denaturing kit is not available for solid dosages?

Answer 29

1. Crush or grind the solid
   dose formulation and place it into a small amount of warm, soapy water stirring sufficiently to ensure the
   drug has been dissolved or dispersed.

The resulting mixture may then be poured onto an appropriate amount
of suitable product* and added to an appropriate waste disposal bin supplied by the waste contractor

Question 30

What is the method of destruction of liquid dosage forms?

Answer 30

Pour into an appropriately-sized CD denaturing kit

Question 31

What would you do if a denaturing kit is not available for liquid dosages?

Answer 31

Pour the liquid onto an appropriate amount of suitable product* and then to add this to an appropriate waste disposal bin

When a bottle containing a liquid CD has been emptied, small amounts of the pharmaceutical can remain.
Bottles can be rinsed and the liquid disposed using the denaturing kit and then as the correct category of
pharmaceutical waste.

Question 32

When is the only time you can dispose of rinsing of pharmaceuticals via the sewerage system?

Answer 32

IF you have a relevant Trade Effluent Consent from the relevant sewerage undertaker

Question 33

What is the method of destruction of ampoules and vials?

Answer 33

For liquid containing ampoules, open the ampoule and empty the contents into a CD denaturing kit, or dispose of in the same manner as liquid dose formulations above. Dispose of the ampoule as sharps pharmaceutical waste

For powder containing ampoules, open the ampoule and add water to dissolve the powder inside. The resulting mixture can be poured into the CD denaturing kit and the ampoule disposed of as sharps pharmaceutical waste

Question 34

What is the method of destruction of patches?

Answer 34

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

Question 35

What is the method of destruction for aerosol formulations?

Answer 35

Expel into water and dispose of the resulting liquid in accordance with the guidance above on destroying liquid formulations.

If this is not possible because of the nature of the formulation, expel into an absorbent material and dispose of this as pharmaceutical waste

Question 36

CD register is for Sch 1 and 2 (as well as Sativex sch4 part 1)

For CD received what should be recorded? (3)

Answer 36

1. Date supply received
2. Name and address from whom received
3. Quantity received.

Question 37

For CD supplied what should be recorded in register? (7)

Answer 37

1. Date supplied
2. Name and address of recipient
3. Details of authority to possess – prescriber or licence
   holder’s details
4. Quantity supplied
5. Details of person collecting Schedule 2 Controlled Drug – patient, patient’s representative or healthcare
   representative (if the latter, also record their name
   and address)
6. Whether proof of identity was requested of the
   person collecting
7. Whether proof of identity was provided.

Question 38

What are the requiremnts of the nature of CD register enteries?

Answer 38

1. Entered chronologically
2. Entered promptly - must be same day or next day
3. In Ink or indelible
4. Unaltered -entries must not be cancelled, obliterated or altered. Corrections must by by dated footnotes. Should be marked to show who made the amendments - name, sig, gphc number

Question 39

If a pharmacy has an electrical CD register what does legislation require of computerised entries and registers in general?

Answer 39

1. Attributable
2. Capable of being audited
3. Compliant with best practice
4. Must also be accessible from premises and capable of being printed

Registers:

1. Author of each entry is identifiable
2. Entries cant be modified at a later date
3. A log of all data is kept and can be recalled for audit purposes

Question 40

What is the aim of running CD balances and stock checks?

Answer 40

to ensure that irregularities or discrepancies are identified as quickly as possible

Question 41

What is the aim of running CD balances and stock checks?

Answer 41

to ensure that irregularities or discrepancies are identified as quickly as possible

if there is any - investigate

Question 42

How often should stock checks be undertaken?

Answer 42

At least once a week

should be recorded, signed and dated by person doing it