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Flashcards in CDs Deck (42):
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)

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

2

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

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

3

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

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.

4

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

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

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)

1. Possession is taken with the purpose of destruction

2. Purpose of handing it over to the police

6

Who can administer or prescribe a Sch 1 drug?

Only those with a Home Office License

7

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

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).

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?

Yes

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

9

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

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

10

Can supplies be made against a faxed or photocopied requisition?

No

11

Discuss the practice issues with a requisition

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

12

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

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

13

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

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).

14

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

1. Diamorphine
2. Morphine
3. Pethidine

15

What must be on a midwife CD supply order form?

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

16

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

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

17

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

1. Amount of med per instalment

2. Interval between each time the med can be supplied

18

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

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

19

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

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.

20

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

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.

21

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

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.

22

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

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

23

Which CDs should be kept under safe custody?

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

24

Which CDs need to be denatured before disposal?

Sch 2, 3 and 4 part 1

25

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

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.

26

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

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

27

How should CDs be disposed of?

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

28

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

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

29

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

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

30

What is the method of destruction of liquid dosage forms?

Pour into an appropriately-sized CD denaturing kit

31

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

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.

32

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

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

33

What is the method of destruction of ampoules and vials?

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

34

What is the method of destruction of patches?

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

35

What is the method of destruction for aerosol formulations?

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

36

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

For CD received what should be recorded? (3)

1. Date supply received

2. Name and address from whom received

3. Quantity received.

37

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

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.

38

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

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

39

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

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

40

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

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

41

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

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

if there is any - investigate

42

How often should stock checks be undertaken?

At least once a week

should be recorded, signed and dated by person doing it