2. Welcome to Practical Guidance on Controlled Drugs
by Caroline Pond

3. Welcome to Practical Guidance on Controlled Drugs
by Caroline Pond

4. Plan For Today Agree Objectives
Have a productive and interactive learning experience
Feel better equipped to carry out CD related tasks in your practice
Finish in good time!

5. Objectives
To review the current legislation and good practice guidance relating to controlled drugs in primary care.
To reflect on the way CDs are handled in your practice and consider how this could be improved.
Anything else?
On 31st January 2000, Harold Shipman was convicted of murdering 15 of his patients whilst working as a GP in Manchester. On the 1st February 2000, the Secretary of State for Health announced that an Independent Inquiry would take place, to investigate how current systems in the medical profession could be changed to safeguard patients in the future. Phase Two, Stage Three of the Inquiry examined controlled drugs in the community and Phase Two, Stage Four examined monitoring, disciplinary systems and complaints in general practice.
It’s also worth mentioning at this stage the sources of information that DAs in DD can use:
MEP (available as paper and electronic copies)
BNF (at the front)
Updates e.g. Merck bulletin
DDA

6. Checklist Cover the following as a minimum: Classification of CDs SOPs
CD Registers
Receipt
Supply
Destruction
Discrepancies
Whistle Blowing

7. Background
The misuse of Drugs Act was passed in 1971, coming fully in to effect in 1973.
The Act set up the Advisory Council on the Misuse of Drugs and introduced the power to introduce strict standards of security.
It used the terms “Controlled Drugs” and “CDs” to replace the previously used expression “ Dangerous Drugs” or “DDA”

8. The regulations govern production, possession and supply
and also control prescribing, safe custody, importation, exportation and record keeping.

9. The basic principle is that it is unlawful to possess a controlled drug or to deal with one in any way without authority. Authority is provided by the issue of a licence or is conferred on certain classes of a person by statue.

10. CD Classifications CDs are classified in to five schedules
Classification is based on the potential for misuse and abuse.
Each schedule is assigned legal requirements relating to the storage and records required for drugs within that class.
Nurse and Pharmacy prescribers are now authorised to prescribe all controlled drugs listed in schedules 2 to 5 within their competence – with the exception of certain drugs used for the treatment of addiction.

11. Schedule 1 (CD Lic) Examples: LSD, Ecstasy, Cannabis.
A Home Office (HO) License is require for possession, supply and manufacture.
Until the recent move to medicinal cannabis the has been virtually no therapeutic use for drugs in this class.

12. Schedule 2 (CD – POM) Examples:
Opiates e.g. diamorphine, morphine, methadone
Amphetamines e.g. dexamphetamine
Pethadine
Safe custody required
Records of receipt, supply and destruction required (we will revisit these requirements later in the session)

13. Schedule 3 (CD – No Reg POM)
Examples:
Buprenorphine Midazolam Phenobarbitone
Temazepam Tramadol
Subject to Special prescription requirements
Most drugs in schedule 3 do NOT need safe custody except:
Temazepam and Buprenorphine
Records of receipt, supply and destruction not legally required
Requisition necessary.

14. From April 2019 Gabapentin and Pregabalin
Subject to Special prescription requirements
NO safe custody
Records of receipt, supply and destruction not legally required
Requisition necessary

15. Schedule 4 Part 1: CD Benz POM Contains most benzodiazepines Ketamine
Zopiclone/Zaleplon
Part 2: CD Anab POM
Contains anabolic and androgenic steroids
No safe custody requirements
No records of receipt, supply or destruction required

16. Schedule 5 (CD – Inv. P or POM)
These drugs are exempt from full CD requirements when present in low strengths:
CD Inv P
Codeine (as codeine linctus)
CD Inv POM
Morphine (as Oramorph oral solution 10mg/5ml)
No safe custody requirements
No records of receipt, supply or destruction

17. Safe Custody of Controlled Drugs
The 1973 Safe Custody Regulations relate to particular Drugs.
The Regulations require these drugs to be stored in a controlled drugs cabinet, approved safe or suitably constructed room.

18. CD Storage in the Practice
Locked CD cabinet or cupboard suitable for it’s purpose
Dr’s bag – must be locked and, if left in a vehicle, be locked in the boot
Who has access to your CD cupboard?
Who holds the keys:
During the day?
Over night?

19. CD Governance Arrangements - SOPs
GP Practices should have systems in place to ensure the safe management of CDs.
Each practice should have clearly written SOPs covering:
Who has access to CDs
Where the keys are stored
Security (both as stock and when transported)
Ordering, storing and destruction
Who to alert if complications arise
Record keeping
CD registers
Records of patient returns
Running balances

20. Staff must be trained so that they understand and follow the written SOPs and have the relevant skills and knowledge to undertake the CD-related tasks they are required to complete.
Staff should know what to do and who to contact if they have a concern about a CD related incident or the performance or practice of other staff.
Staff should know how to contact the Area Team CD Accountable Officer.
SOPs – Sample SOP in delegate pack.

21. The CD Prescription Special prescription writing requirements:
To be valid, on top of the normal prescription requirements for POMs prescriptions for Schedule 2 & 3 CDs MUST also contain the following:
The Dose
The Form
The Strength (where appropriate)
The total quantity or dosage units of the preparation in both words and figures

22. Prescriptions for CDs
Both private and NHS prescriptions for CDs in Sch 2, 3 & 4 are only valid for 28 days
It is recommended that the total quantity supplied be equivalent to 30 days treatment or less
Ideally the patient’s NHS number will be on the prescription
They cannot be dispensed or an owing supplied if it is more than 4 weeks after the date on the prescription
Last bullet point: A stamp is sufficient but must have the date on it (some practices don’t!)

23. CD Prescriptions
On the back of the prescription form there is a space for the person collecting Schedule 2 or 3 CDs to sign
It is not a legal requirement for them to sign the prescription form
The entry in the CD register must be made on the day of the supply
It is a legal requirement to check the ID of someone collecting a schedule 2 CD
NB: One question which I was asked was if one GP signs a prescription which uses another GP’s pad which one do you put in the register.

24. For schedule 2 CDs it is a legal requirement to establish whether the person collecting is the patient, representative or a healthcare professional (name & address needed for healthcare professionals)
ID should be requested (unless the person is known).
CDs may be supplied if ID is not shown.

25. Ordering Controlled Drugs
It is recommended that practice stock levels are kept to a minimum whilst ensuring that they are adequate to meet normal patient demand.
CDs can be ordered electronically but the practice still has to provide the wholesaler with a signed requisition on the mandatory requisition form.
Requisitions cannot be faxed as a fax is not legally signed by the practitioner.
Best Practice?
CD requisition form in delegate pack, how are these managed in your practice?

26. Receiving Controlled Drugs What happens in your Practice?

27. Receiving Controlled Drugs from the supplier
Upon receipt check the stock against the delivery not and your order.
If delivery is correct... Record in the dispensary CD register:
Date
Name & address or firm from whom you received
Good practice to record the invoice number
Quantity received
Form e.g. Tablets
Update running balance

28. The CD Register

29. Controlled Drugs Registers
Any movement of a Schedule 2 CD in to and out of the practice must be recorded in a CD register.
Entries ASAP but within 24 hours.
Best Practice
2 People
Check stock levels
Running balance. Why?
Moving CDs between branch surgeries?
CDs for doctor’s bags?
How/why to close a register?

30. Best Practice:
To avoid lots of amendments in the register, do not make the entry until the point of collection
If a part supply is being made then make that clear in your entry
When a balance is supplied make it clear that the script is now filled

31. Refreshment Break
15 Minutes – Please take some time to visit the sponsors of today’s event.

32. Discussion:
If one GP signs a prescription and uses another GP’s pad… which one do you put in the register?

33. Records of Patient Returns
Good practice to record (and keep for 7 years):
Date of return
Name, quantity, strength & form of CD
The role of the person who returns the CDs
The name and signature of the person who accepted the CDs
The name & address of the patient
The names, positions & signatures of:
The person destroying the CDs
The person witnessing the destruction
Special registers available.

34. Patient Returns Cannot be supplied to another patient
Must be destroyed in practice
Adhere to safe custody requirements whilst waiting to destroy
An ‘authorised’ witness is not required for destruction
Who may do this in your practice?
Best Practice – How to destroy?

35. How to Destroy CDs Commercially available kits denature the drugs
De-blister tablets/capsules etc.
Remove the backing and fold patches over
Open ampoules and pour content in to kit

36. Important How do you do that?
Patient returns and any expired stock need to be kept separate from dispensary stock to avoid accidental supply.
How do you do that?

37. Destruction of Out of Date CDs
May only be destroyed in the presence of an authorised person.
Must be entered out of the CD register and the running balance adjusted accordingly.
Who is authorised to do this?

38. CD Discrepancies Act promptly if you find a discrepancy! Check:
Running balance maths
Out of date stock
Stock destroyed by not recorded
Receipt of stock not entered in to the register
Prescription not entered – check your PMR and the filed prescriptions
Hopefully not!
Patient returns used

39. On 31st January 2000, Harold Shipman was convicted of murdering 15 of his patients whilst working as a GP in Manchester.
On 1st February 2000, the Secretary of State for Health announced than an Independent Inquiry would take place to investigate how current systems in the medical profession could be changed to safeguard patients in the future.
Whistle Blowing
Exercise – Shipman Surgery CD Register
What would raise your suspicions?
What would you do if you were worried?

40. Any questions? Thank you.
Please complete your feedback forms and return to Ché.
Thank you.