Practical Aspects of CDs
 
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  Practical CD dispensing and record keeping

The following article draws largely on- Controlled Drugs,  The Law, Probity and Good Practice with grateful thanks to the author Nigel Morley MRPharmS, Independent Pharmacist

The Law
The law, the Schedules and the Misuse of Drugs Act are set out in Controlled Drugs by Nigel Morley together with a list of which drugs are in which Schedules. If readers have any doubts as to any drug’s classification, either purchase Nigel Morley’s book or enquire through this site’s Feedback facility

 It has been held that it is lawful for a dispensing GP to delegate the act of dispensing medicines for their patients to employed staff.  However the Practice and the Partners have vicarious liability for errors, or any breach of the law.

Suggestions
A dispenser or dispensing doctor employee would be ill advised to dispense a Schedule 2 or 3 Controlled Drug prescription without first checking the dispensed items with a G.P. .Protocols for checking procedures should be in place for all dispensing and Controlled Drugs are no exception

The Doctor must check all prescriptions for Controlled Drugs.

Record Keeping

An extensive list of drugs for which records must be kept is available via feedback or in Nigel Morley’s booklet Controlled Drugs.

The Law
Records for controlled drugs must be kept in a bound and sectioned ‘register’ and be entered on the date of receipt in the purchasing section of the register.

Similarly an entry must be made when the drug is dispensed or administered.

Entries in the register must :

be in date order, be dated, contain the name and address of patient to whom the supply is made, list the amount supplied and the form obtained or supplied.

They must also be indelibly legible and in the proper section

Errors:
Do not obliterate them, just put a light line through and asterisk the error then as a footnote insert "should read...." and sign and date.  Wrong section errors should be re-inserted on the correct page with an indication on the error page.

Suggestions
Ensure there is a balance for easy inspection.
Dispense Schedule 2 drugs on day of use to avoid difficulties  between dispensing and patient death.

 Recycling

The Law
It is illegal to recycle returned Controlled Drugs.
It is fraudulent to claim for recycled Controlled Drugs for drug cost. 

Destruction
Patient returns may be destroyed by the Practice without an outside witness or any record but it is good practice to make a full record and have a signed witness.

Unissued, outdated stock cannot be destroyed without an approved outside witness. 

Witnesses may be any serving Police Officer, Home Office Inspectors, persons authorised by The Secretary of State and RPSGB inspectors, including certain Medical or Pharmaceutical advisors.  

Witnesses can only witness destruction and cannot take drugs away for destruction. They may however take a small sample of the drug which is to be destroyed for forensic purposes. 

The register should record full details of the drug destroyed and be signed and dated by the witness

Disposal or destruction methods

The Law
This comes down to vicarious liability and the Health & Safety legislation.

The Royal Pharmaceutical Society’s protocol:

"Following advice from a company dealing with pharmaceutical waste, the advice to use bleach when denaturing Controlled Drugs has now been revised. It is now recommended that hot, soapy water is used when destroying solid dose and parenteral formulations. Problems can arise if bleach is used in pharmaceutical waste as residual bleach mixes with chemicals used to clear bins if they are to be recycled and toxic fumes can be produced as a result.

Liquid dose formulations Liquid dose formulations should be added to, and absorbed by, an appropriate amount of cat litter, or similar product

Solid dose formulations Solid dose formulations should be crushed and placed into a small amount of hot, soapy water. The resultant mixture should be stirred to ensure that the drug has been dissolved or dispersed

Parenteral formulations Ampoules should be crushed with a pestle inside an empty plastic container. After ensuring that all ampoules are broken, a small quantity of hot, soapy water or cat litter should be added

Fentanyl patches The active ingredient in Fentanyl patches can be rendered irretrievable by removing the backing and folding the patch over upon itself. * Once the above procedure has been carried out, the resultant mixture should be added to the general pharmaceutical waste. It is advisable, therefore, to keep the liquid content to a minimum. (Pharmaceutical Journal 3.6.2000)

*Care should be taken when dismantling or cutting Fentanyl patches. Disposable gloves should always be worn to avoid absorption through the skin.

It should be noted that the Royal Pharmaceutical Society Inspectors do not under normal circumstances witness destruction of controlled drugs in doctors’ surgeries.

Personal Administration

The Law
An entry in a patients notes is not sufficient.  The register must be completed also.  Both records should be identical

Medical Cases

The Law
The Doctor’s bag should be a lockable box, bag or case and should be kept locked at all times. If the receptacle is left unattended at any time in the car it should be out of sight and the car must be locked. The keys to this receptacle should be kept separate at all times.

Suggestions
Cases should not be left in the vehicle overnight or when the vehicle is left unattended for long periods of time. 
Use care if you have a convertible or estate car.
Keyless locks are perhaps simpler for black bags

Record Keeping for medical cases

The Law
Drugs into and out of the bag may be recorded either separately by the doctor or in a central CD register.

Suggestions
GPs should have their own CD books and this may become the law.
It makes for easier audit if a running total is kept.
An audit trail should be simple to follow.
Any central register should indicate supplies to the individual doctor's book.

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(Reference : Controlled Drugs, The Law, Probity and Good Practice by Nigel Morley, £20, Surelines Pharmaceutical Services.  Telephone 01604 859000)

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CDs and the Shipman Enquiry, 2004