What you need to know about controlled drugs
Dr Clare Gerada explains the traps for the unwary GP
Dame Janet Smith, chair of the Shipman Inquiry, will shortly make her final recommendations. She will almost certainly pick up on the confusion around the regulation of controlled drugs (CDs)1.
The legislative framework for CDs is out of date. It does not reflect changes in general practice, such as co-operative out-of-hours working and the changing landscape of clinical practice.
Despite all the regulations and complexities, few GPs have had any training in their duties under the Misuse of Drugs Act.
The increasing use of CDs for malignant and non-malignant pain in recent years can be attributed to the rapid growth of hospital pain clinics repeat prescriptions are almost always be issued by the patient's GP. Moreover, the Pain Society recommends that opiate drugs should be used routinely in cases of severe chronic pain, such as trigeminal neuralgia.
Government policy to increase treatment of drug users in primary care has no doubt contributed to the rise in GPs prescribing methadone. National guidelines recommend methadone as the most effective treatment for opiate substitution, although other treatments such as buprenorphine are gaining an evidence base for detoxification and maintenance.
Most CDs are taken in patient's homes, although hospices account for the highest volume of CD use. Care homes may only hold CDs prescribed by GPs and dispensed by a pharmacist; they do not carry stocks of CDs, so when a user leaves the home the CDs will be transferred to them. The only justification for a home to keep CDs is the existence of a valid prescription for a person actually living in the home.
Classification and control
The class of different drugs reflects the penalties applicable to offences involving different drugs. The schedule, on the other hand, corresponds to their therapeutic usefulness and potential for misuse. For practical purposes GPs need to be familiar with the regulations surrounding schedule 2 drugs, which include pharmaceutical opioids and amphetamines in medical use.
There are two areas that most frequently cause confusion for the GP.
Recording This is the area that is perhaps least complied with and understood. It relates to CDs kept personally, that is obtained through a requisition or wholesale order rather than prescribed on an FP10. A register must be kept and this register must comply with the relevant regulations it must be bound, with a separate page for each drug, and entries must be in chronological order.
All health professions who hold a personal CD stock must keep their own register and are personally responsible for keeping it up to date; in a group practice this responsibility is often delegated to the practice nurse.
Another source of confusion concerns record keeping of personally administered items from the doctor's bag. The doctor's bag and the central practice stock must be considered to be one and the same, with one CD register.
But when doctors share the same bag there is inevitable failure in the audit trail drugs are used but not recorded as such. In all cases it should be considered good practice to keep a separate CD register in each bag, which is then reconciled with the central register.
Disposal Getting rid of CDs returned to the GP by patients is perhaps the hardest part of the audit cycle to deal with. Apart from having two professionals always available to accept unwanted CDs from patients there is perhaps no safe, effective and unobtrusive way of ensuring unwanted CDs are returned and destroyed appropriately and do not get diverted for nefarious use.
Once prescribed, at present all drugs are the property of the patient, who can destroy them if they are no longer required. If returned to the doctor or pharmacist and this refers to prescribed and unwanted CDs then there is no legal requirement to make a record of their destruction.
But it is good practice for pharmacists
and doctors to keep a separate book to
record all CDs returned to them. Stock CDs can only be destroyed in the presence of an authorised person.
Doctors enjoy the unique position that they can purchase, store, prescribe, dispense, deliver and administer controlled drugs with little or no routine audit or monitoring at each stage.
In the main they prescribe according to established good practice and adhere to local and national guidance, but a few notable exceptions have undermined this level of trust and resulted in a major review, the results of which GPs await with interest.
1 Baker R et al. Investigation of systems to prevent diversion of opiate drugs in general practice in the UK. Qual Saf Health Care 2004;13:21-25
The Pain Society:
National Prescribing Centre
Prescribing Support Unit
Clare Gerada is RCGP lead on drug misuse