02 September 2005

No ID - No Methadone? - Proposed changes to Drugs Regulations

The Home Office has launched a public consultation on proposals to make changes to the Misuse of Drugs Regulations. These proposed changes follow on from the Fourth Report of the Shipman Inquiry.

To read the Proposals in full, please go here

The low-key launch of the consultation at the end of July may mean that it escaped the attention of key agencies. We feel that the proposed changes may have some important ramifications for the Drug Treatment and social care field and would urge agencies to respond to the consultation.

The proposed changes are intended to improve the prescribing, audit trail, and safe handling of prescribed controlled drugs. They include proposed changes to the Misuse of Drugs Regulations 2001.

The proposals have been drawn up after consultation with the ACMD and a number of other agencies exclusively drawn from medical disciplines. Unfortunately, this list does not appear to include the National Treatment Agency, Drugscope, Homelesslink nor any other agency primarily concerned with the needs of drug users engaging with treatment providers.

We are concerned that this has meant that some of the proposals could negatively impact on access and adherence to treatment. We are also disappointed that the Home Office has not used this revision as an opportunity to clarify the legal situation relating to the storage of controlled drugs in non-medical settings.

Paragraph 15: Controlled Drug Prescriptions


Prescriptions for controlled drugs to carry a unique identification number so prescriber can be identified

All prescriptions for controlled drugs to carry a patient identifier number (NHS Number) to identify double scripting

Effectively, this proposal represents a return to a "register" of addicts. Within this proposal, all users prescribed controlled drugs will be recorded and identifiable within a central register.

A key concern must relate to homeless and transient patients who do not currently have, or do not know their NHS numbers. The proposals note a need to consider the "obligations on prescribers and dispensers faced with patients who are unable or unwilling to supply their NHS number."

We would go further than this and propose that given the risk of further excluding people who are dependent on drugs from treatment, those engaged in the treatment of drug dependency should be exempted from this requirement.
We would suggest that this exemption should be time-limited as follows:

"Prescribers treating people for dependency on controlled drugs will need to ensure reasonable efforts are taken to ascertain an NHS number. However, in order to ensure access and continuity of treatment, obtaining such a number need not happen prior to commencing treatment but should take place within the first three months of treatment."

Paragraph 22: Dispensing controlled drugs:

Proposal: requirement for dispenser to ask for the name, address and some form of personal identification of people collecting Schedule 2 controlled drugs.

This proposal is mediated by a proposal to ensure that Pharmacists still have discretion to dispense where a person has no form of identification.

We are concerned that this proposal needs more careful attention to ensure that people being treated for drug dependency, especially those who are homeless or transient, are not unfairly treated by this proposal. Many such patients will have no formal documentation to prove identity, and those who are homeless or in temporary accommodation may struggle to prove their address.

In order to facilitate dispensing to such patients, we would propose the following:

Patients attending agencies for drug treatment to be issued with an ID card which includes patient ID number and photograph, which will be an agreed form of identification at local pharmacists. This will be made available at no cost to people attending treatment. Such a system would be extended to patients receiving treatment from GPs within a shared-care scheme.

Paragraph 27: Controlled Drugs in the Community

We have contacted the Home Office on previous occasions requesting clarification of the regulations relating to the storage of prescribed controlled drugs in non-medical settings. It has been our ongoing concern that the storage of prescribed controlled drugs by hostels, day centres and other allied professionals is not robustly legal. We have brought these concerns to the attention of successive Home Secretaries and have been assured that the issue would be addressed when parliamentary time allowed.

We have documented our concerns relating to the current legal position in detail in the KFx guidance document "On Storage." We have appended this to our submission to the Home Office.

In order to enhance the safe handling of controlled drugs in the community we would like to make the following proposals:

" That hostels and day centres be given the authority under the Misuse of Drugs Regulations to store prescribed controlled drugs on behalf of Service Users, and return such drugs to the named patient.
" That while such services should be given this authority, they would not be obliged to store such prescribed drugs for service users or residents.
" Organisations who wish to store controlled drugs would be required to demonstrate that they can operate to agreed standards including:

Storage facilities

Record keeping

Staff references

Joint working with prescribers

The provision would be audited by the Pharmacy Inspectorate who would furnish a Certificate of Compliance, authorising the storage of such controlled drugs.


Whilst it is essential that there are effective strategies in place to monitor the use of prescribed controlled drugs, it is essential that such measures do not have a disproportionately negative impact on patient care.

Where the patients in question are receiving their controlled drugs as part of a package of treatment for drug dependency, it is imperative that access and continuity of treatment is not reduced as a consequence of changes to the Misuse of Drugs Regulations.

We hope that this submission highlights these concerns and that they will receive serious consideration as part of the consultation process.

Kevin Flemen
September 2005

1 comment:

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