Latest Controlled Drugs Advice below.
The recent regulatory hearing concerning the Pharmacist who filled Dr Shipman’s prescriptions for diamorphine, has caused anxiety in primary care. Whilst the Pharmacist concerned, Mrs G Brant, has been exonerated, with no case to answer, reassurance is required by Healthcare professionals, lest they be in the same position of having the misfortune to be in the wrong place at the wrong time in a unique situation not of their making.
It is relevant that Dame Janet Smith is keen that any apprehension by Doctors concerning the use of opiates is dispelled.
She stated: During the hearings of the Shipman Inquiry, I was told that, since Shipman’s crimes had come to light, many general practitioners, who were uncertain about the rules relating to the use of controlled drugs, had become so concerned about possible criticism that they had ceased using such drugs altogether. If that were so, it would be most unfortunate, as controlled drugs have an important role to play in patient care. In writing my Fourth Report, I was determined that any recommendations for change would not make it more difficult for doctors to use controlled drugs for the benefit of their patients. The objective behind my recommendations is that general practitioners should be able to prescribe controlled drugs when appropriate and in a way that is safe and in accordance with the law.
Following the Shipman Report, the burden of responsibility for monitoring misuse, abuse or diversion of controlled drugs by doctors in Primary Care, will fall upon a designated official of the PCO. This person will be expected to liaise with appropriate personnel in the police, Home Office, PPA, Regulatory bodies and other stakeholders concerned with the law, probity and good practice regarding controlled drugs.
It is perhaps worthwhile to look at the particular areas or issues they are likely to confront.
Primary Care Organisations, as part of their clinical governance, are expected not only to have firm SOPs in place regarding the prescribing, dispensing and personal administration of controlled drugs and to show audit of probity in these areas. Likewise, individual general medical practices, including dispensing doctor practices, are expected to have in place clinical governance procedures for all areas relating to controlled drugs, eg. responsible prescribing, record keeping, security and access, disposal and destruction, patient returns, doctors’ bags, personal administration and out-of-hours (OOH) provision.
Uniquely, the PCO “Inspector” is likely to be responsible for auditing and monitoring private prescribers of controlled drugs. This was an area of particular concern of the Shipman Inquiry.
Private prescribers must comply with all legal requirements, including appropriate record keeping, when ordering, prescribing, dispensing, administering and destroying controlled drugs.
Private prescribers and clinics are required to be registered with the Healthcare Commission and, as part of this regulation must demonstrate safe systems in the management of controlled drugs.
Record keeping will be subject to site inspection by the PCO “Inspector”. It is not currently lawful in primary care to ONLY compile the records required under the Misuse of Drugs Act electronically. Where records are kept electronically, full hard copy records must also be kept in a statutory compliant paper register.
Records for Schedule 2 Controlled Drugs must be kept in a ‘register’. The register must be bound and contain individual sections or pages for each Schedule 2 drug.
Details of all Schedule 2 Controlled Drugs purchased or obtained should be entered on the date of receipt in the purchasing section of the register.
An entry must be made in the sales or supply section of the controlled drugs register on the date a prescription is dispensed to the patient or their representative or personally administered to the patient.
There will be occasions when a doctor or practice wishes to destroy Schedule 2 Controlled Drugs. There are two clear categories of such, patient returns and practice’s or doctor’s own unissued stock. Such drugs should be destroyed or denatured so that they cannot be recovered, retrieved and re-used; and may then be disposed of as normal pharmaceutical waste.
Patient returns, which if you choose to accept them, may be destroyed without an outside witness. However, it would be poor practice not to make a record and have an internal witness.
Practice’s own unissued stock which, usually, will only be destroyed because it is out of date stock. Schedule 2 Controlled Drugs, which have to be recorded in a register by law, which are the practice’s unissued stock cannot be destroyed without an approved outside witness. Such persons are any serving police officer, Home Office or RPSGB inspector, certain dental officers and Supervisors of Midwives and other persons authorised by the Secretary of State. These may include certain medical or pharmaceutical advisers. All PCOs include some authorised persons. These authorised persons can only witness destruction and cannot delegate the task of witnessing the destruction of controlled drugs. They should not be given the drugs to take away for destruction.
With general medical practices opting out of OOH, personal administration of controlled drugs will be a much less frequent event for practice based general practitioners. PCOs commissioning OOH services will need to ensure that their provider has robust Standard Operating Procedures (SOPs) in place. The provider will have to show audit trails capable of validation. Likewise, physicians providing out-of-hours services will need to comply with all the appropriate legal requirements and the SOPs of the OOH provider.
Particular problems are likely to occur when the out-of-hours provider is providing physicians with controlled drugs from a central store in relation to authorised storage, possession and supply to the actual physician.
OOH providers are strongly advised to seek expert professional advice relating to their medical and legal responsibilities in relation to controlled drugs.
One area that is often not appreciated by doctors is restrictions on controlled drug passage across sovereign borders.
When patients travel abroad, they will need to take with them their medicines. Practitioners can help ensure a trouble-free trip by advising them, if relevant, about controlled drugs. Many controlled drugs are subject to import and export licensing requirements, however, the Home Office has an open general licence which lists controlled drugs and permitted quantities which can be taken out of and brought into the UK for personal use without a licence. Usually a letter from the patient’s general practitioner or other involved doctor, stating the patient’s drug regimen, is sufficient. Advice should be sought from the Home Office when higher doses are prescribed, as a drugs export licence is likely to be required. Advice and a licence are obtainable from:
The Licensing Section, Home Office, Horseferry House, Dean Ryle Street, London SW1P 2AW. Telephone: 0207 217 8457 or fax: 0207 217 0618
Ref: “Controlled Drugs in Primary Care, The Law, Probity and Good Practice”. Nigel V Morley. Second Edition 2004 (Revised).
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Clarification - Equasym XL is a Schedule 2 Controlled Drug
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