Implications of new CD regulations Print E-mail
Written by Janice Hancock   

In January 2000 Harold Shipman was convicted of the murder of 15 patients he was caring for as their GP. The subsequent public inquiry, chaired by Dame Janet Smith, looked at issues surrounding the police investigation, how the patients’ deaths were reported, the prescribing and handling of controlled drugs (CDs) and the regulation of health professionals. Of these issues, the one of most interest and perhaps concern to community pharmacists is CDs. 

The Fourth Report of the Shipman Inquiry, published in July 2004, made a number of recommendations. Those important to pharmacy covered the prescribing, dispensing and destruction of CDs. Following the publication of this report, the Government acknowledged there was a need for strengthened arrangements and indicated which recommendations would be taken forward.

This article will explain the changes to CDs that affect community pharmacy. At the time of writing (summer 2006) many of these changes were due to be implemented but might be in practice by the time of publication.

Prescribing changes


Handwriting requirements
The Misuse of Drugs Regulations 2001 provides the legislative framework that doctors and other health professionals work within when prescribing CDs. They place requirements on the prescriber to include specific information on the prescription. Previously they required prescribers to write prescriptions for Schedules 2 and 3 CDs in their own handwriting. In November 2005, an amendment to these regulations allowed prescriptions to be computer-generated. This amendment will reduce technical errors and allow prescriptions to be recorded on patients’ medical records. It will also reduce the risk of pharmacists reading a prescription wrongly. In time, it will allow the electronic transfer of this type of prescription.

As this change came into place some time ago, pharmacists should be familiar with receiving computer-generated CD prescriptions. However, they must remember the other prescription requirements still apply, including stating the total quantity in words and figures, and a proper dose for the drug. Pharmacists still have a requirement to ensure the prescription is genuine.

Treatment period
Additionally, the Department of Health in England has recommended prescribers should restrict the amount they prescribe to no more than 30 days’ supply. Only in exceptional circumstances should the treatment period extend beyond this and the prescriber should record the reasons in the patient’s notes. This recommendation has also been taken forward in Scotland. At the time of writing, there had been no announcement on how the changes were to be managed in Wales. The Department of Health in Northern Ireland is not advising this at the moment.

Private prescribing
The next amendment to the Misuse of Drugs Regulations 2001 came into force in Scotland and England on 7 July 2006 and will come into force in Wales on 1 January 2007. Similar amendments to the regulations in Northern Ireland also came into force on 7 July 2006. The changes relate mainly to private prescribing. A new standard form has been introduced for private prescribing of Schedule 2 and 3 CDs. In England this is called an FP10PCD and is similar in format to a standard FP10. However, it is pink in colour and has the words “Private CD” across the top. In Scotland, this form will be a PPCD(1) and in Northern Ireland a PCD1. Wales have not yet announced the form this prescription will take. In Scotland, England and Wales these new private prescription forms will contain a unique prescriber identifier. This will have to be present on the prescription before it can be dispensed.  

Patient identifier
Both NHS and private prescribers will be expected to add a patient identifier to the prescription, although this is considered good practice and pharmacists should not refuse to dispense a prescription if the number is not present. In England, this will be the patient’s NHS number and in Scotland the CHI number. Again, this change is not taking place in Northern Ireland.

Dispensing


Validity
From 7 July 2006 the validity of CD prescriptions was reduced to 28 days. Pharmacists presented with a prescription older than this should not dispense it and should refer the patient back to the doctor. This change applies to Schedules 2, 3 and 4 CDs so includes drugs such as diazepam.

Storage of private forms
In addition, the new private forms (or a copy of them until the relevant legislation is changed) have to be sent to the appropriate NHS pricing body for collation of data on prescribers. This is not a requirement in Northern Ireland. Once the legislation is changed, there will be no requirement to keep a copy in the pharmacy and this will reduce the work required by pharmacists.

CD register requirements
The Shipman Inquiry recommended keeping a running balance of CDs to make it easier for discrepancies to be spotted quickly. While the Government has not made this a legal requirement yet, it has said this will become mandatory once electronic CD registers are in widespread use. Until then, it is considered good practice to have running balances in place. Other requirements for the CD register may change in the future.

Collection/handing out
When a person collects a prescription for a Schedule 2 or 3 CD, they will be expected to sign the back of the prescription and, for Schedule 2 CDs, provide identification (ID). This is not a legal requirement and pharmacists can still give the prescription out, even if the person collecting refuses to sign and/or present ID. However, pharmacists are entitled to refuse to hand out a prescription if they are not satisfied with the identity of the person collecting. If that person were a healthcare professional, pharmacists would be expected to give the prescription, even if they were not satisfied. A list of acceptable ID is available from the RPSGB. This information may need to be recorded in the CD register in the future.

Minor errors
Pharmacists can now amend any minor spelling or typographical error on a CD prescription, as long as they are satisfied the prescription is genuine and they initial the amendment. The pharmacist can also add the words or figures to the quantity if the prescriber omits them. Hopefully, this change will reduce the need for patients to return to the prescriber and ensure they get their medication promptly. Other amendments may be made possible by future changes in legislation.

Future changes


Destruction of CDs
At present there is no requirement for pharmacists to record the destruction of CDs returned by patients. This may change in the future as the Shipman Inquiry felt there was a risk of diversion. The people authorised to witness the destruction of stock will also increase, which should make it easier for pharmacists to find someone to visit their pharmacy to carry out this task.

PDRC
The Government is currently trialling the use of a Patient Drug Record Card (PDRC) – a card given to the patient at the time of dispensing any injectable Schedule 2 drug, e.g. diamorphine, which will be completed by the person injecting the drug and then eventually returned to the pharmacy. Obviously, this may mean more work for the pharmacist and any advances should be monitored closely.

SOPs
Many pharmacies already have standard operating procedures in place for the handling of CDs. However, in time these will become mandatory. The Department of Health is expected to issue guidance on what form these will take.

Inspection and monitoring
Pharmacists are used to police officers inspecting their CD register. However, the Royal Pharmaceutical Society Inspector will take on this inspection in the future. This should reduce the number of inspections a pharmacy has. In addition, pharmacists will have to complete a yearly assessment of the way they handle and dispense CDs.

Good news?


At first sight the changes appear onerous, but pharmacists should not be frightened. Many of the changes will not greatly affect day-to-day practice and some will make the pharmacist’s job easier. Asking for, and recording, identification may be the most time-consuming change but this can be delegated to reliable support staff and will soon become the norm. Pharmacists should remember that, while they may feel some new tasks are unnecessary, they have been introduced to protect the public from another Harold Shipman.
 
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