The Pharmaceutical Journal
Vol 279 No 7481 p653
8 December 2007

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• Controlled drugs
• Locum pharmacy
• Medicines distribution
• Retention fees (2)
• Premises fees
• Supervision
• The profession
• Postgraduate education

Letters to the Editor

Controlled drugs

Clarification of the status of new e-CD register

From Mr N. Siabi, MRPharmS

I would like to clarify the status of the new electronic Controlled Drug register from Denward. It is in use in several pharmacies and has now been seen in use by a Royal Pharmaceutical Society inspector who has looked at all the legal aspects of using this register.

The Society has confirmed that it has been unable to identify any areas of real concern and that the software appears to comply with the relevant requirements of the Misuse of Drugs Regulations 2001 (as amended).

The inspector looked at the e-CD register and ensured that:

• The author of each entry is identifiable

• Entries cannot be altered at a later date

• A log of all data entered is kept and can be recalled for audit purposes

The inspector also pointed out that arrangements must be made so that inspectors can examine computerised records during a visit with minimum disruption to the dispensing process. Since this program is completely stand-alone, and is not integrated with the patient medication records, it is possible for an inspector to perform their duties on a separate computer while the dispensary carries on with normal activities.

Confusion has arisen because the Society and the Home Office are not in a position to endorse, approve or recommend particular products and it would not be right of them to do so. The original news item published in the PJ on 3 November 2007 (p490) stated that the Society and Home Office had approved the product. The subsequent retraction of the word “approved” which appeared on 17 November (p559), led to the confusing statement that the product was “not approved”.

However, e-mail correspondence from the Society reads “The Society is happy to state that the Society’s inspectorate has now had an opportunity to look at the system and provide advice and guidance to assure compliance with legislative and good practice requirements. It is important to note that the enforcement of the Misuse of Drugs Regulations 2001 is not a matter for the Society as this jurisdiction remains with the police.”

Similarly, e-mail correspondence from a Home Office pharmacy inspector dated 6 July 2007, in response to our request to evaluate the e-CD register, stated that “he could not see anything radically wrong with the way the software for the CDR has been set up”. The inspector also pointed out that the headings for each page should change in order to comply with the 2008 regulation.

We have since complied with the new requirement and can state that headings are compliant with regulation coming into force on 1 January 2008.

Nader Siabi
Hornchurch, Essex

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