Safer management of Controlled Drugs(CDs): Changes to Record Keeping Requirements

This document is a guidance to inform and support organisations in implementing changes to the changes to the record keeping requirements fpr CDs, and also supports relevent organisations in implementing the changes requires to the format of the Controlled Drugs register.

It highlights the use of headings and titles of the coloms used to capture the mandatory fields of information that are required as a result of further changes made to The Misuse of Drugs Regulations 2001.

Our software is compliant with all regulations included in this document including the additional information that may be recorded.

Legal Requirements (Section 8 to 12)

From the 1st of February 2008 it will no longer be a legal requirement to maintain a CDR in a prescribed format supporting the increase in electronic registers. Electronic registers must be capable of displaying or printing the name, form and strength of the drug at the top of each page.

Also regulations will require the following information to be recorded when CDRs are obtained:

• Date supply obtained
• Name and address from who obtained
• Quantity obtained

And when CDRs are supplied to patients of practitioners:

• Date supplied
• Name and address of person or firm supplied
• Detail of authority to possess
• Quantity and form in which drug supplied

Computerised CDRs (Section 14 to 15)

For best practice CDRs held in computerised format require:

• Safeguards to ensure the author of each entry is identifiable
• Entries cannot be entered at a later date
• A log of all data entered is kept and can be recalled for audit purposes.

Preservation of Records (Section 19 to 21)

Safeguards ensure all data requisitions and orders CANNOT be altered at a later date and all records must be preserved for at least 2 years. The document also states that when eCDRs are widespread that the person in charge of the local eCDR will be required to preserve secure copies of all records for up to 11 years.

Additional Information that must be Recorded (Section25 to 27)

As of 1st February 2008 it will be a requirement to record the following information in regards to the identity of the person collecting the drugs:

• Whether the person who collected the drug was the patient, the patient's representative or a healthcare professional acting on behalf of the patient and;
• If the person who collected the drug was the patient or their representative and whether evidence of identity was requested;
• if the person collecting was a healthcare professional acting on behalf of the patient, that person's name and address;
• and whether evidence of identity was provided by the person collecting the drug