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Dealing with controlled drugs

With new regulations now in force, National Prescribing Centre expert Steve Morris outlines the implications for GPs

With new regulations now in force, National Prescribing Centre expert Steve Morris outlines the implications for GPs

Most GPs will have been affected by changes in legislation relating to the prescribing, dispensing and record-keeping requirements for controlled drugs introduced over the last 18 months.

These changes have included new requirements for private prescriptions, changes to handwriting requirements, a restriction on quantities to be prescribed and additional record-keeping responsibilities.

In addition, significant legislation, which sets the framework for new governance arrangements, has just been introduced and will have a significant impact on GP practices.

Most controlled drugs legislation dates back over 30 years to the Misuse of Drugs Regulations 1973. The actions of Harold Shipman exposed weaknesses in the system1.

Therefore, changes have been implemented to reduce harm to patients and the risk of illegal diversion. The changes to legislation are not designed to prevent healthcare professionals from legitimately managing and using controlled drugs.

What has changed?

The Controlled Drugs (supervision of management and use) Regulations 2006 came into force on 1 January 20072 in England and will come into force in Scotland in March 2007. There are three main provisions.

• New statutory duty on all NHS health care organisations and independent hospitals that provide services that may involve the management and use of controlled drugs to nominate a specific individual (an accountable officer) to take responsibility for the safe and effective management of controlled drugs.

Accountable officers are required to be suitably removed from the day-to-day management of controlled drugs. GP practices will fall within the remit of the PCT accountable officer.

• New statutory duty of collaboration on health care organisations and other local and national agencies to share intelligence on controlled drugs issues.

• Power of entry and inspection for the accountable officer, and other nominated people, to enter premises to inspect stocks and records of controlled drugs. This will include GP practices.

Implications for GPs

Individuals, including GPs, retain responsibility for following legislation on controlled drugs (Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001), but accountable officers have an overarching responsibility to ensure their organisations or those people working on its behalf (such as GPs) have suitable arrangements.

The inspection of GPs' arrangements for controlled drugs has in the past been very variable, with no one body having overall authority and responsibility for carrying out this role.

Very few GPs will have had their controlled drugs registers or surgery arrangements for controlled drugs inspected. In practices where doctors do keep a stock of controlled drugs, the methods of record-keeping and stockholding are likely to vary because of lack of inspection or support.

The new legislation will mean that GPs will need to ensure they do have systems to deal with controlled drugs.

Annual declaration and self-assessment

A PCT accountable officer may request a periodic declaration and a self-assessment from a GP on their medical performers list. The declaration must state:

• whether the practitioner uses controlled drugs at any of the premises from which they provide primary medical services as part of the health service;

• how the practitioner manages and uses controlled drugs at those premises.

The PCT can determine the frequency of self-assessment. A model declaration and assessment form for use in primary care is available at www.dh.gov.uk/PolicyAndGuidance/MedicinesPharmacyAndIndustry/ Prescriptions/ControlledDrugs/fs/en

Requirement for a standard operating procedure

All health care providers, including GP practices, holding stocks of controlled drugs will need to have standard operating procedures (SOPs), which will be monitored as part of the strengthened governance arrangements for controlled drugs.

The Department of Health is currently in negotiation for the inclusion of SOP requirements into the GMS/PMS regulations.

Minimum requirements for SOPs are outlined in the Controlled Drugs (Supervision of Management and Use) Regulations 20062. These include:

• who has access to controlled drugs

• where the controlled drugs are stored

• security in relation to storage and transportation

• disposal and destruction• who is to be alerted if complications arise

• record-keeping.

Inspection and power of entry

PCT accountable officers are responsible for arranging periodic inspections of premises which are used in connection with the management or use of controlled drugs and not subject to inspection by other bodies (for example, Royal Pharmaceutical Society of Great Britain will inspect community pharmacies).

The accountable officer, and other nominated people, have power to enter GP premises to inspect stocks and records of controlled drugs.

The practical implementation of the new monitoring and inspection arrangements are in their infancy in many areas of the country.

However, it would be wise for practices to reflect on their current practice with regard to controlled drugs and to consider the implementation points highlighted in the second box.

Keeping up to date with legislation and good practice

The National Prescribing Centre is producing a second edition of A guide to good practice in the management of controlled drugs in primary care at the end of January. This will be available online at www.npc.co.uk.

The Department of Health and Healthcare Commission both have specific website sections dedicated to controlled drugs legislation and monitoring. These are at:

• Department of Health www.dh.gov.uk

• Healthcare Commission www.healthcare commission.org.uk

NPC Plus is producing a modular training package that supports the safe and effective use of controlled drugs in line with regulatory changes and best practice.

Modules include GP practices, dispensing practices and prescribers. More information can be found at www.npc.co.uk/npc_plus.htm.

Steve Morris is director of strategic development and operations at the National Prescribing Centre and a pharmacist by training

Competing interests None declared

key points

The new regulations

• Regulations came into effect on 1 January 2007 in England

• PCT accountable officers will ensure that their contractors, such as GP practices, have appropriate arrangements for the management of controlled drugs

• The accountable officer has the authority to ask GP practices for a periodic annual declaration and self-assessment relating to controlled drugs. If controlled drugs are kept as stock, a standard operating procedure (SOP) will also be required

• The accountable officer, and other nominated people, have power to enter GP premises to inspect stocks and records of controlled drugs. Notice of inspection does not have to be given.

Action points

implementation

• Find out who the accountable officer is in your PCT

• Ensure you have an accurate controlled drugs register

• Ensure controlled drugs are stored securely• Have a clear written SOP in place that is known, understood and followed by staff

• Ensure you have appropriate disposal and destruction procedures

• Keep up to date on controlled drugs issues (see website links)

• Report any controlled drugs incident you were involved in to your PCT accountable officer• Report any concerns involving controlled drugs to the PCT

• Ensure staff are appropriately trained and understand roles and responsibilities in relation to controlled drugs.

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