Controlled drugs and the law

The Legislation

The management of Controlled Drugs, including opioids and gabapentinoids, is governed by two key sets of legislation, the Misuse of Drugs Act 1971 and supporting regulations (Home Office legislation) and The Controlled Drugs (Supervision of Management and Use) Regulations 2013 (Department of Health legislation). The main purpose of the Misuse of Drugs Act is to prevent the misuse of Controlled Drugs by imposing restrictions on their possession, supply, manufacture, import and export. The Department of Health regulations set out strengthened governance arrangements for Controlled Drugs used as medicines. 


Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001

Drugs controlled under the Misuse of Drugs Act 1971 are those that have the potential to be misused and they are classified according to their assessed harmfulness: Misuse of Drugs Act 1971.

Many Controlled Drugs are also essential to modern clinical care and their legitimate, clinical use is governed by the Misuse of Drugs Regulations 2001, which categorises them into five schedules based on their therapeutic usefulness and potential harms when misused: The Misuse of Drugs Regulations 2001.

Misuse of Drugs Regulations 2001 amendment for nurse and pharmacist independent prescribers

The Misuse of Drugs Regulations 2001 were amended in 2012 to allow nurse and pharmacist independent prescribers to prescribe any controlled drug listed in schedules 2 to 5 for any medical condition within their competence, with the exception of diamorphine, cocaine and dipipanone for the treatment of addiction. The changes came into effect on 23 April 2012.


The Controlled Drugs (Supervision of Management and Use) Regulations 2013

The Shipman Inquiry was an independent public inquiry set up in 2000 to examine the issues arising from the case of Harold Shipman. The inquiry’s fourth report “The Regulation of Controlled Drugs in the Community” was published in July 2004 and focused on the methods Shipman used to divert large quantities of Controlled Drugs for his own purposes, and considered how he was able to do it for so long without being detected. It concluded that there were serious shortcomings in the systems for regulating the governance of Controlled Drugs. In response, the Controlled Drugs (Supervision of Management and Use) Regulations 2006 were introduced and came into force in England on 1 January 2007. These have now been superseded by the new regulations, the Controlled Drugs (Supervision of Management and Use) Regulations 2013, which came into force on 1 April 2013 to reflect the changes in the NHS: The Controlled Drugs (Supervision of Management and Use) Regulations 2013

Prescriptions for Schedules 2 and 3 CDs can now be sent electronically via the Electronic Prescription Service (EPS) and signed with an Advanced Electronic Signature (AES) as well as handwritten. This follows changes to Home Office legislation on 1 June 2015 and to NHS and Human Medicines Regulations on 1 July 2015.

The Department of Health has also published information about the regulations to support the changes made in legislation: Controlled Drugs (Supervision of Management and Use) Regulations 2013 - Information about the regulations.


    The Role of the Controlled Drugs Accountable Officer

    The 2013 regulations require healthcare organisations such as NHS trusts and independent hospitals to appoint a Controlled Drugs Accountable Officer (CDAO) who has responsibility for all aspects of Controlled Drugs management within their organisation. They must ensure that every aspect of Controlled Drugs management is set out in appropriate and up–to–date standard operating procedures and that these are followed in practice. This does not only include procurement and storage arrangements but also monitoring and oversight to ensure safe practices are in place for prescribing and administration; that Controlled Drugs are used appropriately; that relevant individuals are trained and that there are effective routes for reporting controlled drug related concerns.

    Each area team of NHS England is also required to appoint a lead CDAO with responsibility for controlled drug concerns across their geographical area. As part of this responsibility, all the CDAOs within their geographical area are required to submit to them a quarterly occurrence report of controlled drug incidents from within their organisation so that the Area Team CDAO can identify trends of concern.

    For the purpose of sharing controlled drug concerns and good practice initiatives , the area team CDAOs are required to set up Controlled Drugs local intelligence networks (CD LINs) for their area. Whilst they can determine the specific membership, it is largely comprised of the CDAOs across the area, Clinical Commissioning Group representatives and the relevant regulators and agencies as set out in the regulations.

    Details of all CDAOs in England are held in the Controlled Drugs Accountable Officer register, which is published on the Care Quality Commission website.

    Not all healthcare organisations are required to appoint a CDAO, however, those organisations that fall outside of the 2013 regulations must still comply with the Misuse of Drugs Regulations and must have arrangements in place to ensure the safe and secure management of Controlled Drugs and the reporting of controlled drug concerns. To achieve this, they should consider nominating a lead person to ensure controlled drug governance arrangements are in place within their organisation.


    Opioids and driving

    New drug driving legislation came in to force in England and Wales in 2015

    • It remains illegal in England and Wales to drive when taking prescription medicines if the medication impairs a patient’s ability to drive
    • The new offence refers to driving with a specified controlled drug in the body, in excess of a specified limit
    • The drugs include licensed medicines, including morphine and methadone but not other opioids. The specified limits are generally above the normal therapeutic range so most patients prescribed these drugs are unlikely to be driving with a concentration of a specified drug in their body above the specified limit.
    • The new offence has a statutory “medical defence” to protect patients who may test positive for certain specified drugs taken in accordance with the advice of a healthcare professional or the patient information leaflet that accompanies the medicine
    • It remains the responsibility of all drivers, including patients, to consider whether they believe their driving may be impaired on every occasion when they drive
    • Drivers who tested positive for morphine were between 8 and 32 times more likely to be injured or responsible for a road traffic collision compared with those who did not have a positive test result.
    • A patient on high dose morphine (around 200mg/24hours) could be as impaired as someone with blood alcohol around the level above which it is illegal to drive.
    • A patient also drinking or taking other sedative drugs could be impaired at a lower morphine dose.
    • Patients should be aware that during the period following dose adjustment (up or down) they may be particularly vulnerable to impairment.
    • Prescribers of opioid medicines must be aware of the likely impairing effects of the drugs and must advise patients accordingly.
    • Although this legislation will particularly impact on patients taking morphine, prescribers should be aware that equi-analgesic doses of other opioids are likely to be equivalently impairing.
    • Prescribers should also advise patients of the potentially distracting effects of pain, and other co-morbidities such as fatigue and poor sleep in relation to driving.
    • Discussions in relation to drugs and driving must be clearly documented in the medical notes and a copy given to the patient.


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