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Some prescription medicines are controlled under the Misuse of Drugs legislation and are known as controlled medicines or Controlled Drugs (CDs). CDs are essential in modern clinical care. They include drugs such as diamorphine that are used in a wide variety of clinical treatments, including the relief of acute and chronic pain, end of life treatments or as part of the treatment of substance misuse. Other medicines, such as sleeping tablets, steroids and growth hormones, are also CDs but subject to less stringent controls under the legislation.
Strict legal controls apply to CDs to prevent them being obtained illegally, causing harm or being misused, and controls must be in place to ensure they are correctly produced, supplied, stored and prescribed. The Misuse of Drugs Regulations include five schedules that classify all CDs. Schedule 1 has the highest level of control, but the drugs in this group are virtually never used in medicines, and Schedule 5 has a much lower level of control.
One of the areas the CQC inspection team looks at is caring for people and protecting them from harm. Under Outcome 9: ‘People should be given the medicines they need when they need them, and in a safe way’. Also, one of the things that the CQC has to do each year is produce a report on CDs. There are, of course, much stricter controls now around the use and possession of CDs, particularly since the case of Dr Harold Shipman, who used quantities of CDs to kill patients in his care. Much of Britain's legal structure concerning healthcare and medicine was reviewed and modified as a direct and indirect result of Shipman's crimes.
Five schedules of CD’s
The Misuse of Drugs Regulations 2001 divides Controlled Drugs (CDs) into five schedules corresponding to their therapeutic usefulness and misuse potential:
Schedule 1 (Controlled Drug Licence)
- Practitioners and pharmacists may not lawfully possess Schedule 1 drugs except under licence. Examples include cannabis and LSD.
Schedule 2 (Controlled Drugs)
- These drugs must be stored in a locked container and may be administered to a patient by a doctor or dentist, or by any person acting in accordance with the directions of a doctor or a dentist. Examples include morphine and pethidine.
Schedule 3 (Controlled Drugs – no register)
- Most of these drugs do not need to be locked away and do not need to be recorded in the CD register. Examples include midazolam and phentermine.
- These drugs do not need to be locked away. Possession without an appropriate prescription is an offence. Examples include benzodiazepines and anabolic steroids.
Schedule 5 (Controlled Drug – invoice)
- Certain CD’s are exempt from full control when present in medicinal products of low strengths, as their risk of misuse is reduced. Examples include codeine and pholcodeine.
The CQC’s role and responsibilities
The CQC scrutinises how regulators and agencies work, following the Shipman Inquiry report. They observe different aspects of the management and use of controlled drugs and look at national trends in their use, reporting to Government on how organisations work together. The CQC assesses and oversees how health and social care providers manage controlled drugs and works alongside organisations that monitor local intelligence.
The CQC is required to provide annual reports on the safe management of controlled drugs. They found that prescribing trends in 2013 included the following:
- The total number of controlled drugs items prescribed in NHS primary care was 47,044,814, which is a decrease of 1 per cent compared with 2012.
- Private prescribing of controlled drugs decreased by 6 per cent, compared with 2012. Private prescribing accounts for about 0.1 per cent of overall controlled drug prescribing.
- The use of drugs to provide relief for severe and long term pain management has increased.
- The Attention Deficit Hyperactivity Disorder (ADHD) drug, methylphenidate, continued to rise steadily in use from the previous last year. Private prescriptions for this drug increased by 7 per cent in 2013.
Following the CQC’s last annual report they made seven recommendations including that healthcare providers must determine whether they are required to appoint a controlled drug accountable officer or whether they meet the criteria for exemption.
Prescriptions for CDs
Since 2005 there is no longer a requirement for prescriptions for CDs to be handwritten by the prescriber, but they must still be signed. Whenever a CD prescription is collected it must be signed by the patient, or whoever is collecting it on behalf of the patient, so that there is an audit trail. Prescriptions for Schedule 2, 3 and 4 CDs are only valid for 28 days and it is recommended that the maximum quantity issued does not exceed 30 days. Understandably, professional guidance for prescribers advises that they only prescribe CDs for themselves or family members in exceptional circumstances.
- CDs must be stored appropriately and should not be dispensed until the person comes to collect them.
- The CD register and the returned CD register must be kept up to date.
- Individual medication in stock should match the recorded amount in the CD book.
- Where CDs are returned, records must show it was appropriately destroyed by one authorised member of staff and witnessed by another member of staff.
- Out of date stock must be destroyed by an approved person.
Further guidance about CDs can be sought at the following links, and the QCS GPC11 – Medicines Policy and Procedure provides guidance about prescription medicines and other drugs used within the practice.
CQC – Controlled Drugs
What is a controlled medicine (drug)?
Controlled Drugs (Supervision of management and use) Regulations 2013