Controlled drugs

Abstract

A controlled drug (CD) is a prescribed medication that is governed by the Misuse of Drugs Legislation. This article will explore the legislation and governance surrounding CDs with a focus on how these are prescribed and monitored in primary care; it will also highlight significant untoward incidents related to CDs.

The GP curriculum and controlled drugs

Clinical module 3.14: Care of people who misuse drugs and alcohol states that GPs should:

Be aware of common long-term effects of drug and alcohol misuse including reasons for drug-related deaths

Recognise the widespread use and associated health impacts of performance- and image-enhancing drugs, such as anabolic steroids, and newly synthesised drugs, such as ‘legal highs’

Demonstrate approaches that balance the needs of individual patients with the health needs of the local community, within available resources

Always be aware of possible drug- or alcohol-related problems with almost any presenting problem or prescribing issue

Understand the varying degrees of drug and alcohol use and their implications for future management

Make sure that repeat prescriptions are monitored for long-term prescribing of addictive drugs and appropriate action taken if this is happening

Work in partnership with the wider primary healthcare team including pharmacists, specialist services, the voluntary and criminal justice sectors

Implement the evidence-based treatments for opiate substitution

Be aware of the developing government policy on drug and alcohol treatment

Understand how the Misuse of Drugs Act (1971) affects drug users

What are controlled drugs?

Controlled drugs (CDs) are medications with stricter legal control over how they are prescribed, stored, produced and supplied, due to their ability to cause harm and potential to be misused (NHS Choices, 2015). They are an essential part of clinical care, with uses ranging from pain relief in palliative and obstetric care to mood stabilisers in psychiatry. In the 2016 Care Quality Commission (CQC) report, it was found that over 60 000 000 controlled drug items were prescribed in primary care: the most common being tramadol, zopiclone, diazepam, co-codamol and codeine, which amounted to a total cost of £526 941 061. However, this did not take into account the quantity on a single prescription with some patients being prescribed very large doses of CDs to manage their pain (CQC, 2017).

Controlled medicines are classified based on their benefit when used in medical treatment and their harm if misused (Table 1). The Misuse of Drugs Regulations include five schedules that classify all controlled medicines with Schedule 1 having the highest level of control, but drugs in this group are not usually used as medicines (NHS Choices, 2015).

Table 1.

Different schedules of CDs.

Schedule	Notes	Examples
1	• Most of these drugs have no medicinal use • Practitioners and pharmacists not allowed to possess unless licensed by Home Office	• Includes hallucinogenic drugs, e.g. lysergide and other ‘legal highs’, e.g. benzofuran
2	• All drugs obtained and supplied must be kept in a register and stored in a locked receptacle	• Includes more than 100 drugs such as opiates, major stimulants and amphetamine
3	• Substances open to abuse but less likely to be so than Schedule 2 CDs. Majority are exempt from safe custody requirements	• Includes synthetic opioids, temazepam, tramadol
4	• Possession of Part 1 drug requires an appropriate prescription. No restriction on possessing Part 2 drug when it is in the form of a medicinal product	• Part 1: Most benzodiazepines, zopiclone, zolpidem • Part 2: Anabolic steroids
5	• Certain CDs available over the counter in registered pharmacies • Exempt from safe custody requirements	• Includes preparations of certain CDs, e.g. codeine, dihydrocodeine, morphine

Source: NHS England (2013).

Legislation

In 2007, The Controlled Drugs (Supervision of Management and Use) Regulations 2006 was introduced to strengthen governance in the use and management of CDs in England and Scotland (see Fig. 1). In Wales and Northern Ireland, The Controlled Drugs (Supervision of Management and Use) Regulations 2008 came into force in 2009. After the Health and Social Care Act was passed in 2012, these regulations were revised, resulting in the 2013 regulations with which GP practices need to be compliant (NHS England, 2013). An operating model was drafted to outline Area Team responsibilities.

Figure 1.

Agencies involved in regulation and control of CDs.

NHS England

It is the responsibility of NHS England to ensure that systems are in place for the safe and effective management and use of CDs (Fig. 1). This includes governance arrangements for the conduct of the lead Controlled Drugs Accountable Officers (CDAOs) and determining how many Local Intelligence Networks there should be in England and how many lead CDAOs are required to cover them. CDAOs are senior managers who address concerns or incidents related to inappropriate or unsafe use of CDs. They have the authority to visit a practice unannounced to review the storage and records of CDs (Medical Protection Society, 2017; NHS England, 2013).

Medicines Act 1968

The Medicines Act 1968 authorises the manufacture, distribution, sale, labelling and advertising of CDs across the UK. It also allows exemptions on sale, supply and administration of medicines, e.g. midwives supplying pethidine. Healthcare professionals are permitted to do this under a Patient Group Direction (National Prescribing Centre, 2009).

Misuse of Drugs Act 1971

The Misuse of Drugs Act 1971 controls the availability across the UK of harmful drugs that can potentially be misused. Drugs are divided into Classes A, B and C, based on the level of harm when misused in descending order of severity (National Prescribing Centre, 2009).

Misuse of Drugs Regulation 2001

The Misuse of Drugs Regulation 2001 defines the classes of people authorised to possess or supply CDs and divides them into five schedules. The schedule within which a CD is placed depends on the balance between its therapeutic benefit and harmful effects when misused (Table 1) (UK Government, 2001).

Case study 1: Recognising misuse.

A 32-year-old female patient with pregabalin on repeats attends the practice on multiple occasions requesting prescriptions of pregabalin, dihydrocodeine or codeine and repeatedly claiming that she has lost her previous scripts. She has seen various GPs and practice pharmacists; the potential for misuse was only picked up when she had her medication review. The practice pharmacist noted that she was under the local drug and alcohol misuse team and was on a buprenorphine patch for treatment of dihydrocodeine abuse (which had not been communicated to the practice) and had also attended various hospitals/walk-in clinics to obtain prescriptions. This had been missed by previous healthcare professionals as it had never been read coded in her records.

Learning point: This was written up as a significant event and discussed at the practice meeting, which resulted in a protocol for prescribing CDs being devised. It is important that there is effective communication between agencies involved in prescribing CDs.

Prescribing CDs

Practices need to have systems and processes in place for risk assessment, adequate record keeping, reporting CD- related incidents and monitoring trends. They should have a protocol for the management and handling of CDs in accordance with Department of Health guidance (Medical Protection Society, 2017).

CD prescriptions may be computer-generated, but the signature has to be in the prescriber’s own handwriting. The NHS Security Management Service recommends that if an error is made, best practice is for the prescriber to cross out the error, initial and date the error, then write the correct information (National Prescribing Centre, 2009). If an adhesive label is used, prescribers should also sign the label to prove it has not been tampered with.

A prescription for Schedule 2 and 3 CDs (with the exception of temazepam and preparations containing it) must contain the following details:

The patient’s full name, address and, where appropriate, age

The name and form of the drug

The strength of the preparation, where appropriate (if more than one strength exists)

The dose

The total quantity, or the number of dose units to be supplied, in both words and figures

Signed by the prescriber with their usual signature (this must be handwritten) and dated by them (the date does not have to be handwritten). Prescriptions for medicines in Schedules 2, 3 and 4 are valid for only 28 days.

CD register

Any practice storing CDs should have a CD register (e.g. bound book or electronic form) which must be kept for 2 years and a separate book must be held for branch surgeries. In the book, a separate sheet must be used for the strength and form of each drug. You must record (Medical Protection Society 2017):

The date the supply was obtained

The name and address from whom it was obtained, including the quantity of ampoules

To ensure accuracy, it is best practice to record:

^ Running balances of each drug

^ The prescriber’s identification number and/or the professional registration number of the prescriber

Stock checks

The practice should undertake regular stock checks, ideally by two healthcare professionals. Both should initial the entry if a book is used. Any discrepancies should be investigated and recorded in the CD register correcting the discrepancy in the balance. There should be visual inspection of liquid balances, periodic volume checks, and checks to confirm the balance on completion of a bottle. Keep a record of the action taken when a discrepancy occurs. If you cannot resolve the discrepancy, inform the CDAO (Medical Protection Society, 2017).

Doctors’ bags

When obtaining controlled drugs for use in the community, health professionals in primary care must use the approved mandatory form for the requisitioning of controlled drugs in Schedule 2 and 3, in line with Regulation 14 of the 2001 Regulations (Medical Protection Society, 2017).

If a GP wishes to carry CDs in his/her bag, a staff member should witness the GP stocking the bag from the CD stock and record an entry in the CD register. The CDs should be stored in a lockable receptacle, which can only be opened by the person to whom the regulation applies. A digital combination lock is a convenient solution. Bags containing CDs should not be left in a vehicle overnight, or for long periods of time. Each doctor must keep a register for the CDs carried in their bags. The GP is responsible for those drugs (Medical Protection Society, 2017).

Administration of a CD to a patient should be recorded in the doctor’s CD register. If a CD has expired, the GP should return it to the practice stock awaiting destruction. This should be recorded in both registers. If there is no practice stock, then the expired CD needs to be destroyed directly from the bag and witnessed by an authorised person. A record should be made.

Case study 2: Illegal selling of CDs.

An anonymous caller rings the practice claiming that one of the patients with a history of drug misuse (who is getting weekly scripts of diazepam, oramorph and zopiclone) is selling these drugs to minors. In response, the on-call GP contacts the Medical Defence Union (MDU) and subsequently the police. The MDU advises that the patient be informed of this allegation and that the partners need to have a plan in place for issuing medications to this patient.

Learning point: Complex scenarios involving legal matters may arise when prescribing or supplying CDs, so it is important to get advice from your MDU before taking action.

History taking

Patients who are being managed for chronic pain need to have a clear diagnosis in place, which should be coded if possible. The patient should be managed as per the World Health Organisation pain ladder. There should be an assessment of pain and function at diagnosis (Box 1). There should also be an assessment of the risk of drug misuse (Box 2).

Box 1.

Pain assessment.

Q1: What number 0–10 describes your pain in the last week (0 = no pain, 10 = worst possible pain)

Q2: What number 0–10 describes how your pain has affected your enjoyment of life (0 = no impact, 10 = max impact)

Q3: What number 0–10 describes how your pain has affected your general activity (0 = no impact, 10 = max impact)

Box 2.

Assess risk of harm/abuse.

Check for:

• History of overdose

• History of suicide attempt

• History of addiction

• Taking benzodiazepine, hypnotics, other opioids

• Depression/mental health disorders (are they controlled)

• Non-prescribed drug history (e.g. over-the-counter codeine, illicit drugs)

• Social history – lives alone, any children, social support, smoking, alcohol use

If any of the above exist:

• There needs to be a clear evaluation of risk vs benefit

Shared plan

Realistic goals need to be set for pain control and everyday function based on diagnosis. Discuss benefits, side effects and risks of treatment. Set criteria for stopping, continuing and reviewing therapy. Check the extent of the patient’s comprehension of the situation. Consider if non-opioid therapies and lifestyle intervention are appropriate for the patient.

Prescribing interval

If there is no risk of misuse, then a maximum of 1 or 2 month’s supply can be prescribed. This will need to be assessed on a case-by-case basis. If there is a risk, each patient needs to have a tailored plan and a maximum of 1 month’s supply. However, there needs to be consideration of shorter supply, and for those with high risk it is advised to issue 7–14 days post-dated prescriptions. Patients newly initiated on prescribed analgesics should be reviewed within a month and no further supplies should be given without this review.

Points to consider during medication reviews

Check compliance and assess pain, as well as risk of drug misuse. Review the prescribing interval and have an agreed management plan with a set review date. It is also important to check renal function when using opioid medication, if the estimated glomerular filtration rate is low, then the potential for drug toxicity is high.

Case study 3: End of life prescriptions.

The GP prescribes an end of life drug; however, the prescription does not meet all the requirements to prescribe that CD, resulting in the pharmacist being unable to issue the medication. This results in a significant delay in the patient obtaining the drug.

Learning point: It is important to ensure that you are familiar with the requirements for prescribing CDs and that any patients requiring high doses on a regular basis (such as palliative patients) have frequent reviews.

KEY POINTS

Prescriptions for Schedule 2 and 3 controlled medicines (except temazepam) must include specific details about the medicine, such as its name and what form it is in, strength and dose and total quantity of doses, shown in both words and figures

Prescribers should regularly review patients’ clinical needs to avoid overprescribing

Patients with drug misuse issues should have it clearly documented in their notes

During medication reviews, it is important to assess compliance, symptoms, risk and agree a plan with the patient

References

CQC (2017) The safer management of controlled drugs. Available at: www.cqc.org.uk/sites/default/files/20170718_controlleddrugs2016_report.pdf (accessed 22 September 2017).

Medical Protection Society (2017) Risk alert: Controlled drugs. Available at: www.medicalprotection.org/uk/practice-matters-issue-7/risk-alert-controlled-drugs (accessed 22 September 2017).

National Prescribing Centre (2009) A guide to good practice in the management of controlled drugs in primary care (England). Available at: www.webarchive.org.uk/wayback/archive/20140627111125/http://www.npc.nhs.uk/controlled_drugs/resources/controlled_drugs_third_edition.pdf (accessed 3 October 2017).

NHS Choices (2015) What is a controlled medicine (drug)? Available at: www.nhs.uk/chq/Pages/1391.aspx?CategoryID=73 (accessed 5 October 2017).

NHS England (2013) The Controlled Drugs (Supervision of Management and Use) Regulations 2013. NHS England single operating model. Available at: www.england.nhs.uk/wp-content/uploads/2013/11/som-cont-drugs.pdf (accessed 14 October 2017).

RCGP. Clinical module 3.14: Care of people who misuse drugs and alcohol. Available at: www.rcgp.org.uk/training-exams/gp-curriculum-overview/online-curriculum/managing-complex-care/3-14-drugs-and-alcohol-misuse.aspx (accessed 18 September 2017).

UK Government (2001) The Misuse of Drugs Regulations 2001. Available at: www.legislation.gov.uk/uksi/2001/3998/introduction/made (accessed 23 October 2017).