The safer management of controlled drugs: Annual update 2024

Post Implementation Review of the 2013 Regulations

The Department of Health and Social Care and the Scottish Government conducted a Post-Implementation Review of the 2013 Regulations. A report with the findings of the review will be published on www.legislation.gov.uk. The review reflects on the original policy objectives and whether the regulations are still achieving their intended objectives. The department engaged a range of stakeholders across different sectors to inform the review.

Impact of changes to NHS England

In March 2025, the government announced that NHS England would be re-integrated into the Department of Health and Social Care. This will have an impact on delivering the national controlled drugs accountable officer (CDAO) function and therefore the oversight of governance and safety of controlled drugs across the health and social care landscape.

Currently, each NHS England region has its own CDAO, assisted by a support team. This dedicated role was set out in the 2013 regulations and includes an element of contributing to medication safety more widely than just controlled drugs. There is no similar role elsewhere in the health and care system. Although CDAOs in designated bodies have clear roles and accountabilities in relation to controlled drugs, NHS England regional CDAOs have a crucial role in monitoring, promoting and ensuring their safe use across organisational boundaries, and in sharing learning and intelligence that would not otherwise be available to those with a remit in controlled drugs.

We recognise the value of the role of NHS England CDAOs. We have found they deliver the function and fulfil their duties effectively within the current structure, which comprises both dedicated national co-ordination and regional CDAO leadership. Importantly, this means they support local intelligence networks to function effectively, which is crucial to reducing the risks around the use and management of controlled drugs.

Where CDAO roles are split or shared with other roles, such as in designated bodies, we often see that the lack of time and workload pressures mean that controlled drugs do not always get the appropriate focus needed. This is because in designated bodies, roles such as a chief pharmacist, medical director or chief nurse are often also given the role of CDAO.

In 2006, when the first iteration of the Safer Management and Use regulations were introduced, the national controlled drugs function was spread across primary care trusts. In practical terms this meant that the function was diluted, and it was not as effective in identifying, sharing or acting on incidents or concerns, nor was it as consistent as the current function.

With the impending changes to NHS England, it is important to include the learning from how this crucial function was delivered previously. It is also an opportunity to ensure that teams with the CDAO oversight function have appropriate and consistent resource and capabilities to carry out their statutory functions.

National datasets on controlled drugs prescribing

Controlled drugs prescriptions that are written or produced by prescribers in England may be dispensed in other countries, such as Scotland, Wales and Northern Ireland. This includes private prescriptions. Currently, there is no UK-wide picture of prescribing and dispensing occurring ‘across borders’. This gap in data means that it can be difficult to gather a wider view of risk.

It’s important that the relevant organisations and bodies work together to enable a better understanding of:

• the different processes for managing prescriptions
• what information is available and can be shared
• how this could help to build a better picture of risk across the UK.

‘Corridor care’

We have heard about concerns resulting from a lack of capacity in hospital settings in relation to managing controlled drugs, and people’s medicines more generally, when care is being provided in areas outside wards or emergency departments.

Some services have proactively considered how to support staff and patients to manage their medicines in these settings. This is both to ensure they get essential medicines on time, and to minimise any risks around theft and diversion.

Home Office licences

If your service handles stocks of controlled drugs, you might need to have a Home Office controlled drugs licence. The Home Office Drugs and Firearms Licensing Unit (DFLU) issues these licences.

We receive questions from services in relation to controlled drugs licences and have worked with the Home Office Controlled Drugs Licensing Team to produce an information guide on how to apply for a licence.

Legislation update

The Human Medicines Regulations 2012 were amended in December 2024 to improve access to naloxone (a prescription only medicine) for use in life saving emergencies. Naloxone is used in diagnosing and treating acute overdose or intoxication from both natural and synthetic opioids.

Previously, only drug and alcohol services were able to supply naloxone without a prescription. Now the regulations have been expanded to allow more services and healthcare professionals to supply naloxone to take away without prescription.

Services that intend to supply naloxone must ensure that the staff are trained and competent to store and supply it.

The changes to the law mean that people in the following roles and types of services can supply naloxone to someone without a prescription if they have been sufficiently trained in storing and supplying naloxone products:

• anyone employed or engaged in providing drug treatment services
• pharmacists, pharmacy technicians, nurses, midwives, paramedics
• anyone employed or engaged in providing medical services for the armed forces
• police forces in England, Wales, Scotland, and Northern Ireland
• people working in prison services, probation services and youth justice services

More detailed guidance is available on this, including who can supply naloxone and examples of circumstances in which it may be appropriate to do so.

Designated bodies: Board-level oversight of controlled drugs

Last year, we highlighted the importance of having board-level oversight of controlled drugs in designated bodies. To support this, we worked with NHS England Controlled Drugs Accountable Officers to deliver a webinar on considerations and good practice for boards.

Controlled drug self-assessment tool for care homes

We now provide a self-assessment tool for care homes to support staff to safely manage controlled drugs. Staff can download this from our website and use it anonymously, as we do not have access to details of users. We welcome your feedback to help develop and improve the tool. You can email medicines.enquiries@cqc.org.uk with any questions or feedback about the tool.

• Download self-assement tools from our Controlled drug accountable officers page

Destruction of controlled drugs

We are receiving more enquiries about who can be authorised to destroy controlled drugs in services defined as designated bodies under the 2013 Regulations. Specifically, services that also have a Home Office controlled drugs licence have asked whether their CDAO can appoint an authorised witness who is not named on their licence.

Our understanding of the law is that the CDAO can do this. Preventing services from doing this would lead to an accumulation of stocks of controlled drugs awaiting destruction and the associated risks. We have heard specific examples of this issue leading to increased risks of patient harm and diversion in the last year. Any person authorised to witness destruction should have appropriate training and follow appropriate governance arrangements.

Controlled drugs outside the remit of human healthcare

Over the last few years, we have consistently highlighted the importance of ensuring appropriate support for health and care staff. We continue to hear about cases where staff who are under pressure and emotional distress have inappropriate access to controlled drugs. Although our regulatory remit concerns healthcare for people, we have heard about tragic cases where veterinary staff have procured controlled drugs intended for animal use, with fatal consequences.

It is important to highlight that veterinary staff may also require support and may well need this from the health and care system. We highlight this issue in the Controlled Drugs National Group, of which the Veterinary Medicines Directorate is a member.

Prevention of Future Death Reports

In 2022, we highlighted learning about controlled drugs safety in Prevention of Future Death Reports, sometimes called a ‘Regulation 28 Report’, issued by Coroners. This year, we looked at alcohol, drug and medicines-related reports from January 2023 to December 2024.

The following describes a range of themes that we found, which we are sharing to highlight the risks associated with controlled drugs.

Communication

A recurrent theme is the lack of effective communication between healthcare providers and patients – both within care settings and across boundaries of care. Several deaths have been attributed to not sharing or adequately communicating information in a timely way, such as:

• changes in medicines
• patient histories
• risks associated with specific drugs.

The failure to update and share critical medicines information across care settings is a significant risk to patient safety. Health and care systems need to ensure seamless communication and accurate record-keeping, particularly when managing controlled drugs.

Assuming drug seeking behaviour

Prescribing controlled drugs carries the risk of misuse, which puts healthcare professionals in the difficult position of determining whether a patient's request is genuine. Assuming drug-seeking behaviour without thoroughly reviewing a patient's history has resulted in serious consequences, including:

• inadequate disease management
• delayed treatment
• unnecessary suffering.

We have seen cases where dismissing legitimate medical needs can worsen physical and mental health, potentially leading to self-harm or suicide.

Poor pain management

In some cases, people have died after taking extreme measures to manage their pain, such as doubling their prescribed doses without guidance from a clinician. It is important that people’s care is well-structured, regularly reviewed, and includes a pain management plan to prevent unsafe self-medication and reduce the risk of overdose or other severe complications.

Lack of fail-safes in prescribing and dispensing

Numerous cases in Regulation 28 reports involved issues with prescribing and dispensing controlled drugs. For example, duplicate prescriptions or oversupply of medicines went undetected. One patient with a history of opioid misuse was prescribed a controlled drug by their GP. The patient regularly sought additional emergency supplies from various pharmacies and GP surgeries, exploiting the lack of real-time communication and flagging mechanisms.

This allowed the patient to acquire excessive quantities of opioids, contributing to their accidental overdose.

Polypharmacy and inappropriate drug combinations

Prescribing multiple medicines has contributed to several deaths, particularly central nervous system (CNS) depressants for people who were already on opioids.

In one case, a patient was prescribed a combination of benzodiazepines, opioids, and other CNS depressants, leading to respiratory depression and overdose. Despite this combination posing a significant risk, there was no consideration of the potential for dangerous drug interactions, no formal review of the patient's medicines, and the risks of polypharmacy were not communicated to the patient. This lack of proactive monitoring and review contributed to the patient’s death.

It is vital to implement regular reviews of medication regimens, particularly for patients on long-term prescriptions or those receiving medicines that are more likely to be misused.

Providers need to establish clear guidelines to manage polypharmacy-related risks.

Deviations from policy and procedure

Many deaths resulted from a failure to adhere to established clinical guidelines and policies that are designed to prevent errors. The improper administration of drugs and the failure to follow proper protocols for monitoring vital signs were contributing factors in several cases. Similarly, there were instances where we identified a lack of clear treatment plans or medicines reviews for vulnerable patients, particularly those with a known history of substance use.

Providers should reinforce the importance of adhering to clinical guidelines, policies, and safety protocols, particularly in the administration of controlled drugs and in the care of groups of people in more vulnerable situations.

Controlled drugs governance and management in non-designated bodies

Designated bodies are required under the 2013 regulations to have a CDAO. However, a wide range of organisations still prescribe and/or handle controlled drugs in their day-to-day work but do not meet the definition of a designated body.

These organisations should ensure they have a nominated person as a lead for controlled drugs, to enable relevant focus on governance and oversight, ultimately helping to ensure safe care for people.

Controlled drugs liaison officers

Last year, we reported concerns on resourcing for the Controlled Drug Liaison Officer Role (CDLO) across the 43 police forces. This situation remains stable with a number of forces having now filled vacancies or having plans to do so, but it needs to be monitored. We are aware that consistency and function of the CDLO role across the country is being examined and discussed nationally.

CDLOs remained concerned regarding the use and endorsement of ‘cards’, which can suggest that patients are in lawful possession of cannabis-based products for medicinal use (CBPMs) even though they do not have a prescription issued by a specialist doctor. The Association of Police Controlled Drug Liaison Officers (APCDLO) is developing guidance on CBPMs to support police officers and staff, which will hopefully be endorsed by the National Police Chiefs Council.

The APCDLO is also committed to raising its profile within the Police Service and welcomes the support of healthcare partners.

Currently, there is no published cost, or estimation of cost, attributed to the annual diversion of controlled drugs in the UK. In 2013, government statistics showed that organised crime cost the UK £24 billion each year; having better data on controlled drugs diversion would help to ensure national resources are appropriate to the risk.

Statutory notifications

Registered providers must tell CQC about certain safety incidents. The registered person should record the action taken on the relevant notification form. There is no requirement to notify CQC about medicines errors, but you must tell us if a medicines error has caused:

• a death
• an injury
• abuse, or an allegation of abuse
• an incident reported to or investigated by the police.

This includes where any of these have been caused by a controlled drug. We know that these incidents are not always reported to us, and we encourage services to report any instances associated with controlled drugs that meet these thresholds to us as soon as possible.

Cannabis-based products for medicinal use

Cannabis-based products for medicinal use (CBPMs) are Schedule 2 controlled drugs under the Misuse of Drugs Regulations 2001. They can be prescribed by, or under the direction of, a doctor who is on the specialist register of the General Medical Council to treat patients on a case-by-case basis for an unmet clinical need.

During 2024, we continued to register clinics in the independent sector that provide treatment with CBPMs. At the time of publishing, 35 providers that prescribe unlicensed CBPMs were registered with CQC.

Over the last year, we have seen instances where providers have not always communicated treatment plans and information on prescribed CBPMs in a timely way with other healthcare professionals involved in a person’s care. It is vitally important to share information effectively with people’s regular prescribers (normally their GP) to keep them safe. In some cases, this may also include liaising with secondary care and other independent services.

As in previous years, almost all prescribing of CBPMs continues to be in the independent sector (figure 1).

Figure 1: Number of private unlicensed CBPM items prescribed in England, April 2023 to March 2024

Prescriptions for CBPMs are processed manually because CBPMs are not included in the Dictionary of medicines and devices. This means there is a time lag in the prescribing data available. The most current available prescribing data for unlicensed CBPMs in independent services has shown an increase of 130% between 31 March 2023 and 31 March 2024:

• 1 April 2022 to 31 March 2023: 150,527 items dispensed
• 1 April 2023 to 31 March 2024: 346,600 items dispensed.

Figure 2 also shows the 5-year trend of prescribing, with a steeper increase in the last 3 years.

Figure 2: Number of private unlicensed CBPM items prescribed in England, April 2020 to July 2024

This data relates specifically to prescriptions dispensed in a community setting.

As in previous years, we are not able to publish the data for NHS prescribing of unlicensed CBPMs. This is because the number of items prescribed in the NHS is so small that this could potentially breach patient confidentiality.

Concerns relating to CBPMs

Scope of practice and oversight

The majority of non-medical prescribing for CBPMs is undertaken by pharmacist prescribers. It is important that pharmacists work within their scope of practice, as highlighted in guidance issued by their professional regulator, the General Pharmaceutical Council.

By law, medical specialists must retain oversight of the care of the patient, including prescribing. It is crucial for services that prescribe CBPMs to assure themselves that medical specialists have this oversight in practice and have the time to undertake all duties associated with this.

We remind all providers to advise the relevant NHS England CDAO of any incident or concern that occurs, through the Controlled drug reporting tool.

Unmet clinical need

We continue to hear that services are prescribing for a very wide range of medical conditions – for some of these, there is poor evidence to justify the use of CBPMs. CBPMs must only be prescribed for unmet clinical need. This must be clearly demonstrated before prescribing and recorded in clinical notes.

We note that some services state that to make a patient eligible for CBPMs, they need to have tried 2 previous treatments. It is essential that providers demonstrate unmet clinical need in each person before making the decision to prescribe CBPMs for them. For some people, this may well involve significantly more than 2 previous treatment options.

Peer review of prescribing

During 2024, more smaller providers were interested in prescribing CBPMs. But in some cases, we found that the multi-disciplinary team of GMC registered specialists did not have an appropriate range of specialisms to do this. The general purpose of the multi-disciplinary team is to peer-review and ratify prescribing decisions. It is essential that the team comprises the right specialists to ensure that prescribing decisions are effectively peer-reviewed. For example, if reviewing a patient case involving complex epilepsy, it would not be appropriate for a gastroenterologist with no experience in this clinical area to carry out the peer review.

Providers must notify CQC of certain medicines errors. However, through our inspection activity, we found several examples where this had not happened in cases involving CBPMs.

Advertising

CBPMs prescribed by clinics are unlicensed, prescription-only medicines. This means that providers must operate within the law in any advertising activities. Advertise your medicines guidance from The Medicines and Healthcare Products Regulatory Agency (MHRA) offers useful guidance on this.

If you think a service is inappropriately advertising prescription-only medicines, you can also report this to the appropriate organisation.

Provision of patient information

CDLO colleagues have told us about concerns when clinics do not give patients relevant information about how to prove they are in legal possession of a CBPM. Clinics should offer patients guidance on this when they are prescribed CBPMs. The NHS has published information on this.

Nitazenes and xylazine

Nitazenes

We have previously highlighted the dangers associated with nitazenes, which are synthetic opioids. They remain illicit substances with no clinical value, but colleagues across different sectors report that they are becoming more prevalent, sometimes with tragic consequences for those involved. We are also aware that nitazenes have been detected in some counterfeit medicines.

We therefore reiterate the need to make staff aware of this through the National Patient Safety Alert from the Office for Health Improvement and Disparities. This alert relates to synthetic opioids and the treatment of overdose. It is relevant for organisations whose staff may encounter people who use drugs and those who provide emergency care for opioid overdose, including in health and justice settings.

Xylazine

An amendment to The Misuse of Drugs Act 1971 has classified xylazine as a class C drug. Xylazine is a high-strength sedative used for veterinary purposes. It is increasingly being used illicitly in combination with opioids such as heroin and has also been found in some cannabis vapes.

Drug testing of employees

Drug testing of employees is widely implemented in industries such as transportation and construction due to the significant safety risks involved, aligning with the Transport and Works Act 1992. In contrast, routine drug testing is relatively rare in the healthcare sector in England, as healthcare professionals are not legally mandated to undergo such testing. Typically, healthcare providers do not require routine drug testing for their employees, as they prioritise professionalism, self-regulation, and support and rehabilitation.

Implementing drug testing within health and care settings poses financial and logistical challenges, considering the scale of the workforce. However, individual NHS and private health and care organisations may decide to develop their own policies regarding drug testing as part of employment contracts and workplace regulations.

The approach to drug testing in health and care sectors in England aims to balance patient safety, professional standards, and employment rights. In 2024, there were examples of positive outcomes from drug testing schemes in healthcare settings. These resulted in healthcare staff being able to access support earlier than they otherwise would have, as diversion and addiction was detected sooner. This has also undoubtedly contributed to ensuring that patients have been kept safe.

Individual organisations need to decide whether it is useful and appropriate to introduce drug testing schemes – this is not something that CQC requires. Employers should already ensure they have clear policies on drug and alcohol use in the workplace and provide clear information for staff on how to ask for support or report concerns in relation to these issues.

Further research may be helpful in assessing the potential value of more standardised drug testing policies and the impact on both patient safety and the wellbeing and performance of the healthcare workforce.

Recording medicines in patients’ own homes

The use of controlled drugs in patients' own homes presents a unique governance challenge. Care providers need to carry out a risk assessment and give advice on how to store them safely in the home. This is especially important where there may be family members who are more vulnerable, such as children or those with a history of substance misuse. Patients are able to return unused medicines directly to community pharmacies.

There have been instances over the last year of healthcare professionals visiting patients in their own homes but not recording the administration of controlled drugs. This is not limited to one profession and has included GPs, paramedics and nurses. Ensuring that patients’ records are accurate is not just crucial for safe and effective care, but it also helps guard against inadvertent losses or intentional diversion of controlled drugs.

Any visiting healthcare professional who administers medicines to a person must record this information in the right place, in a timely way.

Self-prescribing of controlled drugs

Prescribing controlled drugs for personal use or to people who are known personally to the prescriber should not happen apart from in the most exceptional of circumstances.

We therefore remind services and healthcare professionals of the standards and guidance from professional regulators, which make clear that this should not happen.

• General Medical Council
• General Pharmaceutical Council
• Nursing and Midwifery Council
• Health and Care Professions Council

Access to prescribing data for independent services

Data relating to prescribing in the NHS is already available to individuals working in NHS organisations. Independent services have told us that they would like access to prescribing data that relates to activity in their organisation, where it exists. This would allow them to further monitor controlled drugs prescribing in their organisation.

We believe there is a need to review how private prescribing data is captured and shared. Wider access to this data should also be explored to promote greater scrutiny of prescribing in the independent sector.

Fraudulent activity and diversion of controlled drugs

Impersonating healthcare professionals

In 2024, there have been cases of people impersonating a range of healthcare professionals, including pharmacists and doctors. When recruiting, it is imperative that employers are vigilant and check all relevant information to be assured of its legitimacy. Among other areas, this includes a person’s professional registration, previous employers and identification documentation. People sometimes use publicly available registers of professionals’ names and registration numbers to claim to be legitimate and gain employment.

Equally, employing organisations must have a process to enable staff to report concerns.

Similarly, when employees leave an organisation, it is important to have a robust process to return any security badges, keys and uniforms to minimise the risk of inappropriate access to controlled drugs.

Switched medication

In some examples of attempted diversion, tablet blisters of controlled drugs have been emptied and replaced with another tablet of similar size and shape containing a completely different medicine, which fits back into the blister pack. Liquid medicine preparations have been diverted and been ‘topped up’ with other liquids so that the volume appears unaltered to avoid detection.

This has helped to conceal the theft of controlled drugs but also puts people at risk of not getting essential medicines that have been prescribed for them, potentially leading to harm. In addition, they could receive a medicine that has not been prescribed, which again could cause harm.

Diversion and electronic systems

Fraudulently producing prescriptions within electronic systems in primary care is still happening. For example, producing a prescription then deleting it, and requesting to ‘re-print’ copies. It is important to ensure controlled and authorised access to electronic systems, as fraudulent activity has not been limited to healthcare professionals, but has extended to support staff, such a prescription clerks working in GP surgeries.

When carrying out audits on electronic systems, staff should be aware of gaps or areas that are more difficult to audit to help identify anomalies or potentially fraudulent activity. This can include paper prescriptions that have been generated and then deleted from a patient’s record or inappropriate access to records of deceased patients.

Sharps bins and diversion

We have heard of instances where used sharps bins have been stolen in order to extract any part-used controlled drugs that may have been disposed of in the bin. In some instances, stolen sharps bins were sealed, and others were unsealed, having been partially used.

Organisations that use sharps bins need to make sure they are managed and secured in a timely way.

Repeat prescribing toolkit

NHS England commissioned a repeat prescribing toolkit to be developed to address recommendation 7 of the National Overprescribing Review. This involved collaborative work between the Royal Pharmaceutical Society and Royal College of General Practitioners. The toolkit aims to help GP practices improve the consistency of repeat prescribing processes supported by training resources.

Millions of patients in England receive their medicines through the repeat prescription process. The National Overprescribing Review, combined with patient feedback, indicated that regular reviews for people who take long-term medicines don’t always happen in a timely way. We know from our inspection activity and reviewing coroners’ reports that this causes harm.

This toolkit is a significant resource as it is the first national good practice guidance on repeat prescribing to be made available in 20 years – and can benefit both patients and services who use it.

Impact of older legislation on patient care and efficient use of resources

Wet signatures

Service providers tell us about the challenges from outdated legislation. For example, there is currently still a requirement for a wet signature when supplying controlled drugs in schedules 2 and 3 for hospitals and for prison services for people being discharged.

In 2023 the Advisory Council on the Misuse of Drugs (ACMD) has recommended that electronic prescribing should be allowed in these settings. However, this has not yet happened. This causes logistical issues, especially for services that operate over large geographical areas. It also leads to instances of delays in supply, and therefore delays to discharge, because of the time and resource required to meet the legislative requirement. Many services have the capability to use secure, auditable systems, with improved safety measures, but are unable to due to legislation. This issue should be prioritised to ensure services are able to operate as safely and effectively as possible, with improved convenience for both patients and staff supporting them.

Good end of life care

In our 2022 report, we talked about the need to ensure good access to medicines at the end of life, and the barriers associated with this. We’re still hearing from the care home sector in relation to the drawbacks of not being able to hold a very small stock of controlled drugs for end of life care, without a Home Office licence. This has also been highlighted by the Royal College of Nursing as an issue that needs to be addressed. Requirements in relation to controlled drugs licences are driven by the Misuse of Drugs Regulations 2001.

Some care homes are not aware that they may be exempt from the need for a Home Office licence if their funding comes from at least 50% charity or public fundings. Others are concerned that it can be difficult to assure themselves that they meet this requirement. Where providers don’t meet this exemption, they can be concerned about the cost of a licence, especially for holding a very small quantity of stock.

In practice, this means that services may often use other processes and supply routes to help provide access to controlled drugs. These are not failsafe and people aren’t always able to access the right medicines on time. They can also represent both an inefficient use of time for health and care professionals and an increased cost, particularly where each person has their own named supply of anticipatory medicines. This may also increase opportunities for diversion.

As we have previously highlighted, good symptom management is a crucial part of end of life care and we know that health and care teams provide excellent work in relation to anticipatory prescribing. Going forward, it is crucial that appropriate government bodies and other national organisations work together to review the impact of current practice on people receiving care, as well as on those supporting them, and how these link to the current requirements of the Misuse of Drugs Regulations 2001.

Good practice and learning

Over the last year, we have heard of a range of good practice initiatives and learning across a range of different settings. The following are some examples.