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The safer management of controlled drugs: Annual update 2020

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We are responsible for making sure that health and adult social care providers, and other regulators, maintain a safe environment for the management and use of controlled drugs in England.

We do this under the Controlled Drugs (Supervision of Management and Use) Regulations 2013.

As part of our responsibilities under the regulations, we report annually on what we find through our oversight. Based on this information, we also make recommendations to help ensure the continuing effectiveness of the arrangements for managing controlled drugs safely in England.

Our findings are important for:

  • all controlled drugs accountable officers (CDAOs) in England and their support teams
  • organisations that manage controlled drugs
  • health and care professionals with an interest or remit in controlled drugs
  • commissioners of healthcare services
  • professional healthcare and regulatory bodies

The data in this annual update relates to the calendar year 2020, but we also include relevant information for the first half of 2021 and cover the period during the COVID-19 pandemic.

Contents

Our oversight activity in 2020

Key issues in 2020

National trends in the use and management of controlled drugs

Concerns discussed at CDLIN meetings

Controlled drug issues we find on inspection

Recommendations

Our oversight activity in 2020

Register of controlled drugs accountable officers

We maintain and publish an online register of controlled drugs accountable officers (CDAOs) across England for those organisations that are registered with us and are required under the 2013 Regulations as amended to have one. These organisations are defined as controlled drug designated bodies under the regulations and are required to notify CQC of their CDAO appointment. We update this register monthly and, at the time of publishing, there are 967 CDAOs listed on the register.

We also provide other information for CDAOs.

NHS England and NHS Improvement regional teams and controlled drug local intelligence networks

In April 2020, NHS England and NHS Improvement (NHSE&I) CDAO teams moved to 7 regions. NHS England appointed a National CDAO Lead to oversee the delivery and governance of the national CDAO function in NHSE&I.

We reported in 2019 that the resourcing of CDAO teams across different regions was inconsistent and, even though these teams have settled into their new regional roles, this remains the case. It is crucial that all NHS England CDAOs are resourced effectively to enable them to continue to deliver their statutory responsibilities.

NHS England regional CDAOs worked collaboratively during 2020, sharing information through regular virtual meetings. The systems for sharing intelligence such as patient alerts, national and local related news and guidance continue to work well. This leads to more consistent messages across controlled drug local intelligence network (CDLIN) meetings. The national controlled drug reporting tool has continued to improve consistency of the information reported and shared at CDLIN meetings.

All CDLINs met at least twice during the year. The pandemic restrictions meant that in-person CDLIN meetings did not take place after March 2020, with subsequent meetings and investigation panels taking place virtually from this time. During the initial response to the pandemic between March and August 2020, NHSE&I did not routinely request occurrence reports from designated bodies to reduce the burden on them. However, incidents and concerns of a serious nature continued to be reported and many designated bodies continued to submit quarterly occurrence reports to NHS England as part of their established governance.

NHSE&I held approximately 60 CDLIN meetings covering all of England throughout the year. We attended 55 meetings along with designated and responsible bodies. They are an effective way to raise concerns and share intelligence and learning, as well as providing valuable networking opportunities for members. Several regions managed to hold virtual region-wide CDLIN learning events, and all CDLINs discussed recent case studies and the impact of the pandemic on members and on their organisation. Many regions now publish controlled drug newsletters for members. Where designated bodies have not attended regularly, NHSE&I CDAOs proactively followed up with those organisations and re-engaged with them.

Controlled Drugs National Group

CQC leads the Controlled Drugs National Group, which met virtually in March, June and November 2020. Membership comprises government departments, key regulators and agencies in England, Scotland, Wales and Northern Ireland with a controlled drug remit.

Key discussion topics included:

  • issues arising from the pandemic
  • cannabis based products for medicinal use (CBPMs)
  • on-going investigations by the Medicines and Healthcare products Regulatory Agency into diversion from the legal supply chain
  • the roll-out of the electronic prescription service (EPS) system

A separate summary of the Controlled Drugs National Group's activity from the past year shows how member organisations contributed to the overall safer management of controlled drugs.

Sub-groups

The operational sub-groups to the National Group also met regularly at virtual meetings during 2020 to address:

  • controlled drug-related policy
  • patient safety
  • thefts and fraud
  • prescribing issues

Membership of the groups comprised:

  • NHSE&I lead CDAOs
  • specialist pharmacists and medication safety officers
  • other government bodies
  • the NHS Business Services Authority
  • chief pharmacists

We also invited other healthcare professionals with relevant expertise where appropriate. The outputs from the groups are shared through our National Group newsletter, published in April, July and December 2020. The circulation of the newsletter continues to grow and now has a readership of around 16,000.

The circulation of the newsletter continues to grow and now has a readership of around 16,000. Subscribe to the National Group sub-group newsletter.

Key issues in 2020

Coronavirus (COVID-19)

Over the last year, we were aware of changes, challenges and risks in the context of controlled drugs in the COVID-19 pandemic.

  • Controlled drugs governance and audits: in some cases, these were condensed to a reduced number of checkpoints and/or reduced frequency. This was considered necessary at the time to enable staff to maximise time with patients. Good governance helps to identify and mitigate potential risks with controlled drugs. This is why we encourage providers to consider governance for controlled drugs as part of their COVID-19 recovery plans.
     
  • Prescribing through remote patient consultations: Many consultations with patients are still held remotely instead of face-to-face in NHS and independent health settings across both primary and secondary care (such as outpatient clinics). It is not possible to know how much this will continue in the future, but we have previously highlighted the risks associated with this type of consultation. We welcome the updated guidance from the General Medical Council, which strengthens recommendations relating to areas of risk with remote prescribing of controlled drugs. Guidance from the General Pharmaceutical Council for pharmacies that provide services at a distance, including through the internet, is also available.
     
  • Use of Electronic Prescription Service: An increasing number of prescriptions are sent through the Electronic Prescription Service (EPS), and this will include prescriptions for controlled drugs. In January 2020, the number of items prescribed using EPS was 74%, and although this fluctuated during the year, in December 2020 use had increased to 89%. As use of EPS progresses, prescribers will not need to hold large quantities of paper prescriptions.
     
  • Medicines for people at the end of their life: There was a continued need for services to have ready access to medicines for people at the end of their life. Through our Provider Collaboration Reviews we saw that many providers have collaborated and worked innovatively to deliver this, including crucial input from the community pharmacy sector.
     
  • Signatures, storage and distribution: The requirement for wet (written, not electronic) signatures for controlled drug prescriptions created practical challenges for providers. In some cases, this caused delays in discharging people from hospital. There was also sometimes not enough controlled drug cupboard space to store larger quantities of controlled drugs. Some providers continue to hold increased stocks of controlled drugs compared with pre-pandemic levels. Delivery drivers were not always trained and assessed as competent (such as volunteers) and audit trails were not always in place.
     
  • Personal protective equipment: Wearing full PPE sometimes made it difficult for staff to make a ‘second check’ on controlled drugs before they were administered. We found that some providers risk assessed their processes and implemented new procedures to support staff with this.
     
  • Unused medicines in care homes and hospices: The Department of Health and Social Care and NHS England and NHS Improvement published guidance to facilitate using patients’ unused medicines in care homes and hospices under certain criteria. Experience of this guidance has been mixed – some services found it useful while others felt it was written without their service type in mind, which made it difficult to use.
     

Controlled drugs in Schedules 4 and 5

There is a lack of national oversight of prescribing Schedule 4 and 5 controlled drugs in the independent health sector. This includes both online prescribing services and independent healthcare provided in clinic locations in England.

Private prescriptions for Schedule 2 and 3 controlled drugs need to be written on a specific prescription form and submitted to the NHS Business Services Authority. This is not the case for Schedule 4 and 5 controlled drugs. This makes monitoring prescribing trends in independent practice difficult, and therefore our ability to understand the scale of potential problems and risks is limited.

Controlled drugs in these lower schedules, for example those containing codeine and dihydrocodeine, can lead to dependence. We continue to hear about instances involving either large quantities or inappropriate prescribing of these medicines that have contributed to individual deaths.

We also hear about theft and diversion of Schedule 4 and 5 controlled drugs. Safe custody does not apply to them and there is no requirement to keep records in a controlled drugs register. This makes it easier to divert them and harder to identify if it does happen. However, we’ve heard examples of good practice across different healthcare settings that helps to address this issue, such as:

  • early auditing of controlled drugs when initial questions or concerns are raised
  • raising the awareness of potential harm associated with these medicines with the staff who handle them
  • robust risk assessments of those with access to the areas where these medicines are stored.

Harm associated with liquid opioids

We continue to receive information about the harms associated with liquid opioids that are for oral (by mouth) use. This includes Schedule 5 liquid opioids, such as morphine oral liquid, 10mg/5ml.

The liquid formulation can make it easy to ingest a large dose quickly, which has resulted in both intentional and accidental overdose.

In some cases, patients have been able to access repeat supplies of these medicines without appropriate review by their clinician.

This underlines the importance of reviews for individual patients, both at the outset of prescribing and on an ongoing basis – including online prescribers. Prescribers and dispensers of opioid liquids also need to think about the importance of providing clear instructions for dosage and how to take these medicines to avoid any confusion for patients.

It is also vital that the dispensing label is appropriately attached to the product so that patients can refer to these instructions as needed.

Guidance on prescribing for chronic pain

In April 2021, the National Institute for Health and Care Excellence published Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain. It represents a step-change in how to manage chronic pain with medicines. The guideline provides a list of medicines that should not be initiated to manage chronic primary pain in people aged 16 years and over, which includes opioids, benzodiazepines and ketamine. It also recommends that gabapentinoids, such as pregabalin and gabapentin, should not be initiated unless part of a clinical trial for complex regional pain syndrome.

This has significant implications for both patients and prescribers across primary and secondary care settings. It will mean that clinicians need to have enough time to speak with patients about their medicines and agree a treatment plan going forward, especially where patients are attempting to reduce or stop taking these altogether.

Sharing learning

COVID-19 has placed unprecedented pressures on staff working across both health and care. Our Provider Collaboration Reviews highlighted that not all teams have yet had the opportunity to reflect on both good practice and concerns. It is important that staff have the opportunity to reflect and contribute to learning from this period, both in terms of when things went wrong and positive experiences. Staff need to be able to share their reflections freely, as part of normal activity, without any negative repercussions. Certain settings, such as NHS trusts, have Freedom to Speak up Guardians to support this process where needed. It is important that learning is shared at system level, and this could be facilitated by CDAOs, CDLINs and Medication Safety Officers.

Sharing information about staff involved in diverting controlled drugs

We are aware of a cross-sector problem of not sharing information about non-registered staff who have been found to be diverting controlled drugs – either for personal or wider use. In many cases, when staff have been dismissed from employment, incidents have not been reported to the police or NHS England controlled drugs accountable officers. The outcomes of investigations are sometimes cited as ‘unresolved’.

This means that any history of diversion is hidden from a future employer, as it will not be evident on a Disclosure and Barring Service check. This is often compounded by the lack of professional registration status, as reporting to the relevant professional regulatory body is another route that helps to flag these concerns.

This means that another organisation could employ a person who is potentially vulnerable and has a history of diverting controlled drugs in a role that requires them to handle controlled drugs as part of their day-to-day work. This has happened in the past and continues to happen. Consequences include harm for those diverting them for personal use, as well as harm to people who eventually have access to them through illegal sources. We must also not forget the lessons learned from the Shipman Inquiry, and that unchecked diversion can also have dire consequences for patients.

Providers need to have the appropriate processes and employment policies to check new staff. It is crucial that employers ask for a CV and references and check their validity and that those who are recruited are appropriate for the role in the context of controlled drugs. Individuals who operate in this way can be mobile across sectors and localities, which employers need to consider. Appropriate information sharing can also enable vulnerable people to access the right support going forward.

Providers also need to be aware of the statutory requirement for sharing information in relation to controlled drugs intelligence under The Controlled Drugs (Supervision of Management and Use) Regulations 2013. The regulations require intelligence sharing among relevant members of controlled drugs local intelligence networks (CDLINs). They have been amended to enable information sharing in the relevant circumstances in light of the General Data Protection Regulation and the Data Protection Act 2018.

Our progress on recommendations from Public Health England’s evidence review

In our 2019 report, we raised awareness of the Public Health England evidence review, Dependence and Withdrawal associated with some prescribed medicines. This addressed opioid medicines for pain, the gabapentinoids, benzodiazepines and z drugs (medicines that act in a similar way to benzodiazepines), and antidepressants.

The review made recommendations for a number of organisations, including CQC. We were asked to use prescribing data to inform our inspections of primary care services. During 2020, we developed prescribing indicators for gabapentinoids and prescribing of multiple psychotropic medicines. There is also ongoing work in relation to both the independent and online health sectors.

We were also asked to consider the availability of accessible information for patients that includes information about the potential harms of medicines. Our key lines of enquiry (KLOEs) support this process. The primary care landscape is diverse and so we speak with providers individually about how they ensure that patients receive high-quality accessible information on this issue.

Transfer of care

Transfer of care with medicines is associated with an increased risk of poorer outcomes for patients. This is no different for controlled drugs and is an ongoing issue, for example with the pathway of care for people receiving treatment for substance misuse. We have heard about issues for people who are prescribed medicines to treat addiction and are admitted to hospital, for example:

  • on admission it is not always ascertained when they last took their medicine
  • the hospital does not prescribe their medicine
  • the hospital prescribes the medicine but does not have it in stock and the patient can’t get timely access to it

In some cases, these issues have resulted in avoidable harm for the patient. This is why we encourage collaboration between medicines optimisation leads across local systems to strengthen communication and flow of information to improve people’s outcomes. Transfer of Care around Medicines (TCAM) projects have been rolling out across England over the last few years. These have aimed to reduce the risks of problems that result when people are discharged from hospital. From February 2021, all community pharmacies must provide the new Discharge Medicines Service. This aims to improve how changes to patients’ medicines are communicated when they leave hospital. Patients can be referred to community pharmacies when they are discharged so they can be supported in the right way for better outcomes.

Disposal of controlled drugs in theatres

Surgical theatres often involve the use of high-strength injectable controlled drugs. Poor adherence to processes for the destruction of controlled drugs leads to an increased opportunity for diversion. For example, at the end of a procedure, partly used vials or syringes of a controlled drug are not always disposed of in a timely way. In some cases, they are also not disposed of properly, resulting in part-filled syringes and vials being retrievable from sharps bins. Providers should ensure they adequately assess and mitigate risks of this issue through good governance.

Cannabis-based products for medicinal use

We have now registered a number of independent clinics that provide treatment with cannabis-based products for medicinal use (CBPMs). This includes providers in both primary and secondary care. Although licensed products are available in the UK, a substantial proportion of prescribing is for unlicensed CBPMs.

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 with a specific unmet clinical need.

Our guidance about our expectations for providers of CBPMs includes what we look at when we register and inspect services.

The pandemic has meant that some providers are more commonly carrying out virtual consultations with patients online. There are specific risks associated with carrying out consultations in this way and providers must assure us that their processes ensure safe and effective care for patients.

In early 2021, the legal complexities associated with medicines and our exit from the EU caused some concern around the continuity of supply among parents of children prescribed a CBPM for epilepsy. The Department of Health and Social Care worked closely with the government in the Netherlands to ensure that this chain of supply has remained in place, and that domestic production of products currently supplied from the Netherlands is established.

Most prescribing of CBPMs remains in independent healthcare. This aligns with the increasing number of independent providers offering prescribing of CBPMs during 2020.

For the first time in our annual update, we include information about use of controlled drugs in secondary care settings. Together with the findings from primary care prescribing, this helps to provide a more complete picture of the use of controlled drugs in England.

Controlled drugs trends in primary care

Note on data: Data on prescribing is collected by an online application, which provides analyses of prescribing data held by NHS Business Services Authority to authorised users. The previous ePACT system (which gives access to prescription data to authorised users) was replaced by ePACT2 in 2017. Data for year-on-year comparisons in this report have been extracted from ePACT2. Some data may differ from previously published data as ePACT2 continually updates.

The prescribing trends for controlled drugs in NHS services are broadly similar each year. We sometimes see fluctuations in trends influenced by prescribing guidance, stock availability and changes to legislation. This year, the COVID-19 pandemic is an additional factor that is also likely to have influenced some of the changes that we report.

During 2020, NHS primary care services prescribed a total of 74,238,303 controlled drug items, which was an increase of 6% compared with 2019. The cost of this was £565,908,615, an increase of 9% compared with the previous year.

This increase in the number of items was larger than usual, most likely because of the rescheduling of the gabapentinoids to become Schedule 3 controlled drugs during 2019. However, if we exclude them, the overall number of items would have decreased by less than 0.5% with an increased cost of 6%.

Overall prescribing of controlled drugs in Schedules 2 to 5 in 2020

We have not seen any considerable variation in the overall prescribing trends of controlled drugs compared with 2019:

  • Schedule 2: up by 2%
    (9,149,292 total items in 2020)
     
  • Schedule 3: up by 19%
    (25,650,246 total items in 2020)
     
  • Schedule 4: down by 2%
    (13,734,624 total items in 2020)
     
  • Schedule 5: down slightly by less than 0.5%
    (25,704,139 total items in 2020)
     

Of all prescribing of controlled drugs in primary care:

  • Schedule 2 accounted for 12%
  • Schedule 3 accounted for 35%
  • Schedule 4 accounted for 19%
  • Schedule 5 accounted for 35%

(Figures add up to over 100% because of rounding)

Patterns of prescribing in primary care

In 2020, of the most commonly prescribed controlled drugs, there was a reduction in prescribing compared with 2019 for:

  • Nitrazepam (Schedule 4): down by 10%
    (382,208 total items in 2020)
     
  • Temazepam (Schedule 3): down by 10%
    (805,609 total items in 2020)
     
  • Co-dydramol (Schedule 5): down by 8%
    (1,631,671 total items in 2020)
     
  • Fentanyl (Schedule 2): down by 7%
    (962,835 total items in 2020)
     
  • Diazepam (Schedule 4): down by 5%
    (4,617,200 total items in 2020)
     
  • Zolpidem (Schedule 4): down by 3%
    (613,051 total items in 2020)
     
  • Dihydrocodeine (Schedule 5): down by 3%
    (1,503,242 total items in 2020)
     
  • Tramadol (Schedule 3): down by 2%
    (5,922,923 total items in 2020)
     
  • Zopiclone (Schedule 4): down by 2%
    (5,023,727 total items in 2020)
     

More notable reductions in prescribing during 2020 include:

  • Pethidine (Schedule 2): down by 37% (11,274 total items in 2020)
  • Diamorphine (Schedule 2): down by 35% (44,637 total items in 2020)

One possible explanation for the diamorphine trend could relate to the supply issues that occurred during 2020.

Of the most commonly prescribed controlled drugs, there was an increase in prescribing in 2020, compared with 2019 for:

  • Lisdexamfetamine (Schedule 2): up by 36%
    (201,611 total items in 2020)
     
  • Pregabalin (Schedule 3)*: up by 6%
    (5,901,856 total items in 2020)
     
  • Methadone (Schedule 2): up by 5%
    (1,848,675 total items in 2020)
     
  • Methylphenidate (Schedule 2): up by 5%
    (1,101,747 total items in 2020)
     
  • Buprenorphine (Schedule 3): up by 4%
    (3,168,805 total items in 2020)
     
  • Lorazepam (Schedule 4): up by 3%
    (1,085,696 total items in 2020)
     
  • Clonazepam (Schedule 4): up by 2 %
    (1,012,667 total items in 2020)
     
  • Morphine (Schedule 2 and 5 preparations): up by 2%
    (5,180,279 total items in 2020)
     
  • Gabapentin (Schedule 3)*: up by 1%
    (5,542,942 total items in 2020)
     
  • Codeine (Schedule 5): up by less than 0.5%
    (5,084,576 total items in 2020)
     
  • Co-codamol (Schedule 5 all stengths): up by less than 0.5%
    (15,068,530 total items in 2020)
     

* Percentage increases for pregabalin and gabapentin are for 9 months of data from April to December in 2019 and 2020, as the 2019 data was for 9 months from April when they became controlled drugs.

We also saw that prescribing for midazolam (Schedule 3) in 2020 was up by 23% (364,639 items) compared with 2019. This is might be linked to the community based treatment of people with COVID-19 at the end of their lives.

Prescribing of Schedule 5 opioids

Schedule 5 opioids continued to account for a substantial number of items prescribed in 2020. The prescribing trends for co-codamol, codeine, morphine sulfate, co-dydramol and dihydrocodeine are broadly similar to 2019 (see the chart). The licence for co-proxamol was withdrawn in 2005, because of a lack of evidence in relation to its effectiveness and concerns around toxicity in overdose. It is still available as an unlicensed medicine. Although co-proxamol prescribing reduced by 28% during 2020, this still equates to a substantial number of prescription items (10,286 items).

The ongoing prescribing trends of these medicines will be of particular interest over the coming years as New NICE guidance recommends these medicines are not initiated for chronic primary pain, and that where little benefit is experienced, patients should be encouraged and supported to reduce and stop taking the medicine where possible.

Ketamine prescriptions in primary care

We have looked at prescribing for ketamine (Schedule 2) in both NHS and independent primary care since 2016. NHS prescribing of ketamine has remained relatively stable between 2016 (1,947 items) and 2020 (1,947 items), with only a small reduction in prescribing in 2017 (1,750 items).

We have seen a slowly increasing number of clinics offering treatments that involve ketamine. The prescribing data echoes this – private prescribing of ketamine remained low between 2016 (12 items) and 2019 (24 items) but increased during 2020 (107 items). Although NHS prescribing of ketamine was spread across different geographical areas, the London area accounted for over 99% of all private prescribing of ketamine in 2020.

Pregabalin and gabapentin

Prescribing trends for pregabalin and gabapentin are of interest, particularly as new guidance from NICE recommends that prescribing them is limited to specific circumstances for chronic pain.

Pregabalin and gabapentin account for 59% of all Schedule 3 prescribing in 2020 and a fifth (20%) of prescribing of all controlled drugs. They were both included as Schedule 3 drugs in April 2019, so 2020 is the first year where we can compare prescribing patterns. To do this, we have compared nine months of data from April to December in both years, as the 2019 data was for nine months from April.

From April to December 2020:

  • combined prescribing of both drugs was up by 3% to 11,444,798 items
  • costs were up by 8% to £46,866,003
  • pregabalin: prescribing by pharmacist prescribers was up by 15%, and by nurse prescribers by 37%
  • gabapentin: prescribing by pharmacist prescribers was up by 59%, and by nurse prescribers by 39%

Although prescribing increased for both pharmacists and nurses, this needs to be viewed both in the context of the pandemic and the overall increase in prescribing by both professions.

Community pharmacist consultation service

The national NHS Community Pharmacist Consultation Service (CPCS) was launched in October 2019. It aims to reduce pressure on primary and urgent care services, including emergency departments and out-of-hours GP services, by referring patients who need advice, treatment and urgent repeat prescriptions to community pharmacies. Certain controlled drugs may be supplied in specific circumstances for a limited period through this service. We can now present information about what controlled drugs have been supplied.

This data was collected between January and December 2020, and should be viewed in the context of the COVID-19 pandemic. Commonly supplied controlled drugs were:

  • Co-codamol (in a range of forms, including tablets and capsules) 30/500mg; Co-codamol 15/500mg; Co-codamol 8mg/500mg
  • Codeine 15mg and 30mg tablets
  • Dihydrocodeine 30mg tablets
  • Co-dydramol 10/500mg tablets
  • Diazepam 2mg and 5mg tablets
  • Zopiclone 3.75mg and 7.5mg tablets
  • Lorazepam 1mg tablets
  • Clonazepam 500mcg and 2mg tablets
  • Oral morphine liquid (10mg/5ml)

NHS dental prescriptions for controlled drugs

This year, we are able to present information on NHS dental prescribing, covering the years 2019 and 2020. This does not include independent dental services. Dentists working in the NHS can prescribe three controlled drugs on NHS dental prescription forms to patients: diazepam, temazepam and dihydrocodeine.

Of these, dihydrocodeine was the most prescribed, accounting for 90% of total dental prescribing in 2020. In 2020, 37,251 items were prescribed – an increase of 81% from 20,528 items prescribed in 2019.

Diazepam and temazepam accounted for 10% of dental prescribing in 2020. Prescribing of both medicines decreased in 2020 (by 31% and 37% respectively) from the previous year.

These patterns could be related to the COVID-19 pandemic:

  • patients are likely to have needed pain relief because of the delays in getting appointments
  • fewer appointments may have resulted in less prescribing of diazepam and temazepam, which can prescribed in relation to dental procedures

Non-medical prescribing

Prescribing of controlled drugs by non-medical prescribers increased for all staff by 37% from 3,087,975 items prescribed in 2019 to 4,215,881 items in 2020. Prescribing by nurses (including independent nurses and community practitioner nurses) accounted for 53% of all non-medical prescribing in 2020.

Over the past few years, we have seen more clinical pharmacist prescribers working in GP practices and Primary Care Networks than previously. Pharmacist prescribing has increased by 159% since 2018 and accounted for almost 47% of all non-medical prescribing in 2020.

Prescribing data for individual professions in 2020 compared with 2019

  • Paramedic prescribing (for controlled drugs, supplementary prescribing only): up by 383%
    (3,328 total items in 2020)
     
  • Nurse prescribing: up by 31%
    (2,249,114 total items in 2020)
     
  • Pharmacist prescribing: up by 44%
    (1,962,615 total items in 2020)
     
  • Physiotherapist prescribing: up by 14%
    (780 total items in 2020)
     
  • Podiatrist prescribing: down by 65%
    (29 total items in 2020)
     

Although the increase for paramedic prescribing is notable, it still accounts for a small proportion of non-medical prescribing. For the first time, data also includes prescribing by radiographers (only 15 items prescribed).

Independent primary care prescribing

In 2020, a total of 71,702 items were prescribed across Schedules 2 to 5, which is an increase of 21% from 2019. Of this, prescribing for Schedule 2 controlled drugs accounts for 80% and Schedule 3 for 19% (57,326 and 13,779 items respectively). We saw that some Schedule 4 and 5 prescribing occurred using FP10PCD private controlled drugs prescription forms (even though this is not a requirement). This accounts for only 1% of the FP10PCD private prescribing we looked at, and is not representative of the wider prescribing of these medicines in independent primary care.

Schedule 2 controlled drugs

In 2020, prescribed items for Schedule 2 controlled drugs increased by 24% compared with 2019. Looking specifically at medicines indicated for attention deficit hyperactivity disorder (ADHD):

  • Methylphenidate accounted for 42% (23,857 items) of all independently prescribed Schedule 2 items in 2020 (up by 25% compared with 2019)
  • Lisdexamfetamine accounted for 34% (19,517 items) of all independently prescribed Schedule 2 items in 2020 (up by 42% compared with 2019).

Some Schedule 2 controlled drugs have seen a reduction in prescribing in 2020 compared with 2019:

  • Tapentadol: down by 37% (300 total items in 2020)
  • Methadone: down by 19% (2,608 total items in 2020)
  • Oxycodone: down by 15% (2,103 total items in 2020)

Schedule 3 controlled drugs

In 2020, prescribing of Schedule 3 controlled drugs increased by 12% compared with 2019 (13,779 and 12,357 total items respectively). Pregabalin was the most prescribed drug under Schedule 3, accounting for 51% of 2020 total prescribed items (7,008 items, an increase of 10% compared with the same nine months of April to December 2019).

Some Schedule 3 controlled drugs have seen a reduction in prescribing in 2020 compared with 2019:

  • Temazepam: down by 29% (838 total items in 2020)
  • Buprenorphine: down by 18% (2,390 total items in 2020)
  • Tramadol: down by 10% (1,593 total items in 2020)

Hospital prescribing for community pharmacy dispensing

Hospital prescribing (on FP10HP prescription forms that can be dispensed in a community pharmacy) was also broadly in line with 2019. There were 969,481 controlled drug items across Schedules 2 to 5 prescribed in hospital using an FP10(HNC) or FP10SS form. This is a decrease of 9% from 2019, with a reduced cost of 9%.

Pregabalin and gabapentin account for 15% of all Schedule 3 hospital prescribing in 2020 and 3% of all controlled drugs prescribed in hospitals, with 27,626 total items prescribed in the full year.

Compared with 2019, we also saw increases in prescribing of:

  • Midazolam (Schedule 3): up by 24% (2,517 total items 2020)
  • Dihydrocodeine (Schedule 5): up by 15% (2,654 total items in 2020)
  • Lorazepam (Schedule 4): up by 1% (24,877 total items in 2020)

Requisitions

Requisitions are documents that allow relevant individuals to order medicines for use in their professional practice, such as ordering a stock of controlled drugs that are later supplied to patients. There has been a 3% decrease in requisitions in 2020; the total number of items requisitioned in 2020 was 15,037 compared with 15,444 in 2019. In 2020, 57% of all requisitions were from NHS providers and 43% were from private organisations.

The top 10 controlled drugs on requisition remain the same as for 2019. The most commonly requisitioned controlled drugs in 2020 were:

  • Oxycodone: 14 % of all requisitions (2,093 total items)
  • Morphine sulfate: 13% of all requisitions (1,967 total items)
  • Pregabalin: 13% of all requisitions (1,908 total items)
  • Methylphenidate: 8% of all requisitions (from 869 total items in 2019 to 1,188 total items in 2020)

Controlled drugs in secondary care

In this update, we are able to present information about controlled drugs in secondary care settings. As this is the first time presenting this data in our controlled drugs annual report, we therefore provide a high-level overview. Our data on controlled drugs in relation to hospitals has previously been limited to looking at prescriptions dispensed on various FP10 forms (prescriptions).

NHS England and NHS Improvement use a service provided by Rx-Info, a third-party medicines data company. This is to standardise and collate the content of NHS provider organisations’ pharmacy stock management systems. It looks at medicines that hospital pharmacy departments issue as stock to wards, departments, and individually to patients. This data is published as the Secondary Care Medicines Data (nhsbsa.net). The NHS uses the data to understand what medicines NHS hospitals in England issue and what stocks they hold.

The data we present relates to the aggregated costs and actual quantities of controlled drugs held across secondary care settings, as opposed to individual numbers of prescription items. This also includes controlled drugs held before they are supplied to other organisations, such as a prison or a private provider through a service level agreement. In this report, we refer to this as ‘stockholding’. Although this means the data is not directly comparable with primary care, it does help to provide a more rounded view of the use of controlled drugs across health and care settings.

We have analysed prescribing data for the years 2017 to 2020. Recent trends in the data must be viewed in the context of COVID-19, and the different needs of patients who were treated. This included a reduction in the number of routine operations and procedures, but also a large increase in number of patients who needed intensive care, sometimes for long periods. It is also important to recognise that the cost of individual medicines fluctuates, and that these changes are more substantial for some medicines than others. This means that costs and volumes are not always directly comparable.

Cost of controlled drugs in NHS hospitals

In 2020, the cost of controlled drugs in hospitals in England was £72,609,854, an increase of 6% compared with 2019. During the three-year period 2017 to 2020, the cost of all controlled drugs reduced by 3%.

Of the costs of all controlled drugs in hospitals in 2020:

  • Schedule 2 controlled drugs comprised 36%
  • Schedule 3 controlled drugs comprised 9%
  • Schedule 4 controlled drugs comprised 42%
  • Schedule 5 controlled drugs comprised 13%
  • Costs of Schedule 2 controlled drugs increased from £25,659,600 in 2017 to £26,013,907 in 2020
  • Costs of Schedule 3 controlled drugs decreased from £17,167,661 in 2017 to £6,824,073 in 2020
  • Costs of Schedule 4 controlled drugs increased from £26,555,834 in 2017 to £30,586,746 in 2020
  • Costs of Schedule 5 controlled drugs increased from £5,143,294 in 2017 to £9,185,128 in 2020

The cost increase for schedule 5 controlled drugs is substantial. Cannabidiol accounted for 49% of the costs of Schedule 5 controlled drugs in 2020 with costs of £4,494,317 compared with £3,109 in 2019.

Trends in stockholding of controlled drugs in hospitals

In addition to the costs of controlled drugs, we present some trends in the actual stockholding of commonly used controlled drugs. In 2020, there was a reduction in stockholding for a significant number of controlled drugs, compared with 2019:

  • Gabapentin (Schedule 3) - down by 26%
  • Lisdexamfetamine (Schedule 2) - down by 26%
  • Pregabalin (Schedule 3) - down by 25%
  • Tramadol (Schedule 3) - down by 23%
  • Temazepam (Schedule 3) - down by 22%
  • Codeine (Schedule 5) - down by 21%
  • Methylphenidate (Schedule 2) - down by 20%
  • Oxycodone (Schedule 2) - down by 19%
  • Morphine (Schedule 5) - down by 19%
  • Morphine (Schedule 2) - down by 14%
  • Dihydrocodeine (Schedule 5) - down by 13%
  • Zopiclone (Schedule 4) - down by 13%
  • Diazepam (Schedule 4) - down by 4%
  • Buprenorphine (Schedule 3) - down by 2%

At the same time, there was an increase in stockholding for:

  • Cannabidiol (Schedule 5) - up by 8,430%
  • Alfentanil (Schedule 2) - up by 51%
  • Midazolam (Schedule 3) - up by 28%
  • Ketamine (Schedule 2) - up by 2%

In recent years there has been significant work around medicines stockholding in hospital settings. The general reductions in stockholding of some of the more commonly prescribed controlled drugs, as well as increases in stocks of alfentanil and midazolam may also be linked to the different numbers and requirements of hospital inpatients during the pandemic.

The increase in midazolam stockholding also mirrored the trend that we saw for primary care and may have been as a result of providing treatment to a greater number of people at the end of their lives.

Although stocks of cannabidiol appear to have significantly increased in quantity, it is important to note that this is set against very low baseline numbers from the previous year.

Finally, we also took the opportunity to look at stockholding for oral morphine solution 10mg/5ml. This has many appropriate uses in both primary and secondary care, but we sometimes hear that when people move between secondary and primary care, the ongoing use of this is not always addressed and can lead to harm. We found that stockholding did not change much between 2017 and 2019. However, in 2020, stockholding dropped 19% compared with 2019.

Concerns discussed at CDLIN meetings

Temporary residents

There are still cases where patients register as a temporary resident with multiple GPs in order to obtain controlled drugs. Prescribers need to be able to access patient records and be assured of the appropriateness of prescribing before doing so. First requests for controlled drugs from temporary residents should initiate further investigation.

Multiple supplies of controlled drugs

We continue to hear of cases where patients have been able to obtain inappropriate supplies of controlled drugs prescribed remotely. In some cases, information has not always been shared with the patient’s GP. New guidance from the General Medical Council is very clear that doctors must not prescribe controlled drugs unless they have access to patient records, except in emergencies. There is also stronger advice on information sharing, making it clear that if a patient refuses consent to share information with other relevant health professionals it may be unsafe to prescribe.

Identity checks

Pharmacy staff should complete identity checks before giving out patients’ medicines to carers or family members. We have heard of some incidents where medicines have been given to people who are not authorised by the patient to collect on their behalf. In other cases, we have heard about the ‘usual’ carer or family member collecting medication for a patient who has died or is in hospital or prison. This is a challenge for pharmacy staff who may not be aware of recent changes to arrangements for individual patients and will have been particularly difficult to manage during the pandemic.

Self-prescribing

We hear reports of prescribers prescribing controlled drugs for both themselves and for use by family and friends. In most circumstances, this type of prescribing is inappropriate. Prescribers must not prescribe controlled drugs either for themselves or for someone close to them, except in the exceptional circumstances.

There is guidance for healthcare professionals, for example from the General Medical Council and General Pharmaceutical Council.

Temporary staff and local policy changes

There are concerns about how policy changes in a service have affected temporary staff during the pandemic. Temporary staff often become familiar with local policies and procedures in the services they work in. However, the rapidly changing nature of services over the last year has resulted in changes to policies or processes in many services. In some cases, temporary staff were not aware of changes such as the recording of controlled drugs. It is essential to communicate changes to temporary or agency staff in a timely and accessible way. We have heard about good examples of digital and paper-based newsletters that help to achieve this.

Controlled drugs balance checks

There is sometimes confusion around how often to conduct balance checks of controlled drugs. These need to be appropriate to the service and identify any risks. For example, services with a high use of controlled drugs in a setting may have risk-assessed the need to balance check more than once a day. Other services may only need to carry out weekly balance checks based on their circumstances. It’s also important that staff are aware of the policies or procedures around frequency of balance checks, and that they are also competent to undertake these checks effectively.

Safe storage of controlled drugs

Questions around safe storage of controlled drugs continue to be an issue raised at LINs. These relate to the type of safe storage used (including electronic drug cabinets), location of the safe storage, access to keys, audit and theft. Although there are specific legal requirements around storage for controlled drugs that need safe custody in specified settings, each organisation must also risk assess who can have appropriate access to keys, cabinets and other areas where controlled drugs are stored.

NHS England has recently published useful guidance on medicines storage in clinical areas.

Prescription security

Lost and duplicate prescriptions create general risks around diversion. Additionally, poor governance could lead to patients having inappropriate access to controlled drugs. This could include people accessing medicines that are not prescribed for them or, through prescription duplication, larger quantities of controlled drugs than had been originally prescribed for them.

There is guidance from NHS Counter Fraud Authority on prescription security.

Electronic prescribing in hospitals

Concerns have been raised about both prescribing and administration errors associated with electronic prescribing systems. As we work more digitally, providers must be aware of the importance in ensuring that staff are trained and familiar with electronic systems. It is also essential to communicate updates to staff who use this technology in a timely way.

Accuracy checks of controlled drugs

Sometimes, untrained staff were asked to complete second accuracy checks for administering controlled drugs when they did not have the knowledge or the confidence to identify an error. Any staff undertaking second checks must be appropriately trained and assessed as competent.

Delivery incidents

The theme of delivery errors has been common during the pandemic. In some cases, drivers had not had an induction or appropriate training and therefore did not know what processes to follow. In other cases, temporary changes to processes led to a less robust audit trail, such as patients’ signatures not being required at the point of delivery. Training and competency assessment are a key part of controlled drugs governance across all sectors. Services should also risk assess any changes they make to their audit trail for delivering controlled drugs and consider if and how any increased risk can be mitigated.

Patients’ own drugs

We still hear about incidents relating to patients’ own drugs (PODs). These included controlled drugs not being appropriately recorded when they were received, or not being stored appropriately. Other incidents involved patients’ own controlled drugs either not being returned to them when discharged or being given to the wrong patient. Providers should consider if the processes for controlled drugs at the point of admission and discharge are fit for purpose and are also appropriate for the settings (such as wards) on which they are used.

Pregabalin and gabapentin incidents

These have been highlighted at LINs over the last year. We have heard examples of pregabalin and gabapentin being dispensed or administered in place of one another because the three letters ‘gab’ in both of their names can make them sound similar. Services should review pregabalin and gabapentin near-misses and incidents to understand contributory factors. Collaboration with other providers and organisations can help to share learning and strategies that have helped to reduce the risk of recurrence.

Controlled drug issues we find on inspection

Controlled drugs accountable officer notifications

We sometimes find that the details of the CDAO on the register do not match those of the CDAO in post – particularly when the CDAO has recently moved to a new role. We expect a timely notification so that the register is up to date to enable us and others to contact the CDAO when needed.

Home Office licences for controlled drugs

There is often a lack of understanding of when a Home Office licence is required and that there are licences for both Home Office possession and Home Office supply. Organisations must discuss their specific requirements with the Home Office. When we inspect, we expect to see evidence that the service has contacted the Home Office where a licence might be needed.

Lack of awareness of relevant guidance and safety alerts

When we inspect, we often ask staff how guidance and safety alerts have been implemented in their organisation. This helps us to understand if the right processes are in place to ensure that the service acts on and communicates alerts and guidance effectively. There is good availability of evidence-based guidance for controlled drugs, such as NICE guidance NG46, and that from Specialist Pharmacy Service and PrescQIPP. Services can also subscribe to alerts about medicines and devices, including those from the Medicines and Healthcare products Regulatory Agency.

Illicit substances

We continue to hear about the issue of illicit substances being brought onto healthcare premises. Providers need to have a clear procedure and maintain a robust audit trail with secure, sealed containment of unknown substances. A small amount can be destroyed locally as an unknown substance. Larger quantities (not for personal use) should be notified to the police. Any trends should be communicated to the NHS England and Improvement controlled drugs accountable officer so they can share the issue and any learning with the CDLIN.

Reporting incidents and concerns

When we inspect, we ask staff about how incidents are recorded, investigated and learned from. This enables us to understand whether there are processes to help ensure that risks of recurrence are minimised. We sometimes find that staff are unaware of who to report incidents to. Providers must have a policy that explains how to report incidents. Safer cultures are those that that encourage open reporting and a fair-blame culture. We often find that providers, including social care providers, don’t know who their NHS England and Improvement local controlled drugs accountable officer is. Up-to-date details are in our register of controlled drugs accountable officers.

Controlled drug mandatory requisition form

There is a general lack of understanding of when to use the FP10CDF form. Providers need to follow guidance from NHS Business Services Authority. They are also sometimes unaware that a doctor must sign the requisition if a supply is requisitioned from a separate legal entity. We expect providers to be aware of the requirements set out in the Misuse of Drugs Regulations 2001.

Controlled drugs record keeping

Records are generally completed well, although we do still find some services, in both health and social care, where records are not always completed or when they are, the records are of poor quality, and in some cases not legible. In the context of hospitals there is sometimes confusion between the controlled drug register and controlled drug record books in wards and departments. There should only be one controlled drug register for each preparation at the premises. Not all theatres follow the good practice requirement to complete the amount used/amount wasted. We expect providers to meet legal requirements and adopt good practice initiatives.

Sometimes the contents of the controlled drugs cupboard do not match what is in the register and/or record book. This is not always a stock issue but can be related to a patient’s own drugs or ‘just in case’ medicines for end of life care. All drugs stored in a controlled drugs cupboard must be recorded appropriately.

Controlled drugs cupboards

We find that some providers still store controlled drugs in wooden cupboards, which do not meet the minimum standard. We expect organisations named in The Safe Custody Regulations 1973 to comply with the regulations, and organisations outside the scope of the regulations to use the regulations as a minimum standard.

There is also uncertainty about managing situations where neither the legislation nor guidance covers a specific situation, for example where controlled drugs are stored in a fridge or robot, or where there is no solid wall to affix the cupboard. In this case, providers should consider other measures, for example strengthening an internal wall or reviewing the location of the cupboard, and record the decision in a risk assessment that is reviewed regularly.

Above all, controlled drugs must remain secure, for example in a separate secure container for controlled drugs that need refrigeration, or secure storage within a robot. An exemption certificate issued by the police may also be required for those organisations that sit outside the safe custody regulations.

Storing high strength preparations of controlled drugs

Not all providers separate high and low strength preparations, or those intended for different routes such as epidurals and intravenous injections. This can increase the risk of selecting and administering the wrong preparation. We have seen incidents linked to the inadvertent use of high strength alfentanil this year. Providers need to carry out their own risk assessment and incorporate relevant guidance into their processes.

Access to controlled drugs

Access to keys and cupboards is generally managed well. We expect a standard operating procedure to be in place that covers access to keys, and staff to adhere to it. We also expect to see monitoring, as controlled drugs (including those in the lower schedules) may be diverted by those with legitimate access. Providers also need to have timely access to controlled drugs used as rescue medicines, such as midazolam to treat seizures. In a few cases we have found access to these medicines so restricted that they could not be obtained quickly enough. Again, providers need to conduct their own risk assessments to determine the right processes that keep patients safe and controlled drugs adequately secure.

Diversion

We continue to see naivety regarding diversion issues. It is important to minimise the quantity of a controlled drug prescribed and to regularly review the patient’s ongoing need. Controlled drugs in the lower schedules are no exception to this. Repeat prescribing intervals must be managed carefully, and good communication between providers is key when a patient is being looked after by several different clinicians across different organisations. It is especially important to consider the quantity issued in an emergency and for temporary residents until checks are carried out.

We often see a lot of focus around the security of blank prescriptions. It is essential to consider how diversion can be made easier when paper prescriptions already written out by a prescriber go missing. It can be difficult for the supplying pharmacy to identify these, as they are more likely to contain the required information than prescriptions that have been forged from a blank state.

Single nurse administration of controlled drugs

There is some uncertainty about administering controlled drugs by a single nurse and the need for two signatures, and some providers are unclear whether single nurse administration is allowed. To clarify, a single nurse is allowed to administer a controlled drug unless the local policy says otherwise. If a second checker is not a registered nurse, they must be trained and assessed as competent. See Professional Guidance on the Administration of Medicines in Healthcare Settings from the Royal Pharmaceutical Society and Royal College of Nursing.

Dose calculation errors

Dose calculations are a cause of errors, particularly with new or unfamiliar formulations or devices. It is important that staff who perform dose calculations have training and competency assessments to support this. Clinicians should be encouraged to ask for a second check if they are unsure or unfamiliar with the product or formulation.

Controlled drugs transdermal (skin) patches

We continue to see problems with how patches are used and recorded. Body maps are not always in place to highlight where transdermal patches have been applied and to provide assurance that they have been rotated to different sites to avoid skin damage. Checks aren’t always made to ensure that old patches are removed, and that ‘current’ patches are still attached to a person’s skin. In some cases, patches that deliver pain relief have dropped off without staff noticing. Good governance and sharing learning across providers can help to support safer use of patches. See our information about the use of patches for providers of adult social care.

Governance

Good governance is essential to ensure controlled drugs are managed safely, but we don’t always see this when we inspect. We expect standard operating procedures or policies to cover all aspects of controlled drug management. These must be kept under review with supporting audits.

We’re aware of thefts and diversion of controlled drugs in lower schedules, for example dihydrocodeine tablets or morphine sulfate solution 10mg/5ml. We expect organisations to risk-assess their controlled drug arrangements, with regular monitoring according to their organisational needs, to keep losses to a minimum.

We sometimes find a lack of clarity around controlled drugs governance where a service had been commissioned through an additional provider. Organisations that commission services from another organisation must ensure that arrangements include regular controlled drug audits and robust stock checks, and that any incidents identified are reported as soon as possible.

Destruction of controlled drugs

Some organisations are unaware of the need to hold a T28 exemption form for denaturing controlled drugs. Organisations that denature controlled drugs must obtain a T28 exemption form from the Environment Agency. Care homes (non-nursing) should be able to return medicines to community pharmacies. We have found that some homes have destroyed controlled drugs because community pharmacies are not accepting returned medicines, citing the pandemic as a reason for this.

There is some confusion around disposing large volume infusions (for example, in hospitals). These should be discarded using an absorbent material to soak up the liquid. We’re also asked about what services should do with their denaturing kits once they have been used. Once full, they must be stored securely until removed by the waste carrier for incineration.

Recommendations

From our analysis of the data on prescribing in NHS primary care services, feedback from controlled drug local intelligence networks (CDLINs), and CQC’s wider inspection and regulatory work, we make the following recommendations to drive improvement in the safer management of controlled drugs:

1. Providers need to include controlled drugs governance as part of their COVID-19 recovery plans

During the pandemic there were sometimes changes to the governance of controlled drugs, including the frequency and content of audits. By including controlled drugs governance as part of recovery plans, services will be able to manage and mitigate risk in the most appropriate way.

2. Providers should enable all health and care staff to freely engage and participate in activities that support reflection and learning

The post COVID-19 recovery period for health and care providers is an important opportunity to reflect on and share learning. This should include positive experiences, innovative and good practice, as well as when things have gone wrong. The opportunity to improve safety is rooted in this process.

3. Those leading and working in local health and care systems need to collaborate to reduce risks of avoidable harm associated with controlled drugs

We know that people have better experiences and outcomes when local providers of health and care services work well together.

4. All health and care professionals need to prioritise personalised patient care in the context of controlled drugs

Incidents with controlled drugs highlight the importance of appropriate prescribing and supply – not just at the outset, but also for ongoing review and monitoring. Those working in adult social care also have an important and valuable role in ensuring that controlled drugs are used safely and in escalating concerns to the appropriate healthcare professionals.

Last updated:
16 July 2021