Controlled Drugs – How Providers can Control the Consequences

The Care Quality Commission (“CQC”) reports annually on its oversight findings to ensure that healthcare providers maintain a safe environment for the management and use of controlled drugs under the Controlled Drugs (Supervision of Management and Use) Regulations 2013 (“CDSMU Regulations”). As part of this, the CQC published, ‘The safer management of controlled drugs: Annual update 2021’ (“the Annual Update”) on 22 July 2022. Notably, this report draws attention to the shortfalls that the CQC has seen in the use and management of controlled drugs in care settings. This will have an impact on how the CQC moves forward in inspecting and upholding industry standards based on the relevant legislation.

In this article I will outline the relevant legislative mechanisms that providers need to be aware of and which the CQC relies on to monitor and regulate the management and use of controlled drugs. I will then highlight their key findings in relation to the management and use of controlled drugs in care settings and outline how providers can use this information to improve the quality of the service they provide and take preventative measures when it comes to the consequences of failing to manage and use controlled drugs correctly.

Relevant Legislation

According to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (“HSCAR”), Regulation 12(2)(f) and 12(2)(g), providers have a responsibility to ensure there are sufficient quantities and proper and safe management of medicines.

Where medications are controlled substances (according to the Misuse of Drugs Regulations 2001 (“MDR”), Regulation 7), any person may administer the drugs set out in Schedules 2-5 of the MDR to patients in accordance with the required directions. This means that care providers may administer controlled drugs to service users and that they will be obliged to do so in line with Regulation 12 of the HSCAR.

Under the CDSMU Regulations, Designated Provider Bodies (i.e. NHS Trusts, NHS Foundation Trusts, and Independent Hospitals) are under a duty to appoint an accountable officer (“CDAO”) who will oversee the management and use of controlled drugs for them.

A key part of the CDAO’s duties is to ensure that appropriate arrangements are set up to ensure compliance with the Misuse of Drugs Act 1971, record concerns and report incidences, and maintain up to date standard operating procedures that cover best practice for prescribing, supplying and administering controlled drugs as well as clinical monitoring of patients receiving controlled drugs. CDAOs also need to ensure that appropriate arrangements are in place to monitor and audit concerns and incidents that relate to controlled drugs and investigate and take actions where these concerns are serious enough. As part of this activity, CDAOs must determine whether information needs to be shared with the relevant responsible body (i.e. CQC) and or make a referral to the relevant regulatory body (i.e. CQC). The CDAO may also enlist a responsible body to carry out any actions or investigations where there are concerns. Thus, the CQC can, and often does, play an integral role in investigating concerns about the management and use of controlled drugs.

Further to this, Designated Commissioning Bodies (i.e. NHSCB) are required to set up intelligence networks designed to facilitate the cooperation of responsible bodies where concerns are raised. Responsible bodies are also obligated to cooperate amongst each other and share information with the relevant designated body, who may then make recommendations based on the concerns raised.

Effectively, this means that the organisations which providers are held accountable by will be working as a network, at least where the management and use of controlled drugs are concerned.

The Annual Update: Key Findings

In the Annual Update, the CQC noted the following findings in relation to the management of controlled drugs: governance systems were not always fit for purpose to safely manage the use and administration of controlled drugs; common themes related to management of controlled drugs were noted in Prevention of Future Death (“PFD”) reports reviewed by the CQC; and failing to utilise local intelligence networks to share information about the misuse of controlled drugs and to submit occurrence reports to the correct authority.

Governance Systems

The CQC’s main criticism of the systems in place were that they did not reflect changes in delivery of service due to the pandemic. This included a lack of robust systems to ensure balance checks were carried out for controlled drugs to help prevent misuse; substandard reporting and reviewing of incidences in relation to controlled drugs for learning lessons; and lack of appropriate risk assessments.

PFD Themes

Where PFDs are concerned, which are reports that can be issued by Coroners following an inquest to identify key learning points when there is the death of a service user, the CQC believes that much can be learned from specific cases so that effective change can be made across individual organisations and local health and care systems. The key themes that the CQC noted amongst the PFDs were: lack of communication between health and social care providers in local systems; poor monitoring of patients in primary care; and lack of integration and communication between independent healthcare providers and the NHS regarding patient records. These mirror the key issues that the CQC found for adult social care (“ASC”) services when it comes to using controlled drugs.

Adult Social Care Services

The most common issues the CQC found in ASC services were:

  • Using transdermal patches incorrectly (i.e. patches are not rotated to prevent skin damage or not checked regularly);
  • Failure to report controlled drug errors to the right organisations. (i.e. ASC providers not knowing who their local NHS England CDAO is); and
  • Controlled drugs not being destroyed promptly or the correct way, sometimes due to providers making changes because of the pandemic.

In summary the CQC is attacking the systems that providers have in place for the management and use of controlled drugs, deeming them subpar and in some cases unsafe. This then becomes a governance issue, which has wide ranging, often negative, effects on the business.

Industry Trends & Provider Impact

In recent months Ridouts has observed a number of ways in which the CQC uses issues with controlled drugs to form the basis for enforcement action. We have seen providers criticised for a number of reasons, including: gaps in charts, failure to make appropriate and timely referrals, and failure to follow prescribing directions to name a few. Where Ridouts sees this negatively affecting providers is often in inspection ratings, which then turn into later enforcement action.

For example, the CQC may criticise a provider on the management of medications in the domain safe and cite a breach of Regulation 12 of the HSCAR. This will then carry over into the well-led section, where the CQC will tie the shortfalls in the safe use of medications to shortfalls in the governance systems for them and cite a breach of Regulation 17 of the HSCAR as a result. Thus a provider has two alleged regulatory breaches based on mismanagement and misuse of medications (i.e. controlled drugs). Controlled drugs up the risk factor for this because there are more serious consequences for misuse and abuse of them, making the oversight more intense and stringent. Thus, these breaches can also form the basis of further enforcement action including: warning notices, notices of proposal and decision, and potentially criminal liability where the concerns/incidents are serious enough.

Taking Action

Providers can learn from these findings and use them to upscale the quality of care they provide. In particular, providers will want to focus on the areas outlined above – transdermal patch procedures, reporting systems, risk assessments, and general management of controlled drugs – and ensure that the policies in place are robust and informed by up to date guidance on best practice.

The starting point for most providers will be their CDAO – making sure they know who this is and how to contact them. The CDAO is also responsible for ensuring that the relevant individuals (i.e. healthcare professionals, non-professional persons providing services in relation to the management and use of controlled drugs, and managers in care settings) receive appropriate information, education, and training. The CDAO will be an invaluable resource when it comes to staying up to date on the management and use of controlled drugs to ensure compliance with regulations.

Secondly, providers will want to keep abreast of the latest guidance for controlled drugs. The CQC and NICE frequently publish guidance and updates in the industry in relation to controlled drugs.

Thus, in order to prevent these negative consequences, providers should not only heed the CQC’s Annual Update but also familiarise themselves with the relevant legislation and guidance in place. This starts with fostering positive and transparent relationships with their CDAOs.

If you feel that you have been treated unfairly or have received unfair criticism in relation to controlled drugs, or any other aspect of your service, our lawyers are trained to challenge the CQC with robust legal arguments. This expertise will ease the burden on you as a provider, allowing you to focus on what’s important – providing a high standard of care. If you need any help or assistance with any type of enforcement action taken by the CQC, please contact our specialist team of solicitors on 0207 317 0340 or email info@ridout-law.com.

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