Medicines Regulations and Inspection

As you will well know, the Care Quality Commission (CQC) inspect providers of health and social care on a regular basis to ensure they are providing Safe, Caring, Responsive, Effective and Well-led services.  Recently, I have been exploring the regulations and reading a LOT of CQC reports (think triple digits!), looking at how medicines are reported and the common issues around medicines identified by inspectors. So, in the spirit of this, this blog takes a look at how medicines management is regulated and inspected in adult social care, with links to the guidance and regulations. I hope that this will be useful for some of you!

Which regulations correspond to medicines?

Regulations outline the key requirements that the provider and registered manager must meet when providing services and a breach of these can lead to prosecution.  Medicines management is mostly covered in CQC Regulation 12: “Safe care and treatment”.  This includes “Regulation 12(2)(g): the proper and safe management of medicines”, which states that, in brief, medicines must be managed in line with current legislation and guidance by trained and competent staff and Regulation 12(2)(f), which covers the ensuring the necessary medicines are in stock and available when needed.  However, some aspects of medicines management are also covered in other regulations. For example, covert administration of medicines is covered under Regulation 11: “Need for consent” and the auditing of medicines is covered under Regulation 17: “Good governance”.

What are the Key Lines of Enquiry (KLOEs) for safe use of medicines?

The KLOEs outline the questions inspectors seek to answer when inspecting services.  S4 covers the KLOEs for safe use of medicines by asking the question “How does the provider unsure proper and safe use of medicines?” (see table for my summary of these).  This is explored in 8 parts:

1) Is the service’s role in relation to medicines clearly defined and described in relevant policies, procedures and training? Is current and relevant professional guidance about the management of medicines followed?

This relates to how the service provider and manager have established clear and robust systems to ensure that medicines are managed safely. This includes ensuring that staff managing medicines are appropriately trained and have their competence assessed at regular intervals, and having an up-to-date, home-specific medicines policy that is in line with current guidance.  The National Institute for Clinical Excellence (NICE) have produced guidance on “Managing medicines in care homes” and the CQC website has FAQ articles on managing medicines in adult social care covering a range of different areas, such as administering covertly, high-risk medicines and medicines reviews.  As a manager or provider, it is important to stay up-to-date with changes in guidance, for example by regularly checking these sites for updates, subscribing to the CQC Adult Social Care newsletter and attending courses.  I have personally attended a few training courses, which have been excellent at refreshing and updating knowledge.

2) How does the service make sure that people receive their medicines (both prescribed and non-prescribed) as intended (including controlled drugs and ‘as required’ medicines), and that this is recorded appropriately?

This is a big one, with lots of details to unpick.  It encompasses both the administration of medicines and the recording of these to ensure that individuals receive their medicines safely and as prescribed.  For this to happen, there needs to be sufficient details recorded on the Medicines Administration Record (MAR) to facilitate this.  This includes information to identify the individual (e.g. name, date of birth, photo), medical information (e.g. health conditions, allergies), the medicine (e.g. name, strength, dose) and how the medicine should be given (e.g. times, route, frequency). 

It is good practice to also record more specific details on the medicines prescribed in the form of medicines care plans. This is especially important for certain types of medicines, for example those prescribed ‘as required’ (PRN).  For these, a PRN protocol should be put in place explaining what the medicine is for, when it should be offered and used, how it should be used (including a body map for topical medicines), how its effect should be monitored and when to seek help if it is not working.  Similar information should be provided for homely remedies (medicines available without prescription) if these are offered.  The CQC have produced FAQ documents providing more details on managing PRN medicines and homely remedies.

Staff should follow robust processes to safely administer medicines.  It is worth noting that the CQC advise that multi-compartment aids (MCAs) should not be the first choice in supporting individuals in care homes with taking their medicines.  Read my blog on MCAs for more details about this.  During medicines administration, interruptions should be avoided and unsafe practices like secondary dispensing (where one member of staff prepares the medicine and gives it to another to administer) must not be used.  Medicines must not be left unattended at any point.  Staff should witness the individual taking their medicine before signing the MAR chart unless the individual is partially self-administering as per their individual risk assessment (for example, only needing assistance removing the medicines from the packaging) and this is clearly documented.

The MAR chart must be completed accurately, following best practice guidance.  Staff should sign when they administer a medicine or provide a reason why this has not been administered and, as a result, there should be no gaps in the MAR chart.  The exact time of administration should be recorded so that the appropriate gaps between doses is maintained (for example a four-hour gap between doses of paracetamol) and if the medicine may be given at more than one dose (variable dose medicines) the dose that has been given should be recorded.  For topical medicines (those applied to the skin, such as creams and patches), the place where this has been applied should be recorded.  Staff should also obtain a witness signature in situations where this is required, for example when controlled drugs are administered, when the MAR is hand-written and when amendments are made to the MAR chart. 

Finally, regular audits should be undertaken to ensure that all medicines can be accounted for and that these have been given as prescribed.  For example, checking that the count of medicines in stock is equal to those received minus those given according to the MAR.  This is even more vital for controlled drugs and the controlled drug register must be an up-to-date and accurate account of these.  It is also worth noting that, to ensure that individuals receive their medicines as prescribed, it is necessary to maintain adequate stock of these at the home; S4.3 relates to this.

3) How are medicines ordered, transported, stored, and disposed of safely and securely in ways that meet current and relevant legislation and guidance?

Medicines should be ordered as needed and checked upon receipt to ensure that there is a consistent supply of all medicines so that they are available when needed.  Medicines must be secured to ensure that they do not go missing and that they are not used by another individual, putting them at risk.  They must also be stored at the correct temperature and dated upon opening where necessary (for example creams and eye drops) to ensure that they remain effective and safe to use.  When medicines are no longer required or are out-of-date, they should be returned to the pharmacy for safe disposal, and this should be recorded to provide a complete and transparent audit trail of medicines stored within the home.

4) Are there clear procedures for giving medicines covertly, in line with the Mental Capacity Act 2005?

Covert administration is when an individual is given a medicine without their knowledge.  This should be a last resort, for essential medicines and where the individual lacks capacity.  Capacity refers to an individual’s ability to make decisions for themselves and the Mental Capacity Act 2005 is the legislation relating to this.  The CQC have a brilliant FAQ document on covert administration, which gives more details on this and I advise anyone involved in covert administration to have a read of.

5) How does the service make sure that people’s behaviour is not controlled by excessive or inappropriate use of medicines?

Services must ensure that psychotropic medicines (medicines that affect the mind) are not used inappropriately to control behavior that challenges.  For more details, take a look at my blog on this topic.

6) How do staff assess the level of support a person needs to take their medicines safely, particularly where there are difficulties in communicating, when medicines are being administered covertly, and when undertaking risk enablement assessments designed to promote self-administration?

Procedures should be in place for assessing the level of support an individual may require in managing their medicines safely.  This includes procedures for assessing capacity where covert medicines administration is being considered.  Individuals should be encouraged to self-manage their medicines to the extent that this is appropriate.  To facilitate this safely, a risk assessment should be undertaken and consideration should be made to the level of support that the individual may need.  More information on self-administration can be found on the CQC FAQ page for this.

7) How does the service engage with healthcare professionals in relation to reviews of medicines at appropriate intervals?

This KLOE relates to supporting medicines optimisation.  Medicines optimisation involves carefully considering and reviewing medicines to ensure that they are used appropriately in a way that is acceptable to the individual.  For example, considering other, non-medicine options; involving the individual and using medicines in a person-centered manner; and reviewing medicines regularly over time to ensure that these are still appropriate to use and acceptable to the individual, as the benefits and drawbacks may change over time.  Adult social care services must work actively in collaboration with other professionals such as GPs, nurse specialists and pharmacists to ensure that routine medicine reviews are conducted regularly and that medicines are reviewed promptly if there are changes in the individuals health or situation. This includes when there is a transfer of care.  The CQC produce FAQ guidance on this.  They also produce guidance on two key aspects of medicines optimisation, polypharmacy (taking multiple medicines) and deprescribing (stopping medicines), which I encourage everyone to read.

8) How do staff make sure that accurate, up-to-date information about people’s medicines is available when people move between care settings? How do medicines remain available to people when they do so?

Poor communication at the transfer of care can put individuals at extremely high-risk of medicine errors and not receiving their medicines as prescribed.  Communication of medicines information must include up-to-date details on administration of these and not just what is prescribed.  This is important as, for example, an individual may receive their medicines twice if the fact that these have already been administered these is not communicated.  It is also important to ensure that there is a process in place to ensure that the individual’s medicines are always available so they can continue taking them as prescribed.  

How are things changing?

The importance of safe medicines management has been brought to the forefront recently with the publication of the CQC report on medicines management in health and adult social care services.  This found that, in adult social care, poor record keeping was the single biggest factor contributing to medicine errors, and that this was a particularly high risk when information was hand-written.  The most common administration error in adult social care to be the administration of the wrong dose, with lack of missed doses due to lack of stock and administration errors due to gaps in MAR charts also highlighted.  For example, the accidental administration of the same medicine dose twice due to a gap in the MAR chart.  Furthermore, while the CQC were previously reporting all of their findings under each domain heading as unstructured free text, they have more recently updated the layout of their reporting, introducing subheadings.  This includes the subheading “Managing medicines safely” under the Safe domain, making report findings on medicines management more prominent.

More broadly, there is a growing movement towards medicines optimisation and deprescribing (stopping medicines) where appropriate.  This includes the formation of the English Deprescribing Network (EDeN), launched in June 2019.  While medicines management refers to the technical processes involved, medicines management goes beyond this and encourages professionals to think about whether the medicines used are appropriate and acceptable to the individual (see table).  The KLOEs S4.5 “How does the service make sure that people’s behaviour is not controlled by excessive or inappropriate use of medicines?” and S4.7 “How does the service engage with healthcare professionals in relation to reviews of medicines at appropriate intervals?” both link in with this, as does the provision of detailed and person-centred ‘when required’ (PRN) protocols, which was highlighted in the CQC report on medicines management in health and adult social care services.  As mentioned before, the CQC have also produced related FAQ guidance on polypharmacy and deprescribing and medicines reconciliation and review.  It is likely that focus on these aspects during inspection will grow alongside the broader medicines optimisation movement.


  • Medicines management is one of the key areas assessed by the CQC during inspection.
  • Providers obligations are outlined in the regulations, notable Regulation 12 and the questions they address surrounding medicines management are outlined in the S4 Key Line of Enquiry.
  • Medicines must be managed safely, in line with current guidance, by trained and competent staff so that individuals receive these as prescribed.
  • Consideration should also be made to ensuring that medicines use is appropriate and acceptable to the individual (medicines optimisation) and care providers must act to ensure that medicines are reviewed routinely as well as promptly when an individual’s situation changes.  

Find out more

I am presenting at the Care Show on the 9th of October! Come along to hear all about my findings from examining CQC reports pre- and post-implementation of ATLAS eMAR, as well as the research on ATLAS eMAR that has been conducted by Cardiff University.

Get in touch if you have any ideas or questions.

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