2. Medication Safety

Box 1 - Higher-risk medicines and higher-risk repeat prescribing scenarios
2.1 Preventing avoidable harm
2.2 Antimicrobials on repeat prescription
2.3 Multiple medicines (polypharmacy)
2.4 Medication reviews
2.5 Suggested questions for practices to consider in relation to higher-risk medicines or higher-risk patient scenarios

While the majority (97%) of primary care encounters are safe, recent research highlights that there are between 19,800 and 32,000 incidents of ‘probably avoidable’ harm in England each year. Of these, 26% are medication related.¹⁵

The NHSE Patient Safety Strategy supports local best-practice through a whole-system approach to medicines harm reduction. This is important for repeat prescribing because the repeat prescribing system is managed by a team and not by one individual. A positive safety culture across general practices and pharmacies is important to make the repeat system safer and reduce avoidable harm.

For information on how to build effective teams in general practice, see The King’s Fund publication, How to build effective teams in general practice.

In collaboration with the RCGP in Wales, we have developed this helpful resource, Multidisciplinary Team Working in a General Practice Setting, that supports the building of effective multidisciplinary teams in general practice, which is essential for the safe functioning of repeat prescribing systems.

The section below sets out the medication safety risks associated with repeat medicines. This should prompt a practice or PCN-level discussion about the different types of repeat medication authorisation and review defined in section 2.4, when they should be deployed and how they should be recorded in the clinical notes.

Particular attention should be paid to the higher-risk medicines and repeat prescribing scenarios defined in Box 1, and making sure that the appropriate level of medication review is carried out with the appropriate frequency and with the appropriate level of clinical input. The frequency of review will be dictated by the nature of the medicine and dose as well as the patient scenario, such as how well they organise their repeats, if they are taking medicines with abuse potential and how well the patient is aligned with the prescribing and monitoring schedule set out by their prescriber.

When things go wrong

The majority of patients access their repeat medicines safely, with regular reviews to check the ongoing appropriateness of the medication. However, medicines remain a significant cause of harm, and practices will need to consider this as they complete the repeat prescribing toolkit self-assessment.

When things do go wrong, practices and pharmacies are recommended to report patient safety incidents via the Learn from patient safety (LFPSE) reporting system. See the NHSE, Learn from patient safety events (LFPSE) service for more information.

Where medicines and prescribing are higher risk

In their report in 2019, the Care Quality Commission (CQC) highlighted that, "Some medicines are considered ‘high-risk’ because of the possible adverse side effects, so patients require frequent tests (blood or other tests) and reviews, and doses may need to be adjusted to ensure they do not cause harm."

Common examples of high-risk medicines included:

• Warfarin
• Lithium
• Methotrexate
• Azathioprine
• Leflunomide.

Inspection reports gave examples of how providers did not always meet these requirements.¹²

In 2007, a systematic review looked at which drugs cause preventable admissions to hospital and identified that the majority of preventable drug-related admissions involved antiplatelets, diuretics, NSAIDs or anticoagulants.¹⁶

Observational studies have also identified polypharmacy as a key driver of adverse drug reactions causing hospitalisation. Drugs commonly implicated in unplanned hospital admissions in adults included diuretics, anticoagulants and antiplatelets, proton pump inhibitors, chemotherapeutic agents and antihypertensives.¹⁷

In addition to particular higher-risk medicines, practices are advised to think about their arrangements for higher-risk prescribing scenarios for more vulnerable patient groups, such as:

• Older people taking ten or more medicines
• Repeat prescriptions of unlicensed, paediatric medicines
• Patients with learning difficulties
• Those who are house-bound and reliant on others to order and collect their medicines
• Women of child-bearing age taking teratogenic medicines such as sodium valproate.

2.1 Preventing avoidable harm

Regulation 28, Prevention of Future Deaths (PFD) reports (commonly known as coroners’ letters) are issued to an organisation or individuals where the coroner believes that action should be taken to prevent further deaths. Approximately half of all deaths in England and Wales are referred to HM Coroner. Since 1984, it has been a statutory duty to report about deaths with a view to preventing future deaths.¹³

In April 2023, a study was published looking at the preventable deaths involving medicines. This work reviewed coroners’ reports from 2013–2022.¹⁸ One in five coroner-reported, preventable deaths involved medicines. It identified that medicines cause over 1,700 preventable deaths annually in England and of the 704 PFD reports, the most common medicines involved were:

• Opioids (22%)
• Antidepressants (9.7%)
• Hypnotics (9.2%).

Coroners expressed concerns around the major themes of patient safety and communication, including minor themes of monitoring and communication between organisations.

For these reasons, general practice and community pharmacies should ensure that all high-risk medicines and particularly opioids, antidepressants and hypnotic medicines are treated very carefully where they are to be prescribed as a repeat medication. The practice, the pharmacy and the patient should all be clear about the arrangements for ordering and monitoring such medicines as well as frequency of and purpose of a thorough, structured medication review.

Published reports are available via the Courts and Tribunals Judiciary website.

Clear themes in all the reports reviewed include:

• Antidepressants, opioids for chronic, non-cancer pain and benzodiazepines were prescribed ‘on repeat’ but review of the ongoing need for these high-risk repeat medicines was limited
• Practices were not always aware of how much medicine was being ordered and so patients were able to gain access to large quantities of, and/or request very frequently, these higher-risk repeat medicines relatively easily
• Opioids and antidepressants were prescribed to vulnerable patients where the risk of intentional or unintentional overdose was high.

Practices should think carefully about their arrangements for repeat prescribing of these classes of medicines when they complete the repeat prescribing self-assessment.

Patients should be afforded regular and very careful review of their medicines and the decision to repeat prescribe these high-risk medicines may need to be considered on an individual basis. Some patients may benefit from a written agreement with the practice to help support safety, and a clear review timeline, e.g., three monthly.

Practices and local pharmacies should discuss and agree how concerns about suspected over ordering of these medicines (especially for vulnerable people) should be communicated and how these concerns will be acted upon.

To help PCNs to assess the consistency of their opioid prescribing, the Health Innovation Wessex opioid checklist for PCNs is included in section 6, good practice examples.

The risk of not supplying

Sadly, there have also been reports of deaths caused when rigid adherence to an agreed repeat medicine process has led to patients being unable to access their highly essential medicines; practices will wish to consider how teams will assess and respond to individual requests for high risk, highly essential medicines, to ensure that the risk of not supplying is balanced against the risk of on-going supply. 

2.2 Antimicrobials on repeat prescription

Antimicrobial resistance (AMR) currently poses one of the biggest threats to healthcare as we know it. Overuse of antibiotics drives AMR, which is associated with over 35,000 deaths each year in the United Kingdom.¹⁹ The cost impact of avoidable antibiotic exposure for respiratory tract infection in primary care in the UK, due to adverse events and re-consultations, has been estimated at £238 million annually.²⁰

In general practices in England, 10% of antibiotics are prescribed for 0.5% of registered patients, equating to 10 or more prescriptions per year for this vulnerable patient cohort experiencing recurrent infection.²¹

Prescribing data indicate large variations across general practices in England in the proportion of patients repeatedly exposed to antibiotics, indicating a potential opportunity for improvement. Evidence-based resources for healthcare professionals have been developed to facilitate structured medication reviews (SMR) with patients to promote interventions to reduce future risk of recurrent infection.

Antimicrobials need to be thought of as high-risk in relation to being repeated. Repeated courses of antibiotics, although common practice, may have limited benefit and can increase the risk of:

• Antimicrobial resistance
• Hospitalisation.

Research from the University of Manchester showed that patients who have had nine or more antibiotic prescriptions for common infections in the previous three years are 2.26 times more likely to go to hospital with another infection in three or more months.²²

Older patients and those with multiple long-term conditions and morbidities are at a higher risk of repeat antimicrobial prescribing. Chronic obstructive pulmonary disease and urinary tract infections have been highlighted as the most common conditions linked to repeat antimicrobial prescribing.²³

Patients who do have a clinical need for the long-term use of an antimicrobial should have a clear indication for this in their notes and their ongoing need for the antimicrobial thoroughly assessed on a regular basis. For example, the NICE guideline for recurrent urinary tract infection recommends a six-monthly review of the ongoing need for the antimicrobial.

Practices should think carefully about their arrangements for repeat prescribing of antibiotics and ensure a clear indication is recorded in the notes where ongoing supply is deemed appropriate, with a specified review date.

The RCGP have produced the Target Toolkit Hub to support more responsible use of antimicrobials.

Good-practice examples in relation to antimicrobial prescribing are included in section 6.

2.3 Multiple medicines (polypharmacy)

Over a million people in England receive ten or more medicines on repeat prescription.²⁴ Evidence shows that up to 16.5% of admissions to hospital can be caused by adverse drug reactions (ADR) with polypharmacy and multimorbidity important factors contributing to this. Reducing inappropriate polypharmacy should be a major aim for preventing ADR.¹⁷

The RPS has previously produced guidance on polypharmacy.

When a new medicine is prescribed for a person already taking other medicines on repeat, a thorough check is needed to ensure any side effects, interactions and contra-indications have been considered. There are digital solutions to help with this in the GP clinical record system, but they can be overlooked.

General practices and/or PCNs should discuss how these warning and alert systems are used, including those suggesting over or under use of repeat medicines. This is convered in the self assessment questions.

Practices are advised to make use of the nationally commissioned new medicines service (NMS) from their local community pharmacies.

An SMR (defined below), is the best tested intervention to reduce polypharmacy. Practices and PCNs should have systems in place to identify patients taking multiple medicines, and high-risk repeat medication, and have a process to invite them for a structured medication review with a healthcare professional. They should incorporate shared decision making into the SMR to ensure that patients are fully engaged with the process and are able to express any issues, concerns and expectations related to their medicines.

See section 5.3 for evidence-based materials, available in a range of languages, to help to engage patients with the SMR process. These materials have been co-designed with patients and have been shown to increase the uptake of SMRs and reduce the number of patients who do not attend their SMR.

2.4 Medication reviews

Millions of people have the experience of receiving a repeat medication, and each year they receive a form of medication review to check that their repeat medication(s) are still appropriate and safe. However, some patients have reported that they don’t have any checks to their repeat medication and this, rightly, worries them.

In addition, there is still much confusion, even in primary care about the term ‘medication review’ and exactly what this should comprise. The generic term ‘medication review’ means different things to different people – for example, must the patient be present, how often should they happen, how detailed should it be, how long should be allocated for the appointment?

To try to address this, we have developed three broad terms for the different levels of medication review and how we think they should happen.

Simple repeat medication check (clinical re-authorisation)

• A check that the medication(s) for a single condition (e.g., asthma) or multiple allied conditions (e.g., cardiovascular diseases) were clinically checked and authorised as suitable repeat medication(s), and for how long
• The medication(s) would have ideally been clinically checked within a patient consultation or via a desktop review
• The authorisation for each medication should be either time-limited by setting the date of the next authorisation (e.g., a maximum of 12 months) or limited by the number of repeats allowed. The quantity of medication should be synchronised with the number of days issued (e.g., 56 tablets if prescribed one tablet twice a day and on a 28-day cycle) or made clear it is for use as required (e.g., 60 sachets for PRN use if repeat medication is needed)
• This review should be clearly visible within the repeat medication section of the clinical record system.

Medication review

• A holistic, clinical review of all medications for all of a patient’s conditions, ensuring any long-term condition/Quality and Outcomes Frameworks (QOF) reviews and/or relevant blood tests for safe prescribing have been undertaken or are scheduled at the required intervals
• This can be undertaken as desk-based review but ideally should be face to face or via a telephone or video consultation
• All the repeat medication should be time-limited by setting the date of the next repeat authorisation or limited by setting the number of repeats allowed
• The review should be clearly visible within the repeat medication section of the clinical record system and ideally all authorisation durations should be synchronised to coincide with the next medication review
• A systematized nomenclature of medicine clinical terms (SNOMED CT/read code) for a medication review should be recorded in the clinical record and include a clear date when the next medication review is due.

Structured medication review (SMR)

• An SMR is defined by NICE as a critical examination of a patient's medicines with the objective of reaching an agreement with the patient (or their carer) as part of a shared decision-making process about treatment, optimising the impact of medicines, minimising the number of medication-related problems and reducing waste²⁵
• Ideally an SMR should be undertaken face to face with the patient but can be via telephone or video call
• All the repeat medication should be time-limited by setting the date of the next repeat authorisation or limited by setting the number of repeats allowed
• This review should be visible within the repeat medication section of the clinical record system and ideally all authorisation durations should be synchronised to coincide with the next medication review
• A SNOMED CT (read code) for a structured medication review should be recorded in the clinical record allowing visibility for all and including a clear date when the next SMR is due (SNOMED code 1239511000000100 SystmOne Read Code Y282b).

2.5 Suggested questions for practices to consider in relation to higher-risk medicines or higher-risk patient scenarios

Higher-risk repeat medicines

1. Do administrative staff have a list of medicines classed as higher risk in relation to repeat requests that they know to manage more carefully (suggestions included in Box 1)
2. How is the repeat process for higher-risk medicines managed? Is it different to that for lower-risk medicines?
3. Careful consideration should be given before any higher-risk medicines (but especially opioids and antimicrobials) are prescribed on repeat. Is this clear in the practice procedure?
4. Where long-term use of a moderate-risk medicine is a safety issue, how does the practice ensure that there will be regular medication reviews before repeats are issued?
5. What is the procedure if a patient does not engage with the medication review or monitoring process? Is this clear to all members of the practice staff and locums?
6. Is the frequency of planned medication reviews appropriate for the risk of the medicine, e.g., no longer than three months for high-dose opioids?
7. Are there robust arrangements in place to ensure regular structured medication reviews for older people taking ten or more medicines regularly on repeat?

High-risk and vulnerable patient groups

1. Is there a practice process to identify and monitor patients taking high-risk medicines on repeat?
2. Does the practice have an agreed process for patients or patient groups deemed to be at greater risk of harm from higher-risk repeat medicines (such as those with a history of substance abuse, the very old, patients with ‘frailty’, those prescribed ten or more medicines, those with learning difficulties and those who are reliant on others to order and collect their medicines)?