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GP mythbuster 84: Managing high risk medicines in general practice

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  • GP and GP out-of-hours services

Some medicines are considered ‘high risk’ because the potential side effects mean appropriate blood monitoring and careful dose adjustment is required.

Examples include methotrexate, azathioprine, lithium, amiodarone, warfarin and some antiepileptics.

How should high risk medicines be monitored?

GMC guidance Good practice in prescribing and managing medicines and devices (2013), states that prescribers should be assured that medicines remain safe and necessary for the individual. This still applies when shared care arrangements are in place, and the legal responsibility to ensure safety rests with the person signing the prescription.

Patients who are prescribed these medicines should be monitored in line with one or more of the following:

  • practice protocol, which reflects national guidance
  • shared care agreement specific to the patient,
  • manufacturer’s summary of product characteristics for the product.

If the practice does not arrange blood testing themselves, they must see the results or a letter stating monitoring remains satisfactory before issuing a prescription. This also applies if a practice is issuing prescriptions while monitoring is managed in secondary care.

CQC expectations

We may request details on how high risk medicines monitoring is provided and safety assured. Before issuing a prescription (including a repeat one) we expect to see prescribers:

  • review the monitoring or know that it has been completed, and
  • can access information showing it remains safe for the patient to receive the medicines.

We may identify patients prescribed high risk medicines in the previous 12 months and review a sample of notes. These patients will usually be identified using the practice’s recall process or inbuilt searches within clinical systems. Patients will be reviewed using nationally accepted monitoring standards or local shared care protocols.

We will examine the patients’ records to determine:

  • frequency of monitoring
  • adherence to any shared care protocols
  • that the prescriber reviewed the results.

The review may include consultation notes, pathology results, letters, and internal and external tasks.

We may review processes around prescribing and monitoring for other medicines.  For example, medicines that:

  • need renal function monitoring
  • are more likely to be misused
  • have been the subject of national patient safety alerts.

Monitoring of high risk medicines comes under key line of enquiry S4 in our healthcare assessment framework.

Last updated:
28 April 2021