In the last 10 years, the MDU has been notified of 149 potential claims and received 34 requests for medico-legal assistance from members where there has been an alleged failure to monitor conditions or prescribed medication. It probably won’t be a surprise to learn that the clinical areas most frequently cited include renal impairment, diabetes and hypertension, while one of the most commonly mentioned medications is lithium.

A complaint or claim might arise if a patient comes to harm. For example, if a practice has failed to act on blood test results and an opportunity to provide early treatment for a potentially serious illness may have been missed.

Such failure may be the sole reason for a patient’s dissatisfaction, or it may be part of a series of events which led to them to make a complaint or claim. It is not uncommon for patients who have progressive illnesses to feel that ‘more should have been done’ to prevent long-term damage.

What are the challenges to effective monitoring?

Many patients have increasingly complex needs, and polypharmacy, particularly among patients over 65 years, is now very common. For a GP, it can be time-consuming to deal with all the patient’s results and counselling in one appointment, and often patients have several problems to address, making it difficult to raise issues such as routine checks on long-term medication.

The GMC says you have a duty to ensure ‘suitable arrangements are in place for monitoring, follow-up and review, taking account of the patients’ needs and any risks arising from the medicines’ (GMC, Good practice in prescribing and managing medicines and devices, 2013, paragraph 51). This is particularly important where:

• the patient may be at risk, for example, if they are frail or have multiple illnesses
• the medicines have potentially serious or common side effects
• the patient is prescribed a controlled or other medicine that is commonly abused or misused 
• the BNF or other authoritative clinical guidance recommends blood tests or other monitoring at regular intervals.

Having adequate systems in place to monitor chronic conditions is therefore vital for all practices. For GP practices in England, the Care Quality Commission (CQC) will, during an inspection, look at the practice’s ‘processes and systems to monitor patient safety through reporting patient safety incidents and the practice’s learning from these incidents and significant events’. The ‘GP mythbusting’ section on the CQC website provides further information regarding patient safety incidents that must reported to the National Reporting and Learning System (NRLS) and provides examples of prescribing errors that could or did lead to harm.

The systems must take into account a wide variety of circumstances. For example, can the practice deal effectively with patients who fail to attend monitoring appointments or attend for blood tests? Or with incoming correspondence to ensure that blood test abnormalities and or changes to therapy are actioned promptly? Is there cross-referencing so that, where necessary, a letter from a clinic prompts a review of prescribing (e.g. in a patient with deteriorating renal or hepatic function)? Are high-risk medications such as methotrexate subject to regular audit?

Who is responsible?

MDU members sometimes ask us where the responsibility of the doctor ends and that of the patient begins? This can be a tricky issue. The obligations on doctors are clear but of course individual clinical situations have to be judged on their own merits. Consideration has to be given to the seriousness of the clinical concerns and the vulnerability of the patient, for example.

But sometimes patients are not willing to take advice or to seek attention for side effects of prescribed medication, or to attend for appointments.

One of the principles of the Mental Capacity Act 2005 is that a person must be assumed to have capacity unless it is established that he or she lacks it. This means that a patient with capacity may make decisions which we, as doctors, think are unwise or find difficult to understand. However, our role is to provide all the advice and information the patient needs to make an informed decision, even if that decision is one we disagree with.

The importance of good communication

Alongside practice systems, the key to effective monitoring is gaining patients’ compliance and in this respect, good communication is paramount. The GMC in its guidance Good medical practice (2013), emphasises the need to work in partnership with patients. The guidance states:

31 You must listen to patients, take account of their views, and respond honestly to their questions.

32 You must give patients the information they want or need to know in a way they can understand. You should make sure that arrangements are made, wherever possible, to meet patients’ language and communication needs. 

This means being aware of communication challenges, for patients with sensory impairment, or for whom English is not a first language, for example. Sometimes written information can be helpful, whether online or in the form of patient information leaflets. It can also be helpful to allow patients some “breathing space” to consider options and return with further queries or to seek extra clarification. Listening to patients and deciding with them on appropriate management is very important.

Pharmacists can also be a source of great help, especially if a patient reports to them problems with tolerance or side effects with taking long-term or new medicines. Of course, this does not absolve you of your duty to ensure your prescribing and medicines management are appropriate, but you should consider and, where necessary, act on information a pharmacist, or indeed any other healthcare professional who has reviewed the patients’ use of medicines, passes on.

When it comes to shared responsibility between primary and secondary care, well-drafted protocols can be very helpful as they set out clearly the responsibilities on the various parties involved in the patient’s treatment.

Top Tips for managing monitoring

1. Encourage colleagues (such as prescribing clerks and pharmacists) to raise concerns or issues with compliance and to act as an early warning system.
2. Document carefully any explanations you give about monitoring when initiating medication. This should include side effects, frequency of blood tests etc. Advise patients what to do if they experience side effects.
3. Document discussions with patients who ignore medical advice. This may need to be in writing to a patient who repeatedly fails to attend, and the use of a signed-for postal service can provide proof that a letter was delivered.
4. Try and tailor the advice re monitoring so that it is appropriate to the patient. For example, the risks of a CVA may be of little relevance to a young diabetic patient but the risks of impotence may be more relevant.
5. Ensure that the practice carries out audits and uses the MHRA Yellow Card scheme and encourages patients to do the same.
6. Ensure that the practice has effective systems to ensure monitoring of chronic conditions (eg a patient may find it easier to remember that their TFT blood tests needs to be done in their birthday month each year)
7. Remember that the risk / benefit ratio of treatments may change with time, eg warfarin in patients with falls. Though good discussions often occur with patients when medication is initiated or a condition is diagnosed, remember that these may need to be repeated in the light of new information.
8. Good communication with patients. Trying to understand why the patient will not attend for appointments may be key to overcoming the problem