The philosophy behind the approach to indemnity in pharmacist diagnosis
Pharmacists have been involved in one form of diagnosis or another for many years. Predominantly, this occurs in a community pharmacy where ‘walk in’ customers ask pharmacists to help them out with minor ailments. This is a relatively anonymous transaction, often, the patient is not known to the pharmacist, there are no comprehensive patient’s records available and patients are told to go to their GP if their condition does not resolve itself in a few days. If, after such a relatively anonymous transaction in a community pharmacy setting, the patient suffers a significant deterioration in their symptoms,( for example in the event that they have congestive heart failure after a pharmacist has considered that they merely have a cold and a self-limiting cough, with a recommendation to seek the advice of the GP if the condition does not clear in a few days) then any potential claimant will have much weaker grounds upon which to seek a claim for compensation from the community pharmacist. Moreover, the regulator would be less likely, in these circumstances to decide that the pharmacist’s fitness to practice was impaired. It would be much easier to defend a pharmacist who may face proceedings in this kind of situation.
The dynamics involving pharmacist diagnosis in a GP surgery are altogether different. The patient is registered with the surgery and has likely made an appointment, the pharmacist has access to the full patient’s notes and a GP is available for advice if necessary. This is not an anonymous ‘retail sale’ transaction, but one which has all the hallmarks of a patient and healthcare professional relationship. The standard of the service that would be expected of a pharmacist in this much more controlled environment are significantly higher as compared to the relatively anonymous transaction seen in a community pharmacy setting. Consequently, pharmacists involved in diagnosis in a GP surgery are involved in significantly more exposure to liability in the event that a misdiagnosis occurs.
There are broadly two types of diagnosis; Differentiated (previously diagnosed by a doctor) and undifferentiated (where a patient comes in to be diagnosed for the first time).
Differentiated Diagnosis
The PDA scheme recognises that any pharmacist Independent Prescribers working in a GP Practice will almost certainly be involved with patients in face to face Differentiated Diagnosis at some point within their role and this cover is therefore provided as an automatic element of their IP extension. As they are working in a GP surgery, they will have full access to the patient’s notes. Cover is provided in the following situations;
Differentiated Diagnosis and Undifferentiated Diagnosis.
- The condition being treated has been previously diagnosed by another suitably qualified Health Care Professional and is now being referred on to the pharmacist. The patient may subsequently experience deterioration in their condition which the pharmacist diagnoses and manages in accordance with their Boundaries of Clinical Practice Statement (BCPS).
- The condition being treated has been previously diagnosed by another Health Care Professional. The patient subsequently develops a complication of the original condition which the pharmacist diagnoses and manages in accordance with their BCPS.
- A patient is triaged by another Health Care Professional who has eliminated ‘red flag’ diagnoses and has established that the condition is a minor ailment. In such a scenario the pharmacist is likely to be operating a Minor Ailments service. They determine the most likely diagnosis and prescribe or recommend treatment in accordance with their BCPS.
- Due to the extent of their experience and higher level qualifications, the pharmacist is working as a ‘specialist pharmacist’. A patient is referred to them with a diagnosis which is within their BCPS. They examine the patient and conclude that the diagnosis is different (for example they eliminate an original diagnosis of asthma and diagnose COPD). The revised diagnosis is also within their BCPS and they subsequently manage the condition.
- Where they may be diagnosing within their BCPS, but where this leads to any recommendation for changes in medication to be authorised by the GP. Or where they are working under a strict protocol, which requires any initial diagnosis made by them to be checked and approved by the GP.
- Where a patient is being seen as part of a repeat prescribing service or medication review or similar and where the pharmacist diagnoses a new condition which they consider to be a minor ailment.
It is recognised that many PDA members have been involved in differentiated diagnosis whilst working in a GP surgery for some considerable time.
Undifferentiated Diagnosis
This is less common practice for pharmacists to be involved in but it is likely to become more common over time. Here, the pharmacist is the first point of contact in a GP practice and is in a position to have full access to patients’ clinical records. They are in a position to diagnose (or rule out) a condition which is not documented in the clinical record nor has it been previously diagnosed by another appropriate Health Care Professional. They should only be involved in undifferentiated diagnosis if it is carried out in accordance with their Boundaries of Clinical Practice Statement (BCPS). This also includes scenarios where they see a patient for management of one condition (within your BCPS) and they ask for advice on a new complaint.
The risks associated with Undifferentiated Diagnosis are significantly higher than many other activities undertaken by pharmacists in primary care and the indemnity premiums are much higher. This cover is only available via the HIGHER RISKS extension. If the cover level for Undifferentiated Diagnosis is taken out, then cover will automatically be provided for Differentiated Diagnosis as this is considered to be a lesser form of risk.
Conditions
Undoubtedly both differentiated and in particular undifferentiated diagnosis exposes pharmacists to a much greater risk of litigation and this is why a number of conditions to the cover provided have been attached.
- Pharmacists must ensure and must be able to demonstrate that they are competent to undertake the diagnostic tasks that they perform. Evidence will be requested for sight of relevant training.
- Pharmacists must have established either a senior clinical practitioner with the required competence and/or a professional peer group to act as a reference point to assist in the event that they need support in any of their diagnostic activities.
- Protocols must be in place and must be observed to include;
- A significant event monitoring process
- A service review process which reviews pharmacist performance in the area of diagnosis.