Preparing for the GPhC registration exams: how to revise learning outcomes relating to clinical knowledge and therapeutic approaches

In part 2 of this series, we looked at the outcomes in section 10.1 of the General Pharmaceutical Council’s registration assessment framework and discussed indicative assessment topics, including resources for your revision and how to tackle example questions. In part three, we will look at the outcomes contained in section 10.2.2 of the framework, which focuses on therapeutic knowledge. This article will provide three worked examples, showing how you can apply the learning outcomes to different therapeutic areas, and will consider some of the general principles that examiners will be following to assess your knowledge. Please note that it is beyond the scope of this series to explore each outcome from the assessment framework in depth or to consider the full range of therapeutic areas and conditions that you will need to know for the exam. The examples provided are intended to illustrate possible approaches that you can apply to the rest of the framework and full range of conditions.

Revising therapeutic areas

When revising outcomes related to therapeutic approaches, it can be difficult to know where to start and how many conditions you need to look at. As a reminder, there are 15 therapeutic areas listed in the GPhC assessment framework, which are weighted as low, medium or high to indicate the proportion of questions they will account for in the exam (see part 1 of the series for more on how the assessment framework is structured). Therapeutic areas are mostly systems based and contain different conditions and sub topics — there is no way of knowing which ones will be used within the exam. The British National Formulary (BNF) provides a useful structure that you can follow to break therapeutic areas down to a more granular level and identify specific conditions to focus on. You should aim to cover as much as you can during revision, while allocating time strategically. It is sensible to prioritise common conditions typically encountered in regular practice across different settings and, if time permits, progress to rarer conditions and lower-weighted therapeutic areas. As an example, for the cardiovascular system, the commonly encountered conditions could include hypertension, stroke, angina, atrial fibrillation, hyperlipidaemia and heart failure.

Worked example 1 — hypertension

Several of the highly weighted outcomes within section 10.2.2 of the GPhC framework broadly follow the assessment, prescribing, dispensing, advice, counselling and follow up of the patient. For these outcomes, it makes sense to approach your revision within the context of a specific therapeutic area and condition. For this worked example, we will use the cardiovascular system as our therapeutic area and will further select hypertension as the condition to focus on. We will explore some of the relevant outcomes and then consider how this can be applied to a typical exam question.

How to meet the outcome

This outcome requires you to understand how hypertension is diagnosed in adults. According to the National Institute for Health and Care Excellence (NICE), hypertension diagnosis is based on clinic and ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM) readings​[1]​. Stage 1 hypertension diagnosis is based on a clinic BP of 140/90mmHg to 179/119 mmHg and subsequent ABPM or HBPM of 135/85mmHg to 149/94mmHg. Stage 2 hypertension diagnosis is based on a clinic BP of 180/120mmHg or more and subsequent ABPM or HBPM of 150/95mmHg or more. NICE provides a visual summary for diagnosis and treatment of hypertension, which shows BP thresholds and associated outcomes. Take a moment to access the summary now as we will refer to it as we progress further through this example.

For this part of the outcome, the GPhC exam questions are most likely to present a scenario where a patient has certain BP readings (clinic and ABPM), with or without comorbiditities or current medications. You may then be asked to select the next step in BP management that you judge to be the single best option — therefore, as part of your revision, you need to be familiar with the information contained in the NICE visual summary. BP readings, age and any comorbidity given in the question will help you to determine what actions to pursue.

In addition to diagnosis, section 10.2.2 also includes the following outcome, which requires you to be knowledgeable about the clinical appropriateness of prescribed medications for your patient.

We will again apply this to the example of hypertension. For this outcome, you need to understand the main prescribing guidelines; for example, NICE guidance and clinical knowledge summaries, and local prescribing formularies. Having previously worked through the diagnosis stage using the visual summary provided by NICE, it should be straightforward to further apply the guidelines to assess the appropriateness of drugs used for hypertension. Using the NICE guideline NG136, you would need to know which treatments or advice would be used for different BP stages, while considering the specific patient characteristics. This information has again been summarised visually by NICE in the form of a flow diagram.

You should apply the treatment guidance in the context of the presenting condition, the patient characteristics and their other comorbidities. The main drug classes used in the treatment of hypertension include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers (CCBs), thiazide-like diuretics, alpha blockers and mineralocorticoid receptor antagonists (MRAs). You should know prescribing information for the main drugs used for hypertension, including indications, dose, contraindications, cautions, interactions, side effects, allergy and cross sensitivity, use in pregnancy and breastfeeding, hepatic impairment, renal impairment and monitoring requirements​[2]​.

For example, for ACE inhibitors, the BNF and summary of product characteristics (SmPC) recommend that a patient’s renal function and electrolytes should be checked before starting ACE inhibitors (or increasing the dose) and monitored during treatment (more frequently if side effects are present)​[2]​. With regards to drug interactions, ACE inhibitors increase the risk of hyperkalaemia if co-administered with spironolactone, non-steroidal anti-inflammatory drugs (NSAIDs), ciclosporin or heparin; therefore, close monitoring of potassium is recommended​[2]​. The full prescribing information for anti-hypertensive drugs can be found in the BNF, or SmPC from the Electronic Medicines Compendium. It is important to know the most used examples of drug in each class as most of the prescribing information is usually related to the class rather than specific drug (with slight variations). You should also consider special populations for which there is specific guidance; in the treatment of hypertension, this would include pregnant and breastfeeding women, patients with type 1 diabetes mellitus or patients with chronic kidney disease. You should also understand what the terms off-licence and off-label use mean; for instance, methyldopa and nifedipine are used off licence for hypertension in pregnancy​[2]​.

Having considered how to clinically evaluate the appropriateness of the prescribed medicines, the next relevant outcome for managing a patient with hypertension relates to providing safe and effective instructions for the use of medicines.

This outcome requires you to bring together your knowledge of medicines with specific patient considerations, while optimising your communication strategy for each individual patient. Let us take the example of a male black African patient, aged 53 years, who has recently commenced treatment with amlodipine for hypertension. The patient would need to be advised to take the drug at the same time each day and instructed on what to do if he forgets a dose. You should provide information on common side effects and what he should do if the side effects are severe and any effects on impairment of driving; for example, severe ankle swelling may warrant referral to the prescriber for the treatment to be reviewed. The side effects of amlodipine include dizziness, headache, fatigue or nausea, and the ability to react may be impaired, so it is important for the patient to be warned about this[2]. Additionally, you should also advise him to avoid grapefruit or grapefruit juice and certain over-the-counter products that can counteract the antihypertensive effects or enhance side effects (e.g. NSAIDs, oral decongestants and St John’s wort)​[2]​.

The final outcome from section 10.2.2 that we will apply to our hypertension example is focused on monitoring and modifying treatments to optimise medicines use and patient outcomes.

According to the Royal Pharmaceutical Society, “medicines optimisation helps the right patients to get the right medicines at the right time. It examines how patients may stop or start their medicines, how they use them over time and how lifestyle changes or non-medical therapies might reduce the need for medicines”​[3]​. For example, in the management of hypertension, you need to know the appropriate drug and dose to be prescribed for each individual patient and any dose adjustments necessary owing to age or comorbidities. The BNF and SmPC both document any applicable dosage modifications; for example in older people, or patients with renal impairment or hepatic impairment. You would need to discuss adherence with the patient and address any issues of non-adherence with them — for instance, a patient may stop or reduce treatments owing to troublesome side effects (e.g. erectile dysfunction caused by thiazide-like diuretics, such as indapamide​[2]​). The way in which side effects are managed would vary depending on the drug and the nature of the side effects; for example, a troublesome dry cough caused by an ACE inhibitor would warrant changing the drug to an ARB. However, serious side effects, such as anaphylaxis, would require a 999 call and to be managed in hospital.

Monitoring for therapeutic benefit and side effects and any subsequent actions to take should be considered. It would be advisable to monitor BP and weight​[2]​. If the patient is taking ACE inhibitors, renal function, urea and electrolytes would need to be measured, and you need to know the implications of any abnormal results and what actions to take​[2]​. The table below summarises some of the key prescribing information for ACE inhibitors that can help you to meet the above outcome. To fully meet this outcome, you need to study all of the main prescribing information of the other classes of drugs commonly used in hypertension, selecting at least one representative drug from each class. The prescribing information can be found in the BNF and SmPC.

Example exam question

Mrs Peters, a woman of black African Caribbean descent, aged 72 years, presents at the GP practice for a follow-up appointment. She suffers from a longstanding history of high blood pressure and type 2 diabetes mellitus, which she has been managing with diet, exercise and drug therapy. Her current BP readings are as follows:

• Clinic BP = 139/89mmHg
• ABPM/HBPM = 134/84mmHg

The patient’s medical record shows that she is currently taking the following current drugs:

• Amlodipine 2.5mg tablets 1OD
• Losartan 100mg tablets 1OD

She is complaining that her ankles are swollen and putting her feet up on a chair does not help.

What would be the best next step in managing her blood pressure?

A: Add indapamide
B: Continue with current regimen and reassure patient 
C: Increase amlodipine dose to the maximum tolerated dose
D: Replace losartan with ramipril
E: Replace amlodipine with indapamide

Correct answer = E

Discussion:

This question requires you to draw from multiple knowledge sets, which need to be applied to the scenario. Below, we will critically look at all the options and justify why E is the best next step.

Option A

Looking at the NICE visual summary for antihypertensives, the patient is at step 2 of drug treatment i.e. ACE inhibitor or ARB + CCB or thiazide-like diuretic. Losartan is currently at the maximum dose, but amlodipine is not. At this stage, if BP was not controlled and there was no concern over side effects, you would consider increasing the amlodipine dose to its maximum dose, and if no control is attained, go on to step 3, where you would add a thiazide-like diuretic (e.g. indapamide). However, the patient’s blood pressure is well controlled, and our concern is the ankle swelling, which presumably is a side effect from amlodipine. According to NICE guidance, if ankle swelling is troublesome, the best option is to stop amlodipine and replace it with a thiazide-like diuretic(1). For this reason, answer option A is partly correct but does not stand out as the best option.

Option B

This option may seem plausible to a candidate who does not have full knowledge about amlodipine side effects and how to manage them. The ankle swelling may also be misinterpreted by a candidate as a sign of worsening hypertension. Patients on amlodipine are warned about potential minor adverse effects and advised that these usually get better after some time. However, according to NICE guidelines and the BNF[2], troublesome ankle swelling caused by amlodipine warrants treatment to be changed to a thiazide-like diuretic; therefore, continuing with the current regimen is not the best next step.

Option C

A candidate who has little knowledge of blood pressure targets after treatment and amlodipine side effects is most likely to select option C. Option C looks plausible as the amlodipine dose has room to be titrated to its maximum dose if, for example, the patient did not have ankle swelling and the blood pressure was not controlled. However, from the scenario, we learn that this is not the case as the blood pressure is well controlled and the patient is suffering troublesome ankle swelling. So, increasing the amlodipine dose is not the best option.

Option D

Option D sounds plausible since, for type 2 diabetes mellitus, the guidelines recommend an ACE inhibitor or ARB to be used. However, the patient is from a Black African background, so losartan (an ARB) should not be replaced. So to assess this answer option you would need to know that ACE inhibitors are not recommended in adults of Black African or Caribbean family origin with ARBs a more effective option.

Option E

Examiners will expect candidates to know the BP targets, how to prescribe various antihypertensives for different patient types and the prescribing information for the main drugs. The candidate should know that the BP readings shown in the scenario suggest that BP is under control. They should also know all the prescribing steps from the NICE visual summary and that the patient is currently at step 2 of drug treatment. This question also requires knowledge of side effects of CCBs and what action should be taken. According to NICE guidelines, if ankle swelling is bothersome, the CCB should be replaced with a thiazide-like diuretic (e.g. indapamide)​[1]​. This question required you to piece together various knowledge; simple recall of isolated facts would not be sufficient.

Worked example 2 — analysing prescriptions

In this example, we will look at one of the medium-weighted outcomes from section 10.2.2 of the GPhC framework, relating to analysing prescriptions for validity and clarity. This outcome can be applied generically to all therapeutic areas.

How to meet the outcome

The BNF and Medicines, Ethics and Practice (MEP) guide provide summaries of what is required for a prescription to be deemed legal​[2,4]​. In most cases, pharmacists can only supply prescription-only medicines under a prescription issued by an appropriate practitioner. The Human Medicines Regulations 2012 provide the legal framework for this. Different types of prescribers have further controls imposed by relevant regulatory and professional bodies. For example, dentists prescribing under the NHS contract can only prescribe medicines listed in the Dental Practitioners’ Formulary. The Human Medicines Regulations 2012 grant exemptions to restrictions on the sale, supply and administration of medicines. Examples of these exemptions include patient specific directions, patient group directions and emergency supplies.

For prescriptions, legible writing in indelible ink (if working on paper) is a prerequisite and must include the following:

• Patient’s name and address;
• Patient’s date of birth (for children aged under 12 years, their age must be stated);
• Address of the prescriber;
• An indication of the type of prescriber (particulars of prescriber);
• The prescriber’s signature in ink or an appropriate electronic signature.

To fully meet the above outcome, you must study the MEP guide, which summarises the legal requirements and any restrictions imposed on each type of prescriber. Be mindful that controlled drugs and veterinary prescriptions carry additional requirements. For example, prescriptions for Schedule 2 and Schedule 3 controlled drugs must stipulate the total quantity to be dispensed in both words and figures.

Example exam question

Consider the following five prescriptions (A to E) signed by the prescribers indicated. Assume there are no technical errors in the way the prescriptions are written; they are all dated and signed, and nothing is missing.

Which prescription would you legally dispense with no query as the prescriber is legally allowed to prescribe the item on the prescription?

1. A dentist prescribes a private controlled drug prescription for diamorphine for treating addiction. He does not have any other licenses, other than registration with the General Dental Council
2. A nurse independent prescriber prescribes an FP10 NHS prescription for dipipanone for the treatment of addiction
3. A pharmacist independent prescriber prescribes an FP10 NHS prescription for diamorphine for the treatment of pain in palliative care
4. A physiotherapist independent prescriber prescribes an FP10 NHS prescription for oral pregabalin for pain
5. A podiatrist independent prescriber prescribes an FP10 NHS prescription for oral buprenorphine

Correct answer = C

Discussion:

To answer this question, you need to familiarise yourself with the prescribing scope for each prescriber, which is clearly stated in the MEP. A pharmacist independent prescriber is allowed to prescribe diamorphine for pain in palliative care. You should consult the MEP to review restrictions imposed on all prescribers. Based on these restrictions, you will notice that the dentist, nurse, physiotherapist and podiatrist have all prescribed outside their scope of practice.

Worked example 3 — confidentiality and disclosing information

The final worked example explores the outcome related to observing confidentiality and the maintenance of appropriate records that comply with both legal, organisational and professional requirements. As with the previous example, it can be applied in a similar way across all therapeutic areas.

How to meet the outcome

To meet the above outcome, you need to understand the principles behind confidentiality and consent, and how to apply this in everyday pharmacy practice. People seeking care from pharmacy professionals expect their privacy to be maintained while divulging personal information during their care. Various policies and pieces of legislation provide guidance for pharmacy professionals. The General Data Protection Regulation and Human Rights Act are important pieces of legislation that you should be familiar with. The legislation is enforced by the Information Commissioner’s Office on behalf of data subjects (people whose data is stored). Confidential information can be continaned in both hard copy and electronic data and includes:

• Personal details;
• Information about a person’s medication (prescribed and non prescribed);
• Other information about a person’s medical history, treatment or care that could identify them;
• Information that people share that is not strictly medical in nature, but that the person disclosing it would expect to be kept confidential.

Pharmacy professionals need to know when to seek guidance from appropriate authorities. When confidentiality is breached, it is important that appropriate reporting procedures are followed. Confidential information does not include:

• Anonymous information — information that does not relate to an identified or identifiable natural person or to personal data rendered anonymous in such a manner that the data subject is not or no longer identifiable;
• Pseudonymised information — the processing of personal data in such a way that the data can no longer be attributed to a specific data subject without the use of additional information;
• Information that is already legitimately in the public domain.

Disclosing confidential information primarily requires the consent of the data subject. Disclosure may also be required by law, in the public interest or vital interest of the data subject. Consent is defined as the expression of willingness to give permission, which may be in relation to receiving a specific professional service, treatment, care or divulgence of personal information. Consent can only be given by a subject who is deemed to have the mental/intellectual capacity to do so. According to the GPhC, capacity is the ability to understand given information, remember, weigh up and make or communicate decisions relating to their care​[5]​. A lack of capacity may arise owing to mental impairment or disturbance that affects the way the mind or brain works. Adults and people aged 16–17 years are presumed to have capacity. Children are not presumed to have capacity and must demonstrate their competency.

The following resources may be useful for enhancing your knowledge on confidentiality and disclosing information:

• In practice: Guidance on confidentiality
• Medicine, Ethics and Practice 
• Guidance to support pharmacy professionals to meet the standards for the pharmacy profession
• Information Commissioner’s Office 
• Adults with Incapacity (Scotland) Act 2000
• Children and young people: consent to treatment

Example exam question

You are the responsible pharmacist in charge of a community pharmacy. Today, you have been approached to disclose confidential information in the following circumstances detailed in options A–E below.

Which one of these options would you legally disclose confidential patient information without patient consent?

A. A husband who has just handed in a prescription for his wife and wants to know what the drug is for

B. A mother of a girl aged 16 years, who has found an empty pack of EllaOne (ulipristal) in her daughter’s bedroom and wants to know what it is for

C. A doctor phoning from a hospital who wants to know what medication a patient in his care is taking as part of caring for that patient

D. A police officer on duty who has arrested a patient who comes in to the pharmacy daily for treatment for addiction and he wants to know what medication he is taking

E. A police officer who brings a labelled packet of tablets retrieved from one of your patient who comes in to the pharmacy daily for treatment for addiction and wants you to confirm if the tablets were supplied to the patient by your pharmacy

Correct answer = C

Discussion

A doctor at the hospital should be given patient information without patient consent to facilitate the care of the patient. All the other persons require consent from the patient (the police officer would need a written authority). According to the GPhC, a healthcare professional should disclose confidential information under the following conditions:

• If they have the consent of the person under their care;
• They must disclose by law;
• They should do so in the public interest, and/or 
• They must do so in the vital interests of a person receiving treatment or care​[6]​.

Summary

The above examples demonstrate how you can apply the clinical and therapeutic learning outcomes in the GPhC assessment framework to example exam questions and focus your revision efficiently. The key is to make full use of the main clinical information sources (e.g. BNF, SmPC and MEP) and take direction from the indicative assessment topics stipulated on the GPhC registration assessment framework. You should use the time available in the lead up to the exams carefully and develop a clear strategy that allows you to spend the right amount of time on the differently weighted outcomes, taking a balanced approach to each therapeutic area. Ensure that you assign enough time to revise each of the 15 therapeutic areas and use the BNF to help you identify a wide range of conditions to focus on. By doing this, you will improve your chances of success and will enter the exams with increased confidence.

Acknowledgements: 

All practice questions were reproduced with kind permission provided by Focus Pre-Reg Revision