EXAMINER ONLY INFORMATION

QUESTIONS

Q1. What are your differential diagnoses for Peter’s symptoms?

• Prompt: How would you differentiate an adverse drug reaction from other causes?
• Prompt: What red flags would prompt urgent investigation?

Q2. What further history would you elicit to confirm the diagnosis?

• Prompt: What risk factors increase the likelihood of statin-related myopathy?
• Prompt: How would you assess for complications such as rhabdomyolysis?

Q3. What investigations would you order and why?

• Prompt: What tests help confirm statin-induced myopathy?
• Prompt: When would you escalate care for potential rhabdomyolysis?

Q4. Outline your management plan for Peter’s suspected statin-induced myopathy.

• Prompt: Would you stop or modify his statin therapy?
• Prompt: What alternative lipid-lowering options are available?

Q5. What are the follow-up and safety-netting considerations?

• Prompt: When should he return for review?
• Prompt: What symptoms would warrant urgent medical attention?

THE COMPETENT CANDIDATE

The competent candidate should be able to:

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Q1: What are your differential diagnoses for Peter’s symptoms?

A competent candidate should consider a structured differential diagnosis, including:

• Statin-induced myopathy (most likely): Common adverse effect, presenting as muscle aches, fatigue, and weakness, especially after dose escalation.
• Statin-induced rhabdomyolysis (severe): Red flags include severe muscle pain, dark urine (myoglobinuria), and elevated creatine kinase (CK).
• Polymyalgia rheumatica: Typically affects older adults with morning stiffness and elevated inflammatory markers.
• Hypothyroidism: Fatigue and myopathy can mimic statin-related muscle symptoms.
• Electrolyte disturbances (e.g., hypokalaemia, hypomagnesaemia): May cause muscle fatigue and cramps.
• Inflammatory myopathies (e.g., polymyositis): Proximal muscle weakness with elevated CK and autoimmune markers.

Red flags requiring urgent investigation:

• Severe muscle pain with weakness.
• Dark urine (suggestive of rhabdomyolysis).
• Systemic symptoms such as fever or weight loss.

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Q2: What further history would you elicit to confirm the diagnosis?

• Medication history: Dose, duration, adherence, other lipid-lowering agents (e.g., fibrates), recent changes.
• Pre-existing risk factors: Renal impairment, hypothyroidism, previous statin intolerance.
• Symptom onset and severity: Gradual or sudden onset, impact on daily function.
• Presence of systemic symptoms: Fever, weight loss, skin rash, or joint pain (suggests alternative diagnoses).
• Dark urine or reduced urine output: Suggests myoglobinuria and possible rhabdomyolysis.
• Physical activity and lifestyle factors: Excessive exercise or dehydration can exacerbate statin-related myopathy.

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Q3: What investigations would you order and why?

• Serum creatine kinase (CK): Elevated in statin-induced myopathy (>10x ULN suggests rhabdomyolysis).
• Renal function tests (eGFR, creatinine): Assess for renal impairment due to myoglobinuria.
• Liver function tests (ALT, AST): Can be mildly elevated in statin use but should not be significantly raised.
• Thyroid function tests (TSH, free T4): Rule out hypothyroidism as a contributing factor.
• Electrolytes (K+, Mg2+, Ca2+): Identify any contributing metabolic abnormalities.

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Q4: Outline your management plan for Peter’s suspected statin-induced myopathy.

• Stop atorvastatin temporarily and monitor symptom resolution.
• Ensure hydration and monitor renal function, particularly if CK is significantly elevated.
• Review necessity of statin therapy:
  • If high CVD risk, consider dose reduction or alternative statin (e.g., rosuvastatin, pravastatin).
  • If statins are not tolerated, consider ezetimibe or PCSK9 inhibitors.
• Monitor CK levels over 2-4 weeks to assess for resolution.
• Rechallenge with a lower dose or alternative agent if symptoms resolve.

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Q5: What are the follow-up and safety-netting considerations?

• Review in 2-4 weeks to assess symptom resolution and CK levels.
• Reassess lipid management and discuss alternative therapies if needed.
• Educate Peter on red flags for rhabdomyolysis: worsening muscle pain, weakness, or dark urine.
• Long-term monitoring for lipid targets and cardiovascular risk management.

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SUMMARY OF A COMPETENT ANSWER

• Uses a structured differential diagnosis, considering other causes of muscle symptoms.
• Takes a thorough history, including medication adherence, risk factors, and systemic symptoms.
• Orders relevant investigations, including CK, renal function, thyroid function, and electrolytes.
• Manages statin intolerance appropriately, including temporary cessation and alternative lipid-lowering therapies.
• Implements a structured follow-up plan, ensuring resolution of symptoms and ongoing cardiovascular risk management.

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PITFALLS

• Failing to consider serious complications, such as rhabdomyolysis requiring urgent management.
• Not assessing for reversible causes, such as hypothyroidism or electrolyte abnormalities.
• Stopping statins indefinitely, increasing long-term cardiovascular risk without considering alternative strategies.
• Neglecting to educate the patient, missing an opportunity to reinforce medication safety.
• Lack of structured follow-up, failing to assess symptom resolution and lipid control.

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REFERENCES

• RACGP – RACGP Clinical Guidelines – Adverse Drug Reactions
• GP Exams – Adverse effect medical agent

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MARKING

Each competency area is on the following scale from 0 to 3.

☐ Competency NOT demonstrated
☐ Competency NOT CLEARLY demonstrated
☐ Competency SATISFACTORILY demonstrated
☐ Competency FULLY demonstrated

1. Communication and Consultation Skills

1.1 Establishes rapport and gathers a detailed medication history.
1.2 Provides patient-centred education about adverse drug reactions and management.

2. Clinical Information Gathering and Interpretation

2.1 Conducts a focused history and physical examination to assess the adverse drug reaction.
2.2 Identifies causative medication and evaluates contributing factors.

3. Diagnosis, Decision-Making and Reasoning

3.1 Recognises an adverse drug reaction and differentiates it from other causes.
3.2 Assesses severity and determines if medication cessation or change is required.

4. Clinical Management and Therapeutic Reasoning

4.1 Develops an appropriate management plan, including medication adjustment and supportive care.
4.2 Reports the adverse reaction as per regulatory requirements.

5. Preventive and Population Health

5.1 Educates on safe medication use and monitoring for future adverse effects.

6. Professionalism

6.1 Demonstrates empathy, addressing patient concerns and fears about medications.

7. General Practice Systems and Regulatory Requirements

7.1 Documents the adverse effect, management plan, and regulatory reporting.

8. Procedural Skills

8.1 Conducts relevant bedside and clinical assessments for adverse drug reactions.

9. Managing Uncertainty

9.1 Ensures appropriate follow-up and safety-netting in case symptoms worsen.

10. Identifying and Managing the Patient with Significant Illness

10.1 Recognises severe or life-threatening drug reactions requiring urgent intervention.

Competency at Fellowship Level

☐ CLEARLY BELOW STANDARD
☐ BELOW EXPECTED STANDARD
☐ BORDERLINE
☐ AT EXPECTED STANDARD
☐ ABOVE STANDARD