You are on page 1of 4

FC Clin Pharm(SA) Part II

THE COLLEGES OF MEDICINE OF SOUTH AFRICA


Incorporated Association not for gain Reg No 1955/000003/08

Final Examination for the Fellowship of the College of Clinical Pharmacologists of South Africa

31 August 2011 Paper 1 (3 hours)


All questions are to be answered. Each question to be answered in a separate book (or books if more than one is required for the one answer)

Mrs Barry is a 46-year-old female with history of a renal transplant 2 years ago and Juvenile Rheumatoid Arthritis for the past 20 years. Her current treatment is cyclosporine, prednisone, and celecoxib. However, her physician was concerned with the continuing use of the celecoxib, stating that he felt that celecoxib was not serving its purpose, and therefore was a potential source of side effects for nothing. a) b) c) d) Comment on the physicians statement that celecoxib was not serving its purpose. (2) Describe two mechanisms of NSAID-induced nephrotoxicity. (6) Describe the mechanism of action of ciclosporin. (2) Briefly discuss common ciclosporin adverse drug reactions. (5) [15] (3) (7) (5) [15] (7) (13) [20]

Regarding Therapeutic Drug Monitoring (TDM) a) Define TDM. b) List the major sources of pharmacokinetic variability. c) Which characteristics of a drug make TDM useful? a) b) Classify the drugs used in Parkinsons Disease. Discuss the principles of treatment in Parkinsonism.

You are approached to be part of a scientific review committee regarding the registration of complementary medicines within South Africa. Discuss the reasons why the regulatory framework for the registration of a complementary medicine may differ from those for an orthodox medicine, and their implications for regulatory authorities. [20] A 57-year-old man was rushed to his local hospital with a 30 min history of severe chest pain associated with dizziness and nausea. On examination he was pale, sweaty and tachycardic and an electrocardiogram demonstrated changes consistent with an acute ST-elevation anterior myocardial infarction. He was treated immediately with aspirin, opiate analgesia, and oxygen and was given early intravenous streptokinase therapy in the absence of any contraindication. Random cholesterol was 4.9 mmol/L, random glucose values were normal and he was normotensive throughout. He settled over the next few days without complications and is ready for discharge. He is free of chest pain and has no evidence of cardiac failure. Discuss drug therapy on discharge, giving a brief overview of the evidence for benefit of each agent that you select. [15]

Discuss the mechanism of action and evidence for/against the use of the following drugs in status asthmaticus. a) Nebulised ipratropium. (5) b) Intravenous magnesium sulphate. (5) c) Intravenous aminophylline. (5) [15]

FC Clin Pharm(SA) Part II

THE COLLEGES OF MEDICINE OF SOUTH AFRICA


Incorporated Association not for gain Reg No 1955/000003/08

Final Examination for the Fellowship of the College of Clinical Pharmacologists of South Africa

1 September 2011 Paper 2 (3 hours)


All questions are to be answered. Each question to be answered in a separate book (or books if more than one is required for the one answer)

Mr Meintjies is a 57-year-old policeman with a past medical history of pulmonary tuberculosis, which he completed treatment for 3 years ago. He presented two months ago with history of a persistent cough, night sweats and loss of weight over the past 3 months. Two sputum samples were smear negative. The GP made a clinical and radiological diagnosis of pulmonary tuberculosis, and started treatment with rifampicin, isoniazid, pyrazinamide, ethambutol and streptomycin. Following voluntary counseling and testing, the diagnosis of HIV infection was confirmed with a CD4 count of 120 cells/L. After following the standard treatment readiness approaches, the patient was commenced on tenofovir, lamivudine and efavirenz three weeks ago. He now presents with confusion. Consider the following two scenarios in this patient Creatinine 1902 mol/L (no prior urea or electrolyte results available). Electrolytes and creatinine are within the normal range, no changes are made to the patients treatment, but confusion progresses until the patient becomes frankly psychotic. For both of the above scenarios a) Identify which drugs are most likely to be causally associated with this patients adverse event described in the above scenarios. (4) b) Based on the information presented in both scenarios above, would you consider the causality of this association as definite, probably, possible, unlikely or unclassifiable? Justify your answer. (6) c) Based on the information presented in both scenarios above, would you consider this adverse drug reaction preventable? Justify your answer. (4) d) How would you manage the patient in each of the scenarios above. (6) [20]

A 40-year-old man is admitted to casualty with agitation, pulse rate 160/min, and a blood pressure of 214/146 following cocaine use. a) Outline your management plan. Give the rationale for your choice of drugs. (7) b) Discuss the neurological complications of cocaine use and their mechanism. (5) c) Discuss the treatment of cocaine dependence (3) [15] A 62-year-old woman presents with palpitations for a few days. She has no relevant past medical history. There is no syncope, chest pain, or dyspnoea. Her blood pressure is 142/86, heart rate is 138/min and irregular. There are no features of cardiac failure and no murmurs. ECG shows atrial fibrillation.

a) Give a brief overview of pharmacological therapy for this arrhythmia, focusing on their mechanism of action. Indicate which drugs could return her to sinus rhythm (16) b) Which of these drugs would you avoid if there was QT prolongation? (4) [20] 4 In several phase II studies, the novel drug Maxibrain has shown to be safe and effective for treatment of Alzheimers disease. A pivotal phase III programme has been designed with amyloid on PET scan as the surrogate endpoint for efficacy. Discuss the definition of surrogate endpoints in clinical trials and their appropriate use. Which are the requirements by regulatory agencies for the qualification and validation of biomarkers as surrogate endpoints and how can a company make sure that the proposed approach will be accepted? What would you recommend to the drug company in this specific case? [20] a) Discuss the indications and adverse effects of rituximab in haematological malignancies. (5) b) Discuss the risk:benefit ratio, side effect profile, and choice of proton-pump inhibitors for gastroesophageal reflux disease. (5) [10] A 3-year-old child is admitted having swallowed an unknown quantity of ferrous sulphate tablets within the last two hours. Discuss the investigation, management and prognosis. [15]

You might also like