The South African Pharmacy Council 591 Belvedere Street, Arcadia, Pretoria, 0083 PO Box 40040, Arcadia 0007 Telephone Number (012) 319 8500 Fax (012) 321 1492 e-mail: interns@pharmcouncil.co.za PRE-REGISTRATION EXAMINATION FOR PHARMACIST INTERNS MARCH 2011 TIME ALLOWED: 180 MINUTES (3 HOURS) MAXIMUM MARKS: 80 MARKS NUMBER OF PAGES: 19 PAGES PASS MARK: 50% EXAMINERS: MS A AUGUSTYN MS U STAPELBERG MODERATOR: PROF AGS GOUS You are allowed 5 minutes to read through the paper. Do not commence writing until you are told to do so. Please read the questions carefully and answer the questions directly on this question paper. Candidates undergoing the internship in the various sectors must answer the following sections of the paper: Community pharmacy Section A + Section B Institutional (Hospital) pharmacy Section A + Section C Academic internship Section A + Section B, C or D Manufacturing pharmacy Section A + Section D Write your full name and P Number (Account No) on each page of the question paper. MARKS ALLOCATED SECTION A SECTION B SECTION C SECTION D QUEST EXAM MOD QUEST EXAM MOD QUEST EXAM MOD QUEST EXAM MOD FINAL MARK A1 B1 C1 D1 A2 B2 C2 D2 A3 B3 C3 D3 A4 A5 A6 A7 A8 TOTAL TOTAL TOTAL TOTAL Examiner Moderator % FULL NAMES: P NO.
2 The South African Pharmacy Council SECTION A SECTION A (Pages 2-7) GENERAL PHARMACY PRACTICE 50 MARKS To be completed by all Pharmacist Interns MANUFACTURING AND COMPOUNDING OF MEDICINES QUESTION A1 (12 marks) A1.1 Calculate the amount of benzocaine that should be used in the following prescription. Rx Benzocaine 2% Polyethylene Glycol Base ad 2g Make 24 suppositories Sig. Insert one as directed A1.2 Lobe ear drops contain 54 mg of antipyrine and 14 mg of benzocaine in each millilitre of solution. Calculate the percentage strength (w/v) of each ingredient in the formula. A1.3 Mrs Gail Summers brings in her new prescription from Dr Clive Gosforth. He reduced her Premarin 0.625mg once daily dose to another tablet containing 0.45mg of conjugated oestrogen. What is the total reduction in conjugated oestrogens taken, during a 30 day month? Give your answer in mg. A1.4 In a clinical trial of ciprofloxacin, paediatric patients were initiated on 6 to10 mg/kg intravenously every 8 hours and converted to oral therapy, 10 to 20 mg/kg every 12 hours. Calculate the ranges of the total daily amounts of ciprofloxacin that would have been administered intravenously and orally to a 40kg patient. A1.5 A patient is given 125 mg of phenytoin sodium (C15H11N2NaO2 m.w. 274) three times a day. How many milliequavalents of sodium are represented in the daily dose? A1.6 How many grams of salicylic acid should be added to 75g of a polyethylene glycol ointment to prepare an ointment containing 6% w/w salicylic acid? A1.7 You need to prepare 24 lollipops, each containing 2mg of fentanyl, which is available as the citrate salt. How much fentanyl citrate will you need to prepare these lollipops? (Fentanyl, MW 336.47; fentanyl citrate, MW 528.59) A1.8 You need to prepare 60ml of a sildenafil citrate suspension with a concentration of 15mg per medicine measure, and you have in the pharmacy Viagra 50mg tablets. (4x1/2 = 2 marks) a) How many of these tablets will you require to prepare the suspension?
3 b) In order to obtain the correct amount of drug, you weigh all the required tablets and find that they weigh 1.24g in total. How much powder will you need to weigh after the tablets are crushed to obtain the needed amount of drug? c) If Viagra 50mg tablets cost R223.03 for 30 tablets, how much money is wasted if the remaining powder from part b is discarded? d) You use 10ml of a 4% w/v methylcellulose gel as a suspending agent in preparing this mixture. What is the percent strength of methylcellulose in the final product? A1.9 A 1g vial of methotrexate should be diluted with 19.4ml to produce a concentration of 50 mg/ml. How many millilitres of diluent should be added to produce a concentration of 80 mg/ml? A1.10 You receive a prescription for a paediatric sedative cocktail to contain 12 mg each of meperidine HCl, chlorpromazine HCl and promethazine HCl. The syrups are commercially available as follows: Meperidine HCl, 50mg/5ml; chlorpromazine HCl, 10mg/5ml; promethazine HCl; 6.25mg/5ml. A1.10.1 How much of each of these syrups would you need and what would be the final volume of the formulation? A1.10.2 How much of each drug would the child receive if a parent mistakenly gives one medicine measure of this mixture to the patient? PROCUREMENT, STORAGE AND DISTRIBUTION OF PHARMACEUTICAL PRODUCTS QUESTION A2 (5 marks) A2.1 In the facility where you work, the average monthly consumption for Enervit is 3 packets. The minimum that you should have on your shelve at any given time is 2 packets. The wholesaler delivers within 48 hours after ordering and you place an order every 2 weeks. The representative for Enervit visits the pharmacy. They have a deal for the next three weeks If you buy 6 packets you get 3 packets free. Would you order the deal? A2.2 Read the following statements carefully and decide whether it is TRUE or FALSE: (1 mark each) A2.2.1 Medicine that has expired should be dissolved in water and rinsed down the basin in order to be destroyed in such a way that it can not be retrieved or recovered. A2.2.2 If a contractor is used to destroy medicine, a pharmacist employed by the applicant must witness the removal of the correct quantities of the medicines, regardless of where the destruction will take place. A2.2.3 The Medicines Control Council may authorize in writing the destruction of specified schedule 5 and 6 substances by a manufacturer of such substances in the absence of an inspector. A2.2.4 The current minimum standards regarding destruction and disposal of medicines were published on 17 December 2004 in the Government Gazette. DISPENSING AND ENSURING THE OPTIMAL USE OF MEDICINES PRESCRIBED TO THE PATIENT QUESTION A3 (9 marks) A3.1 You are the responsible pharmacist at Care Pharmacy. On 15 January 2011, Emile Laing filled a prescription the following prescription at the pharmacy. Rx Ventolin inhaler 2 puffs every 4-6 hours prn Repeat x6
4 He paid cash for the prescription. On 22 January he comes into the pharmacy to have a repeat filled for the Ventolin. What advice and information do you need to provide? (2 marks) A3.2 Sally Williams hands in the following prescription. Rx Yasmin tablets 1x OP Repeat x 5 months What information do you need to provide her with if this is the first time that she will be using this medication? (14 x ½ = 7 marks) PROVIDING PHARMACIST INITIATED CARE TO THE PATIENT AND ENSURING THE OPTIMAL USE OF MEDICINES QUESTION A4 (6 marks) A4.1 Linda Jonas asks for your advice on her 8 year old daughter, Tracey. She has lost weight over the past 2 months and the child is complaining of constant tiredness, abdominal pain and scratching near the anal area. What specific advice and treatment will you give her? (6 x ½ = 3 marks) A4.2 Claudia Mabongo is going on a boat trip from Durban to Mozambique. Her family will be joining her. She wants something to prevent motion sickness. What information do you need from the patient before you can recommend anything? What will you recommend? (6 x ½ = 3 marks) PROVIDING EDUCATION AND INFORMATION ON HEALTH CARE AND MEDICINE QUESTION A5 (6 marks) Hazel Crane was told by the clinic sister that she has scabies and should go to the pharmacy and buys Benzyl Benzoate application. What will you tell her when you sell it to her? (12 x ½ = 6 marks) PROMOTING COMMUNITY HEALTH AND PROVIDING RELATED INFORMATION QUESTION A6 (6 marks) The organisation Mothers-to-be asks you to give a talk on the use of medicine in pregnancy. What would be the main ideas that you would include? (12 x ½ = 6 marks) PARTICIPATING IN RESEARCH TO ENSURE THE OPTIMAL USE OF MEDICINE QUESTION A7 (3 marks) A7 Five college students were surveyed about how many hours they spent exercising per week, with the following results: Student 1: 2 hours
5 Student 2: Student 3: Student 4: Student 5: 4.2 hours 0.75 hours 6.5 hours 3.25 hours From the above data, calculate the following: a) Mean b) Median c) Standard deviation PRACTISING PHARMACY IN A PROFESSIONAL AND ETHICAL MANNER QUESTION A8 (3 marks) A8.1 You are the responsible pharmacist at Chempharm pharmacy. You also have a qualified post basic pharmacist assistant helping you in the dispensary. If you leave the pharmacy, what measures should you have in place? (6 x ½ = 3 marks) ****END OF SECTION A****
6 The South African Pharmacy Council SECTION B (Pages 8-11) COMMUNITY PHARMACY INTERNSHIP 30 MARKS To be completed by pharmacist interns undertaking the internship in community pharmacy or academia QUESTION B1 (15 marks) FOR EACH OF THE FOLLOWING QUESTIONS (B1.1 TO B1.15) CLEARLY CIRCLE THE ANSWER THAT YOU CONSIDER TO BE CORRECT. THERE WILL BE NO MARK ALLOCATED IF MORE THAN ONE ANSWER IS CIRCLED. IF YOU MAKE A MISTAKE, DRAW A LINE THROUGH THE INCORRECT ANSWER AND CIRCLE THE CORRECT ANSWER. B1.1 What is the correct formula for 100g of a cream containing: hydrocortisone butyrate 25mg and clotrimazole 500mg, using Locoid Cream, Canesten Cream and, if required, Aqueous Cream as diluent? a) Locoid Cream 50g, Canesten Cream 50g, Aqueous Cream 0g (not required) b) Locoid Cream 25g, Canesten Cream 75g, Aqueous Cream 0g (not required) c) Locoid Cream 50g, Canesten Cream 25g, Aqueous Cream 25g d) Locoid Cream 25g, Canesten Cream 50g, Aqueous Cream 25g e) Locoid Cream 25g, Canesten Cream 25g, Aqueous Cream 50g B1.2 A drug is 40% bioavailable via the oral route 58% bioavailable via the transdermal route. If a patient is taking 2.5mg oral dose twice daily and is switched to the counterpart 2% ointment, how many grams of the ointment should be administered per day to provide the equivalent dose of the drug? a) 1.7g b) 3.4g c) 0.17g d) 0.85g e) 5g B1.3 Given that 30g of a mild corticosteroid ointment covers the entire surface of any adult for one application, how much ointment (in grams) should be dispensed for an 18 year old patient who requires treatment on approximately 20% of her body with twice daily application for 14 days? a) 6g b) 12g c) 84g d) 124g e) 168g B1.4 A pregnant woman taking medication for which one of the following conditions is at increased risk of giving birth to a baby with spina bifida? a) Asthma b) Crohn s disease c) Diabetes d) Hypertension e) Epilepsy B1.5 The following question consists of a statement followed by a second statement. First Statement: Nifedipine should never be given in combination with atenolol as this may be hazardous. Second Statement
7 Some calcium-channel blockers and beta-blockers given in combination may precipitate heart failure, exacerbate conduction disorders and cause hypotension at high doses. a) Both statements are true and the second statement is a correct explanation of the first statement b) Both statements are true but the second statement is not a correct explanation of the first statement c) The first statement is false but the second statement is true d) The first statement is true but the second statement is false e) Both statements are false B1.6 Which of the following drugs can be safely used in a patient that suffers from porphyria? a) pioglitazone b) cyclizine c) amlodipine d) amoidarone e) orlistat B1.7 Denise Ludwig is a post basic pharmacist. Which of the following services or acts may she not perform? (All under direct supervision of a pharmacist) a) Sell Vermox syrup b) Inform a patient on the correct use of lactulose and give general advice on constipation. c) Order Cymbalta 30mg tablets d) Order Concerta 54mg tablets e) None of the above B1.8 You are required to dispense a prescription for ketorolac tromethamine ophthalmic solution 0.5%. The pack size is 5ml and the dosage directions are: One drop q.i.d. prn for allergic conjunctivitis. How many milligrams of the active ingredient would be present in each drop of the ophthalmic solution if the dropper service delivers 20 drops per millilitre? a) 0.25mg b) 25mg c) 0.025mg d) 1.25mg e) 2.5mg B1.9 The plasma levels of phenytoin may be decreased when used together with which of the following drugs? a) Folic acid b) Allopurinol c) Cimetidine d) Fluoxetine e) Sulphonamide B1.10 Which of the following can be used in alcohol withdrawal? a) Triazolam b) MIdazolam c) Chlordiazepoxide d) Short half-life benzopdiazepines e) Temazepam B1.11 A patient has just started on a drug combination of amiloride and hydrochlorthiazide. Which drug may interact with these drugs? a) Temazepam b) Propranolol c) Enalapril d) Bisacodyl e) Beclomethasone B1.12 Which main side effect would be caused by Clozapine? a) Hepatitis b) Blindness c) Neutropenia d) Depression e) Gastro intestinal side effects
8 B1.13 Symbicort 80/4.5 is an oral inhalation product containing 80mcg of budesonide and 4.5 mcg of formoterol fumarate per inhalation. The dose started as two inhalations twice daily. How much of each drug would be administered daily? a) 160mcg budesonide and 9 mcg formoterol fumarate b) 0.32mg budesonide and 0.18 mg formoterol fumarate c) 320mcg budesonide and 0.18 mg formoterol fumarate d) 0.32mg budesonide and 0.018 mg formoterol fumarate e) 1600 mcg budesonide and 18.0 mcg formoterol fumarate B1.14 A 70 year old female patient presents complains of nausea, diarrhoea and dizziness for the past three days. She is on the following chronic medication: Disprin Half a tablet daily Lanoxin 1 tablet daily Renitec 10mg 1 tablet daily Cordarone 200mg 1 tablet daily She did not change her diet, but believes that she must have picked up a stomach bug and would like something for symptom relief. What would be the most appropriate recommendation to make? a) Take loperamide and dimenhydrinate to relief the symptoms b) Increase fluid intake and bed rest until the symptoms resolve c) Stop the aspirin for the next few days, until the symptoms resolve d) Contact the doctor to discontinue the amiodarone until these symptoms resolve e) Contact the doctor to suggest that a digoxin level should be taken B1.15 A patient developed an allergic reaction after being prescribed Erymycin 250mg capsules. Which of the following drugs would also be contra-indicated for futures use in t his patient? a) Augmentin 1000mg b) Ciprobay 250mg c) Avelon 400mg d) Zithromax 500mg e) Zinnat 250mg QUESTION B2 (10 x ½ = 5 marks) B2.1 Ciprobay suspension contains 250mg of ciprofloxacin per 5ml. You receive the following prescription: Rx Ciprofloxacin 125mg qid x 10 days. You are required to dispense the suspension as the patient; a 20 year old male patient has difficulty in swallowing tablets. a) How many doses are needed? b) How many millilitres should be given per dose? c) How many millilitres of ciprofloxacin oral suspension containing 250mg per 5 ml should be dispensed? d) What important information would you discuss with the patient when you hand out this prescription? e) The price of Ciprobay suspension to the patient will be R 212.34. What would the cost saving to the patient be if you could use Cifloc 250mg tablets in stead? (The price of Cifloc 250mg tablets to the patient is R 16.95 for 10 tablets) Would need Cifloc 20 tablets (1/2 x qid x 10 days = 20) QUESTION B3 (10 marks) B3.1 The pharmacy where you work is opening an immunisation clinic. You have to design a template for the patient records that you will be keeping. What information would you include on the record sheet? (12 x ½ = 6 marks) B3.2 What important aspects regarding the storage of vaccines are important? (8 x ½ = 4 marks)
9 ****END OF SECTION B****
10 The South African Pharmacy Council SECTION C (Pages 12-15) INSTITUTIONAL (HOSPITAL) PHARMACY INTERNSHIP 30 MARKS To be completed by pharmacist interns undertaking the internship in institutional (hospital) pharmacy or academia QUESTION C1 (15 marks) FOR EACH OF THE FOLLOWING QUESTIONS (C1.1 TO C1.15) CLEARLY CIRCLE THE ANSWER THAT YOU CONSIDER TO BE CORRECT. THERE WILL BE NO MARK ALLOCATED IF MORE THAN ONE ANSWER IS CIRCLED. IF YOU MAKE A MISTAKE, DRAW A LINE THROUGH THE INCORRECT ANSWER AND CIRCLE THE CORRECT ANSWER. C1.1 Levofloxacin injection contains 5mg/ml of levofloxacin and 5% of dextrose. How much of each would be delivered to a patient upon the administration of a 100ml injection? a) 5 g levofloxacin and 5 g dextrose b) 50mg levofloxacin and 5 g dextrose c) 500 mg levofloxacin and 500 mg dextrose d) 0.5 g levofloxacin and 5 g dextrose e) 5 g levofloxacin and 0.5g dextrose C1.2 A drug is 40% bioavailable via the oral route 58% bioavailable via the transdermal route. If a patient is taking 2.5mg oral dose twice daily and is switched to the counterpart 2% ointment, how many grams of the ointment should be administered per day to provide the equivalent dose of the drug? a) 1.7g b) 3.4g c) 0.17g d) 0.85g e) 5g C1.3 A patient has been admitted to hospital following a drug overdose. On admission, the plasma concentration of the drug is measured as 96 microgram/ml. The half-life of the drug is 16 hours. What would the plasma concentration, in micrograms/ml, be expected to be after 24 hours? Assume that distribution of the drug is complete and it s elimination is described by a first order process. a) 16 b) 24 c) 36 d) 48 e) 72 C1.4 A pregnant woman taking medication for which one of the following conditions is at increased risk of giving birth to a baby with spina bifida? a) Asthma b) Crohn s disease c) Diabetes d) Hypertension e) Epilepsy C1.5 The following question consists of a statement followed by a second statement. First Statement:
11 Nifedipine should never be given in combination with atenolol as this may be hazardous. Second Statement Some calcium-channel blockers and beta-blockers given in combination may precipitate heart failure, exacerbate conduction disorders and cause hypotension at high doses. a) Both statements are true and the second statement is a correct explanation of the first statement b) Both statements are true but the second statement is not a correct explanation of the first statement c) The first statement is false but the second statement is true d) The first statement is true but the second statement is false e) Both statements are false C1.6 Which of the following drugs can be safely used in a patient that suffers from porphyria? a) pioglitazone b) cyclizine c) amlodipine d) amoidarone e) orlistat C1.7 Denise Ludwig is a post basic pharmacist. Which of the following services or acts may she not perform? (All under direct supervision of a pharmacist) a) Sell Vermox syrup b) Inform a patient on the correct use of lactulose and give general advice on constipation. c) Order Cymbalta 30mg tablets d) Order Concerta 54mg tablets e) None of the above C1.8 You are required to dispense a prescription for ketorolac tromethamine ophthalmic solution 0.5%. The pack size is 5ml and the dosage directions are: One drop q.i.d. prn for allergic conjunctivitis. How many milligrams of the active ingredient would be present in each drop of the ophthalmic solution if the dropper service delivers 20 drops per millilitre? a) 0.25mg b) 25mg c) 0.025mg d) 1.25mg e) 2.5mg C1.9 The plasma levels of phenytoin may be decreased when used together with which of the following drugs? a) Folic acid b) Allopurinol c) Cimetidine d) Fluoxetine e) Sulphonamide C1.10 Which of the following can be used in alcohol withdrawal? a) Triazolam b) MIdazolam c) Chlordiazepoxide d) Short half-life benzopdiazepines e) Temazepam C1.11 A patient has just started on a drug combination of amiloride and hydrochlorthiazide. Which drug may interact with these drugs? a) Temazepam b) Propranolol c) Enalapril d) Bisacodyl e) Beclomethasone C1.12 Which main side effect would be caused by Clozapine? a) Hepatitis b) Blindness c) Neutropenia d) Depression e) Gastro intestinal side effects
12 C1.13 Symbicort 80/4.5 is an oral inhalation product containing 80mcg of budesonide and 4.5 mcg of formoterol fumarate per inhalation. The dose started as two inhalations twice daily. How much of each drug would be administered daily? a) 160mcg budesonide and 9 mcg formoterol fumarate b) 0.32mg budesonide and 0.18 mg formoterol fumarate c) 320mcg budesonide and 0.18 mg formoterol fumarate d) 0.32mg budesonide and 0.018 mg formoterol fumarate e) 1600 mcg budesonide and 18.0 mcg formoterol fumarate C1.14 A 70 year old female patient presents complains of nausea, diarrhoea and dizziness for the past three days. She is on the following chronic medication: Disprin Half a tablet daily Lanoxin 1 tablet daily Renitec 10mg 1 tablet daily Cordarone 200mg 1 tablet daily She did not change her diet, but believes that she must have picked up a stomach bug and would like something for symptom relief. What would be the most appropriate recommendation to make? a) Take loperamide and dimenhydrinate to relief the symptoms b) Increase fluid intake and bed rest until the symptoms resolve c) Stop the aspirin for the next few days, until the symptoms resolve d) Contact the doctor to discontinue the amiodarone until these symptoms resolve e) Contact the doctor to suggest that a digoxin level should be taken C1.15 A patient developed an allergic reaction after being prescribed Erymycin 250mg capsules. Which of the following drugs would also be contra-indicated for future use in t his patient? a) Augmentin 1000mg b) Ciprobay 250mg c) Avelon 400mg d) Zithromax 500mg e) Zinnat 250mg QUESTION C2 (10 x ½ = 5 marks) A physician orders 35 mg of amphotericin B to be administered intravenously in 1000ml of D5W over an 8 hour period to a hospitalised patient. The available source of amphotericin B is a 10ml vial containing 50mg of amphotericin B. a) How many millilitres of amphotericin B should be used in filling this order? b) How many millilitres of the intravenous fluid per minute should the patient receive to administer the fluid over the designated interval? Your answer should be in ml/minute. c) What would the storage conditions of the reconstituted solution be? d) The ward sister wants says the patient is currently on ciprofloxacin IV in 0.9% saline. Could she add the amphotericin B to this line? e) The sister also wants to know what kind of side effects could be expected with amphotericin B IV administration. QUESTION C3 (10 marks) C3.1 Cindy Clarke is a newly appointed pharmacist assistant in the facility where you work. She will be responsible for the care and monitoring of the cold chain items. What are the important aspects that she needs to know in order to carry out her duties? (8x1/2=4 marks) C3.2 The institution where you work, manufactures a preparation containing l-amino acids 80g/100ml for parenteral nutrition.
13 You need to design a label for this preparation. What information would you put on the label? (12 x ½ = 6 marks) ****END OF SECTION C**** The South African Pharmacy Council SECTION D (Pages 16-19) MANUFACTURING PHARMACY INTERNSHIP 30 MARKS To be completed by pharmacist interns undertaking the internship in manufacturing and academia QUESTION D1 (15 marks) FOR EACH OF THE FOLLOWING QUESTIONS (D1.1 TO D1.15) CLEARLY CIRCLE THE ANSWER THAT YOU CONSIDER TO BE CORRECT. THERE WILL BE NO MARK ALLOCATED IF MORE THAN ONE ANSWER IS CIRCLED. IF YOU MAKE A MISTAKE, DRAW A LINE THROUGH THE INCORRECT ANSWER AND CIRCLE THE CORRECT ANSWER. D1.1 Which of the following is true pertaining to maintenance of the refrigerator? a) The temperature of the pharmacy refrigerator must be maintained between 0 C and 8 C b) The temperature of the refrigerator must be monitored and charted daily c) The thermometer must be hung from the top shelf of the refrigerator. d) If the power is off for any length of time the refrigerator door should not be opened until the power supply is restored e) All of the above D1.2 Which of the following are true? a) A pharmacist may register more than one speciality. b) A pharmacist may not register more than one speciality. c) A pharmacist may only practice in one speciality. d) A and C e) B and C D1.3 Which of the following is false pertaining to the responsible pharmacist of a wholesale and manufacturing pharmacy?
14 a) The RP is responsible for safe-guarding product users against potential hazards arising from poor distribution practices b) The RP must ensure that the conditions of the wholesale and manufacturing pharmacy s licence are met c) The RP do not need expert knowledge with regard to the wholesale distribution of medicine and scheduled substances d) The RP must ensure compliance with the standards and guidelines on pharmacy practice. e) None of the above D1.4 Personnel working in a pharmaceutical manufacturing environment: a) Are required to report any contagious diseases b) Should be trained in the basic principles of GMP c) Should not be allowed to move freely form one department to another d) Should comply with the specified dress requirements e) All of the above D1.5 You wish to manufacture a batch of compressed tablets each containing 560mg active ingredient X. The mean weight of each tablet 1.4g. What is the weight of ingredient X required to manufacture a batch size of 840kg? a) 168kg b) 672kg c) 336kg d) 350kg e) 415kg D1.6 Rejected materials and products should not be: a) Clearly marked b) Stored with other products in general storage areas c) Stored in a restricted area d) Reprocessed regularly e) None of the above D1.7 Quality control is concerned with: a) Sampling b) Specifications c) Release procedures d) Testing e) All of the above D1.8 You require 2cm 3 colorants to colour 2 tablets. Calculate the amount of colourant you need to colour 4000 tablets: a) 4L b) 400ml c) 40ml d) 0.4L e) None of the above D1.9 Log books should be kept for major or critical equipment to record: a) Validations and calibrations b) Repair c) Maintenance d) Cleaning e) All of the above D1.10 Calciferol capsules weigh 75mg per capsule and contain 250µg ergocalciferol. Calculate the amount of ergocalciferol required to manufacture a 200kg batch: a) 666.67kg b) 666.67g c) 666.67mg d) 666.67µg e) None of the above D1.11 Each tablet XY contains 500mg active ingredient X and 0.12% w/w potassium sorbate as preservative. Each tablet weighs 1.2g. Calculate the amount of potassium sorbate required to manufacture 10 000 tablets: a) 0.05g b) 50g c) 144g
15 d) 14.4g e) None of the above D1.12 The Responsible Pharmacist: a) Name must be clearly displayed over the main entrance to the pharmacy b) Must be present in the pharmacy if there is no access to schedule 1 and above medicine c) Is required, by the Act, to provide the information as to who is acting as the Responsible Pharmacist in the Responsible Pharmacist s absence. d) All of the above e) A and C D1.13 Manufacturers and wholesalers must keep registers of quantities of specified Schedule 5 and 6 substances that were: a) Used in production/manufacturing b) Destroyed, lost or stolen c) Registers must be balanced on the last day of March, June, September and December each year d) A and B e) All of the above D1.14 Which of the following people are most likely to be not allowed to work in the unit manufacturing albendazole? a) Basic level PA b) Post basic level PA c) Females d) Males e) None of the above D1.15 Calculate the concentration obtained by mixing the following 50ml glucose 10% w/v, 200ml glucose 5% w/v and 100ml glucose 20% w/v: a) 15% w/v b) 5% w/v c) 12.5% w/v d) 17.5% w/v e) 10% w/v QUESTION D2 (5 marks) D2.1 You are contacted by a children s hospital and asked to make 5% w/v glucose using 10 % w/v and 20 % w/v glucose. (4x1/2=2 marks) D2.2 A Benzylpenicillin vial consists of the following ingredients: Benzylpenicillin as sodium salt 1MU (600mg) 4.3% w/w Sodium citrate buffer Calculate the amount of active ingredient required to manufacture 20 000 vials. Give your answer in kg. What will be the final concentration of Sodium citrate buffer used? (1) D2.3 You are manufacturing 1000 tubes Wipe Your Nose Nasal Gels. The weight of one tube is 12 g. It consists of the following ingredients: Wipe 25 mg/100g Your (base) 250 mg/100g Nose 350 mg/100g Preservative XX 0.01 % m/m How much of each ingredient is used. Give your answers in grams.(4x1/2=2 marks) QUESTION D3 (10 marks) D3.1 Why is 70% EtoH / Isopropyl alcohol used as disinfectant and sterilizing agent over absolute alcohol? (4x1/2=2 marks)
16 D3.2 You have to prepare 10L 70% EtoH using 95% available. Describe how you will prepare this: (3x1/2=1 ½marks) D3.3 For the manufacture of sterile medicinal products 4 grades can be distinguished. a) Name the 4 areas and give examples of what procedures can be carried out in each. (4 marks) b) Describe the clothing required for grade A: (5x1/2=2 ½ marks) ****END OF SECTION D****