The South African Pharmacy Council - MM3 Admin : … Which treatment would you consider most...

FULL NAMES: __________________________________________ P NO. _______________ October 2009

- 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 : [email protected]

PRE-REGISTRATION EXAMINATION

FOR PHARMACIST INTERNS OCTOBER 2009

TIME ALLOWED: 180 MINUTES (3 HOURS) MAXIMUM MARKS: 80 MARKS NUMBER OF PAGES: 27 PASS MARK: 50% EXAMINERS: MS A AUGUSTYN MS L PATEL 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

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QUEST

EXAM

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QUEST

EXAM

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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

%

mailto:[email protected]

FULL NAMES: _____________________________________________ P NO. ____________ October 2009

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The South African Pharmacy Council

SECTION A

SECTION A

(Pages X-X)

GENERAL PHARMACY PRACTICE 50 MARKS

To be completed by all Pharmacist Interns

MANUFACTURING AND COMPOUNDING OF MEDICINE

QUESTION A1 (5 marks) A1.1 How many millilitres of a 25% (w/v) dextrose solution and how many millilitres of a 10%

(w/v) dextrose solution are required to prepare 500ml of a 12% (w/v) solution? You are required to use both the 25% and the 10% dextrose solutions together to prepare the 12% solution. (2marks) ……….…..…………………………………………………………………………………………

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……….…..………………………………………………………………………………………… …………...………………………………………………………………………………………… A1.2 The ratio of salt to water in a very concentrated saline solution is 3:8. How much sodium

chloride should be added to 360g of water to prepare a solution with this concentration (3.8)? (1 mark)

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……….…..………………………………………………………………………………………… …………...………………………………………………………………………………………… A1.3 One gram of cod liver oil (sp.g. = 0.923) supplies 850 units of Vitamin A and 85 units of

Vitamin D. Using the conversions below, calculate the amounts of Vitamin A and Vitamin


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D supplied by one medicine measure (5ml) of cod liver oil. (Your answer must be in micrograms)

1 Unit of Vitamin A = 0.3 µg² 40 units of Vitamin D = 1 µg² (2 marks) .…..………………………………………………………………………………………………….

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…………...…………………………………………………………………………………………. PROCUREMENT, STORAGE AND DISTRIBUTION OF PHARMACEUTICAL PRODUCTS QUESTION A2 (7 marks) A2.1 How would you define lead time and procurement period? (2 marks)

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A2.2 Dalene is a pharmacist’s assistant (learner basic) at Med Kem Pharmacy which is a community pharmacy. Describe the ideal storage conditions of the following products in the pharmacy to Dalene.

a. Eprex® 2000/0.5ml pre-filled syringe b. Imodium® tablets c. Lacson® syrup d. Augmentin® 375mg tablets e. Rohypnol® 1mg tablets ……(5 marks)

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DISPENSING AND ENSURING THE OPTIMAL USE OF MEDICINES PRESCRIBED TO THE PATIENT QUESTION A3 (15 marks) A3.1 James Murray is a regular patient at your pharmacy. His cardiologist diagnoses atrial

fibrillation and prescribes the following:

Verapamil 80mg daily Simvastatin 10mg daily Warfarin 5mg daily according to INR Repeat for 5 months A3.1.1 How would you counsel him on this prescription? (12 x ½ = 6 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………


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A3.1.2 Two months after starting treatment for his atrial fibrillation, James visits the pharmacy again after a visit to his GP, Dr Evans. The following is prescribed –

Erythromycin 250mg q6h x 5/7 Metronidazole 400mg q8h x 5/7 Ibuprofen 800mg tds prn x5/7

Comment on the appropriateness of the combination of medicine prescribed in light of the previous prescription obtained at your pharmacy. (8 x ½ = 4 marks)

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A3.2 Dr Smith phones you with a prescription for little Clive Tebogo, who weighs 6kg. He wants you to give him amoxicillin and asks you to check the dosage and calculate the maximum dosage.

A3.2.1 How would you calculate the dosage? (Show all your calculations). How much

will you dispense? (5 x ½ = 2½ marks) ……………………………………………………………………………………………… ……………………………………………………………………………………………… ………………………………………………………………………………………………


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PROVIDING PHARMACIST INITIATED CARE TO THE PATIENT AND ENSURING THE OPTIMAL USE OF MEDICINES QUESTION A4 (8 marks) A4.1 Miriam Saunders had surgery 2 weeks ago. She was in severe pain after the operation.

She now complains about severe constipation. What advice would you give her and what different options are there for the treatment of this condition? (8 x ½ =4 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………


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A4.2 Danielle Young has a 4 year old son who she says ‘has been vomiting all night’. She has

tried cyclizine syrup, but he continued to vomit. She wants to buy Valoid® suppositories. What would you suggest? Provide further counselling on treatment of the child’s condition. (8 x ½ = 4 marks)

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PROVIDING EDUCATION AND INFORMATION ON HEALTH CARE AND MEDICINE QUESTION A5 (4 marks) June Parkin is a HIV positive patient on zidovudine, lamivudine and efavirenz. She has been using the medicine for the past six months. On her visit to the pharmacy to renew her prescription, she asks you for some St. John’s Wort. A friend told her that it is a natural medicine and good for depression. She wants to try it as she is feeling depressed about her diagnosis. What advice and counselling would you give her? (4 marks) ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………….


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PROMOTING COMMUNITY HEALTH AND PROVIDING RELATED INFORMATION QUESTION A6 (5 marks) You are invited to give a talk at a meeting of parents at the primary school about worm infestations. What information do you think is important to include in your talk? (10 x ½ = 5 marks) ……………………………………………………………………………………………………………. ……………………………………………………………………………………………………………. ……………………………………………………………………………………………………………. ……………………………………………………………………………………………………………. ……………………………………………………………………………………………………………. ……………………………………………………………………………………………………………. ……………………………………………………………………………………………………………. ……………………………………………………………………………………………………………. …………………………………………………………………………………………………………… ……………………………………………………………………………………………………………. ………………………………………………………………………………………………………….. …………………………………………………………………………………………………………… ……………………………………………………………………………………………………………. …………………………………………………………………………………………………………… …………………………………………………………………………………………………………… ……………………………………………………………………………………………………………. PARTICIPATING IN RESEARCH TO ENSURE THE OPTIMAL USE OF MEDICINE QUESTION A7 (2 marks)


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A7.1 Explain to a pharmacist's assistant what is meant by a 'double blind prospective study’. What is the advantage of this kind of study? (2 marks)

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PRACTISING PHARMACY IN A PROFESSIONAL AND ETHICAL MANNER QUESTION A8 (4 marks) Comment on the legality of following prescription:

Dr AF Begbie -------------------------------------------------------------------------------------------------------------------------------

A Smith Rx Eetless® capsules x60 1 prn Repeat x 3

AF Begbie

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SECTION B

(Pages 11-16)

COMMUNITY PHARMACY PRACTICE/ACADEMIC 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 Which of the following drugs is not safe to use in a patient with porphyria?

A) Domperidone B) Cyclizine C) Loperamide D) Hyoscine Butylbromide E) Ibuprofen

B1.2 You are the responsible pharmacist at Bewell Pharmacy. Nandi Maloi is a pharmacist’s

assistant (basic) employed at the pharmacy. Which of the following actions may she perform?

A) Counsel patients on interactions between medicine B) Sell S1 and S2 medicine under direct supervision of a pharmacist C) Order medicine from a wholesaler D) Dispense prescriptions under direct supervision of a pharmacist E) Be involved in the control and distribution of S0-S5 medicine

B1.3 Which of the following products are not generic equivalents?

A) Pharmapress® 5mg tablets & Enap® 5mg tablets B) Aspen Simvastatin® 10mg tablets & Zocor® 10mg tablets C) Ranclav® 625mg tablets & Augmaxcil® 625mg tablets D) Angised® 0,5mg tablets & Nitrolingual® spray E) All of the above

B1.4 Type 1 Diabetes Mellitus is associated with which of the following?

A) Low levels of insulin B) Lack of glucagon C) Lack of insulin D) Lack of growth hormone E) Low levels of glucagon


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B1.5 According to the Medicines and Related Substances Act 101 of 1965, diclofenac is classified in –

A) Schedules 1, 2 and 3 B) Schedule 4 C) Schedule 2 D) Schedule 3 E) Schedules 2 and 4

B1.6 When you dispense Moxifloxacin tablets to a patient, what important warning should you always give the patient? A) It may discolour the urine B) Do not exercise as it may cause the rupture of tendons C) You may experience abnormal excessive sweating D) You may experience nightmares E) All of the above

B1.7 Which of the following statement about Oseltamivir is true?

A) Can be used as a replacement for annual flu vaccination B) Must be prescribed for all known cases of Swine Flu C) Side effects such as convulsions, hallucinations and delirium have been reported D) It is only active against the H1N1 virus E) For prophylaxis of influenza patients should take it for the whole flu season

B1.8 Which treatment would you consider most appropriate for Tinea versicolor?

A) Oral Terbinafine B) Selenium Sulphide shampoo C) Hydrocortisone ointment D) Tetmosol soap E) Mepyramine cream

B1.9 Jack Daniels, a rehabilitated alcoholic, visits Dr Jacobs and complains about a very severe headache. The doctor phones you to ask which of the following products he should prescribe –

A) Panado® B) Napacod® C) Synap Forte® D) Myprodol® E) Disprin Plus® F) All of the above

B1.10 You need to prepare 500ml of a normal saline solution. How much sodium chloride do

you need?

A) 9g B) 4.5g C) 0.18g D) 18g E) 7.5g F) None of the above

B1.11 You are asked to dispense 200ml of a 0.05% chlorhexidine solution. The only chlorhexidine available is 500ml of a 5% solution. How much of the concentrate would you need in order to provide the patient with the correct strength?


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A) 2.5% B) 20ml C) 4ml D) 2ml E) 15ml

B1.12 Dr Carl, a dermatologist prescribes a cream containing 2% hydroquinone in UEA. What

would be most suitable diluent in which to dissolve the hydroquinone crystals before mixing it with the UEA, in order to ensure a smooth cream?

A) Water B) Alcohol C) Chloroform D) Surgical spiritus E) Ether

B1.13 You get a phone call from Dr Rowling to supply methylphenidate 10mg daily to 10 year

old Charl Deale, a well known patient of yours. You may: - A) Supply enough methylphenidate for one month B) Not supply anything as it is a S6 drug and thus illegal to supply without the written

prescription C) You may supply one month’s supply as long as you get the written prescription within

7 days D) You may supply enough for 48 hours as long as you get the written prescription

within 72 hours E) You may supply enough for 48 hours as long as you get the written prescription

within 7 days B1.14 Which one of the following side effects is not associated with metformin?

A) Lactic acidosis B) Upper gastro intestinal irritation C) Weight gain D) Metallic taste in the mouth E) None of the above

B1.15 Mrs Cynthia Barendse is on the following medication: verapamil, tramodol, simvastatin

and fluconazole. She complains about constipation. Which of the drugs is unlikely to be associated with her complaint?

A) Verapamil B) Tramodol C) Simvastatin D) Fluconazole E) All of the above

QUESTION B2 (5 marks) B2.1 Ruth Reddy is a 17 year old girl who is 1.60m tall and weighs 46kg. She suffers from

epilepsy which is well controlled on carbamazepine. She has been vomiting since last night and is prescribed metoclopramide 10mg tablets for the nausea and vomiting (dosage prescribed: 1 tablet q8h prn for nausea and vomiting) Comment. (2 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………


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B2.2 Dr Rose prescribes prednisolone 2mg/kg/day for 5 days. The patient is Brandon May who weighs 15kg. What is available on the market? How much will you dispense? What should the instructions on the label be? (3 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………

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QUESTION B3 (10 marks) STATE WHAT YOUR APPROACH WOULD BE AND/OR THE ACTION YOU WOULD TAKE IN EACH OF THE FOLLOWING SCENARIOS. GIVE REASONS TO SUPPORT YOUR DECISION.

B3.1 Nancy Drew is the wife of a farmer who lives on a farm about 1 hour from town. She

found some lice on her 4 year old son’s head and wants to treat him. She has some gamma benzene hexachloride on the farm, but has forgotton how to use it. She is 6 months pregnant and also wants to use it for herself to prevent infestation. She phones you for advice. (10x½ =5marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………


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B3.2 Colin Mullen is on cinnarizine 25mg tds for treatment of his vertigo. He was away on leave and developed an allergic condition 2 days before his return. He bought some promethazine 25mg to relief the allergy. He visits you now, tell you about his holiday and how it was spoiled by the allergy. He wants some eye drops as he is experiencing problems with blurred vision. How would you respond? (4x½=2 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………

B3.3 Cathy Winter comes to the pharmacy, very excited. She is flying to a game park in Botswana for a week. It is an endemic malaria area and she has visited her doctor who prescribed mefloquine for malaria prophylaxis. How would you advise her?

(6 x ½ = 3 marks)

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END OF SECTION B****


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SECTION C

(Pages X-X)

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 Which of the following drugs is not safe to use in a patient with porphyria?

A) Domperidone B) Cyclizine C) Loperamide D) Hyoscine Butylbromide E) Ibuprofen

C1.2 You are the responsible pharmacist at the local hospital. Sandy Stevens is a

pharmacist’s assistant (basic) employed at the pharmacy. Which of the following actions may she perform?

A) Counsel patients on interactions between medicines B) Sell S1 and S2 medicine under direct supervision of a pharmacist C) Order medicine from a wholesaler D) Dispense prescriptions under direct supervision of a pharmacist E) Be involved in the control and distribution of S0-S5 medicine

C1.3 Which of the following products are not generic equivalents?

A) Pharmapress® 5mg tablets & Enap® 5mg tablets B) Aspen Simvastatin® 10mg tablets & Zocor® 10mg tablets C) Ranclav® 625mg tablets & Augmaxcil® 625mg tablets D) Angised® 0,5mg tablets & Nitrolingual® spray E) All of the above

C1.4 Type 1 Diabetes Mellitus is associated with which of the following?

A) Low levels of insulin B) Lack of glucagon C) Lack of insulin D) Lack of growth hormone E) Low levels of glucagons


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C1.5 According to the Medicines and Related Substances Act 101 of 1965, diclofenac is classified in –

A) Schedules 1, 2 and 3 B) Schedule 4 C) Schedule 2 D) Schedule 3 E) Schedules 2 and 4

C1.6 When you dispense Moxifloxacin tablets to a patient, what important warning should you always give the patient? A) It may discolour the urine B) Do not exercise as it may cause the rupture of tendons C) You may experience abnormal excessive sweating D) You may experience nightmares E) All of the above

C1.7 Which of the following statement on Oseltamivir is true?

A) Can be used as a replacement for annual flu vaccination B) Must be prescribed for all known cases of Swine Flu C) Side effects such as convulsions, hallucinations and delirium have been reported D) It is only active against the H1N1 virus E) For prophylaxis of influenza, patients should take it for the whole flu season

C1.8 Which treatment would you consider most appropriate for Tinea versicolor?

A) Oral Terbinafine B) Selenium Sulphide shampoo C) Hydrcortisone ointment D) Tetmosol soap E) Mepyramine cream

C1.9 You need to prepare 500ml of a normal saline solution. How much sodium chloride do you need?

A) 9g B) 4.5g C) 0.18g D) 18g E) 7.5g F) None of the above

C1.10 You are asked to dispense 200ml of a 0.05% chlorhexidine solution. The only

chlorhexidine available is 500ml of a 5% solution. How much of the concentrate would you need in order to provide the patient with the correct strength?

A) 2.5% B) 20ml C) 4ml D) 2ml E) 15ml

C1.11 Dr Carl, a dermatologist prescribes a cream containing 2% hydroquinone in UEA. What

would be most suitable diluent in which to dissolve the hydroquinone crystals before mixing with the UEA, in order to ensure a smooth cream?


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A) Water B) Alcohol C) Chloroform D) Surgical spiritus E) Ether

C1.12 Which of the following is not part of the recommended routine immunisation schedule

for infants and children?

A) BCG vaccine B) Chicken pox vaccine C) Hepatitus B vaccine D) Measles vaccine E) None of the above

C1.13 Mr Andrew Gomes is on chemotherapy treatment. He is experiencing nausea and

vomiting as a result of the treatment. Which of the following medicines would be most appropriate to alleviate the nausea and vomiting? A) Domperidone B) Metoclopramide C) Cyclizine D) Ondansetron E) All of the above

C1.14 You receive a phone call from the mobile clinic visiting the farms. Some farm workers

have been exposed to an organophosphate insecticide. Which of the following symptoms are NOT associated with organophosphate poisoning? A) Lachrymation B) Hypersalivation C) Confusion D) Increased sweating E) Hunger

C1.15 Which of the following drugs are resistant in XDR TB?

A) Fluoroquinolones B) Kanamycin C) Capreomycin D) Amikacin E) Izoniacid F) All of the above

QUESTION C2 (5 marks) C2.1 Sister Mabandla phones you from a medical ward. Dr Bolt has prescribed cefazolin

600mg q6h IV. She needs information on the duration of infusion, the diluents, stability of reconstituted solution and any incompatibilities. Provide her with the information she has requested. (4 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………

C2.2 You need to prepare a morphine mixture that contains 10mg/5ml morphine. Supply

500ml. Show all your calculations. (2x½= 1 mark)


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QUESTION C3 (10 marks) STATE WHAT YOUR APPROACH WOULD BE AND/OR THE ACTION YOU WOULD TAKE IN EACH OF THE FOLLOWING SCENARIOS. GIVE REASONS TO SUPPORT YOUR DECISION. C3.1 Meryl Bright is a 30 year old woman with a 2 week old baby that she is breastfeeding.

She presented at the clinic with nausea and an infection. She is prescribed the following drugs. Metronidazole 2g stat Metoclopramide 10mg tds prn for nausea (2 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………

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C3.2 Dr May asks your advice on how to treat a young adult HIV positive patient with a mild candidiasis infection. What are the options that could be considered? (3 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………


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C3.3 Mrs Daphne Lowe is 39 years old and on the following medication - nifedipine for her blood pressure, simvastatin for her cholesterol, doxycyline for her skin and paracetamol when she gets a headache. She visited the clinic with complaints of tiredness and nausea. A pregnancy test revealed that she is pregnant. Sister Maartens, the clinic sister asks you for advice on Daphne’s medication during pregnancy. (5 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………

****END OF SECTION C****


SECTION D

(Pages X-X)

MANUFACTURING PHARMACY 30 MARKS

To be completed by pharmacist interns undertaking the internship in Manufacturing pharmacy

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 A Pharmaceutical Manufacturer holding a manufacturing licence must ensure that:


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A) All medicines manufactured under their licence are fit for their intended use. B) All products are manufactured according to the information submitted in the

registration dossier. C) Patients are not placed at risk due to inadequate safety, quality and efficacy. D) A and B E) All of the above

D1.2 The head of the Production Department has the following responsibilities:

A) To check the maintenance of his/her department, premises and equipment. B) To ensure that all necessary testing is carried out. C) To ensure batch records are evaluated and signed as required. D) A and C. E) None of the above.

D1.3 Batch Manufacturing Records:

A) Do not detail the materials to be used in the manufacture of the product. B) Can be discarded once all of the product has been distributed. C) Provide a rough guide to the manufacturing process of the product. D) Are completed at the end of the manufacturing process by the Manufacturing

Operator. E) Are numbered with a unique batch number.

D1.4 Process Validation is:

A) Documented evidence that the process, operated within established parameters, can perform effectively and reproducibly, to produce a medicinal product meeting its predetermined specifications and quality attributes.

B) The sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.

C) That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and legal requirements.

D) Concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures, which ensure that the necessary and relevant tests are actually carried out.

D1.5. In a manufacturing facility the person appointed as the Responsible Pharmacist is:

A) The responsible person appointed and registered as such by a company entitled to carry on the business of a pharmacist in terms of the Pharmacy Act and who shall be responsible for performing the duties as prescribed in the regulations.

B) A natural person who is a pharmacist and who shall be responsible to the Pharmacy Council for complying with all the provisions of the Pharmacy Act and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist.

C) The only person permitted to sign on a batch manufacturing document. D) None of the above

D1.6 Printed Foil used as a primary packaging component:


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A) Can be stored in the main warehouse as long as no liquid materials are stored above it.

B) Should be stored in a separate area in the main warehouse so that it is easy to find. C) Can only be issued by the Warehouse Manager when needed for packaging D) Must be stored under lock and key and can only be accessed by the authorised

personnel in the area. E) None of the above

D1.7 Batch Packaging Records should:

A) Detail the necessary packaging components required. B) Contain samples of packaging components used during the packaging process C) Detail the in-process checks. D) All of the above.

D1.8 The contract manufacturer that your company would like to use to manufacture the

generic i.e. Product T is located in India. The MCC will consider the following in its approval process A) The product being manufactured is a generic B) The manufacturer is already manufacturing similar products for the Indian market C) A favourable PIC member country inspection report that is 1 year old is available D) None of the above

D1.9 A raw material is delivered to your site. While checking the raw material to see if it

complies with the minimum in-house standards, it is noticed that the Certificate of Analysis does not have an expiry date or shelf-life on it. This material is also on back order and is urgently needed. What action do you take?

A) Receive the raw material as there is an urgency. The problems can be sorted out

later. B) Receive the raw material because the expiry date is not that important. C) Notify the relevant people of the issue and hold back on receiving the material until

further direction is given. D) Fill out a non conformance report because this is not the way raw materials are

supposed to be delivered. D1.10 Quality Control

A) Is concerned with the sampling, specifications and testing of materials B) Is confined to manufacturing operations. C) Is part of production. D) Is a support function and is not very important. E) None of the above.

D1.11 In-process packaging checks should –

A) Ensure the packages are complete B) Ensure the over-printing is correct C) Cover the general appearance of the packages D) All of the above

D1.12 Contract Manufacturers –


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A) Must have adequate premises and equipment to carry out the work of a Contract

Giver B) Can approve other manufacturers to conduct work on their behalf C) May change suppliers or raw materials without notifying the Contract Giver D) All of the above

D1.13 Engineering personnel:

A) Do not need to follow GMP as they do not manufacture product B) Need to follow change control procedures when altering equipment C) Can enter GMP areas without special dress requirements D) Should only work on equipment after hours when no manufacturing is taking place at

the facility D1.14 Which of the following ingredients would be most expected to improve the Disintegration

Time of a tablet?

A) Lactose B) Gelatine C) Cross-linked Polyvinylpyrollidone D) Microcrystalline cellulose E) Magnesium Stearate

D1.15 Bismuth Oxide is to be sourced from a new Supplier.

A) The Dossier must be updated to include the new Supplier B) The Dossier does not include the source of an inactive ingredient C) Stability Trials need to be performed on the product D) A and B E) A and C

QUESTION D2 (5 marks) D2.1 Amlodipine besylate is an active ingredient in a Product X. Each tablet contains 5mg of

active ingredient and weighs 200mg. If the batch size is 120.00kg, calculate the theoretical number of tablets that will be produced. (1 mark)

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D2.2 You are required to manufacture 150 litres 70% Isopropyl Alcohol solution in water for

the manufacturing plant. On hand you have a 95% Isopropyl stock solution. Calculate the quantities of Isopropyl Alcohol and water that you would use to make up the 70% solution? (1 mark) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………

D2.3 While manufacturing a batch of Get Well, an antibiotic medication used in animals, you are required to use two different lots of the active ingredient Oxytetracycline HCL. However, they have different potencies. The total theoretical quantity required for the


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batch is 3.978 KGA. The first lot with potency of 89.30% weighs 3.081Kg. The potency of the second lot to be used is 91.10%. Calculate how much of the second lot must be used in order to have the total theoretical quantity. (1 mark)

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D2.4 A new consignment of an active ingredient has been received. The lab tests the

ingredient to determine the assay potency, which was found to be 99%. Using this lab result, calculate the actual potency of the active ingredient that would be used in determining how many kilograms are going to be weighed off. (1 mark) The molecular weight of the salt: 567.1 The molecular weight of the base: 408.9. ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………

D2.5 A manufacturing pharmacist has four lots of ichthammol ointment, containing 50% of ichthammol. How many grams of each may be used to prepare 4800g of a 20% ichthammol? (1 mark)

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QUESTION D3 10 marks STATE WHAT YOUR APPROACH WOULD BE AND/OR THE ACTION YOU WOULD TAKE IN EACH OF THE FOLLOWING SCENARIOS. GIVE REASONS TO SUPPORT YOUR DECISION. D3.1. You are a pharmacist working in the tablets packaging department. You opened a line

for packing of Product X, an orange tablet, at 8am this morning. At 11am you are called to the line as tablets from Product Y, a blue tablet, are found in the bulk tablets of Product X. Explain what steps you would take? (10x½= 5 marks) ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… ………………………………………………………………………………………………………


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D3.2 On another occasion, a customer complaint is received. Upon opening a carton of tablets recently purchased, the customer noticed that one of the tablets was blue and not the orange colour that the rest of the tablets were. Explain how you would deal with this complaint. (10 x ½ = 5 marks)

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****END OF SECTION D****

The South African Pharmacy Council - MM3 Admin : … Which treatment would you consider most...

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