COC Part II 2023
COC Part II 2023
COC Part II 2023
PHARMACY
Ginbot 2015/May 2023
Full Name______________________________
PART: TWO TIME ALLOWED: 2:30 HOURS
GENERAL DIRECTIONS
IN THIS EXAMINATION, THERE ARE A TOTAL OF 100 MULTIPLE
CHOICE QUESTIONS. SELECT THE BEST ANSWER AND BLACKEN
ONLY THE LETTER OF YOUR CHOICE ON THE SEPARATE ANSWER
SHEET PROVIDED. FOLLOW THE INSTRUCTIONS IN THE ANSWER
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PENCIL TO MARK YOUR ANSWERS. YOUR ANSWER MARK SHOULD
BE HEAVY AND DARK COVERING THE ANSWER SPACE COMPLETELY.
IF YOU CHANGE YOUR ANSWER, PLEASE ERASE IT COMPLETELY AND
NEATLY.
DO NOT TURN THIS PAGE OVER UNTIL YOU ARE TOLD TO DO SO.
Pharmacy Exam
Ginbot 2015/May 2023
PART TWO
What is the most likely core tablet parameter the production pharmacist needs to check?
A. Friability B. Viscosity C. Dissolution D. Disintegration
2. A pharmacist wants to select gelatin for preparing ibuprofen soft gelatin capsule after
evaluating its grade.
What is the most appropriate packaging material for this tablet product?
A. Waxy paper C. Aluminum foil
B. Polypropylene D. Polyvinyl chloride
5. A production pharmacist assigned in sterile drug production wants to select the primary
packaging material for the drug he produces.
Which parameter of the polarogram is most important for calculating concentration of the
API?
A. Residual current C. Diffusion current
B. Half wave potential D. Decomposition potential
What is the most appropriate procedure needed before the raw materials released?
A. Divide for transporting to production area C. Document, repack and label
B. Change the secondary container D. Sample and test for quality
10. A pharmacist who is working in a hospital pharmacy compounding unit wants to prepare
cream for topical fungal treatment. She has collected excipients for oil and water phase.
Another ingredient, which enhances viscosity of the emulsion, is also required.
What is the most appropriate test the quality control personnel should perform?
A. Minimal fill C. Homogeneity test
B. Stability study D. In vitro drug release
What is the most appropriate container the pharmacist should use for this product?
A. Glass jar C. Collapsible tube
B. Glass tube D. Wide-mouthed plastic jar
13. A patient comes to a community pharmacy with a prescription asking for preparing cetrimide
ointment. A compounding pharmacist used fusion method and prepared a product. Once
congealed, he ensured a uniform and smooth texture of the final product.
What was the most likely technique used by the pharmacist to ensure the quality of the
ointment in this case?
A. Pass through colloid mill
B. Rub with mortar and pestle
C. Melt the entire mixture and cool
D. Collect and remove irritating solid particles
What is the most appropriate material flow pattern into preparation area?
A. Material movement from dirty to clean area
B. Performed in hand lock designed door
C. Bidirectional material flow
D. Under unidirectional airflow
What is the most likely activity performed by the pharmacist in this case to make this
preparation?
A. Use sterile environment C. Use two miscible oily solvents
B. Use organoleptic agents D. Use high solute proportion than solvent
16. A pharmaceutical scientist designed a new form of a peptide drug. And he wants to have a
drug that should be administered through a rout that bypasses the first pharmacokinetic
phase.
What is the appropriate route of administration?
A. Buccal B. Rectal C. Intravenous D. Subcutaneous
18. A pharmacist took 50 ml of a 0.1 M solution of the base diphenhydramine and titrated it with
0.1 M HCl to determine its extent of ionization. The pH was monitored with a glass
membrane. After 3 ml of 0.1 M HCl have been added the pH of the solution is 8.82.
19. Apharmaceutical factory has been manufacturing chloramphenicol eye ointment, 1percent.
To ensure the sterility of the product, the pharmacistuse separately sterilized raw materials.
Additionally, all manufacturing, filling, handling and packing processes are performed under
the controlled environment from microbes.
What is the most likely technique that the pharmacist used to maintain product sterility?
A. Dry sterilization B. Ionizing-radiation C. Autoclaving D. Aseptic
What is the most likely primary container that can be used for this product?
A. Vial B. Ampoule C. Glass bottle D. Prefilled syringe
21. A pharmacist was interested to sterilize a drug product. But, the method of sterilization he
selected has limitations like removes rather than kills the organism, and it is only applicable
to fluids.
What type of sterilization technique does the pharmacist most likely select?
A. Dry heat sterilization C. Filtration sterilization
B. Radiation sterilization D. Steam sterilization
22. A pharmacist is working in sterile production unit of a pharmaceutical industry. She planned
to start production activity of a new batch of ibuprofen injection.
What is the first thing she should do before starting any production?
A. Transfer materials and components from warehouse to classified rooms
B. Cleaning and preparing container items introduced into the preparation
C. Weigh raw materials in a weigh area and transfer to plastic bags
D. Sterilize the equipment in the compounding area
23. A pharmaceutical analyst who is working at a pharmaceutical factory quality control unit is
requested to test the quality of manufactured salmeterol + fluticasone powder for oral
inhalation packed in metered dose inhaler before release.
What are the most appropriate tests the pharmaceutical analyst should conduct?
A. Viscosity test, friability test C. Dissolution test, disintegration test
B. Hardness test, compatibility test D. Microbial count, content uniformity
What is the most appropriate place for relocation of packaging and labeling room?
A. Near warehouse C. Near quality control laboratory
B. Near preparation area D. Near finished product storage room
25. An inspection team from EFDA was visiting a pharmacy retail out late for periodic and
scheduled inspection. During the inspection, they need to know the storage condition of
vaccines. They ask the pharmacist to show an evidence of controlling the storage condition
as per the manufacturing recommendation.
What would be the most appropriate evidence that the pharmacist should provide?
A. The functionality of the refrigerator
B. A humidity record of the refrigerator
C. A temperature record of the refrigerator
D. A calibration certificate of thermometer in the refrigerator
26. A medicines retail outlet establishment was inspected for fulfillment of criteria. The
inspection team identified the medicines retail outlet establishment has wood-reinforced mud
wall, wall painted with water proof paint, Roof allowing direct sunlight into the interior and
Well-cleaned soil floor.
Which building features in the establishment is the most acceptable and suitable in this case
scenario?
A. Roof allowing direct sunlight into the interior
B. Wall painted with water-proof paint
C. Wood-reinforced mud wall
D. Well-cleaned soil floor
28. A broken dry mixing machine in tablet production line of a company was maintained and
checked for its functionality by the maintenance group. The quality assurance manager of the
company orders one of the pharmacists to do equipment qualification test for the maintained
dry mixing machine and make the instrument ready for use.
What is the most likely equipment qualification test to be done by pharmacists in the above
case?
A. Design qualification C. Operation qualification
B. Installation qualification D. Performance qualification
29. Before using newly developed test method, a pharmaceutical analyst in quality control
laboratory conducted method validation test to know the ability of the test method to
distinguish the drug under the test from other similar substances that may be present in the
same solution.
Which method validation parameter is most appropriate to be check in the above case?
A. Specificity B. Accuracy C. Precision D. Sensitivity
What types of products are expected to be 100 percent free from viable microorganisms in
this scenario?
A. Topical preparations C. Liquid oral preparations
B. Solid oral preparation D. Ophthalmic preparations
31. In a medicine dossier application, the applicant has indicated overage use of active
pharmaceutical ingredient during the production process without explainingthe reason for
over use . A medicine dossier assessor asked a justification for the over utilization of the API
during the production process.
What most likely acceptable justification the manufacturer gives in this case?
A. To compensate for losses during manufacture
B. To make the medicine potent throughout the shelf life
C. To extending the shelf-life of the highly degradable product
D. To make the content of the medicine constant throughout the shelf life
32. It is evident that any new generic product seeking registration (market authorization) in
Ethiopia needs to have sufficient evidence of bioequivalence (BE) with a comparator or
innovator product through either in vivo or in vitro studies (whichever is appropriate). Even
though this is the case, there are some exception in which products can be registered without
in vivo bioequivalence BE data.
What type of products may be entertained without an in vivo bioequivalence study data?
A. Transdermal patches intended for systemic effects
B. Modified-release pharmaceutical products designed to act systemically
C. Critical-use oral immediate-release pharmaceutical products with systemic action
D. Gases with pharmaceutical equivalence to the comparator product for systemic effects
34. During the review process a finished pharmaceutical product's dossier, the primary assessor
at the Ethiopian Food and Drug Authority followed an approach which limits the assessment
to the sections of the dossier based on an evidence of cGMP waiver and availability of
market authorization certificate by the claimed stringent regulatory authorities.
35. Pharmaceutical companies hires promoters that execute pharmaceutical promotion services
for them are regulated by the authority.
38. The EFDA receives, investigates, and analyzes adverse drug events from all over the country
as part of its Pharmacovigilance function. It is also in charge of taking regulatory actions to
ensure public safety.
Which of the regulatory actions listed below becomes a proportional measure when the risk
of ADRs clearly outweighs the product benefits?
A. Product recalls
B. Package inserts revisions
C. Letters to health care providers about safety concerns
D. Modifying inadequate designs of product labeling and packaging
What will be the most appropriate measure that should be taken by the certificate issuing
body?
A. Canceling the degree C. Revoking the certificate
B. Suspending the degree D. Suspending the certificate
41. A pharmacist who has been working in a dispensary unit of hospital gets a chance for Msc
program in social pharmacy and left his job to join the program. Two years later, he
successfully completed his class and came to the regulatory body to have a license and
continue his professional practice.
42. Miss Y. studied a bachelor of degree in pharmacy in a foreign country. After getting a
professional license from the country's authority, she could not get a job for more than two
years. Then, she decided to come to Ethiopia.
What is the most appropriate initial step she should take before starting a job in Ethiopia?
A. Complete six months to one-year internship program at assigned institution
B. Get a temporary professional license from the concerned authority in Ethiopia
C. Produce evidence of equivalence of qualification issued by the competent body
D. Get a new professional license from the concerned authority in Ethiopia
45. A research team wanted to import pharmaceuticals that were not registered in the country's
drug registration list. They wanted the product for a clinical trial purpose and consulted on
the legal claim of the scenario.
46. Mr. Z is an athlete who runs on International Olympics. On checking the status of the
athletes, he was banned from the sport as he was diagnosed with taking substance that
improves physical activity.
What is the most likely substance that improves the performance of the athlete?
A. Opioids C. Ox-codeines
B. Marijuana D. Anabolic steroids
48. A health researcher wanted to answer a research question if smoking causes coronary heart
disease in adults. The researcher identified smoker and non-smoker adults based on his
sample size and wanted to examine if coronary heart disease is more frequent among the
smokers.
49. A pharmacist, who is working in community pharmacy drug information center, has received
a drug consultation request about "the temporal relationship between digoxin and
Nifedipine". The pharmacist wants to appraise published scientific researches based on its
method.
50. A researcher proposed a study on the prevalence of social drug use among adults in the
Eastern parts of Ethiopia. He\she calculated a total sample of 384 using a single population
proportion formula. There are 5000 adults in the sampling frame and, he\she selected the 384
respondents at a regular interval.
52. A pharmacist is interested to investigate the health status of patients with major mental
disorder using visual analog scale ranging from 0 (the worst health state) to 100 (the best
imaginable health state). The reported health status for the 10 patients shows 55, 65,
70,100,80,75,45, 35, 28, and 40.
53. In a district, the mean systolic blood pressure of adults aged 20 to 40 is 130 mm Hg with a
standard deviation of 10 mm Hg. A random sample of 64 adults aged 20 to 40 from a village
of the same district has a mean systolic blood pressure of 132 mm Hg. A researcher wanted
to test the hypothesis if the mean systolic blood pressure of the dwellers of village (aged 20
to 40) differs from that of the inhabitants of the district (aged 20 to 40) in general, at 0.05
alpha value.
What is the most likely test statistics used for the hypothesis?
A. Chi-square statistics C. Z-statistics
B. F-statistics D. T-statistic
54. A study revealed, that a variable was associated with antibiotics self medication, with an
adjusted odds ratio of 1.2 and a 95 percent CI is 1.1 to 2.0.
56. A biostatistician is comparing the rates of change of disease occurrence over several years.
What is the most appropriate graphical method to present the result?
A. Pie chart C. Line graph
B. Histogram D. Frequency polygon
57. The head of a hospital pharmacy identified wastage of medicines in an inpatient ward as a
critical problem in the operations of the pharmacy. The head assigned a junior pharmacist to
create a plan to alleviate this problem.
58. Ministry of Health in collaboration with USAID\JSI. Inc has developed health commodities
management systems software, which calculates the stock status of pharmaceuticals and hold
transaction.
Which building blocks of health systems is improved?
A. Health work force C. Information
B. Service delivery D. Finance
59. A head of a hospital pharmacy has planned to achieve more than 90 percent in implementing
Ethiopian Hospital Reform Implementation Guidelines (EHRIG) in the first quarter of 2014
fiscal year. He\she closely checks the progress of pharmacy services by using check lists
every week.
What is the most appropriate role that describes the pharmacist's activity?
A. Monitoring B. Evaluating C. Intervening D. Feed backing
MoH/EHPLE-Pharmacy 2015/2023 IER/AAU/P-II
60. Based on the country's health problems, trained man-power, financial resources and
infrastructure, a National Drug List will be formulated with full consideration of safety,
efficacy, quality and cost. And this is one of the eleven strategies used in facilitating
implementation of the national drug policy of Ethiopia.
61. A pharmaco-economic analysis should be done before selecting and incorporating medicines
in to the National Medicine's List.
62. Tenofovir + Lamuvidine + Efaverinze is one of the first line fixed dose combination Anti
Retroviral Therapy (ART) used by patients on a daily basis. The total number of patients who
are under this treatment is known. In addition, the numbers of patients eligible to take this
fixed dose combination product have been increasing by five percent monthly. The ART
Pharmacy Coordinator is responsible to undergo the quantification of this regimen.
What is the most appropriate quantification method the pharmacist should use?
A. Morbidity Method C. Service level Projection Method
B. Consumption Method D. Adjusted- Consumption Method
63. A hospital has a strong drug management team, where drug transaction information is
recorded appropriately. The hospital started giving services in 2009 E.C. and, a team is
required to conduct quantification for the year 2014 E.C.
65. A health center has 180,000 birr for pharmaceuticals purchase in 2014 fiscal year. The
pharmacy head has quantified pharmaceuticals by categorizing as vital costing 80,000 birr,
essential costing 90,000 birr and normal costing 20,000 birr.
66. A pharmacist is working in the drug supply management unit of a hospital, which was
established ten years back. The hospital mostly purchases its health commodities from local
suppliers, unless there is emergency stock-out. The hospital has a complete record of the
purchase and utilization of pharmaceuticals. There was also a relatively uninterrupted supply
trend of pharmaceuticals. Thus, the pharmacist decided to quantify an amount of
pharmaceuticals for the next budget year.
What is the most appropriate quantification method to use for the above scenario?
A. Morbidity C. Proxy-consumption
B. Consumption D. Service level projection
67. A total of 200 ampoules of Gentamycin injection were set as safety stock to prevent stock out
of the drug from a hospital. The lead time is two weeks.
What is the average monthly consumption?
A. 100 B. 200 C. 600 D. 400
69. A health center purchased a single source medicine at negotiated price. The medicine
purchased was patented to a single supplier.
Which method of procurement is applied by the the health center?
A. Competitive negotiation procurement C. Open tender procurement
B. Restricted tender procurement D. Direct procurement
70. A hospital's purchasing officer purchases 10000 capsules of 500mg Amoxicillin and 8000
tablets of 500mg Ciprofloxacillin. The team have collected Performa invoice from three
potential suppliers with a low prices. However, the suppliers have no a renewed license.
71. A pharmacist needs to place ordering of pharmaceuticals based on the Max-Min inventory
control systems. At the end of the review period, he\she reviewed the stock level of all the
pharmaceuticals and ordered enough stock to equal to reach the maximum stock level.
What is the most likely type of Max-Min inventory control system the pharmacist following?
A. Push ordering system C. Continuous review system
B. Standard review system D. Forced-ordering system
72. In the past month, a primary hospital's store manager reported that 30 male condoms were
expired, 4 IUDs were stolen, 120 sachets of oral rehydration salts were loaned for other
health facility and, 20 treated malaria nets were received from another health facility.
What is the most likely essential logistics data the report contains?
A. Loss or adjustment data C. Stock transfer data
B. Dispensed to user data D. Wastage data
74. A hospital store manager is processing request of pharmaceuticals from OPD dispensary.
He\she is transcribing information from Intra-Facility Report and Resupply Form (IFRR) on
to an issuing voucher. The information transcribed includes date, name-dispensing unit, code
of the product, description of the product, batch number, unit of measurement, quantity
received, total selling price and expiry date.
What is the most likely issuing voucher that the store manager used?
A. Model 20 B. Model 22 C. Model 06 D. Model 19
75. A pharmacist is keeping a stock record of paracetamol 500mg tablet. He\she places the
record on the pallet where the medication is found. The record included the stock on hand of
paracetamol for that batch only. Besides, any losses and adjustments for the specified batch
were recorded.
What is the most likely type of stock keeping record the pharmacist using?
A. Bin Card C. Inventory card
B. Stock card D. Store ledger card
76. A store manager of a hospital does not know and implement when to order or issue, how
much to order or issue and how to maintain appropriate stock levels of pharmaceuticals.
Hence, morbidity increased due to shortage of essential drugs. On the other hand, overstock
of less essential pharmaceuticals was reported which precipitates inefficient budget
utilization.
What is the most likely system that the store manager fails to implement?
A. Distribution system C. Proper storage system
B. Procurement system D. Inventory control system
What is the most likely waste disposal method the department should present?
A. Landfill C. High-Temperature incineration
B. Burning in open place D. Medium-Temperature incineration
78. A pharmacist, who is working in the central medical store, is arranging medicines with the
aim of strengthening the security of medicines.
79. A dispensary pharmacist requested 1000 capsules 500mg Amoxicillin capsules from a store.
There were two batches of the medication. Batch A was received on September 20, 2020 and
have an expiry date of December, 2022 while Batch B was received on January 20, 2020 and
have an expiry date of December 2021.
80. A purchased laboratory reagents were loaded on a transport vehicle. When the vehicle has
arrived to the facility after 24 hours of a drive, some of the reagents were damaged.
What is the most likely activity TMS and EPSA should undertake?
A. Fleet Management C. Performance management
B. Operations Management D. Human resource Management
82. A severely injured patient with fractured femur by traffic accident is hospitalized for 3
months. The patient has been treated with intravenous morphine and he felt better. After
discontinuation of the medication, the patient has developed craving symptoms, sweating,
irritability, nausea and vomiting.
What is the best preferred medication to treat the patient's condition?
A. Pethidine B. Naltroxone C. Oxycodone D. Methadone
83. A pharmacist who is working in a hospital wants to have objective evidence on the extent of
irrational antimicrobials use and its impact. The hospital has a laboratory facility for a drug
sensitivity and culture test. There are also periodic reports of a morbidity data and drug
consumption data in the hospital.
84. A pharmacist who is working in a rehabilitation center wanted to help smokers for behavioral
changes, in addition to the pharmacological treatments. She wants to give a training
equipping with a strategy to assist for behavioral change.
Which strategy is most appropriate to follow?
A. Grouping approach C. Connect with quit lines
B. Judgmental approach D. Motivational interviewing
86. A mother requested for an appetizer bringing her 3-year-old child with irritability and poor
appetite to a community pharmacy. The baby looks wasted, failed to grow with his age and
edematous. The pharmacist suspected that the baby's condition might be kwashiorkor and
advised the mother go to a health facility for further testing.
What is the most indicative sign for suggesting as the child has kwashiorkor?
A. Failure to grow C. Irritability
B. Loss of appetite D. Edema
87. A woman who is a frequent client of a community pharmacy repeatedly asks for post pills.
On further discussion, the pharmacist understands that she has multiple sexual partners.
88. The pharmacist has planned to provide education on an appropriate use of salbutamol puff
for asthmatic patients on the waiting area of the ambulatory follow-up clinic.
90. A client made a verbal request for Amoxicillin capsules for her 8 years old daughter with
complaints of cough and poor appetite. She requested to purchase only ten capsules of the
medication due to financial constraints she has.
91. A patient has a right to know the name of medication, side effects, contraindications, how,
when and for how long to take the drug that has been prescribed for him\her. This is the
promotion of independent choice, self-determination and freedom of action. The pharmacy
professional has ethical obligation to stand for this ethical principle while dispensing drugs to
patients.
92. An adult patient presented to a hospital after being bitten by a dog confirmed to be infected
with rabies virus. Sufficient counseling was given to him by health care providers. However,
the patient refused to be vaccinated.
What is the most likely type of ethical theory that the above description referring?
A. Ethic of caring theory C. Utilitarian ethical theory
B. Teleology ethical theory D. Deontology ethical theory
95. A pharmacist should accept prescriptions only in written format except under emergency or
compelling conditions. In case of a prescription is transmitted orally or through telephone,
the pharmacist has to register it and get the prescriptions signed by the prescriber as soon as
possible. This is one of the ethical standards of pharmacy practice in Ethiopia.
What is the most likely ethical standard of pharmacy practice the above paragraph referring?
A. Rational drug use in pharmacy
B. Dispensing of medications in pharmacy
C. Compounding of pharmaceuticals in pharmacy
D. Pharmaceuticals supply management in pharmacy
What is the most likely conflict resolution skill that the above paragraph describes?
A. Assertiveness B. Mutual respect C. Self-esteem D. Fogging
97. A 65-year old male diabetic patient who discontinued his medication six months ago visited a
private hospital for diabetic complications. The patient used to fill his prescription from a
nearby community pharmacy, but he did not remember the name of the anti-diabetic
medicine he was taking. The physician told the patient to ask the community pharmacy for
the information. The patient was worried the information may be lost as it has been a while
since he last filled his prescription at the pharmacy.
What is the most likely amount of time that the pharmacy is required to keep the patient's
prescription?
A. Two years B. Three years C. Five years D. One year
98. A 27-year-old patient recently diagnosed with diabetes mellitus presented to a pharmacy with
his mother to consult about the oral hypoglycemic medicine he is going to start. The patient's
mother told to the pharmacist that her child lives with autism.
99. A patient presented to a pharmacy with a prescription that calls for an extemporaneous
preparation. However, one ingredient is missing from the ingredients list.
What is the most likely category of factors that the above statement refers to?
A. Pharmaceutical factors C. Human factors
B. Workplace factors D. Economic factors
THE END