October University for Modern Sciences & Arts

Model answer of Midterm Exam

Faculty Pharmacy

Department Pharmaceutics

Module Code PT 541/ PT 531

Module Title Pharmaceutical Ethics and Legislation

Semester Spring 2022

Time Allowed one Hour

Total Mark 60 Marks/ 3(factor) = 20 Marks

No. of Pages 6

Material provided -

Equipment permitted -

Additional Instructions -

No books, paper or electronic devices are permitted to be brought into the examination room other than
those specified above.
 October University for Modern Sciences and Arts PT 541/ PT 531
Faculty of Pharmacy ,Pharmaceutics Department Pharmaceutical Ethics and Legislations

Midterm exam (Model Answer),Spring 2022 1 hour

Course coordinators: Dr Amira Hasha, Dr Nihal Elsayyad,
Dr.Lamis Helmy

All questions to be attempted (Total Marks: 60 points/( 3) factor =20marks)

Question I: Discuss each of the following : (12 marks, each of 3 marks)

1- The department responsible for registration of plasma substitutes and mention its responsibilities
central department for biologicals, innovative products and clinical trials
responsible for:
A) Quality control and stability studies of:
1. Vaccines
2. Biological products
3. Blood and plasma substitues
B) supervision and approval of clinical and pre-clinical trials of new drugs and biologicals.

2- Relation between the pharmacist and the syndicate (mention 3 points only).
1) Pharmacists should fulfill the rules and ethics of their profession.
2) A pharmacist should fulfill the decisions issued by the syndicate or its disciplinary sites.
3) A pharmacist can not sue one of his colleaguesfor a professional reason without getting a written
permission issued from the syndicate.
4) A pharmacist should inform the syndicate about the pharmaceutical establishment where he works and
about any possible change.
5) A pharmacist should inform the syndicate about any incidence or person that may dishonor the
pharmaceutical profession.
6) A pharmacist should not advertise in newspapers for his need of work. He should inform the syndicate.
on the other hand, owners of pharmaceutical establishments should inform the syndicates of their need
of pharmacists.

3- Disciplinary organization of the Egyptian pharmacists syndicate in case of violations.

Page 1 of 6
October University for Modern Sciences and Arts PT 541/ PT 531
Faculty of Pharmacy ,Pharmaceutics Department Pharmaceutical Ethics and Legislations

Midterm exam (Model Answer),Spring 2022 1 hour

Course coordinators: Dr Amira Hasha, Dr Nihal Elsayyad,
Dr.Lamis Helmy

1) The disciplinary organization in the syndicate judges pharmacists who are not working in the
government in case of doing anything against rules or ethics as well as abusing his pharmaceutical
profession .
2) Pharmacists working in the government are judged in their special disciplinary organization in case
of violation of rules of their governmental work.
• 3) Disciplinary organizations of the syndicate alsojudgesany pharmacist against whom there was
judicial decree
Accordingly, MPH informs the syndicate of any legal action taken
against any pharmacist.

4) The journey of a pharmacovigilance report submitted to Egyptian Pharmacovigilance center.

Reporter communicate with pharmacovigilance center

Qualified pharmacovigilance person (QPPV) from EPVC investigates the incidence and report the
findings to EPVC

Report analysis by EPVC to take the required action

Question II: Mention four documents needed for submission of the following files (12 marks, 4
marks each)

1) Registration of a new local antihypertensive drug.

1. Form for the company profile
2. Form of registration application.
3. A copy of the scientific reference of the composition
4. For pharmacopeial product a copy of the most recent pharmacopeia to which depends the product.
5. Pre-clinic and clinic studies on the product are to be presented
6. A copy of the factory license, with reviewing the original
7. Manufacturing contract in case of toll manufacturing
8. Receipt of payment registration and pricing duties fixed by the minstrel degree.
9. Enclosed leaflet in English and Arabic.
10. External package and the internal card proposed for the product.
11. Accelerated stability studies.
Page 2 of 6
 October University for Modern Sciences and Arts PT 541/ PT 531
Faculty of Pharmacy ,Pharmaceutics Department Pharmaceutical Ethics and Legislations

Midterm exam (Model Answer),Spring 2022 1 hour

Course coordinators: Dr Amira Hasha, Dr Nihal Elsayyad,
Dr.Lamis Helmy

12. Statement of composition including effective and ineffective materials

13. The external package of the original product (Innovator).
14. Cost list and proposed price of the product.
15. Names of supplies of the effective material of product.
16. Specifications of packaging materials.
17. CD including all documents

2) Stability study file of an imported human biological product.

1-Covering letter of the file contents on company paper.
2- composition (stamped & on company paper).
3 – Original certificate of manufacturer.
4-Complete stability report with tables for 3 different batches
5-Chromatograms of HPLC analysis of each time interval for all batches
Method of analysis for the finished products.
7-Stability study report.
8 -(CD).
3) Licensing of a drug store.
1. Request of license from directorate of license.
2. Money order for medical district by 5 LE.
3. Copy of birth certificate or extract of which.
4. Copy of national ID or passport.
5. Copy of syndicate ID card.
6. Copy of authorization to practice the profession.
7. 3 copies of Engineering drawing from certified Engineer union.
8. Valid criminal records sent to medical district located in a circle where district location license.
9. Certificate extracted from the pharmacy administration to register a pharmacist manager responsible for
the pharmacy or drug store.
10. Copy of the contract (rent or acquisition) for the pharmacy.

Question III: Rationalize the following statements (12 marks, 4 marks each)

1) The pharmacist should respect some ethical principles in the place where he works.
1. Respect the working hours.
2. Not use the pharmaceutical establishment where he works in other purposes
3. Not use illegal or undignified methods of advertisement
4. Not pretend to have awards

Page 3 of 6
 October University for Modern Sciences and Arts PT 541/ PT 531
Faculty of Pharmacy ,Pharmaceutics Department Pharmaceutical Ethics and Legislations

Midterm exam (Model Answer),Spring 2022 1 hour

Course coordinators: Dr Amira Hasha, Dr Nihal Elsayyad,
Dr.Lamis Helmy

5. Not use or imitate the commercial name, sign, design or reports of other pharmaceutical

2) In order toadd a bathroom in a pharmacy, some health conditions should be met.

1. The sink to be porcelain or stainless steel.
2. Inclined marble beside the basin with height not less than 60cm.
3. Separate corridor for the bathroom
4. A door closing the bathroom corridor.
3) Pharmacist staff in a bioavailability centers’ should meet certain requirement in order to be qualified for
this job.
1. A full-time manager of the centre holds BSC in pharmaceutical sciences and should be Egyptian.
2. A full-time technical manager holds have holds PhD in pharmaceutical sciences and should be
Egyptian.
3. Supervisor dedicated to analysis holds master degree.
4. Specialists in chemical analysis holds BSC in pharmaceutical sciences.

Question IV: read the following cases and answer the relevant questions.(12 marks)
The company you work for an Egyptian pharmaceutical company that manufactures an anti-
inflammatory drug product at concentration of 100 mg. The company wants to add a concentration
of 200 mg while keeping the product name and dosage form the same. Upon inquiry, you found
that 12 local products are already registered in the market, Answer the following questions

1) Suggest the name of legal body you will send the registration application to. (2 marks)
Egyptian Drug Authority: Central department of pharmaceutical products
2) Would it be possible to register this product? (3 marks)
Yes, This is a line extension, They can license the product even if the box has more than 12 products
3) Assume that they would change the type of tablet coat, would they be able to register the product?
(4 marks)
The product will not be considered a line extension and thus the company will register the product as
a new product, and since the box is closed as it has already 12 products, they will not be able to
register it
4) If the same product would be imported from United states of America under a different name,
would your answer to question (3) differ? (3 marks)

Page 4 of 6
 October University for Modern Sciences and Arts PT 541/ PT 531
Faculty of Pharmacy ,Pharmaceutics Department Pharmaceutical Ethics and Legislations

Midterm exam (Model Answer),Spring 2022 1 hour

Course coordinators: Dr Amira Hasha, Dr Nihal Elsayyad,
Dr.Lamis Helmy

No, as there are 12 local products in the box, even if there are no imported products, the product
cannot be registered
Question V: Assuming you are a community pharmacist, read the following case carefully and answer
the relevant questions. (12 marks, each of 3 marks)

A community pharmacist received a prescription for treatment of gastric ulcer, however, the physician
also prescribed Aspirin as an analgesic. From your previous knowledge, you know that Aspirin has an
anticoagulant effect and is known to cause gastric bleeding.

1) Which type of ethical conflict does this case describe? justify your answer. (3 marks)
Patient advocacy, as although the pharmacist doesn’t possess the medical knowledge of the physician, he has to
intervene due to the potential harm to the patient
2) Can the pharmacist replace Aspirin? Justify your answer (3 marks)
No, he can’t replace any medicine before returning to the physician as the pharmacist lack the sufficient
knowledge about patient history
3) From your point of view, is Aspirin an over the counter medication or prescription medication, Justify
your answer (3 marks)
Aspirin is an over the counter medication, as it is prescribed for a minor ailment (headache) and is not a
potent drug.
4) What other actions do you advice the pharmacist to do? Suggest a possible action and justify your answer. (3
marks)
He can call the physician
Refuse to dispense the prescription and tell the patient to return to the physician
Ask the patient to get a second opinion
Justification: According to patient advocacy ethical dilemma, he should refrain from harming the patient and
check the safety and efficacy of the medicine.

------------------------------------------------End of Questions-----------------------------------------------

Page 5 of 6
October University for Modern Sciences and Arts PT 541/ PT 531
Faculty of Pharmacy ,Pharmaceutics Department Pharmaceutical Ethics and Legislations

Midterm exam (Model Answer),Spring 2022 1 hour

Course coordinators: Dr Amira Hasha, Dr Nihal Elsayyad,
Dr.Lamis Helmy

Page 6 of 6