4th EVALUATION

TOPICS:
● Critical Appraisal (Dr. Rita Alvero)

QUESTION RATIONALIZATION

TRUE OR FALSE. Following each statement are numbered sentences or phrases. For each option choose A if
CORRECT and B is INCORRECT

True statements regarding Ethical Criteria for Medicinal Drug Promotion:

1. The Ethical Criteria was developed by Food and Drug ANSWER: B

Administration
The Ethical Criteria was developed by World Health
Organization.

2. Its objective is to decrease cost of essential drugs. ANSWER: B

The main objective is to support and encourage the

improvement of health care through rational use of
medicinal drugs.

3. The criteria apply only to promotional materials. ANSWER: B

The criteria apply to BOTH prescriptions and non-

prescription drugs, as well as traditional medicines.

Applicability and Implementation of the Criteria:

● These criteria constitute general principles for
ethical standards which could be adapted by the
government to the national circumstances.
● They apply to both prescription and
nonprescription drugs, as well as traditional
medicines.
● The criteria could be used by all walks of life.
● The public is encouraged to take the criteria into
account in developing their own sets of ethical
standards in their own field relating to medicinal
drug promotion.
● The criteria do not constitute legal obligations

The recommended information to be included in pharmaceutical advertisements in medical journals:

4. Off-label indication ANSWER: B

The following list based on the sample drug

information sheet from the WHO Expert Committee can
serve as an illustration of the type of information that
advertisements should contain:
 ❖ Brand name
❖ Active ingredient
❖ Name of other ingredients known to cause
problems
❖ Approved therapeutic uses
❖ Dosage form
❖ Side effects and drug reactions
❖ Precaution, warnings, contra-indications
❖ Major interactions
❖ Name and address of the manufacturer/
distributor
❖ Reference to scientific literature

5. Contraindications ANSWER: A

Refer to number 4

6. Brand name ANSWER: A

Refer to number 4

7. Address of manufacturer ANSWER: A

Refer to number 4

The generic name of the drug should always be included in pharmaceutical advertisement for:

8. Identification of the drug class to which drug class it ANSWER: A

belong

9. Prevention of prescribing 2 medicines from the same drug ANSWER: A

class

The following are the components that you should check in promotional materials

10. Message ANSWER: A

MAIN COMPONENTS OF DRUG ADVERTISEMENT

1. Name of Drug
2. Message
3. Graphs and Data
4. Advertising Claim
5. References
6. Pictures and Images

11. Graph ANSWER: A

Refer to number 10
12. Statistics ANSWER: A

Refer to number 10

13. Claim ANSWER: A

Refer to number 10

The following are acceptable references for claims in promotional materials:

14. https://en.m.wikipedia.org.wiki ANSWER: B

The website being cited is not scientifically approved.

Wikipedia is NOT AN ACCEPTABLE reference.

15. Scientific poster: "Demethylated Metabolites of ANSWER: B

Oxycodone and Hydrocodone in Human Hair and Nail
Specimens, 2014" A poster presentation is cited; generally inadequate
information is provided on methods in poster
presentations to judge reported results

16. Kim ES, Mok T, et. al. Gefticib vs Docetaxel in previously ANSWER : A
treated Non-Small Cell Lung Cancer: A Randomized Phase
III Trial. Lancet 2012: 1809-1818 A scientific journal entry is properly cited, and are
considered as an acceptable reference in promotional
materials.

17. Drug X is efficacious in managing cough in children. Use ANSWER : B

of Drug X showed a reduction of cough in guinea pigs.
This is not a reliable claim as the subjects used in the
experiment are guinea pigs. This claim may only be
made acceptable if the subjects in the trial were people.

18.Drug A is preferred over Drug B because it costs less ANSWER : B

Though much more appealing to the customers, lesser

price may not always mean the same quality. However,
this will be acceptable if stated that “Drug A is preferred
over Drug B because it COSTS LESS AND HAS THE
SAME EFFICACY.”

ANSWER : B

19. According to the Generics Act of 1988, the brand name

must be under the generic name. Also, the generic
name must either be IN BOLD, or LARGER IN SIZE.

ANSWER : B
20.
Refer to number 19

ANSWER: A

21. Refer to number 19

Ethical criteria are applicable to these aspects:

22. Advertisement ANSWER: A

23.Symposia ANSWER: A

24. Medical representatives ANSWER: A

25. Packaging and labeling ANSWER: A