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SICAD

The document presents a series of questions on topics related to the regulation of medicines and pharmacies in Mexico. It addresses concepts such as health control, adverse event reporting tools, entry registration requirements for antibiotics, types of licenses for pharmacy operations, medicine entry and exit registration systems, pharmacovigilance, medicine billing, classification of medicines, storage conditions, among others.
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0% found this document useful (0 votes)
54 views9 pages

SICAD

The document presents a series of questions on topics related to the regulation of medicines and pharmacies in Mexico. It addresses concepts such as health control, adverse event reporting tools, entry registration requirements for antibiotics, types of licenses for pharmacy operations, medicine entry and exit registration systems, pharmacovigilance, medicine billing, classification of medicines, storage conditions, among others.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

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Roberto Daniel Maldonado
Home (../Default.aspx) Exit (../Exit.aspx)
Exam Assistant
to the Dispensation

Take the exam

Answer the questions and click the "Finish Exam" button.

What does Health Control refer to?

Education, sampling
Verification and security measures and sanctions
Set of actions, orientation
All of the above

It is the notification tool that registration holders or their representatives must use.
legal entities, institutions or establishments that conduct health research,
distributors/marketers that currently do NOT have the capacity to do so
by another format:*

XLM-E2B Tool
e-Reporting tool
VigiFlow Tool
HTTP Tool

3. These are some elements that must be included in the antibiotic entry log in your records.
of control:

Date of receipt
Progressive internal number assigned to each invoice, complete presentation, name of
responsible laboratory for the antibiotic
Receipt date, distinctive and/or generic name, lot number and expiration date of
antibiotic
Date of receipt, supplier's business name, address, invoice number or receipt of
acquisition
4. The designated key in the health records for these medications, according to their type, is the
letter 'P':

Allopathic
Homeopathic
Herbalists
Multivitamins

5. What legal documentation supports the operation of the Hospital Pharmacy and Drugstore or
homeopathic pharmacy with preparation of magistral and officinal medications?

Health Responsible Notice


Operating Notice
Sanitary License
Health License and Notice of Health Officer

6. The existence of a system for recording the entry and exit of medications and others.
supplies for health guarantees:

The reduction of losses


The cleaning and maintenance of the areas
The absolute control of expiration verification
The traceability of the origin of health supplies

7. They are the activities related to the detection, assessment, understanding, and prevention of the
adverse events, the reported reactions of suspected adverse reactions, the allegedly events
attributable to vaccines or immunization, or any other safety-related issue concerning the
use of medications and vaccines:*

Adverse Reactions Report


Sanitary verification of drugs
Technological surveillance
Pharmacovigilance

8. The system for recording the entry and exit of medications must be:*

Manual or automated
Manual
Automated
Digital

9. The business name and address on the original invoice for health supplies must correspond
con:*

The license or operating notice of the establishment that supplied the medication
The legal name and address of previous invoices
The private address of the health responsible notice of the provider
The private address of the owner

It is any substance or product, solid or semi-solid, natural or transformed, that provides to


organisms elements for their nutrition:

Food
Nutrient
Vitamins
Dietary supplement

11. In the ABC of customer service in a pharmacy, the letter A defines:

Support in the sales work


Approach to your customers
Customer service attitude
Ability for sales and supply

12. Medical equipment, prosthetics, orthotics, functional aids, dental supplies and
Surgical materials are some examples of:

Biotechnological inputs
Hospital-use materials
Medical devices
Medical instrument

13. They are elements that must be included in a medication invoice due to health regulations.
health supplies in a pharmacy:*

Description of the health input, SAT digital seal, invoice number, date
Description of the health input
Description of the health input
Invoice issue date
Presentation

14. It is the meaning of the acronym RAM:*

Authorized Regulation for Medicines


Adverse Drug Risk
Abnormal Drug Regulations
Adverse Drug Reactions

15. The separation criteria for the arrangement of medications include the conditions of
conservation, alphabetical order and by presentation, expiration, first in, first out
y...*

The classification for its sale and supply


Classification by its preparation
Classification by its nature
The classification according to their therapeutic effects

16. They are medications that can only be obtained with a special prescription issued by the
Ministry of Health:

Medications Fraction I
Medications Fraction III
Fraction V medications
Medications Fraction VI

17. If the label of a medication or health product states 'must be stored in a'
"cool place", it can be stored and distributed in a refrigerator at a temperature that
find among:*

10 and 18°C
8 and 15°C
9 and 20°C
5 and 18°C

18. The key assigned to this Health Registration is RH and corresponds to:*

Homeopathic Medicines
Homeopathic Remedies
Herbal Remedies
Herbal Medicines

19. Even if the pharmacy belongs to a corporate entity or chain, the Standard Operating Procedures
of Operation must be:

Directed
Specifics
Generals
Applied

20. They are medical devices whose designation key in health records is according to their
the usage category is the letter 'E':*

Medical equipment and dental supply items


Prosthetics, orthotics, and functional aids
Surgical and healing material
Diagnostic agent

It is the set of methods and observations that allows us to detect adverse incidents during
the use of a medical device, which can cause harm to the patient, operator, or the environment
environment that surrounds it:

Adverse Reaction to devices m


Technovigilance
Pharmacovigilance
Health verification of medical devices

22. It is the minimum education level required for auxiliary staff who are not professionals.
of health and that serves the public:*

High School Diploma


There is no minimum required level.
Secondary
Incomplete degree or student

23. Pharmacies are authorized to supply or sell directly to the public and wholesale.
retail. What does retail mean?

Dispense a maximum of 3 medications in a single display.


Dispense a maximum of 5 medications in a single display
The sale to a natural person
The amount prescribed by the doctor

24. The meaning of the acronym PNO is:*

Normative and Operational Procedure


Standard Operating Procedure
Normalized and Operational Process
Normative and Operational Process
25. They are professionals who have a professional license issued by the authorities.
competent educational institutions that are authorized by the Health Department to prescribe
fraction I medications in special prescriptions:*

Doctors, Doctors with some specialty, Bachelor of Nursing


Doctors, Homeopathic Doctors, Veterinarians, Dental Surgeons
Doctors, Veterinarians, Dentists
Doctors, Homeopathic Doctors, Herbalists

26. It is the prescription issued by authorized professionals for the prescription of


medications of group I:*

Personalized
Ordinary
Authorized
Special

27. They are drugs of natural, semisynthetic, or synthetic origin that destroy and/or inhibit the
growth of bacteria or microorganisms:*

Probiotics
Antibiotics
Painkillers
Laxatives

28. By their nature, according to Article 224 of the General Health Law, medications are
classify in: *

Generic and herbalists


Biotechnology and biocomparables
Pharmaceutical specialties, Magistral and Official
Homeopathic, Herbalists, Allopathic

29. It is the key assigned by the Ministry of Health to the sanitary records of the medications.
Allopathic?

F
M
A
P
30. According to Article 226 of the General Health Law, it is the mandatory label that must be carried.
medications and herbal remedies fraction II:*

Its sale or dispensing requires a prescription or special permission with a barcode, which will be retained.
in the pharmacy.
All of the above
Its sale or dispensing requires a medical prescription, which will be retained at the pharmacy" and, if applicable," its
Prolonged use even at therapeutic doses may cause dependence.
Its sale or dispensing requires a medical prescription that can be filled on three occasions with a validity of
six months" and in their case, "its prolonged use even at therapeutic doses can cause dependence."

31. According to Article 88 of the Health Supplies Regulation, what is a Herbal Remedy?*

Chemical-free substance
Psychoactive or Plant-based Narcotic
Concentrated natural products
Preparation of medicinal plants, either individually or combined, and their derivatives

32. What legal documentation supports the operation of pharmacies without management of
controlled or biological, homeopathic pharmacies without the preparation of magistral medicines
and medicinal herbs and the pharmacy without management of controlled and biological substances?

Health license and Operating notice


Operating Notice
Notice of Health Responsible
Health License

Once the special prescription is filled, it is the means by which the delivery will be notified to
prescribing doctor the delivery:*

Email of the PHARMACOPEIA


The prescribing doctor does not receive notification regarding this.

Email of COFEPRIS
Only by phone

34. The materials and substances that are applied to the surface of the skin or bodily cavities and
those with pharmacological or preventive action are known as:

Hygienic products
Subcutaneous medications
Diagnostic agents
Subcutaneous remedies
35. These are some requirements that the pharmacy must meet at a minimum*

The pharmacies located inside self-service stores must be installed


in specific areas, physically separated
Pharmacies with an Operating Notice must have a sign at the entrance, in a visible place to
public, indicating the name or business name, type of business, and operating hours
All the above
Be independent of any other business name, line of work, or residence.

36. The First In-First Out (FIFO) system for medical devices,
apply to:*

To medical devices that do not expire


Medical devices that have an expiration date
To the surgical materials
All medical devices without exception

37. According to Article 215 of the General Health Law, what are Dietary Supplements?

Herb-based products, plant extracts, traditional foods, added or not of


vitamins and minerals
Plant nutrient mix
Auxiliary products in the treatment of digestive diseases
Concentrates added 100% of Vitamins and minerals

According to Article 421 of the General Health Law, the penalty for the sale and supply of
medications with expired expiration dates will be equivalent to:

Fine of five thousand times the current daily minimum wage


A fine of six thousand to twelve thousand times the current daily minimum wage.
Retention of the health license for 2 weeks
Closure of the establishment for a period of one month

It is the document that supports the possession and lawful origin of medications and others.
health supplies:*

Invoice or proof of purchase


Medication entry log
Control book
Inventory control record

40. The legal and technical documentation, such as the Operating Notice, the Responsible Notice,
Filed with the Ministry of Finance and Public Credit, among others, must be submitted in:

Certified copy
Original and photocopy
Original and certified copy
Only in original

* Required fields Sending...

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