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The document outlines essential information for medication management, including legal requirements, training for pharmacy staff, and documentation needed for medication dispensing. It also covers various regulations related to the sale and supply of medications, including the classification of medications and the responsibilities of health authorities. Additionally, it highlights the importance of pharmacovigilance and the proper storage conditions for health supplies.
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0% found this document useful (0 votes)
31 views11 pages

Take The Exam

The document outlines essential information for medication management, including legal requirements, training for pharmacy staff, and documentation needed for medication dispensing. It also covers various regulations related to the sale and supply of medications, including the classification of medications and the responsibilities of health authorities. Additionally, it highlights the importance of pharmacovigilance and the proper storage conditions for health supplies.
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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It is the information that should be considered for medication management:*

Health registration before the Ministry of Health


Complete data of the laboratory that manufactures the medication
Trade name and concentration of the medication
Most common routes of administration and usage considerations
2. Training for new pharmacies or new staff must
to impart

In the first week of operations


At most one month from the start of operations
Before the fifteen days of starting operations
Before starting the activities or functions
3. The legal and technical documentation, such as the Operating Notice, the Notice of
Responsible, registered with the Ministry of Finance and Public Credit, among others,
they must present themselves at:*

Only in original
Certified copy
Original and certified copy
Original and photocopy
4. According to Article 224 of the General Health Law, these are the medications that
They are prepared according to the formula prescribed by a doctor.*
Compounding Medications
Specialties
pharmaceuticals
Allopathic Medications
Official Medicines
5. This information appears on the back of the label of the secondary packaging of a
medication

Pharmaceutical form and concentration


Expiration date, lot, and mode of use
Generic name, distinctive name, pharmaceutical form and
concentration
Cautionary legend "Keep out of reach of children"
It is a document that contains, among other elements, the prescription of one or
various medications and can be issued by doctors, homeopaths, surgeons
dentists, veterinarians in their area of expertise, interns in social service
from any of the previous careers:*

Patient file
Control Book
Medical control log
Medical prescription
7. The business name and address of the original invoice for health supplies
must correspond with:*

The private address of the health responsible notice of the provider


The owner's private address
The license or operating notice of the establishment that supplied the medication
The business name and address of previous invoices
8. According to Article 215 of the General Health Law, what are Supplements
Food?

Herb-based products, plant extracts, traditional foods, added or


of vitamins and minerals
Auxiliary products in the treatment of digestive diseases
Mix of plant nutrients
Concentrates added 100% of Vitamins and minerals
9. He/She has the responsibility to do what is necessary to minimize the possibility of a
adverse incident involving the use of a medical device:*

The Federal Commission for the Protection against Health Risks


COFEPRIS
The National Center for Pharmacovigilance
The holder of the sanitary registry of the medical device
The establishment that sells medical devices
10. The special recipe differs from the ordinary one by:*

The doctor's handwritten signature


The size and type of the font
The authorization record
The type of medication prescribed and the barcode or
bidimensional
11. It is any substance or product, solid or semi-solid, natural or transformed,
that provides the body with elements for its nutrition:

Vitamins
Food
Nutrient
Dietary supplement
12. Substance or mixture of substances of natural or synthetic origin that has effect
therapeutic, preventive or rehabilitative, which is presented in pharmaceutical form and is
identified as such by its pharmacological activity, physical, and chemical characteristics and
biological:

Vitamin
Herbal remedy
Medication
Input for the
health
13. The elements that must be included in the refrigerator/freezer log for the
medication conservation are the data of the establishment, folio, and data of the
instrument, space for recording readings and...

Signature of the Sanitary Responsible Supervisor


Zone where the temperature is recorded
Barcode authorized by the Secretariat of Health
Day and time
14. What fraction corresponds to the medications that require for their
acquisition of the prescription that must be retained at the pharmacy that fills it and be
registered in the control books that are kept for that purpose. The treating physician may
prescribe two presentations of the same product at most, specifying its
content. This prescription will be valid for thirty days from the date of
preparation of it?

Fraction
IV
Fraction I
Fraction III
Fraction II
15. The special recipe of group or fraction I is safeguarded and has a date of
expedition

No later than 30 days from the date of delivery


No more than 10 days from the date of
prescription
No more than 15 days from the date of
prescription
No later than 20 days from the date of delivery
It is a shared activity between health authorities and the industry
pharmaceutical, health professionals, patients and their families and obtain a
better optimization of economic resources for both the public sector and the
private:*

Technovigilance
Pharmacovigilance
VigiFlog
Health verification of
drugs
They are medical devices whose designation key in the health records
according to its usage category is the letter 'R':*

Diagnostic agent
Surgical and healing material
Prosthetics, orthotics, and functional aids
Dental supplies and products
hygienic
18. According to Art. 171 of the Health Supplies Regulation, they are supplies that
They must have a health registration and present the corresponding documentation to the
make the request:

Formulas for specialized enteral nutrition


Dietary supplements
Allopathic medicines
Herbal medicines
19. It is the supply or delivery of one or more medications and medical devices to
a patient and the respective information about its proper use by a
pharmaceutical professional:

Distribution of medications
Marketing of medicines
Sale of medications
Dispensing of medications
It is the set of methods and observations that allows us to detect incidents.
adverse effects during the use of a medical device, which can cause harm
to the patient, operator or to the surrounding environment:

Adverse Reaction to devices m


Technovigilance
Pharmacovigilance
Health verification of medical devices
21. It is an improper activity in the sale and supply of controlled medications:*
Retain the prescription after filling it
Sell controlled medications of the same group on the same prescription
Sell controlled medications from different groups on the same prescription
Supply a maximum of two presentations of the same medication.
22. It is necessary for adequate control of consumption and stock of the
medications and other health supplies:

Respect the storage conditions


Record the movements of entry and exit
Keep the medicine shelves clean
Check the expirations
23. It is the title of the Agreement that determines the guidelines to which it will be
regulates the sale and dispensing of antibiotics through which instructions are given to the
COFEPRIS, so that in coordination with the health authorities of the entities
federative and within the scope of their respective competencies, carry out the oversight
of the provisions set forth in the Agreement:*

Second
Fourth
Third
First
24. They are activities related to detection, evaluation, understanding and
prevention of adverse events, suspected reactions of reactions
adverse events supposedly attributable to vaccines or immunization, or
any other security issue related to the use of medications and
vaccines

Health verification of
drugs
Pharmacovigilance
Adverse Reaction Report
Technovigilance
25. They are products made with plant material or some derivative of it whose
the main ingredient is the aerial or underground part of a plant or extracts and
tinctures, as well as juices, resins, fatty and essential oils, presented in the form
pharmaceutical, its efficacy and safety have been scientifically confirmed:
Herbal Remedies
Herbal Medicines
Natural Medicines
Homeopathic Medicines
26. Principal condition of conservation that must be maintained in storage of
health supplies:

Temperature
Feels like temperature

Humidity
Pressure
atmospheric
27. The system aims to exchange reports with notifiers
specific such as the pharmaceutical industry and allows for a hierarchical structure
in its operation to enable multiple in coordination with the regional centers
of Pharmacovigilance:*

International Standard System CNFV


No tool corresponds
International standard system ICH-E2B (R2 and R3)
VigiFlow
It is the article of the General Health Law that establishes that it is prohibited
the sale and supply of expired medications.

Art.
226
Art.
234
Art.
233
Art.
224
29. According to the storage conditions of medications and other supplies
for health, to a place with relative humidity not greater than 40% at a
controlled ambient temperature is considered as:
Dry
Warm
Thermal
Sub
humid
30. Homeopathic medicines must be prepared according to the
procedures:*

Established in the operational manual for homeopathic medicines of the


Secretariat of Health
Manufacturing described in the Homeopathic Pharmacopoeia of the United States
Mexicans, in those of other countries or other sources of national scientific information.
international
Manufacturing described in the General Law of Homeopathic Medicines,
Allopathic and Herbalists
Established in the Homeopathic Medicines Regulations of the United States
Mexicans
31. These are some minimum requirements that the pharmacy must meet*

Pharmacies with a Notice of Operation must have a sign at the entrance, in a


publicly visible place, indicating the name or corporate name, business type, and hours of operation
operation
To be independent from any other business name, line of business, or residence.
All of the above
The pharmacies located within self-service stores must be
installed in specific areas, physically separated
32. For the sale and supply of drugs of group or fraction I, it is necessary
present

Special medical prescription

Special medical prescription and official identification


Ordinary medical prescription and identification
official
Ordinary medical prescription
33. It is the minimum education level required for auxiliary staff who do not
health professional and serve the public:*
High School
There is no minimum level
required
Incomplete degree or intern
Secondary
34. According to Article 226 of the General Health Law, it is the mandatory legend
what herbal medicines and remedies must include section II:*

Its sale or dispensing requires a medical prescription that may be filled three times.
with a validity of six months" and in its case, "its prolonged use even at therapeutic doses
it can cause dependence.
Its sale or dispensing requires a medical prescription, which will be retained at the pharmacy.
In his case, 'prolonged use even at therapeutic doses can cause dependence.'
All of the above
Its sale or dispensing requires a prescription or special permit with a barcode.
which will be retained at the pharmacy.
35. It is the compilation of graphic, written or electronic records that contain the
necessary data for the control of medication entries and exits
controlled of the establishment:*

Log of entries and exits


Sales log
Control books
Database of medications
36. Due to its preparation, according to Article 224 of the General Health Law,
medications are classified into:*

Vitamins, Homeopathic and Masterful


Allopaths, Herbalists, and Homeopaths
Masterful, Official, and Pharmaceutical Specialties
Pharmaceutical Specialties and Herbal Remedies
37. Medication that corresponds to group II, according to the classification for its
sale and supply:

Buprenorphine
Biperiden
Clonfenamine
a
Fentanyl
38. It is the allowed temperature operating range for preserving the
properties of medications and other health supplies that require
cooling:

Between 2 °C and 8 °C
Between 2 °C and 6 °C
Between 3 °C and 7 °C
Between 4 °C and 10
°C
According to Article 421 of the General Health Law, the penalty for the sale and
supply of medications with expired expiration date will be equivalent to:

Fines ranging from six thousand to twelve thousand times the current daily minimum wage.

A fine of five thousand times the current daily minimum wage


Closure of the establishment for a period of one month
Retention of the health license for 2 weeks
40. The league called 'Pharmacovigilance/ Did any medication harm you?'
for downloading the Format for the Notification of Suspected Adverse Reactions
Medications can be found on the website:

www.health.gov/
reporteram
www.gob.mx/cofepris
www.cofepris.gob/ram
www.gob.mx/ramcofepris

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