Pharma Regulations and Policies

ConciseLemur avatar
ConciseLemur
·
·
Download

Start Quiz

Study Flashcards

40 Questions

What is a drug defined by?

Its intended use

What is the primary goal of a National Drug Administration?

To implement updated legislation and regulations

What is a medicine, according to the definition?

A substance or preparation used in treating disease

Why is access to essential drugs a fundamental human right?

Because it is a prerequisite for realizing the right to health care

What characterizes essential medicines?

They satisfy the priority health care needs of the population

What is the benefit of the essential drugs concept?

It leads to more rational prescribing, better supply of drugs, and lower costs

What is the scope of the essential drugs concept?

It is a global concept that can be applied in any country, in the private and public sectors, and at different levels of the health care system

What is the primary objective of the Policy?

To address all drugs, both branded and generic

What type of combination products are acceptable?

Fixed-ratio combination products with a proven advantage

What is the purpose of a formulary manual?

To provide a handy reference for prescribers and dispensers

What information is commonly found in a formulary manual?

All of the above

What is the primary goal of Standard Treatment Guidelines (STGs)?

To establish treatment protocols for specific clinical conditions

What is included in the introductory information of a formulary manual?

List of approved abbreviations and acknowledgment

What type of information is included in the supplementary information section of a formulary manual?

All of the above

What is the purpose of prescribing and dispensing guidelines in a formulary manual?

To provide guidance on rational prescribing and dispensing practices

What is the primary focus of a drug-centered formulary manual?

The medicine and its properties

What is the primary focus of organizing drug supply?

Managing basic functions

What determines the quantities to be issued in a pull system?

The person who receives the supplies

Why is it necessary to select pharmaceuticals?

To ensure essential medicines are available

What percentage of healthcare budget is typically spent on pharmaceuticals?

40%

What is the purpose of monitoring and evaluation in logistics?

To track the effectiveness of logistics

What is the primary goal of selecting pharmaceuticals?

To define what is most needed from available alternatives

What is a characteristic of some medicines?

High toxicity relative to their therapeutic benefits

What percentage of pharmaceuticals are often duplicative?

70%

What is the main purpose of ABC analysis in pharmaceutical management?

To categorize medicines based on their potential for life savings

Which group of pharmaceuticals has the highest annual usage and consumes a large percentage of resources?

Category A pharmaceuticals

What is an example of a vital drug mentioned in the text?

Hydralazine

What percentage of drugs consumes around 70-80% of resources in Category A pharmaceuticals?

10-20%

Who should control Category A pharmaceuticals?

Top management

What is the characteristic of Category C pharmaceuticals?

Small amount of funds spent on a large number of items

What is a source of data for ABC analysis?

All of the above

What is the percentage of resources consumed by Category B pharmaceuticals?

15-20%

What is the formula to calculate the recorded consumption?

RC = BB + Received - EB

What is the purpose of adjusting consumption for avoidable wastage and losses?

To get a more accurate estimate of the drug requirement

What is the formula to calculate the consumption adjusted for stock outs?

Cons Adjusted for SO = RC x [Period in Calculation /Period in Stock]

What is the purpose of calculating the average monthly consumption?

To estimate the drug requirement for the next procurement period

What is the formula to calculate the safety stock?

SS = CA x LT

What is the formula to calculate the quantity of each drug required in the next procurement period?

Q0 = CA x (LT + PP) + SS - (Si + So)

What is the unit of measurement for CT in the formula CA = CT/RM – (Dos/30.5)?

Basic units

What is the purpose of ignoring stock-outs up to one month?

Because it is not likely to have a significant effect on the estimated drug requirement

This quiz covers the policies and regulations related to drugs, pharmaceuticals, and medicines, including their intended use and implementation through legislation and authorities.

Make Your Own Quizzes and Flashcards

Convert your notes into interactive study material.

Get started for free

More Quizzes Like This

Use Quizgecko on...
Browser
Browser