Pharma Regulations and Policies
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Questions and Answers

What is a drug defined by?

  • Its brand name
  • Its chemical composition
  • Its manufacturer
  • Its intended use (correct)

What is the primary goal of a National Drug Administration?

  • To promote branded drugs
  • To distribute drugs to remote areas
  • To conduct drug research
  • To implement updated legislation and regulations (correct)

What is a medicine, according to the definition?

  • A medical equipment used in hospitals
  • A substance or preparation used in treating disease (correct)
  • A device used for medical diagnosis
  • A chemical substance used for agricultural purposes

Why is access to essential drugs a fundamental human right?

<p>Because it is a prerequisite for realizing the right to health care (C)</p> Signup and view all the answers

What characterizes essential medicines?

<p>They satisfy the priority health care needs of the population (D)</p> Signup and view all the answers

What is the benefit of the essential drugs concept?

<p>It leads to more rational prescribing, better supply of drugs, and lower costs (B)</p> Signup and view all the answers

What is the scope of the essential drugs concept?

<p>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 (A)</p> Signup and view all the answers

What is the primary objective of the Policy?

<p>To address all drugs, both branded and generic (D)</p> Signup and view all the answers

What type of combination products are acceptable?

<p>Fixed-ratio combination products with a proven advantage (C)</p> Signup and view all the answers

What is the purpose of a formulary manual?

<p>To provide a handy reference for prescribers and dispensers (B)</p> Signup and view all the answers

What information is commonly found in a formulary manual?

<p>All of the above (D)</p> Signup and view all the answers

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

<p>To establish treatment protocols for specific clinical conditions (A)</p> Signup and view all the answers

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

<p>List of approved abbreviations and acknowledgment (C)</p> Signup and view all the answers

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

<p>All of the above (D)</p> Signup and view all the answers

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

<p>To provide guidance on rational prescribing and dispensing practices (A)</p> Signup and view all the answers

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

<p>The medicine and its properties (B)</p> Signup and view all the answers

What is the primary focus of organizing drug supply?

<p>Managing basic functions (D)</p> Signup and view all the answers

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

<p>The person who receives the supplies (D)</p> Signup and view all the answers

Why is it necessary to select pharmaceuticals?

<p>To ensure essential medicines are available (C)</p> Signup and view all the answers

What percentage of healthcare budget is typically spent on pharmaceuticals?

<p>40% (B)</p> Signup and view all the answers

What is the purpose of monitoring and evaluation in logistics?

<p>To track the effectiveness of logistics (C)</p> Signup and view all the answers

What is the primary goal of selecting pharmaceuticals?

<p>To define what is most needed from available alternatives (C)</p> Signup and view all the answers

What is a characteristic of some medicines?

<p>High toxicity relative to their therapeutic benefits (D)</p> Signup and view all the answers

What percentage of pharmaceuticals are often duplicative?

<p>70% (C)</p> Signup and view all the answers

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

<p>To categorize medicines based on their potential for life savings (D)</p> Signup and view all the answers

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

<p>Category A pharmaceuticals (C)</p> Signup and view all the answers

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

<p>Hydralazine (C)</p> Signup and view all the answers

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

<p>10-20% (A)</p> Signup and view all the answers

Who should control Category A pharmaceuticals?

<p>Top management (B)</p> Signup and view all the answers

What is the characteristic of Category C pharmaceuticals?

<p>Small amount of funds spent on a large number of items (B)</p> Signup and view all the answers

What is a source of data for ABC analysis?

<p>All of the above (D)</p> Signup and view all the answers

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

<p>15-20% (A)</p> Signup and view all the answers

What is the formula to calculate the recorded consumption?

<p>RC = BB + Received - EB (A)</p> Signup and view all the answers

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

<p>To get a more accurate estimate of the drug requirement (B)</p> Signup and view all the answers

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

<p>Cons Adjusted for SO = RC x [Period in Calculation /Period in Stock] (C)</p> Signup and view all the answers

What is the purpose of calculating the average monthly consumption?

<p>To estimate the drug requirement for the next procurement period (D)</p> Signup and view all the answers

What is the formula to calculate the safety stock?

<p>SS = CA x LT (D)</p> Signup and view all the answers

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

<p>Q0 = CA x (LT + PP) + SS - (Si + So) (C)</p> Signup and view all the answers

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

<p>Basic units (D)</p> Signup and view all the answers

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

<p>Because it is not likely to have a significant effect on the estimated drug requirement (B)</p> Signup and view all the answers

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