Benefit-Risk assessment in Pharmacovigilance

Introduction

A useful or nonharmful effect of a medicinal product is known as its benefit, whereas exposure to a dangerous or harmful situation is called a risk. For allowing a product to the market ties it should comply with a positive balance between benefit and risk.

How to achieve a positive balance between benefits and risks?

• In the process of marketing authorization, the firm requires to evaluate and demonstrate the benefits and the risk of that product.

•  Implementation of regulatory duties of assessing this benefit and risk management.

•  While allowing a product for marketization, that decision should comply with the balance between benefit and risk.

• At a certain period, if the organization has a great amount of benefit in comparison to risk then and only then it should be allowed to marketize that product.

That’s how you can achieve a positive balance between benefits and risks.

Example-

A previously authorized product for smoking cessation shows the balance between benefits and risks.

Benefits	Risks
Elevate long life	Insomnia
Prevention of respiratory diseases	Nausea
Prevention of CV diseases	Headache
Prevention of Cancer	-
Detox lungs	-
Fresh breath	-

Influence in Real-time

As you allowed a product to be marketization by balancing the risk and benefit ratio, then it will generate new data because while conducting the clinical trials you have just made the required criteria and requirements to conduct clinical trials. In real time you have to face different issues based on race, gender, age, ethnic background, etc. New data will be get generated. What you rarely see in clinical trials you can commonly see in real-time. What to expect to see in real-time may not be seen or sometimes you may see different drug-drug interactions maybe get generated.

     There are possibilities in real time to overcount the number of risks in comparison to the benefit, maybe.

Periodic safety update reports (PSURs)

To maintain the long-term balance between the benefit and risks of products you have to recheck the information about that product after a period. The periodic rechecked data should be mentioned in a document which is known as PSUR.

The PSUR document evaluates the balance between the benefit-risk of that medicinal product.

The periodic safety update report is defined as “A pharmacovigilance document intended to provide an evaluation of the benefit-risk balance of a medicinal product for submission by pharmaceutical companies to regulators at defined time points during the post-authorization phase.”

The quality and submission are independent aspects of benefit-risk assessment. Because in real-time the product can generate new data so the quality changes. And the rate of PSUR submission depends on the amount of new data generation, if new data confirm you have to add it to the PSUR document.

PSUR contains

The action taken for safety reasons:

• In this part, the work like termination of clinical trials, and the communication between healthcare professionals should be done.

Significant findings:

• You have to record what you got in the clinical trials, adverse reaction reports, literature, boiled support program, etc.

Risks:

• Mention the previously known risk and newly generated risk.

Analyses of benefits and risk:

• Whenever the new data get a generator, read and evaluate the balance between benefit and risk.

Exposure of patients:

Maintain the outside authorized content conditions and real use inside.

Signals:

• The work related to the analysis of the new signal should be done here.

Benefits:

• Analysed new information on benefits and previous known benefits should be recorded.

Conclusion:   

• Add on the data captured of a medicinal product with previous and new known information.

Responsibilities of PSUR

The assessment of PSUR done by regulators and ensure results in the proper maintenance, and counting of variations, in any case, if the product is unable to maintain a balance between benefit and risk then withdrawal of that medicinal product is.

What do you have to understand?

The change in benefit-risk balance is a common thing and there is a need to reassess a medicinal product.

      Responsibly re-assessment of a medicinal product is accomplished by PSUR

From the report of PSURs, the required legal action can be taken.

The health of the public should be protected and promoted using minimizing risk and enhancing the benefit of a medicinal product.

 Conclusion

     The assessment of benefits and risks is a continuous process based on a balance between benefits and risks. A medicinal product must comply the more amount of benefits rather than risks so that it can be marketized. For maintaining the information you can take the help of PSURs. PSUR provides periodic updates for medicinal products. It helps to evaluate the benefit and risk ratio

References

1.    1.  Periodic-safety-update-report-procedure-concept-benefit-risk-evaluation, Rodrigo Postigo, Pharmacovigilance and Risk Management Sector, EMA

      2. Davies, M et al (2020), ‘Principles of benefit-risk assessment: a focus on some practical applications’ Journal of faculty of internal medicine, 10 November 2022, available at: https://www.fpm.org.uk/blog/principles-of-benefit-risk-assessment-a-focus-on-some-practical-applications

WRITTEN BY

 Ahemad Noormahamad Nadaf

B. Pharmacy

 ID: csrpl_onl_wkd_168/0922

 Email Id: anadaf0203@gmail.com