5 Challenges that Continue to Plague the $2 Billion Pharmacovigilance Sector

Pharma IQ
Posted: 05/08/2012

The Asia Pacific region is fast becoming the growth center of the worldwide pharmaceuticals market. By 2015, these markets are projected to account for almost a third of the total pharmaceutical sales worldwide. 

But with this increased demand comes an intensified focus on pharmacovigilance and drug safety. Pharma IQ takes a look at 5 challenges that continue to plague the pharmacovigilance sector.

High attrition and staff turnover

Pharmacovigilance is a field that requires years of real world experience, coupled with good mentoring to do proper risk-benefit assessments and good safety reporting. Because of the high turnover rates, recruiting has becomes a risky investment for companies to make.

Like other industries, many pharmaceutical companies neither have the time, nor resources, to properly train the next generation of drug safety experts. As a result, the quality of work becomes reduced.

Additionally, pharmacovigilance is still seen as a cost that reduces margins, and as a risk that might kill revenue sources, due to drug withdrawal or limitations to the populations to which it can be prescribed to.

Management must embrace Pharmacovigilance

Pharmacovigilance and Adverse Drug Reaction reporting requires the completion of long, complex and time-consuming forms, when coupled with the ever increasingbureaucraticburden; this makes it very difficult to explain to senior management.

However, what if a top down approach was exercised, and management was one hundred percent behind pharmacovigilance, instead of just complying with FDA regulations? Resources would be made readily available and companies would continue to invest in pharmacovigilance as an integral part of the business.

The overall product quality will be increased and the image and balance sheet of the organisation would be better off as a result. Pharmacovigilance would also stop being perceived as a cost and instead an integral unit that saves and makes the business millions.

Data Processing & Storage

The medical sector has embraced the digital age, and as a result, there is too much data and too few trained personnel today. This results in too much time sifting through information and not much being spent on detection and the appropriate assessment of safety signals.

Because of the sheer amount of data obtained, information technology should be leveraged as an enabler for pharmacovigilance & drug safety, to aid in retrieving and sifting through the information that comes through.

By combining the latest software technology with the appropriate processes and standard operating procedures, technology can help to solve some of the pain points in pharmacovigilance. The correct selection of a safety system can help corporations overcome the challenges cost effectively and efficiently.

Risk Management

Early signal detection is crucial in order to protect the public health, it can allow for interventions using risk management and risk minimization strategies to prevent unnecessary exposure to patients. Essentially it is the first step of the risk management cycle.

There is an increased awareness in the importance of managing the risk of adverse reactions and protecting the public, for both marketed products and products in development. To ensure that risk is managed properly, all sources of information must be screened regularly to identify any signals that may arise.

Also to ensure appropriate actions are taken to any new evidence that can impact the benefit-risk balance health authorities, healthcare professionals and patients must be kept informed of changes to the benefit-risk balance

Companies have lost billions through poor risk management and having a proper risk management structure from collecting, assessing and distributing case datais crucial for any organisation. It simply cannot be ignored.

Lack of harmonization

Pharmacovigilance professionals globally have lamented on the lack of harmonization between countries and although regulators are putting a system in place to integrate reporting cross country, it is the reporting structure that is a cause for alarm

Taking the ASEAN region as an example, there are different reporting structures across the many culturally diverse countries in South East Asia, this will result in a difference in reporting standards even if a harmonization system is put in place.

Language diversity and proficiency also has to be taken into account. In South East Asia although English tends to be the de facto reporting language, pharmacovigilance professionals across different countries within the region will have a different understanding of the language.

Harmonization in East Asia may be a whole new challenge altogether since Japan, Korea and China submit their reports in their respective languages, while Hong Kong and Taiwan submits reports in English and Mandarin.

Not only must there be a common standard – in terms of language - across the region but there also must be a simpler way for pharmacovigilance reporting throughout culturally diverse regions such as Asia. This reporting standard must also comply with pharmacovigilance regulations in each country.

Dr. Du Wenmin, Executive Director for the Shanghai Centre for ADR Monitoring, SFDA & Dr. Y K Gupta, Coordinator, National Pharmacovigilance Programme, India, Professor and Head, Department of Pharmacology, All India Institute of Medical Sciences, will be taking part in a Regulator-led Roundtable Discussion at Pharmacovigilance Asia 2012.

This regulator led discussion roundtable discussion will help you address the pharmacovigilance reporting guidelines and fields to be clarified as well as explain how the  pharmaceutical industry can play its role to help establish ADR database and in post-marketing surveillance programme.

Email enquiry@iqpc.com.sg top register for the conference or download the complete agenda of the topics that will be discussed at Pharmacovigilance Asia 2012.

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Pharma IQ
Posted: 05/08/2012

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