A Pharmacovigilance audit is important as it ensures the company’s drug safety and risk management procedures comply with applicable laws, regulations and guidance. While it could be a daunting challenge at times to comply with the existing regulations, companies, large and small, still must deal with this reality as the organization’s entire business operations could not be put to risk of failing an audit or inspection.

CHALLENGES IN ASIA In Asia, there are a couple of unique challenges that affect pharmacovigilance (PV). In a previous interview with Pharma IQ, Dr Deepa Arora, a Physician with more than 15 years of experience and currently the

Global Head, Drug Safety &

Risk Management at Lupin Limited, she identified some of these challenges. Among them are: Poor availability of trained manpower. The lack of systematic material to learn about pharmacovigilance is a major issue faced in all sectors. The situation is consistently improving over the last few years as some big projects have been awarded by MNCs to BPOs based in Asia; therefore, these BPOs have hired and trained staff in PV. Several institutes are also offering training courses in PV for beginners. Expectations sometimes don’t match reality. The pharmaceutical industry in Asia

expects detailed guidance from regulators and better harmonisation of regulations for pharmacovigilance. As regulatory authorities don’t have necessary manpower, this in turn leads to poor implementation of regulations, delays in planning and regulatory action. Safety of herbal drugs. The safety of herbal drugs or allied medicine-herbal and herbo-mineral drugs is a challenge more specific to Asia than other regions due to the extensive usage of these drugs. Efforts are on-going to define the methodology for monitoring the safety of such drugs. Several regulatory-academia-industry workshops have been organised and extensive work has been done in collaboration with WHO.

www.pharmacovigilanceasia.com

Poor reporting and poor quality of spontaneous reports. Like Western countries, challenges faced by the industry in Asia include poor reporting and poor quality of spontaneous reports. A lack of awareness regarding PV amongst healthcare professionals and consumers is a major issue and probably the most important target for improvement, as growing awareness amongst healthcare professionals and consumers is likely to result in a significant improvement in overall mplementation of PV by all sectors, especially regulatory authorities and Pharma industry. Medication errors. Medication errors are an important cause of adverse reactions resulting in significant morbidity and mortality. Due to poor reporting, it is quite difficult to estimate the extent of medication errors in Asian countries. Various forums are being used to increase the awareness of HCPs regarding the importance of collection of ADR data. (Note: These responses are based on Dr. Arora’s experience and opinion and may not reflect the current processes followed at Lupin)

Understanding these challenges is the first step in coming up with effective strategies and plans moving forward but this is not enough. BUILDING A HOLISTIC RISK

MANAGEMENT PROGRAM To mitigate the known and unknown challenges, companies must establish robust drug safety and risk management strategies that provide a holistic point of view, and not just dealing with isolated issues or concerns. The World Health Organization (WHO) defines Pharmacovigilance (PV) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” The pharmaceutical industries manufacturing drugs are dealing and treating human lives. Consequently, it is considered a special industry manufacturing products (drugs) which need special care and a significantly higher safety standards than those imposed on other industries. As a result, even when the incidence of adverse effects (AEs) and signal detection is low,

drugs can still be withdrawn from the market based on the seriousness of the incidences and its occurrence in many areas of the world. Patients are always looking for the perfect drug, which gives rapid cure, low cost, and with no side effects. Pharmaceutical companies from their side are trying to overcome this challenge which seems to be not so realistic especially within a complicated, highly competitive business, with its social and political implications. The role of pharmaceutical companies is to decide how to manage the results of an AE signal. Some drug companies develop and prepare the safety programs that are implemented from the moment drugs enter their product portfolio. Also, collecting and analysing data in an advanced way is an important tool in drug safety and risk management program. In this concern, whatever the approach selected, each program needs to be reasonably relevant to the nature of the risk. When a signal of a potential side effect is detected it should be documented with its response.

To mitigate the known and unknown challenges,

companies must establish robust drug safety and

risk management strategies that provide a

holistic point of view.

www.pharmacovigilanceasia.com

www.pharmacovigilanceasia.com

6 THINGS TO REMEMBER The following recommendations could be taken in consideration to deal with the drug safety and risk management. Others could be included based on pharmaceutical companies’ diversified strategies:

Learn practical tips to implement risk management, audit, inspection and

adverse drug reaction management strategies whilst complying to

regulatory requirements at the 4th Annual Pharmacovigilance Asia 2013.

To find out more, visit www.pharmacovigilanceasia.com

Review of previously conducted clinical trials. 1 Implement a signal monitoring program. This is a must to determine as soon as possible any harm that evolved from the drugs – either newly launched or already in market.

2

Regularly fill in the needed data in the PSURs (Periodic Safety Update Reports) which is an important tool to follow up and update worldwide the safety data of drugs.

3

Any signal detected should be carefully identified with the adverse event that could potentially occur. 4

The validation of the signal and its analysis should be done carefully considering the variable demographic issues such as age and gender.

5 Randomised safety trials could be conducted by pharmaceutical companies to implement information and different education program to HCPs (Health Care Professionals) and patients.

6

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