With a history of more than 50 years, pharmacovigilance is defined by the World Health Organization (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.’
The WHO Programme for International Drug Monitoring started in 1968 and was introduced to systematically collect all available information on drug adverse effects and reactions as a worldwide response to the thalidomide disaster. Ten years later, in 1978, the Uppsala Monitoring Center (UMC) was set up to support the Drug Monitoring programme. The UMC is an international, independent and non-profit foundation based in Uppsala, Sweden. It was founded to investigate in depth the harms, potential risks, and benefits of medicines and to ensure a safe and efficient consumption of these drugs by patients.
Modern PharmacovigilanceFast forward 50 years and the aims of pharmacovigilance are broadly unchanged. The primary goal remains to improve patient care and safety in relation to the use of medicines, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, as well as to encourage safe, rational, and more effective use. Additionally, pharmacovigilance should promote understanding, education, and clinical training in medical safety and provide effective communication to health professionals and the public.
One significant change that has occurred and is becoming increasingly scrutinized is cost-benefit analysis and health economics. The rising cost of healthcare globally has impacted the way that the public interacts with drugs, particularly with an aging global population and increasing incidence of chronic conditions.
From a regulatory point of view, detailed and complete monitoring and reporting has been recognized as the best way to build a strong, sustainable system for medicine safety and for public confidence in medicines.Regulatory’s Role in Drug SafetyThe provision of good quality, safe and effective medicines—as well as ensuring their appropriate use—is the responsibility of national governments and in some instances regional legislative bodies such as the European Union and FDA. It is a responsibility that has grown significantly over the past 10 to 15 years as the industry has expanded and additional complexities have been introduced as well as increasing expectations as to what is possible to monitor. The global pharmaceutical industry, universities and non-governmental organizations (NGOs) are, by necessity, joining forces to educate the general public on the rational use of medicines and pharmacotherapy monitoring.
So, pharmacovigilance is now an established and integral part of healthcare systems worldwide centered by the WHO. The WHO provides a lead and guidance for pharmacovigilance operations as well as providing technical support in reporting the building block of safety reporting – Adverse Drug Reactions (ADRs). Guidance is then disseminated to the country’s regulatory authority.Many countries now have well-built sophisticated pharmacovigilance systems, but the actual incidence of ADRs is considered by most to be much higher than what is actually being reported. This underreporting of ADRs is a major problem as is the quality and timeliness of the reporting itself. Given that the basic objective of pharmacovigilance is the safe use of drugs, patient safety, and ultimately, safeguarding public health, this shortcoming is a significant issue.
Public Health & ADR ReportingGoing forward, in order to achieve the goal of improving public health, national regulators and international organizations have to:
Empower healthcare professionals and the public to report more ADRs: Programs like FDA MedWatch in the US and MHRA Yellow Card scheme in the UK allow healthcare professionals and patients to report adverse reactions of different types of medicines and devices into a central consolidated database.
However public awareness of such schemes is limited and wider exposure and knowledge of them is vital if the trend of underreporting is to be addressed. Data collection from what has been seen as non-traditional sources, such as social media, has to be better integrated into the ADR reporting process.Utilize advances in technology to expedite the reporting process: Improved ADR reporting is only part of the solution. The next step in the process—reporting findings to the appropriate regulatory body—is a complex and costly exercise for those legally bound to do so.
Though the parameters of timeline and type of adverse reaction is generally well defined, the variation of reporting country to country is a major challenge. By better utilizing technology to manage this process, reporting can be significantly more efficient, which has the dual benefit of reducing the resource needed by organizations to meet their reporting obligations and allows the regulatory authorities to build a much more complete and timelier picture. This in turn allows authorities to act quicker and therefore improve public awareness—and ultimately public safety.
Pharmacovigilance has advanced considerably since its inception and the public is undoubtedly much better informed and drugs are safer than they have ever been. However, the pace of change, complexity of interaction, and the expectation on drug companies and regulators to be better will all continue to increase. It is therefore up to all stakeholders—patients, pharmaceutical, biotech and medical device companies, regulators and technology organizations, to meet the challenge and ensure that, as far as safety of medicines and devices is concerned, improving public health remains paramount and continues to improve. John Buchan is a Life Science Technology Specialist for pharmasol (www.pharmasol.de).
He has spent his career in Life Sciences and Life Science technology, the latter specializing in Pharmacovigilance. Having worked in Sales & Marketing roles in major Pharma companies, John moved into working with organizations supplying technology, software and services for Life Science and Healthcare organizations across Europe and North America. He is a passionate advocate of utilizing the best of technology to solve the challenges that the pharmaceutical industry faces. He is based in the southern United Kingdom. He can be reached at email@example.com