Robust training programmes will enable integration of good pharmacovigilance practice in the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post marketing surveillance. Dr Pipasha Biswas, Chairperson, Special Interest Network Consultation Committee for Drug Safety & Pharmacovigilance, Faculty of Pharmaceutical Medicine, The Royal College of Physicians, London, UK and Director QPPV, Symogen, UK, gives an overview
| Dr Pipasha Biswas |
An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. In Europe, there has been an extensive overhaul of the pharmacovigilance regulations and as of July 2012, pharmaceutical companies are busy adapting and implementing to the New EU Pharmacovigilance Regulations and to the Good Pharmacovigilance Practice Modules.
Year-on-year, pharma companies have been reporting substantial increases in volume of Adverse Drug Reactions (ADRs) resulting in the demand for having trained resources, capable of handling and understanding pharmacovigilance to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in this modern world. It is a challenge to codify and standardise the act of signal detection and risk management in the context of clinical trials and post-marketing pharmacovigilance. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in India, and this has been mostly due to lack of proper trained personnel available in this highly disciplined and regulated field.
However, with more pharmacovigilance activity being conducted in India, there is an immense need to train and build the expertise of personnel working in this area to western standards. For this to happen in India, a complete holistic training in the curriculum needs to be adapted and the mind set of people working in the field of clinical research and pharmacovigilance needs to be adapted. This article describes and discusses the various strategies and proposals to develop training programmes to build, maintain and implement a robust pharmacovigilance system for various stakeholders and increase the knowledge and competency skills to be at par with the western world.
Pharmacovigilance and its importance
Pharmacovigilance is defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term adverse effects of medicines. Pharmacovigilance is an important and integral part of clinical research and clinical drug development. Both clinical trials safety and post marketing pharmacovigilance are critical throughout the product life cycle. With a number of recent high-profile drug withdrawals, the pharmaceutical industry and regulatory agencies have raised the bar. Early detection of signals from both clinical trials and post marketing surveillance studies have now been adapted by major pharma companies in order to identify the risks associated with the medicinal product and effectively manage the risks by applying robust risk management plans throughout the life cycle of the product. Signal detection and risk management has added a new dimension to the field of pharmacovigilance and as an evolving discipline; it requires ongoing refinement in order to increase its applicability and value to public health.
Pharmacovigilance is still in its infancy in India and there exists very limited knowledge about the discipline. While major advancements of the discipline of pharmacovigilance have taken place in the western countries with several training programmes developed by various stakeholders in both academia and the pharma industry, not much has been achieved in India.
However, robust training programmes in this discipline is required in India, which will enable integration of good pharmacovigilance practice in the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post marketing surveillance. As the worldwide movement for the improvement of patient safety gains momentum, the subject of drug safety becomes even more prominent, thereby helping to reduce the risk of drug-related harms to patients. In India, as elsewhere in the world, the challenges and opportunities are substantial.
The enormity of the problem of ADRs
Several studies conducted worldwide have demonstrated that ADRs significantly decrease the quality of life, increase hospitalisations, prolong hospital stay and increase mortality. A landmark study by Lazarou in 1998 described ADRs to be the 4th -6th largest cause of death in the US and ADRs are estimated to cause 3-7 per cent of all hospital admissions. More than half of these ADRs are not recognised by the physicians on admission and ADRs may be responsible for death of 15 of 1,000 patients admitted. Furthermore, the financial cost of ADRs to the healthcare system is also huge. With more new medicines being approved for marketing more quickly without long-term safety studies by the regulatory authorities and switching of prescription-only medicines (POM) to over-the-counter (OTC) to be used more widely by patients for self-medication, the general public is at risk of exposing itself to ADRs.
In the past, India’s regulatory agencies and drug companies based their safety assessments on experiences derived from long-term drug use in the Western markets and there was no real urgency for the government to establish a strong pharmacovigilance system of its own. In recent years, however, the lag between when a drug is placed on the market and its subsequent availability in India has decreased considerably so that the much needed longer-term safety data is no longer available. In addition, India-based drug companies have increased their capacity to develop and launch new drugs through their own research efforts and this has heightened the importance of developing adequate internal pharmacovigilance standards to detect adverse drug events.
However, what needs to be more important along with the funding is a focussed vision and effective strategy for developing robust pharmacovigilance training programmes which is lacking. Traditionally, pharmacovigilance was never done in India in pharma companies, be it Indian or MNCs, so there is an immense shortage of knowledgeable people who will be able to train and advice on this matter, as pharmacovigilance is a very complex subject, intertwined with regulations and complex systems. The need is therefore to engage trained pharmacovigilance experts having extensive and practical knowledge on pharmacovigilance, who can effectively train personnel to implement the systems and policies on pharmacovigilance.
India is a vast country and there is a surfeit of drug brands — more than 6,000 licensed drug manufacturers and over 60,000 branded formulations. India is the fourth largest producer of pharma in the world and is also emerging as a clinical trials hub. Many new drugs are being introduced in the country, so there is an immense need to improve the pharmacovigilance system to protect the Indian population from potential harm that may be caused by some of the new drugs. With more and more clinical trials and other clinical research activities being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product. Given this situation at present, the Drug Controller General (India) (DCGI) should act quickly to improve pharmacovigilance so as to integrate Good Pharmacovigilance Practice into the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post marketing surveillance.
The need for holistic pharmacovigilance training
As organisations strive to compete in the global economy, differentiation on the basis of the skills, knowledge, and motivation of their workforce takes on increasing importance. According to a recent industry report by the American Society for Training and Development (ASTD), US organisations alone spend more than $126 billion annually on employee training and development. ‘Training’ refers to a systematic approach to learning and development to improve individual, team, and organisational effectiveness. Alternatively, development refers to activities leading to the acquisition of new knowledge or skills for purposes of personal growth. Training not only may affect declarative knowledge or procedural knowledge, but also may enhance strategic knowledge, defined as knowing when to apply a specific knowledge or skill. In addition, training may enable consistency in performance across conditions.
Training is encompassing everything that is expected for the enhancement of organisational development and competencies. In order to improve total performance, pharma organisations, service providers for pharmacovigilance and staff working at Central Drugs Standard Control Organisation (CDSCO) need to have trained and experienced people. The pharmacovigilance training programmes need to be purposive and meant to equip the employees with the necessary skills that are required for carrying out day-to-day pharmacovigilance activities smoothly. With the complexities of pharmacovigilance, emerge the importance of training and development programmes.
Training programmes in pharmacovigilance in western countries
Pharmacovigilance is a relatively new and evolving science and is not a well-established academic specialism. Current curricula in the training programmes of professions such as clinical medicine, clinical pharmacy, clinical pharmacology or medical biology do not cover all the skills needed in pharmacovigilance. Very few universities in the world offer specific courses in pharmacovigilance. One reason might be that pharmacovigilance spans a wide range of subjects, e.g., pharmacology, epidemiology, clinical medicine, data management, drug legislation and communication, and they do not easily fit within the competence area of any of the existing academic departments.
Unlike India, there are several robust taught face to face pharmacovigilance courses and training programmes in universities to help individuals gain knowledge and build expertise of this complex discipline. In the UK, the well known Post Graduate Programme for Training in Pharmacovigilance is conducted by the University of Hertfordshire’s MSc in Pharmacovigilance. This course trains professionals interested to pursue this discipline in a robust structured manner. A Post-Graduate Certificate Course in Pharmacovigilance and Pharmacoepidemiology is conducted by The London School of Hygiene and Tropical Medicine, University of london, is mostly for professionals working in the pharma industry wanting to advance their knowledge and expertise in this field. Similarly, the Drug Safety Research Unit (DSRU), based at Southampton, UK, is also a leading provider for several pharmacovigilance courses on various topics related to pharmacovigilance which are very popular.
With the advent of technology, several organisations have offered online training courses and training programmes in pharmacovigilance, which are self taught and can be done at ones leisure. The International Society of Pharmacovigilance (ISoP) is active in providing specialised ad hoc training courses in pharmacovigilance. Another organisation that does provide ad hoc training courses is the Drug Information Association (DIA) is yet another organisation that helps in building the expertise and knowledge of professionals working in this field.
Training programmes in pharmacovigilance in India
With the globalisation of the pharma industry, and with off-shoring of pharmacovigilance activities to India, the need to maintain universal standards, as well as the demand for qualified and trained professionals to provide valuable inputs on Indian, European Union and American Regulatory, research and safety requirements in pharmacovigilance has propelled the need for a knowledge-packed training in this field.
Pharma companies, Clinical Research Organizations (CROs), Business Process Organisations (BPOs) companies, regulatory agency i.e. DCGI office and CDSCO need professionals with good understanding of medical ethics, clinical research, pharmacoviiglance practices and patient safety, western regulations and effective communications.
Keeping this in mind, and in response to this unmet need, Symogen, took the first initiative in conducting the first ever Certificate Course in Pharmacovigilance and Pharmacoepidemiology in India. This course was started in September 2007, in New Delhi and subsequently in Mumbai, taught by highly experienced and knowledgeable international faculty from the West for several years, covering all aspects of pharmacovigilance and drug safety management, endorsed by The Faculty of Pharmaceutical Medicine, The Royal College of Physicians, London (96 Credits), WHO Uppsala Monitoring Centre and the International Society of Pharmacovigilance. This course sensitised the students and equipped them with knowledge on pharmacovigilance practices worldwide and on the Indian scenario in detail. This course gave the young executives an opportunity to remain ahead of competitors in a very nascent yet competitive environment. This course is the first of its kind in India.
With a growing demand for pharmacovigilance training in India, various private initiatives have been taken to meet this demand and profit from it. It is well known that there are a very few knowledgeable and experienced pharmacovigilance experts in India. Even if the existing experts spent all their time on pharmacovigilance teaching and training, they would still not be able to satisfy the need. Some providers of pharmacovigilance training might bring in pharmacovigilance experts from abroad or rely on a faculty of less-qualified and less-experienced tutors. However, bringing foreign experts to India contributes seriously to high tuition fees. It is therefore tempting for providers of pharmacovigilance training courses to include persons with limited pharmacovigilance expertise and experience in their faculty which has been happening in India. For professionals wanting pharmacovigilance training, it may become very important to critically assess the quality of the training being offered by various course providers.
Since then, there has been mushrooming of organisations offering pharmacovigilance courses by Indian providers. However, these courses lacked both experienced trainers and content and did not provide the required skills set needed in this highly complex discipline. This has not only resulted in poorly trained pharmacovigilance staff in Indian organisations but has also affected the quality of the work tremendously that is been churned out from India.
The content in pharmacovigilance training
Holistic training in pharmacovigilance needs to be adapted in accordance with the country specific keeping in mind the extent of pharmacovigilance knowledge of the trainees. Since there are many different stakeholders in society with a need for and an interest in pharmacovigilance, training has to be offered at different levels, with different content and given for different length of time. Health professionals working in hospitals, caring for patients in healthcare might need basic short course training for a week on ADR mechanisms, reporting requirements and patient management. Pharmacovig-ilance professionals involved in data collection, processing and analysis should have at more dedicated days to pharmacovigilance training. Apart from this, specific in-depth training in special sub-areas has to be provided. The 12- module certificate course in pharmacovigilance and pharmacoepidemiology along with practicals associated with each modules, provided by Symogen provides a framework of topics that should be covered in a comprehensive pharmacovigilance training programme. Any pharmacovigilance programme being offered is likely to focus on a sub-set of these topics. It is very rare for any one individual to acquire full proficiency in all the aspects of pharmacovigilance and patient safety monitoring by only attending a training course and expertise needs to be built with continuous training on the job.
Module 1: Principles of pharmacovigilance
Module 2: Medical aspects of adverse drug reactions from various System Organ Class (SOCs)
Module 3: Pharmacovig-ilance reporting systems and tools for management of reports
Module 4: Global pharmacovigilance and safety standards
Module 6: Methodologies in pharmacovigilance
Module 7: Management of Drug Safety Data
Module 8: Signal Detection
Module 9: Benefit Risk Determinations
Module 10: Communication In Pharmacovigilance
Module 11: Setting up of Pharmacovigilance Department; Standard Operating Procedures used in Pharmacovigilance & Department links to Pharmacovigilance
Module 12: Pharmacovig-ilance Compliance and Inspections
Practicals to be covered in each Module
- Hands on experiences and discussions
- Projects and presentations
- Case studies where required (reporting of ADRs, causality, signal detection, benefit-risk etc)
- Discussions on risk management plans
Training physicians; pharmacists and nurses on pharmacovigilance
All postgraduate students of all disciplines in medicine, pharmacy and nursing in India should be taught pharmacovigilance and have a thorough knowledge of pharmacovigilance. Since most medical colleges have a pharmacovigilance cell, post graduate trainees should spend considerable time developing themselves by attending to pharmacovigilance programmes in their medical colleges or teaching hospitals and should be made aware of pharmacovigilance, the need for and importance of reporting ADRs and the reporting procedure. They should be sensitised to ADR reporting during their residency training.
To boost the reporting of ADRs and to encourage physicians serving throughout India, physicians and in particular general practitioners and specialists working both in urban and rural India need to be trained in pharmacovigilance and encouraged to report ADRs to the pharmacovigilance programme. Pharma companies and CDSCO have an important role in creating awareness among physicians, pharmacists and nurses working in the community. Training programmes for physicians, pharmacists and nurses should cover practical aspects and carried out in small groups in a modular format so that they are able to recognise ADRs and develop a culture of reporting ADRs in the future.
For those healthcare professionals in rural areas where the need to recognise ADRs is more important, continuous medical education (CMEs) programmes need to be conducted annually by the relevant professional councils. Newsletters developed by the DCGI in conjunction with the relevant councils should be distributed and mailed to doctors, nurses and pharmacists posted to the primary healthcare centres (PHCs). An awareness programme and a training schedule (both by distance education and face-to-face learning) covering all aspects of pharmacovigilance should be designed.
Conclusion
With the ever increasing responsibilities and regulations to get to grips with, the role of pharmacovigilance grows increasingly complex. The science of pharmacovigilance is important for every country to ensure the safe use of medicines. Teaching and training pharmacovigilance to medical, pharmacy and nursing students will make them aware of their responsibility to report ADRs and increase and build expertise in pharmacovigilance. Pharmacovigilance is a demanding science offering great opportunities for reducing harm to patients and saving costs to healthcare systems. With holistic training and with the right knowledge and skills amongst professionals, pharmacovigilance can make an important contribution to the health of the nation.
The author can be contacted at pipasha.biswas@gmail.com