Guest Editorial
Pharmacovigilance: Curriculum and career
Drug related deaths account for the fourth largest category of mortality in the United States.[1] In addition, in USA, estimated total cost of medication errors and adverse drug reactions (ADRs) exceed 136 billion dollars annually.[2] Although such accurate figures are not available for this category of mortality in India, a logical estimate may place drug related deaths very high in this country as well. This and this fact alone tell us that pharmacovigilance (PV) must be an integral part of the drug development during clinical trials and the actual use of the drug in patient population post marketing. The World Health Organization (WHO) defines PV as the science and activities relating to the detection, evaluation, understanding and prevention of ADRs or any other drug‑related problems. ADRs (especially the serious ones), medication and prescription errors and poor products qualities are the major reasons and areas of the practice of PV. Thus, risk management, risk mitigation plans and discovery of toxic signals from data mining of existing safety data bases are extremely important activities during both development and post approval phases in the life cycle of a drug.[3] From 2007 onwards, both EMA and USFDA have empowered their agencies such that right now registration of any drug product in the USA and European countries is impossible without a thorough post marketing PV program (along with pre‑marketing risk management plan).[4] An essential part of a proper PV program is also to maintain huge safety data bases. Such data bases often contain several million individual safety records of large pharmaceutical companies’ marketed drugs, for example. Such requirements of maintaining very large data bases alone have prompted these firms to look for cost‑effective PV set ups in economically emerging Access this article online Quick Response Code:
Website: www.japtr.org
DOI: 10.4103/2231-4040.126978
2
countries like India. Thus pharmaceutical MNCs require trained professionals for their PV data bases and related activities. The national PV programs as guided by WHO are also major hubs of PV activities wherein very specific and relevant curricular training and experience are required. It is interesting to note that the outsourced PV activities to India is on the rise for last 3 years or so even as the overall clinical trial activities coming to India are on a decline for the same period. A career in PV requires adequate qualifications, proper training and also an employment which has both short and long term prospects. The basic qualifications for adapting to a PV career include undergraduate and/or graduate degrees in human and veterinary medicine, pharmacy, nursing or allied health sciences. Direct exposure to collection and organization of PV data, their processing and analyzes and further implications are required for anyone aspiring for such a career. There are at least half a dozen institutions in India where one can attend a course of duration of 1‑2 years following graduation with an appropriate degree to get an initial orientation, exposure to some data and case studies and preparation for a real job. Needless to say, on the job training and experience offer the most significant portion of career motivation and insight. The central theme in a PV career revolves around providing comprehensive medical, safety and analytical services. Such services include medical evaluation, assessment of expectedness and drug‑ADR associations, casualty assessment, case narratives and processing, use of medical dictionaries, data mining and signal detection, medication error related activities and finally some specialized services. While the hard core knowledge base (e.g., medical or pharmacy) is essential, a good familiarity over data management, data base construction and data mining are additional huge assets in such careers. Specializations in PV include data collection and organization, safety administration and evaluation, regulatory submissions, data mining and unknown toxic signal identification etc. Currently, pharmaceutical companies, CROs, IT firms, KPOs and consulting firms are the ones who are offering
Journal of Advanced Pharmaceutical Technology & Research | Jan-Mar 2014 | Vol 5 | Issue 1
Chakraborty: Pharmacovigilance: Curriculum and career
bulk of the PV positions as jobs in India. The regional PV centers and hospitals could be other major sources of finding the type of job being discussed here. These latter sources would not only provide some PV jobs, they can potentially open up a very caring side of the pharmacy and medical profession and reduce the gap between the taught syllabus and professional practice to serve the society. Dr. Bhaswat S. Chakraborty Senior Vice‑President and Chairman, Research and Development Core Committee, Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad, Gujarat, India E‑mail: [email protected] J. Adv. Pharm. Technol. Res.
REFERENCES 1. US FDA. ADRs: Prevalence and incidence. Available from: http://www.fda.gov/drugs/developmentapprovalprocess/ developmentresources/druginteractionslabeling/ucm110632.htm [Last accessed on 2014 Jan 20]. 2. Johnson JA, Bootman JL. Drug‑related morbidity and mortality. A cost‑of‑illness model. Arch Intern Med 1995;155:1949‑56. 3. Gavali DK, Kulkarni KS, Kumar A, Chakraborty BS. Therapeutic class‑specific signal detection of bradycardia associated with propranolol hydrochloride. Indian J Pharmacol 2009;41:162‑6. 4. Härmark L, van Grootheest AC. Pharmacovigilance: Methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008;64:743‑52. How to cite this article: Chakraborty BS. Pharmacovigilance: Curriculum and career. J Adv Pharm Technol Res 2014;5:2-3.
Author Help: Online submission of the manuscripts Articles can be submitted online from http://www.journalonweb.com. For online submission, the articles should be prepared in two files (first page file and article file). Images should be submitted separately. 1) First Page File: Prepare the title page, covering letter, acknowledgement etc. using a word processor program. All information related to your identity should be included here. Use text/rtf/doc/pdf files. Do not zip the files. 2) Article File: The main text of the article, beginning with the Abstract to References (including tables) should be in this file. Do not include any information (such as acknowledgement, your names in page headers etc.) in this file. Use text/rtf/doc/pdf files. Do not zip the files. Limit the file size to 1 MB. Do not incorporate images in the file. If file size is large, graphs can be submitted separately as images, without their being incorporated in the article file. This will reduce the size of the file. 3) Images: Submit good quality color images. Each image should be less than 4 MB in size. The size of the image can be reduced by decreasing the actual height and width of the images (keep up to about 6 inches and up to about 1800 x 1200 pixels). JPEG is the most suitable file format. The image quality should be good enough to judge the scientific value of the image. For the purpose of printing, always retain a good quality, high resolution image. This high resolution image should be sent to the editorial office at the time of sending a revised article. 4) Legends: Legends for the figures/images should be included at the end of the article file. Journal of Advanced Pharmaceutical Technology & Research | Jan-Mar 2014 | Vol 5 | Issue 1
3
Copyright of Journal of Advanced Pharmaceutical Technology & Research is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Pharmacovigilance: Curriculum and career
Drug related deaths account for the fourth largest category of mortality in the United States.[1] In addition, in USA, estimated total cost of medication errors and adverse drug reactions (ADRs) exceed 136 billion dollars annually.[2] Although such accurate figures are not available for this category of mortality in India, a logical estimate may place drug related deaths very high in this country as well. This and this fact alone tell us that pharmacovigilance (PV) must be an integral part of the drug development during clinical trials and the actual use of the drug in patient population post marketing. The World Health Organization (WHO) defines PV as the science and activities relating to the detection, evaluation, understanding and prevention of ADRs or any other drug‑related problems. ADRs (especially the serious ones), medication and prescription errors and poor products qualities are the major reasons and areas of the practice of PV. Thus, risk management, risk mitigation plans and discovery of toxic signals from data mining of existing safety data bases are extremely important activities during both development and post approval phases in the life cycle of a drug.[3] From 2007 onwards, both EMA and USFDA have empowered their agencies such that right now registration of any drug product in the USA and European countries is impossible without a thorough post marketing PV program (along with pre‑marketing risk management plan).[4] An essential part of a proper PV program is also to maintain huge safety data bases. Such data bases often contain several million individual safety records of large pharmaceutical companies’ marketed drugs, for example. Such requirements of maintaining very large data bases alone have prompted these firms to look for cost‑effective PV set ups in economically emerging Access this article online Quick Response Code:
Website: www.japtr.org
DOI: 10.4103/2231-4040.126978
2
countries like India. Thus pharmaceutical MNCs require trained professionals for their PV data bases and related activities. The national PV programs as guided by WHO are also major hubs of PV activities wherein very specific and relevant curricular training and experience are required. It is interesting to note that the outsourced PV activities to India is on the rise for last 3 years or so even as the overall clinical trial activities coming to India are on a decline for the same period. A career in PV requires adequate qualifications, proper training and also an employment which has both short and long term prospects. The basic qualifications for adapting to a PV career include undergraduate and/or graduate degrees in human and veterinary medicine, pharmacy, nursing or allied health sciences. Direct exposure to collection and organization of PV data, their processing and analyzes and further implications are required for anyone aspiring for such a career. There are at least half a dozen institutions in India where one can attend a course of duration of 1‑2 years following graduation with an appropriate degree to get an initial orientation, exposure to some data and case studies and preparation for a real job. Needless to say, on the job training and experience offer the most significant portion of career motivation and insight. The central theme in a PV career revolves around providing comprehensive medical, safety and analytical services. Such services include medical evaluation, assessment of expectedness and drug‑ADR associations, casualty assessment, case narratives and processing, use of medical dictionaries, data mining and signal detection, medication error related activities and finally some specialized services. While the hard core knowledge base (e.g., medical or pharmacy) is essential, a good familiarity over data management, data base construction and data mining are additional huge assets in such careers. Specializations in PV include data collection and organization, safety administration and evaluation, regulatory submissions, data mining and unknown toxic signal identification etc. Currently, pharmaceutical companies, CROs, IT firms, KPOs and consulting firms are the ones who are offering
Journal of Advanced Pharmaceutical Technology & Research | Jan-Mar 2014 | Vol 5 | Issue 1
Chakraborty: Pharmacovigilance: Curriculum and career
bulk of the PV positions as jobs in India. The regional PV centers and hospitals could be other major sources of finding the type of job being discussed here. These latter sources would not only provide some PV jobs, they can potentially open up a very caring side of the pharmacy and medical profession and reduce the gap between the taught syllabus and professional practice to serve the society. Dr. Bhaswat S. Chakraborty Senior Vice‑President and Chairman, Research and Development Core Committee, Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad, Gujarat, India E‑mail: [email protected] J. Adv. Pharm. Technol. Res.
REFERENCES 1. US FDA. ADRs: Prevalence and incidence. Available from: http://www.fda.gov/drugs/developmentapprovalprocess/ developmentresources/druginteractionslabeling/ucm110632.htm [Last accessed on 2014 Jan 20]. 2. Johnson JA, Bootman JL. Drug‑related morbidity and mortality. A cost‑of‑illness model. Arch Intern Med 1995;155:1949‑56. 3. Gavali DK, Kulkarni KS, Kumar A, Chakraborty BS. Therapeutic class‑specific signal detection of bradycardia associated with propranolol hydrochloride. Indian J Pharmacol 2009;41:162‑6. 4. Härmark L, van Grootheest AC. Pharmacovigilance: Methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008;64:743‑52. How to cite this article: Chakraborty BS. Pharmacovigilance: Curriculum and career. J Adv Pharm Technol Res 2014;5:2-3.
Author Help: Online submission of the manuscripts Articles can be submitted online from http://www.journalonweb.com. For online submission, the articles should be prepared in two files (first page file and article file). Images should be submitted separately. 1) First Page File: Prepare the title page, covering letter, acknowledgement etc. using a word processor program. All information related to your identity should be included here. Use text/rtf/doc/pdf files. Do not zip the files. 2) Article File: The main text of the article, beginning with the Abstract to References (including tables) should be in this file. Do not include any information (such as acknowledgement, your names in page headers etc.) in this file. Use text/rtf/doc/pdf files. Do not zip the files. Limit the file size to 1 MB. Do not incorporate images in the file. If file size is large, graphs can be submitted separately as images, without their being incorporated in the article file. This will reduce the size of the file. 3) Images: Submit good quality color images. Each image should be less than 4 MB in size. The size of the image can be reduced by decreasing the actual height and width of the images (keep up to about 6 inches and up to about 1800 x 1200 pixels). JPEG is the most suitable file format. The image quality should be good enough to judge the scientific value of the image. For the purpose of printing, always retain a good quality, high resolution image. This high resolution image should be sent to the editorial office at the time of sending a revised article. 4) Legends: Legends for the figures/images should be included at the end of the article file. Journal of Advanced Pharmaceutical Technology & Research | Jan-Mar 2014 | Vol 5 | Issue 1
3
Copyright of Journal of Advanced Pharmaceutical Technology & Research is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
