Perspectives in Clinical Research

: 2012  |  Volume : 3  |  Issue : 3  |  Page : 85--86

Safety reporting - making it safely effective or effectively safe?

Viraj Rajadhyaksha 
 Director Medical affairs, Sanofi, Mumbai, India

Correspondence Address:
Viraj Rajadhyaksha
54/A Mathuradas Vassanji Road, Andheri East - 400 093, Mumbai

How to cite this article:
Rajadhyaksha V. Safety reporting - making it safely effective or effectively safe?.Perspect Clin Res 2012;3:85-86

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Rajadhyaksha V. Safety reporting - making it safely effective or effectively safe?. Perspect Clin Res [serial online] 2012 [cited 2020 Jul 11 ];3:85-86
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Fifty one years ago, an alert Australian physician WG McBride raised the first alarm of a possible relationship between exposure of thalidomide in utero and congenital abnormalities. Over the next few months, thalidomide was withdrawn and became history. The role of medical practitioners in identification of safety signals cannot begin without this event in medical history. [1]

In the last decade, clinical trials and meta-analysis supported the high risk of cardiovascular toxicity associated with rofecoxib, rosiglitazone ultimately leading to the withdrawal or limited usage of these high potential block bluster drugs. The hypothesis, methodology of these was quite different from that of thalidomide but the final action was similar- either restricted use or complete withdrawal. [1] The role of sustained pharmacovigilance - in development as well as post approval phase became more pronounced.

The limitations of complete safety information being obtained as part of drug development programs (pre-approval phase) are very well known. These would include restricted patient populations, limited numbers, short duration of clinical trials, under representation of some patient groups etc. Hence the needs of continuous surveillance in the post approval phase in form of post marketing studies-descriptive or analytical. Of these, spontaneous reporting system (SRS), a descriptive method has been widely used since the post thalidomide era. Simplicity and ease of use being its main advantages. Evidence from spontaneous reporting system has resulted in withdrawals of eight out of eleven (73%) products between 1999-2001. [1] In Europe six of nine significant drug safety issues were detected by spontaneous reports. [1] Thus, the role of spontaneous reporting systems cannot be belittled in any way. However, selective and under reporting can also be the main disadvantages. Several awareness and training programs have been conducted globally to increase awareness and hence action amongst physicians, pharmacists and patients so that optimum safety data is generated, reinforcing on the safety of new as well as old medicines.

In this Journal, Kharkar M et al, report a high awareness and perception of adverse drug reactions (ADRs) but paradoxically a low reporting of ADRs. The fact that this study population covered a sizable number of practicing medical practitioners in the community setting makes the data more pragmatic and realistic. Converting thoughts and ideas into action can often be a universal challenge and hence these findings reinforce the same in the medical field.

Another study by Agu KA et al, from Nigeria evaluates the knowledge and attitudes in patients. This study again shows a high level of awareness and understanding amongst patients. Focusing on counseling and education could have resulted in these findings. The study in institutional setting also points to high understanding of what patients would do in case of adverse events.

In a country like ours, with diverse socio cultural practices, presence of multiple health systems, the role of non-medical personnel such as pharmacists in influencing patient decisions, SRS cannot be relied as the only method of detecting safety signals. The National Pharmacovigilance program, established in 2004 through its various peripheral centers, regional centers and zonal centers has been a concrete step in strengthening the safety framework. [2] However it alone may fall short of a truly pragmatic but at the same time well-structured and result oriented system unless it is made mandatory and not just voluntary.

What are the various options that we have? One approach is to assess intensive monitoring systems such as the prescription event monitoring in the UK. [1] This can provide real world clinical data. Since it is based upon event monitoring, it is capable of identifying signals for events that were not necessarily suspected as being ADRs. The renewed interest in this method even by the European Commission makes this as one of the options available in addition to existing systems. [3]

The second approach is to use a General Practice Research Database. [1] While many general practitioners in India come in private, unorganized sector, the role of general practitioners in providing information on patients including diagnosis and treatment is paramount. This system could be evaluated to begin with, in municipal dispensaries of big cities such as Mumbai and Delhi. This database has been found to be useful for pharmacoepidemiology as well as disease epidemiology - both of which are unmet medical needs in India. If possible, we could even map this database to Aadhar, the unique identification number project in India.

The third approach is to include drug dispensing records from community pharmacies and hospital discharge records. This records linkage system was developed in Netherlands (PHARMO). [1] This can also be linked to other epidemiologic data. Studies on drug utilization, persistence with treatment, ADRs have been done on this system. We could evaluate this in pharmacies in private corporate hospitals which have good infrastructure and technological support, to make this useful and effective.

The success of safety reporting systems is not only on increasing awareness and hence possibly increasing reporting of adverse drug reactions. It is also in making the system more user friendly and more result oriented, informing reporters of what happened after analysis of report, guiding physicians on how this information will make a difference in their selection of treatment, identifying patient populations who have the highest risk and those in whom the risk is less. Unless the reporter (physician, pharmacist and patient / consumer) finds this to be useful to him directly (and paradoxically not merely to the whole world) the challenges in implementation of a robust pharmacovigilance system would continue. In addition to strengthening the SRS as above and setting up of few other systems such as the event reporting or database systems, we propose a cross pronged approach of all stakeholders.

Physicians: Targeting students and residents who often see these events as part of their clinical training. This would expose them to be more alert in identification of new ADRs. Encouraging these groups to present and publish case reports should also be done.Pharmacists: Similar to physicians, incorporating safety reporting training in pharmacy education is also likely to make pharmacists more aware of their pharmacogivilance responsibilities in practice.Patients and consumers: We must encourage patient reporting as has been the case in some countries. While this is likely to increase the workload, it would make the process more practical and valuable to the end user. Many non-serious but common ADRs are likely to be reported this way.Industry: The industry must develop enhanced tools for safety, signal detection using databases, broader and deeper application of epidemiology, data-mining algorithms, phased launches, robust risk management plans to make it more effective. [4] Regulators and Government: For the success of any existing program and development of new programs, government has a key role in planning and sustenance. [5] Rewards as well as punishment should be a part of this strategy.

The focus of any safety reporting system is often to identify adverse events and signals which can prompt authorities to issue warnings, precautions and prompts into more serious actions if warranted. On the other hand, we must focus on combining epidemiology and pharmacovigilance to describe patients who are at risk of developing the adverse drug reaction, and what is the likely course of the adverse drug reaction. As researchers, we focus on safety often assuming efficacy. As practitioners, we often focus on efficacy assuming safety. The challenge is to develop a middle path-to reinforce the patient's confidence in therapy-which is more important than anything else.


The article is written in personal capacity. All opinions expressed herewith are those of the author only and not necessarily those of Sanofi.


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3European Commission Enterprise and Industry Directorate-general. Strategy to better protect public health by strengthening and rationalizing EU pharmacovigilance. Brussels: European Commission Enterprise and Industry; 2007.
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