Direct Consumer Reporting of ADRs to PvPI, a Position Paper of Indian Pharmacopoeia Commission

Patients/consumers are end user of medicines and should play important role in reporting the Adverse Drug Reactions (ADRs) to pharmacovigilance system. Consumers can provide detailed first-hand in formation about their experiences with medicines and how these medicines have affected their life. Direct consumer reporting leads to earlier identification and accumulation of signals and may provide neglected details related to psychiatric feelings and quality of life. Consumers may report ADRs due to “over the counter” (OTC) medicines, herbal medicines, and ADRs related to excipients and potential interactions. Direct patient/ consumer reporting will also rectify the under-reporting by patients to physician and will change the attitude related to importance of patient’s experience. NCC-PvPI (National Coordination Centre-Pharmacovigilance Programme of India), IPC (Indian Pharmacopoeia Commission) had launched “Medicines Side Effect Reporting form for Consumer” (blue form) at the National level conference on “Participation of patient/consumer organization in PvPI” on 1st August, 2014, which encourages patient or his/her representative (relative) to report ADRs directly either by submitting the form to the NCC-PvPI or to the nearest AMC (Adverse Drug Reaction Monitoring Centres) under PvPI. Consumers can also reports through toll free helpline number: 1800-180-3024 or email id: pvpi.compat@gmail.com to NCC-PvPI. Direct Consumer Reporting of ADRs to PvPI, a Position Paper of Indian Pharmacopoeia Commission


Introduction
The primary aim of pharmacovigilance is to identify new signals and to alert the health system regarding the same; in turn it enhances the quality of medical therapy and promotes the rational use of medicines for patients [1]. Adverse drug reactions (ADRs) are a major cause of morbidity and mortality worldwide [2,3]. About 0.3% to 11% patients hospitalized were due to ADRs [4,5]. Traditionally ADRs are reported to national pharmacovigilance system by healthcare professionals (HCPs) only but patients are the end users of the medicines, who have fundamental rights and equity to report the adverse or side effect they experience due to drug therapy.
Patients will provide unique experience and their perception of drug use, which may become a signal. To make use of patients experience during drug treatment various countries in the world encourages the consumer reporting system through forms, online data submission or telephone and included the same in spontaneous reporting system of the country [6]. Since 1964, Australia being whistle blower for including consumer/patients in spontaneous reporting system, almost 11 countries included patients in their system of pharmacovigilance and their experiences are favorable and significant. A well-documented data showed that only small proportion of HCPs contribute to the pharmacovigilance of the country as compared to the patients [7]. A report from UK also states the data received from patients/consumers directly were for long term, provides first line in formation on suspected ADRs and suspected Drugs as compared to Healthcare professionals (HCPs) [8,9]. World Health Organization (WHO) also developed a guideline for reporting of ADR by consumers/ patients directly [10].

Pharmacovigilance programme of India-IPC
Monitoring of ADRs are of great concern to the Indian healthcare system since 1998 and has become an official member of WHO India's existing system for monitoring ADRs relies on voluntary reporting by health care professionals as its main source of in formation and are encouraged to report by submitting 'Suspected Adverse Drug Reaction Reporting form for Healthcare Professionals' (red form) available from official websites of IPC and CDSCO such as www. ipc.gov.in and www.cdsco.nic.in, respectively [11,12]. Traditionally, physicians have been the major source of spontaneous reports of ADRs but currently PvPI encourages other HCPs and pharmaceutical industries also to submit ADR reports to NCC.

Consumer reporting to PvPI
A report states that developing countries report contributes only for 3% of report as compared to developed countries, this problem of underreporting could be reduced by promoting direct consumer reporting [13,14]. Developed countries (e.g. Australia, Canada, Denmark, Netherlands, Sweden, United Kingdom, and United States) consumers are being encouraged to report adverse reactions to medicines through spontaneous reporting system [15]. In order to strengthen the patient safety and direct participation of consumer/ patient in pharmacovigilance programme, NCC-PvPI has recently launched "Medicines Side Effect Reporting form for Consumer" (blue form) at the National level conference on "Participation of patient/ consumer organisation in PvPI" at IPC on August 1, 2014. Patient or his/her representative (relative) are encouraged to report ADRs either directly to the NCC -PvPI through toll free helpline number: 1800-180-3024 or email id: pvpi.compat@gmail.com or to their nearest AMC under PvPI by submitting 'Medicines Side Effect Reporting form for Consumers' (blue form) which can be downloaded from the official website of IPC www.ipc.gov.in (Figure 1) [11].
Promoting direct ADR reporting by patients/consumers is initiated on pilot scale basis across all the 150 AMC under PvPI to gauge the impact it creates among the patients and on whether the patients/ consumers are comfortable with the module and form. On successful analysis of this pilot scale reports NCC-PvPI plans to promote it across As of now, there are two forms available for reporting of ADRs; one is red form 'Suspected adverse drug reaction reporting form for healthcare professionals' and another is blue form 'Medicines side effect reporting form (For consumers)' is for consumers/ patients to report adverse events due to medicinal and health products administration. Language used in the consumer reporting form is very simple and understandable by the amateur and can report ADR in non-technical words and is less descriptive as compared with suspected adverse drug reaction form for health care professionals (Table 1) [11]. NCC will be revising or amending the form periodically as per the suggestions or comments received from the stakeholders, to make it better acceptable. After the release of consumer reporting form in English, NCC-PvPI released first version of "Medicines Side Effect Reporting form for Consumer" in different regional languages (Hindi, Bengali, Tamil, Gujarati, Kannada, Oriya and Malayalam). The objective is to encourage the important role of consumers/patients as a key partner to enhance the ADRs reporting without the issue of any language barrier [11].
Consumers while calling to NCC-PvPI through the PvPI helpline number, the designated person at NCC-PvPI will collect reporter's in formation such as name, type of reporter, address and contact details, age, sex and the reaction as it is described by reporter to make the report more authentic and will be helpful further during data analysis. These in formations were collected in Suspected ADR reporting form and will be mailed to nearest AMC for further follow up and validation of the report [11]. After that ICSR data can be entered manually into VigiFlow with support from latest version of terminologies such as WHO-Drug Dictionary for coding of drugs and WHO-Adverse Drug Reaction Terminology, used for coding of Adverse Drug reaction. Once the data regarding ADR reporting is entered into the VigiFlow, the first version of ICSRs is generated and it will automatically saved in Vigibase (WHO Global ICSRs Database). Vigibase is updated with incoming ICSRs on continuous basis. It is easy to retrieve the reports for amend the content or add follow-up in formation [11]. The in formation available in Vigibase is now also accessible by the general public by using "VigiAccess" i.e, database that allows viewing the data on suspected side effect from various medicines and vaccines.

Significance of consumer reporting
HCPs may usually report ADRs from hospitalized patients but consumers will report the effects that they experience in their day-today activities. Also it may not be possible for HCPs to capture the ADRs due to self medication, OTC products, herbal medicines, excipients or their potential interactions [8][9][10]. Direct consumer reporting leads to earlier identification and accumulation of signals [16], provide first line and new in formation, safety in formations unfiltered through the view of HCPs, may provide different details particularly nervous system related [17], psychiatric feelings and quality of life (emotional, social impact etc.) which are important and often neglected. It will also be helpful in identifying how the medicines are actually used and can also highlight issues around lack of adherence (compliance). Direct patient/ consumer reporting will also rectify the under-reporting by patients to physician and will change the attitude related to importance of patient's experience [18]. Consumers are active players in drug safety and key stakeholders in relation to pharmacovigilance and can actively contribute through an integrated and efficient reporting system. Direct reporting is an essential tool to empower consumers and to improve their involvement in the management of their own health.

Challenges
Various studies state that direct consumer reporting may result in reporting of unspecific symptoms like indisposition, dizziness and insomnia and consumers may use lay terminology for describing the symptoms, which may lead to data inappropriate for causality analysis [19]. To rectify these limitations NCC-PvPI encourages the consumers to report nearest AMCs and the reports received at NCC-PvPI directly from patients will be reverted to concern AMC for further follow up action to collect complete detail of the ADR and patient. Another challenge faced by consumers is poor knowledge regarding drugs and their reactions especially severe in India where lack of education and illiteracy are widespread. Medical mysticism is still dominant, characterized by a desire to maintain secrecy around medical facts and thinking. Good governance may be another hindering factor for proper development of such programs. Lack of funding to run, establish and ensure good atmosphere for pharmacovigilance centre and create safety culture among health professionals and public, lack of human resources dedicated for pharmacovigilance program is another major constraint.

Conclusion
Safety of medicines or patient safety cannot be addressed unless otherwise patients are not actively involved in pharmacovigilance, therefore PvPI initiated to move with patients as key stakeholders through a separate side effect reporting form for consumers. To create awareness among public on reporting ADRs is the biggest challenge a head. NCC is intended to organize workshop/meetings in collaboration with professional bodies and NGOs/ consumer forum representatives and also through media and by other modes is need of an hour.