Improving ADR reporting habit

ADR reporting: Adverse Drug reactions are inevitable outcome of drug therapy. We can’t avoid it but we can try to mitigate it by expecting or predicting it based on the previous documented reports. Uppsala Monitoring Centre (UMC) in Sweden_WHO initiative, have provided certain guidelines and facilities to voluntarily report ADR by any health care faculty. In few countries, it is even done by patients themselves. But India lags behind reporting ADR even after setting up of National Coordination Centre by Pharmacovigilance Program of India (NCC-PvPI). The nodal body is Indian Pharmacopoeia Commision (IPC) at Ghaziabad which comes under the purview of Ministry of Health and Family Welfare, Govt. of India and works in collaboration with CDSCO, India.

Reason:

  • Being complacent
  • Lack of awareness
  • Lack of responsibility
  • Lack of sustained motivation by the nodal bodies
  • Lack of facilities

Indians have this “Chalta Hai” attitude for lot of things. If not all, many have. We just crib over lack of change but we never take steps to be a part of the movement which will bring change. Just being complacent for anything which happens to us.

This combined with lack of awareness and responsibility of such happenings do more harm than good. Many practitioners outrightly project reporting ADR is a responsibility of nurses or interns or Department of Pharmacology! Unless they intimate about an ADR, no signal can be detected! I have seen lame scenarios like physicians laughing over the reporting habit by just saying that “We will make sure ADR doesn’t happen in our wards”. Nothing more to be said. Period.

Lack of motivation by nodal bodies plays a big role in denting the reporting habits among the health care professionals. Starting PvPI program doesn’t ensue successful reporting. Previously there were many confusions like where to report, whom to contact for queries. But now IPC website mentions everything about reporting. Still just mentioning doesn’t give full flexibility in reporting. Many AMC (ADR Monitoring Centres) don’t have VigiFlow, a web-based Individual Case Safety Report (ICSR) management system that is specially designed for use by national centres in the WHO Programme for International Drug Monitoring. It is provided free of cost by WHO to report ADRs directly to UMC and to IPC. Login authorisation leads to uploading of ADRs. Many centers applied in vain and still waiting for any response from PvPI/IPC. Lack of these prime facilities still create a huge dent in reporting practices.

In many medical colleges, post graduate students walk through all the wards in the hospital to check for any ADRs, even after sensitising the practitioners and staff nurses towards reporting ADR. This “ADR collection” happens in this way even after:

  • Providing the contact numbers of the staffs of Department of Pharmacology
  • Providing the duty rosters with contact numbers of the duty PGs of department of Pharmacology
  • Providing ADR drop boxes at every wards
  • Sensitizing the clinicians at the weekly clinical meetings

So this lead to a scenario of frustration and lack of interest among the ADR “collectors”. Sometime later the whole habit of reporting vanished only to reappear when it’s mandatory requirement for some “regulatory purpose”.

As we all have become app savvy, Dr. Sachin Kuchya, Associate Professor of Pharmacology, NSCB Medical College, Jabalpur conceptualised and developed an android app, named ADR Reporting. Later he was invited by IPC / PvPI to give a presentation on the same which lead to the authorisation of the app by IPC as an official reporting app for ADRs. But a lack of clarity in the authorisation documents keeps the usage of the App under abeyance by many AMCs.

As quoted by him:

“Let me share something very relevant,this app has been my brainchild and I have invested close to (INR) 1.80 lakh plus, towards its development and updation (updating). With the help of NCC Pvpi, I could connect all the 179 AMC’s recognized till may 15, (2016) & also I could dedicate the app to the nation. Now, I don’t have money. What I wish henceforth that NCC Pvpi should take it forward. Develop even a better version, which works across all platforms, is user friendly. But again I wish to assure you all that it’s still the best way to report ADRs, let’s continue with the same. With the app based data, at least the reporter is verifiable, the paper based has everything questionable. Feel free to use the app and spread the same. Best wishes, however if you all need some assistance I am always their. Thanks and Regards.”

IMPAS.in appreciates Dr.Sachin Kuchya’s effort in developing and dedicating this app. We have few suggestions to improve the reporting habit through an app, either by this ADR Reporting app or by any third party app authorised by the Indian government. ( Note: Many Big Pharma have their own ADR reporting app developed for their own purpose and also a paid version for third party use)

  • Release the official authorisation document of the app by IPC in their website
  • Gov. of India should invite the cellular companies, as a part of their Corporate Social Responsibility (CSR) to provide free data usage for these apps which will promote the usage and reporting irrespective of the reporters data balance.
  • Go a level up and provide a smart phone, with inbuilt  authorised app for ADR reporting, used only for this purpose. Keep this in all the wards of the hospital. If it is made as a mandatory requirement for MCI recognition, all the colleges will be obliged to have this

But this app reporting is not the only solution. We as a healthcare faculty should have a moral responsibility of reporting any ADR. Even it’s a trifle reaction like itching or sneezing, it has to be reported as the severity varies between patients. and the responsibility of reporting has to be extended from the hands of department of Pharmacology to the clinical departments.

Recently we saw a spurt in the promotional activities of ADR reporting by NCC\PvPI. They have also started a WhatsApp group for discussion and promotional activities for ADR reporting. Send a request to #7042343309 to join the group.

India is moving towards a healthy ADR reporting practices. But this movement is in a snail pace. It needs to be speeded up and let’s all work towards it!

Also, recently IPC has initiated Hemovigilance program of India (HvPI) as an important tool for improving safe blood transfusion practices in a country. It is a set of surveillance procedures covering the whole transfusion chain from  the collection of blood and its components to the follow-up of its recipients intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products and to prevent their occurrence and recurrence. In this program the blood banks has to be registered under HvPI and after which a username / password is provided to report the adverse events in the portal provided within the webpage. Click here to view HemoVigil. There is also a similar portal named DonorVigil.

IPC have also started Materiovigilance Programme of India (MvPI) to monitor the safety of medical devices in the country.

Useful Links:

ADR Reporting App: https://play.google.com/store/apps/details?id=sADRReporting.sADRReporting

ADR reporting form: http://www.cdsco.nic.in/writereaddata/ADR%20form%20PvPI.pdf

Medicinal Side Effects Reporting form_ENGLISH: (also available in major regional languages)  http://ipc.nic.in/writereaddata/mainlinkFile/File262.pdf

Transfusion Reaction Reporting Form: http://nib.gov.in/Haemovigilance/TRRF_Form.pdf

Also, check out this article written by Ashish Jain and Ravneet Kaur on “Hemovigilance and blood safety”, published in Asian Journal of Transfusion Science. Read this article hereJain A, Kaur R. Hemovigilance and blood safety. Asian Journal of Transfusion Science. 2012;6(2):137-138. doi:10.4103/0973-6247.98911.

Drugs<>Therapeutics<>Big Pharma
impas Natesh Prabhu Administrator & Chief Editor | Clinical Pharmacologist | Diabetic-Sexual Medicine-Regenerative Therapy Consultant | President, Indian Medical Pharmacologists Association
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