Suspected ADR Reporting made easy– “ADR Reporting” app for India Dr Sachin Kuchya, MBBS MD DNB Associate Prof. in Pharmacology & Deputy Coordinator, AMC NSCB MC Jabalpur (MP, INDIA)

Glossary sADR – Suspected Adverse drug reaction PvPI – Pharmacovigilance Programme of India NCC – National Coordinating Centre IPC – Indian Pharmacopoeia Commission, Ghaziabad (UP) AMC – ADR monitoring centre, around 200+ are recognized by PvPI at Medical Colleges, all over India CDSCO – Central Drugs & Standards Control Organisation VIGIFLOW, VIGIBASE- Software platforms, by WHO, to upload & Store drug safety data from 205+ countries Signal – Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously".

Pharmacovigilance Is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effect or any other possible drug related problems.

What all does it involve….. any untoward medical occurrence in a patient administered a pharmaceutical product, which is suspected to have a causal relationship with this treatment. It also includes, Lack of Efficacy Eg. Contraceptive failure, from drug overdose whether accidental or intentional, from drug abuse / misuse / non-approved use from drug withdrawal Failure to produce the expected pharmacological action for an approved indication.

Needs very effective pharmacovigilance programme. India with - A population of 125 crore plus. Fourth largest pharmaceutical industry. More than 1000 drugs. More than One lakh formulations. No adequate data about efficacy & safety of drugs in our population. Needs very effective pharmacovigilance programme.

How it works in INDIA - PvPI? Data Collection Signal generation Evaluation Communication Intervention National Coordination Centre for PvPI , IPC Ghaziabad Govt of India, Central Drug Standard Control Organization VIGIBASE, WHO led Global Drug Safety Database at UMC, Sweden via 200+ Adr Monitoring Centres,

Why to report Suspected ADR’s ? Shall build up Drug Safety data, for our own Indian Population. Will have a large impact on health care quality, esp in pediatric age group, pregnant & lactating women, elderly >65 yrs of age. Will lead to better designing & implementation of RISK EVALUATION & MITIGATION STRATEGIES, for their prevention. Stimulates research, easiest and cheapest way to find newer ADR’s & Indications. ( Aspirin – for prevention of heart attack, was discovered with the help of Pharmacovigilance)

Our role as Physician, Surgeons… Recognize & Report suspected ADR’s. Paper based sADR forms ADR reporting app, an android based mobile application. Be a part of PvPI. Create, “Safer therapuetics for a Better tomorrow”.

The benefit for us, Once we IDENTIFY the ADR’s (Pharmacovigilance) ↓ We can ASSESS the risk in our patients Plan our own, Risk Evaluation & Mitigation Strategies (REMS) Use the drugs & formulations, more rationally Improve our own patient care & Diagnosis.

The benefit for the Nation “Safer therapeutics, for a better tomorrow” ↓ Better Health Indices Healthier Nation

How to do it paperless……………. Idea & Concept …….. Aug 13 Development started….. Jan 14 Uploaded to Google playstore…… Nov14

Patient information The Adverse Drug Reaction & timelines

The Suspected drug Severity & Outcome

Reporter Information Once submitted *A Health care professional practicing in any part of our country, can submit sADR reports, directly to any of the 179 Adr Monitoring Centre's, all over India.

suspected ADR reporting Mandatory fields for suspected ADR reporting Patient initials Age at onset of reaction Reaction term(s) Date of onset of reaction Suspected medication Reporter information

generates PDF copies of duly filled in IPC format How it works? Reporter uses the app, submits an sADR. adrreporting.in, generates PDF copies of duly filled in IPC format A copy is sent to the REPORTER’s email account, for his record, review & research purpose Another pdf copy goes to the PREFERRED ADR MONITORING* centre, for analysis, record keeping & entry into VIGIFLOW. *A Health care professional practicing in any part of the country, can submit sADR reports, directly to your AMC.

Email to reporter The filled sADR

“ADR reporting” app Is Paperless, will not require round-the-clock availability of ADR forms, need to store them once duly filled & need courier / scanner / email etc. (Once submitted, it will reach the centre in a matter of seconds, 100% always ). Will be legible ( 100 out of 100) Will enrich the reporter.

The benefits……… sADR reporting becomes, Easier follow ups. Instantaneous, Very easy as it, needs minimum data entry. With Causality assesment, it enriches the reporter, reinforces the relation between his observation ( the suspected ADR ) & the drug. Easier follow ups.

Enrich………How ? It works for the reporter, auto entry. It rewards the reporter, has an inbuilt algorithm, for causality assesment .

Legal issues ? None

Pharmacovigilance It’s a full – fledged science. Adverse Event Following Immunization programme (since 1987) has made VACCINES, safer for us & is a glaring example. PRESCRIBER information is not asked for, It’s outside the ambit of RTI.

Confidentiality: The patient’s identity is held in strict confidence and protected to the fullest extent. Programme staff is not expected to and will not disclose the reporter’s identity in response to a request from the public. Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.

Outcomes achieved…. by PvPI, Letrozole for induction of ovulation in anovulatory infertility. GSR NO. 752(E) Dated 12.10.2011 On the basis of its recommendations, CDSCO instructed manufacturers of CARBAMAZEPINE to include Steven Johnson Syndrome in their product label. ( Mar 2015) Updated drug safety information ( Indian & global data) is now available for public. www.vigiaccess.org (April 15)

Achievements of ADR Reporting app, Has been downloaded, on 2150+ devices. Received, almost 1500+ sADR’s till date. Has a Rating of 4.789/5, on google playstore. Currently in use at 200+ Medical Colleges & Institutions.

Kindly download & report Any event subsequent to drug administration, which we don’t wish to see in our friends, family & foes. “The safety of more than 1.25 billion population is a concern & occurrence of ADR constitutes a significant economic burden on the patient & government” – PvPI. Small contributions from each one of us, will be a huge service to our nation

My Mentors, Dr P Nyati, Prof & Dean Academics, Index Medical College, Indore (MP) Dr S P Dhaneria, Prof & Dean Academics, AIIMS Raipur (CG) Dr C B Tripathi, Prof Government Medical College, Bhavnagar ( Gujarat) My Institution & every Health Care Professional, who has ever tried to submit a sADR.

Feel free to Call me / sms at, 9827255744 Thank you, Email: sachinkuchya@yahoo.com Join me at, https://www.facebook.com/Make-In-India-Suspected-ADR-reporting-app-482592828570522/ Feel free to Call me / sms at, 9827255744