PHARMACOVIGILANCE- 10 DAYS SKILL DEVELOPMENT PROGRAMME IN PvPI ,DELHI

PHARMACOVIGILANCE- 10 DAYS SKILL DEVELOPMENT PROGRAMME IN PvPI ,DELHI

bY SHAMNA AND PALLAVI

Some experiences nourishes our knowledge and give us some sort of realisations. In our internship period of  Pharm D, we got a valuable experience by attending 10 days skill development programme in PvPI at Indian Pharmacopoeia Commission,Ghaziabad. Being a Pharm D intern, we are always curious to learn how a Pharmacovilantes (PVLs) is fulfilling his/her responsibilities. PVLs are the professionals engaged in detection, assessment, understanding and prevention of ADRs. The budding PVLs must have qualities to set the highest professional standards and to bring the phase of transformation in pharmacovigilance(PV) by setting up of AMC, patient empowerment through helpline toll free number (1800 180 3024) and ADR reporting forms, by providing training and education in collaboration with national health programmes and regulatory interventions.

In this programme, various expertise in the field of pharmacovigilance took sessions on different aspects of PV. Another matter of happiness is we were able to get the hands on training on ADR reporting, causality assessment and softwares like Vigiflow, Argus etc. On the first day  we had a spectacular beginning with the inaugural session by Dr.G.K.Singh( DCGI) and Dr.kalaiselvan(officer in charge,PvPI) and introduction of each candidate and team members of PvPI. The first session was truly a milestone of our training programme in which the technical department of PvPI presented a video, which was so heart touching, showing the thalidomide tragedy effects and pictures of the all baby victims that literally melted our young hearts. It made us realise that  pharmacovigilance is  really the work of God.  Afterwards we went through basic concepts and  history of PV. We also had a lecture about effective communication in PV delivered by Vivek Mahajan, GMC, Jammu. Second days session was literally a feast to us, we were lucky to have Dr. A Ray, AMC coordinator and Dr. Kavita Gulati, Professor Pharmacology from Vallabhbhai Patel chest Institute (VPCI), New Delhi who discussed the Science & Pharmacological Aspects of ADRs and the process of reporting ADRs respectively. Monitoring & Reporting AEs/ADRs and  Establishing Pharmacovigilance system in Institutions / Hospitals where also discussed on the 2nd day. After lunch break  Mr. Pranay Kumar who is one of the crew member of PvPI introduced the Suspected ADR reporting Form & Consumer reporting Form- PvPI to us. Followed by this we did workshop on ADR reporting forms (CIOMS I, MedWatch 3500, PvPI form). Third day of programme covered Good Pharmacovigilance Practices (GVP) & Risk Minimisation Measures (RMM) and Sources of drug information & Literature Search, its Importance & Methodology. In the afternoon session Dr. Pooja Gupta,(AIIMS,New Delhi) shared the logics and methods of causality assessment of ADRs using both Naranjo scale and WHO alogorithm. We were provided with 4 cases and assessed the causality in teams. It was a completly different and informative experience for us. Next day of programme covered the Case Processing & management and End to End (ICSR) Case Processing & Case Management using Safety Database(Live navigation of database). After lunch we had very intresting session from Dr. Abdus Samad, Head Medical Information Lupin Ltd., Mumbai. He discussed about the importance of label management and had a practical session in it. Practical session consisted of case study of analyzing a Pack   Insert (PI)/ SmPC to understand Medication Error. In that session we identified different possible medication errors from the give cases. We were so happy to attend the same speaker next day covering the Post Marketing Safety Studies, Regulatory requirement & industry practice of PASS and various aspects of registries & its role in Pharmacovigilance. We had a discussion about vaccine surveillance as well as its global aspects in India. He  appreciated for the good interaction from the keralites throughout the class. Dr Padmapriyadarsini from National Institute for Research in Tuberculosis, Chennai helped us in understanding the concept of Pharmaco-Epidemiology & its application in  PV & Drug Safety and the burden of ADRs and study based approach. Next day was a entirely different experience for us because session move out from the four walls of classroom to a practical environment of a famous hospital Vallabhbhai Patel chest Institute(VPCI), New Delhi. We visited the AMC centre and went through the , case collection procedures, ADR reporting and causality assessment . On the 8^th day, there were sessions in Pharmacovigilance system master file, ICH guidelines, safety management during clinical studies. We were taught about the public health programs and its  importance,  methods and process of signal detection on 9^th day. Risk benefit assessment was covered by Dr. Ambili Bhaskaran,Team manager medical safety Cognizant, Mumbai, which was one of the excellent lecture that showed the real marketing world in global aspects. On the final day, we  got an oppurtuity to study more about  PBRER and PSUR and also about regulatory authorities and regulatory requirements . We winded up the session with a valedictory function which wrapped up a wonderful journey.

It was an incredible experience and we could really get an insight into how pharmacists of our nation can prove serviceable in the pharmacovigilance scenario.

 “LET’S JOIN OUR HANDS TO ENSURE PATIENT SAFETY”

If  you come across any ADR just dial toll free number 1800 180 3024