Building ADR reporting culture for patient safety.pptx

This presentation was prepared and presented on World Pharmacovigilance Day

1. Building ADR reporting culture for patient safety Presented by, Dr. Shazma Imam Assistant Professor School of Pharmacy, Techno India University,WB

2. Why ADR reporting is important An Adverse Drug Reaction (ADR) refers to any unexpected or harmful response resulting from taking a medication or drug. Some common examples of ADR include nausea,vomiting,skin rashes,dizziness , GI disturbances and allergic reactions. In more severe cases ADR can lead to organ damage, anaphylaxis or even death. The WHO established the Programme for International Drug Monitoring (PIDM) in collaboration with Uppsala Monitoring Centre (UMC) in Sweden. PIDM aimed to collect and analyze information on adverse drug reactions from various countries, fostering international cooperation in drug safety.

3. Classification of ADR 1) Type A Reactions (augmented)- ADRs that occur as the result of known pharmacological properties of the drug are called  Type A  reactions. They can happen in any individual given a sufficient dose. Type B Reactions (bizarre)- ADRs that occur when the known pharmacological properties of the drug do not predict the reaction are called  Type B  reactions

4. Causality assessment of adverse drug reactions Causality assessment of ADRs is a method used for estimating the strength of relationship between drug(s) exposure and occurrence of adverse reaction(s). One of the most widely used CATs is the Naranjo ADR probability scale. This is a simple 10-item questionnaire that classifies the likelihood that a reaction is related to a drug using concepts such as timing, plausibility/evidence, de-challenge and rechallenge/previous exposure.

5. A simplified version of the 10 questions is provided below: Are there previous conclusive reports of this reaction? Did the adverse event appear after the drug was given? Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given? Did the adverse reaction reappear upon readministering the drug? Were there other possible causes for the reaction? Did the adverse reaction reappear upon administration of placebo? Was the drug detected in the blood or other fluids in toxic concentrations? Was the reaction worsened upon increasing the dose? Or, was the reaction lessened upon decreasing the dose? Did the patient have a similar reaction to the drug or a related agent in the past? Was the adverse event confirmed by any other objective evidence?

6. Cont. The actual ADR Probability Scale form and instructions on how it is completed are provided below. T he reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.

7. Severity assessment of Adverse drug reactions The Hartwig Scale is used to assess the severity of ADRs. The Hartwig Scale categorizes ADRs into seven levels of severity. Levels 1 and 2 are mild, levels 3 and 4 are moderate, and levels 5, 6 and 7 are severe. Mild ADRs are defined as self-limiting and able to resolve over time without treatment. Moderate ADRs are defined as those that require treatment or increase length of stay by at least one day. Severe ADRs are defined as those that are life-threatening or cause permanent harm or death.

8. Methods of ADR reporting Spontaneous reporting- Mostly used ADR for monitoring, it records the safety of a drug based on post marketing surveillance to identify new, rare, serious ADRs of a drug. Case series reporting-it is used to develop a hypothesis between approved drugs and its outcome. Stimulated reporting-It encourages and facilitates health professional report ADRs under special situation. Active surveillance-It is pre-designed process which is conducted in additional to process passive surveillance to find out more serious adverse drug events.

9. CASE STUDY-1 Adverse drug reactions reporting: Five years analysis from a teaching hospital. In this retrospective study, ADRs reported to the pharmacovigilance unit of tertiary care teaching hospital, Navi Mumbai by HCPs between 2017 to 2021 and were analyzed. The objective of this study was to analyze pattern and completeness score of ADRs during past five-years.   A total of 104 ADRs were reported among 61 (58.6%) female and 43 (41.4%) male patients. Adults (18-65 years) comprised the most affected age group, accounting for 82 (79%) patients. Out of all, 35.5% ADRs were reported in 2018, whereas 27% were reported during 2021.

10. Cont. The objective of this study was to analyze pattern and completeness score of ADRs during past five-years. Based on the finding it was found that Antibiotics (22.11%), antitubercular drugs (AKT) (20.19%), and vaccines (12.4%) represented the most common agents with which ADRs were reported. ADR reporting was very low in 2017 (4/104). Percentage improvement in completeness score in 2021 vs. 2018 was 11.95%. Positive trend in the improvement of average completeness score with number of sensitization programs was observed.  Increase in awareness of ADR reporting through sensitization programs can help to improve rate and quality of reporting.

11. Group of drugs causing ADR

12. Case Study -2 Exploration and Evaluation of Adverse Drug Reactions Documented in a Tertiary-Care Hospital in Chennai: An In-Depth Retrospective Observational Study All adverse drug interactions reported in the hospital from January 2019 to February 2024 were included after screening for inclusion and exclusion criteria. A total of 252 ADRs reported in the hospital during the study period were included in the study. All the ADRs were reported in CDSCOs' suspected ADRs reporting form. Antibiotics were the most common group of drugs causing ADRs 149 (59.1%) followed by vitamins and mineral supplements 21 (13.8%), contrast dye 15 (6%), antituberculosis (anti-TB) drugs 15 (6%), analgesics 13 (5.2%), and gastrointestinal (GIT) drugs 8 (3.2%).  The gender distribution showed 123 cases (48.8%) in males and 129 cases (51.2%) in females, with a higher prevalence in the 20-40 age group.

13. Group of drugs causing ADR

14. Channels of data flow in PvPI

15. Channels of data flow in PvPI 1. Central Drugs Standard Control Organization (CDSCO) Headquarters, New Delhi : CDSCO is the national regulatory authority responsible for ensuring drug safety in India. It oversees pharmacovigilance activities under PvPI and works in collaboration with national and international bodies. Interaction with Marketing Authorization Holders (MAHs) : Marketing Authorization Holders are pharmaceutical companies that receive approval to sell drugs. They are required to report ADRs to CDSCO as part of their pharmacovigilance obligations.

16. Cont. 2. Uppsala Monitoring Centre (UMC) Located in Sweden, UMC is the global coordinating body for pharmacovigilance under the World Health Organization (WHO). It manages VigiBase , the global database for ADR reports. CDSCO collaborates with UMC : ADR data collected in India is shared with UMC to contribute to international drug safety monitoring.

17. Cont. 3. National Coordinating Centre (NCC) - Pharmacovigilance Programme of India Location : Indian Pharmacopoeia Commission (IPC), Ghaziabad. Role : The NCC at IPC acts as the central hub for receiving, analyzing, and managing ADR reports across India. It coordinates the entire pharmacovigilance system and ensures compliance with both national and international standards.

18. Cont. 4. CDSCO Zonal Offices CDSCO has several zonal offices spread across the country to manage the regulatory aspects of pharmacovigilance at the regional level: North Zone : Ghaziabad South Zone : Chennai West Zone : Mumbai East Zone : Kolkata These offices work in coordination with ADR Monitoring Centres (AMCs) and other stakeholders to ensure consistent ADR reporting and follow-up.

19. Cont. 5. ADR Monitoring Centres (AMCs) AMCs : These centers are spread across various hospitals, medical institutions, and healthcare facilities across India. They serve as the first point of contact for ADR reporting from healthcare professionals and patients.

20. Cont. 6. Healthcare Professionals / Patients Healthcare Professionals (doctors, pharmacists, nurses, etc.) : They play a critical role in identifying and reporting ADRs, as they are on the front lines of patient care. Patients : They can also directly report ADRs they experience via various channels such as online forms, the PvPI mobile app, or by contacting their healthcare providers.

21. Summary PvPI operates in collaboration with various stakeholders, including healthcare professionals, regulatory bodies (CDSCO), pharmaceutical companies (MAHs), and international organizations (UMC). AMCs serve as the primary data collection points for ADRs, which are then reviewed and assessed by various panels at the NCC. CDSCO and PvPI work together to ensure that safety signals are detected early, actions are taken, and the results are shared both nationally and internationally. This systematic approach helps ensure that ADRs are effectively reported and managed to protect patient safety and improve drug safety standards in India.

22. Role of Pharmacist India's ADR reporting rate is less than 1%, compared to 5% globally . 43% of ADR are considered preventable. Pharmacists, being drug experts and guardian of safe and effective use of medicines, have an important role in not only detecting, reporting, and monitoring of ADRs but also preventing ADRs. Pharmacists can promote the importance of ADR reporting among healthcare colleagues and encourage a culture of safety and vigilance. They are expected to stay informed on the latest medications, adverse reactions, and guidelines through continuing education, allowing them to recognize and respond to new and emerging ADRs.

23. Career in Pharmacovigilance Clinical Pharmacist- Pharmacist can work in clinical settings where they have to review patient medication histories. Pharmacovigilance Officer- Pharmacist can work in Pharmaceutical companies, research organisations where they have to monitor, identify and assess ADRs. Pharmacovigilance Scientist- They can work in research institutiuons , pharmaceutical companies where they have to evaluate drug safety data from clinical trials and post marketing suveillance . Regulatory affair specialist- Pharmacist can work in regulatory bodies and pharmaceutical companies where they ensure that regulatory requirements are met.

24. Cont. Drug safety associate- They can work in pharmaceutical companies and research organisations where their work is to ensure accurate documentation. Medical writing- Pharmacist are involved in writing clinical trial documents, prepare documents for submission to regulatory authorities.

25. References Al Dweik R, Stacey D, Kohen D, Yaya S. Factors affecting patient reporting of adverse drug reactions: a systematic review. Br J Clin Pharmacol . 2017;83(4):875-83 Coleman JJ, Pontefract SK. Adverse drug reactions. Clin Med ( Lond ). 2016 Oct;16(5):481-485 Adverse Drug Reaction Probability Scale (Naranjo) in Drug Induced Liver Injury 2019 May World Health Organization. International Drug Monitoring: The Role of National Centres . Geneva: World Health Organization; 1972. (Technical Report Series No. 498). Thakre V,Patil A,Jain M etal . Adverse drug reactions reporting: Five years analysis from a teaching hospital. J M , 2022 Nov; 11(11): 7316–7321

26. Cont. Muacevic A, Adler J, Exploration and Evaluation of Adverse Drug Reactions Documented in a Tertiary-Care Hospital in Chennai: An In-Depth Retrospective Observational Study,  2024 May; 16(5): e60977 Kommu S, Carter C, etal , Adverse Drug Reactions; 2024 Jan.