Post-Marketing Safety Surveillance: Detecting Adverse Events

Post-marketing safety surveillance, also known as post-marketing pharmacovigilance, is a critical process in monitoring the safety of pharmaceutical products after they have been approved and are available in the market. It involves the systematic collection, analysis, and evaluation of real-world data to identify and assess adverse events and other safety-related issues associated with medications. Here's an overview of how post-marketing safety surveillance detects adverse events

1. Welcome POST MARKETING SAFETY SURVEILLANCE : DETECTING ADVERSE EVENTS Tejasri Namana Pharm D 126/072023 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

2. Index Phases of Clinical Trials Introduction Need of PMS Limitations of Pre-marketing Clinical Trials Benefits of PMS Adverse Events Sources Types of PMS studies Outcomes Conclusion 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

3. Phases of Clinical Trials Phase 1 : Micro dosing Phase 2 : First in patient -dose, dosage form Phase 3 : Efficacy, ADRs, Phase 4 : Post Marketing Surveillance (Evaluation in the real clinical setting) 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

4. Introduction Post Marketing Surveillance/PMS is the act of monitoring the safety of a pharmaceutical drug/ medical device after it has been released in the market. Safety surveillance is designed to detect any rare or long term adverse effects ina much larger patient population over a longer time period than was possible during phase I-III trials. It is an important part of science of Pharmacovigilance Safety Surveillance.PMS gives more realistic results as they occur in a more natural setting and afford evidence to safeguard or enhance the safety of approved. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

5. Need PMS study is a non-interventional study requested by regulatory authorities to verify the safety, tolerability & effectiveness of a marketed drug in a particular population per the locally aproved label. Phase IV trials involve the saftey surveillance & ongoing technical support of a drug after it receives permission to be sold These may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive or other reasons 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

6. Limitations of Premarketing Clinical Trials The safety and efficacy evaluations of any new medicinal product via clinical trials will provide only limited information on rare ADRs Limited variety of conditions, described as the ‘five toos: too few, too simple, too narrow, too median-aged and too brief’, referring to the narrow patient selection criteria and sample size along with the short duration of clinical studies 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

7. Benefits of PMS Safety monitoring is just one form of post-PMS Ensures that information is collected in a varied spectrum of patients PMS studies exemplify the differnce between efficacy & effectiveness Discovering ‘rare’ (1 in 1000) and ‘very rare’ (1 in 10,000) is possible only in post marketing trials 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

8. Adverse Events Adverse events are undesirable experiences associated with the use of a medical product. In the regulatory setting, adverse events are categorized as adverse drug events(ADEs) & a subset of ADE. ADE - Unfavourable & unintended response to a drug, whether or not cosidered related to the product. It includes medical errors & adverse drug reactions ADR - Noxoious & unintended response to a medicinal product if a medicine properly prescribed & administered 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

9. Sources Expert user groups Customer surveys Customer complaints & warranty claims Literature reviews Device tracking /implant registries User reaction during training programmes Media www.clinosol. com | follow us on social media @clinosolresearch

10. Types of PMS studies Controlled clinical trials Control refers to strict adherence to the protocols, the purpose of which is to reduce the variability of many factors & biases that might influence the trials. They are often costly 2. Spontaneous/voluntary reporting of cases A communication from an individual to a company or regulatory authority which describes a suspected adverse events But the actual incidence of adverse drug reaction cannot be determined through spontaneous reporting 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

11. Types of PMS studies 3. Cohort studies A cohort group is one into which patients are entered according to their exposure status 4. Case control studies It involves assembling of subjects in groups based on the outcome found in those subjects 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

12. Outcomes Signals Pharmacoepidemiological information Need for controlled studies Labelling changes with modified undesirable effects section Indications & dosing schedules Regulatory action (boxed warning, risk minimization action plan, withdrawl) 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

13. Conclusion Optimizing patient safety requires the reduction of potential harm before and after the marketing of a drug. Identifying the exact benefit- to-risk-ratio in a drug is necessary and those drugs in which risk outweigh benefits should be reserved only for specific diseases or populations. The post marketing of drugs needs to include doctors & patients to make informed decisions. Reporting of ADRs has become common practice and further studies must focus on implementing new ideas an dperhaps AI based models for easy detection of adverse events 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

14. Reference https://www.fda.gov/drugs/surveillance/postmarketing-adverse-event-reporting-compliance-program https://pubmed.ncbi.nlm.nih.gov/21829783/ 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

15. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch