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251008-CQS Learning-Professional Development-PVDS.pdf
Certificate Course by Centre for Quality Sciences, Karachi for selected professionals
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251008-CQS Learning-Professional Development-PVDS.pdf
- 1. From validated methodsto real evidence …. Centre for Quality Sciences …. Where insight and integrity matters Wednesday 08 October 2025 09.30 to 3.30 pm At Hotel Marriott Karachi CQS Learning Pharmacovigilance & Drug Safety 1st Session of Professional Development Exercise for limited Professionals
- 3. CQS Learning Pharmacovigilance &Drug Safety 08 Oct 2025 – Hotel Marriott, Karachi Gathering: 09.30 am Opening & Introduction: SQ 09.45 to 10.00 am Overview of the Program: RO 10.00 to 10.30 am A Back Mirror Review: RO 10.30 to 11.15 am Tea Break: --- 11.15 to 11.45 am Current Historical Moves: OA 11.45 to 12.30 pm Discussion & Exercise: OA 12.30 to 01.15 pm Lunch & Namaz Break: --- 01.15 to 02.15 pm Experience based Learning: RO 02.15 to 02.30 pm Q& A: OA 02.30 to 03.30 pm Closing: 03.30 pm
- 4. Overview of theProgram
- 5. Tutorial Discussions Case Studies Group Discussions IndividualHomework Dr. Ajaz S. Hussain Dr. Obaid Ali Roohi B. Obaid
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- 7. Pharmacoepidemiology Study of theuse and effects of drugs in large populations It combines pharmacology and epidemiology
- 8. Pharmacoepidemiology Key Features • DrugUtilization • Safety • Efficacy • Comparisons • Policy Impact
- 9. Pharmacoepidemiology Example Questions • Doeslong term use of omeprazole increase the risk of kidney disease in general population? • Is acetaminophen use during pregnancy linked to autism in children?
- 10. Pharmacoepidemiology Methods: • Observational studies:cohort, case-control, cross-sectional • Database Research: analyzing prescriptions, hospital records • Signal detection: using pharmacovigilance systems • Clinical trial follow ups in real world settings
- 11. Pharmacoepidemiology What are thechallenges in way of ensuring drug safety? What do you think are we losing public trust or gaining public trust? How much it is complex? Please share your views
- 12. Pharmacoepidemiology What are thechallenges in way of ensuring drug safety? What do you think are we losing public trust or gaining public trust? How much it is complex? Please share your views
- 13. Pharmacoepidemiology What are thechallenges in way of ensuring drug safety? What do you think are we losing public trust or gaining public trust? How much it is complex? Please share your views
- 14. What is effective& What is safe?
- 15. What is effective& What is safe? What is quality & what is high quality? What are the benefits & what are the risks? How we calculate it? How Regulatory Authority calculate it?
- 16. What is effective& What is safe? What is quality & what is high quality? What are the benefits & what are the risks? How we calculate it? How Regulatory Authority calculate it?
- 17. What is effective& What is safe? What is quality & what is high quality? What are the benefits & what are the risks? How we calculate it? How Regulatory Authority calculate it?
- 18. What is ADE AdverseDrug Event How ADE is detected? How it is monitored? What are the legal frameworks?
- 19. What is ADE AdverseDrug Event How ADE is detected? How it is monitored? What are the legal frameworks?
- 20. What is ADE AdverseDrug Event How ADE is detected? How it is monitored? What are the legal frameworks?
- 21. What is ADE AdverseDrug Event How ADE is detected? How it is monitored? What are the legal frameworks?
- 22.
- 23. CQS time commitment 30 hoursformal teaching & one to one contact 50 hours self directed study 50 hours for projects
- 24. CQS time commitment 30 hoursformal teaching & one to one contact 50 hours self directed study 50 hours for projects
- 25. CQS time commitment 30 hoursformal teaching & one to one contact 50 hours self directed study 50 hours for projects
- 26. CQS time commitment 30 hoursformal teaching & one to one contact 50 hours self directed study 50 hours for projects
- 27. Assessment 3000 to 5000words written project 2 hour exam 15 min presentation
- 28. Assessment 3000 to 5000words written project 2 hour exam 15 min presentation
- 29. Assessment 3000 to 5000words written project 2 hour exam 15 min presentation
- 30. Assessment 3000 to 5000words written project 2 hour exam 15 min presentation
- 31. A Back MirrorReview
- 32. From 19 &20th Century Small Pox Vaccine Tetanus Toxoid And many more No vigilance and if so it was meaningless
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- 38. Challenges Chronic diseases Everything isgrowing except health Half a million dollar gene therapy Cancer, Diabetes, Cardiovascular, Allergies, Asthma, Autism About 10 billion doses of analgesic in Pakistan/year
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- 41. Just imagine & sharethe name of drug …. That you consider safe or relatively safe …. With residual risk
- 42. Why? What are theblind spots? What are the unknowns? What may go wrong?
- 43.
- 44. Studies • Publication • SampleSize • Exposure • Association • Causal Approach
- 45. JAMA 2024 2.48 Msingletons (1995 to 2019). Exposure: Registry/dispensation. Population: Small increased ASD/ADHD risk. Causal Probe: Sibling (within family) comparisons, associations attenuated to null. Interpretation: Familial confounding likely.
- 46. JAMA Psychiatry 2020 (BostonBirth) N = 996 mother infant dyads. Exposure: Cord plasma acetaminophen metabolites. Finding: Higher biomarkers Higher ASD/ADHD odds (tertile dose response). Causal Probe: Covariate adjusted models; biomarker reduces misclassification but residual confounding remains.
- 47. Am J Epidemiol 2019 N= 8,856 children; 721 ADHD cases. Exposure: Prospective maternal self report. Finding: Regular prenatal use associated with ADHD. Causal Probe: Negative-control exposure analyses (pre/post pregnancy comparisons), strengthens pregnancy specific signal but not definitive.
- 48. Autism Res 2016 (DanishDNBC) N ≈ 64,322 children. Exposure: Prospective maternal report; duration assessed. Finding: Longer duration linked to increased ASD risk for some phenotypes. Causal Probe: Dose response analyses; confounding and indication bias possible
- 49. MoBa Cohort Analyses (Norway) Analytic Nsvary; cohorts ~112,000 children. Exposure: Prospective self report. Finding: Prolonged use (weeks) associated with higher ADHD risk. Causal Probe: Adjusted regression; some sibling analyses attenuate effects.
- 50. JAMA Pediatrics / Meconium+ MRI (2020) N = 345 with meconium data; 199 positive for acetaminophen. Exposure: Meconium (cumulative fetal exposure). Finding: Acetaminophen detected Higher ADHD odds Brain connectivity differences partially mediated effect. Causal Probe: Biomarker & mediation improves plausibility; sample small.
- 51. Key Points • Knowns •Unknowns • Strengths • Weaknesses
- 52. Known Repeated Associations Multiple cohortsshow population level positive associations between prenatal acetaminophen and ADHD/ASD in offspring.
- 53. Known Exposure Measurement Matters Biomarkers (cordplasma, meconium) reduce misclassification and often show stronger signals versus self report.
- 54. Known Dose Duration Pattern Severalstudies report larger risk with longer duration or higher cumulative exposure.
- 55. Unknown Causality No randomized trials.Sibling comparison analyses (largest study) nullify associations, suggesting confounding.
- 56. Strong Evidence • Largeregistry data (power) • Biomarker confirmation • Dose response signals • Negative control analyses • Each strengthens inference in different ways
- 57. Weaknesses • Residual confounding •Indication bias (fever/infection) • Exposure timing/dose uncertainty (Self Report) • Limited mechanistic human data
- 58. Balanced Interpretation • Association repeatedly observedbut inconsistent under stronger causal designs • Evidence is concerning yet inconclusive
- 59.
- 60. Q-1 Signal or Confounder Are observedAssociations due to acetaminophen itself, maternal illness, genetics, or shared environment?
- 61. Q-2 Exposure Quantification Can Pakistan implement biomarkersampling (cord blood, meconium) to improve exposure specificity?
- 62. Q-3 Dose & Timing Whatthresholds (dose/duration/gestational window) if any, increase risk meaningfully?
- 63. Q-4 Mechanism Is there reproduciblehuman mechanistic evidence (inflammation, oxidative stress, neurotransmitter changes)?
- 64. Let’s see whatcan be done
- 65. National Sentinel Surveillance • Establishmaternity hospitals to collect standardized maternal exposure data • Neonatal cord blood, meconium, and follow up neurodevelopmental outcomes
- 66. Strengthen Pharmacovigilance • Add pregnancyexposure reporting to national PV system • Enable rapid linkage of mother child records
- 67. Strengthen Pharmacovigilance • Add pregnancyexposure reporting to national PV system • Enable rapid linkage of mother child records
- 68. Biomarker Pliot Program A multi-sitepilot (cord plasma & meconium) with N≥1,500 to provide Pakistan specific exposure outcome data
- 69. Registry Linkage & SiblingAnalyses Create mother child registries enabling within family (sibling) analyses to control familial confounding
- 70. Clinical Guidance Advise Clinicians •Use acetaminophen in pregnancy only when necessary • Lowest effective dose • Shortest duration • Emphasize fever control when indicated
- 71. Reserach Priorities • SupportMechanistic Studies • Larger Biomarker Cohorts • Data sharing with international consortia for meta-analyses
- 72. Communication Strategy Public Messaging Honest &non alarming Occasional short-term use reasonable Avoid prolonged or frequent use without medical advice.
- 73. Minimum DataSet for Pilots •Mother ID & Sibling IDs • Gestational age • Indication (fever/pain) • Dose/duration • Cord plasma acetaminophen • Meconium assay • Neurodevelopmental screening at 12/24/36 months
- 74. Cost Benefit Note Pilotbiomarker program & Registries are moderate cost with high policy value Enable evidence based guidance and targeted risk mitigation.
- 75. Conclusion Evidence: repeated associations butno definitive causality. Pakistan should rapidly build real time exposure surveillance plus biomarker studies to inform safe, contextual public health policy.
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- 78. Experience based Learning • #of years on the job is not real experience • Experience is practical contact with events … Experience is to feel (emotions) • It comes through reflection on doing
- 79. Experience based Learning Your emotionsshapes your thinking ….. Your emotions are your feelings ….. that design your attention …..
- 80. Experience based Learning Experience isin between information & knowledge Feel the information in practice, it becomes knowledge
- 81. Experience based Learning Between Knowledge& Wisdom there are two processes • Understanding • Sense making
- 82. Experience based Learning 21st Centuryis the experience economy Real world experience in the market where … Patient experience Therapeutic outcome … is more fundamental today than ever before
- 84. Viktor E. Frankl Betweenstimulus and response there is a space. In that space lies our power to choose our response. In our response lies our growth and our freedom
- 85. Jalal ad-Din Mohamamad Rumi Alwaysremember you are braver than you believe, stronger than you seem, smarter than you think, and twice as beautiful as you'd ever imagined. Yesterday I was clever, so I wanted to change the world. Today I am wise, so I am changing myself.
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