CURRENT STATUS OF PHARMACOVIGILANCE IN PAKISTAN

2. CURRENT STATUS OF PHARMACOVIGILANCE IN PAKISTAN DR. ABDUR RASHID Deputy Director General (Pharmacovigilance) Division of Pharmacy Services Drug Regulatory Authority of Pakistan

3. The Science & activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. • Source: The Importance of Pharmacovigilance, WHO 2002 • From: Greek Pharmakon – Drug Latin Vigilare – To keep awake or alert, to keep watch PHARMACOVIGILANCE

4. QUESTIONARISES ? • Has the disease been correctly diagnosed? • Has the right dose of the right strength of the right formulation of the right medicine been prescribed? • What are the risks of the treatment producing and adverse drug reaction (ADR) or side effect? • What is the potential, seriousness and duration of possible harmful effects? • Is the patient taking anything else which may interact badly with the medicine or prevent its working at all? TAKE TWO TABLETS, THREE TIMES A DAY FOR TEN DAYS…!

5. Does the patient have any medical or genetic or allergic condition which might cause a bad reaction to the medicine? • Is the manufacturing source of the medicine safe and reliable? • Does the patient understand the instructions and will they comply with them? Vital Questions..? Concern of Pharmacovigilance TAKE TWO TABLETS, THREE TIMES A DAY FOR TEN DAYS…!

6. An ADR is officially described as:- “A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnoses or therapy of disease, or for the modification of physiology function.” WHO Technical Report No. 498 ADVERSE DRUG REACTION (ADR)

7. Results in death • Results in hospitalization or prolongation of existing hospitalization. • Results in persistent or significant disability or incapacity (e.g. paralysis) • Life threatening Source: WHO International Drug Monitoring Programe REMEMBER ! DEFINITION SERIOUS ADVERSE EVENT / REACTIONS

8. THALIDOMIDE Left:(S)-Thalidomide (Teratogen) Right:(R)-Thalidomide (Sedativum)

9. CLINICAL TRIALS: • If it has any harmful effects • If it does more good than harm, and how much more; • If it is a potential for harm, how probable and how serious is the harm? PHARMACOEPIDEMIOLOGY: • Conducted by academic scientists or commercial research organizations. HOW DO WE FIND OUT ABOUT THE RISK OF DRUGS

10. PHARMACOVIGILANCE: • Such data comes from ‘Spontaneous Reporting’ of information by Health Care Professionals like Physicians, Pharmacists, Nurses, Technicians & Patients and Parents etc…… • One of the problems with this voluntarily system of “Spontaneous Reporting” is that hard pressed medical professionals don’t always see it as a high a priority. HOW DO WE FIND OUT ABOUT THE RISK OF DRUGS

11. SPECIAL MEASURES: • Countries require “Spontaneous Reporting” by law. • Most countries require from Manufactures and is mandatory to submit to the National Drug Regulatory Authority. • Intensive programes concerning a new drug or involve Pharmacist in reporting. HOW DO WE FIND OUT ABOUT THE RISK OF DRUGS

12. Medicine – Related Morbidity & Mortality $177.4 billion in 2000. • Hospital admissions for nearly 70%, $121.5 billion. • Followed by long-term admissions 18%, $32.8 billion. • Total cost of drug-related morbidity & mortality exceeds the cost of the medications themselves. • ADR is a serious and urgent - but largely preventable – medical problem. SIXTHMAJOR CAUSE OF DEATHIN USA

13. DETECT REPORT INVESTIGATE ELEMENTS OF ADVERSE EFFECT SURVEILLANCE RESPOND

14. Detection • Reporting • Investigation • Analysis • Corrective Action • Communication / Feedback ELEMENTS OF ADVERSE EFFECT SURVEILLANCE

15. DECIDE ON THE FOLLOWING IN YOUR SYSTEM: • WHICH events to be reported? • WHO should report and to whom? • HOW should reporting occur? • WHAT is the route of reporting? • WHEN should adverse event be reported? • HOW to improve / encourage reporting? REPORTING OF ADVERSE EVENTS

16. Monographies/Compendia • Davies: Textbook of adverse effects • Dukes: Meyler`s side effects of drugs • Journals • Regulatory Toxicology and Pharmacology • Newsletters • Drug Safety Update – published by MHRA • Regulatory Agencies • FDA: http://www.fda.gov/ • EMA: http://www.emea.europa.eu/ WHERE TO FIND INFORMATION‏?

17. Early detection of unknown safety problems • Detection of increases in frequency • Identification of risk factors • Quantifying risks • Preventing patients from being affected unnecessarily RATIONAL AND SAFE USE OF MEDICINES PHARMACOVIGILANCEMAJOR AIMS

18. Pharma Bureau • Pakistan Pharmaceutical Manufacturing Association (PPMA) • Provincial Governments • Public & Private Hospitals (like ShuakatKhanum Cancer Memorial Hospital) • Vertical Programs like EPI, TB, HIV & Malaria Program Report Submission 15th of Every Month INDIVIDUAL CASE SAFETY REPORT (ICSR)

19. Speaker: UsefyMuazzam • Director Quality Assurance: German Drug Regulatory Authority • Number of Participants: 20 • Regulators: Chief Executive Officers of Pharma Industry Quality Assurance Personnel from Pharma Industry Production Pharmacist LOCAL TRAINING

20. Official Collaboration with World Health Organization Monitoring Center, Sweden with Government of Pakistan • Establishment of National Pharmacovigilance Center (NPC). • Focal Person • Training Under WHO International Monitoring Center at Uppsala, Sweden on Webinar • Annual Meeting in Beijing of 147 Countries on Pharmacovigilance during August 2014 COLLABORATION WITH UPPSALA MONITORING CENTER

21. TRAINING BY WHO CENTER

22. Experts from General Medicines, Surgery, Cardiology, Toxicology, Clinical Pharmacy, Drug Information & Poison Control, Quality Assurance, Regulation and Pharmacy Services. • Coordination with Provincial Governments, Public Sector Hospitals, Private Hospitals, Cases from Print & Electronic Media. THEGUARDIANSOF DRUG SAFETY DRUG REGULATORY AUTHORITY OF PAKISTAN (DRAP) PHARMACOVIGILANCE COMMITTEE