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Pharmacovigilance AN

Pharmacovigilance is the science and activities aimed at detecting, assessing, and preventing adverse drug reactions (ADRs) and drug-related problems to enhance patient safety. The document highlights the historical context of pharmacovigilance, including the Thalidomide disaster, the importance of monitoring drug safety, and establishes the concept of the pharmacovigilance system, particularly in Saudi Arabia. It emphasizes the need for reporting, investigations, and regulatory actions to minimize medication errors and adverse effects.

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Related topics:
Drug Safety Overview•
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BY: Ahmed Nouri Clinical Pharmacist, internal medicine and cardiology Pharmacovigilance
Outlines What is Pharmacovigilance? Drug Related Problems and ADRs Why do we need Pharmacovigilance? The concept of Pharmacovigilance system Pharmacovigilance in KSA
What is Pharmacovigilance? Pharmakon (Greek) – Medicine Vigilare (Latin) – To keep watch The science and activities relating to the detection, assessment, and prevention of adverse drug reactions and other drug related problems in humans a type of continual monitoring of unwanted effects and safety related to drugs post marketing. The Importance of Pharmacovigilance, World Health Organization 2002
Aims of Pharmacovigilance • Improve patient safety in relation to medications use. • Encouraging the safe, rational and cost-effective use of drugs • Detection of drug related problems at early stages. • Promotion of understanding and education toward drug safety.
Pharmacovigilance Safety Drug Related Problems
Drug Related Problems • An event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes. • In 1990, classified the DTPs into different categories according to: indication, effectiveness, safety, compliance. Introduction to Health Care Delivery: A Primer for Pharmacists Strand et al1990
Drug Related Problems 1. Abuse/Misuse of medications A. Unnecessary drug therapy. Patient taking unneeded medications for his condition. B. Wrong drug. Patient taking medication that does not treat the patient's condition. C. Additional drug therapy needed. Patient needs more medication to treat his condition D. Dosing Sub-therapeutic dose , over-dose , dosage adjustment
Drug Related Problems cont. 2. Inappropriate adherence or compliance. 3. Medication Errors Manufacturing or compounding, prescribing, transcribing, dispensing, or drug administration. 4. Lack of efficacy 5. Adverse reactions.
ADR vs AE vs SE • Adverse event Harmful and undesirable effect to patients with no direct causal relationship which may be related to medications (by medication error, incorrect dosing or an allergic reaction) or may result from other interventions such as surgery or procedure.
ADR vs AE vs SE • Adverse drug reaction Any noxious and un-intended unexpected response to a drug occurring with a direct causal relationship between the event and the drug.
ADR vs AE vs SE • Side effect Imprecise term usually used to describe drug’s unintended and expected effects within the therapeutic range related to the pharmacological properties. e.g. antihistamines producing sedation
Side Effect Adverse Effect can be both therapeutic or harmful. Harmful and undesirable. Expected usually Not expected. Do NOT hinder the main effect of the drug. can hinder the treatment and lead to more complications mild and self-resolving more severe and life threatening
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION) Type A Augmented Dose related – expected pharmacological effects e.g. respiratory depression with opioids and bleeding with warfarin Type B Bizarre Non dose related – more serious – non expected e.g. anaphylaxis with beta-lactam antibiotics Type C Continuing Dose and time related – related to cumulative drug use e.g. osteonecrosis of the jaw with bisphosphonates Type D Delayed After the use of a medicine e.g. Teratogenicity Type E End of use Due to withdrawal e.g. Addisonian crisi after steroid withdrawal Type F Failure Failure of therapy
Adverse Events Medications Errors Adverse drug reactions Medication errors that cause events that are not ADRs Medication errors that do not cause adverse events ADRs from medication Errors
Why do we need Pharmacovigilance?
Historical Background: Thalidomide Disaster • 1956, Thalidomide was launched to the market. • Prevention of nausea in pregnancy, hypnotic, morning sickness • 1960, Reports of fetal abnormalities (>20,000 cases ) ᴥ Severe birth defects in children of women who had been prescribed this medicine during pregnancy. Phocomelia.
Phocomelia
Results of the tragedy Change in drug regulations • The disaster made many countries to introduce tougher rules for the testing and licensing of drugs • By 1965, thalidomide had been removed from the market.
1. Insufficient safety evidence from clinical trials
2. Protect patients from avoidable harm • Studies found that of all ADRs, 70% are preventable • Patients experienced ADRs (19%) (59%) were avoidable
3. To reduce healthcare expenses • Costs related to the ADRs exceeded the cost of the medications themselves in some countries. • Patients with ADRs were hospitalized for an average 8 – 12 days longer than other patients. • Permanent disability may occur in 9.7% of patients with ADRs. • Cost due to ADRs in EU: € 79 billions/year Ref: Press Release from Brussels, 10 Dec 2008.
The Concept of Pharmacovigilance System
1. Detection • New drugs: report ALL suspected reactions including minor ones • Well known drugs: report all serious, unexpected, unusual reactions. • ADRs with generics that are not experienced with innovator products • All suspected drug-drug, drug-food interactions • ADRs associated with drug withdrawals • ADRs due to medication errors • ADRs due to lack of efficacy
2. Reporting Patients Healthcare Professionals Pharmaceutical industries Regulatory Authorities (SFDA)
2. Reporting A. Small scale • any suspected ADR, DTP shall be reported. • ADR reporting form (SSH-2056) in Saad Specialist Hospital B. Large scale Pharmaceutical companies play an important role in gathering ADR reports on their own products.
3. Investigations • Proper History is required • Establishing time relationship : Some response are quick / delayed. • Thorough physical examination with appropriate laboratory investigations. • Search literature for medicine suspected causing the ADR
4. Actions • Setting guidelines • Package inserts • Warnings • Drug withdrawal from market
Drug withdrawal from market Drug Year Reason Lumiracoxib 2008 Hepatotoxicity Aprotinin 2008 Kidney and cardiovascular toxicity Tegaserod 2007 Cardiovascular ischemic events Ximelagatran 2006 Hepatotoxicity Valdecoxib 2005 Dermatology adverse events Pemoline 2005 Hepatotoxicity Rofecoxib 2004 Thrombotic cardiovascular events Levomethadyl 2003 Fatal Arrhytmia Rapacuronium 2001 Risk of fatal bronchospasm Cerivastatin 2001 Rhabdomyolosis Trovafloxacin 2001 Hepatotoxicity Amineptine 2000 Hepatotoxicity, dermatological side effects, abuse potential Cisapride 2000 Cardiac arrhythmias Troglitazone 2000 Hepatotoxicity
Regulatory Authorities
WHO program for international drug monitoring • 1968, after the thalidomide disaster, the WHO set up its International Drug Monitoring Program • 1978 , Uppsala Monitoring Centre (UMC) in Sweden responsible for the collection of data about ADRs from around the world • Members submit reports of adverse reactions associated with medicinal products to the WHO global database, VigiBase
124 countries have joined the WHO Program for International Drug Monitoring (May 2016)
Yellow card scheme • The main ADR reporting scheme in the UK collecting information on suspected adverse drug reactions (ADRs). • Introduced in 1964 after the thalidomide tragedy. • It receives more than 20,000 reports of possible side effects each year. • In July 2015 a Yellow Card smartphone app was launched for iOS and Android, allowing patients and healthcare workers to report adverse reactions to medications.
Sentinel Initiative • In May 2008, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the launch of FDA’s Sentinel Initiative. • A long-term program designed to build and implement a national electronic system for monitoring the safety of FDA- approved drugs and other medical products.
Pharmacovigilance in KSA
Saudi Vigilance • Saudi Food & Drug Authority (SFDA) established National Pharmacoviglance Center (NPC) • (NPC) was announced to be functioning in March 2009. • Contribute in protection of public health by: - Monitoring of the safety and quality of medicines - Ensure healthcare professionals and patients have access to up to date safety information about medicines
UMC membership
Reports facts Total number of reports received 1296 100% ADRs 1126 87% Herbals 17 1% Cosmetics 14 1% Medication Errors 39 3% Product Quality 100 8% Saudi Vigilance, 2014
• “Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable.” Lepakhin V. Geneva 2005 • “First, Do no harm” Hippocrates (460 –377 B.C.) • PV improves patient care and drug safety. • If you suspect an ADR.. Do not assume someone else will report it! unacceptable
Thank You .. Questions? Ahmed Nouri