Pharmacovigilance PDF

PHARMACO VIGILANCE Presented By Group 1 December 2, 2024  TABLE OF CONTENTS 01. Pharmacovigilance 02. Monitoring and Reporting Adverse Drug Reactions 03. Monitoring and Reporting of Medication Error 04. Drug Interactions 05. Drug Incompatibilities PHARMACOVIGILANCE  WHAT I...

PHARMACO VIGILANCE Presented By Group 1 December 2, 2024  TABLE OF CONTENTS 01. Pharmacovigilance 02. Monitoring and Reporting Adverse Drug Reactions 03. Monitoring and Reporting of Medication Error 04. Drug Interactions 05. Drug Incompatibilities PHARMACOVIGILANCE  WHAT IS PHARMACOVIGILANCE (PV)? Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) or any other drug-related problems. It involves the continuous monitoring of the safety and efficacy of pharmaceutical products, particularly after they have been authorized for use in the general population. Pharmacovigilance aims to identify, evaluate, and minimize the risks associated with drug use, ensuring that medications are used safely and effectively.  HISTORY OF PHARMACOVIGILANCE: Early Beginnings Ancient Times: Early physicians, like Hippocrates, recognized the importance of observing drug effects but lacked systematic methods for tracking adverse reactions. 17th-18th Centuries: Growing awareness of drug risks, though the concept of drug safety was rudimentary. Early 20th Century 1900s: Physicians started documenting adverse drug reactions (ADRs), especially as new drugs like morphine and aspirin were introduced.  HISTORY OF PHARMACOVIGILANCE: Early 20th Century 1930s – The Thalidomide Disaster: One of the earliest and most significant catalysts for the development of modern pharmacovigilance was the thalidomide tragedy. In the late 1950s and early 1960s, thalidomide, originally marketed as a safe sedative and treatment for morning sickness, caused thousands of birth defects in babies worldwide. The thalidomide crisis prompted widespread regulatory reforms and led to the establishment of formal systems to monitor drug safety.  HISTORY OF PHARMACOVIGILANCE: Mid 20th Century – Formalization and Regulatory Foundations 1960s – The World Health Organization (WHO) and International Cooperation: In response to the thalidomide disaster, the World Health Organization (WHO) began to play an instrumental role in advancing pharmacovigilance. In 1968, WHO established the International Drug Monitoring Program to facilitate the collection and analysis of data on adverse drug reactions worldwide. This was a major step towards creating a standardized and global approach to pharmacovigilance.  HISTORY OF PHARMACOVIGILANCE: Mid 20th Century – Formalization and Regulatory Foundations 1962 – U.S. Drug Amendments (Kefauver-Harris Amendments): In the United States, the Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act were passed in response to the thalidomide disaster. These amendments required manufacturers to provide evidence of the safety and effectiveness of drugs before approval. They also led to the creation of systems to report adverse drug reactions, thereby increasing post-market surveillance.  HISTORY OF PHARMACOVIGILANCE: Late 20th Century 1980s-90s: National pharmacovigilance systems grew, with the Uppsala Monitoring Centre coordinating global efforts. The Yellow Card Scheme in the UK and MedWatch in the U.S. became key systems for ADR reporting. 21st Century – Advancements 2000s-Present: Technological advances, including AI and big data, improved ADR detection. Global efforts like the ICH pharmacovigilance guidelines standardized practices across countries. Patients became more involved in ADR reporting.  KEY OBJECTIVES OF PHARMACOVIGILANCE: Identifying and assessing adverse drug reactions (ADRs) and other medication-related issues. Improving patient care and safety through the timely identification of potential drug risks. Ensuring the continuous monitoring of drug safety after market approval to detect any new, unexpected, or long-term adverse effects. Facilitating regulatory decision-making regarding product safety, labeling, and recommendations for use. Promoting rational drug use by informing healthcare professionals and the public about potential risks associated with medications.  PHARMACOVIGILANCE ACTIVITIES: Collecting and managing data on the safety of medicines Looking at the data to detect "signals" (any new or changing safety issue) Evaluating the data and making decisions with regard to safety issues Pro-active risk management to minimise any potential associated risks Acting to protect public health (including regulatory action) Communicating with and informing stakeholders and the public Audit of the outcomes and key processes involved.  THOSE INVOLVED IN PHARMACOVIGILANCE: Patients who are the users of medicines Doctors, pharmacists, nurses and other health care professionals Regulatory authorities, including the World Health Organization (WHO), U.S. Food and Drug Administration (FDA), Commission, the European Medicines Agency (EMA) and national authorities The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) Pharmaceutical companies and companies importing or distributing medicines.  ROLE OF PHARMACISTS IN PHARMACOVIGILANCE: Monitoring ADRs: Pharmacists are well-positioned to detect ADRs during medication counseling. Reporting ADRs: Encouraging patients and healthcare providers to report adverse events. Patient Education: Educating patients about the risks and benefits of their medications. Medication Review: Conducting medication therapy management (MTM) to prevent and manage ADRs.  CHALLENGES IN PHARMACOVIGILANCE: Underreporting of ADRs: Lack of awareness or perceived significance of adverse reactions. Data Quality: Incomplete or inaccurate ADR reports. Post-Marketing Surveillance Limitations: Limited control over how drugs are used in the real world. Global Discrepancies: Variations in pharmacovigilance infrastructure and practices between countries.  ROLE OF PHARMACISTS IN PHARMACOVIGILANCE: Monitoring ADRs: Pharmacists are well-positioned to detect ADRs during medication counseling. Reporting ADRs: Encouraging patients and healthcare providers to report adverse events. Patient Education: Educating patients about the risks and benefits of their medications. Medication Review: Conducting medication therapy management (MTM) to prevent and manage ADRs.  WHEN SHOULD PHARMACOVIGILANCE BE APPLIED? Pharmacovigilance should be applied when a new drug or therapy is studied and introduced to the market. This allows for any potential adverse effects to be identified and monitored. It is also essential to monitor for adverse effects even after a drug or therapy has been on the market for some time, as new ones may emerge. Pharmacovigilance has three main phases: pre-clinical, clinical trial, and post-marketing. Each phase has its importance in ensuring the safety of medicines.  THE THREE MAIN PHASES: Pre-Clinical Pharmacovigilance This phase includes the identification of potential risks associated with medicine before its approval for use by regulatory authorities. This is done through animal testing and clinical trials. Clinical Pharmacovigilance This phase assesses the safety and efficacy of a medicine in a controlled setting. Clinical trials are conducted before a medicine is approved for use. Post-marketing Pharmacovigilance This phase monitors the long-term safety of a medicine after it has been approved for use and is available on the market. This is done through voluntary reporting of adverse events by patients, doctors, and pharmacists.  MONITORING AND REPORTING ADVERSE DRUG REACTIONS  WHAT IS ADVERSE DRUG REACTION (ADR)? An Adverse Drug Reaction (ADR) is an unwanted or harmful response to a medication that occurs at doses normally used for the prevention, diagnosis, or treatment of a disease or condition. ADRs are unintended and often occur after a medication has been administered to a patient, even if the drug was prescribed correctly. The primary goal of monitoring ADRs is to detect and assess any potential risks associated with the use of medicines in the general population, particularly once they are available on the market.  IMPORTANCE OF REPORTING ADRS: Early Detection of New ADRs: Reporting helps identify new, unexpected, or rare ADRs that may not have been detected in clinical trials due to their limited scope. Risk Assessment: Regulatory agencies assess the severity, frequency, and potential causes of ADRs to decide whether further actions (such as product recalls, label changes, or restrictions) are necessary. Public Health Protection: Continuous ADR reporting ensures the safety of the population by providing valuable data to refine drug usage recommendations and safety measures.  CHALLENGES IN ADR REPORTING: Underreporting: Many ADRs go unreported due to lack of awareness, time constraints, or skepticism about the significance of certain reactions. Incomplete Data: Incomplete or inaccurate reporting can hinder the accurate analysis of ADRs and delay necessary actions. Reporting Burden: Healthcare professionals may feel overwhelmed by the demands of reporting ADRs, leading to inconsistent data submission.  KEY CHARACTERISTICS OF ADRS: Harmful Effects: ADRs can range from mild side effects like headaches or nausea to severe reactions like anaphylaxis, liver failure, or organ toxicity. Dose-Dependent or Independent: Some ADRs are dose-dependent, meaning they occur more frequently or severely with higher doses (e.g., liver toxicity from acetaminophen overdose). Others are dose-independent, meaning they can occur even at normal therapeutic doses (e.g., allergic reactions, idiosyncratic drug reactions).  TYPES OF ADRS: Type A (Augmented): Predictable and dose-related. These reactions are an extension of the drug's normal pharmacological effects (e.g., sedation with antihistamines). Type B (Bizarre): Unpredictable and not dose-related. These include allergic reactions, genetic predispositions, or rare, unexpected side effects (e.g., anaphylaxis from penicillin).  TYPES OF ADRS: Type C (Chronic): Related to long-term use of the drug, such as kidney damage with prolonged use of non-steroidal anti-inflammatory drugs (NSAIDs). Type D (Delayed): ADRs that appear after prolonged use or following some latency period (e.g., carcinogenesis from chemotherapy drugs). Type E (End-of-treatment): Occur when the medication is suddenly discontinued or withdrawn (e.g., withdrawal syndrome after stopping benzodiazepines).  TYPES OF ADRS: Type F (Failure): Occurs when the drug fails to achieve the desired therapeutic effect (e.g., resistance to antibiotics).  CAUSES OF ADRS: Pharmacological Effects: Direct, predictable consequences of the drug’s action on the body. Idiosyncratic Reactions: Rare, unpredictable reactions that may involve genetic or immune system factors (e.g., Stevens-Johnson syndrome). Allergic Reactions: Hypersensitivity responses where the body’s immune system mistakenly identifies the drug as harmful. Drug Interactions: ADRs resulting from the interaction between two or more drugs, leading to either increased toxicity or reduced therapeutic effects. Patient Factors: Age, gender, genetic makeup, existing medical conditions, or liver and kidney function can affect how a person responds to medication.  SEVERITY OF ADRS: Mild: These reactions are often self-limited and may resolve without intervention (e.g., mild rash, drowsiness). Moderate: May require medical intervention but typically are not life- threatening (e.g., gastrointestinal discomfort, dizziness). Severe: These reactions are potentially life-threatening and may require hospitalization or lead to permanent damage (e.g., anaphylaxis, severe liver damage).  REPORTING AND MONITORING OF ADRS: Pharmacovigilance systems are in place to monitor and report ADRs globally. Reporting ADRs helps to detect new, unexpected reactions and can lead to actions such as product recalls, changes in drug labeling, or withdrawal from the market. Common reporting systems include the FDA’s MedWatch (U.S.), Yellow Card Scheme (UK), and VigiBase (WHO). Risk Management of ADRs: Risk factors can be managed by dose adjustments, changing medications, educating patients on potential side effects, or discontinuing a problematic drug. Pharmacovigilance efforts aim to detect ADRs early, assess their frequency and severity, and ensure that the benefits of a drug outweigh its risks.  KEY STAKEHOLDERS IN REPORTING: Healthcare Providers (Doctors, Pharmacists, Nurses): They are the first to notice ADRs during patient care and play a crucial role in reporting. Patients In many countries, patients can directly report ADRs via websites, apps, or toll-free numbers provided by regulatory agencies. Pharmaceutical Companies: Manufacturers are required to report ADRs from their products, especially if the reaction has a significant impact on public health. MONITORING AND REPORTING OF MEDICATION ERRORS  WHAT ARE MEDICATION ERRORS? Medication errors are preventable events that may cause or lead to inappropriate medication use or patient harm. Key Elements: Errors may occur at any stage: Prescribing: Incorrect drug, dose, or route. Dispensing: Mislabeling or wrong medication given. Administration: Given at the wrong time or to the wrong patient.  TYPES OF MEDICATION ERRORS 1. Prescribing Errors: These occur when there is an inappropriate selection of a drug, dose, or route based on the patient's condition.incorrect drug choice. Example: Prescribing a beta-blocker like propranolol to a patient with asthma, which can exacerbate respiratory issues. 2. Dispensing Errors: Errors made during the preparation and provision of medication. Example: Dispensing look-alike, sound-alike drugs such as Lasix (furosemide) instead of Losec (omeprazole).  TYPES OF MEDICATION ERRORS 3. Administration Errors: Mistakes during the actual administration of the drug to the patient. Example: Giving a drug via the intravenous route instead of intramuscularly, which can lead to toxicity. 4. Monitoring Errors: Failure to properly monitor the effects of a medication, leading to undetected adverse effects or therapeutic failure. Example: Neglecting to monitor serum potassium levels in a patient on digoxin, resulting in arrhythmias.  CONSEQUENCES OF MEDICATION ERRORS Patient Impact Medication errors can lead to adverse drug reactions, prolonged illness, or even death. Healthcare Provider Impact Providers may experience guilt, legal consequences, and loss of trust from patients and colleagues. Healthcare System Impact Medication errors increase healthcare costs due to longer hospital stays and additional treatments.  IMPORTANCE OF MONITORING MEDICATION ERRORS Error Identification Monitoring helps detect patterns in medication errors, such as recurring mistakes with high-alert drugs like insulin or anticoagulants. Preventive Measures By understanding trends, healthcare providers can implement targeted interventions to prevent future errors. Enhancing Patient Trust Patients feel safer and more confident in a healthcare system that actively works to identify and correct errors.  REPORTING MEDICATION ERRORS Why Reporting errors promotes transparency, accountability, Report? and learning within the healthcare system. Follow institutional protocols, such as filling out an How incident report form. to Utilize systems like NCCMERP or FDA MedWatch for Report? standardized reporting. A clear description of the incident, including: What Patient details (anonymous if required). to Drug(s) involved, circumstances, and outcomes. Include? Example: Patient received 100 mg of metoprolol instead of 10 mg, resulting in bradycardia. REPORTING MEDICATION ERRORS  ROLE OF PHARMACISTS IN MEDICATION SAFETY Pharmacists are integral to minimizing medication errors, as they directly influence patient care and medication management. Their roles can be categorized into prevention, monitoring, and reporting: 1. Prevention: Pharmacists ensure prescriptions are accurate, complete, and legible. This includes checking for correct drug names, dosages, and routes of administration. Educating patients on proper medication use, including dosage timing, side effects, and storage, reduces the risk of misuse. Implementing strategies like color-coded labels or automated dispensing systems to prevent errors.  ROLE OF PHARMACISTS IN MEDICATION SAFETY 2. Monitoring 3. Reporting Monitoring for drug-drug Accurately recording interactions, adverse effects, medication errors, including and contraindications. near-misses, and their root Regularly assessing laboratory causes helps prevent recurrence. values to guide therapy. Reporting incidents like look- Recommending dose alike, sound-alike drug errors to adjustments based on institutional safety teams. monitoring findings, such as Encouraging a blame-free renal function tests for patients culture where errors are seen as on nephrotoxic drugs like opportunities to improve the aminoglycosides. system, not punish individuals.  STRATEGIES TO MINIMIZE ERRORS Use Technology Regular Training Automation reduces human error by Ongoing education ensures all healthcare improving accuracy and efficiency. staff are updated on best practices. Electronic Prescribing (ePrescribing) Training also includes simulations for eliminates errors due to illegible handling complex scenarios, like handwriting or transcription. pediatric dosing. Standardized Protocols Foster a Non-Punitive Culture Implementing clear guidelines for high-risk processes ensures consistency. A blame-free environment encourages Tall Man Lettering (e.g., "predniSONE" vs. healthcare workers to report errors "prednisoLONE") highlights look-alike, without fear. sound-alike drugs.  DRUG INTERACTIONS  DRUG INTERACTIONS Definition: Drug interactions occur when one drug alters the effect of another drug. Types of Drug Interactions: Pharmacodynamic Interactions (alteration at the site of action) Pharmacokinetic Interactions (affects the absorption, distribution, metabolism, or excretion of another drug)  WHY DRUG INTERACTIONS MATTER Drug interactions can: Alter the effectiveness of drugs. Increase the risk of adverse effects. Cause treatment failure or toxicity. Statistics: About 20% of hospital admissions involve drug-related issues.  PHARMACOKINETIC INTERACTIONS Definition: How drugs affect the absorption, distribution, metabolism, and excretion (ADME) of each other. Key processes: Enzyme induction/inhibition Altered protein binding  ABSORPTION INTERACTIONS Definition: Drugs can alter stomach pH or motility, affecting absorption. Example: Antacids reduce the absorption of ketoconazole by increasing stomach pH.  DISTRIBUTION INTERACTIONS Definition: Competition for plasma protein binding sites. Example: Warfarin and sulfonamides compete for albumin binding, increasing free warfarin levels and bleeding risk.  METABOLISM INTERACTIONS – ENZYME INDUCTION Inducers: Increase enzyme activity, reducing drug levels. Example: Rifampin induces CYP3A4, decreasing oral contraceptive efficacy.  METABOLISM INTERACTIONS – ENZYME INHIBITION Inhibitors: Decrease enzyme activity, increasing drug levels. Example: Grapefruit juice inhibits CYP3A4, enhancing simvastatin toxicity.  EXCRETION INTERACTIONS Definition: Alteration in renal clearance. Example: Probenecid reduces renal excretion of penicillin, increasing its plasma concentration.  PHARMACODYNAMIC INTERACTIONS Definition: Drugs with additive, synergistic, or antagonistic effects. Examples: Additive: 1+1 = 2 Synergistic: 1+1 > 2 Antagonistic: 1+1 < 2  ADDITIVE EFFECTS Definition: Combined effects of similar drugs. Example: Aspirin and clopidogrel both inhibit platelets, increasing bleeding risk.  SYNERGISTIC EFFECTS Definition: Enhanced effect when combined Example: Sulfamethoxazole and trimethoprim work together to block folic acid synthesis.  ANTAGONISTIC EFFECTS Definition: Opposing effects reduce efficacy. Example: Naloxone reverses opioid effects by blocking receptors.  DRUG-FOOD INTERACTIONS Definition: Food can delay, enhance, or interfere with drug activity. Example: High-fat meals increase the absorption of lipophilic drugs like griseofulvin.  CLINICAL IMPLICATIONS AND RISK FACTORS Risk factors: Polypharmacy Age Chronic diseases Genetic factors Prevention: Review medication history. Use drug interaction checkers.  PHARMACIST'S ROLE IN DRUG INTERACTION MANAGEMENT Identify and Assess Drug Interactions: Review patient medications (prescription, OTC, and supplements) to identify potential interactions, using drug interaction databases and clinical knowledge to evaluate their severity and impact. Collaborate with Healthcare Providers: Communicate with doctors and other clinicians to discuss potential interactions and recommend adjustments to drug regimens, such as switching medications or altering dosages.  PHARMACIST'S ROLE IN DRUG INTERACTION MANAGEMENT Educate Patients: Counsel patients on the risks of drug interactions and provide guidance on proper medication use. Monitor and Adjust: Track patient response, monitor for side effects, and adjust treatments as needed to ensure safety.  CASE STUDY: DRUG INTERACTION BETWEEN WARFARIN AND AMOXICILLIN Patient: A 68-year-old female patient with atrial fibrillation is on long-term anticoagulation therapy with warfarin. She is prescribed amoxicillin for a urinary tract infection (UTI). Drug Interaction: Warfarin is metabolized by the liver through the cytochrome P450 enzyme system, while amoxicillin can alter the gut flora, affecting vitamin K production, which in turn influences warfarin’s anticoagulant effect. The antibiotics can also affect the metabolism of warfarin, leading to increased levels of the anticoagulant in the bloodstream.  CASE STUDY: DRUG INTERACTION BETWEEN WARFARIN AND AMOXICILLIN Clinical Outcome: The patient experiences prolonged prothrombin time (PT) and international normalized ratio (INR), which are indicators of bleeding risk. She develops minor bruising and slight bleeding from the gums. Management: Monitor INR levels closely when starting antibiotics. Adjust warfarin dosage to maintain therapeutic INR. Provide patient education on signs of bleeding.  DRUG INCOMPATIBILITIES  DRUG INCOMPATIBILITIES Definition: Drug incompatibility refers to physical, chemical, or therapeutic reactions between two or more drugs, or between a drug and its environment, rendering them unsuitable for use. Key Types: Physical incompatibility Chemical incompatibility Therapeutic incompatibility  UNDERSTANDING DRUG INCOMPATIBILITIES Importance : Prevent therapeutic failure Avoid adverse effects or toxicity Ensure drug stability and patient safety Example: Improper mixing of intravenous drugs like phenytoin and dextrose leads to precipitation.  PHYSICAL INCOMPATIBILITY Definition: Occurs when drugs physically alter one another, affecting appearance, solubility, or viscosity. Common issues: Precipitation Cloudiness Separation.  PHYSICAL INCOMPATIBILITY – PRECIPITATION Definition: Happens when drugs are insoluble in solution or incompatible with solvents. Example: Mixing calcium salts with ceftriaxone in IV solutions forms precipitates.  PHYSICAL INCOMPATIBILITY – ADSORPTION/ABSORPTION Definition: Adsorption: Drugs stick to containers or tubing, reducing dosage. Example: Insulin adsorbs to IV tubing, decreasing effective delivery.  CHEMICAL INCOMPATIBILITY Definition: Reactions that alter a drug’s chemical properties, affecting potency or creating harmful byproducts. Common reactions: Oxidation Hydrolysis Reduction  CHEMICAL INCOMPATIBILITY – OXIDATION Definition: Drugs lose electrons and degrade. Example: Vitamin C oxidizes when exposed to air, reducing effectiveness.  CHEMICAL INCOMPATIBILITY – HYDROLYSIS Definition: Breakdown due to water interaction. Example: Aspirin hydrolyzes in the presence of moisture, forming acetic acid and salicylic acid.  CHEMICAL INCOMPATIBILITY – PH DEPENDENCE Definition: Drug stability is affected by pH changes. Example: Amphotericin B is unstable in acidic solutions and precipitates in saline solutions.  THERAPEUTIC INCOMPATIBILITY Definition: When combined drugs produce an undesired therapeutic effect. Can involve : Additive effect Antagonistic effect Synergistic effect.  THERAPEUTIC INCOMPATIBILITY – ADDITIVE EFFECTS Definition: Combined drugs amplify adverse effects. Example: Warfarin and aspirin together increase bleeding risk due to additive anticoagulation effects.  THERAPEUTIC INCOMPATIBILITY – ANTAGONISTIC EFFECTS Definition: Drugs counteract each other’s effects Example: When beta-blockers like propranolol reduce the effectiveness of beta-agonists like albuterol, as the beta-blockers block the receptors that the beta-agonists need to activate, potentially worsening asthma symptoms.  THERAPEUTIC INCOMPATIBILITY – SYNERGISTIC EFFECTS Definition: A synergistic effect occurs when two drugs, when combined, produce an effect greater than the sum of their individual effects. This can enhance therapeutic outcomes, but in the context of therapeutic incompatibility, it may also increase the risk of side effects or toxicity. Example: Raltegravir and Tenofovir exemplifies a synergistic effect, improving the efficacy of HIV treatment by targeting multiple viral mechanisms.  CASE STUDY: DRUG INCOMPATIBILITY BETWEEN WARFARIN AND RIFAMPIN Patient: Stephen, a 45-year-old male with bipolar disorder, prescribed lithium for mood stabilization and hydrochlorothiazide (a thiazide diuretic) for hypertension. Drug Interaction: Hydrochlorothiazide, a thiazide diuretic, reduces renal clearance of lithium by causing sodium depletion, which leads to increased lithium reabsorption in the kidneys. This can result in elevated lithium levels in the blood.  CASE STUDY: DRUG INTERACTION BETWEEN WARFARIN AND AMOXICILLIN Clinical Outcome: After starting hydrochlorothiazide, the patient experiences symptoms of lithium toxicity, including tremors, confusion, and nausea. Management: Discontinue or reduce the diuretic dose. Monitor lithium levels closely and adjust as needed. Educate the patient on signs of toxicity and hydration status.  CONCLUSION: Pharmacovigilance is a critical component of healthcare aimed at ensuring patient safety by identifying, assessing, and mitigating risks associated with medication use. Monitoring and reporting adverse drug reactions (ADRs) help healthcare systems detect and prevent harmful effects of medications, improving drug safety and therapeutic outcomes. Monitoring and reporting medication errors are essential for identifying preventable mistakes, reducing harm, and fostering a culture of continuous learning and system improvement. Drug interactions must be actively managed to avoid negative clinical consequences, especially for patients on multiple medications or with complex medical conditions. Drug incompatibilities highlight the importance of proper drug formulation, preparation, and administration to prevent physical, chemical, or therapeutic conflicts that could compromise efficacy or safety. Effective pharmacovigilance relies on collaboration among healthcare providers, regulatory agencies, and patients to ensure safe and effective medication use.  REFERENCES Pharmacovigilance. (2024, November 21). Public Health. https://health.ec.europa.eu/medicinalproducts/pharmacovigilance_ en Nick. (2022, September 28). All you need to know about pharmacovigilance. Biomapas. https://www.biomapas.com/all-you- need-to-know-about-pharmacovigilance/