Pharmacovigilance(0).pptx continuous edu
- 1. PHARMACOVIGILANCE • Definition: Pharmacovigilance is the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems.
- 2. Definition of terminologies • A drug or medicine is a pharmaceutical product, used in or on the human body for the prevention, diagnosis or treatment of disease, or for the modification of physiological function. • An unexpected adverse reaction is an adverse reaction, the nature or severity of which is not consistent with domestic labeling or market authorization, or expected from characteristics of the drug. Here the predominant element is that the phenomenon is unknown. • A side effect is any unintended effect of a pharmaceutical product occurring at doses normally used in man, which is related to the pharmacological properties of the drug. • An adverse reaction is a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man.
- 3. Definition of terminologies • A signal refers to reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. • Suspected adverse reactions in which the causal role of the drug is unproven and may be doubtful, and that pharmacovigilance data usually refer to only suspected adverse reactions and side effects. • An adverse event or experience is any untoward medical occurrence that may present during treatment with a medicine but which does not necessarily have a causal relationship with this treatment. The basic point here is the coincidence in time without any suspicion of a causal relationship.
- 4. Definition of terminologies • Benefits: Refers to the proven therapeutic good of product but also include the patient’s subjective assessment of its effect • Drug interaction: A drug interaction occurs when the effects of one drug are affected by the presence of another drug, food, drink or an environmental chemical agent. • Effectiveness: Is the extent to which a drug works under real world circumstances, i.e. in clinical practice
- 5. Definition of terminologies • Efficacy: The extent to which a drug works under ideal circumstances i.e. clinical trials • Causal relationship: Is said to exist when a drug is thought to have caused or contributed to the occurrence of an adverse drug reaction. • Temporal relationship: Is said to exist when an adverse event occurs when a patient is taking a given drug. A temporal relationship does not necessarily in itself prove that the event was caused by the drug.
- 6. Definition of terminologies • Dechallenge and Rechallenge Refer to a drug being stopped and restarted in a patient, respectively. A positive dechallenge occur when an adverse event resolves completely following a drug discontinuation. A positive rechallenge occurs when the adverse event reoccurs after the drug is restarted. This two plays an important role in determining whether a casual relationship between an event and a drug exists • Control group This is a group of individual patients that is used as a standard of comparison within a clinical trial. The control group may be taking a placebo or where different active drug is given as a comparator
- 7. Definition of terminologies • Clinical trial: Refers to organized program to determine the safety and/or efficacy of a drug in patients • Phase: This refers to the four phases of clinical research and development Phase 1: small scale safety trials early on in a drug’s development Phase 2: medium sized trials for both safety and efficacy Phase 3: large trials, which includes key (pivotal) trials Phase 4: large post marketing trials, typically for safety reasons
- 8. Definition of terminologies • Risk: Probability of harm being caused, usually expressed as a percentage or ratio of the treated population • Risk factor: An attribute of a patient that may predispose, or increase the risk of that patient developing an event that may or may not be drug related • Triage: Refers to the process of placing a potential adverse event report into one of three categories: – a) non-serious case – b) serious case – c) no-case (minimum criteria for an AE is not fulfilled)
- 9. Main aims 1. Early detection of unknown adverse reactions and interactions 2. Detection of increases in frequency of (known) adverse reactions 3. Identification of risk factors and possible mechanisms underlying adverse reactions 4. Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve drug prescribing and regulation.
- 10. Ultimate goals of pharmacovigilance 1. The rational and safe use of medical drugs 2. The assessment and communication of the risks and benefits of drugs on the market 3. Educating and informing of patients.
- 11. Pharmacovigilance Centre • For the case of Uganda, it is located in NDA but MOH can also be a good host for a pharmacovigilance centre. • Within the country, any department in a hospital or academic environment, working in clinical pharmacology, clinical pharmacy, clinical toxicology or epidemiology, may be a suitable starting point for pharmacovigilance. • In some countries professional bodies such as the Pharmaceutical society of Uganda may be a good home for the centre.
- 12. Pharmacovigilance Centre • The reporting of adverse drug reactions may start locally, perhaps in one hospital, then extend to other hospitals and family practices in the region, and progress step by step into a national activity. This will require much effort, especially in effective communications before a substantial proportion of practitioners are contributing. • In Uganda, the centre is hosted in NDA which has now established regional centers in all the regional hospitals in Uganda. • In this regional centers, it takes only one dedicated professional such as a physician or pharmacist to get the center functioning. • Where ever the location of the centre, pharmacovigilance is closely linked to drug regulation.
- 13. Pharmacovigilance Centre • Governmental support is needed for national co-ordination. Pharmacovigilance is nobody's individual privilege. • Good collaboration, co-ordination, communications and public relations are needed for coherent development and for the prevention of unnecessary competition or duplication. • Maintenance of contacts with international institutions working in pharmacovigilance is needed, e.g. the WHO Department of Essential Drugs and Medicines Policy (Geneva) and the Uppsala Monitoring Centre, Sweden.
- 14. Reporting Of Adverse Drug Reactions • Reporting form • A case report in pharmacovigilance can be defined as: A notification relating to a patient with an adverse medical event (or laboratory test abnormality) suspected to be induced by a medicine.
- 15. Case report information • A case report should (as a minimum to aim at) contain information on the following elements: The patient: age, sex and brief medical history (when relevant). In some countries ethnic origin may need to be specified. Adverse event: description (nature, localisation, severity, characteristics), results of investigations and tests, start date, course and outcome. Suspected drug(s): name (brand or ingredient name + manufacturer), dose, route, start/stop dates, indication for use (with particular drugs, e.g. vaccines, a batch number is important).
- 16. Case report information All other drugs used (including self-medication): names, doses, routes, start/stop dates. Risk factors (e.g. impaired renal function, previous exposure to suspected drug, previous allergies, social drug use). Name and address of reporter (to be considered confidential and to be used only for data verification, completion and case follow-up).
- 17. Methods of reporting • The primary method in pharmacovigilance is spontaneous reporting, which is a regional or country-wide system for reporting of suspected adverse drug reactions. • Other methods include; Prescription Event Monitoring, Case-Control Surveillance and linkage of records from multipurpose databases. Drug utilization data is of value in safety assessment.
- 18. Means of reporting • Special free-post or business reply reporting forms (commonly known as ADR reporting forms) • It may be effective to include; Reply-paid reporting forms in the national formulary, drug bulletin or professional journals. Telephone Fax and Electronic mail or internet
- 19. Who reports AR? • Professionals working in healthcare are the preferred source of information in pharmacovigilance, for example family practitioners, medical specialists and pharmacists. Dentists, midwives, nurses and other health workers may also administer or prescribe drugs and should report relevant experiences. • Pharmaceutical manufacturers reported to the competent authority. • If adverse reactions are reported directly by patients to the national or local centre, it is useful to consider the possibility of communication with their physicians for additional information and data verification.
- 20. What to report? • In the early stages of any pharmacovigilance system, reports on all suspected adverse reactions - known or not, serious or not - are welcome and useful. • In established pharmacovigilance systems, reporting of all suspected reactions (serious or unusual), including minor ones for new drugs. • If an increased frequency of a given reaction is suspected this is also a reason for reporting. • Adverse reactions associated with drugs used in traditional medicine (e.g. herbal remedies) should also be considered.
- 21. What to report? • Drug abuse and drug use in pregnancy (teratogenicity) and lactation. • lack of efficacy and suspected pharmaceutical defects, especially when there is the possibility of manufacturing problems, counterfeit pharmaceuticals or of the development of resistance (e.g. antibiotics). • Adverse reactions to cosmetics may need to be reported, especially when cosmetics contain obsolete or toxic ingredients (e.g. mercury compounds or corticoids in bleaching creams). • Problems related to medical devices and equipment.
- 22. Causality assessment or imputation. • The WHO causality categories largely based on four considerations: 1. The association in time (or place) between drug administration and event, 2. Pharmacology (including current knowledge of nature and frequency of adverse reactions), 3. Medical or pharmacological plausibility (signs and symptoms, laboratory tests, pathological findings, mechanism), 4. likelihood or exclusion of other causes.
- 23. Challenges in Pharmacovigilance • Limited data on ADRs • Rare ADRs some not detected in phase III clinical trials • Difficult to detect and interpret pharmacovigilance data. • Many doctors unaware • Limited knowledge and skills in detection. • Budgeting constraints which retards follow up and collection of forms- monitoring • Irrational drug use • Self medication practices common • Culture of reporting still low • Delay in reporting • Private sector not yet covered • Privacy and medical secrecy regarding the detailed reporting and use of histories of patients with iatrogenic injury (Confidentiality of personal data)
- 24. Strategies to improve pharmacovigilance • Always include detail drug history during consultation • Use drug treatment when there is a clear indication • Stop drugs that are no longer necessary • Check dose and response especially in risk groups (elderly, and children)- TDM • Inform patients on common side effects and drug interactions • Follow-up and re-evaluation • Sensitization against self medication • Rational drug use • Training of staffs.
- 25. Conclusion • Pharmacovigilance is needed for the prevention of drug-induced human suffering and to avoid financial risks associated with unexpected adverse effects. In conclusion, medicines on the market need continuous monitoring in every country.
- 26. END
Editor's Notes
- #2: Essential elements in the definition 0f a side effect are; the pharmacological nature of the effect, that the phenomenon is unintended, and that there is no overt overdose. An adverse raection. In this description it is of importance that it concerns the response of a patient, in which individual factors may play an important role, and that the phenomenon is noxious (an unexpected therapeutic response, for example, may be a side effect but not an adverse reaction).
- #3: Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information. In these definitions drug or drug food interactions are also included.