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Pharmacovigilance and Safety Monitoring For Herbal Medicinal Products PowerPoint Presentation

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Description : Check out this medical PowerPoint presentation titled "Pharmacovigilance and Safety Monitoring for Herbal Medicinal Products" by Dr. Konstantin Keller.

This medical PowerPoint presentation tells us how pharmacovigilance and safety monitoring are essential for herbal medicinal products (HMPs).

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems associated with the use of medicinal products. Herbal medicinal products (HMPs) are products derived from plants or plant extracts, which are intended for therapeutic use. Pharmacovigilance for HMPs is essential to ensure their safety and efficacy.

Herbal medicines have been used for centuries to treat various ailments, and their popularity has increased in recent years due to their perceived safety and effectiveness. However, like any medicinal product, HMPs can have adverse effects. These effects can be due to various factors such as the plant species used, the preparation method, the dosage form, and the route of administration.

To ensure the safety of HMPs, it is necessary to have a pharmacovigilance system in place that can detect and monitor any adverse effects. The pharmacovigilance system for HMPs should include the following components:

Adverse event reporting: The reporting of adverse events associated with the use of HMPs is essential for the identification and evaluation of safety concerns. The reporting system should be easy to use and accessible to healthcare professionals, patients, and consumers.
Signal detection and evaluation: The pharmacovigilance system should be able to detect signals of potential safety concerns through various methods such as data mining, signal detection algorithms, and literature monitoring. The evaluation of signals should be done systematically to determine the significance of the safety concern.
Risk assessment: The safety concern identified through signal detection or adverse event reporting should be assessed for its potential risk to patients. The assessment should take into account the severity, frequency, and preventability of the adverse event.
Risk management: Based on the risk assessment, appropriate risk management strategies should be implemented to minimize the risk of adverse events associated with the use of HMPs. This can include changes to the product labeling, restriction of use, or even withdrawal of the product from the market.

In summary, pharmacovigilance and safety monitoring are essential for HMPs to ensure their safety and efficacy. The pharmacovigilance system for HMPs should include components such as adverse event reporting, signal detection and evaluation, risk assessment, and risk management.

Tags : pharmacovigilance, herbal medicinal products, pharmaceuticals, pharmaceuticals PowerPoint presentations

Published on : Jun 23, 2023 | Views : 885 | Downloads : 1

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Slide 1-

Pharmacovigilance and Safety Monitoring for Herbal Medicinal Products Dr. Konstantin Keller Chair of the Herbal Medicinal Products Working Party European Medicines Evaluation Agency, London Federal Institute for Drugs and Medical Devices, Bonn Federal Institute for Drugs and Medical Devices
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Definition All activities taken to ensure or to enhance the safety of a therapy with authorized, registered or frequently individually prescribed medicinal products. “Post-approval” activities related to safety Pharmacovigilance
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Authorisation of new products Pre-approval development and assessment Positive benefit-to-risk ratio based on results from Clinical trials  efficacy, clinical safety Pharmacological / toxicological tests  safety Physical, biological and chemical testing  quality Why Pharmacovigilance?
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New Medicinal Products Limited experiences at date of authorization:  Small numbers of patients in clinical trials  No detection of rare (< 1:1000) ADR  Specific, artificial conditions in clinical trials  Highly selected patients: no co-morbidity, no children or elderly, no pregnant women etc.  excellent monitoring of patients Why Pharmacovigilance?
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“Old” Medicinal Products Updating of the clinical safety profile Identification of new risks, not recognized empirically(e.g. cancer, genotoxicity; toxicity on reproduction) Identification of rare ADR Updating of the benefit/risk ratio and comparison with new options for treatment Updating information for consumers and health professionals Why Pharmacovigilance?
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NON-CLINICAL TESTING OF HERBAL DRUG PREPARATIONS WITH LONG-TERM MARKETING EXPERIENCE Guidance to facilitate mutual recognition and use of bibliographic data September 1998 Effects that are difficult, even impossible to detect clinically - Toxicity to Reproduction - Genotoxicity - Carcinogenicity Expert-Report points out the necessity or not of new studies
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Herbal Medicinal Products in the EU (e) Post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue. COMMISSION DIRECTIVE 2001/83/EC “..vegetable pills have taken root in my nose. It was reddish before but now it is carotty” Morrison’s universal vegetable pills, 1834/1834
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Tests not required, if sufficient experience in humans is available: single dose toxicity, repeated dose toxicity, immunotoxicity local tolerance testing pharmacological tests including safety pharmacology, pharmacokinetic studies. NON-CLINICAL TESTING OF HERBAL DRUG PREPARATIONS WITH LONG-TERM MARKETING EXPERIENCE
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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 Community code relating to medicinal products for human use Official Journal No. L 311 of 28 November 2001, p. 67 Title I Definitions Title IX Pharmacovigilance
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Directive 2001/83/EC of the European Parliament and of the Council Title I Art. 1, Definitions 11. Adverse reaction: A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy …
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Directive 2001/83/EC of the European Parliament and of the Council Title I Art. 1, Definitions 12. Serious adverse reaction: An adverse reaction which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. 13. Unexpected adverse reaction: An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.
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Directive 2001/83/EC of the European Parliament and of the Council Art. 101 Member States shall encourage doctors and health care professionals to report suspected adverse drug reactions to the competent authorities Art. 102 Member States shall … establish a pharmacovigilance system, … collect information … with particular reference to adverse reactions … and to evaluate such information scientifically. … take into account … information on misuse and abuse of medicinal products …
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Directive 2001/83/EC of the European Parliament and of the Council Article 103 The marketing authorization holder (MAH) shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance Article 104 The MAH shall be required to … maintain detailed records of all suspected adverse reactions …, to record and to report … adverse reactions … Unless other requirements have been laid down … records of all ADR shall be submitted to the competent authorities in the form of a periodic safety update report … The PSUR shall include a scientific evaluation of the benefit and risks
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Pharmacovigilance systems in each Member State EMEA, European Medicines Evaluation Agency CPMP, Committee for Proprietary Medicinal Products (scientific evaluation board) working parties: pharmacovigilance, efficacy, safety, quality, biotechnology, herbal, ad hoc working parties European Commission Pharmacovigilance in the EU
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Which Medicinal Products are covered by Pharmacovigilance Activities? any medicinal products authorised in the EU i.e. centrally authorised authorised through mutual recognition procedure purely nationally authorised new medicinal products (NCE), old medicinal products biologicals: vaccines, blood products, others herbal medicinal products alternative and complementary medicinal products
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Elements of Pharmacovigilance Established sources of risk information Health care professionals (doctors, pharmacists, traditional practitioners) Industry Local health authorities International organisations (WHO, EU, FDA) Published literature (journals, handbooks, databases) Registries / mortality statistics
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National level: • collection of ADR reports and other relevant safety information in each member state • evaluation and assessment • running a data base • regulatory actions EU level: • running a data base • exchange of information • Pharmacovigilance Working Party discussions • Directives, guidelines, SOPs • risk assessment, conclusions, recommendations Routine Work in Pharmacovigilance
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Spontaneous Reports recorded at the BfArM
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Herbal Medicinal Products in the EU Hepatotoxicity of Kava-Kava > 41 cases reported to BfArM exposure one week to two years, different extracts, dosages, co-medication Hepatitis, Enzymes , Icterus, Liver necrosis Liver transplant (6 cases) Death (3 cases)
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Interactions of herbal medicinal products with other medication Hypericum extract Phenprocoumon  Digoxin  Ciclosporine  Indinavir  Theophylline  OC  Anti-epileptics  Irinotecan  Garlic Aspirine / risk of bleeding  Saquinavir AUC  Ginkgo extract Aspirine / risk of bleeding  Kava-Kava extract Alprazolame / ADR  Isphagula husk Lithium / absorption  St. Michael, Bamberg, 1614 a.d.
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Year Products Substance/Reason 1981 336 Aristolochic acid / carcinogen 1987 59 Vinca minor / immunotoxicity 1988 1 Echinacea (parenteral) / anaphylaxis 1990 2,817 Pyrrolizidinic alkaloids / carcinogen 1991 / 1993 14 Ginkgo biloba (parenteral) / anaphylaxis 1991 95 Rauvolfia / aflatoxins 1992 1,427 Anthranoids / chronic toxicity 1992 159 Rubia tinctorum / genotoxicity Pharmacovigilance Actions in Germany
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Year Products Substance/Reason 1992 7 Teucrium chamaedris / hepatotoxic 1994 44 Sassafras albidum / genotoxic carcinogen 1997 84 Cumarin (e.g. Melilotus) / hepatotoxic 1997 105 Ginkgo / Ginkgolic acid / allergic reactions 1999 180 Chelidonium / hepatotoxic reactions 1999 11 Royal Jelly / allergic reactions / asthma 2000 374 Hypericum / interactions) 2000 78 Kava-Kava / hepatotoxic reactions 2001 9 Tussilago farfara / Pyrrolizidinic alcaloids Pharmacovigilance Actions in Germany
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Elements of Pharmacovigilance Data storage Availability of an ADR data base Equipement for rapid and easy retrievals Use of an accepted medical terminology MedDRA (Medical Dictionary for Regulatory Activities Terminology) WHO-ART (WHO-Adverse Reaction Terminology) Electronic data transmission facilities EMEA, WHO Network on national level (if appropriate)
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Elements of Pharmacovigilance Continuous surveillance of drug safety profiles Professional staff for single case assessment, evaluation of studies and aggregated data (periodic safety update reports) Advisory board or external expert panel Training of assessors
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In Case of Safety Concerns Established and structured procedures for compiling information Established and structured procedures for exchange of information with external partners (industry, doctors, pharmacists) Participation of concerned / interested parties Established and structured procedures for the decision making process Catalogue of possible and appropriate actions
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Openness for information and communication Adequate information to the public / patients Transparency of the decision Legal recourse (decision of the applicant) Follow-up surveillance: Have the actions been successful in the way you wanted? After the Decision
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Challenges and Problems Huge amount of data to be recorded, assessed and exchanged Pharmacovigilance requires sufficient technical and human resources within the Agency Spontaneous reporting: underreporting no information on frequency of AE Quality of reports sometimes poor, e.g. Product not clearly identified,Outcome not clearco-medication not specifiedinformation not complete / depending on primary assumption of the medical doctor
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Trends in Alternative Medicine Use in the US 1990-1997 Eisenberg et. al. JAMA 280:1569-1575 (1998) Patients using herbal medicines / megavitamins concurrently with prescription medicines estimated: 15 Million (18.4 % of all prescription users) 39.8% of alternative therapies were disclosed to physicians 46.0% of alternative therapies was done without any input from a medical doctor or alternative practitioner
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Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: Interview with 515 users Br. J. Clin Pharmacology 1998, Vol. 45: 496-500 Consumers’ Reaction to Adverse Drug Reactions no for OTC yes for OTC yes for herbal no for herbal Consult GP (serious* ADR): 0,8% 26.0% Consult GP (minor** ADR): 0.4% 14.6% *serious = “worrying or alarming” **minor = “some discomfort”
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Rates of Spontanous Reporting of Adverse Drug Reactions in France Bégaud B, Martin K, Haramburu F, Moore NJAMA 288: 1588 (October 2, 2002) Analysis of 3 studies in France Conclusions “ … No more than 5 % of serious Adverse Drug Reactions were reported …”
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Elements for a Strategy Herbal Medicinal Products Identify the market: Which products Which constituent(s) New or well-established Industrially prepared Identify Stakeholders: Industry Medical doctors Pharmacists Other health-care providers, e.g. trad. practioners, nurses
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Elements for a Strategy Herbal Medicinal Products Create reporting lines and centers of competence Reference to established systems, e.g. WHO, EU/MeDRA Trained assessors Advisory pannels Identify areas of potential concern, e.g. Genotoxicity, Carcinogenicity Use in Children / pregnancy Interactions with modern medicinal products Symptoms of chronic toxicity interfering with symptoms of diseases (hepatotoxicity)
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Elements for a Strategy Herbal Medicinal Products Identify information gaps Systematic literature search on the medicinal plant, related species Search for information on isolated constituents, e.g. aristolochic acid, pyrrolizidinic alkaloids, phorbole-esters, safrole etc.; concept of “negative markers” Search for information on “traditional misuse” e.g. as an abortive agent
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Elements for a Strategy Herbal Medicinal Products Take appropriate actions Discussion with stakeholders Explore possibilities of systematic studies, e.g. cohort-studies, case-control-studies, observational studies Be aware of the publics’ acceptance of risks and notion possible benefits of natural medicines Balanced information of the public on risks and benefits of herbal medicines will increase publics’ confidence in administrative actions Overreacting will not solve, but add to the problem!
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However be prepared to be criticized having reacted too late or too early and, especially, too weak or too strong “Awful effects of Morrisons’ Vegetable Pills” 1834/1835