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This ppt is about pharmacovigilance in India & spontaneous reporting of adverse drug effect and there regulation by WHO or uppsala. It also include drug interaction in herbal medicine.

Veröffentlicht in: Gesundheit & Medizin
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  1. 1. Presented By: Shikha Bhardwaj Zeba usmani Shahi Bushra Tulsi Ram Varsha Srivastav Monalisha Samal M.Pharmacy Pharmacognosy PHARMACOVIGILANCE
  2. 2. What is Pharmacovigilance? • Pharmakon (Greek) = Medicinal Substances • Vigilia (Latin) = To keep watch • Pharmacovigilance, also known as drug safety is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
  3. 3. Historical Background Thalidomide  1960 marketed in 46 countries (hypnotic, prevention of nausea in pregnancy)  Thousands of congenitally deformed infants were born as the results of exposures in utero to an unsafe medicine promoted for use by pregnant mothers.  WHO Pilot Research Project for International Drug Monitoring held in 1968.
  4. 4. WHO & UMC • Uppsala monitoring Centre (UMC) is a field name of the WHO collaborating centre for international Drug Monitoring. • It is responsible for management of the WHO program for International drug Monitoring. • Nationally adverse effect is analysed and reports are submitted to WHO through ‘Vigimed’ an e-mail information exchange systems.
  5. 5. Definitions • Side effect : any unintended effect of pharmaceutical product occurring at doses normally used in humans that is related to the pharmacological properties of the drug. • Adverse event: any untoward medicinal occurrence that may present during treatment with a pharmaceutical product but that dose not necessarily have a causal relationship with the treatment. • Adverse reactions : a response to a drug that is noxious and unintended, and that occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.
  6. 6. Pharmacovigilance in India
  7. 7. For safety of those using herbal medicine, four complementary actions are required I. Clear identification of nature of adverse effect II. Management of the risks III. Institution of measures to prevent adverse effect IV. Good communication of the risks and benefits of herbal medicine
  8. 8. WHO Guidelines Objectives • Support member states in the context of WHO International Drug Monitoring Programme ,to strengthen national pharmacovigilance capacity in order to carry out effective safety of herbal medicine • Provide technical guidance on principals of good pharmacovigilance and the inclusion of herbal medicines in existing national drug safety monitoring systems, and where these systems are not in place, to facilitate the establishments of inclusive national drug safety monitoring systems. • Provide standard definitions of terms relating to pharmacovigilance , and safety monitoring of herbal medicines.
  9. 9. • Promote and strengthen internationally coordinated information exchange on pharmacovigilance, and safety monitoring of herbal medicines among Member States. • Promote the safe and proper use of herbal medicines. Aims of Pharmacovigilance  Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.  Improve public health and safety in relation to use of medicines.  Promote understandings, education and clinical training in pharmacovigilance and its effective communication to public.
  11. 11. CONTENT 1. Challenges in monitoring the safety of herbal medicines  Regulation, quality assurance and control Appropriate use 2. Safety monitoring of herbal medicines  Sources of reports
  12. 12. Challenges in monitoring the safety of herbal medicines • Regulation :-National regulation and registration of herbal medicines vary from country to country. Herbal medicine Prescription Non prescription medicines medicines
  13. 13. Quality assurance and control :- Quality assurance and control measures, such as  national quality specification  standards for herbal materials,  good manufacturing practices (GMP) for herbal medicines,  labeling, and licensing schemes for manufacturing,  imports and marketing, should be in place in every country
  14. 14. contd… • Weak regulation and quality control may result in a high incidence of adverse reactions attributable to poor quality of herbal medicines, in particular resulting from adulteration with undeclared potent substances and/or contamination with potentially hazardous substances and residues.
  15. 15. Appropriate use • Providers of herbal medicines :- A variety of health-care professionals serve as qualified providers of herbal medicines, according to each country’s national health-care delivery system and legislative framework.
  16. 16. In those countries where herbal medicines are classified as:- o Prescription medicines • prescribers and dispensers other than physicians, • dentists and pharmacists are sometimes excluded from • current reporting systems. • Prescription medicines
  17. 17. Contd… • In many countries, prescriptions are not required • herbal medicines since these are categorized as nonprescription • medicines or products suitable for self-care.
  18. 18. Action required • All providers of herbal medicines should play a role in monitoring the safety of non-prescription herbal medicines. • Nurses are becoming increasingly involved in this area and are making a valuable contribution to safety monitoring .
  19. 19. Lack of proper knowledge of herbal medicines • Providers of medicines, such as physicians, nurses and pharmacists, may have little training in and understanding of how herbal medicines affect the health of their patients, who are often also taking other medicines, prescription or non-prescription. • Health professionals who work in poisons centers and health information services also need to be informed about herbal medicines.
  20. 20. Patient/consumer attitudes to herbal medicines • a misconception that “natural” means “safe”. • Patients who use herbal medicines and other medicines together, as is often the case, will often not mention the use of herbal medicines to their physician. • Likewise, patients commonly fail to mention the use of other medicines to their providers of herbal medicines.
  21. 21. Safety monitoring of herbal medicines Source of Reports:- • The most common sources of information on adverse events and reactions to medicines are clinical trials and spontaneous reports • In many countries, providers of herbal medicines other than physicians, dentists, pharmacist, nurses are excluded from reporting system
  22. 22.  Reports from health-care professionals.  Reports from consumers.  Reports from other sources.
  23. 23. HERBAL PRODUCTS TARGETED FOR SAFETY MONTORING Herbal products in the following categories:- According to their regulatory status I. Herbal medicines in the prescription medicine category. II. Herbal medicines in the non prescription medicine category. III. Other herbal product intended for use in health care.
  24. 24. According to their registration/marketing status I. herbal medicines undergoing the new drug development process: in clinical trials prior to national drug regulatory approval II. herbal medicines undergoing the new drug development process: under post-marketing safety surveillance III. herbal medicines undergoing re-evaluation under the current protocol: in clinical trials
  25. 25. SPONTANEOUS REPORTING:- Its an unsolicited communication by health professionals or consumers, pharmaceutical company to NCC or other organisation (CDSCO, AMCs) that describes one or more suspected ADRs in a patient given a medicinal product that doesn’t drive from study or any organised data collection scheme. Presently PvPI is following spontaneous reporting system to collect data on drug safety.
  26. 26. Adverse drug reactions can be monitored through two ways:- a)Active surveillance system b)Passive surveillance system PASSIVE SURVEILLANCE:- Health professionals are encouraged to report adverse reactions which they believe are related to drug directly to- -Regulatory authority directly -The company marketing the suspected product
  27. 27. • ACTIVE SURVEILLANCE:- Requires a continuous pre-organised process. Ex: as in CEM (Coherent event monitoring), systems for intensified follow up of selected medicinal products. PSUR- Periodic safety update report. PVPI is under control of:- CDSCO Directorate general of health services. Indian Pharmacopoeia Commission (GZB). National Coordination Centre (NCC).
  29. 29. Separate forms are available to record adverse drug reactions associated with:- a)transfusion of blood b)blood and blood related products c)Adverse event following immunization(AEFI) ADR form consist of:- a)Patients information:- Patients initials, age, sex, weight. b)Suspected adverse drug reactions:- Date of reaction started, date of recovery, reaction description.
  30. 30. c)Suspected medication:- Dechallenge details, rechallenge details, concomitant drugs, relevancy tests, seriousness of the reaction, outcomes. In case complete information is not available then fill all the Essentially Required Items(ERI) for a quality ICSR. In case ERI not available make sure that form contain all the mandatory fields. MANDATORY FIELDS:- Patient initials age at onset of reaction date of onset of reaction
  31. 31. Suspected medication Reporter’s information ESSENTIALLY REQUIRED ITEMS:- Patient initials, gender, date of onset of reaction, suspected medication, dose, date of therapy started, indication of use, seriousness, outcomes, rechallenge and dechallenge details, reporter’s information and date of report. WHO CAN REPORT? Healthcare professionals and non healthcare professionals like consumers can report suspected adverse drug reaction. Pharmaceutical companies can also send ICSRs specific for their product to NCC.
  32. 32. WHY TO REPORT ? It is a moral responsibility as a healthcare professional to work in the interest of public health. The safety of more than 1.2billion is a concern and must be taken seriously. Use of multi-modal practices, poor patient compliancesare the other factors requires ADR reporting.
  34. 34. Content: • Spontaneous report • Establishment of AMC(Adverse Drug Monitoring Centre) • Data Flow • Assessment of Individual Case Safety Reports • Utilization of Data • Reporting Requirements in Special Population • (a) Pregnancy • (b) Breastfeeding • Pediatric and Geriatrics • Reporting in the event of a Public Health Emergency
  35. 35. Spontaneous Report A spontaneous Report is an unsolicited by healthcare professionals or consumers , pharmaceutical company to National Coordination Center or other organization( Control Drug Standard Central Organization ,Adverse Drug Monitoring Center )that describe one or more suspected ADR in a patient given a medicinal product that does not drive form study or any organized data collection scheme .
  36. 36. Establishment of an AMC ( Adverse Drug Monitoring Center ) • A letter of Intent is required to b submitted by the Heads of the Institutions to participate in this nationwide programmed to monitor drug safety . After examining the suitability , the concerned center may be inducted as AMC under PvPI(Pharmacovigilance Program in India ).
  37. 37. Data Flow • Once the medical institute is enrolled as an AMC , the AMC starts reporting ADRs to NCC.(National Coordination Centre ) • ICSRs uploaded in VigiFlow at AMC ICSRs uploaded in VigiFlow at AMC Received at NCC for Quality assessment Valid or complete ICSR Invalid or incomplete ICSR WHO-UMC Sweden Submit to CDSCO HQ Safety updates Revert to AMC
  38. 38. Assessment of individual case safety reports • The quality of the ICSR will be assessed for completeness of information and it will be reviewed for : 1. Quality of documentation 2. Coding 3. Relevance 4. Identification duplicate reports 5. Causality assessment
  39. 39. Utilization of the Data • Data collected in pharmacovigilance can b used in variety of ways : 1. Signal generation and strengthening 2. Risk management 3. Drug regulation 4. Education
  40. 40. Reporting Requirement in special population 1. Pregnancy : The clinical trial program of a medicinal product under development rarely includes pregnant women, unless the product is intended specifically for use during pregnancy. All pregnant women coming for routine pre –natal check-ups must be monitored by a healthcare professionals for medication use . 2. Breastfeeding: All lactating mother exposed to medicinal product should be monitored to collect information on outcome of lactation on neonates and infants .
  41. 41. Pediatric and Geriatrics • The collection of safety information in the pediatric and geriatric population is important as ADRs can lead to significant morbidity and death among these populations . • Immunization is one of the most common and widely used public health interventions in pediatric population. • On other hand geriatric population is at higher risk of developing ADRs due to factors like polypharmacy and co-morbidities. • The pediatric and geriatric population are more vulnerable to some adverse reactions. • Therefore, data collection from these program will provide a national database for drug safety information in these vulnerable populations . • To ensure safe and effective medicines for children and elderly ,efforts are needed at different levels (CDSCO, pharmaceutical industries , health care professionals , and parents ).
  42. 42. Reporting in the Event of a public Health Emergency • A public health emergency is a public health threat duly recognized either by the WHO or Ministry of Health and Family Welfare Government of India . In the event of a public health emergency , regular reporting requirements may be amended .
  44. 44. What is a Drug interaction? • A Drug interaction may be defined as a situation when a substance/condition(usually another drug, food, or any disease) alters the effect of the major drug that is taken. • The effects observed include:  Increase in the activity of drug(Addition/Synergism)  Decrease in the activity of drug(Antagonism)  Production of a new effect altogether which cannot be produced by its own (i.e. when taken alone) • Various types of drug interactions include:  BIO DRUG-FOOD INTERACTION  BIO DRUG-DISEASE INTERACTION
  45. 45. What is the cause?  Accidental misuse or due to lack of knowledge  Diet and lifestyle  Medication errors  Genetic factors
  46. 46. HERB-DRUG INTERACTIONS • The concurrent use of drugs/herbs may mimic/magnify or oppose the effect of drug. • Possible cases of herb-drug interactions include "bleeding when Warfarin is administered along with Gingkobiloba or Garlic". • Majority of the general population consume herbal drugs because: • They are considered safe for use • They are readily available • BUT some tests are the evidences that EVEN HERBAL DRUGS ARE NOT COMPLETELY SAFE such as: • Preclinical studies(using animal models) • Single case reports • Multiple case reports, etc. • This implies that like modern medicines the herbal drugs also requires vigilance for monitoring the interactions and adverse drug reactions.
  47. 47. • Herbs are often administered in combination with therapeutic drugs raising the potential of herb-drug interaction. • Some common Herb- Drug interactions include:
  48. 48. ALFA-ALFA (Medicago sativa) DRUG ALFA-ALFA 1. Warfarin (Anticoagulant) Effectiveness of Warfarin(contains large amount of Vitamin K) 2. Contraceptives (Birth control pills) Effectiveness of birth control pills 3. Prednisolone, Corticosteroids, Cyclosporine (Immunosuppressant's) Effectiveness of immunosuppressant's 4. Photosensitizing agents Increases sensitivity to light
  49. 49. ALOE (Aloe Vera) DRUG ALOE GEL 1. Digoxin (Cardio tonic) Increases the toxicity of digoxin 2. Anti-diabetic drugs Hypoglycemia CINNAMON (Cinnamomum zeylanicum) DRUG CINNAMON 1. Hepatotoxic drugs Increases toxicity 2. Antidiabetic drugs Decreases blood sugar level
  50. 50. GARLIC (Allium sativum) DRUG GARLIC 1. Isoniazid Reduces absorption of isoniazid 2. Antiviral Drugs Increases metabolism of antiviral drugs 3. Oral Contraceptives Increases breakdown of estrogen, dereases effect of oral contraceptives GREEN TEA (Camellia sinensis) DRUG GREEN TEA 1. Stimulant drugs (Cocaine, Amphetamine, Ephedrine) Increases heart rate Increases blood pressure 2. Oral Contraceptives Increases side effects of oral contraceptives 3. Hepatotoxic Drugs Increases risk of liver damage 4. Anticoagulants Synergistic effect (slows down
  51. 51. LIQUORICE (Glycyrrhiza glabra) DRUG LIQUORICE 1. Estrogen Decreases hormone levels 2. Antihypertensives Decreases effectiveness EPHEDRA (Ephedra gerardiana & Ephedra nebrodensis)DRUG EPHEDRA 1. Stimulant drugs (Ephenephrine, Pseudoephedrine) Synergistic effect (can precipitate toxicity) 2. Antidiabetics (Glimepride, Glipizide) Elevates blood sugar level thereby decreasing the efficacy of antidiabetics) 3. Anticonvulsants (Phenobarbitone, Phenytoin) Effects brain chemicals thereby decreasing the effectiveness of anticonvulsants)
  52. 52. ST. JOHN'S WORT (Hypericum perforatum) DRUG ST. JOHN'S WORT 1. Cyclosporin (Immunosuppresant) Decreases effectiveness 2. Digoxin (Cardiotonic) Induction of intestinal efflux transporter P-glycoprotein (P-gp) 3. Saquinavir, Indonavir (Antiviral) Induction of Cyt P3A4 4. Oral Contraceptives Induction of Cyt P3A4 ARTIMISRIN (Arimisia annua) DRUG ARTIMISRIN Omeprazole Decreases bioavailability
  53. 53. CONCLUSION• Not all herbs and supplements are safe. • Like conventional medicines, dietary supplements may cause side effects, trigger allergic reactions or interact with prescription and non- prescription medicines or other supplements. • Using supplements with medications could lead to harmful or even life threatening consequences. • One should consult a doctor or a pharmacist to know about the safety of a supplement or herb. • Other than vitamins and minerals, the long term effects of most dietary supplements are not known.
  54. 54. DRUG-FOOD Interaction
  55. 55. TERMINOLOGIES • DRUG INTERACTION: A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. • DRUG-NUTRIENT INTERACTION: A drug-nutrient interaction occurs when a drug affects the use of a nutrient in the body. • DRUG-FOOD INTERACTION: A food-drug interaction occurs when a food, or one of its components, interferes with the way a drug is used in the body. • BIOAVAILABILITY: It is defined as the degree to which a drug reaches the circulation and becomes available to the target organ or tissue. • ADVERSE EFFECT: Any unwanted or undesirable effect of a drug.
  56. 56. DRUG-FOOD INTERACTION • Medicines can treat and cure many health Problems. However they must be taken properly to ensure that they are safe and effective. • Many medicines have powerful ingredients that interact with the human body in different ways. Diet and lifestyle can sometimes have significant impact on drugs. • A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. • Drug interactions can alter the pharmacokinetics or pharmacodynamics of a drug. • These interactions may occur out of accidental misuse or due to lack of knowledge.
  57. 57. n• Majority of food-drug interactions are caused by food induced changes in the bioavailability of drug. • Food can alter the pharmacokinetics of drugs i.e. 1. Absorption 2. Distribution 3. Metabolism 4. Excretion • Therapeutically important critical interactions are those that: 1. Alter the therapeutic response to the medication. 2. Cause severe drug toxicity. 3. Alter nutritional status.
  58. 58. food/nutrition effects on drugs: grapefruit juice • Grape fruit juice inhibits metabolism of many drugs: it inactivates metabolizing intestinal enzymes resulting in enhanced activity and possible toxicity. • Its effect persists for 72 hours making it problematic to separate the drug and grapefruit juice.
  59. 59. Food/nutrient effects on drug: maois • Monoamine oxidase inhibitor(MAOI) interacts with food( tyramine, dopamine, histamine) • These are deaminated rapidly by MAO; MAOIs prevent breakdown of tyramine and others. • Significant intake of high tyramine foods like cheese, cured meats etc on MAOIs can precipitate hypertensive crisis.
  60. 60. Food/nutrient effects on drug: caffeine • Increases adverse effects of stimulant such as theophylline, amphetamine causing nervousness, tremors and insomnia. FOOD/NUTRIENT EFFECTS ON DRUG: WARFARIN • Warfarin (anticoagulant) when taken with vegetables containing vitamin k interferes with the effectiveness and safety of warfarin therapy, with cooked onions increase warfarin activity.
  61. 61. food/nutrient effects on drug: alcohol • In combination with some drugs produce additive toxicity. • With NSAIDS it can increase risk of liver damage or stomach bleeding.
  62. 62. Drug side effects that affect food status EFFECTS DRUGS • Appetite changes 1. Decrease appetite cardiovascular drugs 2. Increase appetite anti convulsants o Oral taste and smell captoprill (anti hypertensive) , phenytoin(anti convulsant) o Dry mouth amytriptyline( anti depressants) o Glucose level 1. Decrease glucose level metformin,glimepiride( anti diabetic drugs) 2. Increase glucose level furosemide hydrochlorothiazide( diuretics) o G.I. effect aspirin, NSAIDS
  63. 63. REFERENCES • www.sciencedirect.com • Pharmacognosy- G.E. Trease and W.C. Evans. Saunders Edinburgh, New York • Slideshare.net • In.images.search.yahoo.com • www.wikipedia.org • Pharmacognosy & Phytochemistry by Biren Shah. • WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems