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Adverse drug reactions

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detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments

Publicado en: Salud y medicina
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Adverse drug reactions

  1. 1.  Definition  Types of ADRs  Detection of ADRs  Severity Assessment  Seriousness and Predictability Assessment  Reporting of ADRs  Reference
  2. 2.  According to WHO Adverse drug reaction is defined as ”A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.” Excludes overdose(either accidental or intentional), drug abuse, treatment failure and drug administration errors.  Adverse event is defined as ” Any medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related ”
  3. 3. 1. Pre- marketing studies 2. Post- marketing surveillance 3. Assessing Causality 4. Communicating ADRs 5. Postal Survey Method
  4. 4.  During the development of new medicines, their safety is tested in animal models.  Specific animal studies for carcinogenicity, teratogenicity and mutagenicity are also available.  Clinical trials are carried out in 3 different phases prior to the submission of a marketing authorization application.  Clinical trials normally identifies ADRsof frequency greater that 0.5-1.0%.
  5. 5.  Pharmavigilance methodologies are used for detection of risk and for the collection of risk information.  Powerful and cost effective system for the identification of unknown drug-related risk is spontaneous adverse drug reactions reporting.  Health care practitioner should see it as a part of professional duty report ADR result in a patient under his care.  Concerned identifying product defect, intoxicants and abuse and unexpected lack of therapeutic effect.
  6. 6.  Two epidemiological methods are most commonly used are : 1. Cohort studies 2. Case-Control studies 1. Cohort studies: Patient exposed to a particular drug are followed up actively and systematically and ADR frequencies are compared to an unexposed control population. Cont.. 2. Case-Control studies  Individuals affected by the adverse event being studied are identified . Each case is matched with several disease – free control patients randomly recruited from the study base.  Both cases and controls are investigated their exposure to possible causative agents prior to occurrence of the event.  The odd ratio calculated on the basis of exposure data.
  7. 7.  Causality assessment is a method by which the extent of relationship between a drug and a suspected reaction is established.  If an ADR is suspected, the assessment starts with the collection of all the relevant data pertaining to patients demographics; medications including OTCs; time of onset and duration of reaction; treatment of reaction and it's outcome and reports.  In assessing causality, any of the following approaches may be appropriate: - opinion of individual experts - opinion of penal of experts - formal algorithms
  8. 8. Using formal algorithms, collected data are subjected and assessed by using one or more standard algorithms. Formal Algorithms Cont..  Naranjo’s algorithm  Kartch Lasagna’s algorithm  WHO probability Scale  Spanish quantitative imputation scale  Kramer’s scale  Jones scale  European ABO system  Bayesian System
  9. 9. WHO Probability Scale
  10. 10.  Knowledge about rational and safe use of medicines needs to be provided, 1. During basic training of health professionals 2. Through continuous education programmes to health professionals. 3. By specially designated drug information centers. 4. Through packaged inserts and patient counseling
  11. 11.  This consists of a specific drug related questionnaire.  This method is primarily used for ADR monitoring of new drugs. 1-2 years after the drug is launched.  The questionnaire asks for details of drug, usage, dose, brand used, number of patients treated in a given period.  Common ADRs seen with the drug as mentioned in the literature are listed at the end of questionnaire.  The questionnaire along with a prepaid envelope is then mailed to practitioners all over the city/state who are likely to use the drug.
  12. 12.  Severity describes the extent to which the ADRs influence the everyday life of a patients.  Karch and Lasagna classify severity into minor, moderate, severe and lethal. 1. Mild(Minor) 2. Moderate 3. Severe 4. lethal
  13. 13. Severity Description Example Mild No antidote or treatment is required; hospitalization is not prolonged Some Antihistamines(some) Drowsiness Opioids; constipation Moderate A change in the treatment (e.g. modified dosage, addition of a drug), but no necessarily discontinuation if drug is required; hospitalization may be prolonged, or specific treatment may be required Hormonal contraceptives: Venous thrombosis NSAIDs: Hypertension and edema Severe ADR may be life threatening and requires immediate discontinuation of drug and specific treatment for ADR ACE inhibitors: Angioedema Phenothiazines: Abnormal heart rhythm Lethal Contributes to patient’s death Acetaminophen over dosage: Liver failure Anticoagulants: hemorrhage
  14. 14.  Hartwig et al categorized ADRs into seven levels as per their severity.  Level 1 & 2 fall under mild category, level 3 & 4 under moderate and level 5, 6 & 7 fall under severe category.
  15. 15. Mild = Levels 1 and 2; moderate = Levels 3 and 4; severe = Levels 5, 6 and 7. Level 1 An ADR occurred but required no change in treatment with the suspected drug Level 2 The ADR required that treatment with the suspected drug be held, discontinued, or otherwise changed. No antidote or other treatment requirement was required. No increase in length of stay (LOS) Level 3 The ADR required that treatment with the suspected drug be held, discontinued, or otherwise changed. AND/OR An Antidote or other treatment was required. No increase in LOS Level 4 Any Level 3 ADR which increases length of stay by at least 1 day. OR The ADR was the reason for the admission Level 5 Any Level 4 ADR which requires intensive medical care Level 6 The adverse reaction caused permanent harm to the patient Level 7 The adverse reaction either directly or indirectly led to the death of the patient
  16. 16.  Seriousness of an ADR is related to its life threatening nature and is defined as any untoward reaction to the medicinal product that may result in death and requires patient hospitalization.  Seriousness of reaction is categorized according to FDA criteria on the basis of their life threatening nature.  Death  Life-threatening  Hospitalization (initial or prolonged)  Disability or Permanent Damage  Congenital Anomaly/Birth Defect  Required Intervention to Prevent Permanent Impairment or Damage (Devices)
  17. 17.  According to WHO factsheet, it is estimated that at least 60% of ADRs are preventable. In some countries ADR-related costs, such as hospitalization, surgery and lost productivity, exceed the cost of the medications.  Historically, studies have shown that between 20% and 80% of ADEs and ADRs are preventable with the majority of latter studies showing around 60- 70% preventability.  Preventability of ADRs is assessed by using Schumock and Thornton scale.
  18. 18. Definitely Preventable 1. Was there a history of allergy or previous reactions to the drug? 2. Was the drug involved inappropriate for the patient’s clinical condition? 3. Was the dose, route or frequency of administration inappropriate for the patient’s age, weight or disease state? 4. Was a toxic serum drug concentration (or laboratory monitoring test) documented? 5. Was there a known treatment for the Adverse Drug Reaction? Probably Preventable 6. Was required Therapeutic drug monitoring or other necessary laboratory tests not performed? 7. Was a drug interaction involved in the ADR? 8. Was poor compliance involved in the ADR? 9. Were preventative measures not prescribed or administered to the patient? Not preventable If all above criteria not fulfilled
  19. 19.  Type A(Predictable)  Extension of pharmacologic effect  Often predictable and dose dependent  Responsible foe at least 30% od ADRS  E.g. anticholinergics and dry mouth  Type B(unpredictable)  Idiosyncratic or immunologic reactions  Rare and unpredictable  E.g. chloramphenicol and aplastic anemia, penicillin induced anaphylactic shock
  20. 20.  WHAT TO REPORT All types of suspected ADRs- irrespective of whether they are known or unknown, serious or non-serious, frequent or rare and regardless of a established causal relationship.  WHO SHOULD REPORT All health care and non-health care professionals, hospitals, health centres, consumers, Pharmaceutical companies.
  21. 21.  HOW AND WHOM TO REPORT Use the “Adverse drug reaction reporting form” which is available on official site of IPC as well as CDSCO. Helpline Number : 1800-180-3024 E-mail : pvpi.ipcindia@gmail.com
  22. 22. 1. Parthasarathy G, Hansen k Nyfort, Nahata CM; A textbook of Clinical Pharmacy Practice; pp 89-97 2. Schumock GT and Thornton JP. Focusing on the Preventability of Adverse Drug Reactions. Hosp. Pharm. 1992;27:538. 3. Uppsala Monitoring Centre. Hospital based pharmacovigilance: a clinical pharmacist’s perspective. Uppsala reports. 2002;20:10–11. 4. G Petrova, A Stoimenova, M Dimitrova. Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy. SAGE Open Medicine; Volume 5: 1–8 5. Gogtay NJ, Mangalvedhekar SS, Kshirsagar NA; Adverse Drug Reaction (ADR) Monitoring in India and the Postal Survey as a Useful Tool for ADR Detection; Pharmacoepidemiology and drug safety 2000; 8:235-236

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