Adverse Drug Reactions Medication Errors

1. Adverse Drug ReactionsMedication Errors Oregon Poison Control Center

2. Adverse Drug Reactions • ADR’s account for 10-20% of all hospital admissions. • 45% of all admissions in those >70 y.o. • 106,000 Americans die needlessly from ADR or med error each year. • 4th to 6th leading cause of death each year

3. What is an ADR? • Definition: Any undesirable or unexpected event that requires some change in the clinician’s care of the patient, including discontinuing the medication, modifying the dose, prolonging hospitalization, or initiating supportive care. • It does not include withdrawal, abuse, overdose or error in administration.

4. Types of ADR’s • Type A or Predictable: when normal effects of drugs are exaggerated to the point of being undesirable. • They are dose dependent and related to the expected pharmacologic action of the drug. • Most common types of reactions. • Example: nausea from pain medication

5. Types of ADR’s cont.. • Type B, Unpredictable: occur when there is an effect from medication that is unrelated to the drug’s known pharmacologic action. • Includes idiosyncratic, immunologic, allergic, carcinogenic, and teratogenic reactions.

6. Types of ADR’s cont... • Type C: Associated with the long term use of a drug, chronic exposure, or total dose exposure. • Example: chronic renal failure from long term use of NSAID’s. • Type D: Delayed adverse drug effects, carcinogenicity, teratogenicity • Example: teratogenic effects of chemotherapeutic agents.

7. Examples of ADR’s in History • Mercury • Acrodynia with death in 5% - 1948 • Thalidomide • phocomelia- congenital absence of limbs-1961 • Flecainide • CAST trial- more died from Flecainide than from placebo 1985

8. Examples of ADR’s in History…. • Cacium Channel blockers • short acting increases risk of MI? 1995 • Terfenadine • torsade de pointes from interactions 1992 • Fenfluramine and Dexfenfluramine (Redux) • valvular heart disease in 1997

9. More history of ADR’s... • Nonsteroidal Anti-inflammatories (NSAIDS) • 70,000 hospitalizations and 7,000 deaths/yr from GI bleeding or acute renal failure. • Troglitazone • hepatotoxicity (2000)

10. Adverse Drug Reactions Levels. • Minor: no antidote, no therapy or prolongation of hospitalization required • Moderate: requires a change in drug therapy, specific treatment or an increase in hospitalization by at least one day. • Severe: potentially life threatening, causing permanent damage, or requiring intensive medical care • Lethal: directly or indirectly contributes to the death of the patient

11. Mechanism of Adverse Drug Reactions • Idiosyncrasy: an uncharacteristic response of a patient to a drug, usually not occurring on administration. • Hypersensitivity (allergic reaction): a reaction, not explained by the pharmacological effects of the drug, caused by altered reactivity to the patient and generally considered to be an allergic manifestation from an immunologic drug.

12. Mechanisms of ADR cont.. • Intolerance: a characteristic pharmacological effect of a drug produced by an unusually small dose, so that the usual dose tends to induce a massive overreaction. • Idiopathic: pertaining to conditions without clear pathogenesis, or disease without recognizable cause.

13. Mechanisms of ADR cont.. • Pharmacologic: a known, inherent pharmacologic effect of a drug, directly related to the dose given. • Side Effect definition: a well known reaction that occurs with predictable frequency. Usually mild in nature, resulting in little or no change in patient management.

14. Mechanism of ADR’s cont... • Toxic reaction: dose-related and predictable reaction de to greater than recommended drug dosage or drug concentration in the body. Some toxic reactions are due to intentional overdose.

15. Indicator drugs of an ADR event • Antidiarrheals Potassium • Atropine Protamine • Dextrose (IV push), Steroids (topical) • Diphenhydramine Vitamin K • Epinephrine Narcan • Flumazenil • Kayexalate

16. Reporting ADR’s • Kefauver-Harris Amendment required FDA to have a spontaneous reporting system for ADR’s. • FDA developed MedWatch program in 1993. • Drug companies are required by FDA to submit quarterly reports of all ADR’s for first 3 years that a drug is on the market

17. What is MedWatch? • Voluntary reporting system for health care professionals. • Pharmacists report most ADR’s. • Can send ADR reports via mail, phone, fax and computer, using MedWatch reporting Form • JCAHO requires hospitals to have ADR reporting program via P&T and Rx dept.(part of CQI)

18. Goals of MEDWATCH • To increase awareness of drug and device-induced disease. • To clarify what should and should not be reported to the agency. • To make it easier to report by operating a single system for health professionals to report adverse events and product problems • To provide regular feedback to health care community about safety issues of medical products

19. Adverse Events to be Reported • Death: if the patient’s death is suspected as being a direct outcome of the adverse event. • Life-threatening: if the patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patient’s death.

20. Adverse Events to be Reported • Hospitalization (initial or prolonged): if admission to the hospital or prolongation of a hospital stay results from the adverse event. • Disability: if the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities or quality of life.

21. Adverse Events to be Reported • Congenital anomaly: If there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child. • Prevention of permanent damage: If the adverse event requires intervention to prevent permanent impairment or damage.

22. Medication Errors • Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging and nomenclature; compounding, dispensing, distribution, administration, education, monitoring; and use.

23. The 5 Drug “Rights” • Each medication dose dispensed must comply with these five rights to be free of error: • Right patient • Right drug • Right dose • Right route • Right time

24. Types of Errors • Prescribing errors Compliance error • Omission errors Monitoring error • Wrong time errors Deteriorated drug error • Unauthorized drug error • Improper dose error • Wrong dosage form error • Wrong drug preparation error • Wrong administration technique

25. Drugs Causing the Most Errors • Hospitals • Intravenous drugs (70% of med errors) • Pharmacist malpractice cases • warfarin, corticosteroids, hypoglycemic agents, digoxin, amoxicillin and phenytoin. • Physician malpractice cases • antibiotics, corticosteroids, narcotics, cardiovascular agents

26. Causes of Errors • Performance Error • Excessive task demand (workload) • personal characteristics (fatigue, stress level) • Extra-organizational factors (sound a like drugs • Work environment (distractions, noise) • Intra-organizational (high output demand)

27. Causes of Errors cont.. • Lack of communication (not clarifying order) • Dispensing errors (not double/triple checking drugs, label, Rx, etc) • Lack of knowledge (covering in specialized area where you’re not experienced) • Lack of patient counseling- should be last safety check for drug/indication/dose etc.

28. Reporting of ADR and Errors • ADR • MedWatch- developed by FDA • monitors ADR’s for quality, performance, and safety of medical products. ERRORS • USP-ISMP Medication Errors Reporting Program (MERP). • Errors can be reported anonymously 24hr/day • Errors are reviewed by USP and forwarded to the manufacturer and the FDA • MedMARx:developed by USP, fee for use system • compare error rates between organizations • perform root cause analysis as required by JCAHO

29. USP- United States Pharmacopeia • Independent, science-based, non-profit, public health organization for 185 yrs. • Official public standards-setting authority for all prescription and OTC medicines, dietary supplements and healthcare products in the United States.

30. USP-ISMP • Non-Profit agency founded in 1994 • Not a governmental agency, does not set policies, laws, or accreditation • Work collaboratively with governmental, regulatory, inspecting and accrediting agencies to influence medication safety • Funded by charitable donations, unrestricted grants, subscriptions, fees from consulting and educational services

31. ISMP at Work • Children's Tylenol recall • From the June 2005 issue • In late March, we received a report from a pharmacist regarding potentially confusing labeling and packaging of Children's TYLENOL MELTAWAYS (acetaminophen) that could lead to accidental overdoses. We investigated the problem and alerted our subscribers about our findings in the April 2005 issue of this newsletter. The product, for kids aged 2 to 6, comes in blister packs that contain either one or two 80 mg tablets, but the front of the carton indicates "medicine per dose 80 mg," and all of the blister packs are labeled "Children's Tylenol 80 mg." With the two tablet blisters, parents or healthcare practitioners may assume that BOTH tablets should be given to provide the 80 mg, resulting in a dangerous double dose that, if repeated over time, could even cause liver damage. • ISMP promptly followed up with both the FDA and Johnson & Johnson's McNeil Consumer & Specialty Pharmaceuticals division to suggest a recall and urge that future labeling and packaging clearly indicate the exact milligram amount enclosed in each blister. On Friday, June 3, McNeil announced the recall of several Tylenol products for children. Your reports really do make a difference!

32. USP-MEDMARX • Internet-based medication error and ADR reporting program, designed for use in hospitals and health systems. • Works with JCAHO • Fee based service • Gives trends, statistics, etc for health care institutions in the US for your institution to compare with

33. Oregon Poison Control Center and Drug Information Center • 24 hr health care information center at OHSU serving Oregon with DI and Poison info. • Goals: • Public education • Medical treatment information • Professional education to health care providers

34. OHSU Drug Information Service • Respond to provider requests • Support P&T Committee at OHSU • Formulary Management • ADR reporting • Education resource • Residents, clerkship students, interns • Pharmacist, nurse, physician in-services

35. Oregon Poison Control Center • Where is it? • OHSU, Portland • How do I get ahold of them? • National toll free number: 1(800)222-1222 • What states does Oregon’s center (OPC) serve? • Oregon, northern Nevada, Alaskan terr.

36. Establishment of OPC • OPC established by act of Oregon State Legislature in 1978 to provide emergency treatment information for patients experiencing a poisoning or toxic exposure. • Provides public education and professional education to health care providers

37. OPC staff • Nurses, and pharmacists, Medical toxicologists serve as backup/resource. • 70,000 calls a year (191 calls/day) • Resources: computer databases, textbooks, journal articles • Provide follow-up with patients for 3-7 days after initial contact

38. Who calls the OPC? • 60%: parents of young children— • Primary patients receiving assistance are children less than 6 yrs old • Most calls originate from the public • Medications are most frequent substance of exposure • Household products are 2nd most frequent

39. OPC- Pharmaceuticals • Pain relievers represent largest substance exposure • OTC pain relievers represent greatest number of poisoning incidents and greatest number of hospital visits. • Most fatalities occur in adults- • Suicide and drug abuse leading causes of DEATH

40. OPC working with Health Professionals • Poison information • Drug identification • Plant/substance identification • Treatment information

41. OPC cuts death rate from poisoning • 4 million poisonings each year in US • With legislation for poison control centers, drug information centers, child proof containers, death rates from poisonings have decreased 10 fold since 1965.

42. Examples of common poisons • MEDICINES: • Pain or fever relievers • Iron tablets • Vitamins with iron • Cough and cold preparations • CLEANERS • Toilet cleaners, drain openers • Laundry detergent and bleach • Kerosene, gasoline and lamp oils • Antifreeze and windshield washer fluids

43. Tips to prevent poisonings • Buy products with child resistant caps • Always tightly close caps after use • Keep meds and cleaners out of sight • Use child resistant latches on cabinets • Don’t put poison in empty food containers • Clean up after working in garden,garage • Dispose of cleaners, old, expired meds • Call PCC or 911—have container with you