Adverse Drug Reactions Medication Errors

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Adverse Drug ReactionsMedication Errors

• Oregon Poison Control Center

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Adverse Drug Reactions

• ADRs account for 10-20 of all hospital
  admissions.
• 45 of all admissions in those gt70 y.o.
• 106,000 Americans die needlessly from ADR or med
  error each year.
• 4th to 6th leading cause of death each year

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What is an ADR?

• Definition Any undesirable or unexpected event
  that requires some change in the clinicians 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.

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Types of ADRs

• 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

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Types of ADRs cont..

• Type B, Unpredictable occur when there is an
  effect from medication that is unrelated to the
  drugs known pharmacologic action.
• Includes idiosyncratic, immunologic, allergic,
  carcinogenic, and teratogenic reactions.

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Types of ADRs 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 NSAIDs.
• Type D Delayed adverse drug effects,
  carcinogenicity, teratogenicity
• Example teratogenic effects of chemotherapeutic
  agents.

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Examples of ADRs 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

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Examples of ADRs 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

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More history of ADRs...

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

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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

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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.

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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.

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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.

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Mechanism of ADRs 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.

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Indicator drugs of an ADR event

• Antidiarrheals Potassium
• Atropine Protamine
• Dextrose (IV push), Steroids (topical)
• Diphenhydramine Vitamin K
• Epinephrine Narcan
• Flumazenil
• Kayexalate

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Reporting ADRs

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

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What is MedWatch?

• Voluntary reporting system for health care
  professionals.
• Pharmacists report most ADRs.
• Can send ADR reports via mail, phone, fax and
  computer, using MedWatch reporting Form
• JCAHO requires hospitals to have ADR reporting
  program via PT and Rx dept.(part of CQI)

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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

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Adverse Events to be Reported

• Death if the patients 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
  patients death.

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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 patients
  body function/structure, physical activities or
  quality of life.

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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.

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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.

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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

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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

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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

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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)

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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 youre not experienced)
• Lack of patient counseling- should be last safety
  check for drug/indication/dose etc.

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Reporting of ADR and Errors

• ADR
• MedWatch- developed by FDA
• monitors ADRs 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

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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.

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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

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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!

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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

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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

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OHSU Drug Information Service

• Respond to provider requests
• Support PT Committee at OHSU
• Formulary Management
• ADR reporting
• Education resource
• Residents, clerkship students, interns
• Pharmacist, nurse, physician in-services

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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 Oregons center (OPC) serve?
• Oregon, northern Nevada, Alaskan terr.

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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

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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

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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

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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

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OPC working with Health Professionals

• Poison information
• Drug identification
• Plant/substance identification
• Treatment information

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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.

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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

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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
• Dont put poison in empty food containers
• Clean up after working in garden,garage
• Dispose of cleaners, old, expired meds
• Call PCC or 911have container with you