Transcript Newsletters, ADR, MEDWATCH

Adverse Drug Reactions
Medication Errors
Oregon Poison Control Center
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
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.
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
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.
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.
Examples of ADR’s in History
• Mercury
– Acrodynia with death in 5% - 1948
• Thalidomide
– phocomelia- congenital absence of limbs1961
• Flecainide
– CAST trial- more died from Flecainide than
from placebo 1985
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
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)
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
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.
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.
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.
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.
Indicator drugs of an ADR event
• Antidiarrheals
•
•
•
•
•
•
Atropine
Dextrose (IV push),
Diphenhydramine
Epinephrine
Flumazenil
Kayexalate
Potassium
Protamine
Steroids (topical)
Vitamin K
Narcan
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
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)
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
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.
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.
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.
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,
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
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
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
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)
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.
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
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.
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
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!
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
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
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
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.
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
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
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
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
OPC working with Health
Professionals
•
•
•
•
Poison information
Drug identification
Plant/substance identification
Treatment information
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.
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
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