ADR Flashcards
What is an ADE?
Adverse Drug Event
Injury resulting from medical intervention related to a drug, which can be attributable to preventable and non-preventable cases.
Can occur even if the correct medication was prescribed and administered.
Can be categorized as preventable, nonpreventable, or if they have not actually occurred, POTENTIAL. Institute of medicine
What is ME?
NCCMERP(national courting counsel for medicine error reporting and prevention) defines it as PREVENTABLE, involves any mistake in the medication process, regardless of patient outcome. Not all lead to serious consequences.
What is ADR?
WHO(world health organization) says it is any noxious, unintended, and undesired effect of a drug that occurs at doses used in humans for prophylaxis, diagnosis, or therapy; and it implies a casual relationship between use of the drug and the noxious event.
What is a medication misadventure?
Unexpected and undesirable to patient. An inherent risk when medication therapy is indicated. Whose outcome may or may not be independent of the preexisting pathology or disease process. May be attributable to error, immunologic response, or idiosyncratic response.
Adverse drug event reporting is important in what part of the drug approval process?
Post-marketing
What are the limitations to premarketing clinical trials?
Short duration - drugs with long latency period effects cannot be detected. Small sample size Narrowly defined populations Narrow set of indications limited comparison groups
To improve the representativeness of populations included in clinical trials, the FDA has:
Issued guidelines on the inclusion of geriatric patients in phase II and phase III studies.
Issued guidelines and incentives to encourage manufacturers to provide efficacy, safety, pharmacokinetic, and pharmacodynamics information in support of the use of drugs and biologic products in pediatric and geriatric populations.
What does the FDA’s Post Marketing Surveillance (PMS) program do?
Monitors approved drug use
Monitors the serious ADRs associated with the use of approved drugs.
Initiation of epidemiologic studies to estimate the risk or test specific hypotheses.
What is one of the primary uses of drug PMS?
Modification of the drug product labeling or package insert.
The FDA used to communicate to the public and healthcare providers about medication safety using?
Early Communication for an Ongoing Safety Review
Public Health Advisories
Letters to Healthcare Professionals
Information for Healthcare Professionals.
Now the FDA uses what to communicate to the public and healthcare providers about medication safety?
Drug Safety Communications on the FDA website
What drugs are listed on the drug safety communications as of Oct 19 and 20?
09/22 - dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam)
09/21 - safety of tramadol in children aged 17 and younger.
09/15 - Neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines
FDA’s Center for Drug Evaluation and Research (CDER
s) Division of pharmacovigilance and epidemiology monitors safety of marketed drugs by requiring:
Drug manufacturers to notify FDA of all adverse events they are aware of.
Clinicians are to report ADEs to the manufacturer and to MedWatch system at the FDA.
What are the types of ADE’s?
Medication errors (preventable) Therapeutic failures Adverse drug withdrawal events Overdoses Adverse drug reactions
What is a medication error?
Any preventable event that may cause or lead to inappropriate medication use or patient harm regardless of outcome. All MEs are preventable and not all lead to serious consequences.
Where do clinicians report medication errors to?
Institute for Safe Medication Practices MERP (medication errors reporting program)
What is a therapeutic failure?
Suboptimal amounts of a medication are given to a patient and the patient’s condition fails to stabilize or symptoms become even worse as a result. Usually seen in medication nonadherence. Ex: Clopidogrel needs to be bioactivated by CYP2C19
What is a drug overdose?
Doses that are not normally used to treat disease. Accidental overdoses occur most commonly in pediatric and geriatric populations.
What is an adverse drug reaction?
Any noxious, unintended, and undesired effect of a drug that occurs at doses used in humans for prophylaxis, diagnosis, or therapy; and it implies a causal relationship between use of the drug and the noxious event.
