Adverse Drug reaction
Adverse Drug reaction
Adverse drug reactions (ADRs) are types of adverse drug events (ADEs) (1). ADEs include ADRs, medication errors, and other drug-related problems. ADEs are the negative conscqucnces of drug misadventures. Henri Manasse defined drug misadventure as the iatrogenic hazard that is an inherent risk when drug therapy is indicated. This chapter will focus on ADRs.
Definitions
The World Health Organization’s (WHO) and Karch and Lasagna’s definitions of an ADR are quite similar. An ADR is any response to a drug that is noxious and unintended, and occurs at doses used for prophylaxis, diagnosis, or therapy, excluding failure to accomplish the intended purpose
(2). The Food and Drug Administration (FDA) focuses on ADRs that have unexpected rcactions and/or those of more signilkant morbidity. These ADRs would include those where the patient outcome is death, life-threatening, hospitalization, disability, congenital anomaly, or required intcrvention to prevent permanent impairment or damage
(3). The Joint Commission on Accreditation of Hcalthcare Organizations (JCAHO) is conccrned with the reporting of significant ADRs. Thosc that result in morbidity, require additional treatment, require an incrcased lcngth 01 stay, temporarily or pcrmanently cause disability, or cause death must be reported to the FDA
(4). The American Society of Health- System Pharmacists (ASHP) defines significant ADRs as any unexpected, unintended, undesired, or excessive response to a drug that includes thc following:
Requires discontinuing the drug
Requires changing the drug therapy
Requires modifying the dose
Necessitates admission to thc hospital
Prolongs stay in a health care facility
Necessitates supportive treatment
Significantly complicatcs diagnosis
Adverse drug reactions (ADRs) are types of adverse drug events (ADEs) (1). ADEs include ADRs, medication errors, and other drug-related problems. ADEs are the negative conscqucnces of drug misadventures. Henri Manasse defined drug misadventure as the iatrogenic hazard that is an inherent risk when drug therapy is indicated. This chapter will focus on ADRs.
Definitions
The World Health Organization’s (WHO) and Karch and Lasagna’s definitions of an ADR are quite similar. An ADR is any response to a drug that is noxious and unintended, and occurs at doses used for prophylaxis, diagnosis, or therapy, excluding failure to accomplish the intended purpose
(2). The Food and Drug Administration (FDA) focuses on ADRs that have unexpected rcactions and/or those of more signilkant morbidity. These ADRs would include those where the patient outcome is death, life-threatening, hospitalization, disability, congenital anomaly, or required intcrvention to prevent permanent impairment or damage
(3). The Joint Commission on Accreditation of Hcalthcare Organizations (JCAHO) is conccrned with the reporting of significant ADRs. Thosc that result in morbidity, require additional treatment, require an incrcased lcngth 01 stay, temporarily or pcrmanently cause disability, or cause death must be reported to the FDA
(4). The American Society of Health- System Pharmacists (ASHP) defines significant ADRs as any unexpected, unintended, undesired, or excessive response to a drug that includes thc following:
Requires discontinuing the drug
Requires changing the drug therapy
Requires modifying the dose
Necessitates admission to thc hospital
Prolongs stay in a health care facility
Necessitates supportive treatment
Significantly complicatcs diagnosis
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