PART IIIC: [CPS] REPORTING & EVALUATING ADRs

Adverse Drug Reactions (ADR)

noxious, unintended reaction to drug in doses used in prophylaxis, diagnosis, and treatment

A - Augmented

[ADR] based on pharmacologic activity, dose dependent and predictable

B - Bizzare

[ADR] abnormal reactions unpredictable, non-dose dependent

C - continuous

[ADR] dependence, tolerance, addiction

D - delayed

[ADR] carcinogenicity; teratogenicity

E - End of Use

[ADR] tapering dose with steroids

F - Failure of therapy

[ADR] resistance

Analysis

[Guidelines on ADR] ____________ of each reported ADR.

drugs and patients at high risk

[Guidelines on ADR] Identification of ___________ and ____________ for being involved in ADRs.

policies and procedures

[Guidelines on ADR] The development of ____________ and _____________ for the ADR monitoring program.

pharmacists, physicians, nurses, risk managers, and other health professionals

[Guidelines on ADR] A description of the responsibilities and interactions of ________, ________, ________, ________, and _________ in the ADR program.

educational purposes

[Guidelines on ADR] Use of the ADR program for ______________

Development, maintenance, and evaluation

[Guidelines on ADR] ___________, ___________, and ___________ of ADR records within the organization

organizational dissemination and use of information

[Guidelines on ADR] The ______________ and _____________ obtained through the ADR program

reporting

[Guidelines on ADR] ______________ of serious ADRs to FDA or the manufacturer (or both)

Pediatrics

[Special Populations] It includes:

(1) Underdeveloped organs

(2) ADRs associated with UDP-glucoronosylacetyltransferase (Gray Baby Syndrome) and Kernicterus

Chloramphenicol

This drug causes Gray Baby Syndrome

Sulfonamides

This drug causes Kernicterus

Geriatrics

[Special Populations] Comorbidity, Polypharmacy, Less functional organs

Pregnant

[Special Populations] Teratogenic agents

Category A

[FDA Pregnancy Category] have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy

Category B

[FDA Pregnancy Category] No evidence of harm to the fetus. No observed adverse effects in animal studies. Failed to demonstrate risk to the fetus in any trimester.

Category C

[FDA Pregnancy Category] Have shown adverse effects in animal studies. No adequate and well-controlled studies in pregnant women.

Category D

[FDA Pregnancy Category] Demonstrated a risk to the fetus. Benefits may overweigh the potential risk.

Category X

[FDA Pregnancy Category] Demonstrated positive evidence of fetal abnormalities or risks

Category A

Levothyroxine

Category A

Folic Acid

Category A

Liothyronine

Category B

Metformin

Category B

Hydrochlorothiazide (HCTZ)

Category B

Amoxicillin

Category B

Pantoprazole

Category B

Cyclobenzaprine

Category C

Tramadol

Category C

Gabapentin

Category C

Amlodipine

Category C

Trazodone

Category D

Lisinopril

Category D

Alprazolam

Category D

Losartan

Category D

Clonazepam

Category D

Loranzepam

Category X

Warfarin

Category X

Valproin

Category X

Methotrexate

Category X

Isotretinoin