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Contents

·Determining likelihood of causality
·Scale to describe severitiy
·Finding information about known ADRs
·Reporting
·Avoiding ADRs by understanding drug interactions

Definition of an adverse drug reaction (ADR):

"any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment"(1)

Assessing causality

A simple scale is Table 2 at http://annals.org/cgi/content/full/140/10/795

Note that an ADR should not be labeled as 'certain' unlessthe ADR abates with dechallenge and recurs with rechallenge are true.

Naranjo Causality Scale

1. Are there previous conclusive reports on this reaction?

Yes (+1) No (0) Do not know or not done (0)

2. Did the adverse event appear after the suspected drug was given?

Yes (+2) No (-1) Do not know or not done (0)

3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given?

Yes (+1) No (0) Do not know or not done (0)

4. Did the adverse reaction appear when the drug was readministered?

Yes (+2) No (-1) Do not know or not done (0)

5. Are there alternative causes that could have caused the reaction?

Yes (-1) No (+2) Do not know or not done (0)

6. Did the reaction reappear when a placebo was given?

Yes (-1) No (+1) Do not know or not done (0)

7. Was the drug detected in any body fluid in toxic concentrations?

Yes (+1) No (0) Do not know or not done (0)

8. Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?

Yes (+1) No (0) Do not know or not done (0)

9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure?

Yes (+1) No (0) Do not know or not done (0)

Scoring

Severity Scale

http://www.fda.gov/medwatch/report/DESK/advevnt.htm

The ADR is severe (FDA definition) if:

Finding information about known ADRs

PDA programs These generally only list ADRs that are either severe or common.
MicroMedex

Probably the best resouce and much more extensive than PDA programs; however, some uncommon reactions may not be listed in MicroMedex. If you think you have encountered an ADR not listed in MicroMedex, use MEDLINE at the link before.

To access MicroMedex:
MEDLINE

http://clinical.uthscsa.edu/pubmed/

  • has a filter for ADRs
  • be sure to unceck the 'not letters' option; rare ADRs may be reported in letters to journals.
FDA http://www.fda.gov/advsearch.html (select MedWatch)
Note: SUMSearch simultaneously searches MEDLINE and the FDA if you select the adverse effects filter.

Reporting

ALMMVAH, do one of:

UHS:

FDA:

Avoiding ADRs

More information

References

1. Nebeker JR, Barach P, Samore MH. Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting. Ann Intern Med. 2004;140:795-801.
PMID: 15148066
2. Phillips KA, Veenstra DL, Oren E, Lee JK, Sadee W. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review.
JAMA. 2001;286:2270-9.
PMID: 11710893
3. Goldstein DB. Pharmacogenetics in the laboratory and the clinic.
N Engl J Med. 2003 Feb 6;348(6):553-6.
PMID: 12571264
4: Evans WE, McLeod HL. Pharmacogenomics--drug disposition, drug targets, and side effects.
N Engl J Med. 2003 Feb 6;348(6):538-49.
PMID: 12571262
5: Weinshilboum R. Inheritance and drug response.
N Engl J Med. 2003 Feb 6;348(6):529-37.
PMID: 12571261
6: Guttmacher AE, Collins FS. Genomic medicine--a primer.
N Engl J Med. 2002 Nov 7;347(19):1512-20.
PMID: 12421895
7. Robinson RL, Burk MS. Identification of drug-drug interactions with personal digital assistant-based software. Am J Med. 2004 Mar 1;116(5):357-8. PMID: 14984827


Last update 6/3/2004 3:17PM.