Evidencias Medicas : MedicalMedicina General y Familiar

04 junio, 2013

Adverse Drugs Reactions: The Naranjo algorithm

7. Is your patient experiencing an unexpected side effect or new symptoms? Ask your patient where they got their prescription filled. (Photo credit: SafeMedicines)

The Naranjo algorithm, Naranjo Scale, or Naranjo Nomogram is a questionnaire designed by Naranjo et al. for determining the likelihood of whether an ADR (adverse drug reaction) is actually due to the drug rather than the result of other factors. Probability is assigned via a score termed definite, probable, possible or doubtful. Values obtained from this algorithm are sometimes used in peer reviews to verify the validity of author's conclusions regarding adverse drug reactions. It is also called the Naranjo Scale or Naranjo Score.

Questionnaire

1. Are there previous conclusive reports on this reaction?

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

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

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

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

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

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

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

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

10. Was the adverse event confirmed by any objective evidence?

Scoring

> 9 = definite ADR
5-8 = probable ADR
1-4 = possible ADR
0 = doubtful ADR

References

Naranjo CA, Busto U, Sellers EM et al. (1981). "A method for estimating the probability of adverse drug reactions". Clin. Pharmacol. Ther. 30 (2): 239–45. doi:10.1038/clpt.1981.154. PMID 7249508.

External links

Vycor Viewsite Brain Access System (VBAS): Class 1 Recall - Unidentified Fiber Found on Device

AUDIENCE: Neurology, Surgery, Risk Managers

ISSUE: Vycor Medical recalled its VBAS because an unidentified black fiber was found on the device. This product may cause serious adverse health consequences, including death.

BACKGROUND: The Vycor Medical Viewsite Brain Access System serves as a self-retaining retractor system for brain tissue and provides access to allow the surgeon to see the surgical site during brain and spinal procedures.

RECOMMENDATION: Vycor Medical called their customers requesting that they place products of Model # TC171105, Lot # VM83450 into quarantine until further notice. Vycor Medical asked customers holding the affected lot numbers to call the company immediately. Customers in immediate need of the product should advise the Vycor customer service team who can assist in providing an alternative product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178