Reporting of Medication Errors and Adverse Drug Reactions

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Several national and international reporting programs have been established to allow health professionals and others to report adverse drug reactions and medication errors. Reporting of these medication-related problems serves an important public health benefit, to alert other health professionals of problems so that injury can be prevented to other patients from a repeat of the same problem in the future.

All health professionals are encouraged to submit confidential reports to these reporting agencies so that others can learn from these experiences. Information is provided below on submitting a variety of types of reports, including:

  1. Medication errors
  2. Vaccine adverse drug reactions (VAERS)
  3. Other medication adverse drug reactions (MedWatch)
  4. Medical device related malfunctions or problems
  5. International reporting programs

Medication Errors

The Institute for Safe Medication Practices (ISMP) operates a confidential, national, voluntary medication error reporting program. To report a medication error, visit ISMP Medication Errors Reporting Program (MERP).

Vaccine Adverse Drug Reactions

The U.S. Food and Drug Administration operates two programs for reporting adverse drug reactions: VAERS and MedWatch. The Vaccine Adverse Event Reporting System (VAERS) is designed to capture information related to any unusual event following administration of a vaccine product. VAERS has a toll-free telephone number at 1-800-822-7967. This number can be called for assistance in reporting vaccine adverse events.

Other Adverse Drug Reactions

For all other adverse drug reactions, the FDA operates the MedWatch program. Adverse drug events can be reported by: Telephone: 800-FDA-1088 FAX: 800-FDA-0178

Medical Device Problems

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse event reports from manufacturers, importers and user-facilities, so they can be detected and corrected quickly.

User-facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

For more information about Medical Device Reporting, visit FDA MDR.

For questions about Medical Device Reporting you may contact FDA at:

Reporting Systems Monitoring Branch (HFZ-533)
Center for Devices and Radiological Health Food and Drug Administration
1350 Piccard Drive
Rockville, MD 20850

Phone numbers for specific questions (please use FAX numbers except for emergencies):

Interpretation of policy:
301-827-0038 (FAX)   
301-594-2735 (voice)

Emergencies outside of normal East Coast business hours:
301-443-3333 (FAX)    
301-443-1240 (voice-24 hours/day)

Telephone Numbers for Medical Device Reporting
Voluntary Reporting Program    240-276-3001
Mandatory Reporting Program    240-276-3000

International Reporting Programs

The information presented below is provided by the Institute for Safe Medication Practices.

Pharmacists, nurses, physicians worldwide!
All medication errors are preventable as are many adverse drug reactions. One of the most important ways to prevent adverse drug events is to share information about them along with prevention recommendations.

Please use this forum to communicate information about interesting medication errors and preventable adverse drug events as they occur at your practice site. An emphasis is placed on events that have a high educational value.

Report adverse drug events in confidence to ISMP via their website. If published on the ISMP Web site, all identification, other than country of origin, will be removed to assure confidentiality is maintained. All reports are submitted in confidence on the following ISMP reporting Web site.

When reporting errors, please include all of the following:

  1. Describe the error or preventable adverse drug reaction. What went wrong?
  2. Was this an actual medication accident (reached the patient) or are you expressing concern about a potential error or writing about an error that was discovered before it reached the patient?
  3. Patient outcome.
  4. Type of practice site (hospital, private office, retail pharmacy, drug company, long-term care facility, etc).
  5. Generic name (INN or official name) of all products involved.
  6. Brand name of all products involved.
  7. Dosage form, concentration or strength, etc.
  8. Where error was based on communication problem, is a sample of the order available? Are samples or pictures available if requested?
  9. Please state your recommendations for error prevention.

Include your Name, Title, Address, FAX, Email, Phone and Location (confidentiality maintained).

If you would like to coordinate discussion of adverse drug events outside the US or if you are a representative of a governmental authority, or regulatory agency with a medication error reporting program underway or you are interested in starting one in your country, send an email to ismpinfo@ismp.org.

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