Pharmacoeconomics and Safe Medication Use

The FAERS and VAERS databases are used as postmarketing surveillance systems. Limitations of

FAERS and VAERS include the following:

Lack of certainty of adverse event (i.e., may not be validated)

Underreporting

Less severe adverse events likely to be underreported

Reporting of ADEs by health care professionals and consumers to the FDA is voluntary and may be

done through the FDA’s MedWatch program (begun in 1993). All of the following may be reported with

respect to an FDA-regulated medication, biologic, tobacco product, dietary supplement, cosmetic, or

medical device:

Serious ADE

Serious ADR

Product quality problem

Therapeutic inequivalence

Therapeutic failure

Clinicians may report an ADE directly to the drug’s manufacturer. The pharmaceutical manufacturer

has a legal responsibility to follow up with the reporter on all ADEs reported and to report the ADE to

the FDA.

ADE reports and medication error reports submitted directly by health care professionals or manufacturers

are entered in the FAERS database.

If the FDA detects a safety concern, regulatory action may be needed to protect the public, such as

updating the product labeling, restricting the drug, communicating the safety concerns to health care

professionals and consumers, or removing the drug from the market.

A comprehensive ADE program should have a policy and procedure, with guidelines for ADE detection,

reporting, management, surveillance, and education.

The purpose of a reporting program includes improving patient care, education of health care

professionals, complementing organizational risk management with respect to medication use, and

assessing safety of medication therapies.

A comprehensive program includes a surveillance system, which includes prospective and

retrospective surveillance systems, and tools to improve medication safety, including event

monitoring and CDS.

Appendix 1 shows an ADE reporting form.

ADEs, pharmacists often serve as chair or co-chair of the ADE/medication safety committee.

The ADE committee should be interdisciplinary and composed of the following:

Prescribers

Pharmacists

Nurses

Quality assurance and performance improvement personnel

Other health care providers

Informaticist

Administrator

In general, the ADE committee is a subcommittee of the pharmacy and therapeutics (P&T) committee

that reports to the P&T committee.