2007_02_01_archive

Case reports and post-marketing surveillance

The Food and Drug Administration has launched an online training

seminar, "FDA MedWatch and Patient Safety," about the role of the

MedWatch program in monitoring drug, device, blood, and other biologic

product safety in the US.

It's a fantastic and informative course, about an hour of video

presentation, covering the role that the program plays in monitoring

safety after drugs, devices, etc, are approved by the FDA - commonly

called "post-marketing surveillance."

Programs like this realize that, while clinical trials are designed to

establish general safety and efficacy of the products regulated by the

FDA, they do not have adequate size to detect all possible side

effects; the MedWatch program is particularly interested in serious

adverse events associated with these products, i.e. those causing

significant morbidity and mortality to individuals taking the drug.

This type of program also is intended to catch issues with:

- how drugs are prescribed (what patients and physicians "do" with the

drugs outside of the controlled setting of a clinical trial, such as

problems with how they're dosed, possible interactions with other

medications, etc)

- how devices or other products are used in the "real world"

- quality of products (issues regarding how the devices, drugs,

products are produced and distributed to patients, e.g. faulty

devices, manufacturing/handling errors leading to problems with the

end product, etc)

The stated objectives of the MedWatch program:

- To educate both healthcare providers and their patients about the

importance

of reporting serious adverse events IN to FDA, and to facilitate

that reporting

- then...once those reports have been received and evaluated by

FDA, to

take the new safety information that results from analysis of these

reports and

disseminate it OUT from FDA and back to clinicians and their

patients, in a

timely fashion for use at the point of care.

The FDA pulls these reports together, analyzes and investigates them,

and determines an appropriate course of action for dealing with an

issue that truly exists. Any interventions or changes are often

accompanied by educational strategies aimed at the provider and the

patient.

The MedWatch site notes:

Changes to the label, also known as the prescribing information or

package insert, are the most commonly used strategy. These range

from boxed warnings placed at the top of the prescribing

information, to additional statements in contraindications,

precautions or adverse reactions sections about new interactions,

monitoring recommendations or dosage adjustments. Certain drugs are

required to have medication guides - a 'patient-friendly'

instruction sheet that is provided to the patient by the pharmacist

each time a prescription is dispensed.

How does this tie in to this month's case study?

The foundation of the MedWatch program is voluntary and mandatory

reporting of adverse events (errors, product problems, side effects)

potentially associated with FDA-regulated products -- in essence,

providers and patients sharing case reports of problems potentially

associated with the products. Investigators at the FDA use principles

of epidemiology to wade through all of the case reports, identify

clusters or common issues, investigate those issues, and figure out

which problems are "real" and begin figuring out what to do with them

-- all based on case reports from providers and patients.

The system is not without its flaws, and potential reform at the FDA

is currently the subject of much attention and debate in the US

consumer and healthcare communities. An editorial in JAMA highlights

some of the main critiques or weaknesses of the current system, and

proposes potential solutions for addressing these issues:

Editorial: Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing

surveillance--lack of vigilance, lack of trust. JAMA. 2004 Dec

1;292(21):2647-50. (PubMed abstract with link to free full-text)

Additional information:

- A transcript of the presentation is available here.

- There are a number of articles looking at how MedWatch data is used,

available via a quick PubMed search.