MedWatch Tutorial Transcript: FDA MedWatch and Patient Safety
Welcome. My name is Norman Marks. I am a physician and the medical director
of the FDA's MedWatch program. Having worked for many years in a community
practice setting in the Midwest, I recognize the critical role that our nation's
physicians, nurses, pharmacists and other healthcare professionals play in
helping FDA monitor the safety of all the clinical medical products that we
use, prescribe or dispense - and our patients rely on every day - whether
in the office, clinic, hospital or extended care facility.
This learning module will introduce you to the work that our MedWatch Safety
Information and Adverse Event Reporting Program does in order to insure that,
when healthcare provider and patient sit down to make a decision to choose
a particular treatment or diagnostic test to improve or maintain their health
that the drug, device, blood or biologic product is safe and that the risks
and benefits of use are understood.
Patient safety has been on the minds of healthcare providers since the time
of Hippocrates - remember "Primum Non Nocere", meaning 'first, do
But patient safety recently reached the forefront of public awareness with
the 1999 Institute of Medicine's report, "To Err Is Human". That
report suggested that at least 7000 deaths annually were due to medication
errors. It is estimated that between 5 and 25% of hospitalized adult patients
experience a serious adverse drug reaction at some point during their hospitalization.
A recent study of serious adverse drug reactions in an elderly ambulatory
population showed that these events were common and often preventable and
that the more serious adverse drug events are more likely to be preventable.
Some of these known adverse reactions are expected and unavoidable in patient
care, while some may be prevented and avoided by either careful monitoring
or management. Other adverse reactions have not yet been recognized or identified,
are unexpected and are therefore not yet preventable or avoidable.
It is these unexpected adverse reactions that are the focus of this learning
module and the cornerstone that supports FDA's post-marketing safety surveillance
activities. Adverse event reporting by healthcare professionals to FDA is
voluntary. It is suspected that serious adverse events are greatly under-reported.
Our FDA MedWatch program's has two interconnected goals:
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.
Upon completion of this learning module, you should be able to:
accomplish these four objectives that explore the process that FDA uses to
work with clinicians to identify unexpected safety concerns about medical
products once they are in use in patient care and deliver that new safety
information back to providers and their patients.
FDA's mission since its inception, 100 years ago, in 1906 has been a focus
on SAFETY; FDA is the first consumer safety protection agency; FDA recognizes
that the new and ever more effective products that are approved for your use
must, first and foremost, be safe when used in the real world.
Each law passed by the US Congress, first to create what became the FDA in
1906, then again to strengthen it in 1938 and 1962 have been to address the
public uproar over safety issues that caused serious harms, especially to
Until 1938, federal law did not require a drug's manufacturer to test a drug
for safety before it was sold. That year, sulfanilamide, the first antibacterial
"wonder drug" and an effective treatment for diseases like strep
throat and gonorrhea, was sold as an Elixir and marketed for use in children.
But the 'elixir' contained ethylene glycol, antifreeze, and it killed 107
people, most of them children. Congress corrected this weakness in the law
the next year when it passed the Federal Food, Drug, and Cosmetic Act. This
law, for the first time, required companies to prove the safety of new drugs
before putting them on the market.
In 1962 another tragedy was averted, when a FDA medical officer refused to
approve the sedative thalidomide already approved and popular in Europe. The
drug was subsequently found to cause profound birth defects in many children
born to mothers who used the drug during pregnancy. The 1962 Kefauver amendments
directed FDA to require pharmaceutical manufacturers to report adverse events
to the FDA.
30 years later, FDA launched the MedWatch program to stimulate the voluntary
reporting of serious adverse events by healthcare professionals and patients.
Many healthcare professionals and their patients do not know that, in approving
medical products - drugs, biologics and devices -- for sale and use, that
FDA does not develop or test the products itself. FDA reviews the results
of laboratory, animal and human clinical testing done by companies to determine
if the product they want to put on the market is safe and effective.
Because FDA's review is based on a relatively small number of users, and
because variations in quality can happen in manufacturing, FDA keeps careful
watch on reports of adverse experiences with products after they are marketed.
If this monitoring turns up a problem that needs to be corrected, FDA can
take timely actions to improve the safety of the product.
This second FDA role - Postmarketing Monitoring for Safety - is a critical
one because of the limitations of pre-marketing review and the controlled
clinical trials used to prove the effectiveness of the product before it is
approved by FDA.
For example, the reliance of FDA and the manufacturer on the controlled clinical
trial to demonstrate the efficacy of a drug for its intended use in a controlled
population during NDA approval is strength. It can be determined with some
certainty that the product is effective when compared with placebo and the
common serious adverse reactions will be identified.
But, limitations such as number of participants and subject characteristics
results in uncertainties about the safety of the pharmaceutical once it is
marketed and used in a wider population, over longer periods of time, in patients
with co-morbidities and concomitant medications and for 'off-label' uses not
previously evaluated. This is a weakness of the clinical trial as a safety
Therefore, the true picture of product safety actually evolves over the months
and even years that make up a product's lifetime in the marketplace.
Let me emphasize again this important point - one that is not well understood
by many hcp's and patients.
Before a product is marketed, the safety experience is limited to its use
in clinical trials, which do not fully reflect the way the product will be
used in real life conditions once it is marketed. Continued monitoring of
adverse events is thus essential and depends on voluntary reporting of adverse
events, medication errors and product problems by health professionals and
consumers to the FDA, either directly or via the manufacturer.
Individual health professionals are not required by federal law or regulation
to submit AE reports on any medical product, except for vaccines. Therefore,
adverse event reporting is voluntary.
The story of the drug, Depakote, illustrates that even after twenty years
of use, new information that will improve the safe use of a medical product
will be detected with the help of voluntary reports from healthcare professionals.
In July 2000, FDA added new safety information, a Boxed Warning, for Depakote
after receiving multiple reports of a serious adverse event, pancreatitis,
in patients taking the drug. Although the condition was listed as a possible
adverse reaction when first approved in 1978, the severity of this serious
condition was found to be much greater when used more widely for newer and
common indications such as migraines, depression, and seizures. It was with
this increased use that spontaneous reports began to be received at FDA, prompting
the new warnings to inform doctors and patients of this new risk.
Even after twenty years, new information that will impact the clinical use
of a medical product can be detected. Consequently, all medical products need
to be continually assessed for safety.
Transition slide - 2 sec
With this background, I will next discuss the reporting In to the FDA - what,
when, how and why to report.
A spontaneous report is a observation during direct patient care - not part
of a clinical trial - reported voluntarily by a healthcare professional or
patient either directly to FDA or indirectly to the manufacturer and then
Because MedWatch uses the same form for all voluntary reports, reports for
drugs, biologics, devices and special nutritional products can be submitted
on a single form. Vaccine adverse reactions are not reported to FDA through
MedWatch but through VAERS, the Vaccine Adverse Event Reporting System.
At FDA, we are particularly interested in receiving three types of reports,
those involving suspected serious adverse events associated with drugs, either
prescription or OTC, biologic products, medical devices, cosmetics and special
nutritional products such as dietary supplements, medical foods and infant
Second, reports, especially from our pharmacist colleagues and nurses of
product quality problems that might suggest manufacturing or other quality
problems with drugs or devices. In addition, FDA is very interested in reports
of suspected counterfeit products.
And, third, reports of medication and device use errors, for example, the
wrong drug/wrong dose errors that may be caused by either product name confusion
or confusion resulting from packaging and labeling.
MedWatch is interested in receiving reports of serious adverse events for
all medical products, except vaccines.
An adverse event is defined as any unfavorable and unintended sign, symptom,
or disease temporally associated with the use of a medicinal product, whether
or not considered related to the product.
Examples of serious adverse events are listed on this slide.
However, health professionals and their patients are encouraged to report
any adverse event that they judge to be clinically significant. Suspicion
that a medical product may be related to a serious event is sufficient reason
to submit a report. Proof of causality is not necessary.
Since 1998, the MedWatch website, www.fda.gov/medwatch, has offered an online
reporting form as an alternative to reporting by mail or fax;
In addition, a toll free 800# is available for answers to reporting questions
and to submit a report.
Reporting to us is simple: a one page paper form that can be returned to
FDA by pre-paid mail or fax.
The four core elements of the report include: a reporter's name, a suspect
drug or device product a narrative report of the adverse event or problem
and an identifiable patient. The FDA, however, hold the identity of patients
in strict confidence, protected by federal law and regulation
Patients are encouraged to take this form to their healthcare professional
so that the report contains more detailed information when received by FDA;
however, patients may submit reports directly to FDA.
Why Report……….because even a few voluntary reports, arriving at FDA from
the four corners of the country, can become the signal, as in the case of
Depakote, that leads to a label change or other FDA actions to improve the
safe use of the medical product.
Slide 17 - Transition slide
Now that you have an understanding of how to report, you will learn how the
FDA uses these voluntary reports once the report is received.
Here are a few examples of the actions we can take if you report an adverse
event, a product problem or a medication or device use error.
When you report an adverse event for a drug, biological product or device,
it is entered immediately into a post-marketing surveillance database and
reviewed on a case-by-case basis by a safety evaluator, usually a pharmacist,
physician or nurse.
If she determines that the safety signal is potentially significant, she
will examine the database for similar reports to develop a case series. Each
case report is evaluated for the adequacy of the information, the temporal
association of the product and the event, potentially confounding factors
such as patient disease or concomitant therapy, and dechallenge-rechallenge
The safety issue is explored further within the agency and with the manufacturer
and further epidemiologic investigations may be done.
Once your voluntary report of a safety signal is evaluated and found to represent
a previously unrecognized safety issue, the FDA has a variety tools to use
in our efforts to keep effective drugs and devices on the market while reducing
the risk of harm to patients. For example, the Center for Drugs, CDER, will
often chose from these labeling or educational options.
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
Occasionally, these educational strategies, directed at either providers
or their patients, are found to be inadequate and more formal risk management
plans are agreed upon between FDA and the manufacturer. Tools that might be
considered, shown here, may require limitations on who prescribes or dispenses
these products, based on training or certification, require proof of a recent
laboratory test finding before the patient receives the drug, or even the
registration and tracking of all patients receiving the drug.
With all these opportunities available to FDA to keep useful drugs and devices
on the market, while improving their safety, it is rarely necessary to remove
a product from market, but occasionally this action is the most appropriate
When you report a suspected product quality problem with a drug or device,
FDA will evaluate the reports and work with the manufacturer to identify whether
it represents a problem with the quality of the manufacturing process, the
distribution process, or errors in use due to problems in design of drug packaging,
instructions for use of a device, or design of the device itself.
When you report a medication or device use error, FDA will investigate the
root cause by evaluating your report and comparing it with similar reports
in the database and the literature.
Since FDA regulates both the name of the drug product and the packaging,
errors that are due to name confusion or confusing packaging can be addressed
by FDA requests to the manufacturer for changes in name or packaging and modifications
or clarifications in the instructions for use.
Slide 23 - Transition Slide
Now that you understand how to report and what happens to the report at the
FDA, let me discuss how the FDA's MedWatch program takes this valuable information
from your reports and sends safety information out to you at the point of
The MedWatch program provides safety information in three ways:
on the MedWatch web site at www.fda.gov/medwatch.
by e-mail broadcast to over 54,000 individuals, providers and patients
by working with MedWatch partner organizations to amplify the safety information.
The Medwatch website offers visitors two types of medical product safety
Safety alerts about the most important labeling changes, recalls, and public
health advisories. When the individual alert is posted on the website, email
notification is sent to all Partner organizations and individual e-list subscribers.
Monthly safety labeling changes for all drug products are provided in a user-friendly
table format along with the updated prescribing information or label.
The MedWatch e-list is an email distribution process that allows healthcare
providers using email in their day to day care to receive immediate notification
when new safety information is available from the FDA on drugs, biologics,
devices, and dietary supplements.
In 2005, over 54 ,000 subscribers are taking advantage of this process.
Joining the e-list is easy. Signing up for the e-list is available on the
MedWatch page. Just click on "Join the E-list" and enter your email
In this example, pediatricians and pharmacists were notified by email that
extra caution should be used when treating patients, especially children with
'product x' due to their increased risk of experiencing decreased sweating
and hyperthermia, preventable by either prevention or prompt recognition of
The MedWatch Partners program includes 170 organizations, primarily health
care provider organizations in medicine, nursing and pharmacy but also consumer
and health care media organizations. Each organization works with FDA to amplify
the new safety information. Examples of partners include the American Association
of Nurse Anesthetists, American Society of Health System Pharmacists, American
Academy of Pediatrics, Medscape, and ePocrates.
The increasing reliance by clinicians on their PDAs for real-time drug reference
information has allowed MedWatch to send alerts and labeling updates to clinicians
at the point of care. For example, both the ePocrates drug reference resource
and mobile PDR update their databases with new FDA safety information regularly.
Now that you've reached the end of this self-learning module we hope that
Understand how the FDA monitors medical product safety and also appreciate
that there will always be limitations inherent in the drug approval process
that will require cooperation between the nation's providers - doctors, nurses,
pharmacists - and the FDA
Learn how to voluntarily report adverse events to FDA and also the what,
when, and why to report
Appreciate how these voluntary reports, once received from you by FDA are
evaluated by FDA and then used to improve product safety
Know the methods used by FDA to send new safety information gained from this
voluntary reporting process about medical products to providers at the point
To learn more about the FDA and the MedWatch Program, please visit us at: www.fda.gov/medwatch