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MedWatch Tutorial Transcript: FDA MedWatch and Patient Safety

Slide 1

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.

Slide 2

Patient safety has been on the minds of healthcare providers since the time of Hippocrates - remember "Primum Non Nocere", meaning 'first, do no harm'.

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.

Slide 3

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.

Slide 4

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.

Slide 5

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 vulnerable children.

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.

Slide 6

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.

Slide 7

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.

Slide 8

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 identification process.

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.

Slide 9

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.

Slide 10

Transition slide - 2 sec

With this background, I will next discuss the reporting In to the FDA - what, when, how and why to report.

Slide 11

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 to FDA.

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.

Slide 12

At FDA, we are particularly interested in receiving three types of reports, first

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 formulas.

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.

Slide 13

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.

Slide 14

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.

Slide 15

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.

Slide 16

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.

Slide 18

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 information.

The safety issue is explored further within the agency and with the manufacturer and further epidemiologic investigations may be done.

Slide 19

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 is dispensed.

Slide 20

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 course.

Slide 21

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.

Slide 22

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 care.

Slide 24

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.

Slide 25

The Medwatch website offers visitors two types of medical product safety information:

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.

Slide 26

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 address.

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 symptoms.

Slide 27

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.

Slide 28

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.

Slide 29

Now that you've reached the end of this self-learning module we hope that you:

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 of care

Slide 30

To learn more about the FDA and the MedWatch Program, please visit us at: www.fda.gov/medwatch


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