# Presentation: 844792

## FDA MedWatch and Medication SafetyCommunicating Risk to Healthcare ProfessionalsDIA Annual Meeting - Washington, DC Norman S. Marks, MD

- FDA MedWatch and Medication SafetyCommunicating Risk to Healthcare ProfessionalsDIA Annual Meeting - Washington, DC** **Norman S. Marks, MD

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

The FDA’s MedWatch program represents one of the primary outreach efforts to healthcare professionals and to their patients by the FDA; while other FDA offices have outreach responsibilities, for example the Office of Training and Communication [OTCOM] in CDER, or the Office of Special health issues or the Office of Women’s health in the Office of the Commissioner, our MedWatch program is a widely used method for the agency to broadcast product-specific safety information updates as part of our public health mission and our risk communiction efforts 

we perform this important public health function by disseminating safety information, on drugs and other clinical care products, in a timely fashion to providers – physicians, pharmacists, nurses and their patients. Our goal is to deliver this information in a useful format and at the point of care so that it can be incorporated into those clinical decisions about the use of a particular drug products, taking into account the specific risk/benefit calculation that is dependent of the knowledge of that patient’s condition by the provider and the patient’s own risk preferences.

Before I describe the specific activities of the current risk communication efforts, let me review with you the FDA’s history of risk communication of safety issues for drugs and other medical products..............

## FDA MedWatch and Medication SafetyImpact of Adverse Events on the Public’s Health

**1906 – Pure Food and Drug Act**
**1993 – MedWatch announced by Commissioner Kessler**
**1999 - *****“Managing the Risks From Medical Product Use”***** ; Report to the FDA Commissioner from the Task Force on Risk Management**
**1999 -Institute of Medicine [IOM] Report – 1999**
***“******To Err Is Human”***
**2003 – FDA Commissioner’s Strategic Plan**
**	****Better Informed Consumers**
**	****Patient and Consumer Safety**
**	****Efficient Risk Management**
**   ****A Strong FDA**
**   ****Counterterrorism**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
FDA, since it’s inception 100 years ago has recognized its public health function as a consumer protection agency- identifying safety problems with medical products and alerting the public about these identified risks.

The passage of the Pure Food and Drug Actin 1906 was partly in response to public outcry in 1904 when diphtheria anti-toxin was found to be contaminated with tetanus and resulted in the deaths of many children; 

Again, in 1938, the Food Drug and Cosmetic Act that guides our work to this day was passed by Congress after the deaths of many children and adults who ingested an elixer of sulfanilamide that contained ethylene glycol, or anti-free a potent renal toxin.  With that act, manufacturers, for the first time, were required to provide evidence that their drug products were safe before they were approved for marketing;  the Kefauver amendments to the Act, in 1962, first required manufacturers to report ADRs to the FDA.

During the first 50 years of the FDA’s history, there is little evidence that the agency had implemented any regular activity that could be described as risk communication.  The primary impetus for the current FDA efforts to communicate risk of drug products began during the 1950’s when the effective new antibiotic, chloramphenicol was found to be associated with significant myelosuppression and aplastic anemia; 

This experience prompted FDA in 1960 to collaborate with pharmacists [ Am Soc Hosp Pharm], hospital librarians societies to develop a pilot reporting system that by the mid- 1960s had expanded to over 200 reporting sites.  This ADR information was shared with the network of hospitals and medical staff personnel that participated in the FDA monitoring program and available as a monthly bulletin of selected cases.  

In addition, the FDA staff published a monthly document from the mid- 60s to the mid-70s called the Clinical Experience Abstracts [CEA], a compendium of ADR abstracted from leading medical journals.

By the 1970’s, the FDA Drug Bulletin, later the FDA Medical Bulletin, was developed to increase communication with the public; this publication was discontinued in 1998.

As you’ll hear later, the launching of the MedWatch program in 1993 by Commissioner David Kessler, represented the first concerted effort to develop a risk communication outreach effort.

The report to the commissioner, in 1999, confirmed the agency’s commitment to risk communication, as one of the critical elements in the agency’s new risk management framework;

the IOM report, in december 1999 further raised the interest of the public, governmental policymakers, healthcare professional organizations and the healthcare industry in patient safety, adverse reactions, errors and the need for further focus on risk communication and other efforts to reduce the harms of medical products;

Finallly, Commissioner McClellan’s strategic plan of this past year, targets better informed consumers and healthcare professionals as a focus for the agency’s efforts in coming years 

## FDA’s MedWatch ProgramOutreach to Healthcare Professionals and their Patients

- 1993 - MedWatch, The FDA Adverse Event Reporting Program announced by Commissioner David Kessler
- “Introducing MedWatch”; JAMA, 269(21), June 2, 1993
- Make it easier for providers to identify and report adverse events
- make it clear what types of reports the FDA wants to receive
- increase physician understanding and awareness of drug induced disease
**more widely disseminate information on the FDA’s actions that have resulted from adverse event and product problem reporting**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

When the MedWatch program began 10 years ago, the focus was almost entirely on REPORTING IN of adverse events
in 2004 our emphasis has change to the broadcasting of SAFETY INFORMATION
 with the intention that it be both timely and clinically useful and delivered at the point of care where healthcare decisions by providers and their patients takes place

## FDA MedWatch and Patient SafetyMedWatch program goals

- Reporting IN to FDA
- Educate about importance of reporting
- Facilitate the reporting
- Improve the quality of the reports
- Safety Information OUT from FDA
- Disseminate clinically useful, new safety information to providers and patients

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

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.

## FDA MedWatch and Medication Safety How FDA Evaluates Medication Safety  

**Pre-Market Review and Approval**
** ****FDA does not develop or test products ****	****itself **
** ****FDA reviews the results of laboratory, ****	****animal   and human clinical testing done ****	****by companies**** **** **
**Post-Market Monitoring for Safety**
** ****Careful review of adverse experiences with ****	****products once they are marketed**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
One of the primary MedWatch outreach messages, to both hcp’s and their patients involves educating them about the drug development and drug approval process; as a former clinician practicing in the heartlands of the midwest, I was one of many who had little understanding of the nature of this process or of its limitations;

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. 

## FDA MedWatch and Patient Safety The Benefits and Limitations of Clinical Trials

**What Clinical Trials Do Well**
- Determine with some certainty that the product is effective when compared with placebo
- identify the common serious and non-serious adverse reactions

**Limitations of Clinical Trials**
**Seldom more than 3000 pts**
**Patients with complicated medical conditions often excluded**
**Patients receiving certain concurrent meds often excluded**
**Pediatric and elderly populations;  limited numbers studied**
**Trials often last only weeks to months; limited data on long term exposure**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

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.  Again, this information is not well understood  by most clinicians and this message in included in our outreach activities.

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 a 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 inherent in the controlled clinical trial setting in the identification of rare, but clinically important, adverse events insures that uncertainties will remain 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 the great 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. 

## Risk ManagementThinking About Risks and Benefits

**Risk Management framework**
**FDA proactively manages risks both before and after approval**
**Stakeholders include industry, clinicians and their patients**
- from *“Managing the Risks From Medical Product Use” ; Report to the FDA Commissioner from the Task Force on Risk Management*, May 1999

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
The new RM framework from the 1999 report emphasized that RM required proactive consideration by the agency and sponsor prior to approval and during the marketed life of the product

and that stakeholders in this process also included clinicians and the patients that would be using these drugs and would be at risk of harm  -- again emphasizing the role of risk communication in the agency’s activities;

## Risk ManagementThinking About Risks and Benefits

- Risk and Benefit May Change over Time
- The anticipated benefits of use of medications and the uncertainties of risk of harm from that same use _changes over the lifetime_ of the drug
- from *“Managing the Risks From Medical Product Use” ; Report to the FDA Commissioner from the Task Force on Risk Management*, May 1999

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
the report emphasized that

the risk-benefit of a given drug may change over its marketed life

some drugs may be found to have previously unknown risks, some may be found, with use to be able to be used more safely than anticipated,

some products may become relatively more ‘risky’ as alternative therapies, felt to be equally efficacious but safer become available

other products have an unchanged safety profile, but concurrent use of other drugs with this drug may increase the potential for interaction and harm

## Risk ManagementThinking About Risks and Benefits

- Shared decision-making
- The risk/benefit assessment is _dependent on patient characteristics and preferences_ and must be done as a shared decision-making process between doctor and patient
- from *“Managing the Risks From Medical Product Use” ; Report to the FDA Commissioner from the Task Force on Risk Management*, May 1999

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
Finally, the report re-affirmed that one of the goals of risk communication, and of our MedWatch program, should be to deliver safety information on drugs to both parties in the shared decision-making process, provider and her patient, ideally at the point of care for use at the time of decision; as we will see, the availability of new electronic technologies, computers, handheld PDAs, and the internet, are making this goal easier to achieve.

## 2003 - Commissioner's Initiatives

_**Better Informed Consumers**_** **** Helping consumers to get truthful information about products they use so they can make informed decisions**
_**Patient and Consumer Safety**_** **** Helping to prevent adverse events involving FDA-regulated products **
- _Efficient Risk Management_ Searching for new and better ways to reduce risks to public health.
- _A Strong FDA_ Maintaining a strong science-base to support FDA's risk management responsibilities.
- _Counterterrorism_ Quick responses to counterterrorism and enhancing food security.

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
These five initiatives represent Commissioner McClellan’s focus including:

new and better ways to reduce risks to public health
helping to prevent adverse events involving FDA-regulated products
and helping consumers to get truthful informatino about products they use so they can make informed decisions

## Better Informed Consumers Truthful information and informed decisions

**Helping consumers to get truthful information ****about products they use so they can make informed decisions**** **
**“****Ensure that consumers, health professionals and other FDA stakeholders have ****accurate and timely information**** about ****potential benefits and health consequences**** associated with the products regulated by FDA; and a transparent view of FDA processes”**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
or, to read further in the strategic plan:

“Ensure that consumers, health professionals and other FDA stakeholders have accurate and timely information about potential benefits and health consequences associated with the products regulated by FDA

## Timely, Useful Information and Informed DecisionsObstacles to Medication Safety in Clinical Care

**More to know every day**
**new safety updates added all the time**
**not easily accessible as part of routine clinical work**
**Demands for more efficiency**
**less time per patient**
**more documentation**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
What are the obstacles that we hear about when we take our FDA MedWatch messages out to practitioners at the point of care?

more to know – with use of paper record, not easily accessible

demands for more efficiency means less time for clinical care

## Timely, Useful Information and Informed DecisionsObstacles to Medication Safety – Patient Factors

**Many patients are receiving large numbers of medications [poly-pharmacy]**
**Patients are older and sicker **
**Patients often practice self-care with OTC and dietary supplements**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

the aging of the coming baby boomer generation means that over the coming decades, more patients will be at risk of harm due to these factors inherent in aging

combined with, what I suspect is an inexorable trend, toward self care with OTCs and DS, thereby eliminating the ‘learned intermediary’ from the shared decision making process

## Timely, Useful Information and Informed DecisionsObstacles to Medication Safety – Medical Care Delivery Factors

**Patients change doctors/pharmacists much more often than in the past**
**Patients receive their care from multiple specialists and multiple facilities**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
several medical care delivery factors work against delivering useful timely information to patients and caregivers:

as patients and their providers are more loosely connected than in the old days of Marcus Welby-type care

## Timely, Useful Information and Informed DecisionsObstacles to Medication Safety – Drug Development Factors

**Providers have an increasing number of drugs to choose from in their patient care decisions**
**Once approved, new drugs are ‘launched’ and marketed more aggressively than in the past**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
and finally, the nature of the drug development and drug marketing process will potentially add a bit more to the ‘information overload’ that works against the efforts of that provider and her patient;

## How FDA Sends Safety Information To You

**MedWatch Safety Information**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
with this then as context, let me describe to you how the agency, and specifically our MedWatch program, is attempting to reach providers and patients, stakeholders in the risk management process, with product specific safety information they may chose to use in their shared decision-making;

## How FDA Sends Safety Information Broadcasting new safety information

**MedWatch website**
**MedWatch E-list**
**MedWatch Partners program**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

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 40,000 individuals, providers and patients

by working with MedWatch partner organizations to amplify the safety information. 

## How FDA Sends Safety Information MedWatch Website

- How FDA Sends Safety Information MedWatch Website

**MedWatch website  safety information**
**Individual safety alerts**
**Monthly safety summaries**
**Links to other FDA approved information**
**CBER, CDRH, CFSAN safety pages**
**FDA Enforcement report for recalls**
**CDER drug shortages**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

The Medwatch website offers visitors three 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.  

and, links to a variety of safety information that is collected by other centers and offices and posted on the FDA website

## How FDA Sends Safety Information MedWatch E-list notification

- How FDA Sends Safety Information MedWatch E-list notification

**E-mail notification of ****individuals of new ****postings on website**
**over 41,000 subscribers **
**	****in 2004**
**E-list notification example:**
**Company X and FDA revised the WARNINGS and PRECAUTIONS sections of the prescribing information to provide updated information about oligohidrosis (decreased sweating) and hyperthermia, which have been reported in product x-treated patients. Oligohidrosis and hyperthermia may have potentially serious sequelae, which may be preventable by prompt recognition of symptoms and appropriate treatment****. **** **

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

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 2004, over 42,000 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.

## How FDA Sends Safety Information MedWatch Partners Program

**170 organizations**
**Health professional**
**medical**
**nursing**
**pharmacy**
**Consumer**
**Healthcare media and news**

**American Association of Nurse Anesthetists**
**American Society of Health-System Pharmacists**
**Texas Medical Society**
**Medscape**
**ePocrates**
**and many others**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

The MedWatch Partners program includes 170 organizations, primarly 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, Texas Medical Society, Medscape, and e-Pocrates. 

## How FDA Sends Safety Information How a MedWatch Partner Amplifies Our Messages

**Portable drug reference information**
**ePocrates**
**over 700,000 subscribers**
**mobilePDR**
**Regular updates of references weekly/monthly**
** ****FDA alerts at time of synchronization**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

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.  

## The Future

**Computerized Medical Records**
**The potential to facilitate reporting of suspected serious adverse events**
**The potential for clinical reminders about:**
**previous drug reaction history**
**drug-drug, drug-food interactions**
**dosage adjustments**
**new safety alerts**

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**
Just a few comments about the future --
although the use of the paper clinical record seem firmly entrenched in U.S. healthcare, the digital computerized record is making slow gains
the VA’s VISTA EMR is a good example; linked across all facilities in the country and between inpatient/outpatient and remote clinic sites

the EMR has the potential to allow for automatic identification of ADR signals
to prompt for and facilitate the initiation of a report
and, to facilitate our risk communication efforts, to offer realtime clinical reminders about safety alerts, labeling changes, other patient or drug specific information that will reduce ADR’s

## FDA MedWatch and Medication Safety

- FDA MedWatch and Medication Safety

- Visit us online atwww.fda.gov/medwatch

- The views expressed are those of the presenter and not necessarily those of the FDA

**Notes:**

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