Lec 5: ADE Reporting, MedWatch, NMBOP ADE Flashcards
REVIEW OF LANDMARK LEGISLATION AFFECTING CURRENT PHARMACY PRACTICE
1.) 1906: The Federal Food and Drug Act
2.) 1938: The Food Drug and Cosmetic Act
3.) 1962: The Kefauver-Harris Drug Amendment
1.) 1906: The Federal Food and Drug Act prohibited the interstate commerce of misbranded or adulterated drugs. The 1912 Shirley Amendment prohibited false therapeutic claims. (This is a landmark cuz this is the first time there is every any law!)
2.) 1938: The Food Drug and Cosmetic Act as a result of Sulfanilamide poisoning, manufacturers required to submit application to receive approval for a drug and prove safety but not efficacy. The FDA also gained authority to regulate devices to ensure that they are not adulterated or misbranded. (all about safety NOT efficacy)
3.) 1962: The Kefauver-Harris Drug Amendment-as a result of Thalidomide
tragedy, required well controlled trials to be conducted to prove efficacy for Rx and OTC drugs. It also defined rules for informed consent of research participants.
LANDMARK LEGISLATION AFFECTING CURRENT PHARMACY PRACTICE CONTINUED
1.) 1976: The medical device amendment
2.) 1983: The Orphan Drug Act
3.) 1990: The Safe Medical Device Act
4.) 1997: Food and Drug Administration Modernization Act
1.) 1976: The medical device amendment required manufacturers to register with the
FDA and follow quality control standards for devices prior to marketing.
2.) 1983: The Orphan Drug Act first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed. Rare diseases are classified as those affecting fewer than 200,000 persons in the United States.
3.) 1990: The Safe Medical Device Act required the post marketing surveillance and adverse event reporting of implanted devices.
4.) 1997: Food and Drug Administration Modernization Act regulated the advertising of drugs and devices for unapproved indications. Also an accelerated review process for orphan drugs and diseases that had no current available
ADE DEFINITION
-An adverse drug event (ADE)
-An unfavorable and unintended response to a drug, whether or not it is considered related to the product (may or may not be causal.)
-ADE includes medical errors, adverse drug reactions, allergic reactions, and overdoses.
STATE OF ADE REPORTING
While adverse event reporting guidelines are a common component of:
- Institutional policies and procedures
- State boards of pharmacy regulations
- Part of good practice guidelines at the professional-society level
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Health care professionals (HCPs) are currently not required by federal law or regulation to submit reports of ADEs.
o Due to difficulty in enforcing such mandates NOTE: it not required b/c it is hard to enforce but we should do it because it is beneficial.
BARRIERS TO ADE REPORTING BY HEALTHCARE PRACTITIONERS (HCP)2
- Many ADEs are likely never reported since the association is not recognized as causal (you should report it any ways even if you do not think there is a relationship/ association)
- They are not recognized as safety concerns.
- HCP are unfamiliar with the reporting process and its importance.
- Takes too much time to submit a report.
MEDWATCH MILESTONES and MORE INFO ON MEDWATCH
Designed to expedite and broaden voluntary ADEs reports by HCPs and and Consumers.
- Serious adverse events
- Non serious but unexpected
- Potential to cause harm (labeling issues).
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Reports should be submitted even when the HCP is not certain the product caused the event.
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MedWatch is the FDA’s safety information and adverse event reporting program. Through FDA MedWatch, healthcare professionals should report serious and non serious however unexpected adverse events and other situations which have a strong
potential for harm. Healthcare professionals can submit the completed Form 3500 to the FDA MedWatch system online, by fax, or mail.
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NOTE: MedWatch went online v quick! :) in 2013 - they want consumers to contribute to it as well! not just HCP. They want this to be accessible and simple so other’s can join in!
WHY REPORT?
Limitations of clinical trials to identify safety signals before marketing
- Number of patients tested may be too small to detect serious but rare problems
- Trials are too short to identify delayed adverse events
- The patients using the drug may have different comorbidities as compared to the clinical trial population.
- The drug may be used in a different population after approval for different
conditions
WHAT TYPES OF EVENTS TO REPORT
Serious ADE
– Is fatal.
– Is life-threatening.
– Is permanently disabling.
– Requires/prolongs hospitalization.
– Causes a birth defect.
– Requires intervention to prevent permanent impairment or damage.
– Potential for harm/close calls (drugs or devices).
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Non-Serious but unexpected
– Previously unidentified adverse effects of drugs (not in the package insert)
REPORTING – POTENTIAL FOR HARM
FDA is also interested in cases where the potential for harm exists Such reports help FDA identify and better understand the risks
associated with medical products
IMPORTANT CRITERIA FOR ADE REPORTING
1.) Description of adverse event-time to onset of signs and symptoms
2.) Suspected and concomitant product therapy(s) details: (lot number, schedule, dates of use and duration)
3.) Include OTC meds, herbal products, dietary supplements and any recently discontinued drugs.
4.) Patient characteristics
o Demographic information
o Medical condition prior to therapy
o Comorbid conditions
o Concomitant therapies
o Relevant family history
o Any possible risk factors associated with ADE.
5.) Clinical course of the events and patient outcomes (hospitalization, disability and death)
6.) Relevant therapeutic measures such as laboratory data
o at baseline,
o during therapy
o subsequent to adverse event should be noted
7.) Information about the response to dechallenge and rechallenge of medication
8.) Any other pertinent information
MEDWATCH - REPORTING
How to Report:
– Online (www.fda.gov/medwatch/report.htm)
– Download the form
—– Mail
—– Fax 1–800–332–0178
MEDWATCH REPORTING - VOLUNTARY FORM VS MANDATORY FORM
Voluntary Form: Clinician Form 3500 and Consumer/Patient Form
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Mandatory form:
MANDATORY Form 3500A
- User Facilities (medical devices)
- Manufacturers: Drugs, Biologics, Human Cell and Tissue Products, OTC Products, Medical Devices
REPORTING TUTORIAL – MEDWATCHLEARN
Online practice portal
– Students/Health Professionals
– Consumers Section
– Learn how to fill out a MedWatch Report
WHAT HAPPENS TO YOUR MEDWATCH REPORT?
– Report is captured in a database.
– FDA safety evaluator reviews the report.
– FDA safety evaluator looks for similar reports.
– FDA review division may consult with manufacturer.
– FDA /manufacturer conducts further epidemiological studies or post-market clinical trials as needed.
EXAMPLES OF OUTCOMES OF POSTMARKET ADE REPORTING
- Letters to health care professionals (“Dear Doctor” letters)
- New warnings, precautions (updated the product label)
- Modified contraindications
- Dosage adjustments (prescribing or dispensing limitations)
- Required Medication guides provided by the Pharmacists with each dispense (Part of REMS)
- New or additional monitoring recommendations
- Request a change in the product’s design, process, packaging, or distribution
- Boxed warnings
- Mandatory product recall and withdrawal from the market.
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NOTE: drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks
