National Drug Safety Delta Group: Tawni Cunningham, Kimberly Hahn, & Marwah Zagzoug A Need for Change and Improvement
When a drug is approved and placed on the market, it does not necessarily mean it is safe! <ul><li>This is the valuable le...
Is the FDA doing all that it can to protect the public from unsafe drugs, including those that have already reached the ma...
Evaluating the Issues <ul><li>The nation’s current system in tracking adverse events and side effects is flawed. </li></ul...
Evaluating the Issues <ul><li>The FDA is heavily influenced by pharmaceutical companies </li></ul><ul><ul><li>Their decisi...
What can be done to change/improve the system? <ul><li>Establish a Drug Safety Monitoring Board independent of the FDA </l...
Purpose of the Data Safety Board <ul><li>The mission of the board should not be to totally overhaul the efforts currently ...
Functions of the Drug Safety Board <ul><li>Institute changes from a passive post marketing reporting system of AE’s from ...
Functions of the Drug Safety Board <ul><li>Through legislation, mandate pharmaceutical companies to conduct post-marketin...
Functions of the Drug Safety Board <ul><li>Ask Congress to give the board power to enforce stiff penalties on drug compani...
Final Thoughts <ul><li>By implementing this new board, drugs can be removed from the market faster, therefore limiting the...
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National Drug Safety: A Need for Change and Improvement

Published on: Mar 3, 2016
Published in: Health & Medicine      Business      
Source: www.slideshare.net


Transcripts - National Drug Safety: A Need for Change and Improvement

  • 1. National Drug Safety Delta Group: Tawni Cunningham, Kimberly Hahn, & Marwah Zagzoug A Need for Change and Improvement
  • 2. When a drug is approved and placed on the market, it does not necessarily mean it is safe! <ul><li>This is the valuable lesson learned after the events that occurred with high profile drugs such as Vioxx and Baycol. Recently, there has been growing scrutiny towards the FDA in its incompetence in monitoring drugs after they reach the market. </li></ul><ul><li>The public’s confidence has been shaken. </li></ul>
  • 3. Is the FDA doing all that it can to protect the public from unsafe drugs, including those that have already reached the market?
  • 4. Evaluating the Issues <ul><li>The nation’s current system in tracking adverse events and side effects is flawed. </li></ul><ul><li>The current system does not move fast enough to remove dangerous drugs from the market upon discovery of side effect or adverse effect. </li></ul><ul><li>The current system is slow in warning consumers about risks that emerged after drug approval. </li></ul>
  • 5. Evaluating the Issues <ul><li>The FDA is heavily influenced by pharmaceutical companies </li></ul><ul><ul><li>Their decision on drug approval is based on the data received from pharmaceutical companies which may not be complete. </li></ul></ul><ul><ul><li>There is a possibility of drug makers concealing unfavorable data to gain approval. </li></ul></ul><ul><li>Many adverse events go unreported. </li></ul><ul><li>Several drug companies agree to conduct post marketing studies but more than half fail to do so. </li></ul>
  • 6. What can be done to change/improve the system? <ul><li>Establish a Drug Safety Monitoring Board independent of the FDA </li></ul>
  • 7. Purpose of the Data Safety Board <ul><li>The mission of the board should not be to totally overhaul the efforts currently being conducted by the FDA Office of Drug Safety, but rather to remove the possibility of a conflict of interest and enact changes to improve the system already in place. </li></ul><ul><li>The new board should be able to set standards and make regulations for improvement in the system. It should act as an “impartial and unbiased jury” by seeing the system in place with a different perspective </li></ul>
  • 8. Functions of the Drug Safety Board <ul><li>Institute changes from a passive post marketing reporting system of AE’s from physicians/providers to mandatory reporting. </li></ul><ul><ul><li>Although this seems like an impossible task to enforce, it is vital that providers take on responsibility of reporting AE’s experienced by their patients in order to protect the health of the public. </li></ul></ul><ul><ul><li>This could be accomplished by enacting standards similar to the work being done by cancer registries who collect on the incidence of cancer diagnosis. For more incentive, institutions who provide and AE registry can receive accreditation or be tagged to current accreditation. </li></ul></ul><ul><ul><li>There should be strict repercussions for not reporting AE’s or any information pertaining to patients that could be detrimental to their health. </li></ul></ul>
  • 9. Functions of the Drug Safety Board <ul><li>Through legislation, mandate pharmaceutical companies to conduct post-marketing trials. This does not have to be as complicated as a pre-market trial but rather formatted as a registry where the goal is to collect adverse events in a large population. </li></ul><ul><ul><li>Done electronically it can be done very efficiently and may actually benefit a company if their safety is proven better than another similar drug. It may also save them money in the long run as it could prevent possible law suits. </li></ul></ul><ul><li>Once the post marketing trials are complete, it would be the board’s responsibility to cross reference trials with similar drugs to see if there is a pattern and to report back to the FDA all findings. </li></ul><ul><li>Getting cooperation from drug companies would probably be the greatest challenge to overcome. The board can offer incentives and emphasize the benefits that turning all post market evaluation can give them, such as official recognition and favorable comparisons between them and other companies. </li></ul>
  • 10. Functions of the Drug Safety Board <ul><li>Ask Congress to give the board power to enforce stiff penalties on drug companies who are found to conceal data that affects public safety. </li></ul>
  • 11. Final Thoughts <ul><li>By implementing this new board, drugs can be removed from the market faster, therefore limiting the amount of AE’s patients experience. Companies can benefit by having a kind of insurance that would minimize the risk of lawsuits. </li></ul>

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