Docket Management
Docket: 02N-0115 - Risk Management of Prescription Drugs; Public Hearing
Comment Number: EC -4

Accepted - Volume 1

Comment Record
Commentor Ms. Johnette Mason Date/Time 2002-05-22 04:20:41
Organization Revolution inc.
Category Consumer Group

Comments for FDA General
Questions
1. What improvements are needed to enhance communication about safety issues for drugs? What improvements are needed to communicate information about the efficacy of drugs? This is in regaurds to Psychiatric medications. The Drug Companies should be made to provide information about each drug in layman terms to the Patient what the drug How it works on the Brain,what the desired effects are from the treatment of the drug and possible side effects in laymans terms so that the Patient can make an intelligent decision if they want to take the drug or not. THIS SHOULD BE MANDATORY.
2. What are the strengths and weaknesses of the agency's current risk labeling approach? THE STREGTH IS THAT THE HEALTH CARE PROFESSIONAL KNOWS WHAT IT DOES,THE WEAKNESS IS THAT THE PATIENT DOESNT.
3. How can communication with health care practitioners become more effective (e.g., improve the "dear health care practitioner letter" and other current communication strategies)? I SUPPOSE THAT IS GOOD
4. What other steps should FDA be taking to communicate risks and benefits? MAKING THE DRUG COMPANIES ACCOUNTABLE TO THE PATIENT ON THE EDUCATION OF THE PRESCRIBED MEDICATION.
5. What methods should FDA be using to manage risk? What new tools can be created to better address specific drug risks? CONSUMER SURVEYS IN THE MENTAL HEALTH COMMUNITY ON DRUGS FOR ADULTS AS WELLAS CHILDREN BECUASE MANY ADULTS ARE PARENTS AND NEED TO BE IN GOOD HEALTH TO TAKE CARE OF THE LITTLE ONES THAT DEPEND ON THEM.
6. What are the advantages and disadvantages of restricted marketing as a risk management tool? A: NOT TOO MANY PEOPLE WILL BE AFFECTED IF THE DRUG IS FAULTY D: IF THE DRUG IS NOT FAULTY MANY PEOPLE WILL NOT HAVE ACCESS TO IT
7. What risk interventions can FDA initiate for pharmacists, physicians, patients, and drug manufacturers? PROVIDING INFORMATION IN LAYMANS TERMS IN THE DR. OFFICE
8. Evaluation of Risk Management Strategies and Interventions: What risk management interventions should be studied for effectiveness? What criteria should be used to judge if a risk management intervention is effective? I HAVE NOT READ ABOUT THE RISK MANAGEMENT STRATEGIES ALREADY IN PLACE




EC -4