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Home My WebLink AboutResolutions - 2007.06.14 - 28440REPORT (MISC. 107138) July 14, 2007 BY: General Government Committee, Christine Long, Chairperson IN RE: MR #07138— BOARD OF COMMISSIONERS — REQUIRE OAKLAND COUNTY HEALTH DEPARTMENT TO PROVIDE CONSUMERS WITH EDUCATION BROCHURE FOR REPORTING SEVERE ADVERSE REACTIONS TO THE FEDERAL DRUG ADMINISTRATION AND THE VACCINE ADVERSE EVENT REPORTING SYSTEM To the Oakland County Board of Commissioners Chairperson, Ladies and Gentlemen: The General Government Committee, having reviewed Miscellaneous Resolution #07138 on June 4, 2007, reports with a recommendation that the resolution be amended, as follows: 1. Amend the NOW THEREFORE BE IT RESOLVED paragraph, as follows: NOW THEREFORE BE IT RESOLVED that the Oakland County Board of Commissioners requires the Oakland County Health Division to develop a brochure or other mechanism for the purpose of educating and encouraging county residents to report serious adverse effects of vaccines, prescription drugs, generic drugs, over the counter medications and medical appliances to the FDA. 2. Amend the 1 st BE IT FURTHER RESOLVED paragraph, as follows: BE IT FURTHER RESOLVED that the Oakland County Health Division fetaGit advise consumers of the reporting options for serious adverse effects that they become aware of to MedWatch or VAERS as long as such reporting is consistent with state and federal patient privacy statutes. Chairperson, on behalf of the General Government Committee, I move acceptance of the foregoing report. GENERAL GOVERNMENT COMMITTEE u‘t General Government Committee Vote: Motion carried on a roll call vote with Kowall absent. Miscellaneous Resolution # 07138 By Commissioners Sue Ann Douglas, Christine Long, Eileen Kowell RE: Board of Commissioners — Require Oakland County Health Department to Provide Consumers with Educational Brochure for Reporting Severe Adverse Reactions to the Federal Drug Administration and the Vaccine Adverse Event Reporting System Chairperson, Ladies and Gentlemen, WHEREAS the Federal Drug Administration (FDA), the Department of Health and Human Services (HHS), and the Centers for Disease Control and Prevention (CDC) provide healthcare professionals and consumers with access to MedWatch, an adverse event reporting system for serious adverse events, potential and actual product use errors, and product quality problems associated with the use of FDA-regulated drugs, biologics (including human cells, tissues, and cellular and tissue-based products), medical devices (including in-vitro diagnostics, special nutritional products and cosmetics); and WHEREAS MedWatch allows healthcare professionals and consumers to report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use; and WHEREAS, the Federal Drug Administration (FDA), the Department of Health and Human Services (HHS), and the Centers for Disease Control and Prevention (CDC) also provide The Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance; and WHEREAS products are tested prior to FDA approval on a relatively small group of people and sometimes negative product effects are not recognized until the product is distributed to the general population; and WHEREAS healthcare providers are not required to report serious adverse effects and product quality problems to the FDA; and WHEREAS reporting serious adverse effects of vaccines, prescription drugs, generic drugs, over the counter medications and medical appliances helps ensure the product safety for end users of these products; and WHEREAS if a consumer believes that he/she or a family member has experienced a serious adverse effect from a product, they are encouraged to provide their information to the FDA; and WHEREAS reporting problems can lead to improved labeling, warnings being issued or product recalls; and WHEREAS reports can be filed either online, by fax, by telephone or by mail. The FDA will respond to let the person reporting know that their report was received. c ommissioner Sue Douglas District # • loner Eileen KowIll 11\1/valk;_, Commissioner District District #1 Co Di Corrimissioner District # *-c ommissioner District # &02-e-r 6G024t-L(1 Commissioner District # C5iioner District # Comtnissioner District # , • Commissioner D istri ct # Ompfssioner Djsirict # y Coryfmissioner Eti§trict # NOW THEREFORE BE IT RESOLVED THAT the Oakland County Board of Commissioners requires the Oakland County Health Division to develop a brochure for the purpose of educating and encouraging county residents to report serious adverse effects of vaccines, prescription drugs, generic drugs, over the counter medications and medical appliances to the FDA. BE IT FURTHER RESOLVED that the Oakland County Health Division report serious adverse effects that they become aware of to MedWatch or VAERS as long as such reporting is consistent with state and federal patient privacy statutes. BE IT FURTHER RESOLVED that the educational brochure be available on the ,Oakland County Website. Mr. Chairman, we move adoption of the foregoing resolution. District # Conimis)sioner Distiict # 5- C?4t Commissioner District # Corfimissioner District #7_73 missioner District # g;Z Commissioner District # ts? Commissioner District # Commissioner District # Commissioner District # Commissioner District # Commissioner District # Commissioner District # Commissioner District # Commissioner District # Attachment: FDA Reporting Websites: - Vaccines (VAERS) - https://secure.vaers.orgNaersDataEntryintro.htm - Other medications & medical appliances https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm htm Resolution #07138 May 24, 2007 The Chairperson referred the resolution to the General Government Committee. There were no objections. Ruth JaTigiin-, County Clerk a 2, Resolution #07138 June 14, 2007 Moved by Long supported by Douglas the resolution be adopted. Moved by Long supported by Douglas the General Government Committee Report be accepted. A sufficient majority having voted in favor, the report was accepted. Moved by Long supported by Douglas the resolution be amended to coincide with the recommendation in the General Government Committee Report. A sufficient majority having voted in favor, the amendment carried. Vote on resolution, as amended: AYES: Gosselin, Gregory, Greimel, Hatchett, Jacobsen, KowaII, Long, Middleton, Nash, Potter, Potts, Rogers, Scott, Spector, Suarez, Woodward, Zack, Bullard, Burns, Coulter, Crawford, Douglas, Gershenson, Gingell. (24) NAYS: None. (0) A sufficient majority having voted in favor, the resolution, as amended, was adopted. "MM. I HEREBY APPROVE THE FORRING RESOLUTION STATE OF MICHIGAN) COUNTY OF OAKLAND) I, Ruth Johnson, Clerk of the County of Oakland, do hereby certify that the foregoing resolution is a true and accurate copy of a resolution adopted by the Oakland County Board of Commissioners on June 14, 2007, with the original record thereof now remaining in my office. In Testimony Whereof, I have hereunto set my hand and affixed the seal of the County of Oakland at Pontiac, Michigan this 14th day of June, 2007.