Washington, D.C. – U. S. Senator Kirsten Gillibrand this week introduced the Cody Miller Initiative for Safer Prescriptions Act (CMISP), new legislation that would finally require the FDA to approve and standardize information distributed to patients when they pick up their prescriptions. Current information is not subject to any review or standard. The new requirements would ensure patients are kept up to date about potential adverse side effects and dangerous drug interactions.
On August 4, 2007, Cody Miller, a Queensbury teenager, committed suicide after switching prescription allergy medications. Senator Gillibrand’s legislation would ensure that if new side effects are discovered, they are added to the information provided with the prescription.
“I was shocked to learn that the pharmacist-provided information for my children’s prescriptions were not subject to any standards or oversight. How can parents know about dangerous drug interactions or risky side effects to look for in their children if the information provided by the pharmacist is incomplete or out of date,” asked Senator Gillibrand. “Consumers have a fundamental right to know the risks associated with their prescription medications.”
“As a consumer, I was completely unaware that this information from my pharmacy was not directly regulated by the FDA. Many consumers do not understand that without this being done, they will receive watered down information that may or may not be completely current and accurate,” said Kate Miller, who lost her son Cody. “It is a no brainer, we must look at this as just another consumer safety issue, one that has been sorely overlooked and can be corrected with these changes this bill proposes. My child and many other consumers that have fallen between these crevices would have benefited as a direct result from this bill, had it been in place for them.”
AARP said, “As prescription medicine use increases with age for most older adults, it is not always easy to stay on track with medicine regimens. Combined with talking with a pharmacist and other health care professionals, a key resource to help patients use medicines safely and appropriately is at one’s fingertips: the written information that comes with a prescription medicine. Today, AARP is pleased that Senator Gillibrand has recognized the value of this resource, through this legislation that would strengthen patient medication information’s quality, timeliness, and scientific accuracy. Enhanced patient medication information, distributed at the pharmacy, can help patients use their medicines safely, minimize risks, and — in combination with conversation with pharmacists and other health care providers — get the most value out of their medicines.”
In 1995, the Food and Drug Administration (FDA) recommended standards for the distribution and quality of information given to patients about their prescription drugs. The goal was to have 75 percent of new prescriptions contain useful written information by 2000 and 95 percent of all new prescriptions in 2006. A 2008 study conducted at the request of the FDA showed that 94 percent of pharmacies do provide written information with a prescription, although varying widely in detail, ranging anywhere from just 33 words to nearly 2,500 in length. On 43 percent of the information that was distributed, no publisher was identified. This legislation will finally enshrine these recommendations in law.
The CMISP legislation would require the Secretary of Health and Human Services to issue regulations on the content, format and distribution of Patient Medical Information (PMI) in easy to understand language for consumers. The content would include approved labeling, common side effects, serious risks, and when a patient should contact a health care professional along with proper storage instructions for their medication. Regardless of what drug store or prescription mail order company a family uses, the information would be uniform, accurate and up-to-date.