TRENTON – Senator Barbara Buono announced today the introduction of two pieces of legislation that would increase patient safety by creating a registry of clinical trial data for prescription drugs and requiring medical facilities to implement more stringent infection-control practices.
The first bill would require State-licensed special and general hospitals, nursing homes and inpatient rehabilitation facilities to implement infection-control practices that incorporate guildelines established by the Society for Healthcare Epidemiology of America (SHEA). The guidelines seek to reduce the number of healthcare facility-acquired infections, especially those caused by the drug-resistant bacteria Methicillin-Resistant Staphylococcus Aureus (MRSA) and Vancomyacin-Resistant Enterococcus (VRE).
“The treatment of patients infected by MRSA is costing the United States over $3 billion a year – an amount we need to reduce as we seek to keep health care costs under control,” said Senator Buono, D-Middlesex.
According to the Centers for Disease Control and Prevention, MRSA has become the dominant cause of staph infections over the past three decades, rising from 2% of all reported cases in 1974 to more than 60% of all cases in the United States today.
“Through the practices outlined in this bill, hospitals in Denmark and Holland have been able to significantly reduce the prevalence of staph infections amongst their patients,” explained Senator Buono. “These sensible, cost effective means of infection control are the type of practices our hospitals need to enact here in New Jersey.”
The SHEA guidelines include a three-pronged approach to infection control: screen and isolate carriers of MRSA and VRE; adhere strictly to hand washing and hygiene guidelines; and use antimicrobial agents prudently.
The other bill, the “Prescription Drug Right-to-Know Act,” would require prescription drug manufacturers to report clinical trial data to the Department of Health and Senior Services. This data would be used to establish a clinical trials registry that would be accessible to the general public through the Department’s website.
“As the recent Vioxx trials have shown, even FDA approval doesn’t guarantee that a prescription drug is 100% safe,” said Senator Buono, D-Middlesex. “As the number of prescription drugs continues to rise, access to information like the results of clinical trials will play an important role in helping patients to make the right health care decisions.”
Under the bill, any pharmaceutical company initiating a clinical trial would need to notify DHSS of the trial within 30 days of its start and submit the outcome of the trial within 90 days of its conclusion. Any pharmaceutical company that violates the provisions of the bill would be liable to a civil penalty of between $250 and $10,000 per day in violation.
Senator Buono added, “This registry won’t be intended to replace the advice of a trusted doctor, but rather help to make those conversations more complete.”
Both bills await a hearing by the Senate Health, Human Services and Senior Citizens Committee.