China institutes first-ever drug recall policy
BEIJING, China China began on Wednesday a nationwide recall system that makes companies responsible for recalling harmful drugs, according to published reports. The move came a day after U.S. and Chinese officials signed an agreement on the safety of medicine and medical devices.
Under the new law, companies must establish systems to recall harmful drugs within a set time period and alert the government of any noticeable negative reactions to the drugs among patients.
The new recall rule puts the responsibility on companies to have such systems in place. Each drug will be recalled within different timeframes, ranging from 24 hours for the most serious drugs to 72 hours for those deemed less life-threatening.
They are also encouraged to carry out voluntary recalls and may escape legal punishment if they do. Drug distributors and medical institutes must also notify authorities of any safety risk to a particular drug.
Unlike the United States’ policy of voluntary drug recalls by companies, the Chinese government can also order a compulsory recall of bad drugs. A fine of three times the total value of the recalled drugs will also be levied on any company that did not voluntarily recall a bad drug.
“We hope that government and companies can cooperate to enhance and perfect the establishment of the system and not just rely on the government’s information. The companies should make efforts to monitor drug reactions,” State Food and Drug Administration deputy director Yan Jiangying said.
FDA grants Mylan tentative approval for generic Lamictal
PITTSBURGH, Pa. Mylan Pharmaceuticals has received tentative approval from the Food and Drug Administration for a generic version of Lamictal.
Lamictal, by GlaxoSmithKline is used to treat epilepsy and bipolar I disorder. The generic version, lamotrigine, will be available in 25 mg, 100 mg, 150 mg and 200 mg tablet strengths.
The drug had sales of about $1.97 billion for the 12 months ended Sept. 30, 2007.
NoMoreClipboard.com, ReliefInsite.com partner to offer online pain management module
FORT WAYNE, Ind. NoMoreClipboard.com and ReliefInsite.com have teamed up to ease pain management for patients, practitioners and caregivers. The two have incorporated a free pain management module into the NoMoreClipBoard.com interface.
NoMoreClipboard.com, an online personal health record company, works with health care providers and industry groups to simplify transactions between patients, providers and payors, saving each party significant time and effort. Within NoMoreClipboard.com, patients or caregivers can store information such as allergies, medications and medical conditions in a secure environment. The patient can then choose to share their records with selected health care providers, and NoMoreClipboard.com takes care of securely transferring the record to physicians on behalf of the patient. ReliefInsite.com is a health care information technology company that provides secure online pain management services.
The ReliefInsite.com pain management module within NoMoreClipboard.com allows patients to share their daily pain diary with doctors, nurses, therapists, family members and friends. In addition, ReliefInsite.com offers dynamic, real-time graphical reports to help improve patient compliance, and assists case managers by monitoring therapy effectiveness with time-stamped records, revealing the interaction between pain levels and the patient’s personal and professional lifestyle.
“NoMoreClipboard.com allows patients to store and manage health information and share it with their health care providers, easily and seamlessly,” said Jeff Donnell, NoMoreClipboard.com vice president of marketing. “The ReliefInsite pain management module makes our personal health record even more valuable for the 50 million Americans who currently suffer from chronic pain.”