Pharmapack Europe kicked off its patient-centered conference and exhibition on February 13 in Paris, promoting ideas and technologies for driving product safety and ease of use, patient compliance, and anticounterfeiting. Speakers at the conference urged attendees to consider the importance of packaging and labeling for effective product use.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued new instructions to promote safe use of the fibrin sealants Tisseel, Tissucol, Artiss, and Beriplast P during surgery. This advice follows that issued for two other fibrin sealants, Evicel and Quixil, in November 2012. Employed to help reduce local bleeding, these sealants are typically dripped or sprayed onto bleeding tissue to form a fibrin clot.
Safe in Common (SIC), a non-profit organization aiming to end needlestick and sharps-related injuries, is hosting a panel of healthcare safety experts this week to discuss development of a unified plan to address the shortcomings in injury prevention. According to the group, "The Unfinished Agenda" picks up where federal regulations left off more than 10 years ago and examines modern needlestick safety from its roots in the 1980s HIV/AIDS crisis to where we stand today.
In response to a number of queries from stakeholders, RB confirms that Reckitt Benckiser Pharmaceuticals Inc. confirms that it notified the U.S. Food and Drug Administration (FDA) on September 18, 2012 that the company is voluntarily discontinuing the supply of Suboxone Tablets in the US (buprenorphine and naloxone sublingual tablets [CIII]) due to increasing concerns with pediatric exposure.
The U.S. Food and Drug Administration is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a health care provider. Intestinominica contains the prescription drug ingredient, chloramphenicol. Oral forms of chloramphenicol were formally withdrawn from the United States market in July 2012 due to the risk of serious and life threatening injuries.
Little did I know that I would hear HHS Secretary Kathleen Sebelius extoll iTriage's benefits at Datapalooza 3. The app is among new tools that seek to mine healthcare data for innovation and progress.
Human behavior has been all but ignored as the root cause for the failure of healthcare adherence, argues John Bitner, a design engineer who has studied human interaction with packaging for decades. “People are adverse to change,” he says. “Even when faced with a very bad disease, and they know a lifestyle change is essential to survival, for whatever reason, they cannot.”
FDA has approved SPRIX (ketorolac tromethamine), an intranasal formulation of the analgesic drug ketorolac, as an alternative to opioids. While the nonsteroidal anti-inflammatory ketorolac has typically been given in hospitals as an injection for short-term pain, SPRIX has been approved as a nasal spray for outpatient use. The new drug uses a nasal spray pump from Aptar Pharma.
Combination products and copackaged medical products are evolving. Growth in drug self-administration is being fueled by changing patient populations, efforts by managed-care providers to control healthcare costs, and a focus on safety and compliance. According to Code of Federal Regulations Title 21, a combination product comprises any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.