|
ANNOUNCEMENT! In our coverage of NIOSH, OSHA, and EPA, we have completed our NIOSH summaries and will begin with OSHA next week.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
|
|
News
Biotin May Interfere with Lab Tests Related to Heart Attacks
The FDA is communicating to the public, healthcare providers, lab personnel, and lab-test developers that biotin, often found in dietary supplements, can significantly interfere with certain lab tests causing a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks; this may lead to a missed diagnosis and potentially serious clinical implications. The FDA reported initially on this in 2017, and some lab-test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it.
https://www.fda.gov/medical-devices/vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference
The FDA Has Little Authority to Control Quality of Foreign-Made APIs
About 80% of manufacturers of active pharmaceutical ingredients (APIs) for the domestic drug market are located outside the U.S., according to the FDA. But for some drugs, China is the only supplier. At a congressional hearing last week, lawmakers expressed alarm, and sometimes disbelief, at the lack of oversight the FDA demonstrates over these foreign suppliers — despite the fact that U.S. drug firms are continuously outsourcing their manufacturing needs. To the surprise of lawmakers in the room, regulators at the hearing said they cannot control or properly monitor these dangerous drugs until long after they've reached U.S. shores.
https://www.newsweek.com/congress-spooked-tainted-chinese-drugs-eyeing-pharmaceutical-supply-chain-1468753
Counterfeit Prescription Medications Made of Fentanyl are Killing Americans
The DEA issued a warning on Monday about counterfeit prescription drugs saying they are "killing Americans." "Mexican drug cartels are manufacturing mass quantities of counterfeit prescription drugs containing fentanyl," according to a press release from the DEA. Twenty-seven percent of counterfeits seized by the DEA contain "potentially lethal doses of fentanyl" and are capitalizing on the opioid epidemic and prescription drug abuse in the U.S. Drug trafficking organizations are now sending counterfeits made with fentanyl in bulk to the U.S. for distribution. The counterfeits look almost identical to oxycodone products.
https://abcnews.go.com/International/counterfeit-prescription-pills-made-fentanyl-killing-americans-dea/story?id=66740190
UPS Drone Makes First Home Prescription Deliveries for CVS
United Parcel Service In. (UPS) Flight Forward drones have flown prescription medications to the front lawn of a private home and to a retirement center; the UPS unit's first revenue-generating deliveries for drugstore chain CVS Health Corp (CVS.N). Flight Forward's maiden delivery flight last week in Cary, North Carolina, beat rivals in one phase of the race for this market. The second drone flight delivered medications to a public space at a retirement community. The packages, roughly the size of small shoeboxes, were lowered from drones hovering at an altitude of about 20 feet.
https://www.reuters.com/article/us-ups-drones/ups-drone-makes-first-home-prescription-deliveries-for-cvs-idUSKBN1XF2JC
|
|
Tip of the Week
How many people do we see today that want their "5 minutes of fame" and will do anything to get it, even lie, tell partial truths, or sell themselves down the river. It makes one wonder how they feel about themselves when they are all alone in a quiet room!
|
