Archives for September 2017

Closed-System Transfer Devices: Important Considerations for Pharmacists

 

Closed-system transfer devices (CSTDs) mechanically prohibit the transfer of environmental contaminants into a system and the escape of hazardous drugs or vapor concentrations outside the system. Although the first CSTD was approved in the United States in 1998, several products are currently available, including those with widely varying design characteristics.1-3

Pharmacy Tech Pleads to Taking Morphine and Dilaudid Intended for Hospice Patients

BIRMINGHAM – The U.S. Attorney’s Office today charged the former lead technician at a central Alabama pharmacy with tampering with vials of opioid painkillers used in the compounding of intravenous fluid bags intended for hospice and homecare patients. U.S. Attorney Jay E. Town, Drug Enforcement Administration Assistant Special Agent in Charge Bret Hamilton and Food and Drug Administration, Office of Criminal Investigations, Special Agent in Charge Justin D. Green announced the charge.

 

FDA plans new compounding pharmacy policy, agency head says

The head of the U.S. Food and Drug Administration said on Friday the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company.

The Underappreciated Risks of Hospital IV Compounding

A typical hospital room can be described as a patient lying in a bed with an IV drip bag hanging from a pole. But when you take a closer look at IV administration of fluids and medications, it is so much more than a common task. What can be viewed as an uneventful procedure, even by  health-care professionals, is too often accompanied by major errors.

Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.

A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities

By Andrew Walsh; David G. Dolan, Ph.D.; Andreas Flueckiger, M.D.; Igor Gorsky; Robert Kowal; Ester Lovsin Barle, Ph.D.; Mohammad Ovais; Osamu Shirokizawa; and Kelly Waldron

 

Part of the Cleaning Validation for the 21stCentury series