Author: Peter

Pfizer Inc and BioNTech SE have asked the U.S. health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers...Approval by the Food and Drug Administration could send a strong signal to other regulators around the world that may ease distribution of the shot in lower-income countries...The companies have submitted new temperature data to the FDA to support an update to the current label that would allow vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks...READ MORE

Preventing medication errors is an essential component of caring for patients and must be a core mission of every pharmacy. For medication error–prevention efforts to be effective, they must be a priority...The information in the tables of this review summarizes many of the significant error-prevention strategies recommended in the ISMP Medication Safety Alert! Acute Care newsletter from January through December 2020...READ MORE

Table 1. Safety Issues Related to Labeling, Packaging, and Nomenclature
Auxiliary label obscures critical reconstitution information on label of REVATIO (sildenafil; Pfizer) oral suspension carton

Table 2. Safety Issues Associated With Order Communication and Documentation
Confusion between LYUMJEV and HUMALOG (both insulin lispro by Lilly), which have different onsets of action

Table 3. Problems Involving Drug Information, Patient Information, Patient Education, and Staff Education
Administer adenosine rapidly for cardioversion

Table 4. Safety Issues Related to Medical Devices and Equipment
Bypassing soft low-dose alerts for subtherapeutic heparin infusions

Table 5. Other Discussion Items
Differences between human error, at-risk behavior, and reckless behavior

Table 6. ISMP’s Targeted Medication Safety Best Practices for Hospitals
FDA removes syringe administration from vinCRIStine labeling

Fed up with a lack of federal action to lower prescription drug costs, state legislators around the country are pushing bills to penalize drugmakers for unjustified price hikes and to cap payment at much-lower Canadian levels...These bills, sponsored by both Republicans and Democrats in a half-dozen states, are a response to consumers’ intensified demand for action on drug prices as prospects for solutions from Congress remain highly uncertain...READ MORE

Fresenius Kabi Oncology fell afoul of the FDA in 2013 when the agency discovered employees had hidden records before a manufacturing inspection. Now, the drug ingredients manufacturer is admitting fault—and has reached a deal with the U.S. Department of Justice to put the investigation to bed...The Fresenius Kabi unit agreed to pay a $30 million fine, forfeit another $20 million and plead guilty to concealing and destroying records ahead of a 2013 FDA inspection in Kalyani, India...READ MORE

A federal judge has dismissed a lawsuit filed by several hospital groups seeking to get the Department of Health and Human Services to clamp down on drugmakers restricting access to products...Federal Judge Yvonne Gonzalez Rogers issued a ruling...that hospitals had to use a new dispute resolution process to settle the feud with the drugmakers, which the hospitals cannot sue individually under federal law for 340B violations...READ MORE

The World Health Organization has granted an emergency authorization to AstraZeneca’s coronavirus vaccine, a move that should allow the U.N. agency’s partners to ship millions of doses to countries worldwide as part of a U.N.-backed program to tame the pandemic...the WHO said it was clearing the AstraZeneca vaccines made by the Serum Institute of India and South Korea’s AstraZeneca-SKBio...“Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk,” said Dr Mariângela Simão, the WHO’s Assistant-Director General for Access to Medicines and Health Products....READ MORE

Florida-based drugmaker Allay Pharmaceuticals is in hot water with the FDA after it failed to right the manufacturing wrongs flagged in an inspection last May...FDA slapped Allay for failing to set up proper procedures and process controls for tablet manufacturing at its plant in Hialeah, Florida, according to a warning letter...Inspectors turned up potency problems, substandard API testing and biologics manufacturing without FDA approval...READ MORE

Nearly 82% of hospitals surveyed by the Joint Commission in 2019 were noncompliant with at least one Medication Management chapter item. Still, experts say they are hopeful that recent revisions will help those hospitals meet the accreditor’s expectations...Topping the list of noncompliance in 2019 was the medication administration standard, which 49% of hospitals failed to adhere to, Mansur noted. “Surveyors have been finding medications being administered for an indication when another medication was specified, or an ordered medication given for a different indication, and often this is done without a documented explanation,” she said. “Surveyors will also often see that administration of medication, particularly titration medication, is performed differently than is directed by the order.”...READ MORE

Dozens of pharmacy chains and grocery stores with pharmacy counters are slated to start offering COVID-19 vaccinations this week, creating a wealth of employment opportunities. The companies are vying with one another—offering lucrative signing bonuses, in some cases—to hire established pharmacists, pharmacy technicians, student pharmacists, nurses, and other help. CVS Health is working toward 15,000 new vaccine-related hires, Walgreens has targeted 9,000, Kroger plans to recruit nearly 1,000 health care workers, and Rite Aid is looking to fill more than 2,000 pharmacy jobs...READ MORE

CPI, one of the founding partners in the Medicines Manufacturing Innovation Centre, has announced the signing of an agreement with PwC, making the company the latest partner in the collaborative effort. The Centre (established via a partnership among CPI, the University of Strathclyde, UK Research and Innovation, Scottish Enterprise and founding industry partners AstraZeneca and GSK) seeks to promote more innovative drug manufacturing processes and enable a more agile supply chain...PwC and the existing partners will work to maximize technological opportunities across the pharma supply chain. Efforts include...projects, intended to advance emergent and disruptive technologies. The program is partially funded by Innovate UK through the Industrial Strategy Challenge Fund and Scottish Enterprise via the Scottish Government...READ MORE