Archives for July 2015

Pharmacy Recalls Compounded Drugs Due to Sterility Concerns

A pharmacy in Washington is recalling unexpired human and veterinary compounded drugs due to concerns about their sterility.

Moses Lake Professional Pharmacy compounded these recalled products between July 21, 2014, and July 21, 2015. The drugs were then dispensed to patients or distributed to physicians to administer to patients in Arizona, Idaho, Florida, Oregon, Texas, and Washington.

The pharmacy issued the recall after a recent inspection identified an issue with sterility assurance. All recalled products have a label that includes the pharmacy name and the name of the compounded drug product. The recall does not affect any non-sterile compounded medications it prepared, or any sterile products it compounded after July 21, 2015.

Although the compounding pharmacy has not received any reports of adverse events or product contamination to date, patients who use tainted products intended to be sterile could face risk for serious infections that may be life threatening.

“We are fully cooperating with the FDA and we regret any impact this voluntary recall may have on our patients,” stated Moses Lake Professional Pharmacy owner and pharmacist Shawn Needham, RPh. “Patient safety is our highest priority.”

The company has already begun notifying patients of the recall via telephone, fax, regular mail, and e-mail. The FDA advised recipients of recalled unexpired products to immediately discontinue use and return them to the pharmacy.

Unexpired lots of the following sterile compounded products have been recalled:

PP&P July 2015 Digital Edition – Detecting and Responding to Drug Diversion

800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. settles false claims against pharmacy for $8 million

The United States has settled allegations that a Jacksonville-based compounding pharmacy knowingly billed the government for improper and medically unnecessary compounding pain prescriptions. The allegations resolved included liability under the False Claims Act.

How Automated Compounding Can Reduce Hospital Costs

The $200 million fund created to compensate victims of the 2012 meningitis outbreak tied to tainted drugs from the New England Compounding Center is an extreme example of how expensive compounding errors can be.

7 Tips to Create Good Documentation Practices in Your Lab

Quality process and testing are the foundation of every good compounding pharmacy but we are often asked, “How does a pharmacy know that their quality assurance programs are paying off?” A second question usually follows – how they can also build their business utilizing these quality efforts.

Pharmaceutical Innovation Highlights the Need for Creative Solutions to Common Problems, Says Medlife Pharmacy

An article published June 24th on YourStory.com outlined a report from Cambridge ConsultaTagsnts that discussed how innovation and technology would be the “key factors” in the growth of pharmaceutical companies going forward. The article outlined the need to address issues of accessibility and affordability, especially in emerging and growing markets. According to the compounding pharmaceutical specialists at MedLife Pharmacy in Irvine, innovation really is key in successfully delivering pharmaceuticals to costumers in need of generally unavailable solutions to certain medical problems, and it applies to pharmacists as well as manufacturers. “Pharmaceutical compounding is all about providing customized medications to patients with special needs,” said the Los Angeles pharmacy. “It is one of the ways that 21st century medical professionals are meeting new patient needs with innovative solutions.” Medlife says that, because the big bio-tech companies are focused on profitable solutions for the masses rather than specialized care for the individual, it is up to compounding pharmacists like themselves to craft solutions for patients with needs that fall outside of the scope of traditional pharmaceuticals. According to Medlife Pharmacy in Irvine, several of these specific needs include:

FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy

The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.

FDA again delays drug ‘track and trace’ enforcement

The Food and Drug Administration is giving pharmacies another four months before they’re penalized if they can’t document the chain of custody for the drugs they dispense. The requirement was adopted under a 2013 law passed in response to a meningitis outbreak traced to a compounding pharmacy.The agency previously intended to begin enforcing the policy July 1 for all businesses involved in the prescription drug supply chain. The policy is intended to speed the ability to find harmful products and remove them from the supply chain.

At the end of last year, the agency announced a phased approach to enforcing the rules, beginning with manufacturers, wholesale distributors and repackagers on Jan. 1. The FDA twice delayed enforcement for those companies, finally pushing the date to July 1 after they complained that complications in the exchange of information could disrupt patients’ access to drugs.