Compounding Pharmacy Safety violations

by | May 9, 2018

Safety violations hit compounding pharmacy

In December, the Food and Drug Administration issued a thorough inspection report on PharMEDium’s Tennessee plant that resulted in a pause in pharmaceutical production, until otherwise permitted. PharMEDium, one of the nation’s largest compounding pharmacy companies, is owned by AmerisourceBergen. It supplies medications to about 77% of hospitals nationwide.

There are two kinds of compounding pharmacies: ones that mix custom prescriptions for individual patients, from chemotherapy cocktails to thyroid drugs, and those like PharMEDium, which mass-produce ready-to-use IV bags, prefilled syringes and other sterile medical solutions for hospitals, surgery centers and other healthcare facilities. Pharmaceutical packaging and production typically is undergone in a cleanroom environment, guaranteeing an aseptic controlled space for production.

California’s Board of Pharmacy barred the distribution of medications in late March including lidocaine and other local anesthetics that were produced in a pharmaceutical production factory in Texas belonging to PharMEDium. After a cease-and-desist order was provided to the pharmaceutical compounding facility, the factory operations were discontinued, warranted as an immediate and severe threat to public health and public safety.

A Compounding Pharmacy Dibacle

AmerisourceBergen has repeatedly been rapped on the knuckles by regulators and state authorities who have cited violations and raised public health concerns relating to several facilities in its PharMEDium business.

But the company noted its other plants remain open and called a recent FDA warning concerning its Lake Forest, Illinois facility “procedural”.

Prior to the crackdown on PharMEDium, health care facilities’ compounding pharmacy were experiencing sever shortages of injectable opioid painkillers Dilaudid, Morphine and Fentanyl. These shortages were commenced with the manufacturing delays at Pfizer. The more recent delay of production at PharMEDium’s Memphis, Tennessee plant has further increased these shortages.

Prior to the crackdown on PharMEDium, health care facilities were experiencing sever shortages of injectable opioid painkillers Dilaudid, Morphine and Fentanyl. These shortages were commenced with the manufacturing delays at Pfizer. The more recent delay of production at PharMEDium’s Memphis, Tennessee plant has further increased these shortages.

Doctors have had to be creative to treat pain in patients, often times selecting less desirable pain medications and also increasing usage of local anesthetics such as lidocaine. Now even the local anesthetics are becoming scarce and not readily available in the hospital pharmacies.

PharMEDium is keen on reinstating it’s tenure of pharmaceutical production and sets forth to deliver compliant and safe pharmaceutical products to the nation. Pharmaceutical Compounding Pharmacy environments seek to provide the highest levels of safe pharmaceutical delivery to their patients.

California’s Board of Pharmacy has barred the distribution of medications — including lidocaine and other local anesthetics — from a Texas factory belonging to a company that supplies medications to about 77% of hospitals nationwide. (John Daley / TNS)

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