Thursday, August 29, 2013

New York denies Mercaldo Apothecary pharmacy’s application to be Medicaid provider after investigation found pharmacy stocked expired drugs and unsanitary and unsafe condition

 

The state Office of the Medicaid Inspector General has denied the application of a Manhasset pharmacy for its enrollment application to be a Medicaid provider after an investigation found the pharmacy stocked expired drugs and operated under unsanitary and unsafe conditions.
In a press release Tuesday, Medicaid Inspector General James Cox said Mercaldo Apothecary, which operates as Maclennan Pharmacy at 588 Plandome Road, had been rejected as a Medicaid provider. 
According to the release, state investigators found 38 expired drugs among the pharmacy’s inventory, including one that had expired in 2006, according to the release. State regulations prohibit pharmacies from carrying expired drugs without segregating the drugs from other medications.
In addition, investigators found a dirty pharmacy refrigerator that did not have an inside thermometer and also stored food, which is prohibited, according to the release.
The pharmacy’s counter, the Medicaid inspector general said, was found to be dusty and cluttered, and investigators found the store appeared so disheveled that wheelchair access to its aisles was thought to be impossible. Federal regulations prohibit the enrollment of an applicant whose location limits access to those with disabilities into any program that receives federal reimbursement.
The pharmacy’s sink had no running hot water and its drain was clogged, according to the release. State regulations require that hot and cold water be available in a pharmacy’s compounding and dispensing area, according to the release.
“The fact that this provider violated so many of Medicaid’s pharmacy standards has a direct bearing on their ability to provide quality medical services or supplies to Medicaid patients,” Cox said in a statement. “And they will be prohibited from doing so as long as they continue to disregard basic standards meant to protect Medicaid consumers from such practices.”
According to the release, the pharmacy was referred to the state Education Department’s Office of Professional Discipline for continued investigation.
Anthony Mercaldo, a licensed pharmacist and the company’s vice president, said he was unaware of the conditions found by the state’s investigators and declined further comment, saying Maclennan “just received a nice article in the Manhasset Press about our decades and decades of service, and we don’t really want this out there.”
Mercaldo told Newsday the company initially applied for the Medicaid program as a “favor to a few customers,” but pulled its Medicaid provider application after Medicaid officials began trying to obtain “more and more information.”  
Mercaldo told Newsday the program was not worth the company’s small number of Medicaid customers.
“They kept coming back for more information and we kept providing them more and more information,” Mercaldo told Newsday of Medicaid officials. “At some point, we decided to stop the application.
quoted from here
 

While it is claimed that large-scale compounding pharmacies only make up 10% of the compounding market, they may supply much more (NY Times). The pharmacies inspected by the FDA are thought to be some of the largest outsourcers in the country. -


Prescription for Meningitis? Unsafe Pharmaceutical Practice Linked to Nationwide Death and Illness

Posted August 28, 2013 |

By: Tatum Brontë and Mark Zamora, Esq.



Last fall, the outbreak of fungal meningitis, which spanned across at least 20 states and took as many as 63 lives, was not an isolated event nor entirely unexpected. The outbreak joins the ranks of many other adverse events caused by the shady practices of drug manufacturing—practices the Food and Drug Administration has failed to gain authority over for nearly 15 years.

At the center? Lives lost and some injured for life. Traditional compounding is still a vital part of the drug industry today. What started as a way for local pharmacists to prepare tailor-made medicine made perfect sense; a liquid product for a mom to give her infant or a dose without an allergen (such as dye). Given their nature, compounding pharmacies fall under the state law and larger protective stipulations, including a 2002 protective ruling from the Supreme Court and the Food and Drug Administration Modernization Act of 1997 (FDAMA). For example, FDAMA exempts, under certain criteria, compounding pharmacies from registration and the obligation to permit access to records during an inspection.

In other words, compounding pharmacies are exempt from FDA oversight.

Where this gets ugly: Free from federal binds and offering drugs for cheaper prices (compare brand name Makena at $1,500 a dose to $25 offered by pharmacies), the demand for compounding pharmacy supply is growing. Now, with shipment across state lines and unregulated mass production, these “pharmacies” are comfortably in the grey area between state and federal jurisdiction. The risk? Lack of appropriate air filtration and insufficient microbial testing, among other risks of contamination—grounds for fungal meningitis and tainted medicine.

continue to read here