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By William J. Beerman, Sr.
A Pittsburgh area institutional pharmacist who filled prescriptions for nursing home residents was sentenced in federal court to 2 years probation and 150 hours of community service on October 17 after being convicted of conspiracy in a fraud scheme. According to the U.S. Department of Justice (DOJ), MedFast pharmacy drivers picked up leftover drugs from nursing homes. Then, the Beaver County manager for MedFast oversaw repackaging of the picked-up drugs for reuse in other prescriptions.
DOJ said drugs from different manufacturers with different lot numbers and different expiration dates were commingled in pharmacy stock bottles after the pharmacy picked them up from nursing homes. When it was necessary for pharmacy employees to enter lot numbers and expiration dates as they filled new prescriptions, the employees were instructed to use inaccurate and false information, rendering the drugs “misbranded,” according to DOJ. In addition, DOJ said Medicare, Medicaid, and other insurers were not reimbursed for the unused drugs, but they were billed for the illegal, “misbranded” leftover drugs used to fill new prescriptions.
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This might seem like an innocuous case — a victimless crime — and possibly no patients were harmed in the MedFast case, but the case called to mind an unrelated occurrence in which my mother was stricken with critical digoxin poisoning in July 2011.
After my mother’s nursing home called the EMTs and sent her to the hospital emergency room because she was apparently unconscious and having difficulty breathing, the hospital found her to be suffering from critical-level digoxin poisoning.
The poisoning could have been caused by a combination of her significant loss of weight during a short stay in the nursing home and the nursing home’s inadequate monitoring of her medication dosages as her weight declined. Digoxin’s effects are extremely dose-specific and too much can lead to serious and potentially life-threatening digitalis toxicity.
I found out that a number of digoxin recalls had occurred. In April 2008, a recall was issued for all lots of a generic version of digoxin called Digitek because some of the tablets were twice as thick as they were supposed to be. In another case, a specific lot of digoxin was recalled because some tablets were thicker than others.
All tablets of a specific brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which were not expired and were within the expiration date of September, 2011, were recalled because they might differ in size and therefore could have had more or less of the active ingredient, digoxin.
I found myself wondering whether my mother’s nursing home might have had some of the unexpired — but recalled — defective digoxin tablets on hand in July, 2011, when she suffered poisoning. Could my mother have been given drugs from recalled lots that were double the supposed strength? Based on my experience with the particular nursing home and the Pennsylvania Department of Health back then, I did not expect they would help me look into the matter, so I did not pursue it. I also observed that the nursing home ordered considerable quantities of some drugs for my mother shortly before the end of her stay there, and I wondered what the nursing home did with such leftover drugs, which had been paid for by Medicare.
It seems that comingling of drugs from different lots could make it easier for recalled drugs to slip through a recall.
In an unrelated but interesting matter involving digoxin, in 2003, a nurse, Charles Cullen, who is suspected of being the most prolific serial killer in American history, admitted to killing as many as 40 hospital patients by using overdoses of heart medications – including digoxin – at hospitals in New Jersey and Pennsylvania.
The DOJ news release about the sentencing of the Beaver County pharmacist can be found at my website, https://wbeerman.com, under the heading “Related Court Documents,” along with other information about nursing homes and government oversight of nursing homes.