The owner of several retail pharmacies in Massachusetts agreed to pay $200,000 to settle allegations of recordkeeping violations and improper dispensing of controlled substances, according to the U.S. Attorney’s Office for the District of Massachusetts.

Hamid Mohaghegh, owner of Fitchburg Family Pharmacy, Gardner Family Pharmacy, and Worcester Family Pharmacy was investigated in connection with improper dispensing of Schedule II controlled substances and “flawed recordkeeping” by eight retail pharmacy stores in 2016. A memorandum of understanding with the Justice Department requires Mohaghegh and Family Pharmacies to take steps that include annually conducting a full inventory to determine an actual, not estimated, count of all federally scheduled Schedule II to V controlled substances on hand, and developing and implementing due diligence protocols to ensure that controlled substances are dispensed for a legitimate medical purpose.

Alleged violations by staff at Mohaghegh’s pharmacies included filling prescriptions for Suboxone that were written by a provider who was not certified to prescribe the drug and not immediately reporting the theft or loss of controlled substances to the Drug Enforcement Administration (21 C.F.R. §1306.04(a)). Suboxone, which contains buprenorphine and naloxone, is used for chronic pain or to treat opioid dependence.

According to the memorandum of agreement, inspections revealed numerous violations between April 2014 and August 2016 at various pharmacies owned by Mohaghegh. These included:

• filling of prescriptions under incorrect DEA numbers at least 27 times (21 C.F.R. §1306.05(a));
• filling prescriptions for buprenorphine without an “x” designator, an indication that the prescriber was not certified to prescribe that substance (21 C.F.R. 1306.05(b));
• failure to maintain complete and adequate records, as evidenced by a shortage of morphine and an overage of methadone at one pharmacy location (21 C.F.R. §1304.21(a));
• commingling of records for Schedule II substances with records for substances in schedules III to V (21 C.F.R. §1304.04(h)(1));
• failure to maintain controls and procedures to guard against theft and diversion by not securing usernames and passwords to systems used to order controlled substances (21 C.F.R. §1301.71);
• failure to timely report a loss of 36 tablets containing oxycodone-acetaminophen and 60 tablets of morphine that was discovered in May 2015 and not reported until August 2015 (21 C.F.R. §1301.76(b));
• acceptance of controlled substances from customers without being an authorized collector (21 C.F.R. §1317.40);
• failure to electronically record received quantities (21 C.F.R. §1305.22(g)); and
• failure to maintain two years’ worth of invoices and/or order forms (21 C.F.R. §1304.04(a)).

Controlled substances handled by pharmacies are subject to strict requirements because of their potential for harm and abuse and to ensure that medications are not stolen or sold on the street, said U.S. Attorney Andrew E. Lelling in the written announcement. Massachusetts will continue to monitor pharmacies to ensure that they comply with all legal requirements related to the handling, dispensing, and recordkeeping of controlled substances, he added.

For More Information

For more on the importance of accurate recordkeeping, see the Practice Tool in Tab 1304.