A sizable aspect of the job of a pharmacy is logistics. Pharmacies deal with controlled substances and life-saving medication, and everything involved in making sure the right people are getting the right medication. Pharmacy laws can change and differ around the country. Pharmacy malpractice can take multiple forms and can be the result of gross negligence or simple oversights. Even a simple oversight can be mistakenly disregarded and subsequently repeated. Pharmacies must also do due diligence to make sure the prescribers are trustworthy and both you and they aren’t being influenced by any outside factors.
A medication error is defined as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer,” according to the National Coordinating Council for Medication Error Reporting and Prevention. (FDA)
An example of a medication error is the administration of a wrong dosage or the wrong medication altogether. This can happen at any point in the process of prescribing or delivering medication. This can occur as a result of misreading/miswriting prescriptions, mislabeling medications, or incorrectly calculating a dosage for medication, amongst other potential causes. Electronic prescribing has grown in prominence in the last two decades in response to medication errors born of human error. Studies have shown that the use of electronic prescriptions can help reduce medication errors.
Even if the correct medication and dosage are delivered, an error can still occur with the instructions given to the pharmacy by a doctor or pharmaceutical manufacturer. These errors are no fault of the pharmacy, but rather a failure of another party in the process. In these instances, whichever party is responsible for the negligent act may also be responsible for medication errors.
Pharmacies also need to make sure that what they’re delivering doesn’t conflict with their other medications or patient allergies/sensitivities. Certain medications, when taken in the same period, can have an adverse compounding effect on a patient’s health. Additionally, it’s important for pharmacists to monitor patients for any notable reactions to medications prescribed.
Dunn Meadow Pharmacy – Dunn Meadow LLC (operated under the name Dunn Meadow Pharmacy) pleaded guilty to conspiracy to distribute illegal fentanyl and giving kickbacks to healthcare providers. The organization also settled federal civil cases for violations of the False Claims Act and the Controlled Substances Act.
Dunn Meadow was a licensed pharmacy that sent prescriptions through the mail, including transmucosal immediate-release fentanyl (TIRF) medications. Dunn Meadow had received payments from pharmaceutical companies that marketed these medications. The company would fill prescriptions for TIRFs and other controlled substances even though they knew many of the prescriptions were not for legitimate medical purposes and came from suspicious doctors.
PillPack, LLC – PillPack, LLC is an online pharmacy, owned and operated by Amazon.com, Inc. The organization settled allegations that it was improperly billing government healthcare programs (including Medicare and Medicaid) for more insulin than its patients required as well as falsely reporting its day-of-supply insulin dispensed. PillPack agreed to pay approximately $5.79 million to settle the allegations levied against the company.
“Pharmacies are trusted to provide accurate information to Government healthcare programs and to prevent waste when dispensing medications to patients,” said Damian Williams, United States Attorney for the Southern District of New York. “PillPack abused this trust by dispensing insulin refills long before patients needed them and by falsely reporting the days-of-supply of insulin actually dispensed to prevent its claims for reimbursement from being denied. This Office will continue to hold pharmacies accountable when they submit false information and waste taxpayer dollars.”
Mitchell Spivack and Verree Pharmacy – Mitchell Spivack operated Verree Pharmacy, a retail pharmacy in Pennsylvania, and faced civil and criminal charges for fraud and violation of the controlled substance act as well as other charges. Spivack was sentenced to 3.5 years for conspiracy to distribute oxycodone and fraud. He and his pharmacy paid $4.1 million to resolve his civil liability under the Controlled Substances Act, False Claims Act, and forfeiture.
Amongst the allegations and charges levied against Mitchell and his pharmacy were allegations of blatant disregard for questionable prescriptions, forged prescriptions, and evidence that the prescribed drugs would be abused.
Given that the pharmacy industry is heavily regulated, it’s recommended that those who work in the industry or run a pharmacy speak to a pharmacy law attorney to better understand the regulations that you need to follow. If you believe you may have or currently are in violation of any of the pharmacy laws or regulations, we recommend that contact a pharmacy law attorney, Fenton Law will be able to work through you and guide you through any legal circumstances you find yourself in. For more information on how hiring an attorney can help you or your pharmacy, fill out our online contact form today.