In the United States, pharmacies are subjected to different sets of law obligations under federal legislation. Law obligations regulate most aspects of pharmacy practices, from drug billing to drug ordering, inventory management, and pharmacist training. These legal obligations put pressure on pharmacies to be in compliance and avoid being investigated by law enforcement agencies.
Over the years, many pharmacies have been charged with kickback schemes or fraudulent overcharges by law enforcement authorities. In case compliance efforts are less than expected, pharmacy owners, as well as pharmacists who are involved, can face significant consequences. Therefore, compliance obligations should be treated as a priority for every pharmacy to avoid federal liability.
Here are the primary law obligations that pharmacies in the U.S. need to fulfill.
Pharmacy Compliance Programs
In recent years, many pharmacies have been charged with either committing fraudulent acts or breaching their legislation obligations. From pharmacists to pharmacy technicians, anyone can be held responsible for committing a violation, and pharmacy compliance programs can effectively reduce illegal practices in pharmacies. A pharmacy compliance program can prevent both pharmacists and pharmacy technicians from violating the law while protecting pharmacy owners from criminal prosecution in cases of a law violation. For instance, if fraud occurs, having a useful and well-designed compliance program can show federal authorities and prosecutors that you did not condone or intend to permit criminal acts inside your pharmacy.
A pharmacy compliance program normally includes internal rules, employee training programs, and enforcement mechanisms to ensure that everyone in the pharmacy acts in compliance with the law obligations. As there are many obligations under federal law, pharmacy compliance rules should be posted in employee’s handbooks, company emails, and common employee areas. Overall, there should be evidence that the pharmacy compliance program has been enforced throughout the pharmacy in case of criminal prosecution.
Furthermore, training sessions should be made regular for pharmacists and pharmacy technicians. You should consider having a compliance officer who is responsible for preparing and conducting training seminars related to the pharmacy compliance program. Suggested areas that can be covered in training sessions are fraud, the Stark Law, kickback laws, and OSHA and HIPAA regulations.
The Drug Supply Chain Security Act (DSCSA) Compliance
DSCSA compliance is an important piece of federal legislation that was enacted in 2013 to protect consumers from counterfeit prescription medications. The DSCSA aims to protect consumers from medications that are counterfeit, contaminated, stolen, diverted, and unfit for dispensing.
Regarding the DSCSA compliance, pharmacies are obligated to limit counterfeit medications by doing transactions with entities who are registered with the U.S. Food and Drug Administration (FDA) and entities who are licensed under state legislation. Moreover, pharmacies are obligated to detect counterfeit prescription medications by tracing documentation and investigating questionable medications. For instance, pharmacists are recommended to check the registration of both the manufacturers and the repackagers, as well as the wholesale distributors and the logistics providers.
Prescription Drugs
Regarding drug ordering, pharmacies must order prescription drugs using the Drug Enforcement Administration (DEA) Form 222. When ordering drugs, pharmacies must ensure that the ordered medications are legitimate, and the medication suppliers are legitimate sources. For every drug order, pharmacies must document and maintain all documentation related to their orders, including documentation for every received shipment.
Pharmacies are obligated to have both logical and physical security measures to prevent theft or fraudulent acts regarding prescription medications. This includes the protection of prescription medications in transit, in inventory, at the store, and monitor fraud. Pharmacies must prevent prescription fraud with specific protocols and policies. For instance, each pharmacy is expected to adopt an adequate security measure to assess prescriptions and their validity before refilling any request by patients.
Electronic Prescriptions
Apart from paper prescriptions with compliance obligations as stated above, pharmacies are further required to utilize software applications to properly handle electronic prescriptions and document all transactions regarding digital scripts.
As a general rule, pharmacies should accept medications with all tracing documentation, including transaction information, transaction statements, and transaction history. Moreover, all tracing documentation is required to be stored in either paper format or electronic format for six years. In suspicious cases of counterfeit medications, pharmacies should notify the FDA or other authorities to issue further investigation.
Recordkeeping
For pharmacies, recordkeeping is a significant component of law compliance, and proper recordkeeping can help pharmacies to avoid serious liability and ramifications. When requested by federal law enforcement, pharmacies must be able to provide all necessary records to prove their compliance with the laws. Due to the importance of recordkeeping for this purpose, pharmacies must generate and store their documentation properly.
Inventory Management
Aside from recordkeeping, inventory management is an important task for pharmacies. By managing their inventory well, pharmacies can avoid unwanted investigations from the Drug Enforcement Administration and other federal authorities. With comprehensive and well-planned inventory management protocols, pharmacies can maintain all documentation of incoming and outgoing medications as well as avoid having unwanted losses and discrepancies in their inventory.
Pharmacy Personnel and Required Training
Pharmacists and technicians that work in pharmacies should be trained according to their roles to maintain compliance with law obligations. Even though each person is required to participate in different training according to his respective position, all personnel are required to be certified at the end of their required training programs.
Pharmacy Technicians and Pharmacist Ratios
In both institutional and retail pharmacy settings, pharmacy technicians are important personnel members who play an integral part in pharmacies. Depending on regulations in different states, the accepted ratios between pharmacist supervisors and pharmacy technicians are between 2 to 3 technicians per pharmacist.
It is an essential duty for pharmacies to appropriately comply with the latest law regulations for the pharmacy sector. In today’s world, pharmacies are under the pressure of different law obligations. It is up to them to comply with the law to prevent unwanted investigations from federal authorities such as the Drug Enforcement Administration. Pharmacies should stay up to date with the latest legislation by participating in education programs, registering with the Drug Enforcement Administration and the Food and Drug Administration for email alerts on recent legislation changes.