Pharmacies play a crucial role in the healthcare industry, providing patients with access to medications that can improve their quality of life. However, with this important responsibility comes the challenge of ensuring compliance with regulations such as the Controlled Substances Act (CSA), which helps government agencies efficiently regulate the manufacturing, distribution, and usage of controlled substances.
This article explores some of the main challenges pharmacies might face in achieving and maintaining CSA compliance.
Requirements of the CSA for Pharmacies
Registration
The CSA requires drug manufacturers, pharmacies, and other relevant entities to register with the government. In the case of pharmacies, registration validity is three years, and they need to re-register after that period.
Record Maintenance
Pharmacies must maintain detailed logs of all the medication inventories and transactions for two years. They should also allow open inventory access to federal authorities when requested.
Security
The Drug Enforcement Administration (DEA) requires licensed distributors to store controlled drugs in locked cabinets. Pharmacies must not lock their drugs but must have security measures to guard them. In cases of theft or loss, pharmacists must report it to the authorities within one business day using DEA Form 106.
Dispensing
Pharmacies cannot dispense controlled substances to anyone without a prescription. The act also advises them to look for fraudulent activities like false prescriptions and frequent requests.
Disposal
If pharmacies discard controlled drugs, they can use a reverse distributor to send them back to the manufacturer/distributor or dispose of them according to the local environmental safety law.
Consequences of Violations
A CSA violation can occur if pharmacy staff does not comply with the requirements, resulting in fines, license suspension/termination, reputational damage, and even imprisonment.
Staff education on CSA requirements and efficient recordkeeping and drug management with third-party providers is crucial.
Six CSA Challenges Pharmacies Face
Although compliance with the CSA may seem straightforward, implementing certain requirements and processes can pose challenges for pharmacies. Here are some of the main difficulties encountered in daily practice:
1. Lack of Financial Resources
One of the major challenges faced by pharmacies when complying with the Controlled Substances Act is a lack of financial resources. Pharmacies handling controlled substances must maintain detailed and accurate records of all transactions. This may be impeded by other responsibilities including negotiating with Pharmacy Benefit Managers (PBMs) or fighting DIR Fees. Maintaining a comprehensive record of dispensed drugs requires an efficient inventory management system and qualified personnel, which may be beyond the financial capabilities of some small pharmacies.
2. Lack of Adequate/Modern Tools & Reliance on Manual Processes
Maintaining a proper perpetual inventory with specific details for losses is the best way to identify theft or diversion earlier. While the DEA requires pharmacies to keep records of all the categories of controlled drugs, it is better to maintain a separate C2 log for Schedule II (CII) drugs. This is because CIIs are much more strictly regulated than the lower-schedule drugs (C3–5), making it critical to have a good inventory management tool.
Small pharmacies can avoid consequences by adopting new technologies to automate and streamline inventory management. Replacing the manual process with third-party software can help manage inventory, ensure compliance, improve patient care, and avoid legal issues.
3. Lack of Time and Competing Priorities
Pharmacies have a busy schedule as they have to handle prescriptions, manage inventory, communicate with healthcare providers, and attend to patient queries. Among all these responsibilities, CSA compliance can become neglected. Unexpected situations like staff shortages, emergencies, or system failures also affect the time and effort required to achieve CSA compliance. These and other operational issues could cause the pharmacy to lose focus on its CSA compliance, resulting in fines.
4. Lack of Knowledge Until It’s Too Late
Pharmacists may face compliance issues with the Controlled Substances Act due to its evolving structure, like allowing the DEA to add or remove controlled drugs. For instance, a drug may be temporarily added as a Schedule II controlled drug for experimentation and later moved to Schedule III. Pharmacies that are not constantly monitoring the regulations risk non-compliance..
Moreover, pharmacists may be unaware of specifics within the CSA, such as the requirement to format the biennial report in a particular way. They also need to keep abreast of new legal or regulatory changes related to drugs. Failure to comply with the CSA can result in severe consequences such as fines, license suspension, and even imprisonment.
5. Differences Between State & Federal Requirements
While the federal Controlled Substances Act applies to all entities handling controlled drugs in the USA, each state might have specific requirements. Some states might have stricter regulations on storing and destroying controlled substances. For example, Kentucky amended its state CSA to exclude some drugs and stay consistent with the federal CSA in 2014—however, some states have labeled some drugs as controlled that aren’t controlled federally, so it is essential for pharmacies to understand the difference between state and federal requirements.
6. Siloed Systems
A silo effect can occur in pharmacies that use disconnected systems. Disconnected, siloed systems can lead to inventory discrepancies and reporting errors. One of the best ways to overcome this is to use a comprehensive pharmacy inventory management and compliance tool.
Mitigating CSA Challenges Pharmacies Face
At C2 Keep, we understand the importance of CSA compliance and offer innovative solutions to help pharmacies navigate this complex landscape.
From secure record-keeping to employee training and regular audits, our platform simplifies the compliance process, ensuring that pharmacies can focus on what matters most: providing safe and effective care to their patients. To learn more, schedule a demo today.
