As the opioid crisis continues to be an ongoing problem in the United States, with a record number of fentanyl drug overdoses, drug diversion has become an increasingly important issue in the healthcare industry. Drug diversion occurs when prescription drugs are illegally taken, sold, or otherwise misused. Pharmacies, which play a crucial role in dispensing prescription drugs, are under increased scrutiny to ensure they take appropriate steps to prevent drug diversion.
Regulatory agencies use two key processes to monitor pharmacy compliance: drug diversion audits and investigations. Let’s explore the differences between both processes and what pharmacies can expect from either one.
Differences between a Drug Diversion Audit and a Drug Diversion Investigation
What Is Drug Diversion?
According to Angela Livingood, a drug diversion specialist at Novant Health, drug diversion is the “hijacking of medications from their intended use.” It can occur anywhere, from transporting drugs to the facility to receiving them within the facility. In other words, any occurrence when the drug does not follow the prescribed path to the intended patient is drug diversion.
What Is a Drug Diversion Audit?
A drug diversion audit is a proactive assessment of a pharmacy’s compliance with regulations surrounding drug diversion. Audits are typically conducted by regulatory agencies such as the Drug Enforcement Administration (DEA) or state pharmacy boards. The goal of an audit is to identify any areas where the pharmacy may be vulnerable to drug diversion and ensure that the pharmacy is taking appropriate measures to prevent it.
Audits typically involve a review of the pharmacy’s records, including prescription records, inventory records, and dispensing records. Auditors will also examine the physical security of the pharmacy to ensure that medications are stored securely and that appropriate measures are in place to prevent unauthorized access to drugs. The audit may also include interviews with staff members to assess their knowledge of drug diversion prevention techniques.
Why Would a Pharmacy Go Through an Audit?
Pharmacies may be required to undergo audits as a condition of their licensure or as part of a compliance agreement with a regulatory agency. In addition, many pharmacies choose to undergo voluntary audits as a way to demonstrate their commitment to preventing drug diversion and to identify any areas where they may be able to improve their practices.
What Can a Pharmacy Expect While Going Through an Audit?
During an audit, a pharmacy can expect to be asked to provide a range of records related to its dispensing practices. Auditors may also request to conduct interviews with staff members to assess their knowledge of drug diversion prevention techniques.
Pharmacies should be prepared to provide documentation related to inventory control, such as records of medication purchases and sales, as well as records related to the dispensing of controlled substances. Auditors will also evaluate the pharmacy’s physical security measures to verify the secure storage of medicines and the implementation of suitable precautions against unapproved drug access.
What Are Some Potential Outcomes of an Audit?
The outcome of an audit will depend on its findings. If the audit uncovers no issues with the pharmacy’s drug diversion prevention practices, the pharmacy may receive a favorable report and will not need to take any further action. However, if the audit identifies areas where the pharmacy could improve its drug diversion prevention practices, it may be required to take corrective action and may be subject to additional monitoring.
In some cases, an audit may uncover evidence of drug diversion at the pharmacy. In such cases, the regulatory agency may launch an investigation into the pharmacy’s practices.
What Is a Drug Diversion Investigation?
A drug diversion investigation is a reactive response to suspected drug diversion at a pharmacy. Investigations are typically conducted by law enforcement agencies such as the DEA or state police. The goal of an investigation is to determine whether drug diversion is occurring at the pharmacy and to identify the individuals responsible for the diversion.
Why Would a Pharmacy Go Through an Investigation?
Pharmacies may be subject to investigations if there is suspicion of drug diversion occurring at the pharmacy. Investigations can be triggered by various factors, including suspicious prescribing patterns, reports of missing or stolen medications, or tips from employees or members of the public. Investigations can also be triggered by audits that uncover evidence of potential diversion.
What Can a Pharmacy Expect While Going Through an Investigation?
During an investigation, pharmacies can expect to have law enforcement agents on site who will conduct interviews with staff members and review prescription records to gather evidence. Investigators may also request surveillance records from the pharmacy.
Pharmacies should be prepared to provide documentation related to inventory control, including records of medication purchases and sales, as well as records related to the dispensing of controlled substances. As with an audit, investigators may also request to examine the physical security of the pharmacy.
What Are Some Potential Outcomes of an Investigation?
If an investigation uncovers evidence of drug diversion at a pharmacy, the pharmacy may face serious consequences. These can include fines, loss of licensure, loss of job, and even civil penalties for the individuals responsible for the diversion. In addition, the pharmacy’s reputation may be damaged, potentially leading to a loss of business.
It is important for pharmacies to take drug diversion prevention seriously and to take appropriate steps to ensure that their practices are in compliance with regulations. These can include implementing physical security measures to prevent unauthorized access to medications, training staff on drug diversion prevention techniques, and regularly reviewing and updating policies and procedures related to drug dispensing.
Conclusion
Drug diversion audits and investigations are important processes that regulatory agencies use to monitor pharmacy compliance with drug diversion prevention regulations. To avoid potential negative consequences, pharmacies should take proactive steps to ensure safety to avoid potential negative consequences.
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