According to 2014 Centers for Disease Control and Prevention (CDC) data, 78 Americans die from an opioid overdose each day. The CDC has declared that the U.S. has a prescription drug abuse epidemic. The Drug Enforcement Administration (DEA), along with many other law enforcement agencies, recognize that “we are not going to be able to arrest our way out of this crisis.” Therefore, the DEA and other stakeholders have implemented 360 approaches to combat prescription drug abuse, prevention of overdoses and deaths. The 360 strategies include:
- Educating prescribers about U.S. Food and Drug Administration (FDA) guidelines regarding opioid prescribing and black box label warnings, which should decrease the quantities prescribed to patients
- Educating patients about the dangers and proper storage of controlled substances
- Increasing availability of treatment centers
- Evaluating supply and demand of controlled substances
- Mandating Prescription Monitoring Program (PMP) reviews by prescribers and pharmacists
- Providing safe and effective ways to destroy drugs
- Increasing the number of accountability audits and inspections of registrants
- Aggressively prosecuting individuals and registrants who are involved with illicit activities 1
In the past few years, prescribers and pharmacists have been sued for patients’ addictions, overdoses and deaths. The responsibility of issuing a controlled substance prescription for legitimate medical purpose rests on the prescribers; however, a corresponding responsibility rests on pharmacists who dispense controlled substance prescriptions (DEA regulation, 21 C.F.R. § 1306.04).
Pharmacists are an integral part of the healthcare profession and have daunting tasks, including:
- Analyzing the appropriateness of the medication prescribed
- Filling the prescriptions correctly
- Educating patients about the medication
- Explaining the indications
- Warning patients about the potential side effects and drug interactions
- Communicating with other healthcare professionals
- Recommending over-the-counter (OTC) products
- Managing employees
- Remaining in compliance with all pharmacy rules and regulations
Risks and Accountability
As pharmacists, we are considered the “gatekeepers” of some of the most dangerous legal drugs. Pharmacists have to take into consideration the external risks, such as armed robbery and break-ins, and the internal risks, such as internal theft, record keeping and providing proper storage and security of the drugs in the pharmacy. Pharmacists are urged to contact their local law enforcement agency to conduct onsite visits and provide suggestions on how to minimize their external risks. Some of the online resources available to pharmacists include:
In the majority of diversion cases, internal theft incidents are even bigger challenges because they can remain undetected for a long time. As an employer, your philosophy should be to trust but verify. Verification processes for your “checks and balances” begin with conducting a thorough background check on applicants before hiring them. Other counter measures include:
- Limiting the number of employees who have access to the pharmacy and the controlled substances safe; each employee should have a different pass code to deactivate the pharmacy alarm
- Ensuring the employee placing orders is not the same employee receiving the orders
- Keeping a perpetual inventory of all your controlled substances in stock or conducting random accountability audits
- Installing video surveillance cameras to monitor various areas of your pharmacy
- Checking your monthly summary reports provided by your wholesalers to make sure all invoices are accurate and accounted for
Inspection and accountability audits are important tools used by regulatory agencies to detect diversion, review pharmacies’ records and ensure records are readily retrievable. The question often asked is how does one prepare for inspections and audits? Controlled substance record keeping requires daily, weekly and monthly reviews. Some of the records reviewed during inspections are inventory, invoices, DEA 222, e-222, returns, DEA 41 and 106 forms, prescription files and other necessary controlled substance records.
The controlled substance inventory record is one of the most important records maintained. Although the DEA requires that each registrant who possesses controlled substances conduct a biennial inventory, many states’ requirements are different. Therefore, you should comply with the most stringent regulations. Recording controlled substance inventory begins with accurately counting each dosage unit of all controlled substances on-hand. Estimated counts of controlled substances is not recommended. The inventory should be marked with the date the count was conducted, indicate if counted at opening or closing of business and include the names of all employees who assisted with the inventory count.
DEA 222 and e-222 records should be maintained separately. DEA 222 forms, which are maintained by the pharmacist, should be completed when an order is received. If you are using e-222 (CSOS), you must electronically accept the controlled substances. Many pharmacists choose to make copies of their e-222 and maintain them with the schedule II file. Invoices for schedule III, IV and V drugs should be maintained separately from schedule II and non-controlled substance invoices. The DEA and many states allow records of schedule III-V to be commingled with non-controlled substances, as long as the controlled substance invoices are stamped with a red C. However, it is strongly recommended that schedule III-V records are separately maintained.
The Power of Attorney (POA) form permits other employees to order controlled substances on behalf of the registrant. Therefore, all POAs should be readily retrievable. Make sure to keep and maintain revoked POAs if the employees have discontinued employment, or their duties change and they are no longer in a position that requires them to place orders. Theft, transfer, sales invoice and drug destruction forms should also be readily accessible for review by the inspector and/or the auditor. Prescriptions should also be separated in three different files: schedule II, schedule III-V and non-controlled. How do the auditors conduct the accountability audit?
- Auditors begin the audit using your last controlled substance inventory.
- After selecting certain controlled substances, the auditors will conduct a closing count by counting the selected controlled substances on hand the day of the audit.
- The auditors then add all the selected controlled substances purchased from your wholesalers’ invoices and subtract the returns, destructions and transfers.
- Finally, the dosage units of the selected controlled substances are subtracted and the results should be zero.
Some of the most common reasons audits do not balance are inaccurate inventory, missing invoices, missing transfer forms and failure to properly maintain records. The other possible reasons to consider are inaccurate dispensing reports, failure to provide the auditor with all the drugs on hand and/or theft.
Know Your Prescriber
Know Your Prescriber (KYP) is a file that should be created by pharmacists to prevent drug diversion. Many pharmacists are conducting their own due diligence by generating a KYP file. The information needed to create the file is available to pharmacists via public information or from the DEA’s website. The KYP file should include a copy of the prescriber’s medical license and sanctions, as well as the prescriber’s DEA registration. Pharmacists should also pay close attention to ensure the prescriber has authority to prescribe prescriptions for schedule II-V controlled substances.
In conclusion, in many cases pharmacists possess even greater pharmacological knowledge about prescription drugs than prescribers. This knowledge includes the indication, dosages and side effects of various drugs. The current push is to classify pharmacists as providers and allow them to bill for services that are currently provided for free. The recent rules providing pharmacists with the ability to administer vaccines is the beginning. As we continue to increase the services we can provide, we will have a greater opportunity to make an impact on healthcare and be recognized for our cognitive skills regarding the use of medication and easy accessibility.
1“Understanding the Epidemic.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 14 Mar. 2016. Web. 13 May 2016.