As the United States’ opioid epidemic continues to garner the attention of the Drug Enforcement Administration (DEA) and other federal agencies, pharmacies are increasingly finding themselves on the front lines of the government’s fight to deter and prevent opioid diversion.
The statistics on opioid abuse in the United States are well-known among pharmacists and other healthcare professionals. Overdose deaths have skyrocketed over the past two decades, and there is a well-established correlation between the misuse of prescription opioid medications and the subsequent use of heroin. Yet, statistics show that prescription opioid medications – not heroin – are responsible for the substantial majority of opioid-related deaths in the United States.
In October 2020, the U.S. Department of Justice (DOJ) announced an $8 billion settlement with Purdue Pharma, the manufacturer of OxyContin. In announcing the settlement, the DOJ wrote:
“As part of the plea, Purdue will admit that from May 2007 through at least March 2017, Purdue conspired to defraud the United States by impeding the lawful function of the DEA by representing to the DEA that Purdue maintained an effective anti-diversion program when, in fact, Purdue continued to market its opioid products to more than 100 health care providers whom the company had good reason to believe were diverting opioids and by reporting misleading information to the DEA to boost Purdue’s manufacturing quotas. . . . The conspiracy also involved aiding and abetting violations of the Food, Drug, and Cosmetic Act by facilitating the dispensing of its opioid products, including OxyContin, without a legitimate medical purpose, and thus without lawful prescriptions.”
While the Purdue Pharma settlement is notable for its size and for the company’s admissions of knowingly and intentionally facilitating the diversion of OxyContin, Purdue Pharma is far from the only entity that has fallen within the DOJ’s crosshairs. In addition to targeting pharmaceutical companies, the DOJ has recently been targeting pharmacies and other healthcare providers as well. As the conduit between patients and the pharmaceutical companies, pharmacies serve a crucial role in the fight against opioid diversion—and those that fail to do their part can face severe consequences.
What Can (and Should) Pharmacies Be Doing to Help Prevent Opioid Diversion?
Given the important role that pharmacies play combined with the DOJ’s readiness to target pharmacies that are suspected of contributing to the epidemic, what can (and should) pharmacies be doing to protect their patients—and themselves?
Maintaining a comprehensive and up-to-date pharmacy compliance program is as important as ever. Pharmacies need to ensure complete compliance with the Controlled Substances Act and all other pertinent laws, rules, and regulations, and they need to be able to demonstrate their complete compliance in order to avoid administrative, civil, and criminal penalties.
There are a number of aspects of pharmacy compliance that are pertinent to diversion prevention. Central among them is the ability to identify red flags for diversion and proactively prevent opioid medications from being dispensed to dependent patients or falling into the wrong hands. “I was simply filling a prescription from a physician,” is not a defense to facilitating opioid diversion; and, with this in mind, pharmacies need to have policies and procedures in place that are designed to spot and address red flags.
For example, the following are all red flags for opioid diversion of which pharmacies need to be cognizant, and which they should proactively address in their compliance programs:
Red Flag #1: Taking Doses Higher than What is Prescribed (Early Refill Requests)
Prior to providing refills, pharmacies must ensure that patients’ requests are not premature. If a patient is running out of a medication before he or she should, this should be considered a potential sign of misuse or diversion.
Red Flag #2: Forged and Altered Prescriptions
In addition to maintaining comprehensive electronic prescription compliance, pharmacies must have policies and procedures in place to ensure appropriate scrutiny all paper prescriptions submitted by patients at the pharmacy counter. Forgeries of opioid prescriptions are common, with red flags including excessive information, overly-neat handwriting, and lack of use of common abbreviations.
Altered prescriptions present risks for opioid diversion as well. Along with mismatched ink, scratch-outs, inconsistent handwriting, and information added in the margins are common red flags for opioid prescription alterations as well.
Red Flag #3: Financial Incentives from Pharmaceutical Companies and Prescribers
In light of the recent Purdue Pharma settlement discussed above, pharmacy owners and pharmacists must have a clear understanding of what is (and, more importantly, what isn’t) permissible with regard to the payment of financial incentives. By and large, these types of incentives are prohibited under federal law. While there are various exceptions, it is absolutely essential to make sure that a financial incentive offered by a pharmaceutical company or prescriber is lawful prior to accepting.
Red Flag #4: Prescriptions from Multiple Physicians
If a patient presents prescriptions from multiple physicians, this too should be considered a potential red flag for misuse or diversion. While physicians have an obligation to avoid prescribing medications to patients who already have prescriptions from other doctors, pharmacies cannot necessarily rely on this obligation in evaluating the risks associated with filling prescriptions from multiple physicians for a single patient.
Red Flag #5: Prescriptions from Geographically-Diverse Physicians
If a patient comes from far away to fill an opioid prescription at your pharmacy, this should raise a simple question: “Why?” While there may be a valid explanation (i.e. perhaps the patient commutes to work at an office near your pharmacy), it could also very well be the case that the patient has been unsuccessful in his or her attempts to obtain medications from other pharmacies.
Red Flag #6: Commonalities Among Multiple Prescriptions
In some cases, multiple individuals who are working together will come into a pharmacy together or in quick succession, all seeking to obtain prescription opioid medications. Alternatively, family members may all seek to obtain the same opioid prescriptions, or one family member may attempt to have multiple prescriptions filled—allegedly on behalf of his or her other family members.
Red Flag #7: Signs of Opioid Dependence
Finally, pharmacies must also provide adequate training to their staff members so that they are able to identify the signs of opioid dependence. Appearing sedated or intoxicated, confusion, aggression, and symptoms of withdrawal should all be viewed as red flags that some form of intervention may be necessary.
Red Flat #8: Cash Payments
While there is nothing inherently wrong with paying for a prescription medication in cash, statistically speaking, dependent patients and individuals who are seeking to divert opioid medications are significantly more likely to conduct cash transactions.
Red Flag #9: Evasiveness or Evidence of Untruthfulness
If a patient is evasive when asked simple questions such as what doctor issued the prescription or how long he or she has been taking a particular medication, this should also be considered a potential red flag. Likewise, if there is evidence that the patient is being untruthful (or has been untruthful in the past), then the pharmacy may have an obligation not to dispense any opioid medications.
Red Flag #10: Prescriptions for Common “Cocktails”
Patients who present prescriptions for multiple drugs that are commonly combined into “cocktails” (such as opiates, benzodiazepines, and muscle relaxers) present risks to themselves, the pharmacy, and others. All such circumstances should be handled very cautiously and with a clear understanding of the pharmacy’s legal and ethical responsibilities.
FAQs: DEA Compliance and Opioid Diversion Prevention Strategies for U.S. Pharmacies
Q: What are pharmacies’ obligations with regard to preventing opioid diversion?
Pharmacies face substantial obligations when it comes to helping to stem the flow of diverted prescription opioid drugs. From maintaining adequate inventory controls to carefully evaluating patients’ prescriptions and even scrutinizing patients’ conduct at the pharmacy counter, pharmacies must comprehensively address all risks for opioid diversion.
Q: What risks do pharmacies face if they fail to prevent opioid diversion?
The risks of failing to take adequate steps to prevent opioid diversion can be substantial. In addition to the risk of losing their DEA registration, pharmacies (as will as individual pharmacy owners, pharmacists, and staff members) can also face potential civil or criminal liability. If charged with a federal offense, potential consequences can include substantial fines, imprisonment, and loss of licensure.
Q: What if a patient is able to fraudulently obtain a prescription despite a pharmacy’s diversion prevention efforts?
Even when a pharmacy implements adequate opioid prevention protocols, it is still possible that a patient could succeed in fraudulently obtaining opioid medications. When this occurs, the key is for the pharmacy to take a proactive response and work with its federal defense counsel to take appropriate remedial action before being contacted by the DEA.
Q: Can pharmacies rely on electronic prescriptions to dispense opioid medications without concern?
No, not necessarily. Prior to filling electronic prescriptions, pharmacies must take reasonable steps to ensure that these prescriptions are both (i) legitimate, and (ii) medically necessary. Unfortunately, physician diversion is a concern as well, and federal authorities expect pharmacies to do more than simply fill electronic prescriptions as they come in.
Q: What are the steps involved in implementing effective diversion prevention protocols?
There are several steps involved in implementing effective diversion prevention protocols, the first of which is to engage experienced pharmacy compliance counsel. Working with your compliance counsel, your pharmacy will need to develop custom-tailored policies and procedures, and then it will need to provide appropriate training to all pertinent personnel. Depending on the specific risks that your pharmacy needs to address, other implementation measures (i.e. adoption of additional physical or logical security controls) may be necessary as well.
Speak with a Senior Pharmacy Compliance Lawyer at Oberheiden P.C.
Do you have questions about your pharmacy’s legal obligations with regard to opioid diversion prevention? If so, we encourage you to get in touch. To speak with one of our senior pharmacy compliance lawyers in confidence, please call 888-680-1745 or contact us online today.