Does Your Controlled Substance Compliance Program Adequately Address Pharmacists’ Corresponding Responsibility?

DEA rules governing the issuance and filling of prescriptions dictate that a physician must prescribe controlled substances only for a “legitimate medical purpose,” while acting “in the usual course of his professional practice.” Pharmacists and pharmacies have a corresponding responsibility to ensure that a prescription is valid. A pharmacist who knowingly fills a prescription that does not meet the legitimate medical purpose standard is subject to the same penalties as the prescriber.

The key phrases “legitimate medical purpose” and “in the usual course of his or her professional practice” are not defined by DEA rules, and the DEA has provided limited guidance. Many states have implemented their own variations of the responsibilities described above, which further complicates matters. In light of this lack of instruction, you should thoughtfully consider whether your compliance program meaningfully addresses the issue of corresponding responsibility.

Prescriptions for controlled substances are increasingly gaining national attention. The epidemic of opioid abuse has rapidly spread across America, and the DEA, along with most state boards of pharmacy, have made addressing this issue a priority by way of heightened enforcement and larger fines. Pharmacists in some states have a duty to dispense legally prescribed drugs unless the pharmacist knows, or should know, that the prescription was not issued for a legitimate medical purpose.

There is obvious tension between this duty and the corresponding responsibility doctrine. Pharmacists struggling to reconcile their duty to dispense with legal obligations to prevent drug diversion should avoid simply deferring to the prescribing practitioner, and must exercise a degree of independent judgment when determining whether a prescription is suspect or legitimate. To help pharmacists evaluate suspect prescriptions, the National Association of Boards of Pharmacy stakeholders’ coalition and the DEA have noted certain red flags for pharmacists to identify and resolve prior to dispensing a controlled substance.

These red flags include a doctor frequently prescribing the same drugs in the same quantities, a doctor repeatedly  » prescribing cocktails of frequently abused controlled substances, geographic anomalies (eg, a doctor located far from pharmacy), and prescriptions for illnesses or conditions inconsistent with the prescribing physician’s area of expertise.

What Happens When You Don’t Comply?

On January 19, 2017, the Department of Justice announced that Costco Wholesale will pay $11.75 million to settle allegations that it failed to properly oversee its pharmacies. Specifically, the settlement resolves allegations that Costco’s pharmacies, among other things, violated the Controlled Substances Act by filling prescriptions that were incomplete, lacked DEA numbers, or were for substances prescribed outside the scope of the prescriber’s usual course of professional practice.

As a result of the settlement, Costco has made improvements in its pharmacies to address the issues uncovered by the investigation, including purchasing a new pharmacy management system at a budgeted 5-year cost of approximately $127 million. Costco was also forced to implement a 3-tier audit program for its pharmacies, which includes annual audits conducted by an external party. The settlement, most importantly, provides the DEA unfettered (and unannounced) access to all DEA-registered Costco pharmacies, without warrants, for the next 3 years.

State pharmacy boards have also taken on this issue. In August 2013, the California Board of Pharmacy disciplined a pharmacist and a pharmacy for engaging in unprofessional conduct for failing to comply with their corresponding responsibility. The decision provides additional examples of red flags that should cause a pharmacist to pause before filling a script, and establishes that a reasonable inquiry is required to satisfy the standard of care in California when filling a controlled substance.

A reasonable inquiry should include determining that the prescription is valid on its face and that the person presenting the prescription is the patient or the patient’s legitimate representative, asking whether the patient is taking other medications to ensure that there is no allergy to the new medication and that there will be no adverse drug interactions, and evaluating whether the drug therapy is appropriate. In short, a dispensing pharmacist must verify every suspicious prescription. The board revoked the pharmacy’s permit, the pharmacist’s license, and ordered both to pay for investigation and enforcement costs, a total just under $40,000.

Assessing Your Controlled Substances Compliance Program

The potential penalties are severe, and the pressures to comply—from the DEA, state boards of pharmacy, the media, and public opinion—are greater than ever. Yet, most pharmacy controlled substance compliance programs focus on quantifiable measures (eg, prescription elements for CII prescriptions and the number of DEA Form 106s that have been submitted) rather than on the compliance elements that require pharmacists to use their professional judgment.

Does your controlled substance compliance program adequately address a pharmacist’s corresponding responsibility? The best way to determine this is to assess your compliance program or, in other words, to perform a simple due diligence of your current controlled substances compliance practices.

• Education and Training: Does your current pharmacist training address corresponding responsibility and the use of red flags? Awareness of the issue is critical. In addition to formal training, a pharmacy can also provide its pharmacists with tools that help them make good decisions on whether to fill a suspect prescription—for example, a practical red flag checklist that a pharmacist can use at the point-of-sale.

• Policies and Procedures: Do your policies and standard operating procedures (SOPs) address corresponding responsibility? Once again, awareness of the issue is critical. Policies and SOPs can serve as a good platform to encourage your pharmacists to use their independent, professional judgment when deciding whether to fill a suspect prescription.

• Use of Available Resources: Does your pharmacy appropriately consult the state’s prescription drug monitoring program (PDMP)? The PDMP database is a valuable resource for stemming diversion and, depending on your home state, consulting it may be required.

• Documentation: Is there documentary evidence that your pharmacists are considering the red flags, and then acting to resolve them? When attempting to resolve red flags, all interactions between the pharmacy and physicians and/or physician offices should be documented.

• Monitoring and Self-Assessment: Does your pharmacy periodically review its dispensing activity for evidence of improper dispensing or diversion? Use the data available to you. Look for patterns of prescribing (eg, same physician, same drug, same quantity). If there are multiple pharmacies in your organization, look at each pharmacy’s controlled substance dispensing activity over a period of time. Are there any outliers? Why?

• Investigations and Corrective Action: Is there evidence that your pharmacy’s compliance program is more than just a paper-only program? If potential issues with a particular prescriber, pharmacist, or pharmacy are self-reported, or found during monitoring, the pharmacy should investigate and take corrective actions.

The pharmacist is the last line of defense in determining whether a prescription has been written for a legitimate medical purpose. Provide your pharmacists with the tools they need to make good decisions on whether to fill a suspect prescription. Encourage and empower your pharmacists to use their education, experience, and professional judgment to say no when there is a legitimate question of diversion.

This will raise awareness within your pharmacy and strengthen your overall controlled substance compliance program. A due diligence review of your current processes might end up saving your pharmacy from the time, expense, and continued scrutiny associated with a DEA or state compliance action. â—†

About the Authors

MICHAEL R. HESS is a member of Bass, Berry & Sims PLC and leads its Specialty Pharmacy, Pharma Services, and Distribution Practice, and is based in the firm’s Memphis, Tennessee, office. He is the former chief counsel and vice president of Strategic Development at Accredo Health Group and assistant general counsel for Accredo’s parent, Medco Health Solutions. Bass, Berry & Sims PLC has more than 220 attorneys representing numerous publicly traded companies and Fortune 500 businesses. The firm has 3 offices in Tennessee (Nashville, Memphis, Knoxville) and 1 in Washington, DC. Neal B. Curtis is an associate of Bass, Berry & Sims in the firm’s Nashville office, providing operational, regulatory and transactional support for healthcare clients. Paul DelloRusso is counsel through a third party agency for Bass, Berry & Sims and is based in New Jersey. Previously, DelloRusso was Deputy Chief Compliance Officer at Omnicare, Inc., and Assistant Counsel at Medco Health Solutions.