In the landscape of community health, the role of the local pharmacy is indispensable. Often referred to as a “Main Street Pharmacy,” these establishments are more than just dispensaries of medication; they are cornerstones of healthcare access, advice, and community well-being. However, this pivotal role comes with significant responsibilities, particularly regarding the dispensing of controlled substances. A case that underscores the gravity of these responsibilities is that of East Main Street Pharmacy, as reviewed by the Drug Enforcement Administration (DEA). This article delves into the DEA’s proceedings against East Main Street Pharmacy, examining the critical issues of pharmacist responsibility, regulatory compliance, and the overarching concern for public health and safety within the context of what we understand as a main street pharmacy.
This case, documented in a detailed administrative order, provides a stark example of the potential pitfalls and stringent oversight that main street pharmacies face. It highlights the “corresponding responsibility” of pharmacists to ensure that prescriptions are issued for legitimate medical purposes – a duty that is as critical as the prescribing physician’s. The narrative of East Main Street Pharmacy is not just a legal document; it’s a cautionary tale for pharmacies nationwide, especially those operating in close-knit community settings, about the imperative of vigilance, ethical practice, and adherence to federal regulations governing controlled substances.
I. The Genesis of the Investigation: Allegations and Initial Order
The Drug Enforcement Administration’s scrutiny of East Main Street Pharmacy began with a formal “Order to Show Cause” issued on April 23, 2009. This order, emanating from the Office of Diversion Control, proposed a severe action: the revocation of the pharmacy’s DEA Certificate of Registration, identified as BE5902615. This registration, which permitted the pharmacy to operate as a retail dispenser of controlled substances, was under threat due to alleged actions that the DEA deemed “inconsistent with the public interest.” The legal basis for this action was rooted in specific sections of the United States Code, 21 U.S.C. 823(f) and 824(a)(4), which outline the criteria and procedures for registration revocation.
The core allegation against East Main Street Pharmacy was a failure in its “corresponding responsibility” as defined under federal regulations. Specifically, the pharmacy was accused of violating 21 CFR 1306.04(a), a critical regulation stating that a prescription for a controlled substance must be “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” This regulation places a shared responsibility on both the prescribing physician and the dispensing pharmacist to ensure the legitimacy of every controlled substance prescription.
At the heart of the DEA’s allegations was the pharmacy’s relationship with Dr. Paul Volkman, a physician from Portsmouth, Ohio. The Show Cause Order highlighted that East Main Street Pharmacy, owned and operated by Eugene H. Fletcher as the sole pharmacist, had filled a staggering 6,619 controlled substance prescriptions between September 2005 and February 2006. Of these, 4,979 prescriptions originated from Dr. Volkman. This high volume of prescriptions from a single physician immediately raised red flags, especially in light of subsequent DEA findings regarding Dr. Volkman’s practices.
The DEA had already taken action against Dr. Volkman, immediately suspending his DEA registration on February 10, 2006. The agency’s investigation had concluded that Dr. Volkman “repeatedly violated Federal law by prescribing controlled substances without a legitimate medical purpose and outside the course of professional practice.” This prior finding against Dr. Volkman set a critical context for the allegations against East Main Street Pharmacy. The DEA suggested a direct link between Dr. Volkman’s illicit prescribing practices and East Main Street Pharmacy’s dispensing activities.
Further deepening the concern was the allegation that Dr. Volkman was actively directing his patients to East Main Street Pharmacy to have their prescriptions filled. The pharmacy, in turn, purportedly filled these prescriptions predominantly in cash transactions. Geographic data also played a significant role in the DEA’s case. It was alleged that “ninety-eight percent of Dr. Volkman’s patients that filled their prescriptions at [East Main Street Pharmacy] did not reside in the Columbus area,” where the pharmacy was located. This unusual patient demographic, with individuals traveling considerable distances, including from Portsmouth and Chillicothe, Ohio, and even from South Central Kentucky, to a Columbus pharmacy, further fueled suspicions of illegitimate dispensing practices. The order also noted instances of patients obtaining prescriptions from multiple physicians, and tragically, several overdose deaths linked to these prescribing patterns.
The Show Cause Order also pointed to the specific nature of the prescriptions being filled. East Main Street Pharmacy was accused of dispensing prescriptions for “combinations of controlled substances and the non-controlled, but highly addictive drug carisoprodal (Soma), under circumstances indicating that the prescriptions were issued outside the usual course of professional practice.” These combinations often included a benzodiazepine, two narcotic pain medications, and Soma – a drug cocktail medically and pharmaceutically recognized as being favored by individuals seeking drugs for non-medical purposes. The DEA alleged that the pharmacy dispensed “large quantity prescriptions” of these combinations, even when patients should have still had a substantial supply from previous fills, indicating a failure to recognize or deliberately ignore clear indicators of potential drug diversion and abuse.
A particularly damning allegation was attributed to Mr. Fletcher himself. According to the Show Cause Order, when questioned by a DEA Investigator about Dr. Volkman’s prescriptions, Mr. Fletcher reportedly stated that it was “not [his] job to question a physician.” This statement, if accurately attributed and interpreted, suggested a fundamental misunderstanding or disregard of a pharmacist’s corresponding responsibility under federal regulations.
Based on these cumulative allegations, the DEA’s Show Cause Order concluded that East Main Street Pharmacy “knew, or should have known that [the] controlled substance prescriptions it filled for patients of Dr. Volkman were for no legitimate medical purpose.” This marked the formal initiation of proceedings that could result in the revocation of the pharmacy’s ability to dispense controlled substances, placing the future of this main street pharmacy in jeopardy.
II. Legal Proceedings and Escalation: Hearing, Suspension, and Findings
Following the issuance of the Show Cause Order, East Main Street Pharmacy, through legal counsel, formally requested a hearing in a letter dated May 20, 2009. This request initiated the administrative legal process, moving the matter to the docket of the DEA’s Administrative Law Judges (ALJs). An ALJ was assigned to oversee pre-hearing procedures, setting the stage for a formal adjudication of the allegations.
The ALJ’s initial action was to issue an “Order for Pre-Hearing Statements” on May 26, 2009. This order directed both the DEA and the pharmacy to prepare written statements outlining their respective cases. Crucially, it mandated the disclosure of “the names and addresses of all witnesses whose testimony is to be presented.” Furthermore, the ALJ required a “brief summary of the testimony of each witness.” For the DEA, this meant clearly articulating “each and every act, omission or occurrence” that formed the basis for seeking revocation. For the pharmacy, it required a clear indication of “each and every matter as to which it intends to introduce evidence in opposition.” The ALJ emphasized that these summaries should detail the substance of the testimony, not just broad topics, and warned that undisclosed testimony was likely to be excluded at the hearing.
A pre-hearing conference call was conducted on July 31, 2009, followed by a “Prehearing Ruling” from the ALJ. This ruling addressed procedural matters and reiterated the importance of witness disclosure. It stipulated that any amendments to the witness list must be filed as a supplement to the Prehearing Statement, including names and testimony summaries. The ALJ again cautioned that testimony not properly disclosed might be excluded, reinforcing the structured and evidentiary nature of the proceedings.
As the administrative process unfolded, the DEA took a more drastic interim step. On November 10, 2009, exercising authority under 21 U.S.C. 824(d), the DEA issued an “Immediate Suspension Order” for East Main Street Pharmacy’s registration. This order was based on a finding that the pharmacy’s “continued registration * constitutes an imminent danger to the public health and safety.” The Immediate Suspension Order incorporated the allegations from the original Show Cause Order and added new allegations concerning recent dispensing activities.
The new allegations supporting the Immediate Suspension Order involved two specific instances in October 2009. In one case, an individual identified as L.D.C. from Portsmouth, Ohio, obtained prescriptions for 90 tablets of oxycodone 30 mg and 60 tablets of carisoprodol from a physician in Wheelersburg, Ohio. L.D.C. then traveled approximately 100 miles to Columbus and filled these prescriptions at East Main Street Pharmacy. Tragically, the very next morning, L.D.C. was found deceased at her residence, with prescription vials from East Main Street Pharmacy and scattered oxycodone tablets nearby. A preliminary coroner’s report indicated the cause of death as “probable toxic effects of drugs (oxycodone, carisoprodol and others).”
The second instance involved an individual, S.J.P. from Waverly, Ohio. On multiple dates, including July 3, September 1, and October 1, 2009, East Main Street Pharmacy filled prescriptions for oxycodone for S.J.P. These prescriptions were issued by physicians practicing in locations as distant as Lees Summit, Missouri, and also in Dayton and Portsmouth, Ohio – all significantly far from Columbus. Waverly, Ohio, itself, is about 64 miles from Columbus.
These incidents, occurring after the initial Show Cause Order, were presented as further evidence of the pharmacy’s ongoing failure to fulfill its corresponding responsibility. The DEA argued that East Main Street Pharmacy “knew or should have known that the above dispensed controlled substances were likely to be diverted or used for other than legitimate medical purposes.” The Immediate Suspension Order concluded that there was a “substantial likelihood that [East Main Street Pharmacy] will continue to violate its corresponding responsibility to properly dispense controlled substances” and that continued operation posed an “imminent danger to the public health and safety.” Consequently, the pharmacy’s registration was suspended pending the outcome of the revocation proceedings.
The formal hearing before the ALJ took place over several days: November 18-19, 2009, and March 23-25, 2010, in Columbus, Ohio. Both the DEA and East Main Street Pharmacy presented witness testimony and documentary evidence. Following the hearing, both parties submitted briefs containing proposed findings of fact, conclusions of law, and arguments, culminating in the ALJ’s Recommended Decision issued on May 18, 2010.
In her Recommended Decision, the ALJ applied the “public interest factors” outlined in 21 U.S.C. 823(f). These factors are statutory guidelines for determining whether a pharmacy’s registration is consistent with public interest. The ALJ concluded that the “record demonstrates that it is against the public interest for the Respondent to retain its controlled substances registration” and recommended that “Respondent’s registration be revoked and any pending applications for renewal be denied.” This recommendation set the stage for the final decision by the DEA Deputy Administrator, further escalating the legal and regulatory pressure on East Main Street Pharmacy.
III. ALJ’s Assessment: Public Interest Factors and Key Evidence
In her Recommended Decision, the ALJ methodically evaluated the case against East Main Street Pharmacy based on the five “public interest factors” stipulated in 21 U.S.C. 823(f). This legal framework is central to determining whether a pharmacy’s continued registration to dispense controlled substances aligns with the public interest. The ALJ’s analysis of each factor, supported by evidence presented during the hearing, provided a comprehensive justification for her recommendation of registration revocation.
The first factor considered was “the recommendation of the appropriate State licensing board or professional disciplinary authority.” In this case, “the Ohio Board of Pharmacy has not made a recommendation in this proceeding.” However, the ALJ noted a significant prior action by the Ohio Board. On March 5, 2009, the Board had fined Mr. Fletcher and placed his pharmacist license on probation due to security violations. These violations involved three separate instances where controlled substance deliveries were made to East Main Street Pharmacy when a qualified person was not present to receive them, resulting in the drugs being left in unsecured locations. The ALJ concluded that this “security violation weighs in favor of revocation” of the pharmacy’s DEA registration, indicating a pattern of regulatory lapses.
The second factor was “the applicant’s experience in dispensing controlled substances.” Here, the ALJ found significant deficiencies, stating that “Respondent ignored numerous ‘red flags’ when dispensing controlled substances to Dr. Volkman’s patients.” She heavily relied on the testimony and report of the Government’s Expert witness, who detailed multiple concerning patterns associated with the dispensing of prescriptions to Dr. Volkman’s patients. These red flags included:
- Long Travel Distances: Patients were driving “long distances” to have prescriptions filled at East Main Street Pharmacy, bypassing numerous pharmacies closer to their homes and Dr. Volkman’s offices.
- High Volume and Strength: Prescriptions were for “large volumes of controlled substances in the highest strength in each prescription.”
- Lack of Individualized Therapy: A striking “75% of these patients received the same four drug ‘cocktail,’” indicating a lack of patient-specific medical necessity.
- Cash Payments: Patients predominantly paid “large amounts of cash for their prescriptions,” an atypical pattern compared to insurance-based payments.
- Multiple Narcotics: Patients were frequently prescribed “multiple narcotic pain killers on the same day.”
Referencing established legal precedent, particularly the principle that “when prescriptions are clearly not issued for legitimate medical purposes, a pharmacist may not intentionally close his eyes and thereby avoid [actual] knowledge of the real purpose of the prescriptions,” the ALJ concluded that East Main Street Pharmacy “clos[ed] a blind eye to these obvious red flags.” She determined that the pharmacy was not taking its “corresponding responsibility for these prescriptions” seriously, in violation of 21 CFR 1306.04(a).
Further evidence of questionable practices included the fact that “many of Dr. Volkman’s patients had told [Respondent’s owner] that other pharmacies would not fill Dr. Volkman’s prescriptions.” Despite this direct warning, the pharmacy owner did not contact these other pharmacies to inquire about their refusals. The ALJ also highlighted an “unconventional” relationship between East Main Street Pharmacy and Dr. Volkman, characterized by patient referrals, coordinated late operating hours to accommodate Volkman’s patients, and maintaining “large quantities of controlled substances on hand to fill these large prescriptions.” Testimony from one of Volkman’s patients, describing being visibly “high” while filling prescriptions at the pharmacy, further illustrated the lax environment.
The ALJ also considered the tragic consequences of these dispensing practices, noting that “a number of Dr. Volkman’s patients died from drug overdoses after having prescriptions filled at the Respondent.” While acknowledging that these patients were often drug addicts and may not have used the drugs as prescribed, the ALJ emphasized that the “quantities Respondent dispensed provided these patients with the means to ingest such quantities as to cause an overdose death.” She also pointed out that the large quantities dispensed were sufficient not only for personal addiction but also for potential drug diversion and resale.
While East Main Street Pharmacy presented evidence that the owner had made efforts to verify Dr. Volkman’s legitimacy, consulted with an attorney about Volkman’s reputation, verified prescriptions with other physicians, required customer identification, and had no prior security issues beyond the state board violations, the ALJ deemed these efforts insufficient. She concluded that “Respondent’s failure to react to the ‘red flags’ raised by the conduct of Dr. Volkman’s patients and the dispensing patterns the Respondent used for these patients weigh in favor of revocation.”
The third factor, “Respondent’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances,” was found to be neutral, as “the record contains no evidence of a conviction of * Respondent or Mr. Fletcher related to the dispensing of controlled substances.”
However, the fourth factor, “Respondent’s compliance with applicable State, Federal, or local laws relating to controlled substances,” revealed further violations. The ALJ found that East Main Street Pharmacy “violated recordkeeping requirements by failing to have readily retrievable biennial inventories,” a breach of 21 U.S.C. 827(a)(1) and 21 CFR 1304.11(c). Additionally, “Mr. Fletcher failed to do drug utilization reviews prior to dispensing controlled substances,” a critical aspect of safe pharmacy practice. The ALJ also noted that Mr. Fletcher had improperly used the Ohio Automated Rx Reporting System (OARRS) database by conducting searches on individuals who had died, violating the requirement to only search for current customers. Furthermore, the pharmacy’s “banking conduct related to its dispensing business violated bank structuring laws and regulations.” Mr. Fletcher had made multiple cash deposits just under $10,000, intentionally avoiding the reporting requirements of the Bank Secrecy Act, indicating an attempt to conceal the financial scale of his cash-heavy controlled substance dispensing business.
Finally, under the fifth factor, “such other conduct which may threaten the public health and safety,” the ALJ highlighted Mr. Fletcher’s decision not to testify in the proceedings. While acknowledging his Fifth Amendment privilege, she noted that in civil matters, an adverse inference can be drawn from a party’s failure to testify. Although she “declined to draw an adverse inference,” she found Mr. Fletcher’s “inconsistent handling of controlled substances” to be “most troubling.” She observed that Mr. Fletcher demonstrated knowledge of appropriate questioning when dispensing controlled substances but failed to consistently apply these standards to Dr. Volkman’s patients. Even when patients exhibited signs of drug-seeking behavior, prescriptions were filled. The ALJ concluded that this conduct was “adverse to the public health” and supported revocation, particularly given Mr. Fletcher’s failure to provide assurances against future misconduct.
Based on her comprehensive evaluation of these factors, the ALJ concluded that the Government had “met its burden of proof” and demonstrated that East Main Street Pharmacy’s continued registration was inconsistent with “the public interest.” She reaffirmed her recommendation for registration revocation and denial of any renewal applications, setting the stage for the final agency decision.
IV. Final Determination: DEA Deputy Administrator’s Order and Findings
Following the ALJ’s Recommended Decision, East Main Street Pharmacy filed “Exceptions” on June 17, 2010, challenging the ALJ’s findings and recommendation. These exceptions were duly considered by the DEA Deputy Administrator in her final review of the matter. After a comprehensive review of the entire record, the Deputy Administrator concurred with the ALJ’s ultimate conclusion: East Main Street Pharmacy’s continued registration was indeed inconsistent with the public interest.
However, a crucial procedural point had emerged. East Main Street Pharmacy’s registration had expired on August 31, 2010, and the pharmacy had not filed a renewal application. This meant that, technically, “there is neither a registration to revoke nor a renewal application to deny.” Despite this expiration, the Deputy Administrator clarified that the case was not moot. The pharmacy’s registration had been suspended prior to the hearing under 21 U.S.C. 824(d), and the Deputy Administrator upheld this suspension order. She emphasized her role as the “ultimate finder of fact” and proceeded to make her own findings based on the evidentiary record.
The Deputy Administrator’s “Findings” reiterated key factual points established during the proceedings:
- East Main Street Pharmacy had previously held DEA Certificate of Registration BE5902615, authorizing controlled substance dispensing at 1336 East Main Street, Columbus, Ohio. This registration had expired on August 31, 2010, without renewal.
- Eugene H. Fletcher was the sole owner and pharmacist of East Main Street Pharmacy, which exclusively sold prescription pharmaceuticals.
- The case centered around the pharmacy’s dispensing practices related to prescriptions from Dr. Paul Volkman, whose illicit prescribing activities had been previously established by the DEA and upheld in court. Dr. Volkman was effectively identified as a “drug dealer” in plain terms by the Deputy Administrator, underscoring the severity of his misconduct.
The Deputy Administrator’s findings detailed the sequence of events that led to the pharmacy’s involvement with Dr. Volkman’s illicit prescriptions. After DEA actions at Denise Huffman’s pain clinic, where Volkman had previously worked, Volkman began practicing from his residence in Portsmouth. Patients faced difficulties filling his prescriptions elsewhere. D.S., one of Volkman’s patients, initiated a search for pharmacies that would fill these prescriptions, specifically for oxycodone 30 mg, hydrocodone 10 mg, Xanax 2mg, and Soma 350 mg. Other pharmacies reportedly declined, citing lack of stock or unwillingness to fill Volkman’s prescriptions. However, Mr. Fletcher, representing East Main Street Pharmacy, confirmed that he had the drugs in stock and would fill the prescriptions.
Subsequently, D.S. posted notices in Volkman’s office with East Main Street Pharmacy’s details and directions. When Volkman relocated his practice to Chillicothe, similar notices with directions to the Columbus pharmacy were posted. The distance from Volkman’s Portsmouth residence to East Main Street Pharmacy was approximately 94 miles; from his Chillicothe office, it was 56 miles. Dr. Volkman’s former security guard testified that Volkman instructed his staff to direct all patients to East Main Street Pharmacy. Daily communications occurred between Volkman’s clinic and the pharmacy to coordinate closing times to accommodate Volkman’s patients. Patients were reportedly filling prescriptions as late as midnight. The security guard noted that many patients did not appear to be in genuine pain, suggesting drug-seeking behavior.
DEA Diversion Investigators analyzed ARCOS system data, revealing a dramatic increase in East Main Street Pharmacy’s purchases of oxycodone and hydrocodone combination drugs coinciding with its association with Dr. Volkman. Oxycodone purchases surged from 96,000 dosage units in 2004 to 495,000 in 2005, with a significant portion in the latter part of 2005. Hydrocodone purchases similarly increased from 88,000 dosage units in 2004 to 328,000 in 2005. East Main Street Pharmacy’s ranking among Ohio pharmacies for oxycodone purchases jumped from 300th in 2004 to eleventh in 2005 and seventh in 2006.
A search warrant executed at East Main Street Pharmacy on February 10, 2006, led to the seizure of dispensing records. These records showed that between September 1, 2005, and February 10, 2006, the pharmacy dispensed 6,619 controlled-substance prescriptions, with 4,979 (75%) issued by Dr. Volkman. Correspondingly, the pharmacy experienced a “multi-fold increase” in prescriptions filled for oxycodone, hydrocodone, diazepam, and alprazolam.
Crucially, “nearly ninety-nine percent” of Volkman’s patients filling prescriptions at East Main Street Pharmacy were not local to Columbus. Approximately half were from Kentucky, driving three to four hours. Many others were from the Portsmouth area, bypassing about 40 pharmacies en route to Columbus. Moreover, 87% of these customers paid cash, contrasting sharply with the national average of 10-11.4% cash payments for prescriptions. Only 5% paid with insurance, and 8% used a combination.
Testimonies from patients like L.W. and A.S. further detailed the dispensing practices. L.W., a Kentucky resident, obtained large quantities of oxycodone, hydrocodone, alprazolam, and carisoprodol from East Main Street Pharmacy on multiple occasions. She admitted to selling and using the drugs to get high and stated that Mr. Fletcher never inquired about her medical condition, engaging only in “small talk.” She described being visibly intoxicated while filling prescriptions. A.S. testified about receiving similar combinations of drugs and sharing half of her pills with her sister-in-law for resale. She confirmed that Volkman’s office directed her to East Main Street Pharmacy, a two-hour drive from Portsmouth.
The Deputy Administrator also referenced overdose deaths linked to prescriptions filled at East Main Street Pharmacy. While acknowledging the lack of direct coroner’s reports in evidence for S.L.J. and E.R., the cases of L.D.C. and B.A., who died shortly after filling prescriptions at the pharmacy in October and November 2009, were highlighted. L.D.C.’s death was preliminarily attributed to “toxic effects of drugs” including oxycodone and carisoprodol, with prescription vials from East Main Street Pharmacy found at the scene. B.A., a recovering drug addict, obtained multiple prescriptions, including high doses of oxycodone, from East Main Street Pharmacy on November 4, 2009, and was found dead the next morning, with significant quantities of dispensed pills missing from the vials.
Evidence of financial irregularities further strengthened the case. In October 2005, Mr. Fletcher contacted a bank official, Robin Padolik, inquiring about cash deposit reporting thresholds and methods to avoid triggering reports. Ms. Padolik identified six suspicious transactions involving deposits just under $10,000, leading the bank to conclude Mr. Fletcher was engaged in structuring to evade Currency Transaction Reports. The bank closed his accounts, and a DEA investigator estimated Mr. Fletcher’s net profit from dispensing Volkman’s prescriptions at nearly $500,000.
Interviews with Mr. Fletcher revealed admissions that patients told him other pharmacies wouldn’t fill Volkman’s prescriptions, but he did not contact these pharmacies. He stated it was “not his job to question a physician,” despite acknowledging a pharmacist’s corresponding responsibility. He claimed he didn’t find long travel distances, cash payments, drug combinations, or other pharmacies’ refusals suspicious.
Comparative evidence showed East Main Street Pharmacy’s controlled substance dispensations were substantially higher than a nearby CVS pharmacy. However, the Deputy Administrator deemed comparisons of pricing and location characteristics as not rising to the level of substantial evidence due to methodological weaknesses. Similarly, evidence about the pharmacy’s location in a “bad/high-crime neighborhood” and Mr. Fletcher carrying a gun were deemed irrelevant to the core issue of corresponding responsibility.
Evidence post-dating the February 2006 search warrant, including OARRS data, showed East Main Street Pharmacy continued to fill suspicious prescriptions, including those from Florida-based physicians for Kentucky residents. These prescriptions included high-strength oxycodone and alprazolam, with patients traveling long distances.
Based on these comprehensive findings, the Deputy Administrator affirmed the Immediate Suspension Order. She concluded that the evidence overwhelmingly demonstrated that East Main Street Pharmacy had dispensed controlled substance prescriptions it knew or should have known lacked legitimate medical purpose, thereby violating its corresponding responsibility and endangering public health and safety. The order to suspend the pharmacy’s registration, albeit now expired, was upheld, marking a definitive regulatory action against this main street pharmacy.
V. Expert Testimony: Pharmacy Standards and Red Flags
A critical component of the DEA’s case against East Main Street Pharmacy was the expert testimony of Dr. Donald Sullivan, a registered pharmacist with a Ph.D. in Pharmaceutical Administration and extensive experience in pharmacy practice and education. Dr. Sullivan was qualified as an expert witness on “standard pharmacy practice and standards for dispensing controlled substances.” His testimony provided a professional and authoritative perspective on the alleged deviations from accepted pharmacy standards at East Main Street Pharmacy.
Dr. Sullivan testified extensively about the “corresponding responsibility” shared by physicians and pharmacists under both Ohio and Federal law. He refuted the notion that a pharmacist’s duty is merely to fill prescriptions as written by a physician. He emphasized that pharmacists have a legal and ethical obligation to ensure prescriptions are for a “Legitimate Medical Purpose.” He stated, “Don’t just fill it because the doctor wrote it,” highlighting the proactive role expected of pharmacists in preventing drug diversion and abuse.
According to Dr. Sullivan, pharmacists are explicitly taught to question the legitimacy of prescriptions. He provided examples from his own practice where he refused to fill prescriptions with suspicious combinations, dosages, or lack of individualized therapy. He emphasized that merely verifying a prescription with a physician is insufficient; pharmacists must exercise their professional judgment to determine if a prescription is for a legitimate medical purpose. This responsibility includes recognizing and acting upon “red flags” that indicate potential abuse or diversion.
Dr. Sullivan detailed numerous “red flags” that pharmacists are trained to recognize and consider before dispensing a prescription. These include:
- Drug Utilization Review (DUR) Triggers: Pharmacists are required to perform DUR on every prescription to identify issues like high doses, duplicate therapy, potential misuse, and early refills.
- Prescription Patterns: Red flags include “[m]aximum doses being seen for every single patient, lack of individuation of therapy, certain patterns from physicians of potential abuse of seeing the same types of controlled substances over, and over, and over, again.”
- Drug Combinations and Interactions: Suspicious combinations include “drug interactions [such as] [t]wo drugs being used for the same thing, three drugs being used for the same thing, three drugs in different classes[ ] that can cause the same side effects, such as respiratory [depression] where you might see a benzodiazepine, a muscle relaxer, and a narcotic pain killer.”
- Patient Factors: Factors such as patient demographics, travel distance to the pharmacy, method of payment (cash preference), and whether other pharmacies have refused to fill the prescription are also critical red flags.
Dr. Sullivan specifically reviewed prescriptions from 55 of Dr. Volkman’s patients filled at East Main Street Pharmacy between September 2005 and February 2006. His analysis highlighted several alarming patterns. He noted that patients were traveling “2+ hours to Columbus” despite living in “extreme southern Ohio and northern Kentucky,” bypassing numerous closer pharmacies. He considered this long travel distance a “major red flag.” The high proportion of cash payments (73%) was another significant red flag, far exceeding the national average and suggesting illicit drug transactions.
Dr. Sullivan stated he had “never seen such an abuse of controlled substances dispensing by one pharmacy, especially in schedule II controlled substances.” He found the volume of controlled substances prescribed by Dr. Volkman “extremely surprising” and indicative of a “controlled substance prescription mill.” The uniformity of prescriptions was also concerning: “75% of the [Volkman] patients received the same four drug cocktail, which included a benzodiazepine, two narcotic pain killers and Soma.” He testified that this combination is “well known in the pharmacy profession” as being abused by prescription drug users. The simultaneous prescription of two narcotic painkillers further heightened his concern.
Dr. Sullivan explained the concept of “the triple” (benzodiazepine, narcotic painkiller, sleeping pill) and “the homerun” (adding Soma to the triple), terms commonly used by pharmacists to describe abused drug combinations. He emphasized the dangers of these combinations, particularly the synergistic effect on respiratory depression. He noted that in the prescriptions reviewed, dosages were often excessive, with 80% of patients prescribed oxycodone at 15 mg to 60 mg every two to three hours, far exceeding the normal dose. Hydrocodone prescriptions were uniformly for the highest strength, and Xanax and Valium prescriptions were also consistently for maximum strengths and dosages, lacking any individualization of therapy.
Dr. Sullivan cited specific examples of problematic prescriptions, including early refills and patients receiving multiple narcotic prescriptions on the same day. He highlighted cases like J.C., prescribed 720 oxycodone 15 mg tablets and hydrocodone/apap, and M.C., prescribed three different narcotics on the same day. Dr. Sullivan concluded that “[n]o patient could take this much narcotic in one day and not overdose,” reinforcing the lack of legitimate medical purpose in these prescriptions.
In his expert opinion, Dr. Sullivan concluded that the evidence was “overwhelming” and showed “a pattern of dispensing controlled substances to patients who are known drug abusers or are diverting prescription drugs for illegal purposes.” He stated that “[a]ny reasonable pharmacist would notice this as a problem very quickly and easily” and would recognize the “textbook examples of drug abuse and/or drug diversion.” While acknowledging that a pharmacist might occasionally fill a high-dose or large-quantity prescription in a patient’s best interest, the patterns observed at East Main Street Pharmacy far exceeded any legitimate medical justification. His testimony underscored the critical role of pharmacist vigilance and adherence to professional standards in preventing the misuse and diversion of controlled substances.
VI. Respondent’s Defense and Evidence
In defense against the DEA’s allegations, East Main Street Pharmacy presented evidence and witness testimonies aimed at countering the claims of regulatory violations and demonstrating responsible dispensing practices. However, much of the evidence presented by the Respondent was deemed by the ALJ and Deputy Administrator as either irrelevant or insufficient to outweigh the substantial evidence presented by the Government.
East Main Street Pharmacy called fifteen witnesses, a significant portion of whom testified about tangential issues such as the character of the pharmacy’s neighborhood, Mr. Fletcher’s practice of carrying a gun for personal safety, and pricing comparisons with other pharmacies. The ALJ and Deputy Administrator ultimately deemed these lines of evidence irrelevant to the central issue of whether the pharmacy violated its corresponding responsibility under 21 CFR 1306.04(a). Therefore, these testimonies did little to advance the pharmacy’s defense on the core allegations.
Of the fifteen witnesses, only four offered testimony arguably relevant to the critical issues of dispensing practices and awareness of prescription legitimacy. These included Mark Aalyson, Julie Fuller, Carisa Cole, and Catherine Smith.
Mark Aalyson, an attorney practicing in Portsmouth, Ohio, testified that in “early fall of 2006,” Mr. Fletcher called him to inquire about Dr. Paul Volkman’s reputation. According to Aalyson, Mr. Fletcher stated he was “getting a lot of people coming in, and I’m beginning to wonder if the guy is legitimate.” Aalyson testified he did not know Volkman well. This testimony was presented to suggest Mr. Fletcher had concerns about Dr. Volkman and sought to exercise due diligence. However, the timing of this call, in “early fall of 2006,” was problematic as it occurred well after Mr. Fletcher began filling Volkman’s prescriptions in September 2005, and months after the DEA had already suspended Volkman’s registration in February 2006. The Deputy Administrator noted that even if the call occurred earlier, Mr. Fletcher’s statement to Aalyson that he was “beginning to wonder if the guy is legitimate” actually supported the DEA’s case that Mr. Fletcher was aware of potential issues with Volkman’s prescriptions.
Julie Fuller, a sales representative for a drug distributor, testified that during her visits to East Main Street Pharmacy, she observed Mr. Fletcher checking for early refills and drug interactions. However, she acknowledged her visits were not for the purpose of observing his pharmacy practices but to solicit business. Her visits were during daytime hours, and she did not testify to observing Mr. Fletcher dispensing any of Dr. Volkman’s controlled substance prescriptions. Consequently, her testimony was considered of “no probative value” to the specific allegations.
Carisa Cole, Mr. Fletcher’s cousin, worked at East Main Street Pharmacy from December 2004 to October 2009. She testified she never saw anyone appearing under the influence of drugs or alcohol and that Mr. Fletcher would refuse service to such individuals. However, on cross-examination, she admitted she could not recall any instances of refusing service to Dr. Volkman’s patients for this reason. She mentioned instances of refusing prescriptions from Florida-based doctors or for lack of photo ID, but these were isolated and lacked specific context related to the Volkman allegations. Cole maintained that Volkman’s patients complained about frequent blood tests and that Mr. Fletcher would sometimes stay open late for Volkman’s patients. She acknowledged Volkman’s patients were not local to Columbus and came from distant areas. She claimed Mr. Fletcher asked these patients why they chose his pharmacy, and they stated other pharmacies were out of stock or unwilling to fill the prescriptions. However, she admitted not knowing if Mr. Fletcher inquired why patients bypassed closer pharmacies. Cole also testified that Mr. Fletcher “tried calling some of the pharmacies” but then conceded she wasn’t sure if she was present when such calls were made, contradicting Mr. Fletcher’s own statement to DEA investigators that he “did not communicate with other pharmacists.” She acknowledged that Volkman’s prescriptions often included schedule II drugs like oxycodone in combination with Soma and alprazolam and that patients often presented similar prescriptions simultaneously. Cole’s testimony regarding prescription verification for out-of-area prescriptions was deemed “patently erroneous” given the high volume of Volkman’s prescriptions and phone records indicating limited long-distance calls.
Catherine Smith, a pharmacy technician at East Main Street Pharmacy, considered Mr. Fletcher her “best friend.” She testified her duties included front window service, prescription review, and filling. She claimed to review prescriptions for legitimacy (forgeries) and present questionable ones to Mr. Fletcher. She stated Mr. Fletcher would question patients who seemed “not right” or under the influence and would refuse to fill prescriptions in such cases. She claimed Mr. Fletcher would ask patients about their pain medication use, quantities, and ability to work without medication, and would advise them on proper usage and cautions. She initially claimed Mr. Fletcher “talked to everybody about their prescriptions” but later qualified this to “the majority of them” on pain medication. This contradicted DEA investigator interviews with Volkman’s patients, who generally stated Mr. Fletcher did not inquire about their medical conditions. Smith also claimed Mr. Fletcher would call doctors to “make sure that the script is legit.” However, Volkman’s security guard testified that Mr. Fletcher’s calls to Volkman’s office were primarily to coordinate closing times, not patient medical conditions. Phone records also suggested numerous prescriptions filled without calls to Volkman. Neither Smith nor Cole could cite specific instances where Mr. Fletcher refused to fill Volkman’s prescriptions due to lack of legitimate medical purpose.
Notably, Eugene H. Fletcher himself did not testify in the proceedings. The Deputy Administrator highlighted this absence, noting that while he had a Fifth Amendment right not to testify, in civil proceedings, an adverse inference could be drawn from a party’s failure to testify when substantial evidence was presented against them. Mr. Fletcher’s silence left key questions unanswered and weakened the pharmacy’s defense.
Overall, the evidence presented by East Main Street Pharmacy was deemed insufficient to rebut the DEA’s prima facie case. Witness testimonies were often vague, contradictory, or irrelevant to the core allegations. Crucially, the pharmacy failed to provide compelling evidence that Mr. Fletcher actively exercised his corresponding responsibility to ensure the legitimacy of Dr. Volkman’s prescriptions or that he took meaningful steps to address the numerous red flags associated with these prescriptions. Mr. Fletcher’s decision not to testify further undermined the pharmacy’s defense, leaving the DEA’s case largely unchallenged.
VII. Legal and Regulatory Framework: “Corresponding Responsibility” and Public Interest
The DEA’s action against East Main Street Pharmacy hinged on established legal and regulatory principles, primarily the concept of “corresponding responsibility” and the “public interest” standard under the Controlled Substances Act (CSA). Understanding these frameworks is crucial to appreciating the significance of this case and its broader implications for main street pharmacies.
Section 304(a) of the CSA, 21 U.S.C. 824(a)(4), empowers the Attorney General to suspend or revoke a DEA registration to dispense controlled substances if a registrant has committed acts rendering their registration “inconsistent with the public interest” as determined under 21 U.S.C. 823(f). This “public interest” determination involves considering five factors:
- Recommendation of the State licensing board.
- Registrant’s experience in dispensing controlled substances.
- Conviction record under controlled substance laws.
- Compliance with applicable controlled substance laws.
- Other conduct threatening public health and safety.
These factors are considered “in the disjunctive,” meaning the DEA can rely on any single factor or combination thereof, assigning weight as deemed appropriate. The DEA is not obligated to make findings on all factors. The Government bears the burden of proving by a preponderance of evidence that a registrant has acted inconsistently with the public interest. Once a prima facie case is established, the burden shifts to the registrant to refute the Government’s case or present mitigating evidence. Past performance is considered a key indicator of future performance, and registrants must demonstrate acceptance of responsibility and assurance against future misconduct.
A central regulation in this case is 21 CFR 1306.04(a), which states that a controlled substance prescription is lawful only if “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Critically, this regulation imposes a “corresponding responsibility rests with the pharmacist who fills the prescription.” It further specifies that “the person knowingly filling such a purported prescription, as well as the person issuing it, [is] subject to the penalties provided for violations of the provisions of law relating to controlled substances.”
The DEA has consistently interpreted this “corresponding responsibility” as prohibiting pharmacists from filling prescriptions when they “knows or has reason to know that the prescription was not written for a legitimate medical purpose.” Pharmacists cannot intentionally “close his eyes” to obvious signs of illegitimate prescriptions. Courts have upheld this regulation against challenges of vagueness, affirming it provides “fair notice that certain conduct is proscribed.”
East Main Street Pharmacy argued that the Government relied on a “vague allegation” of failing to satisfy “corresponding duty” without pointing to a specific rule violation and that it was held to an “unknown and ambiguous standard.” The Deputy Administrator rejected this, citing judicial precedent affirming the regulation’s clarity and enforceability. Federal courts have consistently applied this regulation, holding pharmacists accountable for not filling orders they know or have reason to know are not legitimate prescriptions.
The Deputy Administrator concluded that the evidence pertinent to factors two and four – East Main Street Pharmacy’s experience in dispensing controlled substances and compliance with applicable laws – established a prima facie case that its registration was inconsistent with the public interest. The pharmacy failed to rebut this case.
The Deputy Administrator emphasized that East Main Street Pharmacy, through Mr. Fletcher, “knew from the outset that Dr. Volkman’s prescriptions lacked a legitimate medical purpose.” She cited the initial phone call where Mr. Fletcher agreed to fill prescriptions for a “cocktail” of oxycodone 30 mg, hydrocodone 10 mg, Xanax 2mg, and Soma 350 mg. Expert testimony confirmed this combination is “well known in the pharmacy profession” as being abused. The Deputy Administrator noted that Dr. Volkman “took this to another level” by prescribing two narcotics in addition to a benzodiazepine and carisoprodol. This “synergistic effect” of these drugs posed significant risks to patients. From the outset, Mr. Fletcher had “reason to know that Volkman’s prescriptions lacked ‘a legitimate medical purpose’” under 21 CFR 1306.04(a).
Despite this, East Main Street Pharmacy repeatedly dispensed these “cocktail prescriptions” for oxycodone, hydrocodone, alprazolam, and carisoprodol to patients like A.S. and L.W., often in excessive quantities and dosages. The Deputy Administrator highlighted red flags such as patients traveling long distances, high cash payment rates, patients informing Mr. Fletcher other pharmacies wouldn’t fill Volkman’s prescriptions, and the coordinated late operating hours with Volkman’s clinic. These factors, combined with expert testimony and evidence of regulatory violations like recordkeeping failures and bank structuring, overwhelmingly supported the finding that East Main Street Pharmacy acted inconsistently with the public interest and posed a threat to public health and safety.
VIII. Implications and Lessons for Main Street Pharmacies
The case of East Main Street Pharmacy serves as a potent reminder of the critical responsibilities and stringent regulatory environment facing main street pharmacies, particularly concerning the dispensing of controlled substances. Several key implications and lessons emerge from this case, relevant to pharmacies across the nation.
Understanding and Exercising “Corresponding Responsibility” is Paramount: The central theme of this case is the “corresponding responsibility” of pharmacists. It is not merely a passive role of filling prescriptions as written. Pharmacists have a legal and ethical duty to actively ensure that every controlled substance prescription is for a legitimate medical purpose. This requires vigilance, professional judgment, and a willingness to question prescriptions that present red flags. The case underscores that ignorance or willful blindness to suspicious prescribing patterns is not a defense. Main street pharmacies must instill a culture of proactive responsibility among their pharmacists and staff.
Recognizing and Acting on Red Flags is Essential: The DEA’s case meticulously detailed numerous “red flags” associated with Dr. Volkman’s prescriptions filled at East Main Street Pharmacy. These red flags, including long travel distances, cash payments, uniform “cocktail” prescriptions, high dosages, early refills, and patient disclosures of other pharmacies’ refusals, were not isolated incidents but rather a pattern of concerning indicators. Main street pharmacies must train their pharmacists and technicians to identify and document these red flags. Policies and procedures should be in place to guide staff on how to respond when red flags are identified, including further verification, consultation with prescribers, and, when necessary, refusal to fill suspicious prescriptions.
Regulatory Compliance Extends Beyond Dispensing: The case highlights that regulatory compliance for main street pharmacies extends beyond the immediate act of dispensing. It includes meticulous recordkeeping, proper drug utilization reviews, adherence to prescription monitoring programs (like OARRS), and compliance with banking regulations. Failures in these ancillary areas, such as recordkeeping violations and bank structuring attempts, further substantiated the DEA’s case and demonstrated a broader disregard for regulatory obligations at East Main Street Pharmacy. Pharmacies must ensure comprehensive compliance programs encompassing all aspects of their operations, not just dispensing practices.
Expert Testimony and Professional Standards are Benchmarks: Dr. Sullivan’s expert testimony was instrumental in establishing that East Main Street Pharmacy’s practices fell below accepted professional standards for dispensing controlled substances. His testimony provided a clear benchmark against which the pharmacy’s conduct was measured. Main street pharmacies should regularly review and update their practices to align with evolving professional standards and best practices in controlled substance dispensing. Engaging in continuing education and staying informed about regulatory updates and professional guidelines is crucial.
Consequences of Non-Compliance are Severe: The DEA’s action against East Main Street Pharmacy, culminating in the upholding of the suspension order, demonstrates the severe consequences of non-compliance. Revocation of DEA registration effectively shuts down a pharmacy’s ability to dispense controlled substances, a critical aspect of most main street pharmacy businesses. Beyond financial losses, such actions damage reputation, erode community trust, and can have legal and professional repercussions for pharmacy owners and pharmacists. This case underscores that regulatory compliance is not merely a bureaucratic formality but a fundamental requirement for maintaining the privilege of operating a pharmacy and dispensing controlled substances.
Patient Safety and Public Health Must be Paramount: Ultimately, the DEA’s action was rooted in concerns for patient safety and public health. The tragic cases of overdose deaths linked to prescriptions filled at East Main Street Pharmacy underscored the real-world consequences of lax dispensing practices. Main street pharmacies, as healthcare providers in their communities, must prioritize patient safety and public health above transactional considerations. This requires a commitment to responsible dispensing, even if it means confronting difficult situations, questioning prescribers, or losing business from questionable sources.
In conclusion, the case of East Main Street Pharmacy offers invaluable lessons for all main street pharmacies. It reinforces the critical importance of “corresponding responsibility,” vigilance in identifying red flags, comprehensive regulatory compliance, adherence to professional standards, and, above all, a unwavering commitment to patient safety and public health. For main street pharmacies to thrive as trusted healthcare resources in their communities, these principles must be deeply ingrained in their operational ethos and daily practices.
References
- U.S. Department of Justice, Drug Enforcement Administration. (2010, October 15). In the Matter of East Main Street Pharmacy, Order of Deputy Administrator. FR Doc. 2010-27096.
