Blais v. R.I. Dep't of Health & Michael Fine

• Decision Date: 22 December 2014
• Docket Number: C.A. No. PC-2012-5791
• Court: Rhode Island Superior Court
• Parties: LEO BLAIS, RPH v. RHODE ISLAND DEPARTMENT OF HEALTH and MICHAEL FINE, M.D. in his capacity as the Director of Health of the Rhode Island Department of Health

LEO BLAIS, RPH v. RHODE ISLAND DEPARTMENT OF HEALTHand MICHAEL FINE, M.D. in his capacity as the Directorof Health of the Rhode Island Department of Health

C.A. No. PC-2012-5791

STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS PROVIDENCE, SC. SUPERIOR COURT

December 22, 2014

DECISION

NUGENT, J. Appellant Leo Blais, R.Ph (hereinafter Appellant or Mr. Blais) appeals the June 17, 2013 decision of Director Michael Fine, M.D. (Director Fine) of the Rhode Island Department of Health, revoking Mr. Blais's license to practice pharmacy in the State of Rhode Island. Jurisdiction in the instant matter is pursuant to G.L. 1956 § 42-35-15.

IFacts and Travel

On March 14, 2012, Dr. Patrick Kelly (Dr. Kelly), the Chief of Compliance and Regulatory for the State Board of Pharmacy (the Board) (Tr. 2, Nov. 20, 2012), received a call from a mother seeking to file a complaint against Apothecare Pharmacy (Apothecare) for a dispensing error. Id. at 18. The prescription she had received from Apothecare and had given to her child "was labeled to contain Omeprazole, the [generic name] for Prilosec, which is a stomach medication for acid reflux." Id. at 20. However, when she took her child to the hospital, concerned about the baby's recent lethargy, the hospital discovered that the baby'sheartburn medicine contained morphine. Id. at 19-20. Morphine does not belong in Omeprazole. Id. at 20.

After speaking with the girl's mother, Dr. Kelly took the drug that was given to the baby and sent it to the State Toxicology Lab for additional testing. Id. at 21. The result confirmed the fact that the medicine labeled as Omeprazole did contain morphine. Id.; Rhode Island Forensic Science Laboratory Report dated Mar. 22, 2012. Upon obtaining these results, Dr. Kelly's next step was to perform a full inspection of Apothecare in search of what may have caused such an error. (Tr. 35, Nov. 20, 2012.)

Apothecare is "predominantly [a] compounding shop, which means that better than 90 percent of what [it] dispense[s] on a daily basis is made by [the pharmacy] from a combination of bases, active ingredients, [and] raw materials, [which in turn are] custom formulated for a patient." (Tr. 9, Dec. 6, 2012.) Apothecare serves a clientele of "people who have more involved medical cases or . . . have conditions that are not treatable by commercially available drugs or [are in] hospice." Id. at 24. In this case, liquid omeprazole had to be compounded because the child could not swallow pills. Mr. Blais, pharmacist in charge of Apothecare, has been a pharmacist for thirty-three years. Id. at 3. Mr. Blais was President of the Rhode Island Pharmacists Association. Id. at 4. Additionally, Mr. Blais served as a member of the Rhode Island Senate for eighteen years and on the Department of Health Board of Pharmacy for twelve years. At his hearing, Mr. Blais speculated that he had filled close to two million prescriptions, having "received an award from Roche Laboratories . . . in the late 90s for doing a million prescriptions." Id. at 6.

In his role as Chief of Compliance, Dr. Kelly conducts routine inspections as well as "investigat[ions of] complaints of alleged violations or misconduct by pharmacists orpharmacies[.]" (Tr. 11, Nov. 20, 2012.) In his tenure with the Board, he has conducted hundreds of such inspections. Id. at 76. He informed the hearing officer, Catherine Warren (Hearing Officer Warren), that he would begin these investigations by speaking to the pharmacist in charge, "who is responsible for the overall conduct and operation of the pharmacy . . . [including the actions of] staff pharmac[ists] or technicians or interns[.]" Id. at 14. Dr. Kelly noted that a pharmacy subject to a routine inspection, typically

"would be in accordance [with applicable regulations], generally drug stock would be organized based either upon some kind of alphabetical system or indication. Everything -- the compounding benches organized, adequate space to effectively discharge duties; records are in order, meaning that they're thorough, complete and available for inspection, and that the pharmacy is clean and led in an organized manner." Id. at 16.

When investigating Apothecare, Dr. Kelly noted that,

"[t]he pharmacy had -- it looked like card tables set up around the perimeter of the room and in the center of the room. On the side of the room, the tables were held up with cinder blocks. The compounding area on the center table was cluttered. . . . It was disorganized, where you had compound ingredients, papers, what looked to be labels. On the floor of the room, there were multiple totes containing various drugs stored on the floor. There were even some loose tablets underneath the tables, and the stock itself was -- the chemicals were stacked on top of each other. There didn't really appear to be any markers separating off one drug from another drug, meaning [a]isles or shelf tags. Everything was on the shelf in, like, a stacked manner." Id. at 49-51.

Ms. Catherine Cordy (Ms. Cordy), Executive Director of the Pharmacy Board, conducted the investigation of Apothecare with Dr. Kelly. (Tr. 11, Nov. 28, 2012.) She testified that, like Dr. Kelly, she had conducted hundreds of pharmacy inspections in Rhode Island. Id. at 6. Her testimony corroborated Dr. Kelly's assertions regarding the disorder within Mr. Blais's pharmacy. She stated that "there was really no organized pattern for where the drugs were located" and that everything was "very cluttered and disorganized." Id. at 20-21. She also notedthat "medications [were] haphazardly placed on the shelves, piled on top of one another." Id. at 125. Dr. Kelly noted that "[w]hen [a pharmacist] store[s] [drugs] next to each other that maybe look alike, based upon either the container or sound alike based upon the name, stored adjacent to each other and also when the ingredients themselves can similarly look the same, [there exists a definite] concern of . . . a mix-up or switch." (Tr. 53, Nov. 20, 2012)

Mr. Blais testified that the adulterated omeprazole was the result of this disorder at the compounding station. (Tr. 12-14, Dec. 6, 2012.) A "bottle of morphine concentrate, which is a 20 milligram per [milliliter] stock solution used for hospice patients was [likely] left out on the counter and hadn't been returned to stock[.]" Id. at 12-13. Mr. Blais admitted that the morphine and flavored sweetening syrups "were in identical bottles[.]" Id. at 13. He noted that one "wouldn't see the difference in the color, because the morphine solution is red [and] [t]he flavoring solution is a reddish orange[.]" Id. at 14. Mr. Blais commented that part of the problem behind the error was that the pharmacy was "not quarantining inactives and active ingredients." Id. at 13. As such, Mr. Blais testified that a "bottle of morphine was grabbed instead of the bottle of [flavoring] solution . . . [and was] mixed into the stock bottle, shaken up and dispensed." Id.

Upon investigation, Dr. Kelly learned of another child who had received the adulterated drug. (Tr. 39, Nov. 20, 2012.) The child's caretaker informed Dr. Kelly that the boy had become "more tired or lethargic than typical" as a result of taking the drug. Id. at 40. Dr. Kelly confiscated this batch of omeprazole as well as drugs which had expired or had no expiration date. Id. at 59.

In 1999, Mr. Blais was disciplined for a dispensing error. (Tr. 32-33, Nov. 28, 2012.) This dispensing error occurred when Mr. Blais filled a prescription for Haldol, an anti-psychoticdrug, with 5 mg tablets instead of .5 mg tablets as per the written order. Id. at 72; Department of Health Board of Pharmacy v. Leo Blais, Consent Order at 1, Jan. 12, 1999. Fortunately, that mislabeled drug was caught in time by the patient's caretaker and not dispensed. (Tr. 7, Dec. 6, 2012.) For this violation, Mr. Blais entered into a Consent Order providing for a license suspension of six months stayed and an eighteen-month period of probation. Tr. 34-39, Nov. 28, 2012; Second Amended Consent Order, Mar. 16, 2000. Mr. Blais was placed back in good standing with the Board in 2000. (Tr. 39, Nov. 28, 2012.)

At the hearing, Mr. Blais explained that filling the prescription with the incorrect dosage of Haldol was caused by a computer program malfunction that was promptly remedied after the incident. (Tr. 7, Dec. 6, 2012). Additionally, Mr. Blais spoke in detail of the procedures he implemented to safeguard against another mix-up during compounding. Id. at 17-20. With regard to the misbranded drugs, Ms. Cordy noted there was no indication that any expired drug was dispensed. (Tr. 120, Nov. 28, 2012.) Additionally, she explained that the only danger of using an expired drug is that there is "no guarantee that that medication is efficacious" and may be "subpotent[.]" Id. at 17. Mr. Blais noted that the disorder observed by Ms. Cordy and Dr. Kelly at the pharmacy was due to the fact that the investigation occurred on "[o]ne of the busiest days" of the week, (Tr. 21, Dec. 6, 2012), when the pharmacy becomes inundated with orders "awaiting check, packaging and shipping[.]" Id. at 23. He noted that it is critical that the Apothecare's especially vulnerable patients receive their medicine in a timely fashion, especially after the weekend when the pharmacy is closed. Id. at 21-24. As a result, the clutter observed by the investigators was caused by the large number of orders being processed at the time. Id. at 23.

On March 23, 2012, Director Fine issued a summary suspension of Mr. Blais's license to practice pharmacy in accordance with § 42-35-14(c). This summary suspension was the first andonly suspension in the history of Rhode Island's pharmacy licensing regulations for a dispensing error. Subsequently, Mr. Blais and the Board entered into a Consent Order, agreeing to a one-year suspension dating back to the issuance of the summary suspension and a subsequent one-year suspension, stayed pending probation. (Drafted Consent Order, Mar. 22, 2013...