ALJDEC - Licensing

23F-22-0034-PHB · Pharmacy Board · 2023-09-13

IN THE OFFICE OF ADMINISTRATIVE HEARINGS

In the Matter of:

FERNANDO E. VELEZ,

Holder of License No. S011146

As a Pharmacist

In the State of Arizona

No. 23F-22-0034-PHB

ADMINISTRATIVE LAW JUDGE DECISION

HEARING: June 21, 2023; the record closed on August 28, 2023

APPEARANCES: Assistant Attorney General Jeanne Galvin represented the Arizona State Board of Pharmacy. Michael Raine, Esq. represented Fernando E. Velez who was present and testified. Dr. Kamlesh Gandhi, Dr. Jennifer Keonavong, and Sandy Sutcliffe appeared as witnesses. Doreen Sutton provided court reporting services.

ADMINISTRATIVE LAW JUDGE: Sondra J. Vanella

FINDINGS OF FACT

The Arizona State Board of Pharmacy (“Board”) is the duly constituted authority for licensing and regulating the practice of pharmacy in the State of Arizona.

Respondent Fernando E. Velez is the holder of Pharmacist License Number S011146, first issued by the Board on July 19, 1996, to practice as a Pharmacist in the State of Arizona.

At all times relevant to this matter, and since January 2020, Mr. Velez has been employed as the Pharmacist-in-Charge (“PIC”) at Food City Pharmacy in Lake Havasu City, Arizona.

Pursuant to A.R.S. § 32-1901(72), a PIC “means the pharmacist who is responsible to the board for a licensed establishment’s compliance with the laws and administrative rules of this state and of the federal government pertaining to the practice of pharmacy, the manufacturing of drugs and the distribution of drugs and devices.”

On or about January 25, 2022, the Board received an anonymous Complaint against Mr. Velez that alleged the following:

I found out recently that pharmacist Fernando E. Velez (lives at 2003 Roy Rogers Way in Kingman, Arizona) has been giving to his family members covid vaccine cards without them actually having had the vaccine. One of his daughters told me directly that her dad (Fernando) gave her a vaccine card and just wrote down the information even though she didn’t get the vaccine so that she could still attend places that required it even though she didn’t have it. I have also happened to have heard him say that he and his other pharmacy friends sell the vaccine cards for $100 each. Someone offered him $50 and he told them it was $100.00. I am concerned because this I believe is a clear violation of his job as a pharmacist.

On or about March 16, 2022, Sharon Richardson, Board Investigator, met with Mr. Velez at the Food City Pharmacy in Lake Havasu City to discuss the Complaint. Mr. Velez denied the allegations in the Complaint and stated that he had administered the vaccines to his wife, daughter, and son-in-law before providing them with the vaccine card and that he has never sold a vaccine card or offered to sell one.

Mr. Velez showed the investigator that the vaccines had been processed and billed.

The investigator also spoke with Grisel Gutierrez, the Pharmacy Technician who was working on the day in question, who told the investigator that Mr. Velez had brought these individuals into the pharmacy one at a time to administer the vaccines in the pharmacy bathroom. Ms. Gutierrez stated that this was not normal practice and that Mr. Velez had stated that he did it for modesty purposes.

Ms. Richardson obtained camera footage from Food City Pharmacy’s Loss Prevention Investigator for the time period that these immunizations were administered. The videos showed that on or about October 28, 2021, Mr. Velez walked his wife, daughter, and son-in-law through the pharmacy area and into the bathroom one at a time.

The pharmacy bathroom was within the pharmacy area, not accessible to the general public, and not the location where other members of the public would be administered an immunization or vaccine.

It was undisputed that Mr. Velez’s family members were not licensees of the Board, employees of the pharmacy, or designated individuals who would be permitted access to the pharmacy area.

Mr. Velez provided a notarized declaration to the Board stating that he had permitted one family member at a time to enter the pharmacy area and that he escorted each of them directly to the restroom.

Mr. Velez provided notarized declarations to the Board from his wife, daughter, and son-in-law in which they each stated that Mr. Velez had escorted them through the pharmacy and into the bathroom. Mr. Velez acknowledged bringing each of his three family members individually into the restroom that was located in the pharmacy area due to the fact that each had to partially disrobe to get the vaccine.

Dr. Jennifer Keonavong, Deputy Director for the Board, testified that the Board investigates anonymous complaints “if there is enough information to investigate.” Dr. Keonavong testified that a PIC is held to a high standard and “sets the tone for pharmacy compliance.” Dr. Keonavong further testified regarding the Board’s interpretation of permitted personnel within the pharmacy area pursuant to Board rule A.A.C. R4-23-610(B). Dr. Keonavong asserted that Mr. Velez violated A.A.C. R4-23-610(B) when he permitted family members in the pharmacy area. Dr. Keonavong explained the purpose of A.A.C. R4-23-610(B) is to protect protected health information and to protect individuals from substances located in the pharmacy. Dr. Keonavong testified that the Board was seeking a Letter of Reprimand as a disciplinary action against Mr. Velez.

Counsel for Mr. Velez read various dictionary definitions of “personnel” to Dr. Keonavong. Dr. Keonavong agreed that “personnel” generally refers to people who are employees of a company or organization. Dr. Keonavong further agreed that Mr. Velez’s family members were not personnel. Dr. Keonavong distinguished between having a plumber present in the pharmacy to perform plumbing services under the supervision of a PIC, versus family members, because patient care occurred in an area where patient care did not normally occur and there was risk involved because the vaccines were administered in an area where they were not traditionally administered.

During cross examination, Dr. Keonavong was questioned about Advisory Letters issued to other pharmacists. An Advisory Letter is a non-disciplinary action. Dr. Keonavong was also questioned regarding the anonymous Complaint filed against Mr. Velez. Dr. Keonavong acknowledged that because the Complaint was filed anonymously, no one from the Board spoke with the complainant, no one from the Board spoke with Mr. Velez’s daughter, and the daughter’s name was not mentioned in the Complaint (Mr. Velez has several daughters), there were no dates specified in the Complaint as to when the allegations occurred, and no information as to where the alleged statements referenced in the Complaint were made.

Mr. Velez testified that he has been a licensed pharmacist for approximately 38 years and served as a pharmacist in the Army and as a Company Commander in the first Gulf War. Mr. Velez was licensed in Nevada in 1985, and then in Arizona in 1996. Mr. Velez testified that he has never been investigated and has never had any discipline against his license.

Mr. Velez testified that he has known Ms. Gutierrez for the past ten years, and she was present in the pharmacy when he administered the vaccines. Mr. Velez testified that he and his wife previously owned a pharmacy, and consequently, his wife understood safety precautions regarding dangerous drugs, as well as confidentiality. Mr. Velez further testified that his daughter was 26 years old and was familiar with the dangers of drugs. She had been married to her husband for seven and a half years and he was a corrections officer. Mr. Velez testified that as the PIC, it is his responsibility to ensure adequate safety precautions are taken to prevent public health risks. Mr. Velez had no concerns that his family members were themselves at risk or posed a risk to the public.

Mr. Velez testified in detail regarding the layout of the pharmacy and referenced the Board’s Exhibits 5 through 8 in describing the area. There was a distance of only approximately five (5) feet, or two (2) steps from the pharmacy door to the bathroom door. To the left of the bathroom door were over-the-counter, non-prescription medications, and there was no patient information that could be viewed between the door to the pharmacy and the bathroom. While there was a pharmacist computer terminal, it was shut down at the time.

Mr. Velez explained that he did not normally serve his family members at his place of employment because they live 62 miles from where he worked. However, they had been waiting for the Johnson & Johnson vaccine and his pharmacy had received doses of that vaccine. Mr. Velez explained that he administered vaccines outside of the pharmacy area by the door, which was a “wide open area in the grocery store with foot traffic.” Mr. Velez testified that when his family came in for their vaccines, it was cold and they were wearing long sleeves and coats and had to partially disrobe, exposing them.

Mr. Velez credibly testified that he had never allowed any other customer in the pharmacy area. Mr. Velez also credibly testified that he never administered a COVID vaccine without a staff member present. Mr. Velez testified that Ms. Gutierrez participated by processing the paperwork for the vaccines and was present in the pharmacy the entire time. Mr. Velez further testified that the view within the pharmacy was unobstructed, and therefore, both Ms. Gutierrez and he could see throughout the pharmacy area.

Mr. Velez explained that all of the patient forms were completed outside of the pharmacy and that only the vaccine itself was administrated within the pharmacy. Consequently, there was “no lingering.” Mr. Velez determined that it would be “safer” to bring one family member at a time into the pharmacy. Mr. Velez testified that he had no concerns that any of his family members would “touch or pick something up.” Further, there was no patient information accessible to them. There was also no issue with sterility of the bathroom area, as it was cleaned three to four times per day.

Mr. Velez testified that this was the first and last time he had done this, and would never do it again.

Sandy Sutcliffe, a Compliance Officer for the Board, testified that she had been in that position for 19 years. Ms. Sutcliffe testified that the Board routinely investigates anonymous complaints. Ms. Sutcliffe also testified that during the March 6, 2022 inspection of the pharmacy, the entry doors were secured, the drugs were properly stored, and the pharmacy area was neat and clean.

Dr. Kamlesh Gandhi, the Board’s Executive Director, testified that he had the authority to dismiss complaints, however, he did not consider dismissing the instant Complaint. Dr. Gandhi explained that while there was no way to corroborate the information contained in the Complaint, the notification to the Board created the opportunity for the Board to investigate and the Complaint was immediately forwarded to a compliance officer for investigation.

Dr. Gandhi testified that the allegation concerning the selling of vaccine cards was not substantiated. Dr. Gandhi also testified that Mr. Velez’s unblemished almost 40 year record was a factor the Board may consider in whether to impose discipline.

Mr. Velez’s counsel questioned Dr. Gandhi regarding complaints against other pharmacists that were recently investigated by the Board that did not result in discipline. The first such complaint concerned a hospital pharmacist that resulted in the death of a patient due to the pharmacist providing a medication dose ten times higher than what was prescribed. That pharmacist was not disciplined by the Board. The instant case did not result in any harm and Dr. Gandhi testified that as far as he was aware, there was no risk to patient confidentiality and nothing on the videos depicted a risk of Mr. Velez’s family members accessing dangerous drugs.

Dr. Gandhi was questioned regarding the April 7, 2022 Advisory Letter issued to PIC Brian Bint in Case Number 21-0686. That Advisory Letter set forth the following:

At its April 2022, public meeting, the Board considered complaint number 21-0686 regarding a consumer complaint alleging that a staff member allowed her child in the pharmacy on more than one occasion. On February 14, 2022, Board staff conducted a complaint investigation at the pharmacy. The investigation revealed the following: (1) two pharmacy staff had allowed their children access to the pharmacy area, with one having her children in an adjoining room with the door propped open while the other allowed her child to wander in the pharmacy area; (2) vaccine records were incomplete in that the following information was missing (a) vaccine name; (b) lot number; (c) expiration date; (d) site of administration; (e) quantity; (f) and the vaccine administration sheet showing date, and the name of the immunizing staff; and (3) many plastic shields were missing from the will call bins thus, exposing the patient names and medications.

. . . .

The Board expressed concern that as the Pharmacist in Charge, you (1) failed to ensure that all security procedures and requirements were followed and that only authorized personnel were permitted in the pharmacy; (2) failed to ensure patient information was stored in a confidential manner by not having appropriate devices in place to shield confidential patient information from public view and (3) failed to ensure appropriate recordkeeping with respect to vaccine administration.

Dr. Gandhi testified that he could not distinguish the difference between the Bint case and this matter, however, that was the Board’s decision, and the Board indicated that the difference was that there were three people in the pharmacy area in this matter.

The evidence presented at hearing established that the Board issued two Advisory Letters to additional pharmacy staff in Case Number 21-0686, similar to the Advisory Letter issued to Mr. Bint. However, the difference regarding the additional Advisory Letters was the fact that the other two staff members who received the letters were not PICs.

Ms. Velez argued at hearing that the above instances in which the Board only issued non-disciplinary Advisory Letters were much more egregious in nature than what Mr. Velez had done and that a greater risk was posed to children wandering in a pharmacy area.

Mr. Velez presented several arguments at hearing as follows:

i) Pursuant to A.R.S. § 41-1010, the Board did not have the authority to investigate an anonymous complaint;

ii) A.A.C. R4-23-610(B) does not apply in this case because Mr. Velez’s family are not “personnel” and the rule does not state that no one else is allowed in the pharmacy area, the Board has misinterpreted the rule, and further, there was no risk to these individuals or the public;

iii) Mr. Velez’s actions were far less egregious than those of the other matters set forth above that involved children in the pharmacy area and the death of a patient, and those individuals received non-disciplinary Advisory Letters.

CONCLUSIONS OF LAW

The Board possesses subject matter and personal jurisdiction over Mr. Velez pursuant to A.R.S. § 32-1901 et seq.

The Board may discipline a pharmacist who has engaged in unprofessional conduct.

A.R.S. § 41-1010 provides, in pertinent part, as follows:

Notwithstanding any other law, a person shall disclose the person’s name during the course of reporting an alleged violation of law or rule. During the course of an investigation or enforcement action, the name of the complainant shall be a public record unless the affected agency determines that the release of the complainant’s name may result in substantial harm to any person or to the public health or safety.

Under A.R.S. § 32-1904(A)(13), the Board may open an investigation “only if the identifying information regarding a complainant is provided or the information provided is sufficient to conduct an investigation.”

A.R.S. § 41-1010 sets forth that the disclosure of a complainant’s name is required notwithstanding any other law. A.R.S. § 32-1904(A)(13) allows the Board to open an investigation as long as information provided is sufficient to conduct an investigation. Had the Board known the identity of the complainant, the Board would have been required to make such disclosure absent the determination that the release of the complainant’s name may result in substantial harm to any person or to the public health or safety. The disclosure of the complainant’s name in this case is an impossibility and under the Board’s statute, it is authorized to investigate an anonymous complaint.

In this case, the evidence presented, including Dr. Keonavong’s, Dr. Gandhi’s, and Ms. Sutcliffe’s testimony, established that the Board routinely investigates anonymous complaints and that the instant Complaint was handled in the same manner an any other anonymously filed complaint. Further, the information provided in the Complaint was sufficient to conduct an investigation. Mr. Velez was not treated any differently by the Board in terms of the actual investigation, and in fact, the allegations in the Complaint were not substantiated in that Mr. Velez was not found to have provided COVID vaccine cards to his family members without having actually administered the vaccine, nor was he found to have been selling vaccine cards.

During the course of its investigation of the anonymous Complaint, the Board determined that Mr. Velez brought his family members individually into the pharmacy area in order to administer the vaccine in the pharmacy restroom. Mr. Velez did not deny having done so.

A.A.C. R4-23-610(B) provides as follows:

Personnel permitted in the pharmacy area of a community pharmacy include pharmacists, graduate interns, pharmacy interns, compliance officers, drug inspectors, peace officers acting in their official capacity, other persons authorized by law, pharmacy technicians, pharmacy technician trainees, support personnel, and other designated personnel. Pharmacy interns, graduate interns, pharmacy technicians, pharmacy technician trainees, support personnel, and other designated personnel shall be permitted in the pharmacy area only when a pharmacist is on duty, except in an extreme emergency as defined in R4-23-110.

The pharmacist-in-charge shall comply with the minimum area requirements as described in R4-23-609 for a community pharmacy and for compounding and dispensing counter area.

A pharmacist employed by a pharmacy shall ensure that the pharmacy is physically secure while the pharmacist is on duty.

Mr. Velez’s argument concerning the fact that the rule regarding who is permitted in the pharmacy does not pertain to his family members because the rule addresses personnel and his family members are not personnel, is not persuasive. Mr. Velez’s family members are not contemplated by the rule and the intent of the rule is to keep non-authorized and unnecessary individuals from entering the pharmacy area in order to protect those individuals from accessing dangerous drugs and safekeeping patient information. The Administrative Law Judge concludes, based on the evidence presented, that Mr. Velez violated this rule.

However, the credible evidence of record, including the videos, established that Mr. Velez personally escorted each family member individually into the bathroom located a few feet within the pharmacy area for mere seconds to administer the vaccine, and Mr. Velez was with them the entire time, with eyes on them, and there was no patient information accessible or within view to any of them, nor was there a risk that any of them could access dangerous drugs.

Moreover, the evidence presented at hearing established that on April 7, 2022, the Board only issued an Advisory Letter to PIC Brian Bint in Case Number 21-0686. Mr. Bint, like Mr. Velez, was also a PIC. Therefore, their roles and responsibilities were identical. In that case, the Board “expressed concern that as the Pharmacist in Charge, [Mr. Bint] (1) failed to ensure that all security procedures and requirements were followed and that only authorized personnel were permitted in the pharmacy; (2) failed to ensure patient information was stored in a confidential manner by not having appropriate devices in place to shield confidential patient information from public view[;] and (3) failed to ensure appropriate recordkeeping with respect to vaccine administration.” In the Bint case, two pharmacy staff had allowed their children access to the pharmacy area, with one having her children in an adjoining room with the door propped open while the other allowed her child to wander in the pharmacy area.

In this case, as distinguished from the Bint case, Mr. Velez allowed three adults, individually, under his direct supervision, to enter the pharmacy area for mere seconds for the purpose of receiving vaccines. The adults were not wandering unsupervised in the pharmacy area for an unspecified period of time. Further, the risk of children wandering in a pharmacy area is greater than the risk of a supervised adult for a specific purpose, for a matter of seconds, with no access to patient information or dangerous drugs.

Further, the evidence presented at hearing established that a PIC for a local hospital provided a dose of medication that was ten times more than what was prescribed, resulting in a patient’s death, and that individual was only issued an Advisory Letter.

Pursuant to A.R.S. § 32-1901(3), an “Advisory Letter” is defined as a non-disciplinary letter to notify a licensee or permittee of the following:

i. While there is insufficient evidence to support disciplinary action, the board believes that continuation of the activities that led to the investigation may result in further board action against the licensee or permittee.

ii. The violation is a minor or technical violation that is not of sufficient merit to warrant disciplinary action.

iii. While the licensee or permittee has demonstrated substantial compliance through rehabilitation, remediation or reeducation that has mitigated the need for disciplinary action, the board believes that repeating the activities that led to the investigation may result in further board action against the licensee or permittee.

The Board charged Mr. Velez with violations of A.R.S. § 32-1901.01(B)(2) for bringing his wife, daughter, and son-in-law into the pharmacy area.

Pursuant to A.R.S. § 32-1901.01(B)(2), “unprofessional conduct” includes, whether occurring in this state or elsewhere, “[v]iolating any federal or state law, rule or regulation relating to the manufacture or distribution of drugs and devices or the practice of pharmacy.”

While Mr. Velez technically violated A.A.C. R4-23-610(B), such violation did not result in harm, and under the facts presented herein, did not have the potential to result in harm given the direct supervision by Mr. Velez, the distance from the entry to the pharmacy and the bathroom where the vaccines were administered, and the lack of any visible or accessible patient information. Further, given Mr. Velez’s long history as a pharmacist, with no discipline, Mr. Velez’s expressed remorse, coupled with his credible testimony that he would never engage in this conduct again, and in comparison to the information provided at hearing to the other matters that resulted in Advisory Letters, the Administrative Law Judge concludes, based upon the evidence presented at hearing, that Mr. Velez’s actions do not warrant disciplinary action.

RECOMMENDED ORDER

In light of the evidence presented, the Administrative Law Judge recommends that the Board dismiss this Complaint against Fernando E. Velez, holder of Pharmacist License Number S011146.

Pursuant to A.R.S. § 41-1092.08(I), the licensee may accept the Administrative Law Judge Decision by advising the Office of Administrative Hearings in writing not more than ten (10) days after receiving the decision. If the licensee accepts the Administrative Law Judge Decision, the decision shall be certified as the final decision by the Office of Administrative Hearings.

In the event of certification of the Administrative Law Judge Decision by the Director of the Office of Administrative Hearings, the effective date of the Order will be forty (40) days from the date of that certification.

Done this day, September 13, 2023.

/s/ Sondra J. Vanella

Administrative Law Judge

Transmitted by either mail, e-mail, or facsimile to:

Kamlesh Gandhi, Executive Director

Pharmacy Board

1110 W. Washington St., Ste. 260

Phoenix, AZ 85007

Jeanne M. Galvin

Assistant Attorney General

[email redacted]

[email redacted]

Michael Raine

Boesen & Snow Law

[email redacted]

By: OAH Staff