Opinion
No. 30912-2-II
Filed: December 14, 2004 UNPUBLISHED OPINION
Appeal from Superior Court of Thurston County. Docket No: 03-2-00020-2. Judgment or order under review. Date filed: 08/29/2003. Judge signing: Hon. Wm Thomas McPhee.
Counsel for Appellant(s), Craig Andrew Ritchie, Attorney at Law, 212 E 5th St, Port Angeles, WA 98362-3008.
Counsel for Respondent(s), Keith D. Armstrong, Attorney Generals Office, 1125 Washington St SE, PO Box 40100, Olympia, WA 98504-0100.
Susan L. Pierini, Assistant Attorney General, PO Box 40100, Olympia, WA 98504-0100.
Michael W. Dutton, a pharmacist, appeals from the superior court's order affirming the Board of Pharmacy's finding that he had committed unprofessional conduct and imposing sanctions. We affirm.
On January 6, 2000, the Washington State Board of Pharmacy (Board) received a complaint against Evergreen Pharmaceutical, Inc. (Evergreen), located in Kirkland, Washington. The complaint alleged that a patient (Patient A) had been given the wrong medication for his heart condition. Patient A, an elderly nursing home resident, submitted a prescription to Evergreen for Lanoxin prior to leaving for a vacation in Florida. Patient A's physician prescribed Lanoxin to help slow his heart rate. Patient A received a medication card labeled Lanoxin, but which actually contained Levothyroxine, a thyroid medication. As a result, he missed 24 doses of his prescribed medication. A Florida pharmacy discovered the error.
Randolph J. Flett investigated the complaint for the Board. Michael W. Dutton was the pharmacist responsible for the final verifications of prescriptions filled at Evergreen; he verified Patient A's prescription as being filled with Lanoxin.
On May 23, 2001, the Board issued a statement of charges against Mr. Dutton. The statement alleged that Mr. Dutton had violated RCW 18.130.180(4) and (7), RCW 18.64.160(5), RCW 18.64.246, RCW 69.41.050, and WAC 246-869-210(1), which govern the professional conduct of health professionals. The statement notified Mr. Dutton that these violations constituted grounds for disciplinary action. Additionally, the statement noted that Mr. Dutton had previously been issued a notice of correction in 1998 for incorrectly verifying a prescription for Lanoxin. During a prehearing conference, Mr. Dutton successfully moved to strike the portion of the statement that referred to the 1998 notice of correction.
RCW 18.130.180 provides in relevant part:
The following conduct, acts, or conditions constitute unprofessional conduct . . .:
. . . .
(4) Incompetence, negligence, or malpractice which results in injury to a patient or which creates an unreasonable risk that a patient may be harmed. The use of a nontraditional treatment by itself shall not constitute unprofessional conduct, provided that it does not result in injury to a patient or create an unreasonable risk that a patient may be harmed;
. . . .
(7) Violation of any state or federal statute or administrative rule regulating the profession in question, including any statute or rule defining or establishing standards of patient care or professional conduct or practice.'
RCW 18.64.160 provides in relevant part:
In addition to the grounds under RCW 18.130.170 and 18.130.180, the board of pharmacy may take disciplinary action against the license of any pharmacist or intern upon proof that:
. . . .
(5) He or she has compounded, dispensed, or caused the compounding or dispensing of any drug or device which contains more or less than the equivalent quantity of ingredient or ingredients specified by the person who prescribed such drug or device: PROVIDED, HOWEVER, That nothing herein shall be construed to prevent the pharmacist from exercising professional judgment in the preparation or providing of such drugs or devices.
RCW 18.64.246 provides:
(1) To every box, bottle, jar, tube or other container of a prescription which is dispensed there shall be fixed a label bearing the name and address of the dispensing pharmacy, the prescription number, the name of the prescriber, the prescriber's directions, the name and strength of the medication, the name of the patient, the date, and the expiration date. The security of the cover or cap on every bottle or jar shall meet safety standards adopted by the state board of pharmacy. At the prescriber's request, the name and strength of the medication need not be shown. If the prescription is for a combination medication product, the generic names of the medications combined or the trade name used by the manufacturer or distributor for the product shall be noted on the label. The identification of the licensed pharmacist responsible for each dispensing of medication must either be recorded in the pharmacy's record system or on the prescription label. This section shall not apply to the dispensing of medications to in-patients in hospitals.
RCW 69.41.050 provides in relevant part:
(1) To every box, bottle, jar, tube or other container of a legend drug, which is dispensed by a practitioner authorized to prescribe legend drugs, there shall be affixed a label bearing the name of the prescriber, complete directions for use, the name of the drug either by the brand or generic name and strength per unit dose, name of patient and date: PROVIDED, That the practitioner may omit the name and dosage of the drug if he or she determines that his or her patient should not have this information and that, if the drug dispensed is a trial sample in its original package and which is labeled in accordance with federal law or regulation, there need be set forth additionally only the name of the issuing practitioner and the name of the patient.
WAC 246-869-210 provides in relevant part:
To every prescription container, there shall be fixed a label or labels bearing the following information:
(1) All information as required by RCW 18.64.246, provided that in determining an appropriate period of time for which a prescription drug may be retained by a patient after its dispensing, the dispenser shall take the following factors into account:
(a) The nature of the drug;
(b) The container in which it was packaged by the manufacturer and the expiration date thereon;
(c) The characteristics of the patient's container, if the drug is repackaged for dispensing;
(d) The expected conditions to which the article may be exposed;
(e) The expected length of time of the course of therapy; and
(f) Any other relevant factors.
The dispenser shall, on taking into account the foregoing, place on the label of a multiple unit container a suitable beyond-use date or discard-by date to limit the patient's use of the drug. In no case may this date be later than the original expiration date determined by the manufacturer.
In response to these charges, Mr. Dutton prepared a written statement in which he admitted that he was responsible for the error with Patient A's prescription. He wrote:
While working @ Evergreen Pharm. Service on 11/8/00. Part of my responsibilities included final verification of prescriptions. Checking product against the label for correctness. On this day I verified Rx 147442 as being filled with digoxin [Lanoxin], while the actual medication was Levothyroxine.
Administrative Board Record (AR) at 825.
Mr. Dutton did not submit a personal plan for corrective action to the Board. However, two of his supervisors submitted reports to the Board. Keith Siny, who was a pharmacy manager at the time of the incident, stated that Evergreen would move the address for Lanoxin further away from the address for Levothyroxine and that this should help `reduce the likely hood [sic] of accidentally picking up the product again.' AR at 1159. And David Doane, the director at Evergreen, stated that he had spoken with Mr. Dutton regarding the incident. He further stated that the pharmacy had implemented several changes as a result of the error: it now scheduled pharmacists throughout the day for verification so as to decrease the `rush' at the end of the day and to help the verifying pharmacist stay `alert,' and it created guidelines for the pharmacy technicians and other staff as to the placement of products on the carousel in order to avoid Spicking' errors. AR at 1161.
An adjudicative hearing was held before a panel of four Board members on October 16, and 17, 2002. Dr. William Fassett, Dean of the College of Pharmacy at Washington State University, testified as an expert for Mr. Dutton. Dr. Fassett testified that the error rate among pharmacists is approximately two percent. And although Mr. Dutton had committed two errors in a 15-month period, his error rate was lower than the average. Dr. Fassett further testified that the average error rate is a `risk that can't be avoided' and, as such, Mr. Dutton's errors were not unreasonable. AR at 1549. He concluded that, based on the average error rate, Mr. Dutton did not fall beneath the standard of care. In sum, Dr. Fassett testified that, in determining whether a pharmacist should be disciplined, the Board should assess `the riskiness of the practice, not the actual harm that occurs.' AR at 1611-12.
During questioning by the Board, Dr. Fassett testified that Mr. Dutton had twice failed to detect misfilled prescriptions, the current incident and an incident that occurred in 1998. He further testified that these two incidents were `virtually the same error' and that he had learned of the 1998 incident from legal paperwork drawn up by the board. AR at 1632. Additionally, Dr. Fassett testified that the goal of long-term care pharmacists is to `deliver the drug that's been ordered.' AR at 1546. Likewise, Mr. Siny testified that the duty of a final verification pharmacist is to check that the prescription is `the right drug, pulled and packaged in the right form.' AR at 1332.
In addition, several witnesses testified regarding a pharmacist's duty to take corrective action in response to mistakes. Mr. Doane testified that he takes corrective action for all mistakes made at Evergreen. Mr. Siny testified that he expects his pharmacists to `own up' and take responsibility for their mistakes. AR at 1292. Finally, Mr. Flett testified that `each individual pharmacist is responsible for their [sic] actions' and for `com[ing up] with a different plan to avoid that mistake in the future.' AR at 1228.
Mr. Dutton also testified. He stated that he was responsible for the error in Patient A's prescription. He testified that he did not think a pharmacist should be disciplined for one error and that the board should consider that all pharmacists make errors in determining whether to discipline a pharmacist. When questioned as to why he did not submit a plan of correction to the board, Mr. Dutton stated that he was not aware that he needed to provide such a plan and that he did not recall Mr. Flett asking him for one. However, the notice of investigation sent to Mr. Dutton required that he submit a `full and complete written response' and `what DETAILED plan of action has been developed to make re-occurrences less likely.' AR at 832.
The Board determined that Mr. Dutton had violated RCW 18.130.180(4) and (7), RCW 18.64.160(5), RCW 18.64.246, and RCW 69.41.050. The Board placed Mr. Dutton's license in probationary status for 24 months subject to a provision that he may apply for reinstatement in 12 months upon satisfaction of the terms and conditions listed in the order. Mr. Dutton filed a petition for judicial review of the Board's order in the Thurston County Superior Court. The court affirmed the Board's order, which Mr. Dutton appeals.
Our review of the Board's final order is governed by the Washington Administrative Procedure Act (WAPA). RCW 34.05.570. We reverse agency findings of fact if the findings are not supported by substantial evidence when viewed in light of the entire record. RCW 34.05.570(3)(e); Heinmiller v. Dep't of Health, 127 Wn.2d 595, 607, 903 P.2d 433, 909 P.2d 1294 (1995), cert. denied, 518 U.S. 1006 (1996). Substantial evidence is "evidence in sufficient quantum to persuade a fair-minded person of the truth of the declared premises." Heinmiller, 127 Wn.2d at 607 (quoting Nghiem v. State, 73 Wn. App. 405, 412, 869 P.2d 1086 (1994)). We review agency conclusions of law de novo. RCW 34.05.570(3)(d). But we accord substantial weight to the agency's interpretation of the law it administers particularly when the issue falls within the agency's expertise. Brown v. Dep't of Health, 94 Wn. App. 7, 12, 972 P.2d 101, review denied, 138 Wn.2d 1010 (1999).
I. Notice of Charges
Mr. Dutton first contends that the Board erred in entering findings of fact 3.7 and 3.8. He argues that, in considering his failure to provide a plan for corrective action and by concluding that he failed to appreciate the responsibilities for corrective action, the Board was essentially disciplining him for `[f]ailure to cooperate with the disciplinary authority' and `[f]ailure to comply with an order issued by the disciplining authority' pursuant to RCW 18.130.180(8) and (9), respectively. Because these allegations were not contained in the statement of charges, Mr. Dutton argues that he was denied proper notice of the charges against him. Mr. Dutton is in error.
Finding of Fact 3.7 states:
Comparatively speaking, Exhibits R-8 and R-9 [reports submitted by Mr. Siny and Mr. Doane] typify responsive information expected in response to a Notice of Investigation. The panel is concerned that the Respondent was unable to provide similar specificity relating to the incident that occurred on November 8, 1999. The panel finds the five-sentence response prepared in response to the inquiry in the present situation, exemplified by Exhibit 2, inadequate and unacceptable.
Clerk's Papers (CP) at 13.
Finding of Fact 3.8 states:
Each pharmacist is charged with the responsibility for providing a personal plan for corrective action under request of the Department. The panel finds that the Respondent's statement does not contain any information that reflects an understanding that immediate remedial measures were indicated. The panel is concerned by the lack of personal accountability and initiative reflected in the tendered response. The panel does not find that submission of reports from the Respondent's supervisors discharge the responsibility of his personal reply as responsible pharmacist.
CP at 13.
In considering Mr. Dutton's failure to provide a plan of corrective action, the Board was not focusing on a failure to cooperate or comply with Board orders. Rather, the Board clearly states that it was concerned with Mr. Dutton's failure to take personal responsibility for his error and his apparent disregard for the potential harm his actions could have caused. The Board has a general duty to regulate the practice of pharmacy. RCW 18.64.005(1). As noted in testimony by Mr. Flett, Mr. Siny, and Mr. Doane, accepting personal responsibility for one's errors is a duty inherent in the practice of pharmacy, a duty that surely all pharmacists recognize. Thus, the Board did not err in concluding that Mr. Dutton's lack of personal accountability for his actions established unprofessional conduct.
Moreover, substantial evidence supports findings of fact 3.7 and 3.8. Mr. Siny and Mr. Doane each testified that pharmacists are expected to take responsibility for any errors that they make. And Mr. Flett testified that `each individual pharmacist is responsible for their [sic] actions' and for `com[ing up] with a different plan to avoid that mistake in the future.' AR at 1228. Here, Mr. Dutton not only failed to provide a plan of corrective action indicating what steps he would take to prevent this type of error in the future, he did not recognize the need to create such a plan. In addition, Mr. Dutton's response to the charges against him gave no indication of personal responsibility or appreciation for the potential harm his error might have caused he simply stated that the error occurred.
II. Sufficiency of the Evidence Regarding Unprofessional Conduct
Mr. Dutton next challenges finding of fact 3.15. Additionally, he argues that the Board improperly substituted its expertise for Dr. Fassett's and erroneously concluded that the standard of care for pharmacists is `zero errors.' Br. of Appellant at 1. The State and the Board respond that the Board may rely on its own expertise in determining the standard of care and that its determination in this case is supported by substantial evidence. The State and the Board are correct.
Finding of Fact 3.15 states:
The panel is not prepared to accept that an error rate is an appropriate measure of competent practice in the state of Washington. The standard of practice in the state of Washington is to assure that the patient receives the right drug, in the right package, with the right label containing proper instructions and patient identifiers.
CP at 15.
Here, Dr. Fassett testified that, because Mr. Dutton's error rate is below average, he did not fall beneath the standard of care. He also testified that the average error rate is a `risk that can't be avoided'; consequently, Mr. Dutton's errors were not unreasonable. AR at 1549. In short, Dr. Fassett opined that the Board should assess unprofessional conduct based on `the riskiness of the practice, not the actual harm that occurs.' AR at 1611-12.
The Board considered Dr. Fassett's testimony, but ultimately concluded that it would not accept an error rate as the appropriate measure of competent practice. Rather, the Board found that the standard is `to assure that the patient receives the right drug, in the right package, with the right label containing proper instructions and patient identifiers.' CP at 15.
An administrative agency may use its experience and specialized knowledge to evaluate and draw inferences from the evidence when finding unprofessional conduct. Davidson v. Dep't of Licensing, 33 Wn. App. 783, 785, 657 P.2d 810, review denied, 99 Wn.2d 1011 (1983). The Washington State Board of Pharmacy is composed almost exclusively of registered pharmacists. RCW 18.64.001. Consequently, it is logical and proper for the Board to draw its own conclusions as to acceptable standards for pharmacists. See Wash. State Med. Disciplinary Bd. v. Johnston, 99 Wn.2d 466, 482, 663 P.2d 457 (1983). As to such specialized matters, we give deference to administrative expertise. Johnston, 99 Wn.2d at 482. Additionally, an administrative board comprised of medical practitioners is competent to determine the propriety of medical conduct without the aid of expert testimony. Davidson, 33 Wn. App. at 786. Expert testimony regarding the propriety of medical conduct can be disregarded by a board of this type and, in all probability, may have little effect on the decision-making process. Davidson, 33 Wn. App. at 786. Thus, the Board was entitled to rely on its specialized knowledge and reject the standard proposed by Dr. Fassett. The purpose of regulating health care professionals is to protect the public; we defer to its determination that unprofessional conduct is to be assessed by the risk of harm to the patient rather than the `riskiness' of the practice of pharmacy.
Moreover, several witnesses testified regarding acceptable standards for pharmacists. Dr. Fassett testified that the goal of long-term care pharmacists is to `deliver the drug that's been ordered.' AR at 1546. Likewise, Mr. Siny testified that the duty of a final verification pharmacist is to check that the prescription is `the right drug, pulled and packaged in the right form.' AR at 1332. And Mr. Flett testified that a verifying pharmacist `want[s] to make sure that the drug is correct, the doctor's correct, the patient's name is correct, the dosage is correct, the directions are correct, the dates, all of those things.' AR at 1260. Thus, substantial evidence supports the Board's finding.
In addition, Mr. Dutton contends that the Board erred in entering finding of fact 3.18, and he argues that the Board's finding that he created an unreasonable risk of harm to Patient A is not supported by clear and convincing evidence. These arguments also fail.
Finding of fact 3.18 states:
The panel finds that dispensing Levothyroxine in lieu of Lanoxin was inconsistent with the intent of the prescribing provider. The panel further finds that the Respondent's failure to note the errors on Prescription No. 147442 created an unreasonable risk of harm to the receiving patient. The panel also notes that the Respondent admits that this incident was not the first occasion where a misfill of this nature, and in fact, this drug had occurred.
CP at 15.
The Board must prove all of the allegations set forth in the statement of charges. WAC 246-10-606. In Nims v. Wash. Bd. of Registration, 113 Wn. App. 499, 505, 53 P.3d 52 (2002), we held that the burden in professional disciplinary proceedings is proof by clear, cogent, and convincing evidence. To sustain an order premised upon clear, cogent, and convincing evidence, the ultimate fact in issue must be shown by evidence to be highly probable. In re Estate of Mumby, 97 Wn. App. 385, 391, 982 P.2d 1219 (1999).
Mr. Dutton argues that he did not create an unreasonable risk of harm because he has a `lower misfill rate than the average pharmacist in the state of Washington' and because no harm was done to the patient. Br. of Appellant at 22. He essentially argues that the very practice of pharmacy entails some risk to patients and that, in assessing misconduct, the Board should conduct a risk/benefit analysis similar to the analysis done in products liability cases. But this is precisely the standard that the Board rejected. Thus, it is of no consequence that Mr. Dutton's rate of error falls below a purported average rate. In addition, actual harm need not be established in disciplinary proceedings. In re Disciplinary Proceeding Against Halverson, 140 Wn.2d 475, 486, 998 P.2d 833 (2000).
Patient A's physician prescribed Lanoxin for his heart condition. Patient A's prescription was instead filled with Levothyroxine, an error that Mr. Dutton, the final verification pharmacist, failed to catch. As a result of this error, Patient A missed 24 doses of his heart medication. The Board was entitled to rely on its own specialized knowledge in determining that Mr. Dutton's actions created an unreasonable risk of harm to Patient A. See Davidson, 33 Wn. App. at 785. Moreover, Mr. Dutton was previously disciplined informally for a misfill of Lanoxin through a notice of correction. In conclusion, ample evidence supports the Board's findings, and those findings support its conclusions.
III. Notice of Correction
Mr. Dutton also asserts that the Board improperly considered his prior notice of correction for a misfill in 1998 in determining whether he committed misconduct. In addition, he argues that, because the Department of Health may not issue a civil penalty for the violations listed in a notice of correction unless the responsible party fails to comply, the Board either determined that he failed to comply with the notice even though the notice was not in the record or it improperly issued a penalty based on the notice. See RCW 43.05.100(3). The State and the Board respond that Mr. Dutton opened the door to discussion of the 1998 incident at the hearing. Mr. Dutton is in error.
Under RCW 43.05.100(1), the Department of Health may issue a notice of correction if it becomes aware of conditions that are not in compliance with the applicable laws and rules that the department enforces. The notice must provide a description of the violation, a statement of what is required to achieve compliance, and the date by which compliance must be achieved. RCW 43.05.100(1)(a)-(c).
Here, Mr. Dutton successfully moved to strike the 1998 notice from the statement of charges. But on direct, Dutton's expert, Dr. Fassett, testified that the `information that [he] reviewed showed two errors in a 15-month period.' AR at 1543. The Board was permitted to cross-examine Dr. Fassett regarding these errors, and he testified that Mr. Dutton had failed to detect misfilled prescriptions on two occasions, the current incident and an incident that occurred in 1998. He further testified that these two incidents were `virtually the same error' and that he had learned of the 1998 incident from legal paperwork that the Board had drawn up. AR at 1632. Evidence that might otherwise be inadmissible is admissible if a witness opens the door to the evidence during direct examination and the evidence is relevant to some issue at trial. State v. Stockton, 91 Wn. App. 35, 40, 955 P.2d 805 (1998). Here, Dutton opened the door by continuously discussing the previously excluded evidence. Thus, the Board properly considered Mr. Dutton's prior error, and he may not now challenge this issue on appeal.
Moreover, the Board did not conclude that Mr. Dutton violated the prior notice nor did it penalize him based on the notice. Rather, the Board considered Mr. Dutton's prior error involving the same drug as a factor in determining whether he had committed misconduct with regard to Patient A.
IV. Discipline Imposed
Lastly, Mr. Dutton challenges the sanctions imposed by the Board. Challenges to the discipline imposed by an agency are reviewed under an arbitrary and capricious standard. Keene v. Bd. of Accountancy, 77 Wn. App. 849, 859, 894 P.2d 582, review denied, 127 Wn.2d 1020 (1995). Agency action is arbitrary and capricious if it is willful and unreasoning action, without consideration and in disregard of the facts and circumstances. Keene, 77 Wn. App. at 859. In addition, action taken by a disciplinary board after giving a licensee ample opportunity to be heard, "exercised honestly and upon due consideration," is not arbitrary and capricious even if an erroneous conclusion has been reached. Keene, 77 Wn. App. at 860 (quoting Johnston, 99 Wn.2d at 483).
Here, in addition to placing Mr. Dutton's license in probationary status for 24 months, the Board imposed 20 hours of community service focused on educating consumers about medication error prevention, 10 hours of continuing education credits encompassing ethics, and required Mr. Dutton to submit a plan of correction to prevent medication errors. These sanctions are not arbitrary and capricious; rather, they were designed to educate Mr. Dutton and help him prevent future errors. And although a 24-month probation is harsh, the action was taken with due consideration of the circumstances.
Affirmed.
A majority of the panel having determined that this opinion will not be printed in the Washington Appellate Reports, but will be filed for public record pursuant to RCW 2.06.040, it is so ordered.
MORGAN, J. and QUINN-BRINTNALL, C.J., concur.