STATE OF VERMONT SECRETARY OF STATE OFFICE OF PROFESSIONAL REGULATION BOARD OF PHARMACY

Transcription

1 SECRETARY OF STATE OFFICE OF PROFESSIONAL REGULATION BOARD OF PHARMACY INRE: HARRY'S DISCOUNT PHARMACY License No.: Docket No.: RX STIPULATION AND CONSENT ORDER ~ -~ --~ STIPULATION NOW COMES the State ofvennont, through State, Edward G. Adrian, and the Respondent, Harry's Discount Phannacy, who stipulate and agree as follows: Board Authority 1. The Vennont Board of Pharmacy has jurisdiction to investigate and adjudicate complaints of unprofessional conduct pursuanto 26 V.S.A. 2032, 2051 and 2052; 3 V.S.A. 129 and 129a; the Rules of the Vennont Board of Pharmacy; and the Rules of the Office of Professional Regulation. Statement of Facts 2. The Respondent is licensed as a retail phannacy by the State ofvennont under license number The Respondent was originally licensed on April 26, 1999 and the Respondent's license is currently set to expire on July 31, From approximately January 29, 2004 through August 5, 2004, Timothy Luneau was employed as the pharmacist-manager at the Respondent pharmacy. 4. Although employed as pharmacist-manager, Mr. Luneau only worked ten hours per week for the weeks ending June 8, 2004, July 6, 2004, July 13, 2004, July 20, 2004, July 27, 2004, August 3, 2004, August 10, 2004 and August 17, Prosecutiug Attorney Office of Professional Regulation 5. Upon infonnation and belief, the Respondent pharmacy was open fifty-six hours per week during the relevant times. Thus, as phannacist-manager, Mr. Luneau was required to work at least 16.8 hours per week, as is required under the Rules of the Vennont Board of Pharmacy, Part B, Section 4, Rule The Respondent's license is currently conditioned pursuant to a Stipulation and Consent Order entered by the Board of Pharmacy on November 1,2004. This discipline was imposed due to the Respondent allowing John J. Marchelewicz, its president and 1

2 ~ managing pham1acist at the time of the incident, to dispense a prescription in the incorrect dosage amount. Charges 7. For each week that the Respondent pennitted Timothy Luneau to work as phannacist-manager for less than 16.8 hours per week, the Respondent violated: i. Rules of the Vernlont Board of Pharmacy, Part B, Section 4, Rule 4.5(the phamlacist-manager shall be manager of only one drug outlet and shall work at least 30 percent of the hours the prescription department is open or at least 40 hours per week, whichever is less.; ii. 3 V.S.A. 129a(b (1(perfornlance of unsafe or unacceptable patient or client care; iii. 3 V.S.A. 129a(b (2(failing to practice competently'by reason of any cause which includes failing to confornl to the essential standards of acceptable and prevailing practice; and iv. 3 V.S.A. 129a(a(3(failing to comply with provisions of federal or state statutes or rules governing the practice of the profession. Understandings 8. Respondent understands that the Board must review and accept the tenns of the Consent Order. If the Board rejects any portion, the entire Stipulation and Consent Order shall be null and void and shall not be admissible at any hearing or other proceeding for any purpose. 9. Respondent has read and reviewed this entire document and agrees that it contains the entire agreement between the parties. 10. Respondent voluntarily enters this agreement after the opportunity to consult with legal counsel and is not being coerced by anyone into signing this Stipulation and Consent Order. 11. Respondent voluntarily waives his right to a contested hearing before the Board. 12. Respondent agrees that the Board may enter the Order set forth below. ORDER Based upon the stipulation above, it is ORDERED AND ADJUDGED as follows: Office of Professional Regulation A. Respondent's actions described above demonstrate grounds for discipline because Respondent violated: 2

3 /;' i. Rules of the Vemlont Board of Pharmacy, Part B, Section 4, Rule 4.5(the pharmacistmanager shall be manager of only one drug outlet and shall work at least 30 percent of the hours the prescription department is open or at least 40 hours per week, whichever is less.; and ii. 3 V.S.A. 129a(a(3(failing to comply with provisions of federal or state statutes or rules governing the practice of the profession. B. The Board ofphannacy hereby imposes an ADMINISTRATIVE PENALTY OF $5,000 (FIVE THOUSAND DOLLARS to be paid within a period of three (3 months from the date of entry of this order. Further, the Board hereby CONDITIONS the Respondent's license for a minimum period of FIVE (5 YEARS commencing with the date of entry of this Stipulation and Consent Order. The conditions are as follows: (1 Phannacv Mana2er AD};!roval. ~y' '+'5~.,J(.d-/ Respondent must obtain pre-approval from the Board, for any pharmacist manager for a period of five years from the date of entry of this order. (2 ResDondent Petition Respondent may petition the Board to request removal of these conditions upon a change in ownership. C. This Stipulation and Consent Order is a matter of public record and may be reported to other licensing authorities as provided in 3 V.S.A. 129(a. D. This Stipulation and Consent Order will remain part of Respondent's licensing file and may be used for purposes of determining sanctions in any future disciplinary matter. AGREED TO: "'-' '/"""'" Dated: 5/ 1~/o5 By: ~1/ (, r State Pr~cutin~ Attome~1 1/ / v Office of Professional Regulation 3

4 ~ APPROVED AND SO ORDERED: VERMONT BOARD OF PHARMACY Date of entry: ~!.;I,;}. f 05 BY:", ~ ',;.qcr7~ Chairperson rx.harrys.stip Montpelier, 4

5 SECRETARY OF STATE OFFICE OF PROFESSIONAL REGULATION BOARD OF PHARMACY IN RE: HARRY'S DISCOUNT PHARMACY License No.: Docket No.: RX SPECIFICATION OF CHARGES NOW COMES the State of Vermont and makes the following Charges againsthe Respondent, Harry's Discount Pharmacy: Board Authority 1. The Vennont Board of Pharmacy has jurisdiction to investigate and adjudicate complaints of unprofessional conduct pursuant to 26 V.S.A. 2032, 2051 and 2052;3 V.S.A. 129 and 129a; the Rules of the Vennont Board of Pharmacy; and the Rules of the Office of Professional Regulation. 2. The phannacist-manager shall be manager of only one drug outlet and shall work at least 30 percent of the hours the prescription department is open or at least 40 hours per week, whichever is less. Rules of the Vermont Board of Phannacy, Part B, Section 4, Rule Failing to comply with provisions of federal or state statutes or rules governing the practice of the profession is a basis upon which the Board can impose disciplinary action. 3 V.S.A. 129a(a(3. 4. Failing to practice competently by reason of any cause on a single occasion or on multiple occasions may constitute unprofessional conduct. Failure to practice competently includes performance of unsafe or unacceptable patient or client care, and failure to conform to the essential standards of acceptable and prevailing practice. 3 V.S.A. 129a(b(1 and (2. Statement of Facts 5. The Respondent is licensed as a retail pharmacy by the State of Vernlont under license number The Respondent was originally licensed on April 26, 1999 and the Respondent's license is currently set to expire on July 31, From approximately January 29,2004 through August 5, 2004, Timothy Luneau was employed as the pharmacist-manager at the Respondent pharmacy. 1

6 7. Although employed as phamlacist-manager, Mr. Luneau only worked ten hours per week for the weeks ending June 8, 2004, July 6,2004, July 13, 2004, July 20,2004, July 27, 2004, August 3, 2004, August 10, 2004 and August 17, Upon information and belief, the Respondent pharmacy was open fifty-six hours per week during the relevant times. Thus, as pharmacist-manager, Mr. Luneau was required to work at least 16.8 hours per week, as is required under the Rules of the Vermont Board of Pharmacy, Part B, Section 4, Rule By way of information, the Respondent's license is currently conditioned pursuant to a Stipulation and Consent Order entered by the Board of Pharmacy on November 1,2004. This discipline was imposed due to the Respondent allowing John J. Marchelewicz, its president and managing phamlacist at the time of the incident, to dispense a prescription in the incorrect dosage amount. (See Attachment A. Charges Counts For each week that the Respondent permitted Timothy Luneau to work as pharmacist-manager for less than 16.8 hours per week, the Respondent violated: i. Rules of the Vermont Board of Pharmacy, Part B, Section 4, Rule 4.5; and ii. 3 V.S.A. 129a(b(1 and (2; and iii. 3 V.S.A. 129a(a(3. Relief Requested WHEREFORE, the license of Respondent should be revoked, suspended, reprimanded, conditioned or otherwise disciplined. ~RETARY OF I\.T!J By: ~ Robert H. Backus State Prosecuting mey rx.harrys.soc 2

7 ~.; ERE. ;. Y'S DISCOUNT PHARMACY icense No SECRETARY~0 STATE OFFICE OF PROFESSIO REGULATION BOARD OF P CY I DOCKET No. RX STIPULAllON AND CQNSENT ORDER t orne now the State of Vermpnt through prosecuti:t1g attorney Robert H. Backus and the esponde~t John Markelewicz, President, and $to~its couns,el,eric Parker and enter into '" e following Board Authority The Vermont Board of Phannacy (the.~oardl"; has jurisdiction to investigate and a; 26 V.S.A. Chapter 35; the Administrative Rules of the Board of Pharmacy Statement of Facts Harry's Discount Phannacy (the,~.il..espondentt or the "Phannacy" located in Berlin, Vermont is a licensed retail phannacyholding license number , issued by the State of Veimont. This license was originally issued on April 26, Harry's Discount Pharmacy is a d/b/a of Jo-Mar, Inc. By way of information, the Respondent=s license was conditioned for a period of one year and reprimanded by way of Stipulation and Consent Order on or about August (!Jct'-.z..'-:'~m:.en~ This sanction was in part based on managingphannacist and president, John J. Marchelewicz, giving a customer the wrong dosage amount of Synthroid. ~ On or about August 23,2001. the Respondent=s license was suspended indefinitely after a hearing, based on failure to comply with the conditions contained in the Stipulation and Consent Order. (~ttolf'].,"""'ai 2~ On or about October 10, 2001, the Respondent=s license wasleinstatedand conditioned. (.~a~!-_~eai c~- ii Office oc ProCessional Regulation ~ J At all times relevant to these charges, JobIi J. Marchelewiczwas a licensed pharmacist, and the president and pharmacist manager of Harry's Discount Pharmacy. On or about December 2,2003, J.B. the father ofk.b., a three month old juvenile, went to the Pharmacy to have a prescription filled. By way of information K.B. has a history of arteriostenosis and had recently returned from treatment at the Childrens Hospital in Massachusetts. The prescription was issued in typed format and was for Digoxin, O.O25MG BID PO. On information and belief, this was for Digoxin in liquid/elixir form. Lanoxin is a brand name for Digoxin.. A

8 I : la, fi At all times relevant, Mr. Marchelewicz knew that K.B. was a three month old juvenile based on the representation of J.B., the prescription from the Children.i,s Hospital and from his prior experience in filling prescriptions for K.B. y When Mr. Marchelewicz filled the prescription, he filled it as Lanoxin.25 MG#60- tablet twice a day. Mr. MarcheleWicz stated to Investigator Jackie Cholewa that after reviewing the script, he realized that the prescription needed to be filled iri liquid form because Lanoxin is not made in tablet form in a.025 MG dose. J.B. questioned Mr. Marchelewicz how the tablets would be given to the three month old juvenile. Mr. Marchelewicz failed to correct his error at this point. In addition, Mr..Marchelewiczfailed to correct his error even after J.B. mentioned dissolving the Lanoxin tablets in water. Mr. Marchelewicz advised J.B. that..1. f 11 give you the pills this time, we don I t have the liquid on hand in the pharmacy and next time weill give you liquid... K.B. ~s father administered one dose of the.25mg Lanoxin to K.B. on or about December 2, 2003 and one dose, on or about December 3,2003. After both administrations, K.B. threw up and acted like she was on Aspeed.r" After observing K.B./:s adverse reactions, J.B. contacted the Children.As Hospital and Fletcher Allen Health Care and informed the facilities that he had given K.B. a.25mg dose oflanoxin and that she was experiencing negative side effects: Based on this information J.B. was advised to immediately bring K.B. to the emergency room. K.B.was later stabilized and given Digibid to counter the effects of the Lanoxin overdose. K.B.'s treating Pediatric Cardiologist at Fletcher Allen stated that the administration of the ten times the dosage level of the Lanoxin could have Acost K.B. her life., Additionally, on or about December 31, 2003 and January 7, 2004 during an inspection of the Pbam1acy, Investigators Cholewa and Ron West found numerous violations of the Board's Rules. (A_Uar;~~@=~~. Count! By allowing the prescription to be dispensed in the incorrect dosage amount, the Respondent has violated: Office of Professional Regulation (i 3 V.S.A. 129a(b(1 and (2(failure to practice competently by reason of any cause on a single occasion by performance of unsafe or unacceptable client care. and failure to conform to the essential standards of acceptable and prevailing practice.

9 ~ Understandings 15 The parties understand that the terms of this Stipulation and Consent Order are contingent upon review and acceptance by the Commission and that irthe Co~ssion rejects any portion the entire Stipulation and Consent Order shall be null and void. 16 Respondent has read and reviewed this document fully and agrees that it contains the entire agreement between the parties. 17 This Stipulation and Consent Order is entered into voluntarily by Respondent after.respondent has not been coerced by anyone 18 As part ofthisagreementresponde~t waives all right to appeal from the order of the entered pursuant to thi$ stipulation and consent order. ';, WHEREFORE, the parties agree that the following constitutes a reasonable resolution of this The Board ofphannacy FINDS as follows: CONSENT ORDER 19 The Respondent has agreed that the Commission may find the facts set out above as established. 20 The Respondent has further agreed that these facts, if found, would constitute a sufficient basis for discipline. 21 Accordingly the Commission finds that, the Respondent failed to comply with 3 V.S.A. 129a(b ( 1 and (2 and tllus engaged in unprofessional conduct. 22 Based on the above stipulation it is ORDERED as follows: The Commission hereby issues a REPRIMAND against the Respondent and Respondent is required to pay an ADMINISTRATIVE PENALTY OF$SOO.OO (Five Hundred DOLLARS. Said penalty will be paid within a period of two (2 months from the date of entry of this order. Office or Professional Regulation 23 Respondent's license is conditioned as followed. a. Fora period of five years from the date of entry of this order the pharmacist manager for the pharmacy must be pre-approved by the Board or its designee. b. The pharmacist manager for Respondent must, within one month of the entry of this order, file a report with the Board detailing the hours of employment of all pharmacists and employees of the pharmacy. This report must be prepared and filed quarterly for the first year and thereafter every six months. c. After five years, and completion of the requirements of this Order, Respondent may petition this Board to have the conditions removed from the license.

10 II ~ d. Within ten days of the entry of this order Respondent shall return its license to the Office of Professional Regulation so that the Office my note the conditioning on the license and return it. to Respondent. 24 The fmal disposition of the complaint against Respondent is public an~ the Commission may notify other states of its disposition as provided in 3 V.S.A. 129( a(8. 25 Respondent understands that this Stipulation and Consent Order will remain part of its licensing file and may be used for purposes of determining sanctions in any future disciplinary matter. 26}The parties understand that the terms of this Stipulation and Consent Order are contingent upon review and acceptance by the Commission and that if the Commission rejects any portion the entire StipUlation and Consent Order shall be null and void. TO: Dated: 4.{ -1~ Dated: -1s.N~ APPROVED AND SO ORDERED: VERMONT Dated:.10/.;2'1 10'/ by: Chairperson Office oc ProCessional Regulation