STATE OF VERMONT BOARD OF PHARMACY

Transcription

1 STATE OF VERMONT BOARD OF PHARMACY INRE: Imants Vitols Shire Apothecary, Inc. License Nos.:O ;O Docket No.:RX Come the State of Vermont through Robert H. Backus, prosecuting attorney, and the Respondent, ImantsVitols in his personal capacity and as license holder for Shire Apothacary, Inc, in person and through counsel, David Reeves, and enter into this stipulation and consent order. Board Authority 1. The Vermont Board of Pharmacy has jurisdiction to investigate and adjudicate complaints of unprofessional conduct pursuanto 26 V.S.A. 2032, 2051, and 2052 and 3 V.S.A. 129, 129a, and 814; Rules of the Office of Professional Regulation and the Board of Pharmacy. 2. Failing to comply with provisions of federal or state statutes or rules governing the practice of the profession may provide a basis for disciplinary action. 3 V. S.A. 129a(a(3. 3. Failure to conform to the essential standards of acceptable and prevailing practice is unprofessional conduct and is a basis upon which the Board may impose disciplinary action. 3 V.S.A. 129a(b(2. 4. Being found by the board to be in violation of any of the provisions of this chapter or rules and regulations adopted pursuanto this chapter is unprofessional conduct and is a basis upon which the Board may impose disciplinary action. 26 V.S.A. 2051(5. 5. The prescription department must be secure from access when the drug outlet is closed and secure from access by the public at all times. Only support personnel directly involved in the prescription dispensing process and non-pharmacist management shall be allowed entry into the prescription department and then only when a pharmacist is present in the drug outlet. Violation of this Rule is unprofessional conduct and is a basis upon which the Board may impose disciplinary action. Laws and Rules Relating to Pharmacy 3.000(3. 6. Any drug or device that is misbranded, adulterated, or expired shall not be sold or given away and shall be removed from inventory and stored in a separate location within the prescription drug area until processed for return or destruction.

2 Violation of this Rule is unprofessional conduct and is a basis upon which the Board may impose disciplinary action. Law and Rules Relating to Pharmacy 3.400(2. Federal Regulations 7. Each person registered or authorized to manufacture controlled substanceshall maintain records with the following information: for each controlled substance in finished form, the number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed. 21 C.F.R (a(2(vii. 8. Each person registt?red or authorized to manufacture controlled substanceshall maintain records with the following information: for each controlled substance in finished form, the number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant. (e.g., by distribution of complimentary samples or by destruction, including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed. 21 C.F.R (a(2(ix. 9. Each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph (a(2(i, (ii, (iv, and (ix of this section. In addition, records shall be maintairied of the number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the manufacturer. 21 C.F.R ( c. Facts 10. Imants Vitols (the "Respondent" of Woodstock, Vermont is a licensed pharmacist holding license number issued by the State of Vermont. 11. Respondent was originally licensed on August 11, 1972 and Respondent's license is currently set to expire on July 31, At all times relevant, Respondent was a practicing pharmacist and owner of Shire Apothecary, Inc. in Woodstock, Vermont. 2

3 13. Shire Apothecary, Inc. (the "Respondent Store" of Woodstock, Vermont is a pharmacy operating under license number issued by the State of Vermont. Respondent Store's license is currently set to expire on July 31, At all relevant times, Respondent Store was an active and operating pharmacy in Woodstock, Vermont. 15. On or about June 12, 2003, OPR Investigator Jackie Cholewa conducted an unscheduled inspection of the Respondent Store. 16. The area of walking space in the pharnlacy area was only approximately 3' X 6' with a small hallway which lead to an office containing a rear access of an unlocked screen door. 7. Respondent advised this access is open to deliveries and UPS personnel 1.8. Two large bottles of Hydrocodone tablets, among other drugs, were located on a shelf in the rear office, which was visible from the unlocked screen door. 19. Located among books on another shelf in the rear office were bottles of the drug Adderall and other drugs. 20. Respondent advised the shelves in the rear office were where expired drugs were placed. 21. One of the bottles of Adderall on the shelf among the books was not expired. 22. Respondent advised expired drugs were placed in a box that was located in the rear office and not in the pharmacy area. 23. The access to the rear office was an unlocked screen door.,!, 24. K.K., a licensed pharmacist working at the Respondent Store, advised it was his responsibility to remove all of the expired drugs. 25. K.K. advised when he removes the expired drugs, he places them in the rear office in a locked box and occasionally, when there is not enough room in the box, he will place the expired drugs on shelves near the books in the rear office. 26. K.K. confumed deliveries were made to the Respondent Store at the rear screen door. 27. As a matter of practice Respondent advised he borrows drugs, including narcotics, from another town pharmacy and other town pharmacies borrow drugs, including narcotics, from Respondent Store without recording the distribution on the required DEA-222 form. 3

4 Charges 28. By committing the above act(s, circumstance(s and/or omission(s, the Respondent has: a. Committed unprofessional conduct by failing to comply with provisions of state statutes or rules governing the practice of the profession violation of 3 V.S.A. 29a(a(3; b. c. Committed unprofessional conduct by failure to conform to the essential standards of acceptable and prevailing practice in violation of3 V.S.A. 129a(b (2; Committed unprofessional conduct by violating any of the provisions of this chapter or rules and regulations adopted pursuanto this chapter pursuanto 26 V.S.A. 2051(5; d. Committed unprofessional conduct by violating Laws and Rules Relating to Pharmacy 3.000(3 which states, the prescription department must be secure from access when the drug outlet is closed and secure from access by the public at all times. e. Committed unprofessional conduct by violating Law and Rules Relating to Pharmacy 3.400(2 which states, any drug or device that is...expired... shall be removed from inventory and stored in a separate location within the prescription drug area until processed for return or destruction; 0 address, distributed;..lated 21 C.F.R. 2 (ix (Each person registered or aut lorized shall maintain records with the IOl mg.jer of in any other manner disposal, ~ 4

5 Understandings 29. Respondent understands that the Board must review and accepthe terms of the Consent Order. If the Board rejects any portion the entire Stipulation and Consent Order shall be void. 30. Respondent has reviewed the entire document with advice of counsel and agrees that it sets out the entire agreement of the parties, freely and voluntarily entered into. 31. Respondent waives any notification period and agrees to have this document reviewed by the Board during its next meeting. Respondent specifically waives any claim that presentation of this stipulation to the Board has prejudiced his right to a fair and impartial hearing should the Board reject this stipulation. 32. Respondent voluntarily waives any right to a contested hearing before the Board. 33. Respondent voluntarily waives any right to appeal from any orders of the Board resulting from this stipulation. Consent Order 34. The Parties have agreed that the Board may find the above facts as true and it does so. Based upon those facts the Board fmds Respondents have committed unprofessional conduct as alleged above. 35. License Numbers and are warned. 36. The Board imposes an administrative penalty of five hundred dollars ($ upon each Respondent, the penalty to be concurrent so that payment by either or both Respondents of a total of $ satisfies this penalty. This penalty must be paid within sixty days of the date of entry or it shall be a violation of this order. 37. Both licenses in this case are conditioned as follows: a: They are conditioned for six months; b: Respondentshall have in place a proper storage security system within 3 5

6 Date: months of the date this stipulation is accepted by the Board. This system must be approved by the Board or its designee. c: Respondentshall have in place a proper storage system for expired drugs within 3 months of the date this stipulation is accepted by the Board. This system must be approved by the Board or its designee. d: Proper procedures for the transferring of Schedule II drugs between stores must be in place by the date this siputlation is presented to the Board. e: Store employees who are not pharmacy technicians or pharmacist shall have no access to the pharmacy area unless such person is an owner of the store who may then have access only when a pharmacist is present. 38. The final disposition of the complaint against Respondent is public and the Board may notify other states of its disposition as provided in 3 V.S.A. 129(a( Respondent understands that this Stipulation and Consent Order will remain part of the licensing file and may be used for purposes of determining sanctions in any future disciplinary matter. Respectfully presented by: a~i~i~ii~~;~~~'~~ A~e'~ 6. StO\nsk. Prosecutor Office of Professional Regulation Secretary of State 5,11~/or 'I~k;~~~~~- Respondent and owner of Respondent Shire Apothecary D"-ES 'b ~ Attorney for Respondent D.tc;"~~~J..-~~.Y APPROVED AND so ORDERED: VERMONT BOARD OF PHARMACY Dated: --:?4* 6

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8 STATE OF VERMONT BOARD OF PHARMACY IN RE: Imants Vitals Shire Apothecary, Inc. License Nos.: ; Docket No.:F~X SPECIFICATION OF CHARGES 1. The Vermont Board of Pharmacy has jurisdiction to investigate and adjudicate complaints of unprofessional conduct pursuant to 26 V.S.A. 2032, 2051, and 2052 and 3 V.S.A. 129, 129a, and 814; Rules of the Office of Professional Regulation and the Board of Pharmacy. 2. Failing to comply with provisions of federal or state statutes or rules governing the practice of the profession may provide a basis for disciplinary action. 3 V.S.A. 129a(a(3. 3. Failure to conform to the essential standards of acceptable and prevailing practice is unprofessional conduct and is a basis upon which the Board may impose di~ciplinary action. 3 V.S.A. 129a(b(2. 4. Being found by the board to be in violation of any of the provisions of this chapter or rules and regulations adopted pursuant to this chaptl3r is unprofessional conduct and is a basis upon which the Board may impose disciplinary action. 26 V.S.A (5. 5. The prescription department must be secure from access when the drug outlet is closed and secure from access by the public at all times. Only support personnel directly involved in the prescription dispensing process and non-pharmacist management shall be allowed entry into the prescription department and then only when a pharmacist is present in the drug outlet. Violation of this Rule is unprofessional conduct and is a basis upon which the Board may impose disciplinary action. Laws arid Rules Relating to Pharmacy 3.000(3. STATE OF VERMONT 6. Any drug or device that is misbranded, adulterated, or expired ~;hall not be sold or given away and shall be removed from inventory and stored in a separate location within the prescription drug area until processied for return or destruction. Violation of this Rule is unprofessional conduct and is a basis upon which the Board may impose disciplinary action. Law and Rules Relating to Pharmacy 3.400(2. Prosecuting Attorney Office of Professional Regulation Montpelier, VT

9 F,~deral Regulations 7. Each person registered or authorized to manufacture controlled substances shall maintain records with the following informatiorl: for each controlled substance in finished form, the number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed. 21 C.F.R (a(2(vii. 8. Each person registered or authorized to manufacture con1trolled substances shall maintain records with the following informatiorl: for each controlled substance in finished form, the number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction, including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or dispo'sed. 21 C.F.R (a(2(ix. 9. Each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph (a(2(i, (ii, (iv, and (ix of this section. In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the rlame and address of the person to whom it was dispensed, the date of di~pensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the manufacturer. 21 C.F.R (c. Facts 10.lmants Vitols (the "Respondent" of Woodstock, Vermont is a lic:ensed pharmacist holding license number issued by the State of Vermont. 11. Respondent was originally licensed on August 11, 1972 and RE!spondent's license is currently set to expire on July 31, STATE OF VERMONT Prosecuting Attorney Office of Professional Regulation Montpelier, VT At all times relevant, Respondent was a practicing pharmacist and owner of Shire Apothecary, Inc. in Woodstock, Vermont. 13. Shire Apothecary, Inc. (the "Respondent Store" of Woodstock, Vermont is a pharmacy operating under license number issul9d by the State of Vermont. Respondent Store's license is currently set to expire on July 31,

10 14.At all relevar1t times, Respondent Store was an active and operating pharmacy in Woodstock, Vermont. 15. On or about June 12, 2003, OPR Investigator Jackie Cholewa conducted an unscheduled inspection of the Respondent Store. 16. The area of walking space in the pharmacy area was only approximately 3' X 6' with a small hallway which lead to an office containing a rear access of an unlocked screen door. 17. Respondent advised this access is open to deliveries and UPS personnel. 18. Two large bottles of Hydrocodone tablets, among other drugs, were located on a shelf in the rear office, which was visible from the IJnlocked screen door. 19. Located among books on another shelf in the rear office were bottles of the drug Adderall and other drugs. 20. Respondent advised the shelves in the rear office were where expired drugs were placed. 21. One of the bottles of Adderall on the shelf among the books was not expired. 22. Respondent advised expired drugs were placed in a box that Vlras located in the rear office and not in the pharmacy area. 23. The access to the rear office was an unlocked screen door. 24. The bookkeeper of the Respondent Store, who is not a license,d pharmacist, was entering and exiting the pharmacy area to access the rear office. 25. All of the store employees were walking in and out of the rear office and the pharmacy area. STATE OF VERMONT 26. Respondent advised the store employees, who are not licensetj pharmacists, occasionally count pills for him. 27. Respondent advised he did not have any "techs" working for him. 28. Respondent advised he guessed he could refer to his employees as "techs." Prosecuting Attorney Office of Professional Regulation Montpelier, VT

11 29. K.K., a licensed pharmacist working at the Respondent Store, advised it was his responsibility to remove all of the expired drugs. 30. K.K. advisecj when he removes the expired drugs, he places them in the rear office in a locked box and occasionally, when there is not E~nough room in the box, he will place the expired drugs on shelves near the books in the rear office. 31. K.K. confirmed deliveries were made to the Respondent Store at the rear screen door. 32. K.K. advised he and the Respondent consider all of the store employees "techs" and the "techs" help them all the time. 33. As a matter of practice Respondent advised he borrows cjrugs, including narcotics, from another town pharmacy and other town pharmacies borrow drugs, including narcotics, from Respondent Store without recording the distribution on the required DEA-222 form. 34. On or about September 12, 2003, OPR Investigator Jackie Cholewa conducted a second inspection of the Respondent Store in orde~r to determine if Respondent had complied with making necessary corrections. 35. Investigator Cholewa advised the Respondent and K.K. that the metal box containing the expired drugs must be kept in the immediate pharmacy area. Respondent removed the metal box of expired drugs frorn the rear office and placed the box on the floor in the immediate pharmal:;y area. 36. Investigator Cholewa again advised Respondent the rear door must be locked at all times. 37. Bags of items were lying in a stack in the back portion of the pharmacy. When this, and other previous problems were raised with the Respondent, he replied "I'm just a slob." 38. Respondent advised they were still borrowing drugs from other town pharmacies and were not utilizing the required DEA-222 forms. STATE OF VERMONT Prosecuting Attorney Office of Professional Regulation Montpelier, VT Charges 39. By committing the above act(s, circumstance(s and/or omission(s, the Respondent has: a. Committed unprofessional conduct by failing to comply with provisions of state statutes or rules governing the practice of the profe~sion violation of 3 V.S.A. 129a(a(3; 4

12 b. Committed unprofessional conduct by failure to conform to 1he essential standards of acceptable and prevailing practice in violation of 3 V.S.A. 129a(b(2; c. Committed unprofessional conduct by violating any of the provisions of this chapter or rules and regulations adopted pursuant to this chapter pursuant to 26 V.S.A (5; d. Committed unprofessional conduct by violating Laws and RIJles Relating to Pharmacy 3.000(3 which states, the prescription department must be secure from access when the drug outlet is closed and secure from access by the public at all times. Only support personnel directly involved in the prescription dispensing process and non-pharmacist management shall be allowed entry into the prescription department and then only when a pharmacist is present in the drug outlet; e. Committed unprofessional conduct by violating Law and Rules Relating to Pharmacy 3.400(2 which states, any drug or device that is misbranded, adulterated, or expired shall not be sold or given away and shall be removed from inventory and stored in a separate location within the prescription drug area until processed for return or destruction; f. Violated 21 C.F.R (a(2(ix (Each person registerl~d or authorized to manufacture controlled substances shall main'tain records with the following information: for each controlled substance in finished form, the number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed; STATE OF VERMONT Prosecuting Attorney Office of Professional Regulation Montpelier, VT g. Violated 21 C.F.R (a(2(ix (Each person registerlad or authorized to manufacture controlled substances shall main'tain records with the following information: for each controlled substance in finished form, the number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction, including the date and manner of distribution o'r disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed; h. Violated 21 C.F.R (c (Each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph (a(2(i, (ii, (iv, and (ix of this section. In 5

13 wl addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and adldress of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the manufacturer. IRelief Requested WHEREFORE, the pharmacist license of Imants Vitols and Shi,-e Apothecary, Inc. should be revoked, suspended or disci~lined. (- State of \ltc~t Secre~7'" 7~te Bv: /,. rx.shire-vitols.soc State STATE OF VERMONT Prosecuting Attorney Office of Professional Regulation Montpelier, VT