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BEFORE THE IOWA BOARD OF PHARMACY
Re: ) Pharmacy License of )^ Case No. 2010- LEEDS PHARMACY ) License No. 227, )^ STATEMENT OF CHARGES Respondent. )
COMES NOW, the Complainant, Lloyd K. Jessen, and states:
- He is the Executive Director for the Iowa Board of Pharmacy (hereinafter, "Board") and files this Statement of Charges solely in his official capacity.
- The Board has jurisdiction in this matter pursuant to Iowa Code Chapters 155A and 272C (2011).
- Effective December 12, 2011, the Board renewed Respondent's general pharmacy license number 227 for Leeds Pharmacy (hereinafter, "Respondent"), allowing Respondent to engage in the operation of a pharmacy, subject to the laws of the State of Iowa and the rules of the Board.
- General pharmacy license number 227 is current until December 31, 2012.
- At all times material to this statement of charges, Respondent was operating a general pharmacy at 4029 Floyd Boulevard, Sioux City, Iowa 51108 with Thomas Dodds as the pharmacist in charge.
A. CHARGES
COUNT I - LACK OF PROFESSIONAL COMPETENCY
Respondent is charged under Iowa Code§ 155A.15(2)(c) (2011) and 657 Iowa Administrative Code§ 36.1(4)(b) with lack of professional competency as demonstrated by Respondent's (a) substantial deviation from the standards oflearning and skill ordinarily possessed and applied by other Iowa pharmacies, (b) failure to exercise in a substantial respect that degree of care which is ordinarily exercised by an Iowa pharmacy and (c) willful and repeated departures from, and a failure to conform to, the minimal standard and acceptable and prevailing practice of pharmacy in the state of Iowa, as evidenced by Respondent's failure to maintain adequate controls over controlled substances.
COUNT II - VIOLATION OF CONTROLLED SUBSTANCES LAWS
Respondent is charged with a failure to comply with controlled substances laws, in violation of Iowa Code §§ 124.306, 124.308, 124.402 and 155A.15(2)(c) (2011) and 657 Iowa Administrative Code§ 36.1(4)G).
COUNT III - FAILURE TO MAINTAIN AND PROVIDE RECORDS
Respondent is charged with failure to maintain and provide to the Board pharmacy records, including records relating to controlled substances, in violation of Iowa Code §§ 155A.15(2) and 155A.15(5)(h) (2011) and 657 Iowa Administrative Code§§ 8.4(3), 10.34, 10.35, 21.5, 36.1(4)(ac), 36.1(4)(ag).
COUNT IV - FAILURE TO GIVE NOTICE OF CLOSURE TO BOARD
Respondent is charged under Iowa Code§§ 155A.15(2)(c) and 155A.19(1)(a) (2011), and 657 Iowa Administrative Code § 8.35(7), with failing to give two weeks prior notice to the Board of Respondent's intention to close a pharmacy.
B.CIRCUM:STANCES
An investigation was commenced on November 3, 2010 which revealed the following:
- At all times material to this Statement of Charges, Respondent was operating a general pharmacy at 4029 Floyd Boulevard, Sioux City, Iowa 51108 with Thomas Dodds as the pharmacist in charge.
- Respondent dispensed Actos 15mg to a patient, rather than the prescribed Celexa 30mg, resulting in the patient experiencing severe edema.
- An inspection of Respondent on March 23, 2011 revealed the following: a. Respondent did not assign prescription numbers to some prescription hard copies. b. Respondent did not keep documentation of the pharmacist responsible for checking cassettes and bubble packs before they were dispensed. c. The refrigerator temperature was below freezing. d. Respondent had no policy or procedure regarding drug recalls; no policy or procedure for giving notice of a recall to patients in nursing facilities. e. Receipts for controlled substances were not signed by a responsible person. Respondent was not creating an electronic record of receipt of Schedule II controlled substances. f. Respondent had no policy covering how a proper temperature will be maintained during delivery of drugs and devices that are temperature sensitive. g. Respondent did not have a formal Continuous Quality Improvement program.
BEFORE THE IOWA BOARD OF PHARMACY
Re: ) Case Nos. 2010-138, 2011-169, Pharmacist License of )^ and 2012- LEEDS PHARMACY ) License No. 227, ) MOTION TO AMEND Respondent. )^ STATEMENT OF CHARGES
COMES NOW the State of Iowa and moves to amend the Statement of Charges
in this matter, as set forth below, and in support thereof states as follows:
- The State seeks to amend the pending charges to assert new factual
allegations.
- The hearing in this matter is scheduled for August 28, 2012.
- The Iowa Supreme Court allowed a similar amendment to the statement of
charges in the case of Rosen v. Board of Medical Examiners, 539 N.W.2d 345 (Iowa
1996). In that case the Supreme Court allowed a request for amendment to enlarge the
factual basis supporting the charges, even though it was made in the course of the
hearing itself.
- It is in the interest of justice to allow this amendment. The new factual
allegations concern Respondent's ability to safely practice medicine, and therefore affect
the public's health and welfare. There is sufficient time to prepare a defense to these
new complaints. It would be unnecessary duplication of the time and resources of both
parties and the Board to require the Board to initiate an entirely new proceeding in this
matter.
- A copy of the amended charges proposed by the State is attached as
Exhibit A. The substantive changes are the additions of Count V and paragraphs 5-9.
1
RECEIVED
AUG 2 2 2012
iOWA BOARD OF PHARMACY
-----~-------------------------------------------
WHEREFORE, the State of Iowa requests the Board amend the charges as set
forth above.
Respectfully submitted,
THOMAS J. MILLER ATIORNEY GENERAL OF IOWA
WEEG Assistant Attorney General Iowa Attorney General's Office 2nd Floor Hoover Bldg. Des Moines, IA 50319 515.281. tweeg@ag.state.ia.us
cc: Connie Diekema FINELY, ALT, SMITH, SCHARNBERG, CRAIG, HILMES & GAFFNEY, P.C. 699 Walnut St., Suite 1900 Des Moines, IA 50309
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COUNT II - VIOLATION OF CONTROLLED SUBSTANCES LAWS
Respondent is charged with a failure to comply with controlled substances laws, in violation of Iowa Code§§ 124.306, 124.308, 124-402 and 155A.15(2)(c) (2011) and 657 Iowa Administrative Code§ 36.1(4)(j).
COUNT III - FAILURE TO MAINTAIN AND PROVIDE RECORDS
Respondent is charged with failure to maintain and provide to the Board pharmacy records, including records relating to controlled substances, in violation of Iowa Code §§ 155A.15(2) and 155A.15(5)(h) (2011) and 657 Iowa Administrative Code§§ 8-4(3), 10.34, 10.35, 21.5, 36.1(4)(ac), 36.1(4)(ag).
COUNT IV - FAILURE TO GIVE NOTICE OF CLOSURE TO BOARD
Respondent is charged under Iowa Code§§ 155A.15(2)(c) and 155A.19(1)(a) (2011), and 657 Iowa Administrative Code § 8.35(7), with failing to give two weeks prior notice to the Board of Respondent's intention to close a pharmacy.
COUNT V - VIOLATING RULES OF THE BOARD
Respondent is charged with violating the rules of the Board, including 657 IAC 3.21(1) and 3.23(6) (delegation of functions to a pharmacy support person); 6.14(3) (suitable counseling area); 657 IAC 8.3(3) (pharmacist-documented verification); 657 IAC 8. (out of date drugs); 657 IAC 8/16(1) regarding confidentiality; 657 IAC 10.31(5) (record book for Schedule V controlled substances); 657 IAC 10.33 (perpetual inventory of Schedule II controlled substances); 10.34(7) (ordering or distributing Schedule I or II controlled substances); 657 IAC 10.35(6) (change of registered location of controlled substances); and 10.35(8) (inventory of newly controlled substances).
B.CIRCUl\llSTANCES
An investigation was commenced on November 3, 2010 which revealed the following:
- At all times material to this Statement of Charges, Respondent was operating a general pharmacy at 4029 Floyd Boulevard, Sioux City, Iowa 51108 with Thomas Dodds as the pharmacist in charge.
- Respondent dispensed Actos 15mg to a patient, rather than the prescribed Celexa 30mg, resulting in the patient experiencing severe edema.
- An inspection of Respondent on March 23, 2011 revealed the following:
a. Respondent did not assign prescription numbers to some prescription hard copies. b. Respondent did not keep documentation of the pharmacist responsible for checking cassettes and bubble packs before they were dispensed. c. The refrigerator temperature was below freezing. d. Respondent had no policy or procedure regarding drug recalls; no policy or procedure for giving notice of a recall to patients in nursing facilities. e. Receipts for controlled substances were not signed by a responsible person. Respondent was not creating an electronic record of receipt of Schedule II controlled substances. f. Respondent had no policy covering how a proper temperature will be maintained during delivery of drugs and devices that are temperature sensitive. g. Respondent did not have a formal Continuous Quality Improvement program. h. Respondent has not documented destruction of returned controlled substances. i. Respondent did not maintain an inventory record of Schedule III, IV and V controlled substances. j. Respondent did not have a policy or procedure relating to receipt and identification of returned drugs. k. Respondent has been re-packaging medication originally dispensed to long term care patients by other pharmacies. The medications were stored by Respondent in bins designated for individual patients, then dispensed in unit dose packages.
- Respondent failed to give the Board 30 days notice of the closing of the pharmacy.
A second investigation was commenced in February 2012, which revealed the following:
- Leeds Pharmacy allowed a pharmacy technician to delegate technical functions to a pharmacy support person.
- Leeds Pharmacy dispensed Furosemide (Lasiz) to a patient, rather than the prescribed Fluoxetine (Prozac).
- Leeds Pharmacy allowed confidential patient information and prescription medication to be available in a public access area.
- Leeds Pharmacy did not keep a conversation with a patient confidential.
- An inspection of Leeds Pharmacy on March 14, 2012, revealed the following:
a. Leeds Pharmacy had not updated its Schedule II perpetual inventory since 1/2/12. b. Leeds Pharmacy had not inventoried refrigerated controlled substances after
BEFORE THE IOWA BOARD OF PHARMACY
IN THE MA TIER OF :
LEEDS PHARMACY
License No. 227, and
THOMAS B. DODDS
Pharmacist License No. 12951
RESPOI\TDENTS
) CASE NOS. 2010-138, ) 2011-169, and 2012-
CASE NOS. 2010-138 and 2012-
RULING GRANTING STATE'S MOTIONS TO AMEND
) ) ) ) ) )
On March 7, 2012, the Iowa Board of Pharmacy (Board) foru1d probable cause to
file Statements of Charges against Leeds Pharmacy and Thomas B. Dodds
(Respondents). On August 22, 2012, the state of Iowa filed Motions to Amend
both Statements of Charges to add one additional legal coru1t and additional
factual circumstances, which relate to a second investigation conducted in
February 2012. Both Motions to Amend included a copy of the proposed First
Amended Statement of Charges.
On September 14, 2012, Respondents' attorney filed an Answer to Amended
Statement of Charges on behalf of both Respondents. Respondents deny all
charges contained in the Amended Statement of Charges. Respondents did not file any resistance to the Amended Statements of Charges.
The Board has delegated ruling on the Motions to Amend to the undersigned administrative law judge. Respondents have been afforded sufficient opportunity to prepare a defense to the additional charges. It is in the interest of judicial economy for the Board to hear and determine all pending charges in one disciplinary proceeding. IT IS THEREFORE ORDERED that the State's Motions to Amend the Statement of Charges filed against Respondents Leeds Pharmacy and Thomas Dodds are hereby GRANTED.
NOV 3 O ;· J;
IOWA BOARD OF PHARMACY
File No. 2010- Page
Dated this 29th day of November, 2012.
Margaret LaMarche
Administrative Law Judge
Iowa Department of Inspections and Appeals
Division of Administrative Hearings Wallace State Office Building-Third Floor
Des Moines, Iowa 5031 9
[For the Iowa Board of Pharmacy]
cc : Connie L. Diekema, Finley, Alt, Smith, 699 Walnut Street, Suite 1900, Des Moines, Iowa 50309-3905 (CERTIFIED) Theresa O'Connell Weeg, Department of Justice, Hoover Bldg, 2nd Fl. (LOCAL) Lloyd Jessen an d Debbie Jorgenson, Iowa Board of Pharmacy, 400 SW 8th Street, Suite C, Des Moines (LOCAL )
- Respondent has chosen not to contest the allegations in the Statement of Charges
and acknowledges that the allegations, ifproven in a contested case proceeding,
would constitute grounds for the discipline agreed to in this Order.
- On the date of the Board's approval of this Settlement Agreement and Final
Order, Respondent's license shall be placed on probation for a period of three (3)
years, subject to the following terms:
a. Respondent shall submit a $2000.00 civil penalty to the Board. This civil
penalty shall be made payable to the Treasurer of Iowa and mailed to the
executive director of the Board within ten (10) days of the date this
Settlement Agreement is approved by the Board. All civil penalty
payments shall be deposited into the State of Iowa's general fund.
b. Respondent shall within thirty (30) days of the date this Settlement
Agreement is approved by the Board complete a current, accurate and
complete controlled substance inventory and submit it to the Board for
review and approval.
c. Respondent shall within thirty (30) days of the date this Settlement
Agreement is approved by the Board establish and implement a
continuous quality improvement (CQI) program for the pharmacy and
submit it to the Board for its review and approval.
d Respondent shall within thirty (30) days of the date this Settlement
Agreement is approved by the Board establish a patient counseling area
which provides privacy for patients.
e. Respondent shall within sixty ( 60) days of the date this Settlement
Agreement is approved by the Board, submit to the Board for its approval
policies and procedures for the following areas of practice. Respondent
agrees to comply with these policies and procedures while operating its
pharmacy.
i. patient counseling
ii. drug recalls
iii. drugs returned to the pharmacy
iv. proper storage of drugs
v. proper repackaging of drugs
vi. proper transport of temperature-sensitive drugs
vii. pharmacy technician duties
viii. pharmacy support person duties
ix. handling of confidential patient information
x. documentation of final verification of dispensed medications
xi. checking for outdated medications and how close to expiration they
will be left on the dispensing shelf
xii. disposal of expired medications
xiii. proper recordkeeping for the dispensing of prescription drugs and
controlled substances
xiv. proper recordkeeping for the sale of non-prescription, Schedule V
controlled substances
xv. proper recordkeeping for the destruction of controlled substances.
- This Settlement Agreement and Final Order is subject to approval by a majority
of the full Board. If the Board fails to approve this settlement, it shall be of no
force or effect to either the Board or Respondent. Ifthe Board approves this
Settlement Agreement and Final Order, it shall be the full and final resolution of
this matter.
- The Board's approval of this Settlement Agreement and Final Order shall .. constitute a FINAL ORDER of the Board.
, Respondent as B. Dodds, R.Ph. acist in Charge
By his signature Thomas Dodd acknowledges he is the pharmacist in charge of Leeds Pharmacy and is authorized to sign this Settlement Agreement and Final Order on behalf of Leeds Pharmacy.
~Stipulr=:•msent Order is accepted by the Iowa Board of Pharmacy on the
I.Id!. day of 'lo&(.( 2012.
Iowa Board of Pharmacy 400 SW Eighth Street, Suite E Des Moines, Iowa 50309-
cc: Theresa O=Connell Weeg Assistant Attorney General Office of the Attorney General Hoover State Office Building Des Moines, Iowa 50319
Connie Diekema FINLEY, ALT, SMITH, SCHARNBERG, CRAIG, HILMES & GAFFNEY, P.C. 699 Walnut St., Suite 1900 Des Moines, IA 50309
Communications. You may contact the Board office (515)281-5944 with questions regarding this notice and other matters relating to these disciplinary proceedings. However, you may NOT contact individual members of the Board to discuss these proceedings by phone, letter, facsimile, email, or in person. Board members can only receive information about the case when all parties have notice and an opportunity to participate, such as at the hearing or in pleadings you file with the Board office and serve upon all parties in the case. You may also direct questions relating to settlement of these proceedings to Assistance Attorney General Meghan Gavin at (515)281-6736.
B. LEGAL AUTHORITY AND JURISDICTION
Jurisdiction. The Board has jurisdiction over this matter pursuant to Iowa Code chapters 17A, 147, 155A, and 272C.
Legal Authority. Ifany of the allegations against you are founded, the Board has authority to take disciplinary action against you under Iowa Code chapters 17A, 147, 155A, and 272C and 657 Iowa Administrative Code chapter 36.
Default. Ifyou fail to appear at the hearing, the Board may enter a default decision or proceed with the hearing and render a decision in your absence, in accordance with Iowa Code section l 7A.12(3) and 657 Iowa Administrative Code rule 35.21.
C. CHARGES
Count I FAILURE TO MAINTAIN A CONTINUOUS QUALITY IMPROVEMENT PROGRAM
Respondent is charged with failing to maintain a continuous quality improvement program in violation of Iowa Code sections 147.55(9) and 155A.15(2)(c), (h) and 657 Iowa Administrative Code rules 8.3(1), 8.26, and 36.1(4)(u).
Count II FAILURE TO PROPERLY VERIFY THE ACCURACY OF A PRESCRIPTION
Respondent is charged with failing to properly verify the accuracy of a prescription in violation oflowa Code sections 147.55(9) and 155A.15(2)(c) and 657 Iowa Administrative Code rules 6.10(1), 8.3(1), (3), and 36.1(4)(u).
Count III FAILURE TO HAVE SUFFICIENT POLICIES AND PROCEDURES
Respondent is charged with failing to have sufficient policies and procedures in violation oflowa Code section 147.55(9) and 155A.15(2)(c), (h) and 657 Iowa Administrative Code rules 6.2, 8.3(1), and 36.1(4)(u).
Count IV VIOLATION OF THE TERMS OF ITS PROBATION
Respondent is charged with violating of the terms of its probation violation of Iowa Code sections 147.55(9) and 155A.15(2(c) and 657 Iowa Administrative Code rule 36.1(4)(i).
D. FACTUAL CIRCUMSTANCES
- Respondent is an Iowa-licensed pharmacy doing business at 2729 Outer Drive North, Sioux City, Iowa 51101.
- In January 2013, Leeds Pharmacy entered into a settlement agreement with the Board. Leeds Pharmacy's license was placed on probation for three years subject to a number of terms and conditions. Amongst those conditions were requirements for Leeds Pharmacy to establish and implement a Continuous Quality Improvement Program (CQI), complete a current, accurate, and complete controlled substance inventory, establish a patient counseling area which provides privacy for patients, and submit for Board approval policies and procedures in a number of practice areas.
- On May 1, 2014, the Board received notification from Pharmacists Mutual Insurance Company regarding the settlement of a claim with the Respondent. The settlement was due to a dispensing error committed by a staff pharmacist at Leeds. The patient was dispensed amitriptyline 100mg tablets instead of the prescribed 10mg tablets. As a result of the error, the patient was woozy and unable to work for two days.
- The dispensing error was not recorded in a CQI program.
- When questioned by a Board compliance officer, Respondent's employees did not appear to know what a CQI program entailed.
- Respondent lacked sufficient policies and procedures. Upon request, Respondent was only able to produce a policy and procedure manual for Rx HealthMart Pharmacy Operations. This manual was not specific to Leeds Pharmacy. Moreover, while the manual did contain procedures for "Dispensing Error Risk Management" and "Documenting Dispensing Errors," Leeds had not actually implemented a CQI program.
- Respondent failed to submit policies and procedures as required by the settlement agreement.
- Respondent failed to complete a current, accurate, and complete controlled substance inventory and submit it to the Board for review and approval as required by the settlement agreement.
- Respondent failed to establish a patient counseling area which provides privacy for patients as required by the settlement agreement.
