Showing posts with label Ohio. Show all posts
Showing posts with label Ohio. Show all posts

Thursday, February 13, 2014

Ohio Board of Pharmacy cracks down on diet clinics ordering non-patient specific compounded drugs for administration and/or dispensing for home administration

 by Dr. Kenneth N. Woliner, M.D., A.B.F.M.

Many physician offices, including weight loss centers such as “The Metabolic Weight Loss Clinic, LLC” operated by John Ross, MD, order non-patient specific compounded medications (a.k.a. “office-use compounded drugs”).  The Ohio Board of Pharmacy considers this to be illegal.  Licensees (clinics, doctors, pharmacies) will be disciplined if they do not have patient-specific prescriptions BEFORE THE DRUGS ARE ORDERED/DELIVERED to the clinic.  The dodge of “the clinic can send to the pharmacy, a manifest of patients to whom drugs were administered/dispensed after the fact” will not cut it. 

Read the Ohio Board of Pharmacy Order here

Saturday, February 16, 2013

Ohio debates ways to carry out future executions --that involve compounded medications


February 16, 2013
Associated Press

COLUMBUS, Ohio (AP) — A low-key announcement that the state's prisons agency wants a law to protect pharmacies that might mix execution drugs underscores a high-profile problem: The state has enough of its current lethal drug to execute four inmates but has nine executions scheduled after that, including one announced Friday.
Continue reading here 

Friday, February 8, 2013

Ohio State Board of Pharmacy Feb. 4-5 Meeting Included Hearings Relating to Compounding Pharmacies


OHIO STATE BOARD OF PHARMACY
77 South High Street, Room 1702; Columbus, OH 43215-6126
-Equal Opportunity Employer and Service Provider-
TEL: 614/466-4143 E-MAIL: exec@bop.ohio.gov FAX: 614/752-4836
TTY/TDD: Use the Ohio Relay Service: 1-800/750-0750 URL: http://www.pharmacy.ohio.gov
S U N S H I N E N O T I C E
The next meeting of the State Board of Pharmacy should be held in Room East B, 31st Floor, Vern Riffe Center for
Government and the Arts, 77 S. High Street, Columbus, Ohio according to the following schedule with all sessions
being open to the public unless otherwise indicated:
Monday, February 4, 2013
10:00 a.m. ROLL CALL/EXECUTIVE SESSION (Closed Session)
10:05 a.m. ADMINISTRATIVE MATTERS ~ Old & New Business/Correspondence Reports/Matters To Be
Adjudicated (No Hearing Requested)- Pharmfinders, LLC, c/o Ryan Hackler, CEO, Tulsa,
Oklahoma
1:30 p.m. ADJUDICATION HEARING- Risa Gethers, R.Ph., West Chester, Ohio
1:30 p.m. ADJUDICATION HEARING- Buckeye Family Medicine, Inc. c/o Rosalie A. Kuriakose, M.D.,
Columbus, Ohio
Tuesday, February 5th, 2013
8:00 a.m. ROLL CALL / ADMINISTRATIVE MATTERS (continued)
8:00 a.m. ADJUDICATION HEARING- Albert D. Fischer, R.Ph., Broadview Heights, Ohio
10:30 a.m. ADJUDICATION HEARING- The Compounding Center, Inc. c/o Joel Gomez, Scottsdale, Arizona
1:30 p.m. RECIPROCITY CANDIDATES REVIEW (Room South-A, 31st Floor)
2:00 p.m. ADJUDICATION HEARING- Jeremy Webster, Intern, Findlay, Ohio
2:30 p.m. ADJUDICATION HEARING- Bryan Dennis Bowman, R.Ph., Mason, Ohio
=\=\=\==/=/=/=
Contact: Kyle W. Parker, M.B.A., R.Ph., Executive Director
Mail: 77 South High Street, Room 1702; Columbus, OH 43215-6126
Tel: 614/466-4143
Fax: 614/752-4836

Saturday, January 5, 2013

In Ohio Compounding pharmacies face new scrutiny


Posted: Saturday, January 5, 2013 12:00 pm | Updated: 5:02 pm, Fri Jan 4, 2013.
LIMA — The facility responsible for the deadly meningitis outbreak in late 2012 was known as a “compounding pharmacy.” However, that Massachusetts facility was a commercial prescription manufacturer, and in reality comparing it to a true compounding pharmacy would be like comparing a mass-food producer with someone cooking in his kitchen. Still, the problems found at the New England Compounding Center have meant increased scrutiny for small compounding pharmacies that mix ingredients for a single prescription. A new report released in December by the National Conference of State Legislatures said several states changed laws regarding regulation of compounding pharmacies and locally, pharmacists report increased inspections.
“You can expect something like that to come out of any event. If there’s an oil spill, everyone gets a closer look,” said John Pack, owner of Pack Pharmacy, which is Lima’s only compounding pharmacy.
Pack said compounding is more complicated than regular pharmacy work.
“We’re doing more, and more is expected of us. People need reassured,” Pack said. “So, two weeks ago, we had the most thorough inspection I’ve ever experienced. It was a surprise visit. You know, business just stops for them. But, it was very positive. We had nothing at fault. They did some educational things; they’re trying to get a more consistent way of keeping records.”
continue reading here

Sunday, December 2, 2012

OOS Representatives TO Meet With The Ohio Pharmacy Board To Discuss Enforcement Of Regulations Surrounding The Purchase Of Avastin From Compounding Pharmacies


11/28/2012

Last week the OOS made a formal meeting request to the Ohio State Board of Pharmacy to discuss the enforcement of current rules surrounding the purchase of Avastin from compounding pharmacies. We hope to hear back in the next several days regarding a proposed meeting date.

As you know, attention at the federal and state level regarding the regulation of drugs distributed from compounding pharmacies has increased dramatically since the deadly fungal meningitis outbreak linked to the New England Compounding Center. While Congress continues to investigate the current level of oversight and discusses developing legislation to create new regulations, state pharmacy boards are focused on enforcing current state level requirements.
The OOS has heard from several practices that have already been investigated or have questions about the current regulations. For a complete copy of the Ohio State Board of Pharmacy’s fact sheet Compounding in Ohio click here. The OOS has heard from several practices that are concerned that a number of the existing provisions make it extremely difficult for most practices to purchase and administer Avastin and potentially compromise what would be considered good patient care. The OOS is aware of these issues and will be articulating them to the Pharmacy Board.
We will update OOS members when we have a meeting date, and additional information to provide, from the Pharmacy Board. Should you have any questions now or in the future, please contact the OOS office directly at (614) 527-6799 or email us at tbaker@ohioeye.org.

Saturday, November 17, 2012

Ohio Board of Pharmacy Guidance Regarding Compounding in Ohio


COMPOUNDING IN OHIO
We recognize and enforce Federal law that compounding is performed by a pharmacist in a
pharmacy and pursuant to a patient specific prescription.  Refer to 21 USCA 353a
 You may not compound FDA approved drugs that are commercially available.
 On July 9, 2012, President Obama signed into law the FDA Safety and Innovation
Act which in part grants permission for hospitals and health systems to repack and
share drugs, not controlled substances, in short supply during an FDA published
shortage plus 60 days after the drug is taken off the list. Caveat: only within the
same health system    
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/Significant
AmendmentstotheFDCAct/FDASIA/ucm313121.htm
Our state law defines compounding in ORC 4729.01(C)
(C) “Compounding” means the preparation, mixing, assembling, packaging, and
labeling of one or more drugs in any of the following circumstances:
(1) Pursuant to a prescription issued by a licensed health professional authorized
to prescribe drugs;
(2) Pursuant to the modification of a prescription made in accordance with a
consult agreement;
(3)  As an incident to research, teaching activities, or chemical analysis;
(4) In anticipation of orders for drugs pursuant to prescriptions, based on routine,
regularly observed dispensing patterns;
(5) Pursuant to a request made by a licensed health professional authorized to
prescribe drugs for a drug that is to be used by the professional for the purpose
of direct administration to patients in the course of the professional’s practice,
if all of the following apply:
(a) At the time the request is made, the drug is not commercially available
regardless of the reason that the drug is not available, including the
absence of a manufacturer for the drug or the lack of a readily available
supply of the drug from a manufacturer.
(b) A limited quantity of the drug is compounded and provided to the
professional.Compounding in Ohio
Page 2 of 5 rev 9/12
(c) The drug is compounded and provided to the professional as an
occasional exception to the normal practice of dispensing drugs pursuant
to patient-specific prescriptions.
Note: also refer to OAC 4729-9-25 below for specifics relating to (5)
We further regulate compounding in the following rules:
DRUGS COMPOUNDED IN A PHARMACY      OAC Rule 4729-9-21
Please review particularly:
(F) A prescription shall be compounded and dispensed only pursuant to a
specific order for an individual patient issued by a prescriber. A
limited quantity may be compounded in anticipation of prescription drug
orders based on routine, regularly observed prescribing patterns.
(G) A compounded prescription that is dispensed to a patient must be
labeled according to rule 4729-5-16 of the Administrative Code.
DRUGS COMPOUNDED FOR DIRECT ADMINISTRATION BY A PRESCRIBER
OAC Rule 4729-9-25
Please review particularly:
A pharmacist may compound a drug pursuant to a request made by a
prescriber, or by an agent of the prescriber, for a drug to be used by the
prescriber for the purpose of the direct administration to patients in the
course of the prescriber's practice pursuant to division (C)(5) of section
4729.01of the Revised Code and the following:
(A) The drug is compounded and provided to a prescriber as an occasional
exception to the normal practice of dispensing drugs pursuant to patient
specific prescriptions:
(1)  A pharmacy may provide compounded drug preparations to
prescribers for direct administration to patients as long as the total
value of those compounded preparations does not exceed five percent
of the pharmacy's total dollar amount of sales of patient specific
compounded prescriptions within the past twelve months.
(2) The pharmacy shall only provide those compounded drugs that are
not commercially available to a prescriber which are needed:
(a) To treat an emergency situation;
(b) For an unanticipated procedure for which a time delay would
negatively affect a patient outcome;
(c) For diagnostic purposes.
(B) A pharmacy shall not supply more than a seventy-two hour supply of a
compounded drug to a prescriber. A prescriber shall not have more than
a seventy-two hour supply of a compounded drug on hand at any given
time. The seventy-two hour supply provided to the prescriber shall be
determined by previous administration patterns provided by a Compounding in Ohio
Page 3 of 5 rev 9/12
prescriber to the pharmacist. The limitation of a seventy-two hour
supply shall not apply to either of the following:
(1) Compounded non-sterile drug preparations for topical administration,
pursuant to paragraphs (A)(2)(b) and (A)(2)(c) of this rule, shall be
supplied to a prescriber in a single container in which the quantity
does not exceed sixty grams or sixty milliliters. A prescriber shall not
have more than one full container of sixty grams or sixty milliliters of
a compounded drug on hand at any given time; or
(2) Compounded non-sterile drug preparations intended to treat an
emergency situation, pursuant to paragraph (A)(2)(a) of this rule, may
be provided to a prescriber in a quantity required to sufficiently treat
individuals in the event of an emergency situation.
(C) A pharmacy shall not sell a compounded drug to another pharmacy
or wholesaler.
(D) Prescribers shall only administer a requested compounded drug directly
to their own patients. Prescribers shall not:
(1) Dispense a compounded drug to a patient;
(2) Sell a compounded drug to another prescriber;
(3) Sell a compounded drug to a pharmacy; or
(4) Return a compounded drug to the supplying pharmacy.
(E)  Compounded drug preparations shall be assigned beyond use dates
that are based on stability and sterility for sterile compounded drug
preparations and stability for non-sterile compounded drug preparations
pursuant to the following:
(1) Beyond use dates for non-sterile compounded preparations shall be
determined by the compounding pharmacy through drug product
testing pursuant to acceptable practice standards; by published peer
reviewed pharmaceutical literature that have been critically reviewed
by unbiased independent experts; or in compliance with requirements
in the current edition of an official compendium, such as the "United
States Pharmacopoeia/National Formulary".
(2) Beyond use dates for sterile compounded preparations shall be
determined by the compounding pharmacy through drug product
testing pursuant to acceptable practice standards or shall be based on
the following "United States Pharmacopoeia/National Formulary"
standards:
(a) Low risk level compounded drug preparations shall be assigned a
beyond use date of not more than forty-eight hours when stored
at controlled room temperature at twenty to twenty-five degrees
celsius, or fourteen days when refrigerated at two to eight
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(b) Medium risk level compounded drug preparations shall be
assigned a beyond use date of not more than thirty hours when
stored at controlled room temperature at twenty to twenty-five
degrees celsius, or nine days when refrigerated at two to eight Compounding in Ohio
Page 4 of 5 rev 9/12
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(c) High risk level compounded drug preparations shall be assigned
a beyond use date of not more than twenty-four hours when
stored at controlled room temperature at, twenty to twenty-five
degrees celsius, or three days when refrigerated at two to eight
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(F) The labeling of a compounded drug preparation must contain the
following:
(1)  The statement "For direct patient administration only" displayed
prominently;
(2)  The statement "Not for resale" displayed prominently;
(3)  Proper storage conditions;
(4)  Beyond use dates pursuant to paragraph (E) of this rule;
(5)  The name(s) of the active and inactive ingredients;
(6)  The amount or percentage of active drug ingredients;
(7)  The quantity of compounded drug provided;
(8)  The route of administration;
(9)  The pharmacy name, address, and telephone number;
(10) The pharmacy control number assigned to the compounded drug
preparation.
(G) Compounded drug preparation containers that are too small to bear a
complete label pursuant to paragraph (F) of this rule must bear a label
that contains at least the following information:
(1) "Not for resale";
(2) The storage conditions if other than room temperature;
(3) The beyond use date;
(4) The drug name(s);
(5) The drug strength;
(6) The route of administration;
(7) The pharmacy control number;
(8) The pharmacy name.
In all cases, a complete label meeting the requirements of paragraph (F)
of this rule must be applied to the outside container in which such
compounded preparation is supplied.
(H) The sale of a compounded drug preparation to a prescriber is
considered a wholesale sale as defined in section 4729.01 of the
Revised Code. A pharmacy is required to follow the record keeping
requirements for wholesale sales listed in paragraph (H) of rule 4729-9-
16 of the Administrative Code.
(I) A pharmacy must follow the compounding requirements pursuant to
rules 4729-5-25 and 4729-9-21 of the Administrative Code, Chapter
4729-19 of the Administrative Code, current professional
compounding standards, and all applicable federal and state laws,
rules, and regulations.Compounding in Ohio
Page 5 of 5 rev 9/12
In addition, all prescriptions must be sent to the PATIENT
If you want to ship ANY patient specific medications to the prescriber rather than the patient,
you must have Board approval (specific to each prescriber office/pharmacy) prior to any such
shipment pursuant to
PRESCRIPTION PICK-UP STATION    OAC Rule 4729-5-10
Please review particularly:
(B)  No pharmacist shall dispense dangerous drugs to a place which offers, in
any manner, its services as a "pick-up station" or intermediary for the
purpose of having prescriptions filled or delivered unless such place is a
pharmacy as defined in section 4729.01 of the Revised Code, has
received board approval to function in such a manner, and paragraphs
(B)(1) to (B)(4) of this rule apply or, if not a pharmacy, unless all of the
following apply:
(1)  The site is appropriately licensed pursuant to Chapter 4729. of the
Revised Code.
(2)  The receipt, storage, control, and distribution of prescriptions or
drugs are in the full and actual charge of a health care professional
licensed pursuant to Chapter 4715., 4723., 4729., 4730., 4731., or
4741. of the Revised Code.
(3) An appropriate recordkeeping system is in place that will provide
accountability for proper receipt, delivery, and return of all
prescription medications.
(4) There is a documented method in place to ensure compliance with
rule 4729-5-22 of the Administrative Code.
(5) The state board of pharmacy has approved the site for such activity
due to clear and convincing evidence that delivery of prescription
medication directly to the patient would result in:
(a) Danger to public health or safety, or
(b) Danger to the patient without increased involvement by a health
care professional in the patient’s drug therapy.
If your special circumstance meets these criteria, you must request approval to ship to a
pick-up station rather than to the patient using the request form that is available on our
website

Ohio Board of Pharmacy Discusses Basic Differences Between Manufacturing and Compounding Under Its Rules

Manufacturing Versus Compounding: 
Basic Differences
Manufacturing and compounding are two very different 
practices that are regulated differently as well. Ohio recognizes and 
enforces federal law that states compounding 
is performed by a pharmacist in a pharmacy and pursuant to a 
patient-specific prescription (refer to 21 USCA 
353a). Manufacturing does not require a patient-specific 
prescription, but requires a manufacturing license from
FDA that enables the company to produce and sell manufactured medications 
(typically in bulk) again without a 
patient-specific prescription. To obtain an FDA manufacturing license, 
the manufacturing site must also pass 
stringent quality assurance standards (good manufacturing practice) 
designed to test manufacturing of sterile 
drug product. Thus, there is much more scrutiny placed 
on this type of practice (manufacturing) typically due to 
the large amounts of drug product being made for resale. 
Medication compounding, on the other hand, involves 
the practice of taking commercially available products 
and modifying them to meet the unique needs of an individual
 patient pursuant to a prescription from a licensed 
provider. Our state law defines compounding in Ohio 
Revised Code 4729.01(C). Also, a pharmacy must follow 
the compounding requirements pursuant to Ohio Administrative Code 
(OAC) Rules 4729-5-25, 4729-9-25, 4729-
9-21, and 4729-19; current professional compounding 
standards; and all applicable federal and state laws, rules, 
and regulations. As required by OAC 4729-19-04, for 
compounding sterile injectables, the Board would expect 
to see in your written policies and procedures adherence 
to United States Pharmacopeia (USP) Chapter 797 guidelines. 
These guidelines are differentiated by the severity/
risk of the type of products being compounded. The Board 
expects that you review and understand these guidelines 
to assess your practice prior to compounding sterile injectable
 prescriptions. For more information regarding 
the USP Chapter 797 compounding guidelines, visit www
.usp.org/store/products-services/usp-compounding. 
Compounding in Ohio does not require a special FDA 
manufacturing license and can be performed with no 
extra licenses other than those required by the Board 
for pharmacy practice (RPh license for the pharmacist 
to practice, a terminal distributor of dangerous drugs 
license for the location, and, if needed, a Drug Enforcement 
Administration license for controlled substances). 
No doubt, compounding is a legal and common practice 
in many Ohio pharmacies and brings incredible value to 
Ohio patients. However, make sure that your processes 
meet all standards for compounding and that you are not 
manufacturing as defined above. The Board has created 
a great compounding document for review, which can be 
accessed from the Board’s Web site at www.pharmacy
.ohio.gov. Click on the “Terminal Distributor (TDDD) Licenses”
 tab and then on the “Compounding in Ohio” link. 
Source found here

Ohio Board of Pharmacy Summary Suspension of NECC in October


New England Compounding Center
Update
As many of you know from the Board’s recent e-mail
blast, the Board announced the summary suspension of the
Ohio Terminal Distributor of Dangerous Drugs license for

the New England Compounding Center (NECC) located
in Framingham, MA, effective October 9, 2012.  The
Board has participated in discussions with the Ohio Department of Health
(ODH) and the investigation conducted by the Centers for Disease Control
and Prevention and
the United States Food and Drug Administration (FDA)
concerning NECC’s contaminated methylprednisolone
acetate injections. To date, these products have resulted
in a fungal meningitis outbreak that has affected people
in 19 states and caused 28 deaths nationwide. Prior to the
issuance of the summary suspension, the Board found that
there was clear and convincing evidence that the continuation of NECC’s
professional practice in Ohio presented
a danger of immediate and serious harm to others.
The contaminated methylprednisolone acetate injections were
administered to 425 people in Ohio. All of
these patients have been notified by ODH and as of this
writing, 14 Ohio patients have tested positive for the
fungal meningitis infection. To date, there have been no
deaths in Ohio from this contamination. It appears that
four clinics in Ohio received the affected methylprednisolone product.
These clinics were located in Cincinnati,
Columbus, and Marion, OH. The Board is additionally
conducting its own investigation. Due to the amount of
product that has been shipped from NECC into Ohio,
there is federal concern that NECC was manufacturing
products, not compounding medications.

Source found here




Sunday, October 28, 2012

Compounding pharmacies face greater scrutiny in Ohio


Staff Writer
Ohio is cracking down on pharmacies that custom-mix individualized prescriptions in the wake of a deadly fungal meningitis outbreak tied to a Massachusetts compounding pharmacy.
Statewide, 17 pharmacies are now specially designated as compounding sites, said Jesse L. Wimberly, spokesman and pharmacy inspector for the Ohio State Board of Pharmacy. Inspectors check pharmacies at least every three years, though they will go more often if complaints are filed or violations are reported. “Now we’re going to every one of these pharmacies that are designated for compounding,” he said.
The state now requires pharmacies to spell out how much of their business is strictly retail sales and how much is mixing up custom preparations, Wimberly said. And when a state inspector comes to call, they have to be able to demonstrate both that their facilities meet cleanliness standards set out by the U.S. Pharmacopoeia, a kind of governing board for pharmacists, and to show that their products are being prepared for specific patients — not mixed up in advance and set aside so it’s ready when and if the order comes in.
“The issue we’re having now is are you doing patient-specific compounding,” Wimberly said. “We don’t do manufacturing. We do compounding for specific patients. We check the records and make sure that they’re in compliance so that when you get a prescription it’s for a specific person and you’re compounding that prescription for that person and giving that prescription to that person,” he said.
Continue reading here

Sunday, June 3, 2012

Ohio: Case Against Elise Miller Who Operated Miller Pharmacy and Three Rivers


March 9, 2012

ELISE MILLER PLAINTIFF-APPELLANT
v.
OHIO STATE BOARD OF PHARMACY DEFENDANT-APPELLEE
Appeal from the Court of Common Pleas, Case No. 2011CI0050
The opinion of the court was delivered by: Farmer, J.
Cite as Miller v. Ohio State Bd. of Pharmacy,
CHARACTER OF PROCEEDING:
JUDGMENT:
DATE OF JUDGMENT:
JUDGES: Hon. Patricia A. Delaney, P.J. Hon. Sheila G. Farmer, J. Hon. John W. Wise, J.
OPINION
Affirmed
{¶1} Appellant, Elise Miller, became a licensed pharmacist in 1979. She owned and operated two pharmacies, Miller Pharmacy which was a retail pharmacy and Three Rivers which provided specialty infusion products. The pharmacies where right next to each other.
{¶2} In 2008, the FBI searched Three Rivers and seized many documents. Three Rivers went bankrupt and was closed by the bankruptcy trustee on April 1, 2009.
{¶3} In April and May of 2009, two investigators from the Ohio State Pharmacy Board, Louis Mandi and David Gallagher, conducted surprise inspections of the pharmacies. Pursuant to a letter from the Board dated March 10, 2010, appellant was charged with 23 counts of misbranding drugs, adulteration of drugs, and failure to keep accurate records. An administrative hearing before the Board was held on December 8, 2010. At the conclusion of the hearing, the Board revoked appellant's pharmacy license. The decision was made an official order on January 14, 2011.
{¶4} On January 28, 2011, appellant filed an appeal with the Court of Common Pleas of Coshocton County. By judgment entry filed June 17, 2011, the trial court affirmed the Board's decision.
{¶5} Appellant filed an appeal and this matter is now before this court for consideration. Assignments of error are as follows:
I
{¶6} "THE TRIAL COURT ERRED IN FAILING TO PROPERLY ADDRESS EACH ASSIGNMENT OF ERROR."
II
{¶7} "THE TRIAL COURT ERRED IN AFFIRMING THE BOARD'S CONCLUSIONS OF LAW, 2, 11, 13, 14 AND 18-24 AS TO WILLFULNESS."
III
{¶8} "THE TRIAL COURT ERRED IN SUMMARILY AFFIRMING THE BOARD'S FINDING NOS. 4, 5, 6 AND 14 AS THERE WAS NO EVIDENCE THAT THESE ITEMS WERE OFFERED FOR SALE AND MS. MILLER HAD ACCESS TO STATE AND FEDERAL DRUG LAWS."
IV
{¶9} "THE TRIAL COURT ERRED IN AFFIRMING THE BOARD'S ADMISSION OF IRRELEVANT HEARSAY EVIDENCE."
V
{¶10} "THE TRIAL COURT ERRED IN SUMMARILY AFFIRMING THE BOARD'S FINDING NO. 12 AS THERE WAS INSUFFICIENT EVIDENCE OF THE DISPENSING OF BACLOFEN AS LIORESAL."
VI
{¶11} "THE TRIAL COURT ERRED IN AFFIRMING THE BOARD'S REFUSAL TO PRODUCE ITS INVESTIGATIVE FILE AND ALL STATEMENTS PRIOR TO THE HEARING."
I
{¶12} Appellant claims the trial court erred in failing to address each of her assignments of error raised in her R.C. Chapter 119 appeal. We disagree.
{¶13} "In reviewing an administrative appeal, the common pleas court is not permitted to either try the issues de novo or substitute its own judgment for that of the administrative agency.***The role of the common pleas court in an administrative appeal is limited to determining whether the judgment of the administrative agency is support by reliable, probative and substantial evidence and is in accordance with law. See R.C. 119.12; see, also, Pons v. Ohio State Med. Bd. (1993), 66 Ohio St.3d 619, 621, 614 N.E.2d 748, 750-751; In re Williams (1991), 60 Ohio St.3d 85, 86, 573 N.E.2d 638, 639." Baughman v. Department of Public Safety Motor Vehicle Salvage (1997), 118 Ohio App.3d 564, 570. (Citations omitted.)
{¶14} "***'Reliable, probative and substantial evidence has been defined as: (1) "Reliable" evidence is dependable; that is, it can be confidently trusted. In order to be reliable, there must be a reasonable probability that the evidence is true. (2) "Probative" evidence is evidence that tends to prove the issue in question; it must be relevant in determining the issue. (3) "Substantial" evidence is evidence with some weight; it must have importance and value. Our Place, Inc. v. Ohio Liquor Control Comm. (1992), 63 Ohio St.3d 570, 571, 589 N.E.2d 1303.' " Vinci v. Ohio State Board of Pharmacy, Tuscarawas App. Nos. 2008 AP 08 0052 and 2008 AP 08 0053, 2010-Ohio-451, ¶85.
{¶15} Appellant argues the trial court is somehow required to follow App.R. 12(A)(1)(c) which states, "[u]nless an assignment of error is made moot by a ruling on another assignment of error, decide each assignment of error and give reasons in writing for its decision." However, trial courts are only required to address the standard of R.C. 119.12. Not only did the trial court sub judice address the evidence as being reliable, probative, and substantial to support the Board's findings, it also addressed evidentiary issues (hearsay) as well as the distinction between Miller Pharmacy and Three Rivers as raised in the appeal.
{¶16} Upon review, we find no necessity for the trial court to follow the Appellant Rules of Procedure.
{¶17} Assignment of Error I is denied.
II, III, V
{¶18} In these assignments, appellant claims the trial court erred in determining the Board's decision was supported by reliable, probative, and substantial evidence. We disagree.
{¶19} Specifically, appellant argues the Board's Findings of Fact Nos. 2, 11, 13, 14, and 18-24 were incorrect because there was no showing of willfulness, Findings of Fact Nos. 4, 5, 6, and 14 were incorrect because there was no showing that the mentioned items were offered for sale, and Findings of Fact No. 12, that she dispensed Baclofen as Lioresal, was not supported by sufficient evidence.
{¶20} " 'On appeal to this Court, the standard of review is more limited. Unlike the court of common pleas, a court of appeals does not determine the weight of the evidence. Rossford Exempted Village School Dist. Bd. of Edn. v. State Bd. of Edn. (1992), 63 Ohio St.3d 705, 707, 590 N.E.2d 1240. In reviewing the trial court's determination [whether] the Board of Review's order was supported by reliable, probative and substantial evidence, this Court's role is limited to determining whether the trial court abused its discretion. Roy v. Ohio State Med. Bd. (1992), 80 Ohio App.3d 675, 680, 610 N.E.2d 562. The term "abuse of discretion" connotes more than an error of law or judgment; it implies that the court's attitude is unreasonable, arbitrary or unconscionable. Blakemore v. Blakemore (1983), 5 Ohio St.3d 217, 219, 450 N.E.2d 1140.' Id. at ¶9, ¶10, 450 N.E.2d 1140. An abuse of discretion shows 'perversity of will, passion, prejudice, partiality, or moral delinquency.' Pons v. Ohio State Med. Bd. (1993), 66 Ohio St.3d 619, 621, 614 N.E.2d 748." Vinci, supra at ¶86.
{¶21} In Payne v. Vance (1921), 103 Ohio St. 59, paragraph three of the syllabus, the Supreme Court of Ohio held, "[w]illful tort involves the element of malice or ill will, but it is not necessary to show actual malice or ill will. It may be shown by indifference to the safety of others after knowledge of their danger, or failure after such knowledge to use ordinary care to avoid injury."
{¶22} Appellant argues no evidence was presented to establish that she willfully dispensed Kineret, a single-use product, into four different syringes, thereby reducing the effectiveness of the drug. See, Findings of Fact Nos. 2 and 11.
{¶23} It is uncontested from appellant's own testimony that she took the commercially packed dosages of Kineret containing 100 mg and repackaged the drug into 25 mg dosages as prescribed by a doctor for a juvenile patient. T. at 61-62. Appellant claimed this had been the practice since 2005 and it was approved by the doctor. T. at 63, 73, 75. However, documented proof of such approval of this method was not presented. Appellant claimed to have no records of the approval or the patient's chart because of the FBI search and confiscation of documents and the subsequent bankruptcy and sale of Three Rivers. T. at 75, 95. Appellant admitted to making dispensing errors. T. at 130, 290.
{¶24} The Board's compliance specialist, Louis Mandi, testified appellant's method was an inappropriate method. T. at 221-222. The single-use dosage can be administered in lesser amounts at the time of injection by injecting the drug into a sterile vial and then the prescribed amount can be removed by a syringe. T. at 222.
Appellant's method compromised the life of the drug from thirty days to four to six hours and exposed it to an unstable environment causing it to congeal or thicken. T. at 221.
{¶25} Appellant disregarded the original packaging and the standard procedures for dispensing the drug and did not have any supporting evidence of approval of her method. We find the trial court did not err in finding this procedure was willful.
{¶26} Appellant argues her failure to have her ID badge on and her failure to have the Drug Laws of Ohio book at hand in Miller Pharmacy was not willful. See, Findings of Fact Nos. 13 and 14. Appellant argued the items were next door at Three Rivers, but also argued she had no control over Three Rivers because the bankruptcy trustee was in control and had shut the place down on April 1, 2009. T. at 267-268. Although technical violations, they were nevertheless violations. These standing alone would not have precipitated the Board's actions, but were part of appellant's "house of cards" when she admitted her life was in chaos. T. at 270.
{¶27} Findings of Fact Nos. 18-24 cover the failure to properly record the dispensing of drugs and keeping patient profiles. Appellant admitted to these errors. T. at 269-272. She attempted to excuse them by arguing her life was in chaos, and she was a small town pharmacist who knew her physicians by voice and first name. T. at 270. She did not state she forgot, she just failed to do it properly. Although all of these claims may very well be true, they are no excuse for failing to comply with the Administrative Code and her own standard of care for her profession.
{¶28} Based upon appellant's admissions and the facts presented via the testimony of compliance specialists Mandi and Gallagher, we find the trial court was correct in concluding there was substantial credible evidence of willfulness.
{¶29} Findings of Fact Nos. 4, 5, and 6 found appellant misbranded drugs. The trial court found these findings were supported by reliable, probative, and substantial evidence. When Mr. Mandi first investigated Three Rivers in April of 2009, he found stored in the refrigerator several unmarked intravenous mixtures and containers that he could not identify. T. at 192-193. There were also unidentified syringes in the refrigerator. T. at 193. The drugs were misbranded because there were no labels on them. T. at 195-196; State's Exhibits 7 and 7a.
{¶30} Appellant was unable to tell Mr. Mandi what was in the containers. T. at 196. Appellant did not deny that they were unmarked, but claimed they were not offered for sale because Three Rivers was closed. T. at 267. This argument is disingenuous because Mr. Mandi and Mr. Gallagher observed activity and persons in Three Rivers at the time of their inspection, and appellant acknowledged compounding drugs there after April 1, 2009. T. at 27, 200-201, 205, 246, 280. We find sufficient evidence of on-going activity and use of Three Rivers after April 2009 to substantiate the fact that unbranded drugs were available for sale.
{¶31} Appellant argues there was insufficient evidence to establish that she was compounding Baclofen and labeling it Lioresal. See, Findings of Fact No. 12. As testified to by Mr. Mandi and admitted by appellant, if the brand drug is available (Lioresal) it is illegal to compound it from the generic (Baclofen) [R.C. 3715.52(A)(2)]. T. at 218-219. While not admitting to compounding Baclofen, appellant admitted it was done for those patients who needed more that the branded amount of 2000 mg; however she was unable to support this claim with prescriptions for those patients she claimed needed more than 2000 mg. T. at 34-35. 37-39, 65.
{¶32} Via the affidavits of Janet Myers who was a technician in the pharmacy in 2008 and Douglas Bolden who was a pharmacist until 2007, there was evidence that appellant oversaw the compounding of Baclofen and labeling it Lioresal. See, Exhibits 3 and 4. Further, Dr. Joseph Poole of the Mt. Vernon Developmental Center provided Mr. Mandi with information that the packaging of Lioresal received from appellant's pharmacy as late as May 13, 2009 was not labeled as the same as the branded Lioresal. T. at 197.
{¶33} Documents compiled by Mr. Mandi compared the purchase versus dispensing records of Lioresal from the pharmacy for 2008-2009. T. at 208-214; Exhibits 34 and 35. Even assuming some overstocking at the commencement of the analysis, the amounts dispensed far exceeded the amounts purchased. T. at 213, 228. This circumstantial evidence plus the direct evidence from Ms. Myers and Mr. Bolden more than substantiated the charge of illegally compounding Baclofen.
{¶34} Assignments of Error II, III, and V are denied.
IV
{¶35} Appellant claims the Board permitted irrelevant hearsay. We disagree.
{¶36} The complained of hearsay testimony consisted of the affidavits of Ms. Myers and Mr. Bolden, statements made by Nurse Busdiecker to Mr. Gallagher, and statements made by Dr. Poole to Mr. Mandi.
{¶37} At the outset, we note the Ohio Rules of Evidence are relaxed in administration proceedings. Simon v. Lake Geauga Printing Co. (1982), 69 Ohio St.2d
41. "Statements that would elsewhere be excluded as hearsay will be admissible in an administrative proceeding where they are not inherently unreliable, and may constitute reliable, probative, and substantial evidence." Vinci, supra at ¶118.
{¶38} Evid.R. 401 defines "relevant evidence" as, "evidence having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence."
{¶39} Each of the complained of statements provide evidence of the illegal compounding of Baclofen to Lioresal; therefore, they were clearly relevant to the issue at hand.
{¶40} Assignment of Error IV is denied. VI
{¶41} Appellant claims she was denied her right to discovery as any criminal defendant would be entitled to to prepare an adequate defense. We disagree.
{¶42} Appellant argues she was entitled to the investigation file that may or may not have included exculpatory evidence.
{¶43} "It is well settled that the Civil Rules pertaining to discovery do not apply to proceedings conducted pursuant to R.C. Chapter 119.12." Baughman, supra at 573; see also Yoder v. Ohio State Board of Education (1988), 40 Ohio App.3d 111. We conclude the same would be the case for the Criminal Rules of Procedure.
{¶44} The Board contends appellant was given every document and a witness list prior to the hearing.
{¶45} Upon review, we find the arguments herein lack merit.
{¶46} Assignment of Error VI is denied.
{¶47} The judgment of the Court of Common Pleas of Coshocton County, Ohio is hereby affirmed.
By Farmer, J.
Delaney, P.J. and Wise, J. concur.
_s/ Sheila G. Farmer_______________ _s/ Patricia A. Delaney_____________ _s/ John W. Wise_________________ JUDGES
[Cite as Miller v. Ohio State Bd. of Pharmacy, 2012-Ohio-1002.]
IN THE COURT OF APPEALS FOR COSHOCTON COUNTY, OHIO FIFTH APPELLATE DISTRICT
ELISE MILLER Plaintiff-Appellant -vs- : OHIO STATE BOARD OF PHARMACY Defendant-Appellee
JUDGMENT ENTRY
CASE NO. 11-CA-9
For the reasons stated in our accompanying Memorandum-Opinion, the judgment of the Court of Common Pleas of Coshocton County, Ohio is affirmed. Costs to appellant.
_s/ Sheila G. Farmer_______________ _s/ Patricia A. Delaney_____________ _s/ John W. Wise_________________ JUDGES
20120309
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