State Board of Pharmacy; 77 South High Street, Room 1702; Columbus, Ohio 43215-6126

Tel: 614/466-4143                     Fax: 614/752-4836                  Eml: exec@bop.state.oh.us

 

 

OHIO STATE BOARD OF PHARMACY NEWS

~~ AUGUST 2003 ~~

 

 

The Ohio State Board of Pharmacy News is published by the Ohio State Board of Pharmacy and the National Association of Boards of Pharmacy Foundation, Inc. to promote voluntary compliance of pharmacy and drug law.  The opinions and views expressed in this publication do not necessarily reflect the official views, opinions, or policies of the Foundation or the Board unless expressly so stated.

William T. Winsley, MS, RPh - State News Editor

Carmen A. Catizone, MS, RPh - National News Editor & Executive Editor

Courtney M. Karzen - Editorial Manager

 

 

State News Section

 

 

ODH Announces Pharmaceutical Case Management Program

 

The Ohio Department of Health (ODH) and the Bureau for Children with Medical Handicaps (BCMH) recently announced the introduction of the Pharmaceutical Case Management (PCM) program. In this pro­gram, several pharmacists will be working in a collaborative practice setting with the man­aging pediatric pul­monologists for several children.  The goal of the program will be to assist in the patient care manage­ment of children with moderate to severe asthma.

 

The pharmacists will, for the most part, be working with the patients at the physicians’ practice sites.  These pharmacists will be able to bill directly for their services using a Health Care Financing Administration 1500 form and utilizing Current Procedural Terminology codes of either 99213 or 99214, depending on the nature of the services provided to the patient during the visit.

 

The process will be reviewed jointly by both the ODH and the Ohio Department of Job and Family Ser­vices (ODJFS) in concert with Ohio Northern University’s College of Pharmacy.  Designated sites where ser­vices are to be provided include the Childrens’ Hospitals in Akron, Cleveland, Dayton, and Toledo, as well as a private pharmacy in Youngstown.

 

The project involves a joint effort between three ODH bureaus: BCMH, the asthma program in the Bureau of Environmental Health, and the Bureau of Health Services Information.  The Ohio Medicaid program will contribute information for the project as well.

 

As this is the first program of its kind in Ohio, the ODH will be studying the ability to replicate such ser­vices at additional sites for strengthening the scope of care for participants enrolled in other govern­men­tal health plans.

 

Questions may be directed to the following people at ODH:

James Bryant, MD, Chief, BCMH ................................................................... 614/644-0663

Allen Nichol, PharmD

Pharmacist Consultant, BCMH ..................................................................... 614/466-6499

Barbara Hickcox, Asthma Coordinator, ODH ............................................... 614/466-1390

 

Pharmacy Board To Submit New Rules for Public Hearing

 

Watch the Ohio Board of Pharmacy’s Web site, www.state.oh.us/pharmacy, for proposed new and changed rules, including the proposed rules dealing with the Drug Repository Bill that becomes effec­tive early in 2004.  On the Web site, click on “What’s New” to find the proposed rules.  These rules will be posted on the Web site as soon as they are filed.  Please submit your comments to the Board office.

 

Disciplinary Actions

 

Anyone having a question regarding the license status of a particular practitioner, nurse, phar­ma­cist, pharmacy intern, or dangerous drug distributor in Ohio should contact the appropriate licens­ing board.  The Web sites listed below may include disciplinary actions for their respective licensees.

State Dental Board--614/466-2580, www.state.oh.us/den/

State Medical Board--614/466-3934, www.state.oh.us/med/

State Nursing Board--614/466-3947, www.state.oh.us/nur/

State Optometry Board--614/466-5115, www.state.oh.us/opt/

State Pharmacy Board--614/466-4143, www.state.oh.us/pharmacy/

State Veterinary Medical Board--614/644-5281, www.state.oh.us/ovmlb/

Drug Enforcement Administration--800/230-6844; www.deadiversion.usdoj.gov/

 

State Pharmacy Board

 

The disciplinary actions listed below include only those where the individual’s license to practice has been suspended, revoked, or restricted, and does not include any other actions taken by the Board.  All actions may be seen in the Board's meeting minutes posted on the Board's Web site under "Board Minutes."

 

Orders of the Board

 

Patty Jane Baxter, RPh; Austinburg – License reinstated June 13, 2003; First six months of prac­tice: May not work more than 25 hours per week and must work with a pharmacist whose license is in good standing; After six months, may not work full-time until an acceptable evaluation by her employer; Pro­bation five years effective June 5, 2003; May not serve as a preceptor or train phar­macy interns, may not serve as a responsible pharmacist, and may not destroy or witness the destruction of controlled substances while on probation.

 

Richard Allen Calendine, RPh; Sarasota, FL – License sus-  pended indefinitely effective April 9, 2003, and may not be   employed by or work in a facility licensed by the Board while suspended.

 

Ralph G. Homer, RPh; Olmsted Township – License reinstated April 25, 2003; May not serve as a pre­cep­tor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy or wit­ness the destruction of controlled substances for five years effective April 9, 2003.

 

Lesley Zimmerman Kennedy, RPh; Cincinnati – License suspended indefinitely effective April 9, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

 

Anthony Kornokovich, RPh; Timberlake – License suspended indefinitely effective May 15, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

 

John Christopher Leasure, RPh; Maumee – License suspended indefinitely effective May 15, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

 

Mark Alan Moore, RPh; Riverside – License reinstated June 9, 2003; may not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy or witness the destruction of controlled substances for five years effective June 5, 2003.

 

James Scott Patton, RPh; Bexley – License reinstated April 16, 2003; May not serve as a pre­cep­tor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy or witness the destruction of controlled substances for five years effective April 9, 2003.

 

James M. Rosselit, RPh; Tipp City – License suspended indefinitely effective May 15, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

 

Steven Martin Salo, RPh; Conneaut – License reinstated June 11, 2003; First six months of practice must work with a pharmacist whose license is in good standing; May not serve as a preceptor or train phar­macy interns, may not serve as a responsible pharmacist, and may not destroy or wit­ness the destruc­tion of controlled substances for five years effective May 15, 2003; Must notify all future employers of his past problems.

 

Nancy A. Womeldorph-Annarino, RPh; Newark – License suspended indefinitely effective April 9, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

 

Settlement Agreements

 

Donald Leroy Bennett, RPh; Westerville – Placed on probation for one year effective April 7, 2003; Will refrain from scheduling interns to perform duties that must only be performed by a phar­ma­cist unless properly supervised by a pharmacist as permitted by law and/or regulation.  [Corrected from the paper-edition of the State Board News]

 

Harold E. Fletcher, RPh; Columbus – May not serve as a preceptor or train pharmacy interns for five years effective May 12, 2003.

 

Bruce Elliott Franken, RPh; Columbus – License reinstated April 25, 2003; May not destroy or witness the destruction of controlled substances until April 7, 2008.

 

Audley D. Stevens, RPh; Conneautville, PA – License suspended for one year effective June 2, 2003; Upon reinstatement, may not serve as a preceptor or train pharmacy interns and may not serve as a responsible pharmacist.

 

Mary Ann Tallarico-Janning, Pharmacy Intern; Grove City – Placed on probation one year, license not in good standing; Probation continues if passes pharmacist licensure exam, then may not serve as a preceptor or train pharmacy interns and may not serve as a responsible pharmacist while on proba­tion.

 

David W. White, RPh; Cincinnati – License reinstated February 4, 2003; May not serve as a pre­ceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy, assist in, or witness the destruction of controlled substances for five years effective January 9, 2003; may be re­leased from restrictions after October 7, 2004, if he meets the conditions set by the Board.

 

Summary Suspensions  [Sec. 3719.121 of the Revised Code]

 

Douglas Edward Birkhimer, RPh; Columbus. Effective April 9, 2003.

 

Dennis Edward Chapin, RPh; Oxford. Effective May 20, 2003.

 

Todd C. Latour, RPh; Lebanon. Effective April 23, 2003.

 

 

 

National News Section

 

Applicability of the contents of articles in the National Pharmacy Compliance News to a particular state or juris­diction should not be assumed and can only be ascertained by examining the law of such state or jurisdiction.

 

FDA Issues Draft Guidance on Potassium Iodide Shelf Life Extenison

 

Food and Drug Administration (FDA) has issued a draft guidance entitled, “Guidance for Federal Agen­cies, and State and Local Governments – Potassium Iodide Tablets Shelf Life Extension,” on how to con­duct drug testing to determine the shelf life of stockpiled potassium iodide (KI) tablets.

 

A number of state and local governments maintain stockpiles of KI tablets for use in a radiation emergency involving the release of radioactive iodine.  Several states have asked FDA how to deter­mine whether stockpiled KI tablets have retained their original quality after passing the expira­tion date.  The methods listed in this guidance could verify the continued viability of these drugs when stored under controlled conditions.

 

FDA, working with other federal agencies and state and local governments that stockpile KI tab­lets for use in the event of a radiation emergency, is providing guidance on how to conduct shelf life test­ing and how to identify laboratories that are suitable for conducting shelf life extension testing.  The FDA draft guidance also provides information on how to notify holders of stockpiled KI tablets about changes in shelf life and how to distinguish stockpiled batches with different shelf lives.

 

FDA Proposes Labeling and Manufacturing Standards for All Dietary Supplements

 

On March 7, 2003, Food and Drug Administration (FDA) proposed a new regulation to require current good manufacturing practices (CGMPs) in the manufacturing, packing, and holding of dietary supplements.

 

The proposed rule includes requirements for designing and constructing physical plants, estab­lishing quality control procedures, and testing manufactured dietary ingredients and dietary supple­ments.  It also includes proposed requirements for maintaining records and for handling consumer complaints related to CGMPs.

 

According to FDA, in recent years, analyses of dietary supplements by a private sector laboratory sug­gest that a substantial number of dietary supplement products analyzed may not contain the amounts of dietary ingredients that would be expected to be found based on their product labels.  For example:

¨

Five of 18 soy and/or red clover-containing products were found to contain only 50% to 80% of the declared amounts of isoflavones.

¨

Of 25 probiotic products tested, eight contained less than 1% of the claimed number of live bacteria or the number of bacteria that would be expected to be found in such a product.

 

FDA has also encountered products being marketed that are not accurately labeled or contain con­tami­nants that should not be present or may be harmful.  For example:

¨

One firm recalled its dietary supplements that were contaminated with excessive amounts of lead, which may have posed a health risk to many consumers, especially children and women of childbearing age.

¨

Another firm recalled a niacin product after it received reports of nausea, vomiting, liver dam­age, and heart attack associated with the use of its product.  A dietary in­gre­di­ent manu­fac­tur­ing firm had mislabeled a bulk ingredient container that sub­se­quently was used by another firm in making a product that contained almost 10 times more niacin than the amount that may be safe.

 

This proposed regulation follows FDA’s consumer initiative announced last December and intended to improve the agency’s policies on providing information about health consequences of food and dietary supplements as well as increase enforcement efforts to prevent misleading health claims made by certain dietary supplement manufacturers.

 

Under the CGMP proposal, manufacturers would be required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements.  If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated.  Some product quality problems the CGMPs would help prevent include products that are superpotent or subpotent; that contain the wrong ingredient, a drug con­tami­nant, or other contaminants (eg, bacteria, pesticide, glass, and lead); that contain foreign material; and that are improperly packaged and mislabeled.

 

This proposal is intended to cover all types of dietary supplements.  However, to limit any dis­ruption for dietary supplements produced by small businesses, FDA is proposing a three-year phase in of a final rule for small businesses.  The proposal includes flexible standards that can evolve with improve­ments in the state of science, such as in validating tests for identity, purity, quality, strength, and com­position of dietary in­gre­di­ents.

 

FDA is soliciting comments from the public and industry on how this proposed regulation can best achieve the goals of promoting accurate labeling information and preventing adulteration with­out imposing unnecessary regulatory burdens.  Written comments will be received until 90 days after the date of pub­li­cation in the Federal Register and may be addressed to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Ln, Room 1061, Rockville, MD 20852.

 

Study Finds Dispensing Errors a National Problem

 

A national observational study of prescription dispensing accuracy and safety in 50 pharmacies re­cently published in the Journal of the American Pharmacists Association (JAPhA) found that dis­pens­ing errors are a problem on a national level.  The study found a rate of four errors per day in a pharmacy filling 250 prescriptions daily; an estimated 51.5 million errors occur during the filling of three billion prescriptions each year.

 

Data was collected by a team of observers between July 2000 and April 2001 from chain, in­de­pendent, and health-system pharmacies in six large United States cities.  An observing pharmacist was present in each pharmacy for one day with the goal of inspecting 100 prescriptions for dis­pens­ing errors (defined as any deviation from the prescriber’s order).  Overall, the dispensing accuracy rate was 98.3%, or 77 errors among 4,481 prescriptions.  Of the 77 identified errors, 6.5% (five) were judged to be clinically important.

 

Taking these results into consideration, the researchers hypothesize that the typical pharmacist will incorrectly fill two new prescriptions each day (based on a workload of 60 new prescriptions).  The most common errors that will occur is giving the wrong instructions for use, but may also include dispensing the wrong drug, wrong strength, or wrong quantity.  The complete study can be found in the March/April 2003 issue of the JAPhA.

 

Is Your Pharmacy in Danger of Missing the Point About Levothyroxine?

 

This column was prepared by the Institute for Safe Medication Practices (ISMP).  ISMP is an in­de­pend­ent nonprofit agency that works closely with US Pharmacopeia (USP) and Food and Drug Admini­stra­tion (FDA) in analyzing medi­ca­tion errors, near misses, and potentially hazardous conditions as re­ported by pharmacists and other prac­ti­tioners.  ISMP then makes appropriate contacts with com­pa­nies and regulators, gathers expert opinion about prevention measures, then publishes its rec­om­men­da­tions.  If you would like to report a problem confidentially to these or­gani­zations, go to the ISMP Web site (www.ismp.org) for links with USP, ISMP, and FDA.  Or call 1-800/23-ERROR to report directly to the USP-ISMP Medication Errors Reporting Program.  ISMP address: 1800 Byberry Rd, Huntingdon Valley, PA 19006. Phone: 215/947-7797. E-mail: ismpinfo@ismp.org.

 

Physician confusion about decimal point placement with levothyroxine doses is a commonly re­ported problem.  For example, we frequently hear about errors where prescribers have ordered levo­thyroxine 0.25 mg instead of the correct dose of 0.025 mg.  Imagine the consequences if an elderly woman with a cardiac condition accidentally received ten times the dose of levothyroxine that was intended?  Another source of error is related to converting the dose from micrograms to milli­grams.  Mathematical errors and decimal point misplacement have been reported often, especially if the con­version occurred mentally.  We have also heard about errors when converting oral therapy to IV doses in the hospital.  The bioavailability of oral products is only 50%, but it is 100% for IV doses.  Some­times the need to cut back on the IV dose goes unrecognized.

 

Because errors are so common with this drug, one pharmacist told us that his pharmacy set up their computer to alert whenever a 0.25 mg dose is entered.  When the warning appears, the correct dose almost always has been 0.025 mg.  Just days after he commented, the same pharmacist received an order for levothyroxine 0.75 mg PO daily.  Upon checking the patient’s drug history from a prior admission, he noticed that the patient had been taking 0.075 mg.  While someone with experience may realize that 0.75 mg is an excessive amount, orders for 0.25 mg could slip by more easily.  After all, levothyroxine is available in a 0.3 mg tablet strength, although Facts and Comparisons mentions that the dose for hypothyroidism rarely should exceed 0.2 mg.

 

Pharmacists must recognize the risks associated with dosing this product and provide feedback directly to prescribers if an excessive dose is suspected.  Avoid decimal points and dose conversions by encouraging prescribers to order the medication the same way that manufacturers express the dose – in micrograms, not milligrams.  Since levothyroxine has a half-life of around seven days, hos­pi­tal pharmacists should remind prescribers that it probably is unnecessary to change an oral dose to IV unless the patient is NPO for several weeks.  Program computer systems to alert if the dose exceeds 200 mcg (0.2 mg) daily.  Finally, consider shelf labels to remind staff to check, if higher doses are prescribed.

 

Beware of Mistaking Aripiprazole (ABILIFY) for a Proton Pump Inhibitor (PPI)

Aripiprazole is an antipsychotic agent used to treat schizophrenia, but potential name con­fu­sion with drugs in the proton pump inhibitor  class has been reported since FDA approved the drug last November.  The thought may arise because the drug’s generic name ends with “prazole,” which is simi­lar to the name stem used within the PPI class such as omeprazole (PRILOSEC), esomeprazole (NEXIUM), rabeprazole (ACIPHEX), lansoprazole (PREVACID), and pantoprazole (PROTONIX).  Also, dose ranges for Abilify (10-30 mg daily) are similar to PPIs, and Abilify is available in 10, 15, 20, and 30 mg tablets, which overlap with the 10-40 mg range of strengths available with PPIs.  The impor­tance of knowing indications, doses, and adverse effects of unfamiliar medications prior to order­ing, dis­pens­ing, or administering them cannot be under­stated.

 

Be MedWise Kit Now Available

 

To promote the wise use of over-the-counter (OTC) medicines, the National Council on Patient In­formation and Education (NCPIE) recently launched a nationwide consumer education campaign called Be MedWise.  The goal of the campaign is to ensure that consumers understand that OTC products are serious medicines that must be taken with care.

 

NCPIE, a coalition of consumer, health care professional, voluntary health, government, and in­dustry members, found evidence for the creation of such a campaign in a study by Harris Interactive®, which found that 59% of Americans use OTC medicines routinely, but only 34% can name the active ingredients in the products they are using.  The Be MedWise tool kit was designed to help health care providers, consumer and patient groups, professional organizations, and government agencies cor­rect this statistic.  The tool kit contains a news release; three informative columns or publication in­serts; a full-page public service print ad to be used as a flyer or poster; a brochure; logos; and special event ideas.  Many of these resources are available for download on www.bemedwise.org.

 

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