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

Tel: 614/466-4143                     Fax: 614/752-4836                  Eml:




~~ AUGUST 2002 ~~



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



Reminder - Please Read Your State Board News

The Ohio State Board of Pharmacy uses these quarterly Newsletters as one means to discuss practice issues, policies, rules, and other topics of interest to Ohio pharmacists and pharmacy in­terns licensed by the Board.  This Newsletter is considered an official communication from the Board.  State Board News items have been intro­duced as evidence in both criminal court pro­ceed­ings and admini­strative hearings to demonstrate that a pharmacist has acted contrary to the appro­priate stand­ards set by the Board.  These Newsletters are published every February, May, August, and November.  The National Pharmacy Compliance News section is also available on our Web site ( and on the National Association of Boards of Pharmacy® Web site at


Board Members Appointed

The Governor appointed Elizabeth I. Gregg, RPh, to the Board for a four-year term beginning July 1, 2002.  Betty is a pharmacist at Grant Hospital in Columbus, OH.  The Governor also reappointed Lawrence J. Kost, RPh, to his second term.  Board members may serve no more than two terms on the Board.  The current Board members and the expiration dates of their terms in office are listed below:


Diane C. Adelman, RPh, president, Beachwood, June 30, 2004


Robert P. Giacalone, RPh, vice president, Dublin, June 30, 2003


Gregory Braylock, RPh, member, Cleveland, June 30, 2005


Suzanne R. Eastman, RPh, member, Cincinnati, June 30, 2003


Elizabeth I. Gregg, RPh, member, Columbus, June 30, 2006


Lawrence J. Kost, RPh, member, North Royalton, June 30, 2006


Nathan S. Lipsyc, RPh, member, Cleveland, June 30, 2005


Dorothy S. Teater, public member, Columbus, June 30, 2004


James E. Turner, RPh, member, Ada June 30, 2004


Distribution of Potassium Iodide in Ohio

This article was submitted by Amy Bennett, RPh, assistant executive director of the Ohio Pharmacists Association.  Amy has been working with the Ohio Department of Health on this issue.  Please note that the potassium iodide used for this program is an over-the-counter strength, so no prescrip­tion should be needed.

Due to events of September 11 and recent federal legislation, a dispensing program for potas­sium iodide (KI) tablets is being implemented in Ohio in the event of a radiation accident.  The program in­volves distributing KI to populations within a 10-mile-radius of nuclear power plants, referred to as emergency planning zones (EPZs).  The EPZ of the Perry Nuclear Power Plant involves Lake, Geauga, and Ashtabula counties; the EPZ of the Davis-Bessie Nuclear Power Station includes residents in Ottawa and Lucas counties; and the EPZ of the Beaver Valley Nuclear Power Plant in Pennsylvania affects Colum­biana County and the city of East Liverpool.

This effort is supported by the US Nuclear Regulatory Commission (NRC), in coordination with the Ohio Department of Health, local health departments, local emergency management co­or­di­na­tors, other emergency personnel, and the Ohio Pharmacists Association.  A proposal is being dis­cussed about initially distributing KI through local pharmacies in the EPZs, with addi­tional supplies at the local health depart­ments.  Health professionals will be important sources of infor­ma­tion and key in quelling concerns and fears.

KI tablets have been requisitioned from the NRC for distribution to these populations to have on hand. In the event of a radiation emergency, the population will be directed to take the KI and evacu­ate the area.

General Information on KI

Potassium iodide prevents damage to the thyroid gland due to exposure to radioactive iodine.  The protective effects are not permanent; one dose protects for 24 hours.  Persons in the EPZ are at highest risk for exposure.  Evacuation from the area is critical.  KI needs to be taken immediately to have any benefit with exposure.  Currently, the Food and Drug Administration approved dose is 130 mg for adults and children over one year of age, and 65mg for children under the age of one.  How­ever, dos­ing guide­lines are currently under review.  KI should not be taken by those with allergies to iodine, and no longer than recommended due to potential for adverse effects.  It remains stable in its original package for sev­eral years, and is available over-the-counter.  However, it should be stressed that most people will not need it, and currently supplies are being directed through the federal gov­ernment.


Drug Laws of Ohio Updates Distributed

Updates to the Drug Laws of Ohio book were recently mailed out by West Group.  If this book is your method of complying with the Board's requirement that you maintain a current copy of state and federal laws, rules, and regulations relating to drugs, please verify that you have the April 2002 Ser­vice update inserted.  Please note that the update pages need to be inserted in the proper locations in the book in order to comply with the requirements of the Board's rule.  Having a pile of updates stacked on the shelf still in their original wrappers does not comply.  Board agents are required by Board policy to issue writ­ten warnings, "pink sheets," to pharma­cies who do not have a functional means of accessing current state and federal laws, rules, and regulations relating to drugs.


Drugs from Canada

The Board office has received numerous telephone calls from pharmacists and patients regarding the issue of importation of drugs from other countries, particularly Canada.  In fact, there are some busi­nesses that have been set up to assist patients by making arrangements with Canadian phar­ma­cies to have the US business transfer the patient's prescriptions to Canada where a Canadian physi­cian will rewrite the pre­scrip­tion and have the medications sent by mail directly to the patient (as you can see in Ohio Admini­strative Code Rule 4729-5-10 [Prescription pick-up station], this type of busi­ness is not legal).

Obviously, the driving force for this process is the difference in price between the two coun­tries.  In some cases, the same brand name drug made in the same production facility in the US can be pur­chased in Canada at a significant price difference.  Patients often feel they are in the position of choos­ing between basic life needs and medications.  One of the problems that can occur, how­ever, is that the drug in Canada that bears the same name as a drug in the US may not be made in the same facil­ity and it may not be made in a Food and Drug Administration(FDA)-approved facility.  In other words, patients may not be getting the drugs they think they are getting.  In addi­tion, there are several legal issues that patients should consider before they choose to use this option to obtain their prescription drugs:


Federal law in the United States appears to prohibit the importation of drugs from other coun­tries as documented in the following articles found on the FDA Web site: Importation of Pre­scription Medicines/Drugs (,  Coverage of Per­son­al Importations (,  and Infor­ma­tion on Importation of Drugs Prepared by the Division of Import Operations and Policy, FDA (


Ohio law prohibits the shipment of prescription drugs by anyone to patients in Ohio unless the shipper is licensed by the Board (Ohio Revised Code Section 4729.551).


Furthermore, at least in Ontario, Canadian physicians are prohibited from issuing pre­scrip­tions without doing a physical assessment, making a diagnosis, etc. (similar to the Ohio Medi­cal Board's rule for Ohio physicians found at 4731-11-09 in the Ohio Administrative Code).

Please keep in mind that these legal issues may change at any time.  It should be no surprise to anyone that this is a very hot political issue for both of the major political parties and will certainly be the subject of tremendous debate during the upcoming elections.  Congress and the Ohio legislature have both debated numerous bills dealing with this issue and the issue of US pharmacies importing drugs from wholesalers outside of the country.


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,

State Medical Board--614/466-3934,

State Nursing Board--614/466-3947,

State Optometry Board--614/466-5115,

State Pharmacy Board--614/466-4143,

State Veterinary Medical Board--614/644-5281,

Drug Enforcement Administration--1-800/230-6844,

State Pharmacy Board

Due to space limitations with this Newsletter, recent Pharmacy Board disciplinary actions will not be listed until the next issue.  All actions may be seen in the Board's meeting minutes, which are posted on the Board's home page (see address above), then click on the "Board Minutes" box.  If you have any questions, please feel free to contact the Board office directly.




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.



Developments in the Office-Based Treatment of Narcotic Addiction;

DEA Proposes to Reschedule Buprenorphine

New legislation, together with new opioid treatment medications will for the first time permit phy­si­cians to prescribe certain opioid treatment medications to treat opiate addiction. These developments will generate new activities and responsibilities for pharmacists, as well as retail, institutional, and community pharmacies.

The Drug Addiction Treatment Act (DATA, P.L. 106-310) enacted in 2000 amends the Controlled Sub­stances Act (CSA) to allow qualified physicians to apply for waivers of the Narcotic Addiction Treat­ment Act and the CSA registration, so that they may dispense or prescribe certain Schedule III, IV, or V controlled narcotic substances specifically approved by the Food and Drug Administration (FDA) for narcotic addiction treatment. Although there are no FDA-approved narcotic treatment medications at this time, products are in the final stages of FDA review.

Importantly, DATA includes a preemption clause that stipulates that until October 2003, states may not preclude practitioners from dispensing/prescribing Schedule III, IV, or V, approved (for the treatment of opiate addiction) narcotic drugs, unless a state enacts new legislation during that time prohibiting dis­pens­ing of such drugs.

To be eligible for a waiver, qualified practitioners (physicians) must submit a written notification of intent to the Substance Abuse and Mental Health Services Administration  (SAMHSA), Center for Sub­stance Abuse Treatment (CSAT). The physicians must have a state license to practice medicine and a US Drug Enforcement Administration (DEA) registration to dispense controlled substances.  In the noti­fi­cation, physicians must certify that they will treat no more than 30 patients (individual or in group practice), and that they have the capacity to refer patients for ancillary services. In addition to these certifications, physicians must meet the following criteria to qualify for a waiver:


Subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties (ABMS), or;


Addiction certification from the American Society of Addiction Medicine (ASAM), or;


Subspecialty board certification in addiction medicine from the American Osteopathic Associa­tion (AOA), or;


With respect to the treatment and management of opiate-dependent patients, the physician has completed not less than eight hours of training provided by ASAM, the American Academy of Addiction Psychiatry, the American Medical Association, AOA, the American Psychiatric Associa­tion, or any other organization the Secretary of the Department of Health and Human Services (HHS) determines is appropriate for these purposes, or;


Participation as an investigator in one or more clinical trials leading to the approval of a nar­cotic drug in Schedule III, IV, or V for maintenance or detoxification treatment, as dem­on­strated by a statement submitted to the Secretary by the sponsor of such approved drug, or;


Other training or experience as the state medical licensing board (of the state in which the phy­sician will provide maintenance or detoxification treatment) considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients, or;


The physician has such other training or experience as the Secretary considers to dem­on­strate the ability of the physician to treat and manage opiate-dependent patients.

Additional information on DATA, including a Standard Notification form, may be found at  The Federation of State Medical Boards (FSMB) has developed Model Policy Guidelines for Opioid Addiction Treatment in the Medical Office. These guidelines may be refer­enced from the FSMB Web site at

Pharmacists have expressed an interest in obtaining additional information to help verify whether a physician has a valid waiver. CSAT is currently taking steps to assist pharmacists in veri­fying a phy­sician’s waiver status. Phar­macists will be able to access the SAMHSA Treatment Facility Locator at and access a list of physicians with waivers. Pharmacists may also contact the CSAT Buprenorphine Information Center at 866/BUP-CSAT, or via e-mail at

As an important related matter, the DEA published a proposed rule in the March 21, 2002 Federal Register that would reschedule buprenorphine from a Schedule V to a Schedule III narcotic. This DEA action is based upon a formal rescheduling recommendation by HHS. The DEA rescheduling proposal is based upon new information available since the initial scheduling review of buprenor­phine in the early 1980s. The rescheduling action, when finalized, will not affect the use of bupre­norphine pro­ducts approved by FDA for the treatment of opiate addiction. The notice states that FDA has issued approvable letters for two products and they are likely to receive final marketing approval in 2002.


FDA Warns Sellers of Nicotine Lollipops, Lip Balm to Discontinue Marketing Products

In an April 10, 2002 Talk Paper, the US Food and Drug Administration (FDA) announced that it issued warning letters to three pharmacies selling nicotine lollipops and/or nicotine lip balm over the Internet stating that the products are illegal and that sales of the products must be discontinued.

The FDA is concerned about the health risk associated with these products, which are promoted on the Internet sites as smoking cessation aides or to treat addiction. According to FDA, the lollipops and lip balms appear to be compounded or dispensed without a doctor’s prescription, contain a form of nicotine that is not used in FDA-approved smoking cessation products, and present a risk of accidental use by children because of their candy-like appearance.

The products cited in the letters include compounds incorporating nicotine salicylate, natural sweet­eners, and flavorings in a sugar-free base, compounded into 0.5 mg, 1 mg, 2 mg, and 4 mg dosages.

For more information, visit the FDA Web site at


DEA Final Rule Amends Comprehensive Methamphetamine Control Act of 1996

The US Drug Enforcement Administration (DEA) published a final rule in the March 28, 2002 Fed­eral Register amending its regulations to implement the requirements of the Comprehensive Metham­phetamine Control Act of 1996 (MCA) with respect to the regulation of pseudoephedrine, phenylpro­panolamine, and combination ephedrine drug products as List I chemicals, and the reporting of cer­tain transactions involving pseudoephedrine, phenylpropanolamine, and combination ephedrine drug pro­ducts. The rule became effec­tive April 29, 2002.

The MCA removed the previous exemption from regulation as List I chemicals, which had applied to pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products, making per­sons who distribute the products subject to the registration requirement. In addition, distributions, importations, and exportations of the products became subject to the existing chemical controls relating to regulated transactions, except in certain circumstances specified in the MCA. The MCA requires that reports be sub­mitted for certain distributions involving pseudoephedrine, phenylpropa­nolamine, and ephedrine (includ­ing drug products containing those chemicals) by Postal Service or private or commercial carrier to non­regu­lated persons.

This final rule amends the regulations to make them consistent with the language of the MCA and to establish specific procedures to be followed to satisfy the new reporting requirement.

For additional information about the final rule, contact Patricia M. Good, chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Tele­phone 202/307-7297. Or visit the US DEA Web site at


Beware of Erroneous Daily Oral Methotrexate Dosing

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 the 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 ( 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 Road, Huntingdon Valley, PA 19006. Phone: 215/947-7797. E-mail:

The perils of low-dose oral methotrexate are clearly evident in the dozens of fatalities reported in patients who have been prescribed this cytotoxic agent for alternative conditions. While methotrexate has a well-established role in oncology, increasingly it’s being used in low doses for immunomodu­lation in rheumatoid arthritis, asthma, psoriasis, inflammatory bowel disease, myasthenia gravis, and inflammatory myositis. Used for these purposes, it’s administered as a weekly dose. But mistakes have been all too frequent because relatively few medications are dosed in this manner and clinicians and patients are much more familiar with daily dosing of medications. For example, one patient died after he misunderstood the directions for use and took methotrexate 2.5 mg every 12 hours for six consecutive days, instead of 2.5 mg every 12 hours for three doses each week. Another patient died after he misread the directions on a prescription bottle and took 10 mg every “morning” instead of every “Monday.” Errors also have been reported with hospitalized patients. In one case, the physician had properly recorded that the patient had been taking methotrexate 7.5 mg weekly as an outpatient. But when he prescribed three 2.5 mg tablets weekly, it was transcribed incorrectly as three times daily. Upon transfer to another unit, the dose was transcribed incorrectly as three times a week. In each case the errors did not reach the patient because they were detected during pharmacy review of the order.

Similar errors have been reported overseas. For example, in Australia, one patient took extra doses of methotrexate as needed to relieve arthritic symptoms. Three elderly patients took the medication daily despite clearly written instructions to take it weekly. Two cases involved incorrect transcription of the dosing schedule with hospitalized patients. Three of the six patients died as a result of the errors.

Because of the number of fatalities from errors with oral methotrexate, clinicians should consider it a high alert medication. As such, there are several measures that can help reduce the risk of an error when oral methotrexate is prescribed:


Build alerts in electronic prescribing systems and pharmacy computers to warn clinicians whenever doses of oral methotrexate have been entered (and to remind staff to check the indication with the patient in a community pharmacy setting). Configure the systems to avoid defaulting to a daily dos­ing schedule.


Have a pharmacist conduct a prospective drug utilization review before dispensing oral metho­trex­ate to determine its indication for use, verify proper dosing, confirm the correct dosing schedule on medication administration records and prescription labels, ensure staff and patient education, and promote appropriate monitoring of the patient.


Establish a system that ensures outpatients receive counseling when picking up new prescrip­tions and refills (eg, mark the bag with a red flag to alert clerical staff that counseling is re­quired, not optional).


Provide patients with clear written instructions that name a specific day of the week for taking the tablet(s). When possible, avoid choosing Monday since it could be misread as “morning.” Prepare instructions in large print to assist elderly patients with poor eyesight.


Advise patients to contact their physician if they miss taking a dose. Tell them that a flare-up of the disease is unlikely with one missed dose.


Ensure that written drug information leaflets are given to patients and that they contain clear advice about the weekly dosage schedule, not a daily dosing schedule.


Explain to patients that taking extra doses is dangerous. Encourage feedback to ensure the patient understands the weekly dosing schedule and that the medication should not be used “as needed” for symptom control.


Solicit help from a responsible caregiver if the patient appears to have cognitive or severe sensory difficulties.


Prescribe the drug as a dose pack (eg, RHEUMATREX by Lederle), which helps to reinforce the weekly dosing schedule.