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

~~ FEBRUARY 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

 

Continuing Pharmacy Education Note

       The Ohio State Board of Pharmacy's annual Jurisprudence Quiz is included as part of this News­letter.  The questions in the quiz relate to the topics covered in this Newsletter as well as the May, August, and November 2002 issues.  If you need them, copies of the previous Newsletters can be found on the Board’s Web site at www.state.oh.us/pharmacy.

       Please note that, due to the changes in the Continuing Pharmacy Education (CPE) program out­lined below, the deadline for submission of the completed quiz has been changed to March 31, 2003.  Cer­tificates will be mailed out beginning April 1, 2003, so any answer sheets postmarked after March 31 will not be accepted for grading.

 

Continuing Pharmacy Education Reminder

       On February 1, 2002, the Board's rules on Continuing Pharmacy Education (CPE) changed. It is still necessary for pharmacists to report six continuing education units (CEUs) (60 hours) of CPE over a three-year reporting period, but the only required subject is 0.3 CEUs (three hours) of Board-approved juris­pru­dence. For those pharmacists whose license numbers begin with 03-3 and who report this year, it will be necessary to show 5.7 CEUs (57 hours) of CPE in any category (01, 02, 03, or 04) and 0.3 CEUs (three hours) in Board-approved jurisprudence. Remember that, as an alternative to the 57 hours, a pharmacist may submit proof of certification in a Board-approved pharmacy practice-specific specialty.

       In addition to changing the reporting requirements, the Board is also in the process of changing the time that CPE is reported by pharmacists. Due to the fact that we now are required to have an outside vendor handle our renewal forms and money instead of the State Treasurer's office, we are separating the CPE reporting from the pocket identification card renewals. Beginning in 2004 with those pharmacists whose license numbers begin with 03-1, pharmacists will be required to report their CPE during the spring, prior to the time for renewal of the pocket identification card. We are phasing in the earlier reporting time by making it voluntary for those pharmacists who report this year (03-3). It will be mandatory in 2004 (03-1). Those pharmacists who have to report CPE this year will receive a CPE report form along with a letter of explanation. If the CPE report form is returned to the Board office prior to May 15, 2003, the pharmacist pocket identification card renewal form will be sent without any CPE paperwork. Since the outside vendor will charge us for any extra paper that they have to handle, early reporting will help the Board save money. Our thanks go out to those pharma­cists who will meet the May 15, 2003 cutoff date. For those pharmacists who will report in 2004 (03-1), you will be required to report your CPE no later than May 15, 2004. For that reporting period, you will be able to use certificates dated on or after March 1, 2001, that were not used for the CPE reporting in 2001. Beginning in 2004, those who do not return the CPE report form by the required date will not receive a pharmacist renewal application until the CPE report form is received in the Board office.

 

What are Electronic Prescription Systems?

       Electronic prescription transmission systems allow prescriptions to be sent electronically from a pre­scriber to a pharmacy. The prescriber can send the prescription directly from his or her computer to a pharmacy computer or facsimile machine. Some of the systems are office-based, some are Web-based, and some use a switching station to route the prescription to the pharmacy. The office-based systems allow the prescriber to send a prescription electronically directly from his or her office to the pharmacy. The Web-based systems allow the prescriber to log onto a Web site, enter a prescription, and the Web site then sends the prescription to the pharmacy. Systems utilizing a switching station allow the prescriber to enter a prescription that is transmitted to a switching station. The switching station identifies the pre­scriber using specific data elements and then sends the prescription to the pharmacy.

       Prior approval by the Board of Pharmacy is required for all electronic prescription transmis­sion systems intended to be used in Ohio. The Board approval process includes ensuring that each system has true "positive identification" of the prescriber sending the prescription as defined in Rule 4729-5-01 (N) of the Ohio Administrative Code (OAC), that every system has security and account­ability of all confidential information, that the pharmacist receiving the prescription can identify that the sys­tem has approvable status with the Board of Pharmacy, and that the pharmacist receiving the prescrip­tion can verify that the prescription is legitimate.

       Some important information to know about electronic prescription transmission systems:

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No Schedule II controlled substances may be sent to a pharmacy using an electronic prescription transmission system.

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There can be multiple prescriptions, including controlled substances in Schedules III, IV, and V, issued on one prescription blank when using an electronic prescription transmission system to send a prescription to a pharmacy (see OAC Rule 4729-5-13).

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"Dispense as Written" or "DAW" does not have to be handwritten on a prescription sent through an electronic prescription transmission system (see Section 4729.38 of the Ohio Revised Code [ORC]). It does, however, require a positive action by the prescriber to physically select "Dispense as Written" or "DAW" when creating an electronic prescription. The electronic prescription trans­mission system cannot automatically default to "Dispense as Written" or "DAW."

¨

You may or may not see a signature on a prescription sent to a pharmacy by a prescriber using an electronic prescription transmission system. Computer-generated signatures are not recog­nized as a means of "positive identification" and, therefore, are not required. If a signa­ture is present, the prescription must indicate that the signature was computer-generated.

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A prescriber may elect to print a prescription from the electronic prescription transmission system in his or her office and give it to the patient to personally present it to a pharmacy. The prescription must be issued as per any written prescription (see OAC Rules 4729-5-30 and 4729-5-13). These pre­scriptions may contain a Schedule II controlled substance, there can only be one con­trolled sub­stance per prescription blank, "Dispense as Written" or "DAW" must be handwrit­ten, and the actual handwritten signature of the prescriber must be on the prescription.

       The systems that currently have obtained an approval status with the Board of Pharmacy are:

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Allscripts

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A4 Health Systems

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E-Physician

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Health Probe

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I-Scribe

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Medical Manager/WebMD

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Pocket Scripts

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RxMadeSimple

 

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 minutes, which are posted on the Board's Web site, then click on Board Minutes.

Orders of the Board:

    Bruce Michael Linnemann, RPh; Cincinnati - License revoked September 19, 2002.

Settlement Agreements:

    Arch Joseph Weber, RPh; Pickerington - License surrendered permanently November 4, 2002, and may not be employed by or work in a facility licensed by the Board.

Summary Suspensions:  [Sec. 3719.121 of the Revised Code]

    Robert C. Hershbine, RPh; North Royalton - Effective October 16, 2002.

    Lesley Zimmerman Kennedy, RPh; Cincinnati - Effective November 4, 2002.

    Anthony Kornokovich, RPh; Timberlake - Effective October 16, 2002.

 

 

 

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.

 

NABP Examination Security Group Detects FPGEE Security Breach, Halts Examination

       The National Association of Boards of Pharmacy® (NABP®) Examination Security Group recently discov­ered a security breach in the Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®) improperly caused by a group of FPGEE candidates. As a result of the breach, administration of the FPGEE has been halted as of November 19, 2002, until a new examination can be established. The Association will notify candidates in writing concerning future examination dates in early 2003.

       "Upon learning of this serious breach of security, NABP, in keeping with its responsibility of aiding the state boards in the protection of public safety and welfare, initiated a large-scale inves­ti­gation and will pursue all workable remedies to the fullest extent as permitted by law," states NABP President John A. Fiacco. "We deeply regret having to take such serious actions, but feel that it needs to be made clear to candidates that NABP does not tolerate such security breaches. We are also creating addi­tional security measures to protect against possible future breaches."

       Although all sources of the cause of the security breach have not been determined, NABP is work­ing to establish which scores have been compromised by the breach. Accordingly, NABP has been forced to take the following steps to protect the public health and welfare and ensure the integrity of its testing program:

 

1.

Computer-based FPGEE scores affected by the compromise will be invalidated.

2.

Foreign Pharmacy Graduate Examination Committee. (FPGEC®) certificates awarded to candidates who passed the exam affected by the compromise will be invalidated.

3.

All existing FPGEE appointments have been cancelled and no new appointments can be made at this time.

       This incident is isolated to the FPGEE and does not affect NABP's North American Pharma­cist Licensure Examination. (NAPLEX®), Multistate Pharmacy Jurisprudence Examination. (MPJE®), or Disease State Management (DSM) examinations.

       Candidates with questions may visit NABP's Web site at www.nabp.net for updated informa­tion or e-mail the Customer Service Department at custserv@nabp.net. Individuals without Internet access may contact NABP.s Customer Service Department at 847/698-6227.

 

FDA Approves Subutex, Suboxone to Treat Opiate Dependence

       The US Food and Drug Administration (FDA) announced on October 8, 2002, the approval of Subutex® and Suboxone® tablets for the treatment of opiate dependence. Both medications treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates. Based on the potential for abuse of the drugs, FDA and the Department of Health and Human Services recom­mended that Drug Enforcement Administration (DEA) place the active ingredient, buprenorphine, in Schedule III under the Controlled Sub­stances Act (CSA).

       These products represent two new formulations of buprenorphine and are supplied in 2 mg and 8 mg tablets that are placed under the tongue and must be allowed to dissolve. The first of these for­mulations, Subutex, contains only buprenorphine, and is in­tended for use at the beginning of treat­ment for drug abuse. The other, Suboxone, contains both buprenorphine and the opiate anta­gonist naloxone, and is intended to be the formulation used in maintenance treatment of opiate addiction. Naloxone guards against intravenous abuse of buprenorphine by individuals physically dependent on opiates.

       Subutex and Suboxone are the first narcotic drugs available for the treatment of opiate depend­ence that can be prescribed in an office setting under the Drug Addiction Treatment Act (DATA)  of 2000. Under this new law, medications for the treatment of opiate dependence that are subject to less restrictive con­trols than those of Schedule II can be prescribed in a doctor's office by specially trained physicians.

       The sponsor, Reckitt Benckiser Pharmaceuticals, in collaboration with FDA and with input from other Health and Human Services agencies, has developed a comprehensive risk-management program designed to deter abuse and diversion from its legitimate use in patients and physicians regarding proper use of these drugs, close monitoring of drug distribution channels, and child-resistant pack­aging.

       The risk-management program also provides for active and passive surveillance to identify if and when the drugs are being abused. The surveillance will include interviews with substance abusers, monitoring local drug markets, data collection, and the monitoring of adverse event reports. Reports of the results of these surveillance efforts will enable FDA to identify untoward effects from the avail­ability of buprenor­phine and, if indicated, to take appropriate actions to protect the public health.

       In addition, the provisions of the DATA include limits on the number of patients individual physi­cians are allowed to treat and a special DEA registration for the use of this drug, thus providing addi­tional safe­guards as this drug enters the office-based treatment setting.

 

USP Launches New Dietary Supplement Verification Program

       The United States Pharmacopeia (USP) announced the launch of its new Dietary Supplement Veri­fication Program (DSVP) that will help inform and guide pharmacists when recommending a dietary supplement.

 

       Currently, some dietary supplement products bear the USP initials that are placed on a label volun­tarily by a manufacturer. By placing the USP initials on a dietary supplement product’s label, a manu­fac­turer states that they have complied with USP standards for one or all of the following: strength and potency, dissolu­tion and disintegration, and purity, which are met by meeting a USP analytical mono­graph standard.

       DSVP is a program that manufacturers join voluntarily. Unlike the USP initials, the DSVP mark repre­sents that a participant’s product was submitted for review and meets USP's rigorous criteria. Under DSVP, USP evaluates and certifies dietary supplements according to stringent standards for purity, accuracy of ingredient labeling, and proper and sanitary manufacturing practices. The DSVP mark helps assure pharma­cists that the dietary supplements they recommend:

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Contain the ingredients stated on the label;

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Have the declared amount of strength of ingredients;

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Will dissolve effectively to release the contents of the dietary supplement for absorption into the body;

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Was tested for harmful contaminants such as heavy metals, E. coli, and pesticides; and

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Have been manufactured using safe, sanitary, and well-controlled procedures.

       Once a product has been certified, USP will periodically conduct random off-the-shelf tests on verified products to ensure they continue to meet DSVP's strict standards. USP also will continue to conduct audits of manufacturer sites for compliance with DSVP requirements.

       Dietary supplement products bearing the DSVP mark began to appear on retailer and pharmacy shelves in December 2002. Currently, several companies have joined DSVP: Pharmavite’s Nature Made, Weider Nutri­tion International Inc's Schiff brand of Move Free joint care products, and Inver­ness Medical Innova­tions.

       For a list of DSVP-certified products or for further information about DSVP, visit www.usp-dsvp.org.

 

Accutane Medication Guide Changes

       The updated version of the Accutane Medication Guide (MedGuide), distributed to pharmacists in early September 2002, is now printed on tan paper and replaces all other versions of the MedGuide. Pharmacists should discard all MedGuides printed on white, yellow, or green paper, and distribute only those printed on the tan paper. This Medication Guide for Accutane summarizes, in simple language, the professional pack­age insert, including the approved indication for Accutane and major adverse events reported in the pack­age insert. The revision to the MedGuide was developed in con­junction with the US Food and Drug Admini­stration (FDA), and replaces the MedGuide released in July 2002.

 

Misidentification of Alphanumeric Characters

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 (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.

       A potentially serious medication error was reported recently because a lower case "L" was the end letter in a drug name and was misread as the number 1. An order for 300 mg of TEGRETOL (carba­mazepine) BID was misinterpreted as 1300 mg BID. The letter "L" at the end of Tegretol had been written very close to the numerical dose of 300 mg on a prescription for the patient (Tegretol300 mg). The pharmacist was unfamiliar with the medication and the pharmacy computer system did not alert him that the dose exceeded safe limits. The patient received only one dose in error before another pharmacist caught the mistake and the patient was informed. The single dose made the patient lethargic, but not seriously toxic. It is not uncommon to read a letter or number differently than the writer intended. Recently, a pharmacist read the word "IODINE" in a space on a patient profile for allergy alerts. Yet, a second pharmacist read the allergy as "LODINE".

       Computerized physician order entry (CPOE) can overcome most problems with poor handwriting and, fortunately, use of such technology is growing. However, even typed or computerized physician orders may not help prevent all problems. Anyone familiar with e-mail knows how easy it is to mis­identify a computer-generated lower case letter L (l) in an e-mail address as the numeral one (1), or the letter O as a zero (0)! Even when using character recognition software, drug names may be translated incorrectly. For example, when we tested Lodine, typed with a lower case L, the software recognized the drug name as Iodine. Likewise, it's easy to confuse the upper case letter Z with the number 2. In fact, research con­ducted by Bell Laboratories found that some symbols are more vulnerable than others to misidentification (Nierenberg GI. Do it right the first time. New York: John Wiley and Sons 1996). The previously mentioned characters (I/1; O/0 and Z/2) plus the number 1, which can look like a 7, accounted for over 50% of the errors caused by character misidentification in the study.

       Adequate spacing between the drug name and the dose is crucial on prescriptions and electronic formats such as pharmacy computer selection screens, computer-generated medication labels and records, printed forms and communications, shelf labels, etc. For example, even a clearly typed order for 25 mcg of LEVOXYL (levothyroxine) could be misread as 125 mcg if it appears without proper spacing as Levoxyl25 mcg, especially since both strengths are available.

       Many drug name recognition errors can be reduced with block printing using upper case charac­ters. We’ve seen some prescription forms incorporate shaded blocks for this purpose. Pharmacists should encourage this style of writing and use of such forms. Symbolic differentiation is another way to distinc­tively convey a symbol's meaning. Throughout Europe, it's common to see a zero written with a slash through it to differentiate it from the letter "O." The number 7 can be written with a bar through it to prevent confusion with the number 1. The letter "Z" with a bar through it also can pre­vent confu­sion with the number 2. Stricter adherence to these principles would help reduce character misidenti­fication. The potential for name-related errors is greatly reduced when pharmaceutical manu­facturers incorporate practitioner testing of drug names and doses into their new drug develop­ment process. By using samples of cursive and printed characters practitioners can often recognize potential problems, which can help manufacturers avoid dangerous product names. Finally, the drug and dose have to make sense to the pharmacist; otherwise follow up with the prescriber is necessary. However, the con­text in which the order is being read may not always be helpful in properly identi­fy­ing alphanumeric characters. While it would be unlikely to read ZETAR as "2TAR," it would be easy to read an order for "HCTZ50mg" as either hydrocorti­sone 250 mg or hydrochloro­thiazide 50 mg (and yes, this has actually happened!). Avoiding drug name abbreviations is a subject we will tackle in the future.

 

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