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 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

 

 

Nursing Board To Begin Licensing APN Prescribers

Shortly after you receive this Newsletter, the Board of Nursing will begin licensing a large number of additional Advanced Practice Nurses (APNs) to prescribe.

As you know, there have been about 350 APNs prescribing under a trial program for the last few years.  As a result of HB 241 (from the 123rd General Assembly), which was signed by the governor on February 15, 2000, the trial program will be phased out over the next year, and any APN who meets the proper criteria will be able to be licensed to prescribe by the Board of Nursing.  In addition to the num­ber of prescribing APNs greatly increasing, the rules governing their prescribing have also changed from the rules in place for the trial program.  This article will attempt to outline the major changes, but it will certainly not be able to cover all of the possible contingencies that may occur during the imple­mentation of the new program.

Please also keep in mind that the collaborating physician may add additional limitations on the APN’s scope of prescribing privileges beyond the limitations placed by the master formulary.  It is the responsi­bility of both the physician and the APN to see that these additional limitations are followed.

Any questions that may come up regarding APN prescribing can be directed to the Board of Nurs­ing office at 614/466-3947 or to the Ohio State Board of Pharmacy office.  In addition, the Board of Nursing has assured us that it will maintain both the list of the APNs authorized to prescribe as well as a copy of the master formulary for APN prescribing on its Web site at www.state.oh.us/nur under the “Advanced Practice” box.  This should help you verify the licensure status of any APN prescription that you may receive.

Major Points to Remember with the New APN Law

1.

An APN must be licensed by the Board of Nursing to prescribe and have a special prescribing license issued in addition to his/her APN license.  Just because a person is licensed as an APN does not necessarily mean that person may prescribe.

2.

Any APN who prescribes is to be considered the prescriber of record for purposes of the pharmacy recordkeeping requirements.  It is not appropriate or legal to list the collaborating physician as the prescriber.

3.

Prescriptions may be issued by an APN in the same manner as those issued by a physician, including oral, fax, board-approved electronic transmission, and handwritten prescriptions.

4.

The prescribing APN is subject to the same restrictions that exist for the collaborating physi­cian.  If the collaborating physician happens to be a podiatrist, the APN may not prescribe out­side of the limits placed on the podiatrist for prescribing.  In addition, if the collaborating phy­sician has had limits placed on his/her license by the Medical Board or Drug Enforcement Administration (DEA) (eg, limits on controlled substance prescribing), then those same limits will apply to the APN, regardless of the content of the formulary with the collaborating physi­cian.

5.

Any APN who wishes to prescribe controlled substances must be registered with the DEA as a mid-level practitioner.  This means that the DEA number assigned will begin with the letter “M”, unlike physicians whose DEA number begins with the letter “A” or "B".  This is the DEA number that is required to be maintained to meet the recordkeeping requirements.  The physician’s DEA number is not the appropriate number to be maintained in your pharmacy computer sys­tem as the prescriber identification.

6.

Controlled substances in Schedules III-V that are included in the APN’s formulary may now be pre­scribed as needed for a legitimate medical purpose.  There will no longer be the 72-hour, one time restriction that applied during the trial program.

7.

Controlled substances in Schedule II may only be prescribed one time for no more than a 24-hour period to a terminally-ill patient who has previously been prescribed the Schedule II sub­stance by the collabor­ating physician.  (Note - Since a podiatrist should not be prescribing opiates for treatment of terminal cancer pain, this also means that an APN whose collaborat­ing physician is a podiatrist may not write any Schedule II prescriptions.)  Other than for this reason, Schedule II substances may not be prescribed by any APN.  In particular, please note that no APN may write for a prescription methylphenidate, Adderall, or any other Sched­ule II stimulant for any reason.

8.

The master formulary that will be listed on the Nursing Board’s Web site will be an exclu­sionary one rather than the listing of approved drugs that exists for the trial program.  In other words, it may specify that the APN may prescribe all antihypertensives except certain drugs; it may specify that the APN may prescribe all oral vitamins but no intravenous vita­mins.

9.

The APN may now possess and supply patients with non-controlled drug samples of pre­scrip­tion drugs included in his/her formulary as long as the quantity provided to the patient is lim­ited to a 72-hour supply (or smallest available size), and the sample is supplied free of charge.

10.

Other than the samples described above, the only prescription drugs that may be personally sup­plied to patients by an APN are drugs listed as antibiotics, antifungals, scabicides, contra­cep­tives, and prenatal vitamins that are included in his/her formulary and are furnished only from a licensed location operated by the Board of Health, a federally funded compre­hensive primary care clinic, or a nonprofit health care clinic or program.  In other words, unlike the trial program, an APN who is located somewhere other than those sites listed above may not per­son­ally supply any pre­scrip­tion drugs other than samples of prescription drugs that are included in his/her formulary.

11.

The Board of Nursing’s rules require that all prescribing APNs must list their prescribing license number on each prescription written.

Again, please note that APNs who are licensed by the Board of Nursing are legally entitled to pre­scribe certain drugs to their patients.  Prescriptions issued by these individuals are valid prescriptions and may be filled by pharmacists in the same manner that prescriptions issued by physicians are filled.

If you have any questions about the legitimacy of an APN prescription or the procedures to be fol­lowed when presented with such a prescription, please take the steps necessary to enable you to make an informed decision on whether or not to fill the prescription.  In these instances - as with all prescrip­tions - please always act in the best interest of the patient as you make your decisions.

 

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 following Web sites 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:

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 Internet at the Board's Web site (see address above), then click on the "Board Minutes" box.  If you have any questions, please feel free to contact the Board office directly.

State Medical Board:

A document of legal actions taken by the Medical Board may be accessed on the Internet at the Medical Board's Web site (see address above) then click on "Monthly Formal Actions."  If you would like a more detailed history of a legal action for an individual practitioner, go "Back" to the Medical Board's Web site, click on the "Licensee Profile & Status" tag, then follow the instructions.  Please contact the Medical Board if you have questions.

 

 

 

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.

 

CDER Drug Preparedness and Response to Bioterrorism Web Page

To help prepare the country for possible bioterrorism attacks, the US Food and Drug Administra­tion (FDA) is working with other federal agencies to ensure that adequate supplies of medicine and vaccines are available to the American public.  FDA's Center for Drug Evaluation and Research (CDER) created a Web site at www.fda.gov.cder/ that provides links to the most current information on drug therapy and vaccines, plus advice on purchasing and taking medication.

The site provides detailed information about Ciproâ, doxycycline, penicillin G, and the anthrax vaccine, frequently asked questions, and links to the US Department of Health and Human Services, the Centers for Disease Control and Prevention, and the National Library of Medicine Web sites.

 

DEA "Pharmacist's Manual" Available

The US Drug Enforcement Administration (DEA) announced that the Pharmacist's Manual, An Information Outline of the Controlled Substances Act of 1970 is available in print.  According to DEA, all field offices will be provided copies of the Pharmacist's Manual for distribution.  Pharmacists inter­ested in obtaining printed copies should contact their local DEA office.  Telephone numbers for DEA offices are on the DEA Diversion Control Web site at www.deadiversion.usdoj.gov under "Offices and Directories."  Requests for 200 or more copies can be submitted in writing to the Liaison Unit (ODLL), DEA, Washington, DC 20537.

The Pharmacist's Manual is also posted on the DEA's Web site in a PDF format.  The DEA plans to provide the Pharmacist's Manual on mini CD-Roms in the near future.

 

FDA Announces Changes to Accutane Pregnancy Risk Management Program

The Food and Drug Administration (FDA) recently announced significant changes to the Accu­taneâ risk management program for pregnancy prevention.  The new program, called S.M.A.R.T.ä (System to Manage Accutaneâ Related Teratogenicity), was developed in consultation with the FDA by Accutane's manu­fac­turer, Hoffmann-La Roche Inc.  The program is designed to enhance the safe and appropriate use of Accu­tane.

Detailed information about the program will be mailed to physicians, pharmacists, and 65,000 phar­ma­cies on January 2, 2002, and physicians, pharmacists, and patients must be in compliance with the pro­gram by April 10, 2002.

The S.M.A.R.T. program partners Accutane prescribers, patients, and pharmacists in an effort to pre­vent fetal exposure.  Specifically, the program requires the following:

¨

Prescribers must read the S.M.A.R.T. "Guide to Best Practices" provided by Roche, and then sign and return to Roche the Letter of Understanding documenting their knowledge of the measures to minimize fetal exposures to Accutane.  The manufacturer has also developed educational materials for prescribers and nurses.  Prescribers will then receive from Roche special yellow self-adhesive Accutane Qualification Stickers.  All prescriptions for Accutane should have the special yellow sticker attached to the prescriber's regular prescription form.  This sticker will in­di­cate to the phar­macist that the patient is "qualified" according to the new package insert, which means that the female patient has had negative pregnancy tests as indicated below, as well as education and counseling about pregnancy prevention.  The pregnancy test will be re­peated every month throughout the Accutane treatment course, and no prescriptions for more than a one-month supply of Accutane should be given at a time.

¨

All female patients must have two negative urine or serum pregnancy tests before the initial Accutane prescription is written, and for each month of therapy they must have a negative preg­nancy test result before receiving their next prescription, regardless of whether they are sexually active.  All female patients must also select and use two forms of effective contra­ception simul­taneously for at least one month prior to initiation of Accutane therapy, during therapy, and for one month following discontinuation of therapy unless they have had a hysterectomy or commit to absolute abstinence.  They must sign a Patient Information/­Consent form about Accutane and birth defects.  Finally, female patients must be given the opportunity to enroll in the Accutane Survey.  This confidential Survey, which has been going on for many years, collects data to help Roche and FDA decide if S.M.A.R.T. is helping to prevent exposure of unborn babies to Accu­tane.  Patients who agree to participate in the Survey will be making a major contribution to the public health.

¨

Pharmacists will dispense Accutane only upon presentation of a prescription with the special yel­low Accutane Qualification Sticker.  Pharmacists will dispense a maximum one-month supply of Accutane, fill prescriptions within seven days from the date of "qualification," and provide a Medi­ca­tion Guide for patients with each Accutane prescription.  Requests for refills (ie, more Accutane without a new prescription) or computerized or phoned-in prescriptions will not be filled.

To measure the effectiveness of the S.M.A.R.T. program, Roche will use several independent out­come assessment approaches.  These include the Accutane Survey, conducted by the Slone Epidemi­ology Unit of Boston University School of Public Health, and an independent audit of pharmacies to assess the use of Accutane Qualification Stickers by prescribers.  Prescribers, patients, and phar­ma­cists all must participate fully in these critically important measures to ensure that fetal exposure to this potent teratogen does not occur.

Exposure of an unborn baby to Accutane is a serious adverse event and should be reported to Roche or directly to the FDA MedWatch Program.  the contacts are as follows:  Roche Medical Services 1-800-526-6367 or FDA MedWatch Program 1-800/FDA-1088.  MedWatch can also be accessed via the Internet at www.fda.gov/medwatch/index.html.

 

Pharmacists and Pharmacy Technicians Unknowingly Provide Personal Information

to Data Collection Organizations

NABP recently learned of efforts by data collection organizations to collect personal information from pharmacists and pharmacy technicians.  in an effort to promote continuing education (CE) materials or professional journals, representatives of these organizations are apparently contacting pharmacies to verify or request the names of employees.  Some pharmacists and technicians have mistakenly assumed these calls are coming from the boards of pharmacy, believing the board is veri­fying the completion of required CE credits.  Most likely, these calls did not originate from the board of pharmacy office.  If a board contacts your pharmacy, board representatives will clearly identify them­selves as such.  In general, state boards do not contact licensees by phone to verify CE credits.

 

DEA Forms Available on Web Site

The US Drug Enforcement Administration (DEA) recently announced the availability of selected reports and applications required by the federal Controlled Substances Act on the DEA Web site at www.deadiversion.usdoj.gov.  The following forms are currently available:

 

DEA Form

Description

 

41

Registrants' Inventory of Drugs Surrendered

 

106

Report of Theft or Loss of Controlled Substance

 

161

Application for Permit to Export Controlled Substances

 

189

Application for Individual Manufacturing Quota

 

224A

Renewal Application for Registration - Retail

 

225

New Application for Registration - Wholesale

 

225A

Renewal Application for Registration - Wholesale

 

236

Controlled Substances Import/Export Declaration

 

250

Application for Procurement Quota for Controlled Substances

 

357

Application for Permit to Import Controlled Substances

 

363

New Application for Registration - Narcotic Treatment Program

 

363A

Renewal Application for Registration - Narcotic Treatment Program

 

486

Import/Export Declaration - Chemical

 

510

New Application for Registration - Chemical

 

510A

Renewal Application for Registration - Chemical

The forms are available in PDF format, so it will be necessary to have Adobe Acrobat or
Adobe Acrobat Reader installed on your computer.  Two versions of each form will be available:

1)

an interactive version, which will allow the user to complete the form online

and print it on his or her printer for signature and mailing; and

2)

a blank form, which can be printed and completed manually.

The DEA recommends completing the form online to reduce errors.

 

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