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

~~ NOVEMBER 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

 

 

Advanced Practice Nurse Questions Keep Coming In

 

     We continue to get telephone calls in this office about the ability of advanced practice nurses (APNs) to prescribe.  If you have questions about the prescribing ability of certain APNs, please first review the State Board News article on this subject in the February 2002 Newsletter.  If you do not have a copy, you can find it on our Web site, www.state.oh.us/pharmacy, under the “CPE NEWS & S.B.N.” tab.  The February article will describe the basics of APN prescribing and should answer many of your ques­tions, thus saving you a telephone call.  This month’s article will attempt to answer some other APN prescribing questions that have come up since February.

     Question: What should I do if the APN does not have a DEA number and the insurance plan demands one for billing?

     Answer: You do the same thing when you have a prescribing APN without a US Drug Enforcement Administration (DEA) number that you would do with a prescription from an optometrist.  As you know, optometrists in Ohio may not prescribe controlled substances under any circumstances and, therefore, are not eligible for a DEA number.  If you want to help the patient get their prescription costs covered, some­one from the pharmacy can call the insurance plan and ask if it is possible to arrange for payment and, if so, how to properly bill for the prescription.  Please keep in mind that the insurance company may not tell you to violate any laws, rules, or regulations.  Your per­ma­nent records for the prescrip­tion, both hard-copy and electronic, must reflect that the APN is the pre­scriber and may not include any other DEA number in association with the APN.  That means, for example, that if the insurance com­pany tells you to bill under a particular doctor’s DEA number or to use a dummy DEA number, you can bill it as directed, but the final record in the computer must be accurate and must not have the wrong DEA number associated with the APN.  Some of the pharmacy systems will allow this kind of an edit on a prescription after it has been billed (but before it is dis­pensed) and some will not.

     Question: What should I do if the APN does not have provider status with an insurance plan, but one of the physicians in the office does?

     Answer: The answer to this question will vary from one insurance plan to another.  The process is similar to the one in the previous question.  Keep in mind that some insurance plans have a closed-panel policy (only plan prescriber prescriptions will be paid) and some plans have a more open-panel policy (under certain circumstances, non-plan prescriber prescriptions can be paid).  Whether you are dealing with an open-panel or a closed-panel plan, changing the name of the prescriber to a covered

prescriber’s name for billing purposes may constitute insurance fraud if it’s done without the know­ledge of the insurance plan.  It may also be illegal if you change the prescriber’s name without receiv­ing authori­za­tion from the new prescriber.  In addition, it may also violate the Board’s recordkeeping requirements and it may even create an illegal prescription, particularly if there is no valid doctor-patient relationship with the physician whose name ends up on the prescription.

     Wanting to help every patient is part of being a pharmacist.  With the wide variance in prescription coverage plans on the market, however, the bottom line is that the pharmacist may not be able to help every patient get every prescription covered.  Some of that responsibility has to fall back on the APNs and the insurance plans.  The pharmacist should not compromise his/her license by knowingly violat­ing the laws and rules in the State of Ohio.

 

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--1-800/230-6844, 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:

Erin R. Allen, RPh; Galloway – License placed on probation for 18 months effective May 13, 2002.  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.

Katherine R. Carson, RPh; Mentor – License suspended indefinitely effective May 13, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

Debra Lynn Cooper, RPh; Mansfield – see Debra Lynn Nign, RPh

Robert C. Ferguson, RPh; Wapakoneta – License revoked July 11, 2002.

Patrica Ann Flack, RPh; Springfield – License suspended indefinitely effective July 11, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

Michael M. Fraulini, RPh; Portsmouth – License suspended indefinitely effective July 11, 2002, and may not be employed by or work in a facility licensed by the Board and may not enter Sciotoville Rx while suspended.

Robert J. Garrity, RPh; Lakewood – License revoked May 13, 2002.

Michael Scott Gladieux, RPh; Perrysburg – License reinstated June 25, 2002; placed on proba­tion five years; May not serve as a preceptor or train pharmacy interns, serve as a responsible phar­ma­cist, or destroy or witness the destruction of controlled substances while on probation.

Vernon A. Infantino, RPh; Akron – License suspended indefinitely effective June 10, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

John H. Keyser, RPh; Cincinnati – License reinstated April 17, 2002; placed on probation five years with conditions: Must only work with another pharmacist present during the first year of pro­ba­tion; may not work in a pharmacy more than 44 hours per week for the first two years of pro­ba­tion; and may not serve as a preceptor or train pharmacy interns, serve as a respons­ible phar­ma­cist, or destroy or witness the destruction of controlled substances while on pro­bation.

Bradley R. Laboe, RPh; Maumee – License revoked June 10, 2002.

Michele M. Midlick, RPh; Columbus – License suspended indefinitely effective June 10, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

Mark Alan Moore, RPh; Riverside – License suspended indefinitely effective April 11, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

Debra Lynn Nign, RPh; Mansfield – License reinstated June 26, 2002; placed on probation five years; may not serve as a preceptor or train pharmacy interns, serve as a responsible pharma­cist, or destroy or witness the destruction of controlled substances while on probation.

Robert Frank Tschinkel, RPh; Hudson – License reinstated May 9, 2002; placed on probation five years with conditions: During the first two years of probation, may only work with another phar­ma­cist present and may not work in a pharmacy more than 44 hours per week; and may not serve as a preceptor or train pharmacy interns, serve as a responsible phar­ma­cist, or destroy or witness the destruction of controlled substances while on probation.

Dale R. Vaughn, RPh; Warren – License suspended indefinitely effective July 11, 2002, and may not be employed by or work in a facility licensed by the Board and may not enter Eastgate Phar­macy while suspended.

Settlement Agreements

Alvin Dorfman, RPh; Cincinnati – License surrendered permanently September 10, 2002.

PetMed Express, Inc., T.D.; Pompano Beach, FL – Placed on probation five years April 11, 2002, with conditions: (1) Agrees to abide by the laws and regulations of the states in which it prac­tices pharmacy and/or dispenses drugs pursuant to prescriptions; (2) When dis­pens­ing medi­cations into the state of Ohio, agrees to refrain from knowingly accepting pre­scrip­tions from veterinarians who have not physically examined the animal and, there­fore, estab­lished a legi­timate veterinarian/­client/patient relationship; and (3) Agrees to promptly disclose to the Ohio State Board of Phar­macy any disciplinary action taken or imposed by any governmental licensing authority.

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

Alan Patrick Horvath, RPh; Hilliard.  Effective August 8, 2002.

Bruce Michael Linnemann, RPh; Atlanta, GA.  Effective June 6, 2002.

Matthew Donavan Nourse, RPh; Lucasville.  Effective August 6, 2002.

Maynard D. Turner, RPh; Bloomingburg.  Effective September 10, 2002.

Corrections to the May 2002 Newsletter:

Mark Alan Moore, RPh; Riverside.  Effective January 9, 2002.

Crystal Edward White, RPh; Warrensville Heights.  Effective January 31, 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.

 

 

FDA Approves Xyrem for Cataplexy Using Centralized Distribution

 

     The US Food and Drug Administration (FDA) approved Xyrem (sodium oxybate or gamma hydroxy­butyrate, also known as GHB) for treating patients with narcolepsy who experience episodes of cata­plexy, a condition characterized by weak or paralyzed muscles.  Because of safety concerns associ­ated with the use of the drug, Xyrem will only be available through a restricted-distribution program.

     Under the Xyrem Success Program created by the drug’s manufacturer, Orphan Medical, Inc, and the FDA, prescribers and patients will be able to obtain the Schedule III controlled substance only through a single centralized pharmacy.  The pharmacy will send Xyrem to patients only after their doctors have pro­vided instruction on the safe and effective use of the drug and after the patients have read the infor­mation provided about the drug.  Physicians will also be urged to see their patients at least every three months and are also expected to report all serious adverse events to the manu­facturer by calling 1-866/Xyrem-88.  A Medication Guide, a special patient information brochure required by the FDA, further advises patients about proper use, administration, and disposal of the drug.  Patients who have further questions are advised to talk to their physician or to call the central phar­macy at the toll-free number.

     In the early 1990s, prior to development by Orphan Medical, GHB was marketed purporting to be a dietary supplement for enhancing athletic performance and sexual activity, and for inducing sleep.  It was also abused as a recreational drug and is well-known for use in date rape.  As a result of a num­ber of serious adverse events, including death, the FDA intervened to prohibit marketing of GHB.

 

Pharmacists to Play Key Role in Reintroduction of Lotronex® (alosetron hydrochloride) Tablets

 

     On June 7, 2002, the US Food and Drug Administration approved the Supplemental New Drug Appli­ca­tion (sNDA) for Lotronex.  This approval provides for the reintroduction of Lotronex under restricted conditions of use.  The restrictions include a Risk Management Program, the Prescribing Program for Lotronex™, which is a component of the Risk Management Program, a revised indication, and the rec­om­mended starting dose of 1 mg QD for four weeks.  These changes are reflective of the serious gas­tro­intestinal adverse events, some fatal, that have been reported with the use of Lotronex.

Revised Indication for Lotronex

     Lotronex is indicated only for women with severe diarrhea-predominant IBS who have failed to respond to conventional therapy, whose IBS symptoms are chronic (generally lasting six months or longer), and who have had other gastrointestinal medical conditions ruled out, which could have ex­plained their symptoms.  As described in the complete Prescribing Information, diarrhea-predominant IBS is severe if characterized by any of the following: (1) frequent and severe abdominal pain and dis­comfort; (2) frequent bowel urgency or fecal incontinence; or (3) restriction of daily activities due to IBS.  Less than 5% of IBS is considered severe.  Safety and effectiveness in men and patients under 18 years of age have not been established.

Prescribing Program for Lotronex and Follow-up Survey for Lotronex

     The Prescribing Program for Lotronex is similar to other restricted prescribing programs.  As part of the Risk Management Program, the Prescribing Program Sticker must be affixed by a physi­cian to all prescriptions for Lotronex (original and all subsequent prescriptions).  Telephone, fac­simile, or computer-generated prescriptions for Lotronex are not to be filled.  A Medication Guide must accom­pany every dispensed prescription.  Therefore, it is imperative that you dispense Lotronex in the original Retail Pack, which includes the Medication Guide for patients, Package Insert, Medicine, and Follow-Up Survey Enrollment Form.  This survey was created to monitor the Prescribing Program for Lotronex and how Lotronex is being used.

     Please consult the complete Prescribing Information and the educational resources available at www.lotronex.com or call 1-888/825-5249 for more information.  Lotronex is expected to be avail­able to patients before the end of the year.

 

Synthroid Receives FDA Approval

 

     The National Association of Boards of Pharmacy® (NABP®) has received a number of calls from patients and pharmacists regarding the availability and interchangeability of thyroid hormone replace­ment products.  Information recently released indicates the controversy surrounding one of the pre­scription thyroid replacement hormone products, Synthroid® (levothyroxine sodium tablets, USP), appears to be resolved.  Abbott Laboratories announced that it received US Food and Drug Admini­stration (FDA) approval of Synthroid for thyroid disease management as replacement or supplemental therapy for hypothyroidism and pituitary thyroid-stimulating hormone suppression.  The decision by the FDA follows Abbott’s submission of a New Drug Application (NDA) on August 1, 2001, and ends specu­lation that the medication would be phased out of production and ultimately removed from the market.

     In 1962, amendments to the Federal Food, Drug and Cosmetic Act required the submission of safety and efficacy data for all pharmaceuticals except those products marketed prior to 1938, a cate­gory into which Synthroid and several other thyroid products were a part.  For those products mar­keted before 1938, manufacturers had to submit such data only if the manufacturer changed product indica­tions or dosage form.  In 1997, the FDA declared levothyroxine products as new drugs and gave manu­facturers three years to submit NDAs for their products.

     Synthroid is the fourth levothyroxine product to receive FDA approval.  Unithroid™ (Jerome Stevens) was approved in August of 2000, Levoxyl® (Jones Pharma) in May of 2001, and Levo-T® (Mova) in March of 2002.  Forest Pharmaceuticals has submitted an NDA for its product, Levothroid®, and is awaiting approval.

     Levothyroxine products receiving approval pursuant to an NDA and listed in the FDA’s “Orange Book” with a BX rating are considered “drug products for which the data is insufficient to determine therapeutic equivalence.” Refer to your individual state pharmacy practice acts and regulations to determine drug product equivalence and interchangability.  In those states that consider the “Orange Book” authoritative, interchange without physician approval is prohibited.

 

New Packaging for Accutane

 

     All strengths of Accutane® (isotretinoin) will now be shipped to pharmacies in a new product blister package that encloses key S.M.A.R.T.™ (System to Manage Accutane Related Teratogenicity) educational program materials including the Medication Guide (MedGuide) and the Accutane Survey Enrollment Form.

     Pharmacies should continue to use their current supplies of Accutane and green MedGuides.  The current packaging continues to conform to US Food and Drug Administration regulations and there is no need to return the existing packages.

     The prescribing physician should continue to provide all necessary product information to the patient, including the S.M.A.R.T. educational materials containing the necessary consent form.  Pharma­cists should dispense Accutane only when the prescription bears a dated yellow Accutane Qualification Sticker, signal­ing that the prescriber has checked to make sure the female patient has had two negative pregnancy tests prior to beginning her Accutane therapy, does not become preg­nant during treatment or for one month after she stops taking the drug, and is using two forms of birth control simultane­ously.  Also, the sticker signifies that she has signed an informed consent about risk of potential birth defects and has been in­formed of the importance of participating in the Accu­tane Sur­vey.  Pharmacists should call 1-800/93-ROCHE with questions.

 

Ways to Prevent Dispensing Errors Linked to Name Confusion

 

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 US 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, and 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.

     Confusion between two products with similar names is one of the most common problems faced by health care practitioners.  Manufacturers and the FDA are working to review new trademarks for error potential prior to new product approval, but there are some things that practitioners should also be doing to help prevent errors.

¨

Look for the possibility of name confusion when a new drug reaches your pharmacy.  Have a few colleagues handwrite the product name and directions as they would appear in a typical pre­scription and ask everyone to view the samples of the written product name and pro­nounce it.  Determine if it looks or sounds like any other product or medical term.  If the poten­tial for confu­sion with other products is identified, take steps to avoid errors as listed below.

¨

Educate patients about the importance of having their physicians include the product’s indi­ca­tion on all prescriptions.  They will need to know this, but since problem name pairs rarely in­volve drugs that are used for the same purpose, this information can be important in clari­fy­ing any confusion.

¨

Accept telephone orders only when truly necessary.  Encourage staff to repeat back all orders, spell the product name, and state its indication.

¨

When feasible, use magnifying lenses and copyholders under good lighting to keep pre­scrip­tions and orders at eye level during transcription to improve the likelihood of proper inter­pre­ta­tion of look-alike product names.

¨

Change the appearance of look-alike product names on computer screens, pharmacy shelf labels, pharmacy product labels, and prescription records by highlighting, through bold face, color, and/or tall man letters, the parts of the names that are different (eg, hydrOXYzine, hydrALAzine).

¨

Install a computerized reminder (also placed on automated dispensing cabinet screens) for the most serious confusing name pairs so that an alert is generated when entering pre­scrip­tions for either drug.

¨

Affix “name alert” stickers to areas where look- or sound-alike products are stored (available from pharmacy label manufacturers).

¨

Store products with look- or sound-alike names in different locations.  Avoid storing both pro­ducts in the fast-mover area.  Use a shelf sticker to help locate the product that is moved.

¨

Continue to employ at least two independent checks in the dispensing process (one person inter­prets and enters the prescription into the computer and another reviews the printed label against the original prescription and the product).

¨

Open the prescription bottle or the unit dose package in front of the patient and invite them to confirm the expected appearance and review the indication.  Caution patients about error poten­tial when taking products that have a look- or sound-alike counterpart.  Take the time to fully inves­ti­gate the situation if a patient states he or she is taking a medication that is unknown.

¨

Encourage reporting of errors and potentially hazardous conditions with look- and sound-alike product names and use the information to establish priorities for error reduction.  Main­tain up-to-date awareness of problematic product names and error-prevention rec­om­men­da­tions pro­vided regularly by ISMP in our medication safety alert editions for acute care or com­mun­ity phar­macy prac­tice (www.ismp.org).

 

National Poison Control Number Available

 

     Consumers can now call a new toll-free hotline to reach poison treatment and prevention ex­perts 24 hours a day, seven days a week.  The new 1-800/222-1222 hotline allows consumers to call from anywhere in the United States and be connected seamlessly to pharmacists, nurses, and physicians at the nearest poison control center.  Local and statewide numbers remain active.

 

=\=\=\=\==/=/=/=/=