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

~~ M A Y 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

 

Reducing Medication Errors in Ohio

       The Ohio State Board of Pharmacy has joined forces with other state health care agencies, educa­tors, and professional organizations as the Patient Safety Discussion Forum (PSDF) to improve the health of all Ohioans. The PSDF has developed a new initiative titled Ohioans FiRXst that is aimed at reducing medica­tion errors and will be an umbrella for many other projects. The goal of the Ohioans FiRXst initial project is to modify the use of five dangerous abbreviations by 2005. The five abbrevia­tions include: using leading zeros (ie, use 0.5 mg, not .5 mg); removing terminal zeros (ie, use 1 mg, not 1.0 mg); and eliminating the use of “qd,” “U,” and “µg”. These last three should be spelled out in longhand (ie, every day, unit, and micro­gram).

       Please visit the Ohioans FiRXst Web site at www.ohioansfirst.org to obtain more information about the project. The Web site contains a tool kit, references, and links that can assist your organi­zation in eliminating dangerous abbreviations.

 

New Rule Changes Effective February 1, 2003

       As a result of the work done by last year’s Ad Hoc Committee on Rule Review, several of the Board of Pharmacy’s rules have been changed as of February 1, 2003. The full text of these rules may be found on the Board’s Web site, www.state.oh.us/pharmacy. Click on “What’s New,” and then click on the docu­ment titled “Rules Effective 02/01/2003 Showing Changes” to see the changes made by the committee and approved by the Board. This copy of the rules shows the additions and deletions so you can easily review the changes that were made. In addition, all of our rules may be seen by clicking on “Laws & Rules,” and then clicking on “Administrative Code Rules.” These are the final rules with the changes incor­porated.

       One of the most significant changes occurred to Rule 4729-5-30 (Manner of issuance of a pre­scrip­tion). Please note that it is now a requirement that all prescriptions bear the manually printed, typewritten, or pre-printed name of the prescriber and a telephone number where the prescriber can be reached dur­ing normal business hours. As all practicing pharmacists know, it is often difficult, if not impossible, to decipher a scrib­bled signature on a prescription blank. This change requires that the name be printed on the blank as well. Most prescribers already comply with this requirement, but there is a particular problem with prescriptions from urgent care centers and emergency rooms.

       Both the pharmacy and medical boards in Ohio have been concerned about the effect that legi­bility can have on the rate of medication errors. This is the first step in a joint effort by both Boards to address this concern. Please understand that these rule changes just took effect in February and that it will take a little while for all of the prescribers to come into compliance. Education of the prescribers is going to be an ongoing process for a while. Please take care of your patients and do not put them in the middle of the learning process for the prescribers.

 

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:

       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:

    James Murray Bayless, RPh; Fort Wright, KY – License reinstated October 4, 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 for five years.

    Dana Frances Casper, RPh; Waynesville – 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 October 21, 2002.

    Bonnie Jean Dolman, RPh; Columbus – May not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not dispense prescriptions for self or family members for 12 months effective December 5, 2002.

    Karen S. Frederick, RPh; Fremont – License suspended indefinitely effective November 12, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

    Elizabeth M. Hartranft, RPh; Bay Village – License suspended indefinitely effective February 6, 2003; May not be employed by or work in a facility licensed by the Board and may not hold any position in Pharmacists Rehabilitation Organization, Inc (PRO) or any treatment program while suspended.

    Todd R. Jaros, RPh; Westlake – License suspended indefinitely effective February 6, 2003; May not be employed by or work in a facility licensed by the Board and may not hold any position in PRO or any treatment program while suspended.

    Kinsman Pharmacy, TD; Kinsman – License revoked effective October 23, 2002.

    Michael Lee Lacy, RPh; Westerville – License revoked effective January 9, 2003.

    Frank A. Leon, RPh; Lorain – License suspended indefinitely effective September 19, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

    Dale E. Lewis, RPh; University Heights – 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 one year effective March 6, 2003.

    Gregory Scott Mills, RPh; Grove City – License suspended indefinitely effective March 6, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

    Betty Jean Minch, RPh; Massillon – May not work in a pharmacy more than 40 hours per week, may not serve as a preceptor or train pharmacy interns, and may not serve as a responsible pharmacist for two years effective September 19, 2002.

    Charles R. Mohr; Wadsworth – Accepted exam application effective December 5, 2002, for rein­state­ment of a revoked license, with conditions: Must work in a pharmacy 500 hours under pharmacist super­vi­sion before taking exams; 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.

    Thomas Allen Oswald, RPh; Wadsworth – License reinstated January 17, 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 January 9, 2003.

    David Angelo Pishotti, RPh; Warren – License reinstated August 5, 2002; May not serve as a preceptor or train pharmacy intern, may not serve as a responsible pharmacist, and may not destroy or witness the destruction of controlled substances for five years.

    Daniel Paul Ruth, RPh; Mountain View, Hawaii – License suspended indefinitely effective March 6, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

    Donald R. Sutton, RPh; Kinsman – License suspended indefinitely effective October 23, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

    Robert C. Sutton, RPh; Kinsman – License revoked effective October 23, 2002.

    John R. Tomko, RPh; Hubbard – License suspended indefinitely effective September 19, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

    Charles R. Willson, RPh; Berlin Center – License suspended indefinitely effective September 19, 2002, and may not be employed by or work in a facility licensed by the Board while suspended.

Settlement Agreement:

    Joseph Anthony Cusma, RPh; Massillon – License surrendered permanently effective January 6, 2003, and may not be employed by or work in a facility licensed by the Board.

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

    Curtis Lee Hull, RPh; Hilliard. Effective January 17, 2003.

    James M. Rosselit, RPh; Tipp City. Effective March 5, 2003.

    Thomas Allen Scott, RPh; Portsmouth. Effective January 7, 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 Releases Draft Guidance for Noncontraceptive Estrogen Drug Products

       On January 14, 2003, US Food and Drug Administration released a draft labeling guidance for noncon­traceptive estrogen drug products that treat moderate to severe vasomotor symptoms and/or moderate to severe symptoms of vulvar vaginal atrophy for new drug applications. The guidance also provides label­ing recommendations for the Patient Information leaflet.

       A draft of this guidance was first issued in September 1999 (64 FR 52100). However, on September 10, 2002, the Agency withdrew the draft guidance (67 FR 57432) pending consideration of the results from the National Institutes of Health Women’s Health Initiative. This second draft is being made available for com­ment.

       Copies of the draft guidance are available from the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Ln, Rockville, MD 20857; phone: 301/827-4573; Internet: www.fda.gov/cder/guidance/index.htm.

       Comments and suggestions regarding this draft document should be submitted within 60 days of pub­lication of the Federal Register notice announcing the availability of the draft guidance. Submit com­ments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Ln, Room 1061, Rock­ville, MD 20852. All comments should be identified with the docket number listed in the notice of avail­abil­ity published in the Federal Register. If you have questions on the content of the draft docu­ment, contact Margaret Kober at 301/827-4243.

 

NABP to Administer FPGEE in June

       The National Association of Boards of Pharmacy® (NABP®) is pleased to announce that the Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®) will be administered as a paper-and-pencil exam on Saturday, June 21, 2003, in four United States locations: Dallas, TX; New York, NY; Northlake (Chicago area), IL; and Oakland, CA. All FPGEE candidates who qualify to sit for the exam have been notified. In November 2002, The FPGEE was halted after NABP detected a security breach of the examination.

       Through its investigation proceedings, NABP found a small number of candidates whose scores were invalidated; all other scores were released. NABP member boards were notified of these invalidations.

       NABP continues to investigate all matters surrounding the breach of security and reserves the right to deny or revoke Foreign Pharmacy Graduate Examination Committee® certification should the circum­stances dictate. These actions are essential to maintain the integrity of the program for all participants.

       For more information on the FPGEE administration and answers to frequently asked questions, please visit the Association’s Web site at www.nabp.net.

 

CDER Releases Consumer Brochure Targeting Misuse of Prescription Pain Relievers

       The Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration recently released an informational brochure for consumers targeted at the misuse of prescription pain medication and symptoms of overdose. The brochure explains that prescription pain medication is safe and effective when used correctly and under a doctor’s supervision, but, when abused or mixed with alcohol or illegal drugs, one dose can lead to death. According to CDER, combining a prescription pain reliever with other prescription drugs (such as antidepressants) or over-the-counter medications (like cough syrups and anti­histamines), can lead to life-threatening respiratory failure.

       CDER outlines in Misuse of Prescription Pain Relievers: The Buzz Takes Your Breath Away. Permanently. that the most dangerous prescription pain relievers when used incorrectly are those containing drugs known as opioids, such as morphine and codeine. Some common drugs containing these substances include Dar­von, Demerol, Dilaudid, OxyContin, Tylenol with Codeine, and Vicodin.

       The brochures is available at www.fda.gov/cder/consumerinfo/buzz_brochure.htm.

 

Final Rules on Security Standards and Modifications to Electronic Data Transactions Standards and Code Sets Published

       Two Health Insurance Portability and Accountability Act (HIPAA) final regulations regarding Security Standards and Modifications to Electronic Data Transactions Standards and Code Sets were published in the February 20, 2003 Federal Register. The Final Rule adopting HIPAA standards for the security of elec­tronic health information specifies a series of administrative, technical, and physical security procedures for covered entities to use to ensure the confidentiality of electronic protected health information. The standards are delineated into either required or addressable implementation specifications. The Final Rule adopting changes to the HIPAA Electronic Transactions and Code Set Standards modifies a number of the electronic transactions and code sets adopted as national standards under HIPAA, and eliminates the National Drug Code (NDC) code set as the stan­dard for all providers except retail pharmacies. It does not adopt a standard reporting drugs and biologics on non-retail pharmacy transactions.

       Under the security standards, health insurers, certain health care providers, and health care clearing­houses must establish procedures and mechanisms to protect the confidentiality, integrity, and availability of electronic protected health information. The rule requires covered entities to implement administrative, physical, and technical safeguards to protect electronic protected health information in their care.

       The security standards work in concert with the final privacy standards adopted by the Depart­ment of Health and Human Services (HHS) last year and scheduled to take effect for most covered entities on April 14, 2003. The two sets of standards use many of the same terms and definitions in order to make it easier for covered entities to comply.

       Covered entities (except small health plans) must comply with the security standards by April 21, 2005. Small health plans have an additional year to comply.

       The final transaction modifications rule combines two proposed rules published May 31, 2002. HHS worked extensively with the Designated Standards Maintenance Organizations (DSMOs) to revise the proposed changes to the standards as required by Congress as part of HIPAA.

       Major provisions of the Final Rule include:

¨

Repealing the NDC as the standard medical data code set for reporting drugs and biologics in all non-retail pharmacy transactions.

¨

Adopting the proposed Addenda to the implementation guides with some technical revi­sions based upon comments received and consultation with the DSMOs.

¨

For retail pharmacy transactions:

·

Adopting the National Council for Prescription Drug Programs (NCPDP) Batch Version 1.1 to support the Telecommunications Version 5.1.

·

Adopting the Accredited Standards Committee X12N 835 as the standard for payment and remittance advice and the NCPDP Telecommunications Version 5.1 and NCPDP Batch Version 1.1. Implementation Guides as the standard for the referral certification and authorization transaction.

·

Continuing the use of the NDC code set for the reporting of drugs and biologics.

       The rule also adopts modified standards for two transactions that were not included in the pro­posed rules – premium payments, and coordination of benefits. The modifications were approved by the DMSOs and merely provide explanatory guidance.

       Copies of both rules can be viewed at www.cms.hhs.gov/hipaa/hipaa2/default.asp.

 

Warning! Repackaged Non-drug Substances May Easily be Confused with Medical Products

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.

       The Institute for Safe Medication Practices (ISMP) recently received a report where a pharmacist reconstituted AMOXIL (amoxicillin) suspension, 250 mg/5 mL, with an alcohol solution instead of distilled water. At the time of the error, the pharmacy stored plastic bottles containing a 50% alcohol and water solution (used for dermatological preparations) on a counter beside the distilled water bottle used for reconstituting antibiotic suspensions.

       Similar errors occurred elsewhere a few years ago in two pharmacies where antibiotic solutions were inadvertently reconstituted with 10% formalin solution (3%  formaldehyde and 15% methanol). In both cases, gallon jugs of distilled water were stocked for use in the pharmacy. The empty distilled water jugs were then used as containers for a 10% formalin solution that the pharmacy specially prepared for nearby surgical centers. Empty jugs labeled “distilled water” were accidentally placed with empty jugs labeled “formalin” that were awaiting refill for the surgical centers. After misfilling all the jugs with formalin, employees stored them for transport. When jugs labeled “distilled water” were delivered with the formalin jugs, they were returned to the pharmacy because the surgical center believed distilled water was sent in error. Assuming that the jugs were filled with distilled water, as they were labeled, pharmacy staff then placed them back in stock with other distilled water jugs. Later, each pharmacy accidentally used these mislabeled jugs to refill empty reservoirs intended for distilled water, which were attached to a burette chamber used to measure anti­biotic diluent. The burettes emptied at eye level and staff did not smell the formalin as it mixed with the powdered antibiotic suspensions. The errors went undetected until parents called to report the suspen­sions’ strange smell and their children’s complaints about the taste. Together, more than 35 children took the tainted antibiotics. Several required hospitalization for vomiting, but none suffered permanent dis­abili­ties.

       Could something similar happen at your practice site, perhaps with a different non-drug item? During visits to pharmacies and hospitals, we’ve often noticed soaps, topical substances, tissue fixatives, deter­gents, and even poisonous substances in bottles that look like drug containers. Who can say for sure that staff would never confuse one of these with an internal or external therapeutic product? Unfor­tun­ately, it has happened all too often, in both health care and other settings.

       Consider having a policy that forbids the practice of repackaging products in empty drug or solu­tion containers. Even go so far as to poke a hole in empty plastic containers to prevent reuse with another fluid. Perform a risk assessment at your pharmacy to determine if any chemicals could be confused with something else due to the container’s color, size, shape, the product’s name or pack­aging, or the solu­tion’s color/clarity, and take the necessary steps to reduce the risk of an error. Examine your current supply of chemicals and discard any that haven’t been used in years. For those that must remain, do not store them near other drugs or diluents. Make sure that labels clearly indicate the contents. Place bold warning labels on any non-drug products. Do not supply surgical centers with chemicals, which can be obtained more safely through health-related laboratory supply houses. Because non-clinicians (tech­nicians, support staff, etc) also may occasionally be involved in practices that lead to medication errors, allot time during staff meetings to review appropriate patient safety issues discovered within the facility or through information that you learn through our ISMP newsletters. For example, at an upcoming meeting, present the antibiotic suspension case described above. Be sure to include all personnel (clinical and non-clinical, pharmacy and non-pharmacy). Ex­plain why it is dangerous to repackage non-drug substances into empty drug, solution, or irrigation solution containers or to add non-drug substances to these con­tainers. And don’t give out any phar­macy bottles or labels to your patients because you do not know how they will be used.

 

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