OHIO STATE BOARD OF PHARMACY; 77 S. HIGH STREET, ROOM 1702; COLUMBUS, OHIO 43215-6126
Tel: 614/466-4143 Fax: 614/752-4836 Email: email@example.com Web: www.pharmacy.ohio.gov
OHIO STATE BOARD OF PHARMACY NEWS
~~ MAY 2004 ~~
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, DPh - National News Editor & Executive Editor
Reneeta C. "Rene" Renganathan - Editorial Manager
State News Section
The Definitely Final CPE Reminder
In the February 2004 Newsletter, you were given the “Final CPE Reminder.” With this Newsletter, you get the definitely final reminder for those pharmacists whose license number begins with 03-1. This is the year for you to report your continuing pharmacy education (CPE). It is due in the Ohio State Board of Pharmacy office no later than May 15. If you have not received your CPE reporting form, either notify us at the Board office immediately so we can get you a replacement or use the CPE reporting form on the Board’s Web site under “Forms.” The Web site form can be filled out on your computer screen and then you can print it, sign it, and mail it to the Board office.
In addition, please be sure that you have the certificates in hand before you enter the number on the form. Every year, we have a few pharmacists who put numbers down before they receive their certificate from the CPE provider. Sometimes, that certificate then fails to arrive. Falsifying the CPE reporting form is not something the Board takes lightly. As long as you have the originals in your possession when you complete the reporting form, you should have no problem with this reporting period. If you fail to submit a CPE form in a timely manner, your renewal form will not be mailed to you until after your CPE reporting form is approved.
News About FDA Actions on Ephedra Products
Food and Drug Administration’s (FDA) Web site, www.fda.gov/oc/initiatives/ephedra/february2004/, contains the following information about FDA’s actions in removing ephedra-containing products from the market. On February 6, 2004, FDA published a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra). The rule was effective 60 days from publication (April 6, 2004). FDA’s final rule concluded that dietary supplements containing ephedrine alkaloids (ephedra) present an unreasonable risk of illness or injury under conditions of use suggested or recommended in the labeling, or if the labeling is silent, under ordinary conditions of use. Therefore, these dietary supplements are adulterated under Section 402(f)(l)(A) of the federal Food, Drug, and Cosmetic Act. The rule applies to all dietary supplements that contain a source of ephedrine alkaloids, such as ephedra, Ma huang, Sida cordifolia, and pinellia. Essentially, all currently marketed dietary supplements that contain ephedrine alkaloids will be affected by the rule. The scope of the rule does not pertain to traditional Chinese herbal remedies. It generally does not apply to products like herbal teas that are regulated as conventional foods. Ephedra is not Generally Recognized as Safe for foods and is not approved for use as a food additive. By the time this Newsletter arrives, the rule will have been in effect for about a month. Please verify that your pharmacy does not have any of the affected products still offered for sale.
Drug Repository Program
House Bill 221 from the last session of the General Assembly took effect in April. This bill changed the law to allow for the donation of previously dispensed prescription drugs to locations that would use them for treating patients who were unable to pay. The Board was required to make rules defining the repository program and these rules are available on the Board’s Web site. Click on “Laws and Rules,” then click on “Administrative Code Rules” to get to a listing of all of the Board’s rules. Chapter 4729-35 contains the rules that were written specifically for the repository program. Anyone who has an interest in participating, either by donating drugs or by dispensing them to patients who would otherwise be unable to afford them, should call the Board office with any questions they may have.
Please note that the rules do not allow drugs that have been in the final possession of the patient to be donated to this program. It is a shame that we have to have such a rule, but we cannot risk the potential public hazard of having patients receive tampered products or products that have not been stored correctly. Many pharmacists and patients will remember the Tylenol® tampering that occurred on the West Coast many years ago. Pharmacists, particularly those working in retail, need to understand this because they are the ones who will be dealing with the patients who bring in their leftover medications to be donated. Once medications have been dispensed to the patient and have left the pharmacy in the patient’s possession, they may not be returned for reuse.
USP Chapter 797: Pharmaceutical Compounding – Sterile Preps
The United States Pharmacopeia (USP) recently published a revision to its sterile product chapter that greatly expands its recommendations for processes and procedures under which sterile products are compounded. This revision addresses several topics in sterile product preparation including contamination risk levels, personnel training, clean rooms, and quality assurance. While these revisions are not revisions in laws or rules and, thus, are not enforceable by the Board the way laws and rules are, they are a realistic model for future pharmacy practice. The Board already has some rules dealing with the same topic. These rules, Chapter 4729-19 in the Administrative Code, are also available on our Web site. The Board’s rules, however, are in need of revision due to the USP’s new standards as well as the recent explosion in compounded sterile products, as has been previously discussed in these Newsletters. For that reason, these rules will be considered by the Board’s 2004 Ad Hoc Committee on Rule Review. While the Committee may not recommend and the Board may not adopt everything in USP Chapter 797, it will give serious consideration to the revised USP chapter as it considers its current rules. The results of the Board’s final determination will be available on the Board’s Web site by early fall 2004. The final rules will probably be effective by early 2005.
Reporting Thefts and Losses
Rule 4729-9-15 requires that prescribers, terminal distributors, and wholesale distributors report the theft or significant loss of any dangerous drug (including, but not limited to, controlled substances) to the Board of Pharmacy by telephone immediately. When a shortage is discovered or even if your suspicions are raised that this might be occurring, the Board of Pharmacy should be called right away by the person who discovers the problem. You might take a few moments to see if the problem is merely one of addition or subtraction, but do not wait for several days before reporting. Pharmacists should not expect Loss Prevention or Pharmacy Management to make the notification to the Board. They should, instead, do it personally.
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.dental.ohio.gov
State Medical Board--614/466-3934, www.med.ohio.gov
State Nursing Board--614/466-3947, www.nursing.ohio.gov
State Optometry Board--614/466-5115, www.optometry.ohio.gov
State Pharmacy Board--614/466-4143, www.pharmacy.ohio.gov
State Veterinary Medical Board--614/644-5281, www.ovmlb.ohio.gov
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 do 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:
Joseph E. Geiser, RPh; Milan, IN – License reinstated October 10, 2003; May not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy, assist in, or witness the destruction of controlled substances for five years.
Curtis Lee Hull, RPh; Hilliard – License permanently revoked effective January 7, 2004.
Vernon A. Infantino, RPh; Akron – License reinstated February 18, 2004; May not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy, assist in, or witness the destruction of controlled substances until February 5, 2009.
Linden Medical Pharmacy, Inc, Terminal Distributor; Columbus – License revoked effective December 11, 2003.
PSS World Medical, Inc, W.D.; Cincinnati – License renewal denied effective March 11, 2004.
Pauline M. Reed, RPh; Whitehouse – License permanently revoked effective February 5, 2004.
Kevin M. Riley, RPh; Kokomo, IN – License reinstated effective September 23, 2003; May not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not fill prescriptions for family members for two years.
Summary Suspensions: [Sec. 3719.121 of the Ohio Revised Code]
Donald Christopher Hart, RPh; Port Washington. Effective February 2, 2004.
Terrell L. Mundhenk, RPh; Centerville. Effective February 18, 2004.
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 Issues Final Rule Prohibiting the Sale of Dietary Supplements Containing Ephedra
On February 6, 2004, Food and Drug Administration (FDA) announced the issuance of a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra). “This FDA rule reflects what the scientific evidence shows – that ephedra poses an unreasonable risk to those that use it,” remarked United States Department of Health and Human Services Secretary Tommy G. Thompson.
In December 2003, FDA issued letters to manufacturers who market ephedra-containing supplements, informing them of this upcoming rule. FDA also urged consumers to stop using ephedra-containing dietary supplements immediately. The ephedra-containing dietary supplement has been shown to have adverse effects on the cardiovascular and central nervous system including high blood pressure, heart palpitations, tachycardia, stroke, and seizures. FDA has linked at least 155 deaths with the use of ephedra-containing dietary supplements.
For more information including a Web link to the final rule, visit the following Web site: www.fda.gov/bbs/topics/NEWS/2004/NEW01021.html
The final rule will be enforceable on April 12, 2004. Illinois, New York state, and California are the few states that already ban the sale of ephedra.
Online Resources for Drug Product Shortages
In recent years, pharmacists have become accustomed to encountering drug shortages and product discontinuances. Manufacturing difficulties, raw and bulk material unavailability, voluntary recalls, manufacturer production decisions, and natural disasters have been cited as some of the principal causes of drug product shortages.¹ These often unanticipated circumstances, may result in prescribers and pharmacists scrambling to find therapeutic alternatives in addition to causing a significant delay in treatment. There are resources, however, that allow pharmacists to take a proactive approach in addressing current and imminent drug shortages regardless of practice setting. In 2001, the American Society of Health-System Pharmacists® (ASHP®) Council on Administrative Affairs published guidelines to assist pharmacists in appropriately responding to drug shortages.¹ The guidelines promoted the development of a contingency plan that is comprised of three key phases: the assessment phase, the preparation phase, and the contingency phase. In the assessment phase, pharmacists estimate current inventory amounts, the duration of the shortage, and the potential consequences to patient care and costs. Next, the preparation phase involves finding therapeutic alternatives and communicating with prescribers, other relevant health care professionals, and patients. Also, the pharmacist may seek other reputable supply sources. Lastly, the contingency phase consists of assessing liability and budget considerations, which are often beyond the direct control of the pharmacist.
Not only is it important for pharmacists to develop contingency plans, but they must also stay abreast of information on drug shortages and discontinuances. Currently, Food and Drug Administration (FDA) requires that manufacturers provide six month’s notification only when discontinuing drugs that are “sole source products that are life-supporting, life-sustaining or for use in the prevention of a debilitating disease or condition.”² Because reporting of most drug shortages and product discontinuances by manufacturers to FDA is voluntary, pharmacists may find such information difficult to obtain. However, resources for such information are available.
FDA’s Center for Drug Evaluation and Research (CDER) Drug Product Shortage Web site is an online source for drug shortage information. FDA’s CDER Web site includes information pertaining to current drug shortages, resolved drug shortages, and drug discontinuances. While this online resource primarily focuses on shortages of medically necessary products (products used to prevent or treat serious or life-threatening diseases or medical conditions for which there is no other available source of that product, alternative drug, or therapy available as designated by the CDER), other products may be listed as well. FDA’s CDER Drug Product Shortage Web site can be accessed at www.fda.gov/cder/drug/shortages/default.htm. Drug shortage information may also be obtained by calling FDA at 301/827-9039.
Drug shortage information pertaining to biological products, including blood and vaccines, may be obtained by contacting FDA’s Center for Biologics Evaluation and Research by calling 1-800/835-4709. Additionally, CDC’s National Immunization Program also lists childhood and adolescent vaccine drug shortage information at the following Web site: www.cdc.gov/nip/news/shortages.
The ASHP’s Drug Product Shortages Management Resource Center is another online source that contains information on drugs with limited availability or that are no longer available, and provides links to other online drug shortage Web sites such as those for FDA and the Centers for Disease Control and Prevention (CDC). The site also provides a mechanism to report drug shortages via the online Drug Product Shortages Report Form. The site’s content is developed in conjunction with the University of Utah Drug Information Service. The ASHP Drug Product Shortages Management Resource Center can be accessed via the following Web site: www.ashp.org/shortage.
1. Mark S, Mark L. ASHP guidelines on managing drug product shortages. Am J Health-Syst Pharm. 2001; 58:1445-50.
2. FDA/CDER resources page. Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/drug/shortages/default.htm. Accessed December 4, 2003.
How to Overcome Drug Name Mix-ups
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: firstname.lastname@example.org.
Not a week goes by that we don’t hear about confusion between two products with similar names. For example, we recently learned about a handwritten prescription for the bronchodilator FORADIL (formoterol) that initially was misinterpreted as TORADOL (ketorolac). In another case, a patient told her doctor she was taking “Plaxil” but she was actually taking PLAVIX (clopidogrel). Her physician later misinterpreted “Plaxil” as PAXIL (paroxetine) and prescribed this medication for the patient, which caused several days of severe disorientation. With so many different products on the market, it is no wonder that clinicians and patients consistently report confusion. While manufacturers have an obligation to review new trademarks for error potential before use, there are some things that practitioners can do to help prevent errors with products that have look- or sound-alike names.
® Look for the possibility of name confusion when adding a new product to the pharmacy inventory or hospital formulary. Have a few clinicians hand write the product name and directions as they would appear in a typical prescription or hospital order. Ask your colleagues to view the samples of the written product name and pronounce it to determine if it looks or sounds like any other product or medical term. It may be helpful to have colleagues first look at the scripted product name to determine how they would interpret it before the actual product name is provided to them for pronunciation. Once the product name is known, practitioners may be less likely to see more familiar product names in the written samples. If the potential for confusion with other products is identified, take steps to avoid errors as listed below.
® Take every opportunity to teach physicians and your patients that prescriptions should clearly specify the dosage form, drug strength, and complete directions. Patients should insist that their doctors include the product’s indication on all prescriptions and on inpatient prn orders. With name pairs known to be problematic, we teach physicians to reduce the potential for confusion by writing prescriptions using both the brand and generic names. Listing both names on medication records and computer screens may also be helpful. Whenever possible, determine the purpose of the medication before dispensing or administering it. Many products with look- or sound-alike names are used for different purposes.
® Accept verbal or telephone orders only when truly necessary. Encourage staff to transcribe the prescription then read back all orders, spelling the product name (and stating the indication where appropriate). Reading back the prescription, rather than repeating back the prescription is important. It best assures that you’ve both heard and transcribed the prescription correctly.
® 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 and bins (including automated dispensing technology), pharmacy product labels, and medication administration 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. If possible, make the reminder auditory as well as visual.
® 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.
® Except for single-employee pharmacies, 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). Experienced pharmacy technicians can serve as one of the checks. Research shows that individuals who are detailed oriented (ie see the trees through the forest) may be able to detect name mix-ups more easily during the final verification process than people whose skills are more oriented to seeing the big picture (ie see the forest, not just the trees).
® Open the prescription bottle (we tell nurses to do this with the unit dose package in the hospital) in front of the patient to confirm the expected appearance and review the indication. Caution patients about error potential when taking products that have a look-alike or sound-alike counterpart. Take the time to fully investigate the situation if a patient states that he or she is taking a medication that is unknown (such as “Plavix” in the example above).
® Encourage confidential 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 awareness of problematic product names and error prevention recommendations provided by ISMP (www.ismp.org) and FDA (www.fda.gov).