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
~~ AUGUST 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
Have You Received Your Pharmacist ID Card Renewal Form?
This year, for the first time, the Ohio State Board of Pharmacy did not send out renewal forms to pharmacists who failed to submit proof of continuing pharmaceutical education (CPE). If your license number begins with 03-1, you were required to submit your CPE form this year by May 15. If you failed to do so and still have not sent in your CPE form, you did not receive a renewal form. You must first complete your CPE requirement and then you will be given the opportunity to renew. In addition to all the reminders in prior Newsletters and license renewals over the last two years, those pharmacists who failed to meet the May 15, 2004 deadline for reporting their CPE were sent a reminder letter in June.
If your CPE has been cleared or you do not report CPE this year, you should have received a renewal form for your license. Remember, your current identification card expires on September 15, 2004. You must have the renewal form and payment in the Board office prior to that date or you may not continue to practice pharmacy in Ohio. If you have not received your renewal form, please contact the Board office immediately. If you have sent in your renewal form and payment, you may verify the receipt within a few days by looking up your record on the Board’s Web site (www.pharmacy.ohio.gov).
What Is a Valid Prescription?
The Board office gets frequent telephone calls from pharmacists who are trying to determine if a prescription is valid. That determination is required as part of the normal filling of each prescription presented due to the requirements of Rule 4729-5-30 in the Ohio Administrative Code as well as Section 1306.04 in the Code of Federal Regulations. Both state that a prescription, in order to be valid, must be issued for a legitimate medical purpose by a prescriber acting in the usual course of professional practice. The prescriber, of course, bears the responsibility to see that this requirement is met, but both state and federal rules require that the pharmacist who fills the prescription bears a “corresponding responsibility” with the prescriber, which means that the pharmacist is equally liable with the prescriber to make sure that the prescription is valid. A pharmacist who knows that a prescription is not valid but fills a prescription anyway is as guilty of violating the law as the prescriber who issued the prescription.
There are several things to keep in mind that may help a pharmacist make a determination on the validity of a prescription. Please remember that the practice of medicine and pharmacy does not always consist of clear-cut choices between right and wrong. That is the reason prescribers and pharmacists are required to make professional judgments for which they are held personally accountable. Failing to properly provide necessary care to a patient is as bad, if not worse, than accidentally filling a prescription that turns out to be false. In all cases, a pharmacist should always act in the best interests of the patient, keeping in mind that sometimes that means saying no. The remainder of this article will list points to be considered when a pharmacist is trying to determine if a prescription is valid.
1. Do you know the patient? What is the patient’s history? Is the history consistent with the medication being ordered? If you are not sure, ask the patient and, perhaps, the prescriber. The Health Insurance Portability and Accountability Act (HIPAA) is not an issue, no matter what the prescriber’s office may try to tell you. When you are presented with a prescription by the patient, you become a treatment provider under HIPAA and you may have access to the information you need to provide that treatment, including information from the prescriber.
2. Do you know the prescriber? What are the prescriber’s reputation, specialty, and usual practice? A physician may treat the whole patient, no matter what his/her specialty, but if a prescriber suddenly goes outside his/her normal practice, the pharmacist should be even more careful in the review process. There must be a valid prescriber-patient relationship in order for the prescription to be valid.
3. Does the prescriber individualize therapy or do all of the patients receive the same drug or drugs in the same, usually maximum, dose? Patients are individual and, therefore, their therapy should be as well. This is especially true for the use of opiates and other controlled substances. If a prescriber always prescribes the same two or three controlled substances in the same doses to all patients, the pharmacist may want to question the validity of the prescriptions. As everyone knows, the dose of an opiate needed to relieve chronic pain in one patient may be half (or double) the amount needed for another patient. When similar dosages are prescribed to everyone, there may be a problem.
4. Is it reasonable for the patient to be at your pharmacy and/or at the prescriber’s office? Most of the prescribers and pharmacists who have found themselves in trouble for false prescriptions were seeing a large number of patients who traveled great distances to receive drugs. While every doctor and pharmacist thinks he/she provides better care than anyone else, is it really reasonable to think that multiple patients have to drive from West Virginia or Kentucky (often in the same vehicle) to Akron to see a doctor and then drive to Columbus to fill the prescription? If the patient presenting the prescription is from a great distance away, the pharmacist should determine the reason he or she is presenting the prescription. Maybe the patient is on vacation, in which case the prescription may be valid. Other than vacations or seeing a legitimate specialist, a pharmacist should question the legitimacy of a prescription from a patient who lives far away. The pharmacist should certainly start to question the legitimacy when the second, third, and fourth patients from the same town walk in the pharmacy shortly after the first!
This article will continue with more issues to consider when filling a prescription in the next Newsletter. Please remember that there is no substitute for professional judgment when filling prescriptions. Always act in the best interests of your patients.
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 – 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 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 under “Board Minutes.”
Orders of the Board:
Melanie A. Beckemeyer, RPh; West Chester – License reinstated May 17, 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 for five years.
Johari Jamille Bradshaw, Pharmacy Intern; Cincinnati – License suspended indefinitely effective May 6, 2004, and may not be employed by or work in a facility licensed by the Board while suspended.
Dennis Edward Chapin, RPh; Oxford – License suspended indefinitely effective April 8, 2004, and may not be employed by or work in a facility licensed by the Board while suspended.
Nancy Lee Dawson, RPh; Uniontown – License suspended indefinitely effective April 8, 2004, and may not be employed by or work in a facility licensed by the Board while suspended.
Jennifer L. Linville, RPh; Olmsted Township – May only work in a hospital setting; may not dispense prescriptions for herself or for any family member; may not serve as a preceptor or train pharmacy interns; and may not serve as a responsible pharmacist for three years effective April 8, 2004.
Tim Ivan Miller, RPh; West Lafayette – License suspended indefinitely effective May 6, 2004, and may not be employed by or work in a facility licensed by the Board while suspended.
James Joseph Parsley, RPh; Wheelersburg – License suspended indefinitely effective May 6, 2004, and may not be employed by or work in a facility licensed by the Board while suspended.
B. Elise Miller, RPh; Coshocton – License suspended for six months effective April 5, 2004.
Paul Raptou, RPh; Youngstown – License permanently surrendered effective June 21, 2004.
Stephen Andrew Summers, RPh; Waynesville – 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 two years effective May 4, 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 Ephedra Supplements
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).
At the end of last year, FDA issued letters to manufacturers who market ephedra-containing supplements, informing them of the upcoming rule. FDA also urged consumers to stop using ephedra-containing dietary supplements immediately. Studies show that ephedra-containing dietary supplement have adverse effects on the cardiovascular and central nervous systems including high blood pressure, heart palpitations, tachycardia, stroke, and seizures. FDA has linked at least 155 deaths with the use of dietary supplements containing ephedra.
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 became enforceable on April 12, 2004. California, Illinois, and New York were the first states to ban the sale of ephedra.
DEA Issues Clarification of the Exemption of Sales of Pseudoephedrine and Phenylpropanolamine
In attempts to clarify existing laws and regulations regarding the over-the-counter (OTC) sale of pseudoephedrine and phenylpropanolamine, Drug Enforcement Administration (DEA) issued an interpretive rule this past January. This interpretive rule does not change any of DEA’s regulations, nor will it have an impact on individual retail customers of such products who have been purchasing them from retailers that have been properly following DEA’s regulations.
Specifically, the interpretive rule emphasizes that sales transactions of ordinary OTC pseudoephedrine and phenylpropanolamine products (“safe harbor” products) are exempt from being regulated transactions as long as each transaction is below the 9-gram threshold to an individual for legitimate medical use. Apparently, some retail distributors have misinterpreted current DEA regulations and believe that they may sell as much “safe harbor” pseudoephedrine and phenylpropanolamine to any person for any purpose as often as that person wishes to make a purchase. The DEA interpretative rule clearly dispels that belief.
Currently, retail distributors of ordinary OTC pseudoephedrine and phenylpropanolamine products are exempt from registering with DEA as a distributor of List I chemicals and complying with the record keeping and other regulatory requirements as long as individual transactions for legitimate personal medical use remain below the 9-gram threshold (in packages of not more than 3 grams).
To obtain more information, please visit DEA’s Diversion Control Program Web site, www.DEAdiversion.usdoj.gov.
Note: Although most products containing phenylpropanolamine were discontinued pursuant to the action of FDA in November 2000, there remains some legitimate veterinary uses for phenylpropanolamine that will ensure some level of its continued production and availability. Therefore, these products are subject to the existing DEA regulations and this interpretive rule.
DEA Introduces Pharmacy Theft Prevention Program
In response to increasing theft and armed robberies against pharmacies, DEA’s Office of Diversion Control has introduced the Pharmacy Theft Prevention Program. The program is based on a previous initiative that was developed during the late 1970s and early 1980s when there was a similar unprecedented spike in the occurrence of thefts and robberies against pharmacies.
The intent of the program is to provide education and increased communication to pharmacists and pharmacy staff to prevent pharmacy theft. The program includes collaboration with and participation from law enforcement, regulators including state pharmacy boards, state and federal prosecutors, the media, and the public along with the pharmacy community. The Pharmacy Theft Prevention Program will also provide a means to maximize the use of limited resources available to law enforcement to address, minimize, and eliminate pharmacy thefts in areas that experience such problems.
Staff members of the DEA’s Office of Diversion Control have begun a series of regional meetings to promote the program to DEA Diversion field elements, state pharmacy boards, and local pharmacy associations. To implement the program in your community, or to obtain more information regarding the program and its operation, call DEA Headquarters, Office of Diversion Control, Liaison and Policy Section, at 202/307-7297.
Concentrated Morphine Solutions and Serious Medication Errors
This column was prepared by the Institute for Safe Medication Practices (ISMP). ISMP is an independent nonprofit agency that works closely with United States Pharmacopeia (USP) and 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: firstname.lastname@example.org.
According to a recent newspaper report, a 91-year-old man being treated for a mild heart attack was mistakenly given a 100 mg dose of ROXANOL™ (concentrated morphine solution) instead of 5 mg as prescribed. The error may have contributed to the patient’s death the following day. Last fall, Elan Pharmaceuticals (the manufacturer of Roxanol at the time; aaiPharma recently acquired the product from Elan) issued a safety alert warning about deaths from accidental overdoses (www.fda.gov/medwatch/SAFETY/2003/roxanol.htm). Most overdoses involved morphine solutions that were mistakenly ordered, dispensed, and labeled by volume (mL), not milligrams. For example, in some cases, patients received 5 mL of Roxanol 20 mg/mL (100 mg) instead of the prescribed 5 mg. The newspaper report did not describe how this most recent error happened; however, it mentioned that Roxanol 100 mg had been given instead of 5 mg, pointing once again to the scenario described in the recent safety alert from Elan.
Several manufacturers distribute morphine solution in different formulations, primarily labeled (and listed in drug references) in mg/mL (eg, 20 mg/mL) or mg/5 mL (eg, 100 mg/5 mL, 20 mg/5 mL). When concentrated morphine is stored in pharmacies or in patient care areas in hospitals or long-term care facilities, it is often kept next to conventional concentrations. Thus, it is easy to confuse these products and dosage strengths. Also, some physicians have prescribed the medication in terms of mL instead of mg, which has led to errors because multiple concentrations exist. Because we continue to hear about these tragic overdoses, we make these recommendations to reduce the risk of errors with concentrated morphine products:
♦ If you consult with nursing homes or hospitals, avoid stocking concentrated morphine solutions in patient units when possible, including the emergency department. Keep in mind that the drug is used primarily to treat chronic pain.
♦ Dispense concentrated solutions only when ordered for specific patients who require higher-than-usual doses due to severe chronic pain.
♦ Affix an auxiliary label to the morphine concentrate bottle to warn about its high concentration and segregate the solution from the other concentrations.
♦ Working with local physicians, purchase and dispense concentrated solutions in dropper bottles (available from at least two manufacturers) to help prevent dose measurement errors and differentiate the concentrated product from the conventional products. For patients in hospitals or long-term care, dispense concentrated solutions in unit doses whenever possible.
♦ Educate others to never prescribe or dispense liquid medications without the dose specified in milligrams.
♦ Educate staff about the risk of morphine errors and develop guidelines to promote its safe use.
♦ Manufacturers should standardize the way strength is expressed on labels, preferably in terms of mg/mL for all forms. This would improve clarity when comparing product labels (eg, it is easier to differentiate 4 mg/mL and 20 mg/mL; harder to differentiate 20 mg/mL and 20 mg/5 mL).
Finally, we disagree with Elan’s suggestion in its recent safety alert for prescribers to include the desired concentration of morphine along with the patient’s dose in milligrams and the corresponding volume (eg, Roxanol 10 mg/5 mL, give 10 mg [5 mL] prn pain). Listing the desired concentration could actually lead to confusion and errors. If the prescribed concentration is not available and a different concentration is substituted, the prescriber’s directions regarding the volume to administer would no longer apply. Yet, if these directions remain on a medication administration record, or a prescription bottle, the wrong dose could be administered.
NABP Releases Updated Model Rules for the Licensure of Wholesale Distributors
On February 20, 2004, the National Association of Boards of Pharmacy® (NABP®) released the updated Model Rules for the Licensure of Wholesale Distributors. The updated Model Rules, part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy, were provided to assist state boards of pharmacy in maintaining the integrity of the US medication distribution system through the regulation of wholesale distributors. The updated Model Rules are the result of a concerted effort between NABP and other representatives from pharmacy, government, and the wholesale distributor industry to protect the public from the ill effects of counterfeit drugs and devices.
In addition to stricter licensing requirements such as criminal background checks and due diligence procedures prior to wholesale distribution transactions, the Model Rules mandate specific drug pedigree requirements for products that are particularly prone to adulteration, counterfeiting, or diversion. These products, as defined in the updated Model Rules, are designated as the “National Specified List of Susceptible Products.” Also, the updated Model Rules introduce the position of “Designated Representative.” The “Designated Representative” of a wholesale distributor is the person who is actively involved in and aware of the actual daily operation of the Wholesale Distributor.
The Model Rules for the Licensure of Wholesale Distributors along with the National Specified List of Susceptible Products can be downloaded from NABP’s Web site, www.nabp.net.
New Bar Code Requirements Aim to Reduce Risk of Medication Errors
In late February, FDA issued the final rule Bar Code Label Requirements for Human Drug Products and Biological Products. This final rule requires the inclusion of linear bar codes on most prescription drugs and certain OTC drugs. Each bar code must, at minimum, contain the drug’s National Drug Code number, but companies are encouraged to include additional information such as the product’s lot number and expiration date. For blood and blood products used in a transfusion, the final rule also requires the use of machine-readable information in a format approved for use by FDA. The machine-readable information must include, at a minimum, the facility identifier, the lot number relating to the donor, the product code, and information on the donor blood type.
FDA is hoping that the bar code rule will encourage the widespread adoption of advanced information systems that, in some institutions, have reduced medication errors by 85%.
FDA expects that, with full implementation, the linear bar codes will result in more than 500,000 fewer adverse events over the next 20 years and a 50% reduction in medication errors that would otherwise have occurred upon dispensing or administration. New medications covered by the rule must comply within 60 days of their approval and previously approved medications and blood/blood products must comply within two years.
More information including a link to the final rule is available on FDA’s Web site at www.fda.gov/oc/initiatives/barcode-sadr.