Tel: 614/466-4143 Fax: 614/752-4836 Email: email@example.com Web: www.pharmacy.ohio.gov
~~ NOVEMBER 2005 ~~
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.
Larissa Doucette - Editorial Manager
State News Section
Reminder – Please Read Your State Board News
The Ohio State Board of Pharmacy uses these quarterly Newsletters
as one means to discuss practice issues, policies, rules, and other topics
of interest to
Board Members Reappointed
What Do I Do With Medications Returned to the Pharmacy?
Frequently, the Board office receives questions from pharmacists wanting to know how to deal with drugs that have been returned to the pharmacy by a patient or family member. Quite often, these questions are in the form of letters requesting the Board’s permission to destroy controlled substances that have been returned. Pharmacists should be aware that the Board has a rule dealing with returned drugs, which reads as follows:
4729-9-04 Returned drugs
(A) No drug that has been dispensed pursuant to a prescription and has left the physical premises of the terminal distributor of dangerous drugs shall be dispensed again except:
(1) Drugs dispensed for inpatients pursuant to paragraph (C) of rule 4729-17-01 of the Administrative Code provided that:
(a) The drugs are packaged in unopened, single-dose or tamper-evident containers and
(b) The drugs have not been in the possession of the ultimate user.
(2) Non-controlled drugs dispensed by a government entity and delivered for outpatients to a psychiatric outpatient facility licensed with the state board of pharmacy provided that:
(a) The drugs are packaged in unopened, single-dose or tamper-evident containers and
(b) The drugs have not been in the possession of the ultimate user.
(B) Drugs that have not been dispensed or possessed in accordance with this rule are considered to be adulterated.
You will note that, with the exception of an inpatient setting or a special psychiatric setting where the drugs are always under the control of licensed health care professionals, drugs dispensed to a patient may not be returned for reuse under any circumstances. Once the drug is in the hands of a patient or caregiver, there is no control over the storage or security of the drug product. It is an unfortunate fact that there have been cases of tampering with drug products in the past and sometimes tampering can be difficult to detect. In addition, patients do not always store their medications properly, thus subjecting them to potential deterioration due to unexpected temperature and/or humidity variations. Therefore, in order to protect the public from the activities of a few malicious individuals who might tamper with products and also from well-meaning but uninformed people who fail to store their drugs properly, the rule prohibits any judgment on the part of the pharmacist about returning or caregiver, they may not be returned and dispensed to anyone else for any reason other than the two exceptions in the rule.
You will also note that the rule does not address the issue of money. Since the Board has no jurisdiction over a pharmacy’s financial transactions (other than the commission of criminal violations such as fraud), there are no requirements regarding refunds. Pharmacists may grant full or partial refunds if they choose, but there is no requirement that they do so. This is an issue that patients do not understand. Patients who call the Board office to complain sometimes understand the issues better if the reasons for the rule are explained and they are asked if they would like to have medications dispensed to them that had been in another person’s home. Most of them understand better at that point, but some of them feel as if their personal integrity has been questioned. Dealing with your patients about this requires the pharmacist to use a great amount of tact. Obviously, each potential refund situation will be different, depending on the reason the drugs are returned.
One thing that must be remembered in this discussion is that it is still in the public interest for patients to remove drugs from their home when the drugs are no longer needed. Patients will continue to bring medications back to the pharmacy. In addition, pharmacists often render a valuable public service by periodically offering “brown bag” sessions where patients can clean out their medicine cabinets and go through their medications with a pharmacist to determine which drugs to keep and which drugs to discard. In all cases, the best thing to do with the medications is to destroy them in the presence of the patient or caregiver. By saying something like “Come with me and I will help you discard them,” there is no doubt about the disposition of the drugs in the minds of the patients and the pharmacist is not maintaining possession of drugs that the Board has determined are “adulterated.”
New Rules Under Consideration
By the time this Newsletter arrives, the Board will
probably have already held a public hearing on proposed new and changed rules. For
those who are interested in the content of these proposed rules, please go to
the Board’s Web site, www.pharmacy.ohio.gov, and click on “What’s New?”
to see a copy showing the changes. The document is titled “Full Text of
Proposed Rules Showing Changes for
Some rules of interest that are being proposed include a
new chapter on Charitable Pharmacies (4729-36) that will allow the distribution
of drug samples under certain special conditions by a pharmacist working in a charitable
pharmacy; a new chapter on the Drug Database program that was discussed in the
last Newsletter (4729-37) that will outline, among other things, the
requirements for pharmacies and wholesalers to follow for submission of data to
the program, the drugs to be included in the program, and the methods that must
be followed to obtain information from the program; and a new rule for
compounding (4729-9-25) that will give the requirements that pharmacies need to
follow to prepare limited amounts of drug products intended for direct
prescriber administration to patients in the prescriber’s office. These rules
will not be finalized by the Board until after the Public Hearing on
Anyone having a question regarding the license status of a
particular practitioner, nurse, pharmacist, pharmacy intern, or dangerous drug
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
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.
DEA Amends Rule for
Reports of Theft or Significant Loss of
Enforcement Administration’s (DEA) amended regulations regarding reports by
registrants of theft or significant loss of controlled substances became
Regarding the timing of initial theft or loss reports, DEA inserted the word “immediately” before the phrase “upon discovery.” While DEA Form 106 is not immediately necessary if the registrant needs time to investigate the facts surrounding a theft or significant loss, he or she should provide, in writing, initial notification of the event. This notification may be a short statement provided by fax. DEA notes that faxing is not the only method a registrant may use, but that the notification should be in writing. If the investigation of a theft or significant loss lasts longer than two months, registrants should provide updates to DEA.
To help registrants determine whether or not a loss is “significant,” DEA has added to the rule a list of factors to be considered. DEA recognizes that no single objective standard can be applied to all registrants – what constitutes a significant loss for one registrant may be construed as comparatively insignificant for another. If a registrant is in doubt as to whether or not the loss is significant, DEA advises the registrant to err on the side of caution in alerting the appropriate law enforcement authorities.
Regarding “in-transit losses of controlled substance,” DEA intends that all in-transit losses be reported, not just significant losses; therefore, the text is being amended to reflect this.
Changes to the
regulations were reported in the
FDA Releases Update
on Combating Counterfeit Drugs
Food and Drug Administration (FDA)
recently released “Combating Counterfeit Drugs: A Report of the Food and Drug Administration
Annual Update (Update).” This Update follows up on the agency’s initial
In 2004, FDA’s Office of Criminal Investigations initiated 58 counterfeit drug cases, a significant increase over the 30 cases in 2003; however, the agency notes that this is likely due to increased vigilance. FDA also states that most of the suspect counterfeits discovered in 2004 were found in smaller quantities than those found in 2003.
The Update reviews steps taken and future actions required for track-and-trace technology, authentication technology, regulatory oversight and enforcement (electronic pedigree), state efforts, secure business practices, heightened vigilance and awareness, counterfeit alert network, and education. The full Update can be accessed at www.fda.gov/oc/initiatives/counterfeit/update2005.html.
“Fax noise” = Medication Errors in the Making
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, 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:
Problem: Most health care practitioners would agree that fax machines have facilitated communication of prescriptions. But there are inherent problems associated with this technology. In fact, an article in the Journal of Managed Care Pharmacy found that prescriptions received by fax required a greater number of clarification calls than those received by other methods of communication. 1 ISMP received a report from a long-term care facility about a patient who had been receiving Neurontin® (gabapentin) 600 mg TID [three times a day]. However, an order had been faxed to the pharmacy to change the Neurontin dose to “300 mg 1 tab QID [four times a day].” The change was made and the new dose was sent to the facility. Later, when the pharmacist received the original order from the long-term care facility and compared it with the faxed copy, he realized that the physician had actually requested a change to “800 mg 1 tab QID.” The left side of the order had been cut off during the fax transmission, making the “8” look like a “3.” Fortunately, since the pharmacist had been sent the original order for comparison, he quickly realized the mistake. Unfortunately, not all pharmacies receive the original prescription for comparison purposes.
In another report received by ISMP, a faxed prescription was received at a pharmacy for what appeared to be Monopril® (fosinopril) 10 mg #90 one tablet daily. Despite the fact that the fax machine created a definite vertical streak that ran between the drug name and the strength, the pharmacist felt confident in her interpretation of the prescription. Unfortunately, it was later discovered that the prescription was actually for 40 mg. The streak had run through the “4” in 40 mg, making it look like 10 mg instead.
The following prescription was faxed to a mail-order pharmacy. Look at the bottom order for “Lisinopril/hctz.” (Note: ISMP does not condone the use of the abbreviation “hctz.”) The pharmacist interpreted this order as “20/25 mg.” But what the prescriber had actually written was “20/12.5 mg.” A subtle vertical gap in the faxed copy (which can be seen “breaking” the circles around “ 3 months supply”) had obliterated the “1” in 12.5. In addition, the pharmacist reading the order had misinterpreted the decimal point as one of many stray marks on the faxed prescription.
Safe Practice Recommendations: “Fax noise” (the random marks and streaks on faxes) is an inherent problem with this form of communication, which may be more common in old or poorly maintained fax machines. Usually, fax noise is just an inconvenience. In the case of prescriptions, however, there is a very real chance that a patient could be harmed by misinterpretations caused by fax noise. To manage this risk, safeguards should be instilled into the fax process. Such safeguards include a careful review of all prescriptions received by fax for fax noise. If the transmission has fax noise in the area of the order, the prescriber should be contacted to confirm the prescription. Whenever possible, compare the faxed order against the original prescription. Prescribers should consider giving a copy of the prescription to the patient to present at the pharmacy for verification. To prevent confusion or duplication of the prescription at a different pharmacy, the copy could be stamped with a statement such as “Verification Copy ONLY” to indicate that the prescription was already faxed to a particular pharmacy. Maintenance should be regularly scheduled for fax machines on both the sending and receiving end. If maintenance fails to improve fax quality, the machine should be replaced.
December 2005 FPGEE Date and Locations Announced
December 3, 2005, NABP will again administer a paper and pencil Foreign
Pharmacy Graduate Equivalency Examination®
examination is being offered at three
To prepare for the December examination, candidates may take the Pre-FPGEE®, a Web-based practice examination for the FPGEE. The practice examination is accessible at www.nabp.net and www.pre-fpgee.com.
For more information on the FPGEE, visit NABP’s Web site at www.nabp.net.
2006 Survey of Pharmacy Law
NABP’s 2006 Survey of Pharmacy Law CD-ROM will be available in late November 2005. New topics include the number of wholesale drug distributors and laws and/or regulations concerning the sales of over-the-counter pseudoephedrine, and information concerning emergency contraception.
The Survey consists of four sections: organizational law, licensing law, drug law, and census data. Most charts specify terms that can be used when conducting searches on NABP’s NABPLAW® Online state pharmacy law and rules database. The Survey can be obtained for $20 from NABP by downloading the publication order form from www.nabp.net and mailing in the form and a money order to NABP. The CD-ROM is provided free of charge to all final-year pharmacy students through a grant from AstraZeneca Pharmaceuticals. If you do not have Web access or would like more information on the Survey, please contact NABP at 847/391-4406 or via e-mail at firstname.lastname@example.org.