Drug Topics - February 11, 2008 - (Page 68) 68 DRUG TOPICS FEBRUARY 11, 2008 www.drugtopics.com VIEWPOINT Jack Rosenberg, Pharm.D., Ph.D.; Aleksandr Domovich, Pharm.D. candidate; Joseph P. Nathan, M.S., Pharm.D.; Sara Schilit, Pharm.D. (top to bottom) Should an Rx label require a use-by date or an expiration date? or the protection of patients, regulations are enforced to prohibit pharmacies from dispensing or selling expired drugs. In addition, many states have adopted policies that are designed to extend this protection even further. As pharmacists, we know that the use of a medication before its expiration date ensures maximum potency if it was stored under proper conditions. Once a medication has been dispensed, the original manufacturer’s expiration date cannot always be relied upon and 22 states and the District of Columbia (see table) require the pharmacist to place on the Rx label a “use-by date” or an “expiration date.” The “use-by date” is one year from the date of dispensing or the expiration date on the manufacturer’s container, whichever is earlier. This “use-by date” required by states is similar to the requirements of the 2007 USP/NF, which indicates that in the absence of stability data for a drug product in a repackaged container, the beyond-use dating period is one year from the date of dispensing or the time remaining of the expiration date, whichever is shorter. Twenty eight states do not require an expiration date on a prescription label and this is also not mandated by federal law. However, even in these states, nothing prevents pharmacists from voluntarily adding an expiration date or beyond-use date to the label and, in fact, certain pharmacies do this as a matter of policy. Arguments may be made for and against the requirement for an expiration date on the Rx label. For example, the Pharmaceutical Society of the State of New York (PSSNY) has opposed proposed legislation to require expiration dates on the labels F Pharmacy boards that require an expiration date or a “use-by”* date Arizona California Colorado Connecticut Florida Georgia Hawaii Idaho Kentucky Maine Maryland Michigan Minnesota Nevada New Jersey New Mexico Oklahoma Oregon Rhode Island Tennessee Utah District of Columbia of dispensed medications. PSSNY argued that once a medication is removed from its original container and exposed to different storage conditions, the stability of the drug cannot be ensured and thus assigning an expiration date for dispensed medications is impossible. Moreover, since patients are instructed not to store medications for reuse, there is no need for expiration dating on a label. A counter-argument to the position stated above can also be made. As pharmacists, we are all familiar with patients who do not discard any medication and have “mini-pharmacies” at their homes. These patients may use these stored medications during future episodes of illness. In such a case, an expiration date on the label may prevent patients from using medications that have degraded and are no longer suitable for use. Additionally, pharmacists are required by some laws to counsel patients and provide drug storage information to them. In nonmandatory states one can envision situations where patients unknowingly use “expired medications.” As an example, a pharmacist dispenses a prescription for drug X to relieve the dental pain of a patient who is to undergo a series of dental treatments. This medication has a manufacturer’s expiration date two months hence. However, this “use-by date” or “expiration date” is not listed on the Rx label. The patient’s dental pain abates in a few days and there is still a portion of the medication unused from this Rx. Four months later the patient undergoes additional dental work and uses drug X from the originally dispensed prescription. The patient has no clue that the medication is expired, although it was stored properly. We believe that the mandated expiration date appears to provide further protection to patients against taking outdated medications. If a pharmacist believes it is in the best interest of the patient not to store a medication for reuse, an expiration date can be placed on the label limiting the use of the medication accordingly. Lack of an expiration date on an Rx label may be interpreted by patients that the medication has none. Shouldn’t all pharmacists voluntarily place this information on Rx labels in states not mandating it? is Professor of Pharmacy Practice and Pharmacology and Director, International Drug Information Center; ALEKSANDR DOMOVICH is a pharmacy student; JOSEPH P. NATHAN is Assistant Professor of Pharmacy Practice; and SARA SCHILIT is Drug Information Specialist, Adjunct Assistant Professor of Pharmacy Practice at Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, N.Y. JACK M. ROSENBERG *The “use-by date” means either the earlier of one year from the date of dispensing, or the expiration date on the manufacturer’s container. http://www.drugtopics.com
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