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Editorial: Expiration Dates, Drug Waste and Pollution

A search for information on expiration dates on the internet raises some interesting questions about their use and relationship to wastage and pollution of the environment.

From the FDA, "The absence of an expiration date on any drug product packaged after September 29, 1979, except for those drugs specifically exempt by 211.137 (e), (f), and (g), is cause to initiate regulatory action against the product and/or the responsible firm."

An expiration date is the time during which a drug product may be expected to maintain its strength and remain stable under the designated storage conditions; it limits the time during which the product may be dispensed by the pharmacist or used by the patient. There is considerable detailed investigation that goes into the establishment of an expiration date.

However, in those cases where the acceptance standard may be 90-110% of their original strength and after three years storage the product still retains 97%, why is a short date applied to the product when it is stable for a much longer period of time? Why is there no system to routinely "extend expiration dates" as was the case with Tamiflu this past year?

With the extremely high cost of many drugs, widespread prescribing resulting in increased prescription drug dispensing, difficulties in destroying unused prescription drugs, this issue may need to be revisited.

Most manufactured drug products must have an expiration date of two to three years to be commercially viable. However, a study was reported in the Wall Street Journal in 2000 on a testing program conducted by the FDA involving over 100 military stockpiled drugs, both prescription and OTC. The results showed that about 90% were still okay.

Expiration dates are not "magical" as they can be adjusted as we saw this past year with Tamiflu. Maybe it's time that this topic was "revisited" to make it more reasonable and appropriate for today. It is extremely wasteful to discard millions of dollars worth of drug products each year because of an "artificial" expiration date. Obviously there are a lot of considerations here, but with costs out-of-control, pollution problems, etc., it needs to be questioned and openly discussed.


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

DEA Unused Drug Take Back Program
The DEA, in conjunction with state and local law enforcement agencies throughout the United States, conducted the first ever National Prescription Drug Take Back Day on Saturday, September 25, 2010. The purpose of this National Take Back Day was to provide for persons who wanted to dispose of unwanted and unused prescription drugs. In total, the American Public turned in more than 121 tons of medications on this first National Take Back Day.

Due to the overwhelming success of the first event, DEA has scheduled the second National Prescription Drug Take Back Day which will take place on Saturday, April 30, 2011, from 10:00 am - 2:00 pm. This is a great opportunity for those who missed the first event or who have subsequently accumulated unwanted, unused prescription drugs, to safely dispose of them.
http://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html

Test of Eye Drug Is Said to Show Success in Elderly
Avastin appears to be a far less expensive alternative that is roughly as effective as Genentech's costly drug Lucentis in preserving or improving vision in elderly people with a common eye disease, according to two people familiar with the results of a closely watched clinical trial.

A clear showing of equivalence between the two drugs could lead to greater use of the less expensive drug, Avastin, which is also made by Genentech, saving Medicare hundreds of millions of dollars a year or more. Avastin costs only about $50 per injection into the eye, compared to roughly $2,000 for Lucentis.

The National Eye Institute, part of the National Institutes of Health, is sponsoring this randomized trial involving 1,200 patients. Results are scheduled to be presented Sunday at the annual meeting of the Association for Research in Vision and Ophthalmology and the results will also be published in The New England Journal of Medicine.

In 2008, Medicare paid for 480,000 injections of Avastin ($20 million) to treat macular degeneration and 337,000 injections of Lucentis ($537 million).

Genentech has already mounted a pre-emptive counterattack aimed at nullifying any results of the federal trial that would shift more patients to Avastin.
http://prescriptions.blogs.nytimes.com/2011/04/27/test-of-eye-drug-shows-success-in-elderly/?partner=rss&emc=rss

Drug Shortage Frustrating to ADHD Patients
A shortage of stimulants to treat ADHD has forced some Minnesota patients to pay more for expensive brand-name medications or make a frustrating switch to short-acting versions of their drugs, according to local physicians. Even though patients could obtain brand name drugs in extended-release forms, many insurers won't pay for them.

Reasons for the shortage listed on the FDA website include increased demand for generic stimulants and federal quotas that prevent too much of certain controlled substances from reaching the market at any given time.
http://pharmalive.com/news/index.cfm?articleID=777122&categoryid=9&newsletter=1

Simpler Prescription Drug Information
A new effort is under way to make prescription drug information clearer and slow down the rise in emergency room visits and hospitalizations resulting from patients incorrectly taking their medicine. The FDA is planning to test single-page consumer information sheets that would replace the multi-page package inserts and medication guides widely used in retail pharmacies. The new standards would require clear instructions on dose and timing and state in simple terms the purpose of the drug-such as "for high blood pressure"-unless the patient prefers that it not appear.
http://online.wsj.com/article/SB10001424052748703521304576279123606877448.html?mod=dist_smartbrief

Government Attempts to Remove Drug CEO Causing Concern
Alarms are sounding in the government's attempt to oust a longtime drug-company chief executive over his company's marketing violations and the potential expansion of federal involvement in the business world. This action has upset the pharma industry because barring the CEO from the drug business is a step outside the enforcement box. If HHS succeeds in forcing him out, then other pharma executives could find themselves in the crosshairs. Also, experts are saying that other U.S. agencies--such as the Defense Department and the EPA--have similar exclusion powers.
http://online.wsj.com/article/SB10001424052748704123204576283283851626952.html?mod=dist_smartbrief

FDA Urged to Ban Medical Use of Latex Gloves
According to the Public Citizen Health Research Group, the FDA's failure to ban latex gloves or the use of cornstarch in their manufacturing process "demonstrates astonishingly reckless and inexcusable disregard for the health and safety of patients and healthcare workers."

The letter to the FDA accused the agency of acting "in the interests of cornstarch-powdered and latex glove manufacturers," who have opposed the ban, rather than "in the interests of public health." Although they are more expensive, non-latex products are now in use at many healthcare systems.
http://www.healthleadersmedia.com/page-1/QUA-265413/FDA-Urged-to-Ban-Medical-Use-of-Latex-Gloves

Peripheral Brain for the Pharmacist
32 laminated cards, 4 x 7.25"; hole-punched with metal ring, $14.95

It's a book�It's a pamphlet�. No, it's the "Peripheral Brain for the Pharmacist", 2nd edition. Remember using index cards to draw figures and tables with important information, either as a student or practitioner? Well, this product arranges 32 core reference materials on lab coat pocket-sized laminated cards containing key clinical information that is frequently used. The color coding is very useful and there is a patient monitoring card that can be photocopied for use. Also available are iPhone apps for the most useful formulas from this product that is free on iTunes.

Over 200 participants have already participated in the "USP <797> Compliance Study" so far; the goal is to have 1,000 participants in this study. See last weeks newsletter for details. Please register for the Study today: www.797study.com - Use Survey Code A797J

Take Back Drugs Tomorrow
To help patients participate in the DEA Nationwide Effort to Take Back Prescription Drugs tomorrow, go to www.dea.gov and click on ""Got Drugs" to find the nearest local site to your location. The event will run local time 10:00 AM - 2:00 PM.