Last week, I listed and commented on 2 of the issues/deficiencies that were raised by the FDA in their WARNING LETTER to Wyeth. Continuing on that subject, additional issues/deficiencies and my comments are furnished below:

3. "Failure to adequately inspect packaging and labeling equipment prior to its use to assure that all drug products have been removed from previous operations as required�.There were several incidents where product from previous lots was found in your non-dedicated packaging lines, while filling and packaging operations were being performed."

   It should be noted that these deficiencies involve Prempro, Advil, and Caltrate products and that these lines had been cleaned and inspected between packaging operations. A report by Wyeth states that "more than 99% of the line clearances were performed successfully." I guess the question that remains is what about the other 1%? What would happen if pharmacists only filled 99% of their prescriptions properly? What if an airplane only had 99% of the required fuel to reach its destination? Obviously, Wyeth has work to do here.

4. "Failure to submit NDA Field Alert Reports (FAR) within 3 working days of becoming aware of information concerning any significant chemical, physical, or other change or deterioration in the distributed drug products as required�."

   The purpose of these FARs is to establish an early warning system so that significant problems are brought to the FDA's attention in order to prevent potential safety hazards from drug products already in distribution. Wyeth did not issue a FAR for more than 5 months between the initial detection of the unknown peak in the Triphasil-21 and Triphasil-28 products. And, the FAR was issued during the FDA's inspection of the Wyeth facility.

5. "Failure of your quality control unit to review production records to assure that errors have not occurred, and to fully investigate errors that have occurred during the manufacturing of your drug products�" The report goes on to state, "All of the deficiencies stated above are indicative of your quality control unit's failure to assure that each deviation from your drug manufacturing operations, impacting the identity, strength, quality and purity of your drug products, has been adequately investigated. Furthermore, your quality control unit has failed to assure that corrective actions have been determined and implemented to prevent the recurrence of these deviations".

Enough said? Wyeth has absolutely no business pointing the finger at anyone if they cannot meet and exceed the standards to which they have agreed to and "must" meet. In fact, if Wyeth cannot, or refuses to, meet these standards to ensure identity, strength, quality, and purity of their products, should they even be allowed to market their products and stay in business? It is understandable for quality deviations to periodically occur and that is to be expected. What is unacceptable, however, is Wyeth's perceived "I don't care" attitude, and their (apparently) placing economic considerations above patient safety and welfare considerations. This may be a symptom of what happens when one becomes isolated from the patient and doesn't have the empathy and concern for patients that is so important.

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

This discussion group of over 1000 pharmacy personnel worldwide continues to actively discuss the practice of pharmacy around the world from the front-line. Some of the most recent topics include:

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Protect Your Personnel — Use a Sealed Container for Blending Powders
Even though the mortar and pestle have been the symbol of pharmacy over time, there are other safer methods of working with potent drugs. Working with an open system, such as a mortar and pestle, can result in powders floating in the air, being breathed in, coming in contact with the skin, and some actually being absorbed. Using a sealed container for blending is safer. Sealed containers are available with electronic mortars/pestles and even glass and plastic jars for tumbling, etc. can be used. After thoroughly mixing and/or rotating the container, let it set on the countertop for a few minutes before opening to allow any particles suspended in the headspace to settle. Then open in a properly vented area. If properly cleaned and dried, these mixing containers can be reused.