Showing posts with label Dr. Loyd Allen. Show all posts
Showing posts with label Dr. Loyd Allen. Show all posts

Friday, August 16, 2013

KUDOS to Dr. Loyd V. Allen, Jr., PhD, RPh for His Recent Editorial Advocating More Adequate Training for Pharmacists to Be Proficient in both Nonsterile and Sterile Compounding!!!


Editorial: The price of a life and pharmacy education?
Academic and organizational pharmacy have been promoting the practice of clinical pharmacy since the 1960s (for about 50 years). In the 1970s and 1980s there was a significant change in the curricula of colleges of pharmacy to become more clinically oriented. These changes resulted in the removal of a significant number of science-based classes and laboratories that acquainted and instilled the importance of the science behind drug dosage forms and drug delivery systems and their manufacture, compounding, and actual use. A few schools have retained compounding and laboratories but some are optional; some schools have NO compounding course or laboratories.
Let's fast-forward to today. We now have compounding pharmacy that has significantly grown since the 1980s and sterile compounding since the 1990s. For example, let's look at the following:
  • Almost 70,000 pharmacies are involved in compounding (e.g., independents, chains, hospitals, nuclear, specialty).
  • Compounding is a $22 to $25 billion dollar industry annually.
  • Over 80% of independent pharmacies compound.
  • Generally all hospital pharmacies perform compounding.
These numbers simply emphasize that compounding pharmacy is a vital and growing part of health care today! The training of pharmacists has long been handled by colleges of pharmacy. However, we are in a situation where the colleges of pharmacy in most universities are not adequately training pharmacists to do the exact thing for which pharmacists are known, and there is no other profession charged with this responsibility.
Yes, there have been many unfortunate events in the past couple of years. The question remains, "Why are pharmacists not being trained to be proficient in both nonsterile and sterile compounding?" Since this is a significant part of pharmacy practice, is this a situation of "malpractice" at the college of pharmacy level or just slow response? When confronted with the question of why compounding isn't taught, college deans often say it costs too much! It almost looks like a price is being placed on a human life.
Let's hope that the "powers that be" will begin the process of re-incorporating the sciences, compounding, and sufficient laboratory experiences to properly train pharmacists in both nonsterile and sterile compounding; patients' lives depend on it! We can all work together to enhance the quality of pharmacy practice by changing to a curriculum that prepares students for the current practice of pharmacy!

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

quoted from Compounding This Week Newsletter

Wednesday, April 10, 2013

Compounding with Commercial Drug Products Can Cause Errors! by Dr. Loyd Allen



Is it wise to use commercial products in compounding? When doing so, can the pharmacist be assured of a quality preparation? Is it possible to meet the standards of United States Pharmacopeia (USP) Chapter <795>, Chapter <797>, and Chapter <1163> when using commercial products as the source of drugs? The answer to these questions is "sometimes, but not always." Commercial drug products are commonly used for compounding human drug preparations. However, pharmacists are placed in an interesting position because the federal government dictates that commercial products be used for veterinary compounding. However, doing so sometimes results in preparations that are outside USP standards and specifications.
Historically, pharmacists have used commercially available medications to prepare different dosage forms. The most common examples are the use of oral tablets and capsules to prepare oral liquids (solutions and suspensions) for pediatric patients and the use of injectable drugs to prepare intravenous admixtures. Even though U.S. Food and Drug Administration (FDA)-approved commercial products may be used, the final compounded preparation does not have FDA approval.
Considerations
Considerations concerning commercial product use include the following:
  1. Using commercial products as a source of active drugs usually will result in a higher prescription cost to the patient than would using bulk drug substances. This is especially true when injectables are used as the drug source.
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It is NOT Just About Sterile Compounding! —OR— What About Nonsterile Compounding? by Dr. Loyd Allen



We must ALL think about ALL of the compounded preparations we make—how we prepare them, the equipment we use, and the environment in which we prepare them!
For obvious reasons, it is natural that institutional pharmacists think more about abiding by United States Pharmacopeia (USP) Chapter <797> when compounding sterile preparations than they do about abiding by USPChapter <795> when compounding nonsterile preparations. However, as this newsletter points out, our patients deserve appropriate considerations for nonsterile compounds as well. Moreover, pharmacists should abide by the requirements in USP Chapter <1163> Quality Assurance of Compounded Preparations.1 Our human and animal patients expect the same of our compounded preparations whether it is:
·Capsules·Creams·Infusions
·Injectables·Intrathecals·Lotions
·Pastes·Powder packets·Solutions
·Suppositories·Suspensions·Tablets
Let's Ask Ourselves a Few Questions
Q:  Are nonsterile compounded preparations at risk for contamination?
 
Certainly! When you go to a restaurant do you expect the restaurant to take the necessary precautions to assure that your food will be free of human and/or animal hair…parts of paper towels…toothpicks…broken off pieces of cooking utensils…dirt…bacteria/mold? I do!

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