Posted on July 21, 2015
Although compounding has played a very large role in the history of pharmacy, there has been a resurgence about the compounding industry that began in the 1980s and continues today.1 Compounding has become increasingly important because of recent manufactured drug shortages where compounding pharmacists have stepped in to fill the gap. Medications such as antibiotics, chemotherapy, and parenteral nutrition are routinely compounded and they save and improve countless patients’ lives.
Every licensed pharmacist is legally permitted to compound both non-sterile and sterile medications. However, not all pharmacists are adequately trained to perform these tasks. This lack of training can be illustrated by the egregious negligence in some compounding pharmacies that has been reported over the last few years.2 Pharmacists have either been unaware of or have blatantly ignored the sterile compounding regulations in USP Chapter 797 resulting in patient injuries and deaths.
Compounding has been traditionally regulated by state boards of pharmacy, with some state boards being more active than others. In November 2013, the Drug Quality and Security Act (DQSA) was signed into law, which has led to an increase in inspections and oversight by the FDA and many state boards of pharmacy. It is very important to have sterile compounding standards and regulations in place and enforce those regulations. However, it is crucial to educate future pharmacists regarding the existence of and proper implementation of these regulations and to provide the necessary skills and tools so that they can comply with them.
As David Newton stated in an editorial published in the American Journal of Pharmaceutical Education, “[T]he FDA is concerned that compounded preparations are likely to have lower quality than manufactured products and particular FDA personnel are aware that compounding instruction is highly variable in pharmacy schools.”1 The Accreditation Council for Pharmacy Education (ACPE) requires the following concepts be included in the didactic portion of the Doctor of Pharmacy Curriculum:
“Preparation of sterile and non-sterile prescriptions which are pharmaceutically accurate regarding drug product and dose, free from contamination, and appropriately formulated for safe and effective patient use. Analysis of the scientific principles and quality standards upon which these compounding requirements are based.”
However, many schools of pharmacy have decreased “hands-on” compounding education3 in favor of more clinical topics, such as patient assessment. In addition, numerous schools have decreased compounding laboratory courses in order to offer more experiential education. Learning about sterile compounding in a pharmacy setting can be very beneficial but could be detrimental if the pharmacy is not in compliance with USP Chapter 797 and the student has not been properly trained to recognize lack of compliance.
Even though the trend has been to teach less compounding in schools of pharmacy, the interest in compounding among student pharmacists seems to be increasing.4 I have observed this in the students who are in my required sterile compounding laboratory course, as well as my advanced compounding elective. Many students begin asking about additional compounding education as soon as they begin their first professional year of the curriculum.
Pharmacy educators may not be able to teach student pharmacists everything they need to know about compounding due to limited hours in the required pharmacy curriculum, however, educators should minimally provide students with a strong base on which to build knowledge and the tools to continue advancing individual compounding education after graduation. This can be done by teaching compounding skills and regulations (particularly USP Chapters 795 and 797) and also “the scientific principles and quality standards upon which these compounding requirements are based” as stated in the ACPE standards.
1. Newton DW. Compounding paradox: taught less and practiced more. Am J Pharm Educ. 2003;67(1):12-14.
2. Eisler P and Schnaars C. Safety, sanitary problems prompt scores of drug recalls. USA Today. October 7, 2014.
3. Vail J and Roberts J. Compounding around the world: Compounding in the United States. IJPC 2015; 19(1):18-27.
4. Carvalho M and Batra B. Pharmacy Students Survey: Perceptions and expectations of pharmaceutical compounding. IJPC 2008; 12(2):114.