Prevalence of Compounding in Independent Community Pharmacy Practice
Prevalence of Compounding in Independent Community Pharmacy Practice
Objectives: To determine the extent of prescription compounding in independent community pharmacies and identify factors that influence the decision of independent pharmacists whether to provide compounding services.
Design: Cross-sectional survey.
Setting: Illinois, Missouri, Kansas, and Iowa.
Participants: 370 pharmacists in charge.
Intervention: Anonymous questionnaire mailed in January 2005.
Main Outcome Measures: Percentage of pharmacies that provide compounding; percentage of dispensed prescriptions that require compounding; factors contributing to decisions whether to provide compounding service.
Results: Overall, 94% of respondent pharmacies provided compounding services at the time of this survey. Prescriptions that required compounding represented less than 1% of total prescriptions for the majority (58.3%) of respondents. The main reasons for the decision to provide compounding service were wanting to provide full pharmaceutical care to patients (73.8% of compounders) and responding to requests by prescribers (48.7%). Pharmacies that did not provide compounding service cited the main reason as not receiving prescriptions that required compounding (63.6% of noncompounders).
Conclusion: Compounding remains a component of pharmacy practice in the independent community setting. Prescriptions that required compounding represented 2.3% of all prescriptions dispensed by compounding pharmacies.
Pharmaceutical compounding, "the preparation of components into a drug product...as the result of a practitioner's prescription drug order or initiative based on the practitioner/ patient/pharmacist relationship in the course of professional practice," has always been a part of community pharmacy practice. Before the availability of manufactured drug products, virtually all prescriptions were compounded. Compounded prescriptions as a fraction of total prescription volume decreased during the 20th century, to an apparent low of less than 1% during the 1970s.
Data on the current status of compounding in community pharmacy practice are lacking. The annual prescription surveys by DeNuzzo, which apparently ceased after 1982, were predominantly limited to pharmacies in New York State and focused on manufactured drug products rather than compounded prescriptions. Schommer et al. studied compounding by Wisconsin pharmacists in a variety of practice settings. The most commonly reported prevalence of compounding was 0.25% of total prescriptions dispensed. However, this statistic also represents only a single state a decade and half ago. An estimate by the Food and Drug Administration (FDA) that 1%10% of all prescriptions require compounding was unsupported by data, according to the U.S. Government Accounting Office.
The contemporary prevalence of compounding is represented by two indicators: (1) the International Academy of Compounding Pharmacists, founded in 1991 to promote pharmaceutical compounding, currently has approximately 1,800 members, and (2) the International Journal of Pharmaceutical Compounding, a journal devoted entirely to various aspects of pharmaceutical compounding, began publication in 1997 and currently has a readership of approximately 13,000 (Susanne Johnson, written communication, June 5, 2005).
An apparent increase in compounding practice has become a justification for increased efforts to regulate the practice. Compounded prescriptions, unlike manufactured drug products, do not require quality control testing (potency, purity, stability). Many compounding pharmacists perform or contract for these tests, but it is done voluntarily. FDA has cited10 widely publicized cases of problems with compounded products to illustrate dangers associated with an increase in compounding practice.
The focus on problem cases calls attention to compounded products from independent community pharmacies, and regulatory proposals implicitly focus on the independent community practice. For example, the Missouri Board of Pharmacy recently defined a new classification, "Class D: Non-sterile Compounding," for pharmacies that compound 5% or more of their prescriptions. Chain pharmacies may provide compounding services, but they are not often mentioned in association with compounding. Hospital pharmacies, where compounding, especially of sterile products, is extensively practiced, are regulated by the Joint Commission on Accreditation of Healthcare Organizations.
Thus, efforts at increased regulation of pharmaceutical compounding are apparently based on assumptions that the practice represents a significant, and increasing, fraction of pharmaceutical services and that the quality of compounded products cannot be assured. Independent community pharmacies are the putative source of compounding services, and they are the focus of current regulatory scrutiny. Data to support these assumptions are clearly lacking. An understanding of the contemporary prevalence of compounding in community pharmacy practice is needed.
Abstract and Introduction
Abstract
Objectives: To determine the extent of prescription compounding in independent community pharmacies and identify factors that influence the decision of independent pharmacists whether to provide compounding services.
Design: Cross-sectional survey.
Setting: Illinois, Missouri, Kansas, and Iowa.
Participants: 370 pharmacists in charge.
Intervention: Anonymous questionnaire mailed in January 2005.
Main Outcome Measures: Percentage of pharmacies that provide compounding; percentage of dispensed prescriptions that require compounding; factors contributing to decisions whether to provide compounding service.
Results: Overall, 94% of respondent pharmacies provided compounding services at the time of this survey. Prescriptions that required compounding represented less than 1% of total prescriptions for the majority (58.3%) of respondents. The main reasons for the decision to provide compounding service were wanting to provide full pharmaceutical care to patients (73.8% of compounders) and responding to requests by prescribers (48.7%). Pharmacies that did not provide compounding service cited the main reason as not receiving prescriptions that required compounding (63.6% of noncompounders).
Conclusion: Compounding remains a component of pharmacy practice in the independent community setting. Prescriptions that required compounding represented 2.3% of all prescriptions dispensed by compounding pharmacies.
Introduction
Pharmaceutical compounding, "the preparation of components into a drug product...as the result of a practitioner's prescription drug order or initiative based on the practitioner/ patient/pharmacist relationship in the course of professional practice," has always been a part of community pharmacy practice. Before the availability of manufactured drug products, virtually all prescriptions were compounded. Compounded prescriptions as a fraction of total prescription volume decreased during the 20th century, to an apparent low of less than 1% during the 1970s.
Data on the current status of compounding in community pharmacy practice are lacking. The annual prescription surveys by DeNuzzo, which apparently ceased after 1982, were predominantly limited to pharmacies in New York State and focused on manufactured drug products rather than compounded prescriptions. Schommer et al. studied compounding by Wisconsin pharmacists in a variety of practice settings. The most commonly reported prevalence of compounding was 0.25% of total prescriptions dispensed. However, this statistic also represents only a single state a decade and half ago. An estimate by the Food and Drug Administration (FDA) that 1%10% of all prescriptions require compounding was unsupported by data, according to the U.S. Government Accounting Office.
The contemporary prevalence of compounding is represented by two indicators: (1) the International Academy of Compounding Pharmacists, founded in 1991 to promote pharmaceutical compounding, currently has approximately 1,800 members, and (2) the International Journal of Pharmaceutical Compounding, a journal devoted entirely to various aspects of pharmaceutical compounding, began publication in 1997 and currently has a readership of approximately 13,000 (Susanne Johnson, written communication, June 5, 2005).
An apparent increase in compounding practice has become a justification for increased efforts to regulate the practice. Compounded prescriptions, unlike manufactured drug products, do not require quality control testing (potency, purity, stability). Many compounding pharmacists perform or contract for these tests, but it is done voluntarily. FDA has cited10 widely publicized cases of problems with compounded products to illustrate dangers associated with an increase in compounding practice.
The focus on problem cases calls attention to compounded products from independent community pharmacies, and regulatory proposals implicitly focus on the independent community practice. For example, the Missouri Board of Pharmacy recently defined a new classification, "Class D: Non-sterile Compounding," for pharmacies that compound 5% or more of their prescriptions. Chain pharmacies may provide compounding services, but they are not often mentioned in association with compounding. Hospital pharmacies, where compounding, especially of sterile products, is extensively practiced, are regulated by the Joint Commission on Accreditation of Healthcare Organizations.
Thus, efforts at increased regulation of pharmaceutical compounding are apparently based on assumptions that the practice represents a significant, and increasing, fraction of pharmaceutical services and that the quality of compounded products cannot be assured. Independent community pharmacies are the putative source of compounding services, and they are the focus of current regulatory scrutiny. Data to support these assumptions are clearly lacking. An understanding of the contemporary prevalence of compounding in community pharmacy practice is needed.
