While the bill claims to improve the safety of compounded medications, the survey finds it would force many small community-based pharmacies to make choices that would decrease the safety of compounded medications if they want to continue filling prescriptions for their patients. It would also reduce patient access to critical compounded preparations, often not found elsewhere, while forcing small pharmacies to accept burdensome new rules and costs, forcing painful cuts in local jobs. The full survey results can be found at ProtectMyCompounds.com.
The survey was conducted by PCCA, a company that provides pharmaceutical-grade ingredients, equipment, education and training to more than 3,800 independent compounding pharmacies in the U.S.
S. 959 requires pharmacies that engage in three common practices that are regulated under state law to register as “compounding manufacturers.” Under the provisions of the bill, a pharmacy is required to register as a “compounding manufacturer” if it prepares sterile preparations for human use, prepares them in advance of receiving a legal prescription order and dispenses them outside of the state in which it is located. As such, they would no longer be permitted to fill individual prescriptions for customers in their community or fill orders for office use by local physicians. As a profession, similar to physicians, dentists and attorneys, pharmacists are regulated and licensed by the state but would now face a new layer of federal regulation and be required to pay burdensome registration fees and inspection fees that could significantly impact their ability to provide services to their local community.
Jim Smith, president of PCCA, said, “The sponsors of S. 959 claim that this legislation will not affect community pharmacies. In fact, 41% of the respondents to this survey meet the bill’s criteria for ‘manufacturing.’ The survey showed that pharmacies would be either forced to give up their pharmacy business or make painful changes to their business that would greatly reduce access to compounded preparations, increase costs and/or eliminate local jobs. If this rate is typical, of 7,500 compounding pharmacies nationwide, 3,075 pharmacies would be forced to give up their pharmacy business or change them in ways detrimental to them, the economy, their patients and prescribers — while doing nothing to improve the safety of compounded medications.”
Smith continued, “66% of those we asked would stop ‘anticipatory compounding’ for preparations that would be dispensed out of state because of S. 959. While some claim that S. 959 would increase safety, it could actually decrease safety since anticipatory compounding of sterile preparations is typically done in batches and samples of each batch are tested before prescriptions are dispensed. Making only a single, patient-specific dose of a sterile compound after a prescription is received would not allow for testing, since that single dose would be destroyed in the process.”
If S. 959 were to become law, 51% of respondents say it is somewhat or extremely likely that they would discontinue all sterile compounding for human health rather than register as a “compounding manufacturer.”
Among the key findings of the survey of compounding pharmacies:
- Given how they practice pharmacy today, 41% would be required to register as “compounding manufacturers” and thus be required to abandon the pharmacy profession. The same percentage say they will change their current business practices to remain as a “traditional” compounding pharmacy rather than register as manufacturers; 30% don’t know what they would do if the bill became law.
- A majority say they are somewhat or extremely likely to discontinue dispensing out of their home states (68%), discontinue anticipatory compounding of sterile medications that will be dispensed in another state (66%) or discontinue sterile compounding for human health (51%) in order to remain as pharmacists.
- If they choose to take steps necessary to remain as compounding pharmacies rather than register as manufacturers, respondents are somewhat or extremely likely to say that:
- Revenue would decrease: 85%
- Number of compounds would decrease: 81%
- They would greatly reduce compounding for office use: 78%
- They could not serve the same patient populations: 73%
- They could not serve the same prescribers: 73%
- They would stop compounding for office use: 71%
- They would eliminate jobs: 69%
- If choosing to register as a “compounding manufacturer,” respondents are somewhat or extremely likely to say that they would cover the new costs by:
- Increasing prices: 85%
- Reducing or eliminating the number of preparations made: 73%
- Eliminating one or more jobs: 66%
- Making across-the-board salary and wage cuts: 57%
- Reducing expenses other than payroll: 51%
- Closing their business: 40%
- Five provisions of the law would have a “large negative impact” on how they practice pharmacy or on patient outcomes:
- Allowing federal officials to restrict or eliminate compounding any variation of a manufactured drug including changing the dose or dosage form: 87%
- Opening the possibility for a federal official to define what makes a “clinical difference” for a patient to justify using a compounded medication rather than a manufactured drug: 87%
- Allowing the FDA to decide what is “demonstrably difficult to compound”: 86%
- Increased administrative requirements on the prescriber and the pharmacy when ordering compounds for office use and adding criminal penalties for failure to comply: 78%
- Requiring prescribers to determine that the compounded drug will produce a clinical difference for the patient as opposed to using a marketed approved drug, and requiring a prescriber to give the pharmacy written permission to compound from bulk ingredients: 74%
- If the FDA were to have significantly greater authority over compounding pharmacies than it already has, respondents say it is somewhat or extremely unlikely that:
- Selection and availability of compounded preparations would increase: 94%
- The cost of compounded medications would decrease: 94%
- The administrative burden would not change: 90%
- There would be a positive impact on patients: 89%
- Patient compliance would increase: 85%
- Patient safety would increase: 77%
- Not change the preparations they compound: 65%
Smith added, “We support efforts at the state or federal levels that would improve the safety of compounded medicines. But S. 959 does nothing to improve safety or prevent another NECC-like tragedy. It inserts the federal government into the practice of medicine by handing added authority to the FDA while imposing burdensome new costs and rules on small businesses that will eliminate jobs and reduce access to life-saving compounded medications. The bill assumes that giving the FDA more federal power and involvement into a state regulated profession will enhance patient safety. We disagree.” http://www.heraldonline.com/2013/09/24/5241830/new-poll-finds-senate-bill-959.html