Feedback for Seeking Feedback on Proposed Implementation Timeline for NAPRA's Sterile Compounding Standards

Chiron Compounding Pharmacy Inc.  ·  June 17, 2016

We appreciate the College allowing pharmacists to provide feedback to the proposed implementation timeline of the Sterile Compounding Standards – hazardous and non-hazardous. There are two aspects to this proposal that must be considered independently:

  1. USP <797> proposal for Pharmacy Compounding of Non-Hazardous Sterile Preparations and

  2. USP <800> component which addresses hazardous sterile preparation. Although the College does not directly reference USP<800> the basis of the document entitled Pharmacy Compounding of Hazardous Sterile Preparations has identical requirements to USP <800>.

These are two very different requirements with huge cost implications to the pharmacy. We do not feel it is acceptable for the College to adopt both requirements at the same time. We appreciate the need for implementing USP <797> to ensure safety of compounded sterile medications. Although the College is not concerned with the cost of implementing these requirements, the College should be concerned with patient access to vital care and how feasible it will be to have continued access to required compounded medications. A pharmacy requiring major renovations to comply with USP <797>, will have difficulty ensuring capital is available for construction costs to comply with both USP <797> and <800> by September 2018. We agree that all pharmacies providing sterile compounding should be well on their way to compliance by September 2018 with full implementation by September 2019.

The regulation entitled Pharmacy Compounding of Hazardous Sterile Preparations (USP <800>) has not been written to protect public safety. It is written to protect the worker. The College should assess if it has the appropriate expertise to audit this regulation or if it is better governed by Occupational Health and Safety. Pharmacies working with appropriate hoods, PPE and policies are already protecting the worker and there is no supporting evidence to indicate that harm has come to any pharmacy worker. By implementing USP <800> the College will definitely adversely affect patient access to medication, at least in the short term. There will be many medications to which patients will have limited access (chemotherapy, special antifungal eye drops, progesterone suppositories, estradiol valerate injections ) which may result in therapeutic failures. The cost to a pharmacy to implement both programs simultaneously, will be between $500K and $1 million depending on the size of the pharmacy. To cover construction costs, increased electricity costs to run a negative pressure room 24 hours a day, training, equipment, developing SOP’s, increased costs for PPE, will require pharmacies to increase prices which will result in increased costs to the patient, ODB and drug plans. The increased costs required to implement Pharmacy Compounding of Hazardous Sterile Preparations (USP<800>)will not result in increased medication or patient safety. Unless the College takes a lead on changes to reimbursement, it will be difficult to expect pharmacies to comply.

Compliance costs associated with Compounding of Hazardous Sterile Preparations USP <800>:

  1. Threatens the continued financial viability of practices

  2. Jeopardizes patient access to pharmacist care and services for vital compounded medications

Compliance with Compounding of Hazardous Sterile Preparations (USP <800>) should be considered best practices not a requirement. We would suggest the College conducts a full risk assessment and reviews the scope of practice before forcing Compounding of Hazardous Sterile Preparations (USP <800>) on pharmacies. Health and Safety of staff members is paramount, but should not be mandated by the College. Manufacturers must comply with GMP regulations: • However, they are not required to follow USP <800> • The possibility adverse reactions in patients is much higher if errors occur with a manufactured product due to the large batch sizes • In a manufacturing environment – the exposure of workers to “hazardous materials” is much higher than in a compounding pharmacy. This requirement places an unfair burden on compounding pharmacies.

Is this requirement a way for the College to try and eliminate the practice of compounding?

We trust that the College will fully consider the implication these standards will have on patient access to compounded medications and on the ability of pharmacies to provide patient care.

For these reasons, Chiron would support a 3 year timeline for compliance with Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations (USP <797>) and five years for the Pharmacy Compounding of Hazardous Sterile Preparations (USP<800>).

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