The pharmacy at Kona Community Hospital needs an additional $2.3 million from the state Legislature to comply with federal regulations or risk closure, potentially affecting over 500 chemotherapy patients.
What put the facility in jeopardy is a 2019 inspection by the U.S. Food and Drug Administration.
From Dec. 2, 2019, to Dec. 13, 2019, FDA investigators inspected the facility, which was remodeled in 2017. During the inspection, the investigators noted serious deficiencies in practices for producing sterile drug products, which put patients at risk.
The FDA issued an official notice to the hospital on Dec. 13, 2019. The FDA said it appeared the hospital produced drug products that violated the Federal Food, Drug and Cosmetic Act.
The investigators noted that drugs intended or expected to be sterile were prepared, packed or held under insanitary conditions and may have become contaminated — and potentially dangerous.
According to the FDA, the pharmacy also failed to evaluate whether the contamination had any impact on pharmaceuticals that were prepared in its clean rooms.
The hospital, under the umbrella of the state-run Hawaii Health Systems Corp. submitted corrective actions. However, at the time, in their responses related to the insanitary conditions, the FDA said it could not fully evaluate the adequacy of corrective actions described in the hospital’s response because it did not include sufficient information or supporting documentation.
At that time, the FDA strongly recommended that management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials and systems. In particular, the FDA said this review should assess the facility’s aseptic processing operations, and that a third-party consultant with relevant sterile drug manufacturing expertise should assist the hospital in conducting this evaluation.
Hospital CEO Clayton McGhan responded that US Pharmacopeia (USP) standards for hospital pharmacies have been in effect for many years. The last version was updated in 2008.
“At the time of our remodel, our pharmacy design was — and still is — appropriate and acceptable. However, USP has revised standards and best practices. Due to our present design, our current room is not considered a clean room suite. We operate as a segregated compounding area. For a facility of our size, the current standard of practice is to have a clean room suite,” he said. “We are well into a pharmacy expansion project that will build an additional suite onto the existing pharmacy, including the needed clean room suite.”
He added that “drawings have been submitted to the County of Hawaii, permits are in process. A general contractor is prepared to begin when the permitting is done and funds are available. Additionally, we have much of the necessary equipment ordered already.”
The hospital received partial CIP funding for the expansion in FY 2022. However, McGhan said inflation has greatly increased the estimated cost of the project, which is why they are seeking funding again this year.
Without funding, the pharmacy risks closing.
“We could be at risk of closure as early as November 2023 by the regulatory bodies that enforce the USP’s standards,” he said. “We do plan to appeal if that happens, but that process could take some time, and we are hopeful that they will allow us to continue providing lifesaving treatment to our patients during the appeals process.”
McGhan said Kona Community Hospital has always — and will continue — to put the community first.
“We want to assure our community that the challenges we face do not prevent us from ensuring quality care for every single one of our patients,” He said. “We are immensely grateful to the community for their support. We encourage our community to reach out to their area legislators, thank them for their support, and share why this issue is so important.”
It will cost an additional $2.3 million to make the necessary improvements to create the required clean room suite and a hazardous drug storage area for the pharmacy.
McGhan said the funds could come from the Legislature or through a gubernatorial emergency declaration, which is rare, and reserved for the most critical of infrastructure projects. However, he hopes state lawmakers will fund project due to the urgent need.
“The Kona Community Hospital is critically important to the health care landscape in West Hawaii. We are strongly supporting KCH in its needs to upgrade its pharmacy to meet all regulatory compliance requirements, to ensure that cancer patients can receive chemotherapy infusion treatments within their community, rather than enduring long commutes to Hilo or Oahu,” said Dr. Linda Rosen, president and CEO, Hawaii Health Systems Corp.
“We are grateful to the House of Representatives for its support of HHSC and look forward to continuing to work with the Senate to recognize and support the needs of Kona Community Hospital, as well as the expansion of Hilo Medical Center,” she said.
