Hartley Medical has written on this topic many times in the past, but today I would like to share two interesting events that occurred over the past two months at Hartley Medical.
In November 2012, a prospective pain clinician in Oregon, Dr. Chiu, contacted us. During the phone call, the doctor requested an opportunity to perform a site visit – a request that we happily accepted. On January 18, 2013, Dr. Chiu flew down to Long Beach to take a tour of our facility. He presented us with many questions regarding our activities and procedures … questions that focused heavily on our quality assurance programs and operation procedures. He interviewed many staff members, including our production manager and quality assurance specialist.
During our working lunch break we were able to discuss specific procedures that enable Hartley Medical to provide the highest quality intrathecal medications to treat patients suffering from chronic pain. The exchange appeared to produce a greater understanding of vital role compounding pharmacies play in caring for patients – especially when they are operating to the highest of quality standards and in compliance with all regulatory mandates. Dr. Chiu departed pleased with what he had seen and heard, and he enthusiastically stated that he looks forward to working with Hartley Medical in the future. We were grateful for his visit.
Another interesting opportunity presented itself in February when a drug information specialist from a major health system located in Texas contacted us. This individual was directed by pharmacy administration to fly out and conduct a site visit; thus, she performed a four-hour, intensive study of Hartley Medical’s operations. Her pharmacy background provided a distinct advantage for her health system in her assessment of our facilities, as she was extremely knowledgeable with the intricacies of USP 797 guidelines.
We spent considerable time discussing Hartley Medical’s clean room area and the sterile compounding staff. She asked detailed questions pertaining to sterile compounding and was impressed to learn of our sterile preparation area’s filtration system employed to provide an optimal environment. We discussed at length Hartley’s quality assurance procedures with Philip Ing, Hartley Medical’s Quality Assurance Specialist. Our visitor appeared impressed with the extensive end-product testing procedures applied to our compounded preparations, and I was pleasantly surprised to observe her comprehension of endotoxin testing for bacterial contamination. Perhaps the most interesting part of the visit was this individual’s revelation that her past endeavors included being the lead singer of a rock band. Further proof that, quite often, there is much more to people than meets the eye. In the end, she returned to Texas with a better understanding of Hartley Medical and satisfaction with her journey and survey.
We at Hartley Medical warmly welcome these opportunities to exchange information and address questions from prospective clients and health systems. We see these as win-win situations. If for some reason we cannot address certain questions to the clients’ satisfaction, we view this as a problem to which we need to seek a solution. On the flipside, if we can address all of their questions satisfactorily, then we can conclude that we are on the right path in providing the highest level of care. We strongly encourage all providers to seek out their compounding pharmacies, perform due diligence and become informed – all for the highest care of their patients. In many ways, this effort provides peace of mind and a greater understanding of the level of risk you’re taking with your compounding pharmacy.
For more on Performing Due Diligence, visit the Knowledge Center by clicking here .
For more information on USP<797>, click here .