Recently, Medtronic released a notice to its physician clients regarding the use of compounded sterile medications within its SynchroMed drug infusion pumps. This notice cited a study performed by Medtronic during which a correlation between the use of compounded medications and early pump failure was discovered. Whether intentional or not, this notice, in addition to the recent meningitis outbreak, has caused concern amongst pain physicians and raised the question of whether or not compounding pharmacies are safe to utilize for intrathecal pain treatment.
It is Hartley Medical’s belief and understanding that this notice was sent to create separation between Medtronic and compounding pharmacies. It is in the best interest of Medtronic to make a public announcement implying that no necessary relationship exists between them and compounding pharmacies, and doing so would presumably eliminate any case that can be made against them as supporters and promoters of compounded medications should another outbreak occur. To the best of our knowledge, Medtronic’s notice does not state that compounded medications have no clinical effect, only that they can affect the life of the SynchroMed devices.
Compounding pharmacies provide a level of service, convenience, knowledge, and care that physicians cannot find with traditional manufacturers. When commercially available pharmaceuticals are not achieving clinical efficacy, pain physicians turn to compounding pharmacies to provide a custom formulation that, more often than not, alleviates patient pain significantly and helps them to achieve a greater quality of life. Compounded medications have an extensive and well documented history with the Medtronic pain pumps and their development. Numerous notable and well-respected medical professionals have devoted many resources to the education and promotion of effective pain treatment through the use of compounded medications, as is evidenced by the formation of the Polyanalgesic Consensus Committee. To reiterate, we at Hartley Medical believe this notice is in the best interest of Medtronic’s business, and does not reflect their opinion about the clinical efficacy of compounded medications. We believe they are strong supporters of compounding pharmacies who are operating at and adhering to the highest quality standards. We assume that this is a precautionary measure that serves to limit Medtronic’s risk in partnering with compounding pharmacies moving forward.