We all have recently heard reports in the news about contaminated injections that were compounded by the New England Compounding Center (“NECC”) in Massachusetts. This has been a tragic series of events that have resulted in several deaths, and that clearly must be investigated to prevent further harm and to guide corrective actions. At the same time, it is important to gather all of the facts and relevant information before we jump to inaccurate or inappropriate conclusions.
Many of us use compounded medications on a daily basis, and I want to reassure you about these types of medications. I believe that they are an essential part of the best therapy for patients at mid-life.
They are also very important for any patient who needs medications with a formulation that is different from the standardized medicines that are produced by the pharmaceutical companies, or for those who need medications that are not produced at all by those companies whether due to convenience or the perceived lack of profitability.
Compounding pharmacies prepare medications based on the needs of the individual patient as prescribed by a clinician. They have been around for a very long time, and used to be the way we obtained most of our medications. This is a very valuable service and a cost effective way to meet the particular needs of individual patients, particularly in providing hormone replacement therapy.
I asked our three greater Santa Rosa area compounding pharmacies to weigh in on the issue, and you will find comments below in alphabetical order from Dollar Drug, HealthFirst, and Redwood Compounding Pharmacy. They each are committed to meet your health needs for compounded medications in a safe and effective manner.
With commitment and confidence,
Jane Kennedy, CFNP, MN, MPH
DOLLAR DRUG – By Mark Gutormson, Pharm D
The unfortunate events that have unfolded at NECC quickly brought to mind an eerily similar event that occurred in our own backyard. In 2001, a Walnut Creek compounding pharmacy produced a batch of contaminated injectable steroids that resulted in the death of 4 patients. The effect was a local and national media hysteria that brought “compounding pharmacies” under tremendous scrutiny, and rightfully so- lives had been needlessly lost. That tragedy spearheaded big changes in the requirements for compounding in California. As a result, there are substantial differences between states, but the mass media have failed to make this distinction in their reporting.
“Sterile compounding labs” like NECC and the Walnut Creek pharmacy produce injectable and other “high risk” formulations, drugs that are designed to be delivered directly to systems in the body (like the central nervous, circulatory, and respiratory systems) that are normally free or nearly free of bacteria and fungus.
Dollar Drug in Santa Rosa is not a sterile compounding pharmacy. For over 30 years we have safely and effectively created “non-sterile” medications such as topical creams and oral preparations for a variety of conditions relating to bio-identical hormone therapy, pain management, veterinary medicine, and much more. We are Sonoma County’s most experienced compounding pharmacy. We ensure the integrity of our compounded medications by regularly sending our finished products to an independent laboratory for quantitative analysis and quality assurance. We are committed to continuing to produce quality compounds that our patients can trust.
HealthFirst – By Mark Burger, Pharm D
Basically, the New England Compounding Center was not a pharmacy but a manufacturer. This is the case not because of their sheer volume (there are successful, high-volume compounding pharmacies that may produce just as many units as NECC), but because of the fact that THERE WAS NO “TRIAD” RELATIONSHIP ESTABLISHED: Prescriber + Patient + Pharmacist. There was a breakdown in enforcement by the Massachusetts Health Department, the Massachusetts Board of Pharmacy, and the Federal Food and Drug Administration. Boards of Pharmacy, through inspections, should assure patients that there is a “Triad Relationship” in place for every dose that leaves one of their pharmacies.
In addition, this pharmacy was also located in a building that also housed a recycling facility. Although we don’t know the source of the “black mold,” it doesn’t sound promising to have a facility of this kind next to a sterile compounding lab. California patients who use local, California pharmacies can be extra confident since the California Board of Pharmacy has enacted more stringent licensing and inspection criteria for compounding pharmacies. In addition, STERILE COMPOUNDERS (like NECC) have to get a separate license, additional inspections, and they must have specific written Polices & Procedures.
At Health First Pharmacy, we have “passed” on many opportunities and have lost business because we have refused to supply prescribers with “bulk medications” that don’t have a patient assigned to each prescription. In California, dispensing prescribers are required to produce a patient-specific label that complies with Board of Pharmacy regulations, to track lot numbers, and to keep track of expiration dates on any prescription-only medication that is dispensed by them. Unfortunately, not every state has the same protections as California.
HealthFirst does not, yet, compound sterile products. We are building a clean room and writing Policies and Standard Operating Procedures (SOPs) for this operation as I write. Again, we have “passed” on taking on this type of compounding until we could build a state-of-the-art clean room in a larger building (we purchased 2 commercial buildings across the street for this purpose). When our clean room and new site are finished, we will be inspected by the California Board of Pharmacy and will correct any deficiencies that the Board might find. After that, our entire facility (Sterile and Non-Sterile Labs) will apply for PCAB accreditation (Pharmacy Compounding Accreditation Board). When we achieve this accreditation, we will announce it to prescribers, patients, and potential patients.
Another, excellent source of information on this tragic situation can be found on the website of the International Academy of Compounding Pharmacists (of which I am a member). Visit their Home Page and Press Release.
Redwood Compounding Pharmacy – By Moussie Haile, Pharm D
What’s happened is absolutely tragic. I hope people understand that it looks like NECC was operating more as a manufacturer than a compounder.
Redwood Compounding Pharmacy is a licensed compounding lab with certified clean room for compounding all our sterile preparations. We chose to operate a “specialty compounding only” pharmacy to minimize distractions and to focus on high quality compounding. This model of specialization means that staff is not bogged down with maintaining sales of front-end store products. Instead, they are able to focus their skills and efforts strictly on compounding.
Furthermore our lab was designed from the ground up for quality, from specialized flooring to a ceiling system with HEPA filtration units to control air quality. Redwood Compounding also utilizes sophisticated technology with equipment such as microprocessor controlled autoclave units, a laminar flow hood and a specialized clean room that not only meets but exceeds USP 797 regulations. We also have independent Quality Assurance and Quality Control programs to ensure that our products and patient care meet high quality standards and requirements.
Our commitment is to provide a level of service that delivers safe compounded products consistently that patients and their clinicians can depend upon.