- Lab experiments identified various bacillus bacteria in medical products from a Massachusetts specialty pharmacy associated with a fungal meningitis outbreak.
- The seriousness of the situation grew when the implicated company recalled all of their medicinal products, sparking concern over the safety of specialty pharmacies.
- The state of Massachusetts responded by issuing emergency regulations that increase oversight of specialty pharmacies, including forcing them to report any investigations by state or federal agencies.
- The fungal meningitis outbreak has caused 28 deaths and caused illness in 386 individuals across 19 states, with thousands potentially at risk from contaminated steroid injections.
- Debate over appropriate regulation and oversight of specialty pharmacies that create customizable drugs has been initiated in light of these events.
Experimental lab tests have recently revealed bacteria in additional medical items forged by the same Massachusetts specialty pharmacy that is implicated in continuing fungal meningitis outbreak, as per the U.S. Food and Drug Administration’s authorities.
While it is still undetermined just how harmful the assorted bacteria discerned in three batches of a steroid implemented in eye surgeries and one batch of a solution utilized to halt the heart while performing cardiac surgeries could prove to be, concerns about the safety of any medical products made by this specific compounding center have been voiced loudly.
A Surge in Concerns
The urgency of these concerns has escalated with the company at the heart of the meningitis outbreak voluntary recalling all of their medicinal products and discontinuing manufacturing at their plant in Massachusetts.
Several varieties of bacillus bacteria were uncovered in three lots of preservative-free betamethasone, with different culture results being produced for each lot. Furthermore, bacteria were also found in a single batch of cardioplegia solution. The discovered bacteria include Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niabensis, Bacillus circulans, Bacillus lentus, Bacillus halmapalus and Brevibacillus choshinens.
Response of Massachusetts State
In a swift response to the unfolding situation, Massachusetts has enacted emergency regulations, now having more oversight and control over specialty pharmacies akin to the compounding center at the center of the crisis.
Under these newly constituted regulations, the state is enabled to monitor the distribution and volume of the drugs produced by these pharmacies, deciding if they ought to be subject to licensing regulations by the FDA. Speciality pharmacies will also be compelled to report if they are under investigation by another state or federal agency.
Failure to comply with these new state directives will have pharmacies facing penalties which include being quarantined or closed down by the state pharmacy board.
State of the Outbreak
The fungal meningitis outbreak has sadly resulted in 28 deaths while causing illness in 386 individuals across 19 states. The U.S. Centers for Disease Control and Prevention have reported declining numbers of deaths in certain states, but the issue is far from disappearing.
The CDC also shed light on the fact that nine out of the 386 cases involve what’s termed as “peripheral joint infection”, which implies infections in areas such as a shoulder, knee, elbow or hip. These infections are seen as less harmful when juxtaposed with injections near the spine done for back pain, these later ones have been linked to potentially fatal meningitis infections.
Meningitis signifies inflammation of the lining surrounding the spinal cord and brain. The steroid injections in question are typically used to treat lower back and joint pain.
Patients who have been infected after steroid injections have shown a variety of symptoms that typically appear one to four weeks following their injections. Any patients who have had injections after July should consult their healthcare provider promptly if they experience symptoms like worsening headaches, fever, light sensitivity, stiff neck, new numbness or weakness in any body part or slurred speech.
The Gravity of the Situation
The state’s health departments, in conjunction with the CDC, estimate that nearly 14,000 individuals may have received these potentially dangerous steroid injections. All these patients, who have so far been identified with fungal meningitis, were believed to be injected with methylprednisolone acetate.
In light of these events, Massachusetts officials have commenced a criminal investigation into this specialty pharmacy, but we await further details.
Federal investigators recently toured the plant found to be at the center of this outbreak, and highlighted potential violations after discovering foreign, “greenish-black” material in some of the steroid’s injectable vials, which are suspected as the illness’s cause.
The FDA announced that a company sharing the same founders as the implicated compounding center voluntarily recalled all its products. Though no infection reports have arisen linked to this company’s products, out of caution, the recall was recommended by the FDA.
As this situation continues to develop, the compounding pharmacies, that combine, mix or alter ingredients to create drugs based on individual patient requirements, have fallen under heightened scrutiny. Discussions regarding whether such pharmacies should be subject to the same FDA oversight as regular drug manufacturers have ensued, solidifying the need for enhanced regulatory control.
If you are looking for more information regarding injections for back pain, you could visit the U.S. National Library of Medicine’s website or a trusted healthcare provider. Always remember, the importance of seeking reliable healthcare advice in keeping ourselves healthy cannot be overstated.