As we come to the end of another Halloween season of
ghouls and ghosts, we’re reminded that real life is much scarier than any
imaginary villain we can concoct.
Few things are more frightening, in fact, than deadly threats against your health or the health of those you love. We have plenty of those types of diseases to deal with, most of which come into our lives unprovoked, which is why it’s particularly upsetting when another one slips through that could have been prevented.
In the case of the outbreak of fungal meningitis at a Massachusetts compounding pharmacy several weeks ago, the deadly component was a fungus in steroid injections that were concocted in a lab and administered to unknowing patients who were simply seeking some pain relief in their backs or joints.
The pharmacy, the New England Compounding Center of Framingham, Mass., recalled three lots consisting of a total of 17,676 single-dose vials of preservative-free methylprednisolone acetate, according to the Associated Press. The doses had been sent to 23 states and fungus was found in more than 50 unopened vials from the company.
More than 35 people in six states were infected with fungal meningitis linked to these shots. Twenty of those people have died as a result of the infection, and it appears that lack of oversight contributed to the deadly situation.
Compounding pharmacies like the one that
made this injectable steroid are not regulated as closely as drug manufacturers,
and their products are not subject to FDA approval for safety or
effectiveness, according the AP report. Clearly, that needs to
change.
This deadly meningitis outbreak is not the only problem that has arisen from such pharmacies, which create custom-mix solutions and medications in doses or forms that are not commercially available.
The AP reported that two people were blinded in Washington D.C., in 2005; three died in Virginia in 2006 and three more in Oregon the following year; 21 polo horses died in Florida in 2009; and earlier this year, 33 people in seven states developed fungal eye infections – all linked to drugs from compounding pharmacies.
When patients receive a drug of any kind from their doctor, they most likely believe that it has gone through FDA approval and the facility has been subject to rigorous inspection, so the drug is completely safe for their use. It’s shocking, frightening and enraging to find out that’s not the case.
The Massachusetts compounding pharmacy had been cited in the past for violations, and now inspectors believe they may have been operating beyond their license by making large batches of mixed drugs instead of customized prescriptions for specific patients. Everyone is looking for someone to blame in this incident and it’s certain that many lawsuits will be filed, particularly by those who lost family members to this disease.
Most importantly, however, this deadly incident offers an opportunity for regulators to take another look at their processes and try to improve the regulation of compounding pharmacies so such an incident can be avoided in the future. Of all the things we have to be afraid of, we shouldn’t have to fear our own medicines, the very thing we turn to for comfort when we’re already in pain.
Few things are more frightening, in fact, than deadly threats against your health or the health of those you love. We have plenty of those types of diseases to deal with, most of which come into our lives unprovoked, which is why it’s particularly upsetting when another one slips through that could have been prevented.
In the case of the outbreak of fungal meningitis at a Massachusetts compounding pharmacy several weeks ago, the deadly component was a fungus in steroid injections that were concocted in a lab and administered to unknowing patients who were simply seeking some pain relief in their backs or joints.
The pharmacy, the New England Compounding Center of Framingham, Mass., recalled three lots consisting of a total of 17,676 single-dose vials of preservative-free methylprednisolone acetate, according to the Associated Press. The doses had been sent to 23 states and fungus was found in more than 50 unopened vials from the company.
More than 35 people in six states were infected with fungal meningitis linked to these shots. Twenty of those people have died as a result of the infection, and it appears that lack of oversight contributed to the deadly situation.
This deadly meningitis outbreak is not the only problem that has arisen from such pharmacies, which create custom-mix solutions and medications in doses or forms that are not commercially available.
The AP reported that two people were blinded in Washington D.C., in 2005; three died in Virginia in 2006 and three more in Oregon the following year; 21 polo horses died in Florida in 2009; and earlier this year, 33 people in seven states developed fungal eye infections – all linked to drugs from compounding pharmacies.
When patients receive a drug of any kind from their doctor, they most likely believe that it has gone through FDA approval and the facility has been subject to rigorous inspection, so the drug is completely safe for their use. It’s shocking, frightening and enraging to find out that’s not the case.
The Massachusetts compounding pharmacy had been cited in the past for violations, and now inspectors believe they may have been operating beyond their license by making large batches of mixed drugs instead of customized prescriptions for specific patients. Everyone is looking for someone to blame in this incident and it’s certain that many lawsuits will be filed, particularly by those who lost family members to this disease.
Most importantly, however, this deadly incident offers an opportunity for regulators to take another look at their processes and try to improve the regulation of compounding pharmacies so such an incident can be avoided in the future. Of all the things we have to be afraid of, we shouldn’t have to fear our own medicines, the very thing we turn to for comfort when we’re already in pain.
• • •
Today’s editorial was written by Managing Editor Kristen Schulze Muszynski, representing the majority opinion of the Journal Tribune Editorial Board. Questions? Comments? Contact Kristen by calling 282-1535, Ext. 322, or via email at
Today’s editorial was written by Managing Editor Kristen Schulze Muszynski, representing the majority opinion of the Journal Tribune Editorial Board. Questions? Comments? Contact Kristen by calling 282-1535, Ext. 322, or via email at
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