Governor Deval Patrick Wednesday accused the Massachusetts pharmacy linked to an outbreak of fungal meningitis, which has sickened at least 137 people nationwide and killed 12, of misleading regulators and operating outside its license by shipping large batches of drugs across the country.
To ensure no others might be breaking the rules, the Board of Registration in Pharmacy took the extraordinary step of ordering all compounding pharmacies in Massachusetts to sign affidavits swearing they are complying with state regulations prohibiting compounders from mass-producing medications.
Comments
Governor, how can something like this happen in Massachusetts?
Excellent question - which requires a logical, honest answer: The DPH Administration were blind to the bigger issues and have long vacated their responsibilities.
DPH Administration appears to not know who is in charge or what they are in charge of!
It is time the Federal Government or the Attorney General started asking some very serious questions due to the risk to both Massachusetts residents and the rest of the U.S.
Patrick claims the pharmacies were misleading regulators and operating outside their license – but – isn’t that why the state has auditors inspecting the pharmacies to ensure this will not happen! Why is the state paying staff to monitor pharmacies, laboratories, long term care homes, hospitals, etc. to ensure they follow laws and regulations that are pertinent to the facilities - if the state staff are unable to perform their jobs? Or is this a situation of the state ADMINISTRATORS who don’t understand their role in this process?
"To ensure no others might be breaking the rules, the Board of Registration in Pharmacy took the extraordinary step of ordering all compounding pharmacies in Massachusetts to sign affidavits swearing they are complying with state regulations prohibiting compounders from mass-producing medications."
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I don't think that asking compounding pharmacies in a more serious tone if they are complying with state regulations is going to be the answer here. That may help with a few businesses that are confused the rules or poorly managed, but the honest will answer honestly, and the dishonest will answer dishonestly. So, future deaths will come with an affidavit that nothing was being done wrong.
National Community Pharmacists Association:
"With an estimated 30 million to 40 million prescriptions compounded each year, the pharmacy profession saw a need for an enhanced, profession-wide system of standards by which each compounding pharmacy can test its quality processes. Compounding pharmacists also wanted a mechanism to allow them to indicate that their quality is high and that their patients are as safe as possible. PCAB Accreditation gives patients and prescribers a way to select a pharmacy that meets high quality standards."
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So, why do 17 states require PCAB certification compliance (per the Globe) and Mass does not? There may be good and sufficient reasons for this, and there may not. The Globe should ask the question of management.
Pharmacy Compounding Accreditation Board: PCAB
Why did Democrats in this state allow a dump next to a pharmacy and a pharmacy next to a dump??!?!?! Obviously, sensitive medical companies should be located away from disgusting dump sites and anything else that can contaminate what they are doing, by law if necessary.
Is there no end to the incompetence in this state. Perhaps the regulators have only hired friends and family as in the probation department!
"It takes a village." And, since everyone knows everyone else in a village you hire only the good people you know, and they hire only the good people they know, and if someone doesn't know someone they ask a known good person and they provide a reference. (Bad people are people who are incompetent, people from the other party, people who push back on management, people who insist on process and facts over knowning who is in charge; If you get any problems it is because you made a mistake and the good person you thought you were hiring was actually a bad person -- so you hang them in effigy as an example to keep the good people in line, as to refocus popular attention away from management.)
By the way, seems like the Department of State is also a village.
Management can relax when they live in a village, because, hey, they know everyone and everything that is going on -- no need to check stuff!
With "village" style management, managers can relax (because they know everyone and everything that is going on) and enjoy life. The public can relax because they know that their own tribe is in charge (hey, they have insider access). But, because stuff (detail and procedure) is not being thoroughly monitored everything works fine until there is a problem, and then you learn that, "holy cow, that wasn't being checked -- and this was going on for years and years?" The other reason this is a bad management style is that, with management relaxed the stream of new ideas is reduced. Why would someone in management want to push for something new? That's pushing against the culture, and pushing back is not valued. And, of couse, most obvious is that external "good ideas" will tend not to be considered. After all, if it's from outside the tribe it's just outsiders telling us what we already know. If it's from the tribe, it's tribe members not having faith in management and letting them do their job. So, the managment culture does not keep up with the changes in society and with best practices (which are continuously improving).
Let us hope that all those tea-party Libertards are paying attention to the reality of the need for regulation. The mythology of Ayn Rand won't save people's lives.