Oct 25 2012
Weak drug regulation and patient tragedies: We’ve seen this story before
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20 Responses to “Weak drug regulation and patient tragedies: We’ve seen this story before”
Perhaps on another day I could use spoon feeding on the bad/good of me-too drugs, and non-inferiority of new drugs.
“prove to be the impetus for the appropriate regulation of compounding pharmacies.”
Scott, is the problem lack of regulation or the lack of enforcement? I’m not arguing a position here, I’m truly not clear on this.
Standards for sterile processing are well understood throughout the medical manufacturing industry. Even in cases where products are not sold sterile (devices now, not drugs), manufacturers pay close attention to bioburden.
It may be that additional regulation is needed. But I’m always cautious about the impulse to add new laws and regulations where existing strictures are not being enforced. When people say, “there ought to be a law,” there often is. What there ought to be is good enforcement of existing law before we decide that we need new ones.
@windriven:
We can generally categorize compounding into two type of practices. There’s individual prescription compounding, for which state/provincial regulations are designed. That’s the practice common to most pharmacies these days – making a suspension of a solid oral dosage form for someone with swallowing difficulties, for example. Then there’s the compounding by pharmacies like NECC which is essentially bulk manufacturing – call it Little Pharma. The scale and magnitude (and potential for harms) are much greater. Compounding pharmacies use the former to argue against regulation, which allows the latter to continue. Yet the oversight and enforcement framework is not comparable to the standards and expectations established by the FDA for manufacturers.
@Scott Gavura
“which is essentially bulk manufacturing – call it Little Pharma”
Bait and switch. Achieve licensure as a pharmacy but operate in fact as a manufacturer.
There ought to be a law
When our first child was born (2007), my wife got a prescription for Newman’s Nipple Ointment (because of an allergy to lanolin) that had to be filled by a compounding pharmacy. While there, the pharmacist handed us some propaganda pamphlets about how there were laws proposed that would severely limit the ability of compounding pharmacies to practice. They did a good job of making it sound like Big Pharma was persecuting the little guy, but a small red flag did go off in my head that something just didn’t seem right about it. Now I think I fully understand what was going on.
Thank you, SG
I see a parallel to this and the issues of small food manufacturers. There have been a number of articles over the last year or two of small food purveyors (up to and including children operating lemonade stands, but primarily people making pies and such from their kitchen) being slapped with fines and threats of legal action for not operating under restaurant standards. Putting a new law into place may help to bind these huge companies that are claiming the ability to compound the medications, but may also suddenly restrict the ability of the drug store down the street to put your medication into a more palatable form. Would it be enough to require explicit labeling of medications that have been reprocessed much like how one can buy unpasteurized honey from the Amish fully knowing and accepting the risks?
I speak, of course, as someone who was largely ignorant of this compounding issue prior to reading the article.
I’ve been following this outbreak of fungal meningitis intently on the CDC website, since it was first reported by media outlets.
Here’s the latest from a Massachusetts TV media outlet, about the Massachusetts laws that govern compounding pharmacies. The compounding pharmacy that sent out thousands of vials to physicians, pain centers and hospitals to “stock supplies” of the injectable steroid, violated the Massachusetts law by failing to have individual patient prescriptions, before shipping the drug.
http://www.cbsnews.com/8301-204_162-57539469/fungal-meningitis-outbreak-claims-24th-victim/
“…..According to Massachusetts law, compounding pharmacies must have a prescription for every patient for each dose they send out. More than 17,000 vials of the suspect steroid went to clinics in 23 states. However, documents released Monday show that complaints against NECC for lack of individual prescriptions date back to 1999…..”
I have been unable to find any demographics (age), of any of the patients who were infected/died (patient confidentiality)…but I’m willing to *bet* that many of these patients were NOT Medicare/Medicaid recipients. Did these physicians/pain centers/hospitals just go for the cheaper drug to keep costs down?
I think I remember hearing early on that drug shortages from the big pharma manufacturers might have played a minor role, as well. Can anyone verify or refute that?
@windriven
“There ought to be a law”
Or perhaps a loophole being closed would suffice, since this seems to be the way the offending pharmacies got by with their practices. But, can a loophole be closed without creating new laws?
To clarify my comments above, about Medicare/Medicaid patients becoming infected through contaminated intrathecal injections, from compound pharmacies.
I should have linked to Scott Gavura’s link at Bloomberg:
http://www.bloomberg.com/news/2012-10-23/meningitis-outbreak-exposes-need-to-stop-drug-shortages.html
“…..To get a sense of what might have happened, consider the forces that cause drug shortages. In most cases, the medicines in tight supply are, like the steroid involved in the meningitis outbreak, older generic injectables, the kind that are typically administered by a nurse, doctor or other health professional. They also include antibiotics and cancer and nutrition drugs.
In an ordinary market, when one company’s production lines shut down, competitors step in to meet demand. The generic injectable drug business is different, however, in that it is greatly influenced by the practices of Medicare, the largest U.S. purchaser of health care. As a Bloomberg Government study points out, Medicare rules from 2005 prevent reimbursement to providers for injectables and other drugs that health-care workers administer from rising more than 6 percent above the average sales price. The cap has reduced suppliers’ incentive to expand capacity when shortages happen.”
This price limit — well intended to prevent Medicare from overpaying for drugs — also puts pressure on generic drug makers to stint on quality control…..”
@Janet
“But, can a loophole be closed without creating new laws?”
I certainly hope so. If you follow the whole thread of my conversation with Scott, that was the point. New law may be required – but let’s enforce the old ones and close any loopholes before we succumb to legislative fever.
@DugganSC Putting a new law into place may help to bind these huge companies that are claiming the ability to compound the medications, but may also suddenly restrict the ability of the drug store down the street to put your medication into a more palatable form
No, because it would be done by ONE prescription from ONE doctor for ONE patient of THAT pharmacy … the way the law now intends. Not batches of thousands of vials shipped over several states. Yes, the will and manpower to enforce the existing laws, and making it impossible for states to write laxer laws woudl be a start.
My dad was a pharmacist from the early 1930s through the late 1970s, and he compounded many things, but always one at a time for a certain patient … and he would never have compounded anything for injection because he couldn’t keep things sterile. He knew how, but he didn’t have the facilities.
He used to make my cough syrup too, because I can’t handle the taste of most of the commercial brands. You haven’t had a cold until you have on treated with terpin hydrate and codeine cough syrup, with REAL rum flavoring.
Sorry if this has been mentioned and I missed it, but maybe it’s not so much the regulation but the funding mechanism for inspections and enforcement. Seems like this is an issue for enforcement. Should the tax payer pay for inspection and enforcement or should the party that profits from the product pay?
Just a thought, I haven’t looked closely at the situation beyond thinking, ‘how very sad’.
I think more regulation is actually needed, but not a great deal more. Currently, compounding pharmacies are regulated primarily under state law — even if, like NECC, they are doing interstate trade. Now, states could certainly increase their enforcement so their regulations have some value, but since different states have very different standards, this doesn’t really solve the problem. I think the regulations should be federal, not state, at least for this, because there is such a potential for abuse, and the main loophole that I see is jurisdictional confusion.
One compromise might be to say that if a pharmacy operates interstate, it is regulated federally. However, that would need to be done carefully, or it will create awkward situations in border cities.
One thing I don’t understand: If there is supposed to be a prescription for each patient dose, aren’t the 23 clinics that ordered the drugs responsible?
@mho
“aren’t the 23 clinics that ordered the drugs responsible?”
As I understand it, no. The regulatory standard seems to be that compounding pharmacies may custom compound a preparation for a specific patient and at the direction of that patient’s physician. That is rather different from mass producing a more-or-less standard preparation and distributing it broadly. That, I believe, falls under the purview of FDA as a drug manufacturer with all of the regulatory burden (and assured quality and safety) that goes with it.
A similar standard exists for medical devices. A physician may prescribe a custom device or prosthetic and generally a manufacturer can fabricate and deliver that device without going through either the PMA or the 510(k) process. But as soon as that manufacturer decides to make multiple copies and sell them for general use – even if a physician’s prescription is required – the manufacturer must submit to the regulatory process.
The difference is uniqueness. The loophole exists so that unusual requirements can be met on a timely basis and at a cost that doesn’t include massive regulatory overburden (even a simple PMA can cost tens of thousands of dollars to file and prosecute).
Here’s the latest on the New England Compounding Pharmacy investigation…
http://www.reuters.com/article/2012/10/26/usa-health-meningitis-fda-idUSL1E8LQCRX20121026
“….The FDA’s report adds to an emerging picture of sanitary conditions at NECC, a matter of interest to U.S. and state investigators trying to determine why the pharmacy was allowed to operate despite problems going as far back as 2002.
Massachusetts health regulators said earlier this week that they had found evidence of problematic procedures, record-keeping and work conditions inside the pharmacy facility.
FDA CITES COMPANY RECORDS
According to the FDA report, company records showed more than four dozen instances of bacterial or mold contamination that exceeded acceptable levels over an eight-month period. Some of the contamination occurred inside two “clean rooms.”
The report quoted NECC personnel as saying the firm shut off clean room air-conditioning each night at 8 p.m., a routine that FDA officials said was not typical for a facility that needs to be kept at a steady temperature.
A number of instances involved “over-growths,” or blooms of bacteria or mold visible to the naked eye.
The FDA said the discoveries were not investigated, the contaminants were not identified, and sterile products made on the days when samples were taken were not inspected. NECC had no evidence that corrective actions were taken, according to the report said.
In a teleconference with reporters, FDA officials strictly limited their remarks to the observations contained in the report. They acknowledged that companies are responsible for correcting contamination that exceeds “action levels.”
“Manufacturers and compounding firms know what to do,” said Steven Lynn, director of the FDA’s Office of Manufacturing and Product Quality.
“They have the responsibility to manufacturer quality drugs and to have processes in place to ensure that there’s no breakdown in the supply or the processes that would cause contamination,” he told reporters in a teleconference.
The FDA said its own inspections found “greenish black foreign matter” and other contaminants in an injectable steroid, 17 vials of steroids containing a “white filamentous material.”
According to the report, officials found microbial growth in 50 of 50 vials tested, tarnished discoloration on the internal services of sterilizing equipment and yellow residue on equipment used to weigh ingredients and other raw materials used to create sterile drugs.
The FDA said the production site abuts a recycling facility that handles mattresses and plastics, where excavators and freight trucks produce dust about 100 feet from rooftop units that serve NECC’s heating, ventilation and air conditioning system.”
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This is a vent more than anything but I recently saw this posted on the fb page for the main campus of the pharmacy school I go to:
“There is a field trip to (redacted) Pharmacy on WEDNESDAY, at 6:30 pm. This means we get the owner’s complete focus and the pharmacy all to ourselves. This is a great opportunity to see a pharmacy focused on non-sterile compounding available for a possible P1 summer rotation or P3 rotation! They specialize in bio-identical hormone replacement, but also do veterinary and pediatrics. Additionally, they offer consultations for their HRT patients.”
Part of me wants to speak out about the lack of scientific evidence supporting BHT, but the other part of me doesn’t want to rock the boat and flare tempers. I personally think compounding pharmacies potentially have an important role in the care of patients, and would possibly be interested in doing a rotation at one, but I think I’m going to have to pass on it because I don’t want to be put in the ethical dilemma of performing a service that I don’t believe in.