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Wednesday, March 27, 2013
Question of the Day: Has the Sky Fallen on Compounders and Compounding Pharmacies Because of Greed or Is it Simply a Failure to Police Ones Own by Enforcing the Laws on the Books or Is it Both?
There will always be at least a few "greedy" companies, but the real failure is in the lack of enforcement by state Departments of Health and the state Boards of Pharmacy. Here's the flaws in the enforcement system as I see them:
1. Inspections are often done by "less-than-fully-trained" inspectors, who are looking more for whether the pharmacy has the statutorily required signage (e.g. Ask your pharmacist about the option to get a generic drug" and less at whether the pharmacy is compounding sterile drugs in a safe manner or whether the pharmacy is engaging in illegal kickback/split-fee relationships, to get more business.
2. Departments of Health are "reactive" to complaints, but don't do any surveillance on their own to look for violations. Waiting for a complaint is basically the same as waiting for 21 polo ponies to die (or human patients tomgo blind from contaminated eyedrops), and then, and only then, find out what went wrong.
3. Complaints that are filed are often shelved due to lack of manpower to investigate and/or prosecute them. A shout out to the crowd that votes for smaller government and less taxes - "You don't get what you don't pay for." If you don't fund regulatory agencies (whether it be e FDA, the FTC, or local Departments of Health), you wont get inspections or enforcement actions. Summary: low taxes = melamine in the baby food and antifreeze in the toothpaste. If we don't fund pharmacy inspections, you'll get more meningitis type deaths.
4. Boards of Pharmacy (and Boards of Medicine, etc) have to discipline licensees harshly enough to cause a DETERRENT EFFECT for other licensees. White collar crime needs more than a light fine, it needs suspension and restriction of practice, to make it hurt enough to not risk engaging in bad behavior. All too often, the "slap on the wrist" begets the impression that a pharmacy can do what it wants with no worry about the repercussions. NECC is a prime example of what happens when you let a pharmacy off easy. They just get bolder and do more crazy stuff.
Plain and simple: LACK OF ENFORCEMENT IS THE PROBLEM.
There will always be at least a few "greedy" companies, but the real failure is in the lack of enforcement by state Departments of Health and the state Boards of Pharmacy. Here's the flaws in the enforcement system as I see them:
ReplyDelete1. Inspections are often done by "less-than-fully-trained" inspectors, who are looking more for whether the pharmacy has the statutorily required signage (e.g. Ask your pharmacist about the option to get a generic drug" and less at whether the pharmacy is compounding sterile drugs in a safe manner or whether the pharmacy is engaging in illegal kickback/split-fee relationships, to get more business.
2. Departments of Health are "reactive" to complaints, but don't do any surveillance on their own to look for violations. Waiting for a complaint is basically the same as waiting for 21 polo ponies to die (or human patients tomgo blind from contaminated eyedrops), and
then, and only then, find out what went wrong.
3. Complaints that are filed are often shelved due to lack of manpower to investigate and/or prosecute them. A shout out to the crowd that votes for smaller government and less taxes - "You don't get what you don't pay for." If you don't fund regulatory agencies (whether it be e FDA, the FTC, or local Departments of Health), you wont get inspections or enforcement actions. Summary: low taxes = melamine in the baby food and antifreeze in the toothpaste. If we don't fund pharmacy inspections, you'll get more meningitis type deaths.
4. Boards of Pharmacy (and Boards of Medicine, etc) have to discipline licensees harshly enough to cause a DETERRENT EFFECT for other licensees. White collar crime needs more than a light fine, it needs suspension and restriction of practice, to make it hurt enough to not risk engaging in bad behavior. All too often, the "slap on the wrist" begets the impression that a pharmacy can do what it wants with no worry about the repercussions. NECC is a prime example of what happens when you let a pharmacy off easy. They just get bolder and do more crazy stuff.
Plain and simple: LACK OF ENFORCEMENT IS THE PROBLEM.
Kenneth Woliner, MD
www.holisticfamilymed.com
You make excellent points Dr. Woliner. Thank you for your comments.
ReplyDelete