Monday, May 27, 2013

Pharmacy Compounding And The Public

There's a very good reason why early 20th century laws, like the Pure Food and Drug Act, the Federal Food, Drug, and Cosmetic Act, and other FDA legislation were enacted.. because many innocent Americans died or suffered as a result of the unbridled quest of a few for greater profits.

When harmful consequences caused by those few begin to affect a significant portion the American public, our Federal political leaders need to act quickly and succinctly in order to protect the public and ensure that it doesn't happen again. IMO, that's not what's happening in pharmacy compounding.

For those unfamiliar with pharmacy compounding, let me explain how the process has worked over the years to give you a better understanding of the problem -

Traditionally, when a physician wants to provide a remedy for one of his/her patients, but such a remedy isn't commercially available (made by a pharmaceutical manufacturer), that physician would write a prescription for that patient, to be compounded (manufactured) by a neighborhood pharmacist.

This type of local manufacturing complies with the FDA rules and regulations for drug compounding because a physician writes a single prescription for a single individual patient, and because there is a direct relationship between the patient, the physician, and the pharmacist.

All three members of this relationship are directly involved in that one patient's care and can monitor whether that compounded prescription is effective or not. If an error was to occur anywhere in the process, only one patient would be harmed, and the source of that error could be easily traced and quickly corrected. This type of relationship has been working fine for decades.

But then, something changed along the way.

Recent medical technological advances made it possible for pharmacists to compound prescriptions in a more sterile environment. A niche was born, and some pharmacists sought to capitalize on it. Compounding pharmacists began to compound injectable prescription products outside of the hospital environment, similar to pharmaceutical manufacturers.

Over time, those pharmacists discovered that there weren't clear and concise laws regarding the compounding and sales of their products. There was an uncertain quasi-regulation of compounding pharmacies between both the State governments and the Federal government.

Somehow, compounding pharmacies were allowed to skirt the traditional rules of compounding and began compounding products without having that direct patient/physician/pharmacist relationship.

They began compounding injectable drugs without a written prescription from a physician, nor just for single individual patients. That niche progressed to the point where pharmacists started compounding injectable drugs in bulk, for local sale to hospitals, clinics, and doctors offices.

The compounding process further progressed to the point where pharmacists began shipping their compounded products interstate, throughout the United States. In essence, their pharmacies now became pharmaceutical manufacturing plants. But unfortunately, these pharmacies weren't being held to the same standards to ensure public safety that apply to pharmaceutical manufacturers.

Then, for various reasons, injectable drug shortages began to appear throughout the country. These compounding pharmacies began to grow and expand in providing replacements for those shortages.

But, no regulators seemed to be monitoring their activity. Compounders were left to self-regulate.

Because the important direct relationship between patient, physician, and pharmacist was missing, because no one outside of the profession was ensuring quality, and because these products were being shipped nationwide, it seemed only a matter of time before something tragic would happen.

A simple error could be "compounded" from only one patient being affected, to a large number of patients being affected, and it would become much harder to trace the source.

And that's exactly what happened. The multistate outbreak of fungal meningitis and other infections among patients who received contaminated steroid injections from just one compounding pharmacy has currently led to more than 740 innocent people being injured, with 55 deaths.

It's been over six months when we first learned of this tragedy, and yet compounding pharmacies are still being allowed to manufacture their potentially unsafe products, and are still allowed to continue shipping their products nationwide. No one in charge is seemingly attempting to stop it.

It's not like members of Congress are unaware of the unnecessary risks to the American public from allowing pharmacies to manufacture and sell injectable products without having to conform to the same sterility and manufacturing standards in which pharmaceutical manufacturers must comply.

Advocates in healthcare serving the interests of their patients as a whole have provided a simple solution to the problem. According to the Institute for Safe Medication Practices,
As we move forward and learn from the most recent outbreak, we call upon Congress to work with key stakeholders to address the need for additional laws on the federal level to fill in regulatory gaps. FDA oversight and regulations must be equal to what is required of pharmaceutical companies when compounding pharmacies dispense in mass quantities without individual patient prescriptions, manufacture sterile products from non-sterile active ingredients, or distribute across state lines.
Congress has also been told by the FDA that unclear laws make it difficult for them to enforce safety.

But yet, while there's reportedly a unconcerted effort on behalf of state and professional organizations in reaction to the problem, nothing is being done by Congress to simply correct the underlying cause.

House GOP members say that the laws don't need to be changed, and blame this tragedy on lack of FDA enforcement. They refuse to change the laws to clarify the regulatory gaps or work with Senate Democrats to quickly and succinctly rectify the situation. They're resolved to do nothing.

Meanwhile the Senate, acting like they are on the public's side, has taken the initiative to create a new regulatory class of drug manufacturers, confusingly called “compounding manufacturers,” that would be exempt from federal premarket approval and related labeling requirements, and thereby maintaining the status quo.

So I have to wonder, what the hell is wrong with all of these people? Don't they care?

To me, it seems as though no one in authority - not professional regulators, not State regulators, not Federal regulators, and neither political party wants to stop compounding pharmacies from behaving like pharmaceutical manufacturers, even when public safety is significantly at risk.

And that's the true tragedy behind this unfortunate incident.


  1. Love this post. You hit a lot of key points.

  2. Thank you. I think I've pretty much spelled it out - patient safety need to be paramount to anything else.

  3. Corrected a mistake on my post. There were over 740 patients affected total, "including" 55 deaths on the May 6th, 2013 CDC reported statistics.

  4. What you're forgetting to understand, Jason, is that the politics of pharmacy is just like the politics of Government. See for yourself and see if the same things don't ring true. - George Carlin: Lying Politicians And Words.

  5. Three proposed bills related to federal oversight of pharmacy compounding would put patients at significant risk by allowing companies calling themselves compounding pharmacies to manufacture drugs without meeting the same safety standards required of brand name and generic drug manufacturers, according to comments submitted by Public Citizen to the Health Subcommittee of the House Energy and Commerce Committee for its hearing today.

    Source: Public Citizen - Pharmacy Compounding Bills Would Endanger Patients, Public Citizen Tells Lawmakers

  6. To help ensure that the entities that compound drugs have appropriate oversight, Congress should consider clarifying FDA’s authority to oversee drug compounding.

    In addition, FDA should ensure its databases collect reliable and timely data on inspections associated with compounded drugs, and differentiate drug compounders from manufacturers. HHS's comments support the need to clarify FDA's authority, and stated that the information in its inspection database could be improved and that it would consider whether it can differentiate compounding pharmacies from manufacturers.

    Read more at: GAO - Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight

  7. What do you suppose a Texas drug compounding company did after the Food and Drug Administration (FDA) told it repeatedly to recall all its potentially “life-threatening” drugs? Well, basically, NuVision Pharmacy told the FDA to fuck off.

    Read more at: Compounders Slip Through Deadly FDA Loophole

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