In-office preparations under threat

In June, legislation was introduced in the U.S. House to make compounded medications more accessible to patients. The bipartisan bill would clarify the Drug Quality and Security Act (DQSA) to balance public safety and patient access. In recent years, FDA restrictions on have severely restricted dermatologists' ability to access and mix preparations. The Academy is urging members to support the Congressional bill to preserve access to compounded medications.

Member to Member recently discussed in-office preparation issues with Murad Alam, MD, Deputy Chair of the Academy’s Congressional Policy Committee.
 

Member to Member: Why are in-office preparations under threat?

Murad AlamDr. Alam: By definition, dermatologists really don’t do in-office compounding. The majority of dermatologists in practice routinely produce simple preparations during patient visits. But under the FDA compounding regulations, which have not yet been finalized, dermatologists will be held to the same strict guidelines as large compounding pharmacies, even for low-risk preparations, such as buffering of lidocaine with sodium bicarbonate or dilution of triamcinolone with lidocaine.

In-office preparations are under threat because of a series of events that began with the contamination of compounded products made by a compounding pharmacy several years back for intrathecal use. It resulted in serious infections and deaths because the pharmacy didn't prepare the materials under sterile conditions.

This created a national health crisis that generated concern that compounded products in general need to be better regulated to ensure their safety. As a result of this incident, the federal government passed compounding legislation.

Once legislation is passed, a federal agency converts the law into rules, which it then implements. In this case, the legislation let the FDA very broadly interpret the mandate to mean that compounding is inherently dangerous and must be highly regulated in all instances. Most observers think this was not the intent of the regulation, which was designed to mitigate serious risks. But as is often the case with regulatory agencies, the FDA over interpreted the legislation to mean that compounding is inherently dangerous.

In addition, the US Pharmacopeia (USP), which works closely with the FDA, essentially eliminated the category of minimal risk compounding. They said that based on this new legislation, no compounding is minimal risk. Instead, all compounding demands a high level of scrutiny and all forms of compounding are potentially dangerous.

Once they eliminated the minimal risk category, it was a hop, skip, and a jump to saying that nothing should ever be mixed in any context, even if you’re just mixing it with water in a doctor’s office.

An associated issue is that even when some degree of in-office preparation of medications is being contemplated as acceptable, there are excessive and unnecessary limits being promulgated on how long these mixtures can be kept before use. In some cases, prepared medications may be kept for just an hour, which is often impractical.

We’ve reached the point where the proposed regulations, if finalized and enacted, may restrict normal operations in a physician’s office.

M2M: What’s the Academy doing to protect dermatologists’ ability to perform in-office preparations?

Dr. Alam: The Academy is participating in an AMA-led coalition on physician in-office preparations. Academy representatives are meeting with the FDA, USP, and other experts who are closely involved with this regulatory process. We’re offering a very reasonable viewpoint on what needs to be regulated and what doesn’t.

Our basic message is that we are in support of the safety of compounded products in office. But there needs to be a distinction on what compounds need to be regulated and what don’t, and what materials are high-risk and what aren’t. We’re trying to clarify this distinction, which appears to have been lost in the regulatory process.

The Academy is advocating that there is a low risk category for compounding and in-office preparations. We know it’s low risk because it’s been done millions of times over many decades and nothing bad has ever resulted from these minimal risk preparations. Further regulation is not warranted because that would be fixing a problem that doesn’t exist.

Our fundamental message is that there is a distinction between high and low risk preparations and that unintended consequences of the legislation have led us to where we are now. We are supportive of safety but we’re not supportive of excessive regulation where no prior safety problem exists.

M2M: Are dermatologists still able to perform in-office preparations? Are the regulations being enforced?

Dr. Alam: Basically, at the moment, dermatologists in most states are able to perform in-office preparations because proposed guidelines are not finalized. Additionally, it’s not clear who would be in charge of enforcement. One of the reasons this is a difficult issue to address is because no specific regulatory agency has purview of it. The relevant players include the FDA; the USP that often marches in lockstep with FDA guidance; and state boards of pharmacy and medicine.

If we approach the FDA and say don’t be so restrictive, the FDA can say that they don’t regulate preparations; they just create guidelines. And that’s true because physician practice of medicine is regulated on the state level. However, when the FDA creates guidance it’s often enshrined in rules by the USP. And rules by the USP are often adopted by state boards of pharmacy. Then state medical boards usually defer to state boards of pharmacy. So, even though the FDA is not specifically controlling what physicians do in their offices, there is this chain of events that may inexorably result in FDA guidance being enforced as a rule.

TAKE ACTION

Earlier this year, a Congressional bill was introduced to ensure access to medications while maintaining the safety of compounded drugs. HR 2871, a bipartisan bill introduced by Rep Morgan Griffith (R-VA) and Rep. Henry Cuellar (D-TX) clarifies the regulatory authority of the FDA. 

Send a letter to your Congressperson in support of the bill on the Academy's Take Action website.

CONTACT YOUR REP


M2M: Are some states enforcing these rules?

Dr. Alam: Ohio and a couple other states have not waited for the final guidance to come out. They have started to enforce the rules even though the FDA guidance and USP proposal is still in the comment period. The FDA has received so many comments that it had to extend the comment period twice.

Some states boards of pharmacy have been a proactive and have enshrined the guidance in their local rules and laws. That’s resulted in the state having to enforce the guidelines.

Most states are waiting for final guidance and the Academy and many other groups are trying to ensure that the final guidance is reasonable and doesn’t restrict the practice of medicine.

M2M: What can members to do maintain the ability to perform in-office preparations?

Dr. Alam: It’s important to get involved in advocacy at the state level. This is extremely important, especially if the FDA final rule doesn’t favor our recommendations. States are given wide deference in how they regulate medicine and pharmacies.

Also, I encourage all members to support the Academy’s advocacy efforts. The compounding page on the AAD website lets members know what the Academy is doing to preserve in-office preparations and gives direction on how members can advocate at the state and federal levels.