Proposed guidelines would severely limit in-office preparation of CSPs

Yolanda-Rosi-Helfrich.jpgBy Yolanda Rosi Helfrich, MD

The majority of dermatologists in practice routinely prepare simple compounds during patient visits. Often we don’t know in advance if a patient will require in-office treatment until they arrive for an examination. So it would be a major inconvenience to the patient if our ability to prepare compound formulas was restricted.

That’s why a recent proposal by US Pharmacopeia (USP) to revise requirements for preparation of pharmaceutical compounding has caused such concern among members of our specialty. USP, which is the organization that issues standards on both sterile and non-sterile compound preparations, is proposing strict new guidelines on all individuals and entities that prepare compound sterile preparations (CSPs). These restrictions have the potential to severely restrict impact our ability to prepare low-risk compounds in the office.

There have been concerns in recent years about the safety of compounding pharmacies following a 2012 incident in which over 700 people developed fungal meningitis or other infections and 64 people died from contaminated steroids dispensed by the New England Compounding Center in Massachusetts. In response to these concerns, the USP proposed revisions to current standards in order to ensure the safety of CSPs and opened the proposal for comments.

In other words, in-office Botox preparation following manufacturer’s labeling would be acceptable. Lidocaine dilution would not.

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Under this proposal, the CSPs prepared by dermatologists would 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.

While the proposal maintains that reconstituting or diluting a conventionally manufactured sterile product with no intervening steps, strictly in accordance with the manufacturer's labeling, is not considered compounding, it states that other reconstitution or dilution of a conventionally manufactured sterile product is considered compounding and must be performed in accordance with the proposed guidelines.

In other words, in-office Botox preparation following manufacturer’s labeling would be acceptable. Buffering of lidocaine or dilution of triamcinolone with lidocaine would not.

Academy action to stop the proposal

In January 2016, the Academy’s advocacy arm, the American Academy of Dermatology Association (AADA), submitted comments disagreeing with key parts of the proposed guidelines.

The AADA stressed that dermatologists support USP’s efforts to safeguard CSPs. However, the proposal threatens the common practice of dermatologists using products compounded in their own practice setting. The AADA explained that dermatologists generally engage in very low risk practices, such as administering compounded diluted solutions for intralesional injections, and that the compounds used in the practice of dermatology do not involve the risks associated with intravenous, intrathecal, or intramuscular injections.

The AADA disagreed with the USP position that reconstitution or dilution of a conventionally manufactured sterile product must be performed in accordance with the proposed guidelines. Steroids are often diluted with sterile saline or lidocaine and used for treatment of many dermatological conditions, including acne cysts, keloids, alopecia areata, hypertrophic scars, and psoriasis. The dermatologist determines the appropriate dilution during the patient visit. It is not always possible to order the correct dilution for intralesional injections prior to the visit.

The AADA also explained that it is common for physicians to buffer or dilute lidocaine, using sodium bicarbonate, epinephrine, and/or saline. This has been proven to significantly reduce the pain associated with the use of this local anesthetic.

The AADA urged the USP to consider the risks associated with the different methods of administration as it develops guidance on preparation of sterile preparations. For example, as with following the manufacturers labeling for dilution of products, preparation of the compounds used by dermatologists must follow aseptic technique, and procedures must be in place to minimize the potential for contact with nonsterile surfaces and introduction of particulate matter or biological fluids.

I encourage all AAD members to contact their members of Congress on the issue. Let them know that it is not reasonable to expect dermatologists who prepare simple compounds or dilutions used for intradermal or subcutaneous injections to adhere to the same standards as large compounding facilities. The USP must not attempt to limit the ability of physician offices to prepare and use compounds used for intradermal or subcutaneous injections, as they have safely done for decades.

Also, take time to educate your patients on this important issue. If this proposal is approved, the new guidelines will prove to be a major inconvenience for your patients. In many cases, instead of receiving treatment the day of their initial visit, their physician would have to order a compound from a pharmacy and the patient would have to return for another visit.

Dr. Helfrich is Residency Program Director and Director of Program for Clinical Research in Dermatology at University of Michigan. She is a member of the AAD Regulatory Policy Committee.