New Hazardous Drug Regs: ‘Sweeping changes’ coming in 2019

Before the advent of mass drug manufacturing, prescriptions were mixed – or compounded – by the hometown pharmacist.

While this old school service still exists for special cases – like medicinal allergies, or cheaper versions of hormonal creams – new regulations could price local pharmacies out of the practice altogether.

USP 800 are new standards outlined by the United States Pharmacopeial Convention, or USP.  USP 800 standards were developed to provide a complete set of standards for all healthcare workers to help ensure the safe handling of hazardous drugs throughout the healthcare system, including in the practice of compounding.

The crux of the matter lies in the new design and engineering specs outlined by USP 800. Among other requirements, after the December 2019 deadline, USP 800 requires that all hoods be vented to the outside, and all compounding equipment be duplicated to accommodate hazardous and non-hazardous work.

Thompson Pharmacy in Traverse City is one of the few remaining pharmacies in the area that is certified to compound medicines. To comply with USP 800, Thompson’s would have to invest up to $30,000 in new equipment, including a $3,000 scale, a $5,000 mixer, a new capsule machine and a rerouted venting system.

“We’re already doing most of the stuff but that’s going to be a big hit,” said Mark Thompson, the pharmacy’s owner. “In a way that’s good – we’re doing a lot of it already – but the hard part will be spending the money without getting any increase in profit. So we’ll have to increase the prices of the [compounded] medicine to offset that.”

Thompson estimates prices for compounded medicine will go up 20 to 50 percent … if the regulations go into effect.

“We’re not sure if they’re going to change some stuff – it was supposed to happen July of this year but didn’t because the changes didn’t make sense,” he said.

One change Thompson believes is nonsensical is a requirement that hazardous drugs and non-hazardous drugs never be in the same room, which caused problems in hospitals sending medication up to patients and for pharmacies that store medications in bins for patient pick-up.

So for now, Thompson says he is going to do as many changes as possible, ” … unless they add on something to make it impossible to do it.”

“[The government] could make sweeping changes at any time,” he said. “[I]f I have to spend $100,000, there’s no way. The compounding is only somewhere between five and 10 percent of my business.”

Thompson says that the 2012 meningitis outbreak that killed 76 and sickened more than 800 is what caused the federal Food and Drug Administration to “come up with a bunch of changes.”

“It’s out of the fact that they didn’t do what they were supposed to do,” said Thompson of the outbreak, traced to the New England Compounding Center in Framingham, Mass., which violated its state license by functioning as a steroid injection drug manufacturer instead of filling individual prescriptions.

“[USP 800] feels emotional and not thought through at all,” he said. “[The FDA is] making decisions about an industry they don’t know much about.”

The dearth of compounding pharmacies relates to the increasing costs of equipment and the new regulations, Thompson said.

“A lot of people are doing less,” he said.

Michigan has stringent policies surrounding compounding practices and standardization. Pharmacies require a special certification and expensive equipment.

Until the deadline, pharmacists are permitted to voice concerns, but the regulations are expected to be enforced across the board.

While Thompson’s isn’t the only compounding pharmacy in the area, they do a significant portion of the work. For example, Munson Healthcare’s pharmacy fills approximately three to five compounding prescriptions per week. At Thompson’s, they do about 15 out of 150 to 200 prescriptions per day.

A compounding pharmacist can specifically craft a medicine for unique cases.

“If an infant were epileptic, you [would] need something liquid,” Thompson said. “You need something that will taste good.”

The services of compounding aren’t limited to infants or those with allergies. Compounds are also used for hormone therapies, thyroid disorders, and for veterinary purposes, such as a fast-absorbing topical cream instead of pills.

Local family practice physician Dr. Gregory Hessler says he often prescribes hormonal cream compounds, which are likely to be less expensive.

“The topical medication that’s most widely available is extremely expensive – around $275 a month – whereas a compounding pharmacist could make something just for you around $30 or $40 a month,” he said.

He worries that patients might forgo their medications if they can’t afford the commercially available drug.

Thompson said that local compounding services are important, especially for people who might need to fill a prescription quickly.

“Having somebody in town allows you that access to make it and to get it to you quickly,” he said.

In the event that the new policies enforced via USP 800 are too expensive, Thompson said closing that side of the business is likely.

“If I have to charge $500 a compound, that’s not going to do anyone any good,” he said.

Thompson said he is hopeful that won’t happen any time soon.

“Sometimes I think, ‘Should we keep doing this?’ ‘Is it even worth it?’ he said. “But I keep thinking people need it.”