Pharmacists Provide Novel Injection Services for Community

By taking advantage of Kentucky's definition of the practice of pharmacy, the pharmacist-run clinic at KentuckyOne Health's Our Lady of Peace administers injections of long-acting medications to a special clientele: patients with opioid addiction or a schizoaffective disorder.

The Louisville clinic opened on March 7, with pharmacy manager Steve Cummings administering a gluteal injection of naltrexone to a 30-year-old woman who, he said, did not fit his picture of a heroin addict.

She returned 4 weeks later for her second dose, given by clinic pharmacist Robert "Bobby" Conzelman.

"It's exciting because we're starting to see our repeats," he said in mid-April.

Conzelman said most of the clinic's patients receive drug products that have an every-4-week dosing schedule. Some patients, however, receive an every-2-week dose of risperidone long-acting injection.

"It really varies patient to patient on which long-acting [product] would benefit them," he said.

Cummings said the all-too-familiar situation of patients with an infection stopping treatment when they feel better and then worsening to the point of hospitalization holds true for patients with psychiatric disorders.

"In behavioral healthcare, . . . you have patients that [when they] stop hearing voices, they stop taking their meds," he said. "Or there's a stigma that's associated with taking a psychiatric medication," prompting some patients to discontinue their regimen.

Those who don't comply with their psychiatric medication regimen end up being readmitted to a behavioral healthcare facility like 223-bed Our Lady of Peace, he said.

The first long-acting injectable antipsychotic, fluphenazine decanoate, became available 45 years ago. Haloperidol decanoate came on the market in 1986.

Cummings said the idea for the clinic occurred to him 8 or 9 years ago: The "decanoates," as he put it, were being prescribed at the facility, and extended-release naltrexone injectable suspension had become available but was cost-prohibitive for inpatient use.

"You can kind of intuitively feel that this [outpatient injection clinic] is going to be something needed for psychiatry because you know that you have patients that go out and they're not compliant with their psychiatric medication," he said.

The facility's administrators, Cummings said, had envisioned staffing the clinic with a nurse who would inject the medications and be paid less than a pharmacist.

But he saw an advantage to having a pharmacist in the clinic to dispense the medications that would be injected.

Then, when the Kentucky Board of Pharmacy added "administration of medications or biologics in the course of dispensing or maintaining a prescription drug order" to the definition of the practice of pharmacy, the answer to the question of who should staff the clinic became obvious.

"Bring in a pharmacist to dispense and administer," Cummings recalled, emphasizing the ability of a pharmacist but not a nurse "to capture that dispensing fee."

He brought in Conzelman, who had been employed at the inpatient facility as an as-needed pharmacy technician while earning his degree and worked earlier there as a mental healthcare technician.

And Cummings hired a medication access coordinator, not a pharmacy technician, for the clinic.

In explaining his hiring decision to the physicians, he said the medication access coordinator, not them, would devote time to obtaining prior authorizations for the long-acting injectable drugs.

That new hire, Jasmine Douglas, "was on the side of trying to reject claims" at her previous employer, a for-profit third-party payer, Cummings said. "Now she's helping get people what they need, what they want."

The clinic has an infusion pharmacy permit and the same address as the inpatient facility, which participates in the 340B Drug Pricing Program.

Cummings said Medicaid accounts for a small percentage of the clinic's payers, with the rest being commercial insurers.

Lacking a computerized outpatient billing system, the clinic bills for medications in cooperation with KentuckyOne Health's specialty pharmacy, he noted. Once a billing system is in place, perhaps in July, he said, the clinic will be able to bill for medication administration and medication therapy management services.

The prescribers, Conzelman said, hail from the inpatient facility, the outpatient program for patients trying to recover from alcohol or opioid dependency, and the larger community.

In processing antipsychotic prescriptions written by outpatient physicians, Conzelman calls their offices to confirm that the patients had been receiving oral therapy and ask about possible hypersensitivity to the drug.

All the patients, he said, are at least 18 years old, save for the fairly large 17-year-old boy for whom special approval from the insurance company's medical director was obtained.

"We're averaging 2 or 3 [injections] per day," Conzelman said, adding that the clinic has been fielding a lot of phone calls about extended-release naltrexone injectable suspension.

So far, he said, 25–30% of the injections given at the clinic have been for opioid- and alcohol-dependence treatment.

Cummings said some of the clinic's calls have come from people who want such treatment but don't have a willing prescriber.

So he has been working on involving a nurse practitioner to ease the prescribing process for those inquirers.

Cummings, who describes heroin-addiction treatment with methadone as "substituting a beer for a bourbon," favors naltrexone for treating opioid addiction.

 The opioid antagonist, he said, offers "a cleaner way to treat people" addicted to alcohol or opioids.

 [This news story appears in the June 1, 2017, issue of AJHP.]