Debra Hughes, MSDisclosures
May 09, 2013
A Win for Patients and Doctors Alike
Image from Medscape.com
Patients with cancer who are prescribed oral oncolytic medications can fill their prescriptions in several ways: at hospital, retail, and specialty pharmacies; via mail order; or in an oncology practice. Although in-office dispensing — defined as drug dispensing by a physician to patients — is controversial in oncology (and other specialties), there are sound reasons to consider offering it in your practice. Patients appreciate the convenience; physicians and staff derive satisfaction from seeing patients adhere to their medication regimens; and it could — some experts would say should — be profitable for your clinic.
Then why the controversy? Detractors point to the potential for a financial conflict of interest when physicians dispense medications in their own practices. However, although offering in-office dispensing can add to a practice’s viability, it’s not the potential for revenue that should guide the decision. Rather, the key question is, “What is the adherence rate of my patients receiving chemotherapeutic agents?”
So says Steven L. D’Amato, RPh, a board-certified oncology pharmacist and executive director of the Maine Center for Cancer Medicine and Blood Disorders, a 14-physician community oncology group with 4 sites. After a year of planning, the center initiated in-office dispensing in April 2011.
Since then, patient adherence rates have climbed to 90%, compared with national adherence rates for many long-term drug therapies of approximately 40%-50%.[1] Lower adherence rates are associated with an increase in physician visits, higher hospitalization rates, and longer hospital stays.[1]
In addition, unmeasurable rewards have resulted from the satisfaction derived when physicians and clinic staff work closely together “to ensure patients are educated on the benefit of adherence, toxicities are identified early, modifications are made rapidly, and symptoms are managed,” says D’Amato.
His group represents nearly 35% of the cancer specialists in Maine and serves approximately 42,000 patients annually, with 2400 new patients per year. The in-office dispensing program is run through the largest site, in Scarborough, and is open from 8 AM to 5 PM Monday through Friday — the same hours as the practice. Patients may choose to use the in-office dispensing program after being informed of all available options, as is required by law. Courier services are used to distribute medications to the other sites.
Improve Patient Adherence to Chemotherapeutic Regimens
From a customer-satisfaction standpoint, in-office dispensing offers convenience for patients who don’t feel well, are very frail, may have limited transportation, and are already in the office for other reasons. Education, financial advocacy, and cost savings on drugs are other key benefits.
Patient adherence to oral oncolytics can be problematic owing to lack of counseling, toxicity, and cost. Therefore, the education your practice can provide is especially important, given the increasing number of oral agents recently approved by the US Food and Drug Administration (FDA), as well as those in the pipeline. Face-to-face contact between patients and staff is essential to ensure that patients don’t misinterpret what they hear or read about a prescribed medication, have the ability to follow instructions, and understand potential toxicities and when to report them, D’Amato says.
“When patients receive drugs from specialty pharmacies, continuity of care is often lost, and there is waste associated with a change in a patient’s condition, so patients may end up with drugs they may not use,” D’Amato maintains. One study found that of patients who filled an entire prescription, 33.8% stopped taking the drug owing to an adverse event.[2]
To circumvent this situation, the center usually dispenses a limited amount of a drug that a patient has never taken before, “with close telephone follow-up within 24 hours to review adherence to a particular oncolytic regimen,” D’Amato says. Any reported adverse reactions or other problems are entered into the patient’s dispensing note and immediately communicated to the prescribing physician. Specialty pharmacies and payers are also now embracing this concept of “partial fills” — drugs dispensed in 14- and 16-day batches — to address the challenge of patients’ inability to adhere to oral oncolytic regimens.[3]
“The patients absolutely love the service that they receive in our practice because it maintains the continuity of care,” says D’Amato. This includes knowing whether patients can afford a prescription before they leave the office. Because copays for oral therapy can be very high, “we use financial advocates to assist patients with copay assistance to help the patient access the drug,” D’Amato says.
“My staff is passionate about patient care and getting the prescription to the patient,” D’Amato observes. “They take it personally and get upset when they cannot fill a prescription.”
If the center can’t dispense certain medications to patients who need them due to insurance or pharmacy benefit management restrictions, “we will triage the prescription for the patient to the appropriate pharmacy,” D’Amato says. Patients receive their medications within a day, compared with up to a week in some instances from a specialty pharmacy. In addition, “patients often find that the cost of their supportive-care medications are cheaper than in a local retail pharmacy,” D’Amato says.
To date, D’Amato’s practice has not faced any oncology drug shortages. Drugs can be ordered from a vendor daily and are delivered the next day. This allows the center to order more expensive products on an as-needed basis while keeping in stock those that are less expensive or for which there is an ongoing demand.
The center’s electronic health record (EHR) documents all aspects of the patient’s encounter with the physician, including education and consent to chemotherapy, before a medication is dispensed. This allows for “tight communication between patients and provider” and offers “the most comprehensive examination of the patients’ therapy to ascertain if there are any interactions before dispensing the agents,” D’Amato says.
Space Design and Workflow Requirements
In setting up an in-office dispensing program, considerations include how many patients are anticipated to use the service; personnel requirements; space and storage needs; hardware, including work stations and dedicated printers; and software, including an e-prescribing system and pharmacy inventory management software.
The Maine Center for Cancer Medicine & Blood Disorders hired a practice management firm specializing in community oncology clinics to provide an initial analysis of payer mix and patient eligibility based on the center’s patient insurance information. The consultants determined that the practice would fill prescriptions for about 60% of its patients. For in-office dispensing to be practical to offer, this assessment needs to be accurate; hiring a consultant to develop a reliable estimate is a worthwhile investment.
On the basis of its estimate, which suggested high usage by patients, the center redesigned 200 square feet of existing space in its main site for pharmacy use. Two full-time staffers — a certified oncology nurse and a certified oncology technician — were hired to run the program.
The new room includes workstations, medication storage and file space, and a window where patients receive their drugs and are counseled on regimen adherence. It’s away from office traffic to afford privacy and protect confidentiality. In addition, “We keep all agents in a separate Nucleus® machine (ION Solutions, Frisco, Texas) for security and tracking,” D’Amato says. “A refrigerator is included in the unit for the rare products that require refrigeration. The room has keypad entry for security.”
The dispensing staff is also tasked with researching a patient’s pharmacy benefit, engaging financial advocates if affordability is an issue, and securing copay assistance. “Time commitments are real,” D’Amato explains, adding that it’s not unusual for a single telephone call to take 30 minutes to an hour. Then “the physician, pharmacist, nurse practitioner, or physician assistant must check the prescription prior to dispensing to the patient,” D’Amato says.
As Risk-Free as You Can Get
Excluding staff, the overall cost to set up in-office dispensing in D’Amato’s practice was less than $50,000, including the cost of the office redesign; the pharmacy portion of the cost included hardware, software, and an initial investment of $20,000 to $25,000 in inventory. Including overhead and staff wages, the program “paid for itself in the first 6 months and has grown exponentially, month to month to month,” D’Amato says.
Experts maintain that this kind of return on investment, far from being lucky, is typical. Some contend that in-office dispensing is a virtually risk-free investment for a community oncology practice. Because it satisfies a multitude of patient needs at once, in-office dispensing tends to be very popular — and therefore profitable. That said, it’s always possible to lose money on a business investment. In this case, drug margins, labor costs, and bad debt must be well-managed for the enterprise to succeed.[4]
“The net revenue that a practice gains will depend on the volume and type of prescriptions filled. It can be a significant cost center for a large practice,” D’Amato cautions. However, “if a dispensing pharmacy is managed correctly and with adequate staffing, break-even should be the worst that you do, while providing a great patient service.”[4]
4 Steps to Success
To lay the groundwork for successful program, start by investigating your state licensing requirements for offering in-house dispensing. In Maine, for example, where D’Amato works, no license is required for a private oncology practice to offer in-office dispensing, nor is a licensed pharmacist required to dispense medications. But this varies by state.
Physician dispensing is prohibited in 4 states — Arkansas, Montana, New York, and Utah — and 3 states (Massachusetts, New Jersey, and Texas) place limitations on this practice., such as distance from a retail pharmacy, special state permits, and limiting profits.[5] A Dispensing Practitioners License or a controlled-substance license (or both), in addition to Drug Enforcement Agency and medical licenses, are required by 30 states.[6] Contact your state medical licensing board and your state board of pharmacy to learn which regulations you need to follow to be in compliance locally and to avoid running afoul of the Stark law, which governs physician self-referral for patients covered by Medicare and Medicaid.
Next, engage your practice physicians in the process, D’Amato says. In-office dispensing is controversial and raises legitimate ethical issues. It’s important to address staff concerns. It’s your doctors, nurses, and other staffers who will need to acquaint patients with the new service, and cancer patients look to their providers for guidance. Your clinicians are also concerned about patient compliance with chemotherapy regimens. Offering in-office-dispensing can help. If your staff isn’t on board, it could defeat the purpose of offering a mutually beneficial service.
The third step is to determine projected volume by tracking the number and type of prescriptions currently being written. Vendors can provide cost estimates to lease a dispensing system, consolidate payer reimbursements, and adjudicate scripts. For example, 2 leading suppliers of oncology drugs helped D’Amato’s center implement their program in less than 6 months, including software installation and staff education. The firms also provide ongoing follow-up, including ensuring that all regulatory and record-keeping requirements are met and that payers recognize the site as a pharmaceutical provider.
Finally, develop a formulary. D’Amato’s group decided “to dispense all agents related to oncology care, not just oral oncolytics,” including all products that the clinic’s physicians routinely order.[4]The group elected not to dispense opioid analgesics owing to “security and staff safety,” D’Amato says. Dispensing these and other controlled substances may require special barriers to prevent theft, as well as adherence to additional regulatory requirements, such as the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, designed to promote safe opioid drug use.
On the basis of feedback to date, “physicians love the education and follow-up provided to patients and the dispensing note in the EHR,” says D’Amato. “The patients know us, they know who to call, and they know who the physician and the nurse are. It’s a really gratifying experience to be able to offer this service to our patients.”