The benefits of adopting clinical pathways specifying a hospital’s preferred chemotherapy combinations and sequences have become evident, especially given the proliferation of current generic chemotherapy drug shortages, as well as the promotion of drug treatment standardization. Standardized drug treatment pathways that provide explicit standards of care for certain disease states may streamline workflow, shorten patient length of stay, decrease costs, and reduce variations in patient care. However, to be effective, clinical pathways must be physician-led, developed by a multidisciplinary team, derived from evidence-based practice, and must be regularly updated and frequently evaluated.
The Dana-Farber Cancer Institute—a principal teaching affiliate of Harvard Medical School and a Comprehensive Cancer Center designated by the National Cancer Institute—employs more than 4,000 people supporting 300,000 patient visits per year and is involved in over 700 clinical trials annually. Given the volume of chemotherapy treatments provided at Dana-Farber, the great complexity of administering such treatments, and the quantity of information available to us through the clinical trials in which we participate, our facility recently decided to begin developing chemotherapy clinical pathways specifying drug combinations and sequences for various cancer disease groups in order to improve patient safety through standardization, streamline workflow, and save on medication costs. We are especially interested in how the use of these clinical pathways will allow us to standardize the measurement of outcomes. While still in the very early stages, our hope is that these standardization efforts will deliver myriad benefits.
Developing Clinical Ordering Templates for Standardization
The complexities of evaluating treatments, coming to consensus, and instituting additional standardization throughout an institution or health system is undoubtedly a challenging process, requiring input and cooperation from physicians, pharmacists, and hospital leadership and administrators. To begin developing ordering templates, pharmacy met with a team of disease experts and reviewed the National Comprehensive Cancer Network (NCCN) guidelines and compendia, the available literature, and our own clinical experiences, and worked to come to agreement on what our standard of care would constitute and which ordering options would be available to providers. The templates are organized by disease group, and feature treatment-specific indications for metastatic, adjuvant, neoadjuvant, or palliative disease. A multidisciplinary team of physicians, pharmacists, and nurses reviewed and approved these disease-specific ordering templates; the medications in the templates are on formulary and had previously been approved by the P&T committee. A provider wishing to order medications not included on the standardized templates must submit an exception order, which requires approval by pharmacy, physician leadership, and finance; these exceptions are managed on a case-by-case basis.
Once the ordering templates have been approved and implemented, the treatment-specific indications by diagnosis are tracked via CPOE. This process allows careful evaluation of prescribers’ adherence to national guidelines, such as those developed by the NCCN, and the use of disease-based templates ensures that we are employing evidence-based practice. To safeguard that appropriate doses are prescribed, templates delineate dose adjustments, and the system requires the prescriber to specify a reason when ordering an adjustment. All dose adjustments are tracked by the CPOE system.
Ensuring Adequate Drug Supply
Pharmacy works to maintain a consistent supply of chemotherapy medications, as we expect that adherence to clinical pathways will increase if prescribers are confident in drug availability. To help guarantee a steady supply of chemotherapy agents to patients, our facility utilizes purchasing through its wholesaler, the GPO, and occasionally directly from the manufacturer. While clearly price is an important determinant when purchasing, we take advantage of all legitimate options to ensure that we have the most vital medications in stock at all times.
Our goal is to provide patients uninterrupted access to drugs they require, both at the start of their treatment and throughout their entire regimen. However, given the surfeit of chemotherapy shortages, this is a demanding pursuit. As ordering templates are developed, we confer with disease experts to determine if alternative drugs are available that could be substituted in the event of a shortage. For example, in certain disease-specific ordering templates, docetaxel is substituted for paclitaxel; we have also instituted automatic substitution of famotidine for ranitidine. However, currently there are no clear guidelines on substitutions for chemotherapy. The adoption of clinical ordering templates allows for proactive handling of potential interruptions in medication supply, and ensures continued standardization and less opportunity for medication error when an alternative agent must be utilized.
To alleviate some of the effects of shortages, the FDA has recently allowed the temporary importation of certain medications, which may prove to be a useful strategy in the short term.
Incentivize Generic Chemotherapy
One of the advantages of clinical ordering templates is that they encourage the use of generic medications, as well as those on formulary. Oncologists at our hospital-based practice are on staff, and are therefore not incentivized to order brand name medications when less expensive, yet equally effective generics are available.
Because clinical ordering templates are constantly evolving based on new literature and physician experience, they are considered living documents. Dana-Farber has a robust clinical trials group, and reaps the benefits of being informed by the results of hundreds of clinical trials performed at our facility and in our network. These results influence standard ordering treatments and are used to update the templates when appropriate. Converting disease-based templates into clinical treatment pathways with a high degree of specificity is the next step, and will improve standardization, reduce unnecessary or unhelpful treatments, increase evidence-based practice, and reduce overall health care expenditures. Our objective is to reduce treatment variation and to document the effect this approach has on patient outcomes. Although our methodology has shown promise, it remains to be seen how this effort will translate into improved patient outcomes.
Sylvia Bartel, MPH, RPh, is vice president of pharmacy and clinical support services at Dana-Farber Cancer Institute in Boston.
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