According to the Institute of Medicine, medication errors are a major source of medical harm that affects more than 1.5 million people annually and is the cause of death for 44,000 to 98,000 Americans each year (the Institute of Medicine, 2000). Medication errors that are deemed “preventable” account for over $3.5 billion in annual hospital expenses alone (the Institute of Medicine, 2007). While it is estimated that 300,000 preventable adverse events occur in America's hospitals each year, it is believed that the number that occurs in outpatient environments is undoubtedly greater but very challenging to quantify (US FDA, 2011).
The pharmacy literature includes numerous examples of clinical pharmacy service integration into medical homes that are associated with improvements in medication safety and health-related outcomes (ACCP, 2007). Although the majority of these reports are not from safety net clinic settings, the principles of initiating and expanding clinical pharmacy services in safety net clinics is similar. Two very helpful resources that provide excellent examples and guidance are the Patient-Centered Primary Care Collaborative (PCPCC) resource guide on Integrating Comprehensive Medication Management to Optimize Patient Outcomes (http://www.pcpcc.net/files/medmanagepub.pdf) and the Health Resources and Services Administration (HRSA) Patient Safety and Clinical Pharmacy Services Collaborative (PSPC) Change Package (http://www.healthcarecommunities.org/WorkArea/DownloadAsset.aspx?id=10312). The PCPCC resource guide was produced by a multidisciplinary group of health care professionals, including physicians, nurses and pharmacists, as well as representation from multiple health care stakeholders including health plans, government health leaders, and pharmaceutical manufacturers. The guide is written in terms that allow non–health care professionals to understand the content, yet provides clear explanations and powerful examples of the value of clinical pharmacy services in the outpatient setting.
The HRSA PSPC Change Package provides specific steps that are often needed to implement and/or spread clinical pharmacy services in safety net clinic settings. The HRSA PSPC is the first government-led effort to spread the practice of clinical pharmacy across the nation, beginning with safety net entities (see http://www.hrsa.gov/publichealth/clinical/patientsafety/index.html). The PSPC has demonstrated that integration of clinical pharmacy services into outpatient medical practices is associated with dramatic improvement in the control of common chronic conditions, including diabetes mellitus, hypertension, dyslipidemia, asthma, HIV/AIDS, depression, and anticoagulation therapy.
The safety net clinic setting is clearly an area that can benefit from comprehensive clinical pharmacy services, but implementing a clinical pharmacy practice in this setting is challenging. The majority of safety net clinics are unfamiliar with clinical pharmacy services. Safety net clinics have very limited budgets and are overwhelmed with a continually increasing demand for appointments with primary care providers. Providers are overworked and turnover is high among physicians. Fortunately, when approached methodically, all of these concerns can be appeased through integrated clinical pharmacy services.
Six-Step Process for Establishing and Sustaining Clinical Pharmacy Services in Safety Net Clinics
The following 6-step process includes elements from both the PCPCC resource guide and PSPC Change Package, and is based largely on experience developing or consulting in the development of over a dozen integrated clinical pharmacy services in Southern California as well as in other states. All of these steps are essential for establishing a successful, self-sustaining service.
Step 1 Identify a Physician Champion and Key Collaborators, Initial Start-Up
This is without question the first and most important step in the process. Clinical pharmacy services have little chance of successfully meeting program goals and long-term sustenance without the support of a well-respected physician. Usually, this physician champion should be the Chief Medical Officer/Medical Director. However, in some cases, the physician champion can be the physician that the medical staff respects and turns to for leadership and direction; this is typically a senior-level staff physician who understands health care quality, the evolving health care system, and the special needs of the population served. A good physician champion needs to understand the role of integrated clinical pharmacy and embrace the concept of team-based care. The physician should be able to anticipate skepticism and questions from colleagues that will allow the program to address these before they become barriers. Sometimes the initial barrier is start-up funding to generate results that can persuade senior leadership that the clinical pharmacy service is well worth the investment. Partnerships with schools of pharmacy are a natural win-win collaboration: Clinics can benefit from the expertise that pharmacy faculty has in providing comprehensive pharmacy services and can bring pharmacy residents and students to help provide extended care to patients, while pharmacy schools benefit by having a practice site for faculty, teaching, and scholarly activity in the form of practice-based research. Another option that is often linked to pharmacy schools is applying for government or foundation grants to support starting up the clinical pharmacy program.
Step 2 Identify a High-Risk Population
Having pharmacists involved in ensuring the safe and effective use of medications throughout the health system is essential to prevent medication-related harm. However, when developing a focused, individualized MTM or disease management service, it is important to recognize that pharmacists are not an inexpensive investment; therefore, it is important to target patient populations that are at the highest risk for medication-related problems and expensive medical care. These include patients receiving multiple chronic medications, patients with multiple disease states, and patients seeing multiple health care providers within a system that does not facilitate efficient communication of health-related information. Other populations that can be targeted include patients receiving medications that require frequent monitoring or are very expensive, patients with chronic illnesses that are difficult to control, and conditions in which medications critical for reducing morbidity and/or mortality are frequently underutilized. Last but certainly not least, patients who frequently utilize high-cost health care resources (emergency department visits, hospitalizations, and readmissions) should be considered as initial targets for MTM. Improving quality of care for these patients can dramatically reduce the use of these expensive resources and help justify the cost of clinical pharmacists. Resources that may be helpful for identifying a target population include electronic health record queries, disease registries, utilization review and hospitalization reports, quality improvement committee reports, and diagnostic/laboratory test results.
Regardless of the initial target population, it is important to include medication reconciliation as a “baseline” service for every patient. The importance of medication reconciliation is strongly emphasized by several government health care agencies including Agency for Health Care Research and Quality (AHRQ), Institute for Health Care Improvement (IHI), Centers for Disease Control and Prevention (CDC), and HRSA.
When initiating clinical pharmacy services, it is highly recommended that the service be limited to only one or two target populations. Many challenges unique to the safety net clinic setting need to be experienced and resolved (see Step 5), and trying to do so with multiple target populations can be overwhelming.
Step 3 Develop a Proposal for the Clinical Pharmacy Service Role in Managing the High-Risk Population Including Protocols and Assignment of Responsibilities
Upon receiving approval to provide clinical pharmacy services for a targeted high-risk population, the next or concurrent step is to develop a protocol outlining the purpose of the service, individuals involved and their responsibilities (pharmacists, supervising physicians, support staff, pharmacy students, etc.), the process by which targeted patients will be referred and receive clinical pharmacy services, how patient information will be communicated, and how appointments will be managed. A flow diagram can be very helpful for explaining the process to senior leaders and other members of the health care team, and is highly recommended for inclusion in the protocol or for explaining patient flow through the service (see Fig. 35-2).
University of Southern California Clinical Pharmacy service flow.
Under the pharmacist responsibilities, the scope of the pharmacists' practice must be clarified in accordance with requirements and limitations set forth by the state board of pharmacy. The clinical pharmacy protocol must be signed off by the appropriate oversight group within the organization, typically the chief medical officer. Other resources are available that offer detailed guidance on pharmacy protocol development.
Step 4 Establish Key Measures of Success
Establishing metrics to quantify the value, impact, and quality of clinical pharmacy services is essential for long-term sustenance and to support spread to other high-risk populations. These metrics should be established prior to starting the service in order to integrate the collection of data elements into the service; otherwise, data collection is viewed as an additional burden and never gets done.
The most widely used method of evaluating health quality utilizes three categories of measures: structure, process, and outcomes (Donabedian, 1966) (See Chapter 9). Outcome measures of quality evaluate the end result of health care services from multiple perspectives including clinical, economic, patients satisfaction, and quality of life. Clinical measures include both primary endpoints (e.g., reduction in cardiovascular events among patients with diabetes or coronary artery disease) and surrogate markers that are correlated with primary endpoints (e.g., hemoglobin A1C, blood pressure, lipid levels). Common economic measures are changes in acute care resource utilization or projections in medical cost savings based on changes in surrogate markers of disease control that are correlated with medical costs (e.g., dollars saved per point reduction in A1C). Evaluating patient satisfaction or quality of life requires the use of survey instruments that have been scientifically validated in the target population.
Step 5 Pilot the Service and Collect All Measures Starting Day 1
Even if given permission to launch a clinical pharmacy service organization-wide, it is best to pilot the service with a few or even a single physician, preferably the physician champion. Despite the best planning, a new clinical pharmacy service will experience problems (e.g., confusion with scheduling, patients referred but not showing up for appointments, limited space/rooms, etc.) Resolving these problems can be accomplished much more simply with the support of a physician mentor than with the entire medical staff.
In addition to the daily logistics associated with providing patient care, piloting the service at a small scale is important for helping the clinical pharmacist understand the unique needs and challenges of the underserved. Many patients, particularly the homeless, lack access to a refrigerator. The majority have very low literacy levels, and cultural beliefs/preferences are powerful determinants of whether patients will adhere to instructions. Transportation in many cities can make follow-up care very difficult to provide. Learning to work efficiently with these challenges would be very difficult if clinical pharmacy services were initiated at a large scale.
Collection of measures established for evaluating the service must occur from the first day. The pilot phase is the time to figure out how to integrate collection of measures into the daily workflow. If this integration is not established, the measures will, at best, be extremely difficult and time-consuming to collect retrospectively. Ongoing evaluation of these measures is critical to support the sustainment and spread of clinical pharmacy services.
Step 6 Share Results with All Stakeholders to Sustain Existing and Expand New Services
To sustain a clinical pharmacy service and grow it to additional sites, data reflecting the impact of the service needs to be shared with all health care stakeholders, including payers/plan vendors, physicians, administrators, allied health professionals, patients, legislators and the community, and potential key collaborators. However, it is important to recognize that each of these stakeholders has slightly different priorities:
- Payers, health plans, and administrators are most interested in economic data reflecting cost savings and clinical data reflecting improved quality of care and medication safety. Cost savings reports also should include the impact of the clinical pharmacist on medication costs through optimization of the 340B program, PAPs, and overall medication formulary management; our experience has demonstrated that health systems can save literally millions of dollars annually by having a clinical pharmacist closely managing medication use.
- Physicians and allied health professionals are most interested in clinical data and patient satisfaction.
- Patients, legislators, and the community are most interested in economic data reflecting cost savings to consumers, clinical data, and patient satisfaction.
As a result, the specific data shared and reporting format will differ depending on the stakeholder.
Spreading the news about the clinic's successes through public relations will generate broad awareness among other payers, patients, providers and elected officials of the impact that integrated clinical pharmacy services have on patient health outcomes, medication safety, and cost savings. Some ideas on how to be successful in promoting your program include
- Develop a public relations strategy. The strategy employed should emphasize the integration of clinical pharmacy services into the organization, focusing on the complexity of medication regimens today in light of the increased prevalence and incidence of chronic diseases, particularly among the underserved and elderly, and that integrated clinical pharmacy services help improve health care quality while lowering costs in the form of more efficient and cost-effective drug formularies and less use of health care resources.
- Seek local targets. Focus promotion of the service on local targets: local newspapers, TV, and radio. Further, getting the story shared through trade groups and associations is a good approach to reaching the target audiences in local markets. For example, reaching out to chambers of commerce and similar groups provides an opportunity to showcase the value of integrated clinical pharmacy services and gives local media a reason to cover the story.
- Employ effective public relation tactics. Identify “media stars” on the team (physicians, pharmacists, patients, payers) and develop a media advisory (one pager—who, what, where, why, how). Patient testimonials can be particularly powerful for the general media, particularly those involving a major transformation in health care associated with clinical pharmacy service integration. Make available interviews with the players on the team. Make available clinic photo/video shooting.
- Offer a Q&A for local print media, radio, and TV with the clinical pharmacy service professionals on a hot topic that is dealt with in the clinic (getting patients immunized, diabetes management, smoking cessation, childhood obesity, cost savings, etc). Tell the story of the clinic while also providing readers/viewers/listeners with clinical pharmacy service expertise applicable to the needs of the general public, as well.
- Keep everything in simple terms. For example, keep in mind:
- Today's medicines are complex, and the “traditional” role of physicians as solo practitioners has resulted in a rushed and overworked system of health care.
- Adding clinical pharmacy services to the health care team for medication therapy management in clinics nationwide is improving patient health outcomes, avoiding dangerous medication side effects, and saving money.
- If asked whether this is a novel, untested program, emphasize that integrating clinical pharmacy services into medical homes is nothing new; it has been done for decades in the Department of Veterans Affairs, Kaiser Permanente, and medical practices across the country in states that have supported an expanded role for pharmacists. The current program is just expanding these past successes to meet today's needs—helping the most vulnerable in clinics across the country but also working shoulder-to-shoulder with physician colleagues in clinics, hospitals, and community pharmacies.
Publishing in peer-reviewed health care journals will increase acceptance and credibility of the clinical pharmacy program within and outside the organization, and is an important method of spreading program successes to a broader audience in a manner that is objective and validated. However, submitting a manuscript can be challenging, particularly for organizations unfamiliar with the publication process. Selecting a journal should be done judiciously, with preference for journals that are not pharmacy-specific; otherwise, the publication ends up being primarily read by a pharmacy audience only.
If Sarah accepts Paul's offer to serve as a pharmacist consultant for CHC, she should first establish a Memorandum of Understanding so that her duties are clearly specified. Next, Sarah should find out if CHC has a formulary. What is the clinic's current drug cost? Is the clinic eligible for the 340B program? Does the clinic have a P&T Committee? She should review the CHC medication formulary and determine whether there are untapped opportunities to save medication costs (e.g., 340B or Patient Assistance Program medications that have not been considered). Organizing the formulary to ensure that maximal cost savings is achieved without compromising the selection of medications available should immediately help CHC's medication budget.
Sarah should next inquire about the patient population. This information will give her some idea as to the number of uninsured, Medicaid, or partially insured patients. Based on the payer mix and prescription volume, Sarah can consider whether the clinic is better off running an in-house pharmacy, a dispensary, or contracting with an outside pharmacy to provide 340B medications. She can seek further guidance from the HRSA Pharmacy Services Support Center.
When exploring the possibility of introducing a clinical pharmacy program into a safety net clinic, Sarah should speak with the lead physician at CHC (typically the Chief Medical Officer) to determine the level of interest and support for improving health care quality and medication safety. Sarah's affiliation with a school of pharmacy can be helpful if start-up resources are needed; schools sometimes seek practice sites for faculty, or are interested in submitting grants to fund clinical pharmacy demonstration projects. She will need to identify an initial target population for clinical pharmacy services based on evidence of treatment gaps, known high-risk patient populations, and/or perceived medication-related burdens to physicians. After establishing a practice protocol and nationally aligned metrics for evaluating the quality of clinical pharmacy services, Sarah should pilot the service with a limited group of physicians (even a single physician mentor) to refine the clinical pharmacy program and ensure that it runs smoothly. She should aggregate the outcome data at least quarterly and share the results with all stakeholders to support the service and spread it to other high-risk populations. Over time, fiscal and clinical outcomes from the clinical pharmacy service will confirm that it is self-sustaining and essential.