Chapter 35. Applications in Safety Net Clinics

Steven Chen, Pharm.D., is associate professor and the hygeia centennial chair in clinical pharmacy at the University of Southern California (USC) School of Pharmacy. His clinical practice experience is in ambulatory care for government-insured, privately insured, and under-/uninsured patient populations. Dr. Chen's research interests include evaluating the impact of pharmacy services on health outcomes, medication safety, and costs. He is a member of research and practice teams that have been awarded the Best Practices Award from the American Society of Health-System Pharmacists in 2002 and 2008, the American Pharmacists Association Pinnacle Award in 2007, and the American Association of Colleges of Pharmacy Inaugural Community Transformative Award in 2009. Dr. Chen is cochair emeritus of the Health Resources and Services Administration (HRSA) Patient Safety and Clinical Pharmacy Services Collaborative, a government-supported program promoting the spread of clinical pharmacy service integration in medical homes across the nation.

Melvin F. Baron, Pharm.D., M.P.A., is associate professor of clinical pharmacy at the University of Southern California School of Pharmacy. He received his Doctor of Pharmacy degree in 1957 and his Masters degree in Public Administration in 1973, both from University of Southern California (USC). He was in private practice from 1957 to 1987 and developed a unique home health care center providing infusion therapy, durable medical equipment, and respiratory, ostomy, and incontinence care. Dr. Baron joined the USC School of Pharmacy fulltime in 1990. He is director of the Level I Externship program, teaches a pharmacy administration clerkship, and also is director of the Pharm.D./MBA program at USC. His research interests include implementation and expansion of clinical pharmacy services in community clinics and development of educational tools for low-literacy, low-income Latino populations. Dr. Baron was the team leader for the development and production of bilingual fotonovelas for clinic patients. Dr. Baron partnered with The National Institute of Transplantation and was awarded a grant from the UniHealth Foundation to fund a kidney transplant series of videos, in both English and Spanish, to educate patients and their families about the transplant process. Dr. Baron is a recognized leader in providing expanded pharmacy services in safety net clinics. On June 27, 2011, Dr. Baron received the American Pharmacists Association Foundation Pinnacle Award for Individual Career Achievement.

Laura L. Feeney, Pharm.D. is adjunct assistant professor of pharmacy practice at the USC School of Pharmacy, and Clinical Pharmacist at Clinicas Del Camino Real, Inc., a federally qualified health center in Ventura, California. She received her Pharm.D. and completed a PGY1 Residency in ambulatory care at USC. Dr. Feeney provides comprehensive pharmacy services at Clinicas Del Camino Real, including disease state/medication therapy management, and operates an in-house 340B pharmacy.

Stephanie M. Iniguez, Pharm.D., is clinical pharmacist and in-house 340B pharmacy manager at Clinicas Del Camino Real. Dr. Iniguez received her Pharm.D. and completed a PGY1 Residency in ambulatory care at USC. She initiated disease management programs and medication access programs at Clinicas Del Camino Real, Inc. Dr. Iniguez serves as a faculty coach for Health Resources and Services Administration's (HRSA) Patient Safety and Clinical Pharmacy Services Collaborative.

After completing this chapter, readers will be able to

1. List key components of a safety net clinic.

2. Describe the 340B Drug Discount Program and list requirements for participation.

3. Identify the legal requirements for dispensary operation.

4. Describe the role of a consultant pharmacist in a safety net dispensary.

5. Discuss the responsibilities of the clinic and the pharmacy entering into a contractual agreement.

6. Describe the general characteristics of patient assistance programs (PAP).

7. List the steps involved in establishing a clinical pharmacy service in a safety net clinic.

Paul Gant, an administrator at a federally qualified health center called Comprehensive Health Center (CHC), has been meeting regularly with senior leaders from other local safety net clinics to share strategies for providing care to their large number of uninsured and Medicaid patients. As a result of these meetings, Paul is now convinced that CHC's medication budget is much higher than it should be. CHC contracts with a local pharmacy to provide prescriptions for their uninsured patients, which Paul thought would save money by eliminating the need to build a pharmacy or dispensary and pay for personnel to run it. However, Paul noticed that most other local clinics have either built a pharmacy or dispensary, and many have recently hired a clinical pharmacist.

Paul contacts his friend Bethany Kim, CEO of Holy Cross Clinic, and asks if she knows of a consultant that can help him determine whether building a dispensary or pharmacy is financially feasible. Bethany refers Paul to Sarah Pike, a pharmacist working at Fair Oaks Pharmacy with a faculty appointment at a school of pharmacy. Beth states that Sarah has consulted on this matter for several safety net clinics. Paul contacts Sarah and offers to hire her as a consultant. If Sarah accepts the offer, what steps should she take to determine whether a pharmacy or dispensary makes good business sense at CHC? What can Sarah do to help reduce CHC's medication budget? And how can Sarah implement a clinical pharmacy program and produces outcomes of interest to Paul and CHC's stakeholders including potential payers?

1. What defines a safety net clinic?

2. How important are patient assistant programs to the clinic dispensary and why?

3. Who can legally operate a clinic dispensary?

4. How can a clinic dispensary be operated without a computer system to generate prescription labels?

5. How can a clinic dispensary become eligible for 340B?

6. Can clinical pharmacy services in safety net clinics be self-sustaining? If so, how?

This chapter will discuss pharmacy management applications in a safety net clinic setting. But what is a safety net clinic? How does it differ from other community clinics? Safety net clinics are largely defined by the patient populations they serve (Altman and Lewin, 2000; Saviano and Powers, 2005). These clinics provide health care services to the medically underserved, including the uninsured, underinsured, and Medicaid populations. These groups must make up a substantial portion of the clinic's patient population for the clinic to qualify as a safety net clinic. Safety net clinics may provide primary, specialty, or urgent care services and provide these services regardless of a patient's ability to pay. In many cases, these clinics are mandated to serve the indigent population to receive government funding as well as reimbursement from other public health programs.

The need for safety net clinics has increased over the years for several reasons. The U.S. population continues to gray. According to the California Department of Aging, between the years 1990 and 2020, the elderly age group will experience an increase of about 112 percent (California Department of Aging, 2011). Furthermore, the market environment has seen an augmented emphasis on prevention (US Dept of Health and Human Services, 2010). The current emphasis on prevention has created an overall rise in consumerism as it pertains to the medical field.

Many of the patients requiring health care services are uninsured or underinsured, so they often look to safety net clinics for alternative, more affordable options. The growth of underinsured populations is due in part to recent federal legislation that limits Medicaid and other benefits to legal immigrants (see http://www.cms.gov/MedicaidDrugRebateProgram/). This legislation clearly excludes illegal immigrants from many of the benefits available to other populations. Since illegal immigrants tend to have high rates of chronic illnesses, they benefit from either free or less expensive alternatives, like safety net clinics. As a result of this legislation, the demand for safety net providers has increased. Fortunately, many safety net organizations have demonstrated outstanding quality of care despite high demand and limited resources, serving as examples for others (Keller et al., 2011)

The 340B Drug Discount Program provides highly discounted medications to eligible safety net clinics (see https://www.340bpvp.com). The name 340B comes from the section of the law from which the program was created: The Veteran's Health Care Act of 1992 under section 340B of the Public Health Service Act (PHSA). However, the origin of this law dates back to 1990 when Congress created the Omnibus Budget Reconciliation Act (OBRA). This act introduced a Medicaid rebate program that reduced the cost of medications reimbursed by state Medicaid agencies. Under OBRA, drug companies were required to enter into a rebate agreement with the Secretary of the Department of Health and Human Services (HHS) to have their drugs covered under Medicaid. This rebate paid to Medicaid is based on the manufacturer's “best price”1 on that drug offered to any organization. Thus, if a drug company offered a discounted price to another organization, they would end up having to pay larger reimbursements to state Medicaid agencies. This deterred drug companies from offering large discounts on drugs to non-Medicaid agencies. As a result, drug manufacturers began raising their prices to avoid paying larger rebates to Medicaid. Consequently, government spending actually increased from drug purchases by other government funded non-Medicaid providers, as these costs offset any savings achieved through the rebate program.

To rectify this situation, the 340B program was created in November of 1992. The Veteran's Health Care Act requires manufacturers to provide covered outpatient drugs to certain covered entities (see next section for explanation of covered entities) at a reduced price. The drugs included in the 340B discount program are medications used on an outpatient basis, either administered to the patient onsite, or dispensed to the patient from the pharmacy or dispensary (a dispensary is further defined later; it does not require continuous staffing by a pharmacist). This includes prescription drugs as well as any over-the-counter medications that may be prescribed. Prescription drugs administered in an inpatient setting and vaccines are not included.

To provide the discounts, the 340B program establishes a maximum price that a covered entity would have to pay for a given drug, referred to as a “ceiling price” (von Oehsen, 2003). These prices would be offered to any establishment enrolled in the 340B program, regardless if the drugs are purchased directly from the manufacturer or through a wholesaler. Drugs purchased through this program cannot be subject to a Medicaid rebate. The 340B discounted prices are roughly 25 percent to 50 percent less than the average wholesale price2 (AWP), thus providing substantial cost savings to the covered entities. In addition, the 340B bill established a “prime vendor” leading to the creation of the Prime Vendor Program (PVP). The prime vendor is the single preferred wholesaler that can serve all entities enrolled in the 340B program. The PVP offers subceiling prices on these covered drugs because they are able to negotiate with the drug manufacturers through their bulk purchases. Covered entities may obtain additional savings by enrolling in and purchasing their medications through the PVP.

The 340B program mandated certain provisions that a covered entity must follow while enrolled in the program. First, 340B participants may not transfer or resell the discounted drugs to anyone other than a patient of that entity. For example, a covered entity reselling its discounted drugs to another pharmacy or hospital would be a violation of the 340B contract. Another restriction, as previously mentioned, is that drugs purchased through the 340B program are not eligible for Medicaid rebates because they are already being purchased at a discounted price. This helps prevent the drug manufacturers from having to give multiple discounts on the same medications. If a covered entity does not comply with these regulations it could become disqualified from participation in the 340B program.

Who Qualifies for the 340B Program?

The 340B program is managed by the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA). It establishes the guidelines and eligibility criteria for participation in the 340B drug discount program. Organizations that qualify for the 340B pricing program are referred to as “covered entities” and are specified government-funded facilities. These organizations are those that cater to medically underserved populations. Covered entities include Federally Qualified Health Centers3 (FQHCs), FQHC look-alikes4, AIDS, tuberculosis, and black lung clinics, other outpatient clinics funded by the Public Health Services Act (PHSA), and disproportionate share hospitals5 (DSH) (see Table 35-1 for full list of covered entities or HRSA OPA Web site at http://www.hrsa.gov/opa/). For a hospital to qualify for the 340B program, it must be nonprofit, owned or operated by or under contract with state or local governments, and have a substantial percentage of its patients that are low-income or Medicaid patients, with the exception of critical access hospitals. (For more information, refer to Safety Net Hospitals for Pharmaceutical Access at http://www.safetynetrx.org.)

For an eligible organization to utilize the 340B program, they must complete the appropriate registration form and submit it to HRSA OPA. Registration applications are accepted on a quarterly basis and forms can be found on the HRSA OPA Web site (http://www.hrsa.gov/opa). After registering and being deemed eligible for the 340B program by OPA, the covered entity must inform its wholesaler of enrollment in the program when ordering medications. The wholesaler will then set them up with a 340B account and provide access to all of the 340B prices. The covered entity may then begin purchasing the discounted drugs either through their wholesaler, directly from the drug manufacturer, or through the Prime Vendor Program.

How Do 340B Programs Support Medication Needs of Health Care Organizations?

The 340B program offers a number of ways to support the medication needs of health care organizations. Covered entities are able to reduce the price of covered medications significantly to the patients to whom they are prescribed when dispensing from their pharmacies and dispensaries. This greatly improves access to medications for the medically underserved, who otherwise might be unable to afford these drugs. This could lead to greater adherence among patients who may have chosen not to purchase their medications due to cost.

The large selection of drugs available through the 340B program allows entities to expand their drug formularies to include more therapeutic classes of medications as well as many brand name drugs that otherwise would be much too expensive. In addition, through the cost savings for the entire health center, covered entities can increase the number of patients they serve, and may be able to expand the range services offered. These factors can all lead to greater access to and quality of health care for the indigent and medically underserved populations that safety net clinics serve.

Providing 340B Medications to Patients

Once a 340B-covered entity has begun purchasing drugs at the discounted prices, it may begin dispensing it to their patients. As mentioned previously, the 340B regulations state that the medications may be dispensed only to someone who is a patient of a covered entity. The 340B program defines patients of covered entities as those who

• Have their medical records maintained at that covered entity.
• Receive health care services from a health care professional employed by that entity or under contract with them, such as an outside referral from the covered entity.
• Receive a health service or services for which FQHC funding is provided.

Dispensaries and in-House Pharmacies

The easiest way for a covered entity to provide its discounted drugs to a patient is directly onsite at their dispensary or in-house pharmacy. In this situation, a covered entity would purchase the medications from its wholesaler or directly from the manufacturer and keep the medications onsite. The patients can then be dispensed the medications as they are prescribed by their providers, abiding all laws regarding the dispensing of any prescription drugs. In addition, the dispensaries and in-house pharmacies must comply with the 340B guidelines of dispensing only to patients of the covered entity and not obtaining any Medicaid rebates on the dispensed medications. The low prices paid through the 340B program often allow the medications to be dispensed to patients at a largely discounted price.

Contracting with Community Pharmacies

Although dispensing 340 medications onsite is the easiest way to provide medications to patients, many covered entities do not possess a dispensary or in-house pharmacy. To enable such entities fully to utilize these drug discounts, the 340B program allows contracting with an outside community pharmacy. Initially, the 340B allowed a covered entity to contract with only a single outside pharmacy; however, that has since been modified, allowing entities to now contract with multiple pharmacies. This arrangement can be established with any community pharmacy willing to enter into such a contract.

In a contract pharmacy arrangement, the covered entity, not the pharmacy, would purchase the medications with their 340B discounted prices. The covered entity then often establishes a “ship to bill” arrangement with its wholesaler or the drug manufacturer, allowing the shipment of 340B medications directly to the contracted pharmacy. The pharmacy keeps the 340B medications stocked separately and maintains records for these medications; alternatively, 340B medications can be mixed with non-340B medications if a virtual inventory is maintained through computer software capable of such management. Records must be kept for all financial statements, status reports of medication collections, and all receiving and dispensing summaries for the 340B drugs. The contracted pharmacy also must develop a tracking system to ensure that the 340B medications are dispensed only to patients of the covered entity, to ensure compliance with the 340B regulations.

1Best price: The lowest price paid to a manufacturer for a drug, factoring in any rebates, discounts, or other price adjustments.

2Average wholesale price (AWP): The national average price that drug manufacturers suggest wholesalers charge pharmacies.

3Federally qualified health centers (FQHC's): Health centers that receive federal grants under Section 330 of the Public Health Services Act (PHSA). They must provide primary care services for all ages and preventative health services on site or by arrangement with another provider. Health centers must provide sliding fee scale discounts based on patient family size and income.

4FQHC look-alike clinic or health center that meets all eligibility criteria of an organization that received a PHS section 330 grant (an FQHC), but does not actually receive any grant funding. These health centers are eligible to receive many of the same benefits as FQHC's.

5Disproportionate share hospitals (DSH): Hospitals that serve a disproportionately large proportion of low-income patients.

Patient assistance programs (PAPs) are available by drug manufacturers to provide indigent patients with free or low-cost medications (Medicine for People in Need, 2003). PAPs are a vital component in providing medication access to a great number of safety net patients. Manufacturers have specific criteria a patient must meet to qualify for a PAP medication. Eligibility criteria for most programs include

• Income and asset guidelines
• Citizenship status
• Veteran's benefit status
• Insurance status

Most programs will not accept patients who are currently receiving prescription drug coverage through private insurance, Medicaid, or Medicare. Patients also must verify their financial status by submitting a variety of income documentation (e.g., Federal tax returns). Each application involves the patient's provider, since a prescription and provider signature is required on most applications. Upon completion of the application and approval by the manufacturer, the medication is either mailed to the clinic or to the patient's home. Although the day supply amount can vary depending on the medication, a qualified patient typically receives a 3-month supply of a medication with 3 refills. Safety net providers often develop a system to help navigate through the PAP process. Although the PAP process is considerably time consuming for a health center, there are many safety net providers across the country providing thousands of PAP medications to indigent patients.

Patient Assistance Programs and Safety Net Organizations

PAPs can be beneficial for both the patient and the 340B safety net organization (Felder et al., 2011). These programs allow providers to prescribe and maintain indigent patients on a variety of brand-name medications that otherwise would be inaccessible. The availability of PAPs provides an avenue to decrease the number of samples utilized by the providers at the health center. Health centers that provide PAP services often run well-organized PAP operations that can decrease the 340B costs accrued by the health center. In addition, safety net organizations that aid patients in completing the entire PAP process may choose to charge patients a fee for processing individual applications, tracking the medication, and dispensing the medication. This fee is known as an administrative fee and typically does not exceed $10. A successful PAP program usually requires at least one full-time staff member who is responsible for overseeing the program, ensuring that paperwork is complete and timelines are met.

Although PAP programs save patients money and give providers additional options to optimize therapy, managing a PAP program can be challenging (Walter, 2004). Review of eligibility information for each individual application is tedious and time consuming. In the safety net population, a noncitizen/resident may present with additional barriers that lead some manufacturers to deem these patients ineligible. Some patients may not be able to provide the detailed financial documentation that is sometimes required by manufacturers. Applications and eligibility requirements are frequently changed without advance notice by the manufacturers; as a result, advocates or clinic staff must spend time on the phone or on various Web sites to find the most updated application information. Once an application is accepted by the manufacturer, it can take up to 4 to 6 weeks for the medication to arrive at the clinic or patient's home. Due to this lag time, most individual PAP medications are more appropriate for chronic therapy as opposed to short-term/acute therapies. All of these challenges and the considerable amount of time and staff required to manage a PAP must be taken into account when a safety net clinic is dispensing both 340B and PAP medications (Carroll, 2007). To maximize a 340B and PAP program, a PAP formulary will help direct providers to efficiently and effectively prescribe medications that are not alternatively provided through the clinic 340B program. A structured program with committed staff is the key to providing a win-win Patient Assistance Program within a safety net clinic (Fig. 35-1). A variety of resources are available to help organizations navigate the plethora of PAP applications.

PAP Resources for Patients and Advocates

Fortunately, most resources for PAP applications are readily available online. There are two ways clinics have chosen to manage PAPs: (1) Manually by utilizing free Web sites or (2) computerized using commercial software. Most health centers launching a PAP will begin the process by downloading individual applications from a variety of free comprehensive Web sites. Once the application is downloaded and completed, these clinics will track the PAP process in a spreadsheet or database program. Large safety net clinic organizations frequently purchase commercial software designed to manage the 340B process by charging a fee per patient per month to process and track active PAP applications. Installation and annual fees might be charged by the software companies. A variety of useful reporting templates and outputs are provided in commercial PAP software programs.

A third option in integrating PAPs into a health center in-house 340B pharmacy is to participate in bulk donation or replacements program by pharmaceutical manufacturers. These programs are commonly known as Institutional Patient Assistance Programs. Institutional PAPs are available from some of the larger pharmaceutical companies, such as Pfizer and AstraZeneca. An agreement between the health center and the manufacturer would allow an in-house 340B pharmacy (and in some cases a 340B dispensary) to obtain bulk quantities of PAP medications to dispense as part of the health center's existing stock. The benefit to institutional PAPs is time saved from completing individual PAP applications. Institutional PAP medications can easily integrate into the pharmacy or dispensary's workflow. Furthermore, there is no longer a wait time of 4 to 6 weeks because the PAP medications would be readily available at the health center. The health center facility can charge a nominal dispensing fee for PAP medications received from institutional programs.

The Pharmacist's Role in PAPs

A clinical pharmacist plays a vital role in implementing and maintaining a successful PAP within a safety net clinic organization. The pharmacy is the key to integrate the 340B medications available for purchase with available PAP medications. Pharmacists can analyze the cost-effectiveness of purchasing a 340B medication at a very low acquisition versus assigning staff to complete and manage individual PAP applications. This is an essential component of the clinical pharmacist's role in comprehensive formulary management for a safety net clinic.

Along with creating a concise and cost-effective PAP formulary, a pharmacist can educate the clinic's providers on newly available PAP medications or changes to various programs that can potentially affect patient outcomes. Clinical pharmacy services can be integrated with medication formulary management to improve patient outcomes. For example, a protocol can be approved by the medical director of the health center to have primary care providers refer all chronic disease patients receiving PAP medications to the clinical pharmacist for medication reconciliation and disease state management.

This section summarizes the requirements for a dispensary license and for operating a dispensary in the state of California. The pharmacy laws and regulations discussed in this unit apply to the state of California, but may not necessarily apply to other states. Readers should check with regulations that apply to their own state.

Dispensary versus Pharmacy

Dispensaries and pharmacies have important regulatory differences that must be considered when deciding which is best for a given safety net organization (California Board of Pharmacy, 2011). A licensed pharmacy falls under the series of laws and regulations set forth by each state's Board of Pharmacy. A dispensary in California has a different set of less stringent criteria that allows for personnel flexibility in exchange for some safety assurances. For example, a licensed pharmacy requires having a pharmacist on duty at all times that the pharmacy is open. A clinic dispensary does not require a pharmacist to be on duty when it is open, but a pharmacist consultant review is required quarterly. Dispensaries cannot supply patients with Schedule II controlled substances. It is recommended that no scheduled drugs be part of the dispensary formulary. Dispensaries are not eligible for professional dispensing fees that are authorized under the Medicaid program.

Memorandum of Understanding

With the rising number of safety net providers, clinics often approach pharmacists requesting their services as a consultant for dispensaries. It is important for pharmacists to create a Memorandum of Understanding (MOU) for the consultative services that will be rendered to the safety net clinic or dispensary. In the MOU, the clinic can specify what it wants from the pharmacist, and the pharmacist can articulate what he or she is willing to do.

The MOU usually opens with a formal and simple greeting that can be accomplished in a small paragraph. Following the greetings, a detailed list or explanation of the services to be provided is summarized, often in bullet-point format. The fee for the services rendered should follow the list of services, including a statement of how the invoices will be billed. Agreement cancellation procedures should be specified. The MOU usually closes with a small paragraph that highlights key points in the memorandum, and explains briefly the next steps to forming the collaboration. The last line is polite and appropriate salutation. MOUs are an important tool to specify relationships among any of myriad business entities, including but not limited to health care organizations. (See Appendix A for a Sample Memorandum of Understanding)

Requirements for a Dispensary License

To obtain a dispensary license in the state of California, the Rules and Regulations outlined in 2001 Pharmacy Law 2011 apply (see http://www.pharmacy.ca.gov/forms/clinic_app_pkt.pdf.) In Article 13 of “Business and Professions Code,” Section 4181, the requirements to obtain a clinic license, as well as an explanation of who may dispense medications at the clinic is provided. Only a physician, a pharmacist, or a person legally authorized to dispense drugs may dispense medications. In addition, they must comply with the rules and regulations outlined in Pharmacy Law in order to legally dispense the medications.

A key requirement for opening a safety net clinic with a dispensary is to have a consulting pharmacist. According to “Article 13, Section 4182: Duties of Professional Director; Consulting Pharmacist Required”:

The consulting pharmacist shall be required to visit the clinic regularly and at least quarterly. However, nothing in this section shall prohibit the consulting pharmacist from visiting more than quarterly to review the application of policies and procedures based on the agreement of all the parties approving the policies and procedures. The consulting pharmacist shall certify in writing quarterly that the clinic is, or is not, operating in compliance with the requirements of this article (Pharmacy Law 2011, p. 92).

Again, the legal requirements for a dispensary may vary from state to state; however, the preceding description, requirements for, and distinctions between a dispensary and a pharmacy are fairly typical across the United States.

Policies and Procedures Manual

Each clinic must develop a Policies and Procedures Manual. A pharmacist, or a combination of a pharmacist and a director or physician, can create the Manual, but it is the consulting pharmacist's duty to verify and approve the policies and procedures. The Policies and Procedures Manual contains specifications related to the laws and regulations of the State Department of Public Health. For example, Manuals often contain licensing requirements that outline who can dispense medications, whether the clinic has a pharmacy permit, and who is responsible for inspection, training, recordkeeping, and so on.

The Policies and Procedures Manual also contains the licensing requirements and duties of the dispensing physician, hours of operation of the clinic, patient rights, pharmacy services offered, medication handling, labeling, and storage procedures, security procedures and dispensary infection control, and patient consultation that considers the health and well-being of the public. In addition, the Policies and Procedures Manual should include information about drug utilization review. The protocol and policies of drug utilization are clearly outlined in the Manual, along with formulary review and formulary manual protocol.

Lastly, it is recommended that the Policies and Procedures Manual include information on pharmacy purchasing. The regulations and procedures involved in initiating, processing, and receiving a purchase may be included.

Options to Reduce Drug Costs for Patients

One of the advantages of safety net clinics is the amount of options they have to help reduce drug cost. As described previously, safety net clinics usually can take advantage of 340B and Patient Assistant Programs. Integrating these efficiently into a comprehensive formulary system can dramatically reduce medication costs to the clinic, as well as drug samples.

Drug samples may be used at clinic dispensaries, but there are certain conditions for the samples to be valid or permitted at the clinics. The most important of these conditions is that the sample must be received in its original, unopened packaging with its label intact. Once drug samples are received, they must store them under the conditions that will maintain the sample's stability, integrity, and effectiveness. In addition, complete and accurate records of donation, receipt, inspection, inventory, and dispensing (i.e., sample medication control record) must be maintained. Donation records must be kept on file for 3 years from the date of donation. The sample drug donation records must include the following:

• Name, address, and telephone number of the donator
• Manufacturer information
• Brand name and quantity
• Lot or control number of the drug sample donated
• Date of donation

Most importantly, the clinic must conduct an inventory of the drug samples, and all other medications, annually.

Dispensaries Without Computer Systems

Dispensaries that do not have a computer system may use a manual labeling system, unit-of-use packaging, or an alternative automated labeling system. Manual labeling systems provide dispensaries with a ready-to-go label. The prescriber must then complete the label by writing the patient's name, date of issue, instructions on how to take the medication, and pertinent prescriber information. After this is done, the prescriber peels the label and affixes it to the prepackaged bottle.

Unit-of-use packaging refers to a sealed, prelabeled prescription drug package. Using currently available pharmacy software, the prescriber has the option of using an automated labeling system. The prescriber can simply write the prescription and generate labels using a printer. This is helpful in maintaining each patient's profile, and tracking spending with periodic reports.

Pros and Cons of an In-House Dispensary, In-House Pharmacy, or Contract with Retail Pharmacy

Perhaps one of the most important decisions made by safety net clinics is whether to create an in-house dispensary or contract with a retail pharmacy to provide 340B medications for their patients. Ultimately, the right decision will depend on the payer mix for the clinic and the prescription volume. If the payer mix and prescription volume are adequate to cover or nearly cover the cost of a pharmacist providing dispensing services, than an in-house pharmacy should be considered. Even if the pharmacy does not generate a profit and only breaks even, having the in-house pharmacy allows all patients (third-party, Medicaid, Medicare, uninsured) to fill prescriptions in the clinic, allowing the clinic pharmacist to ensure optimal medication safety by reviewing every prescription and troubleshoot potential problems for every patient. As discussed previously, the drawbacks of an in-house pharmacy include the need to comply with the stringent laws applicable to pharmacy regulation.

Sometimes, these regulations along with the prescription volume become a barrier to finding time for the pharmacist to develop more comprehensive clinical pharmacy services such as medication therapy or disease state management (please see next section). In this case, and in cases where a pharmacy business model is cost prohibitive, an in-house dispensary can be considered to at least provide 340B medications through the clinic with more flexibility in personnel and management. If other variables work against implementation of an in-house dispensary, such as space or personnel limitations, then contracting with an outside retail pharmacy can be considered. The Health Resource and Services Administration (HRSA) Pharmacy Services Support Center (PSSC) offers excellent tools, resources, and free expert consultations to help 340B program participants optimize the value of the program and provide clinically and cost-effective pharmacy services that improve medication use and advance patient care (see http://pssc.aphanet.org/).

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).

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.

Revisiting the Scenario

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.

Safety net clinics offer pharmacists the opportunity to provide comprehensive services ranging from acquisition and dispensing of medications to providing all levels of medication therapy management, including medication safety screening/reconciliation and disease management for the most challenging patients. The aging U.S. population and forecasts of continued economic struggles are straining all levels of the health care system, perhaps none more so than those organizations that care for the underserved. As health care reform shifts the U.S. health care system toward one that pays for health care quality instead of quantity, many of these quality measures relate to medication use. With government support from major health care branches including HRSA, CMS, and FDA, pharmacists can step forward and accept the invitation to integrate into health care teams and provide medication-related expertise to settings in the public health arena.

1. Check your state regulations that apply to the storage and dispensing of medications from safety net clinics. Are dispensaries allowed? What are the opportunities for pharmacists to be involved?

2. Talk to an administrator at a local safety net clinic about how medications are managed. Is there a formulary? Does the clinic participate in the 340B program or receive drugs though PAP? Does the clinic provide drug samples? How are these accounted for and managed? Are there opportunities for pharmacists to make improvements in cost or efficiency of the processes related to medication acquisition and dispensing?

3. What are the needs that clinical pharmacy programs can fulfill for safety net clinics? What does the profession of pharmacy need to do to take ownership of these opportunities and ensure optimal medication-related health quality and safety?

SAMPLE MEMORANDUM

Date

Address

Dear _____:

I am pleased to have the opportunity of working with you and your staff advising you regarding pharmacy services. To ensure complete understanding between us, I am setting forth the terms of my engagement and the nature of the services I will provide. I understand that you will provide me with all of the basic information required and that you are responsible for the accuracy and completeness of that information to the best of your knowledge. I will advise you about appropriate pharmacy law and its application to your facility. I will attend appropriate meetings and be available for consultation.

In addition, I will provide:

My _____ fee for these services will be _____ for the clinic, etc. My invoices will be _____ rendered _____ and are payable upon presentation. This agreement is cancelable by either party on a 30-day notice.

I appreciate the opportunity and look forward to be of service to _____ clinic and believe this letter accurately summarizes the significant terms of our engagement. If you have any questions, please let me know. If the foregoing is in accordance with your understanding, please sign the copy of this letter and return to me.

Very truly yours,

John Smith, PharmD.

Approved by:__________

Title:__________

Date:__________