Kimberly Binaso, PharmD, RpH, CCP, FASCP, CGP, FASHP

SPECIALTY DRUG TREND IS NOT ONLY INCREASING IN THE COMMUNITY SETTING

, but also among pharmacies that service patients (i.e. residents) who live in senior care settings such as long term care (LTC) facilities.

The 2016 Managed Health Care Associates (MHA) Independent Long Term Care Member Study

 included a section on specialty medications, which consisted of an analysis of LTC pharmacy dispensing data. Although this is MHA’s sixth year looking at specialty within LTC, due to methodology changes (including short cycle dispensing requirements), the results cannot be compared between previous years prior to study period 2015.

This year’s study periods included an analysis of data from January 1 to September 30, 2014 (study period 2015) versus January 1 to September 30, 2015 (study period 2016). The analysis included claims data from 1231 pharmacies encompassing over 184 million claims.

Almost 3.5 million patients from all 50 states were represented in the study. This article will examine some overall trends, as well as take a deeper dive into specific therapeutic categories.

The results from this study illustrated that LTC pharmacies included in the analysis have seen:

		Significant growth among select specialty categories within LTC pharmacies

		25% increase in the utilization of medications used to treat hepatitis C, a marked decrease from the 289% growth seen in this category in the 2015 study

		13% growth in the use of medications to treat multiple sclerosis

		37% increase in medications used to treat inflammatory conditions (including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis)

		9% decrease in the use of injectable osteoporosis medications

		13% increase in the use of medications to treat HIV

		71% increase in immune globulin therapy

		Relatively stable utilization among oncology products with a 2% decrease in oral oncology products. (See Chart 1: Specialty Therapy Percent Growth Rx Count in LTC from 2015 to 2016 Study Period: All Participants) 

Although results from prior years are not comparable, the same methodology was used for the 2015 study (analyzing data from January 1 to September 30, 2013 (study period 2014) vs study period 2015) as the 2016 study. Growth trend for the 2015 study and 2016 study is shown in Chart 2.

Multiple sclerosis (MS) therapies within LTC demonstrated an overall growth of 13% for the 2016 study period. Copaxone (glatiramer acetate subcutaneous injection), the various dosage forms of Rebif (interferon beta-1-a subcutaneous injection), and Gilenya (fingolimod) posted the largest percentage increases.

For the second consecutive year, Rebif remains the most utilized MS drug in the LTC setting by prescription count, overtaking Copaxone in last year’s 2015 MHA Study. Top MS therapies with sustained or increased growth in Rx count in LTC from study period 2015 to 2016 include:

The newer oral disease modifying agents for the treatment of MS, Aubagio (teriflunomide), approved in September 2012, and Tecfidera (dimethyl fumarate), approved in March 2013, continue to have minimal utilization in the LTC setting.

This may be a result of these agents being available via limited distribution through preferred specialty pharmacies, which may be a barrier in accessing these agents through an LTC facility setting.

Recently approved agents Plegridy (peginterferon beta-1a), which was approved by the FDA in August 2014, and Lemtrada (alemtuzumab), which was approved in the United States in November 2014, had minimal utilization in the LTC patient population.

Glatopa (glatiramer acetate), the first generic disease modifying agent for MS, was approved in April 2015 and will be included in the 2017 study. This year marks the first year neurologists have been the primary prescribers of MS treatments for patients residing in LTC facilities. The last 3 years have seen a significant growth in neurologists prescribing MS medications in the LTC space.

Neurologist prescribing constituted 8.7% of MS medications prescribed in the LTC in study period 2014, compared with 25% of prescribing MS medications in LTC in study period 2015, and 32% in study period 2016. Internal medicine and general practice prescribers also have a significant prescribing presence in this space (see Chart 3).

Biologics for inflammatory conditions also saw significant growth of 37% in the 2016 study. These products are used to treat diseases, such as rheumatoid arthritis (RA), ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis.

Year over year growth in prescription count was noted for each of the following:

Xeljanz and Otezla, oral options for RA, psoriatic arthritis, and plaque psoriasis, grew the most in study period 2016. Humira continues to be the most widely utilized biologic for inflammatory conditions in the LTC patient population. Cosentyx (secukinumab) was approved in January 2015 and will be included in the 2017 study. Internal medicine, general practice, and rheumatology prescribers continue to be the lead specialties writing for biologics in LTC facilities (see Chart 4).

Utilization of medications to treat hepatitis C virus (HCV) rose 25% in the LTC population from the 2015 to 2016 study period, but that impressive growth trend paled in comparison with the 289% growth seen in this therapeutic class from study period 2014 to study period 2015.

As anticipated, we do see that the trend and utilization in this therapeutic category continue to increase for the newer agents and decrease for older therapies, as treatment guidelines and clinical practice continue to evolve.

Harvoni (ledipasvir and sofosbuvir) was approved in October 2014 for HCV genotypes 1, 4, 5, and 6; Viekira Pak (ombitasvir, paritaprevir, and ritonavir with dasabuvir) was approved in December 2014 for HCV genotype 1; Technivie (ombitasvir, paritaprevir, and ritonavir) was approved in July 2015 for HCV genotype 4; and Daklinza (daclatasvir) was approved in July 2015 in combination with sofosbuvir to treat HCV genotype 3 HCV.

Additional approvals in this therapeutic category are anticipated in 2016 (see Chart 5). Gastroenterologists lead the prescribing of HCV medications, accounting for 43% of the prescribed prescriptions for LTC residents, up slightly from 40% in last year’s study period.

The trend in oncology in the 2016 study marked the second straight year of a 2% decrease in oral oncology products in the LTC space. Although overall growth dipped slightly in oral oncology, there was significant growth in many branded oral oncology agents from study period 2015 to 2016.

Among the branded agents experiencing growth in the LTC space:

Ongoing flat-to-decreased prescribing in the oral oncology therapeutic category within LTC may be due to many of the newer oral oncology agents being launched as limited distribution products through preferred specialty pharmacies, which may be blocking access to these agents in the LTC facility setting. Prescribing for oral oncology products was driven by internal medicine, representing 40% of prescribers.

General practice accounted for 32% of oral oncology prescribing, as oncologists accounted for 5% of the prescriptions in the oral oncology therapeutic category to LTC residents.  

Prescriptions for HIV therapies in the LTC setting grew by 13% from the 2015 to 2016 study period. This may continue to reflect the fact that a growing number of people aged 55 and older are living with HIV. The CDC estimates that persons aged 55 and older accounted for almost one quarter (24%) of the people living with HIV infection in the United States in 2012.

This represents a jump from 19% in 2010 and is expected to further increase. In addition, older Americans are more likely than younger people to be diagnosed with HIV later in the course of their disease, meaning a delayed start to treatment and potentially more damage to their immune system. This represents a potential opportunity for LTC facilities specializing in HIV/AIDS treatment.

Articles

Long-term care pharmacies have seen significant growth among select specialty categories.

2016 Specialty Trend in Senior Care

Significant growth has been seen in specialty medication use in long-term care facilities.

The specialty drug trend is not only increasing in the community setting, but also among pharmacies that service patients (ie, residents) who live in senior-care settings such as long-term care (LTC) facilities. The 2015 Managed Health Care Associates (MHA) Independent Long Term Care Member Study

 included a section on specialty medications, which consisted of an analysis of LTC pharmacy dispensing data.

Although this is MHA’s fifth year looking at specialty within LTC, due to methodology changes (including short-cycle dispensing requirements), results cannot be compared with studies conducted in prior years. This year’s study periods included an analysis of data from January 1, 2013, to September 30, 2013 (study period 2014), compared with January 1, 2014, to September 30, 2014 (study period 2015). The analysis included claims data from 1145 pharmacies encompassing over 169 million claims. More than 3 million patients from all 50 states were represented in the study. This article will examine some overall trends as well as take a deeper dive into specific therapeutic categories.

		289% increase in the utilization of medications used to treat hepatitis C virus (HCV), mirroring the growth trend for HCV in pharmacy as a whole

		29% increase in medications used to treat inflammatory conditions, including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis (UC), psoriasis, and psoriatic arthritis

		27% growth in the use of medications to treat multiple sclerosis (MS)

		11% increase in the use of injectable osteoporosis medications

		7% increase in the use of medications to treat HIV

		Relatively stable utilization among oncology products, with a 3% growth in the oncology self-injectable products and a 2% decrease in oral oncology products (Figure 1).

MS therapies within the LTC pharmacies studied showed an overall growth of 27% for the 2015 study period. Copaxone (glatiramer acetate subcutaneous injection), the various dosage forms of Rebif (interferon beta-1a subcutaneous injection), and Extavia (interferon beta-1b subcutaneous injection) posted the largest percentage increases. Rebif is now the most-used MS drug in the LTC setting by prescription count, overtaking Copaxone for the first time in the MHA study. Top MS therapies with sustained or increased growth in prescription count in LTC from the 2014 to 2015 study period include:

The newer oral disease-modifying agents for the treatment of MS, Aubagio (teriflunomide), approved in September 2012, and Tecfidera (dimethyl fumarate), approved in March 2013, continue to have minimal use in the LTC setting. The reason for this may be due to the fact that they are only available via limited distribution through preferred specialty pharmacies. Recently approved agents Plegridy (peginterferon beta-1a), which was approved by the FDA in August 2014, and Lemtrada (alemtuzumab), which was approved for use in the United States in November 2014, were not included in this analysis.

Internal medicine and general practice prescribers continue to be the leading prescriber groups who are writing prescriptions for MS treatments for patients in LTC facilities, as evidenced in this study. This year also marks a significant growth in neurologists prescribing MS medications in the LTC pharmacy market. In this study period, neurologists constituted 25% of all prescribed MS medications compared with 9% in the 2014 study period (Figure 2).

Biologics for inflammatory conditions also posted significant growth of 29% in the 2015 study. These products are used to treat diseases such as rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, UC, psoriasis, and psoriatic arthritis. Year-over-year growth in prescription count was noted for each of the following:

Internal medicine, general practice, and rheumatology prescribers continue to be the lead specialties writing for biologics in LTC facilities as seen in this study (Figure 3).

Use of medications to treat HCV rose significantly (289%) in the LTC study population between the 2014 and 2015 study periods due to the introduction of Sovaldi (sofosbuvir) and Olysio (simeprevir). This trend mirrors overall trends in this therapeutic class as Express Scripts Lab Insights estimates that by 2016, spend on HCV treatments will exceed that of more common illnesses such as hypertension and hyperlipidemia.

With the introduction of Harvoni (ledipasvir and sofobuvir combination) approved in October 2014 and Viekira Pak (ombitasvir, paritaprevir, and ritonavir with dasabuvir) approved in December 2014, it is anticipated that utilization in this category will continue to increase for the newer agents and decrease for the older therapies as treatment guidelines and practices continue to evolve (Figure 4). Gastroenterologists lead the prescribing of HCV medications, accounting for 40% of the prescribed medications.

The trend in oncology in the 2015 study showed relatively stable utilization of oncology products with a 3% growth in oncology self-injectable products and a 2% decrease in oral oncology products in the LTC setting. The growth in oncology self-injectable products was primarily driven by Sylatron (peginterferon alfa-2b), Trelstar (triptorelin pamoate), and Yervoy (ipilimumab). Although overall growth dipped slightly in the oral oncology space, there was significant growth in many branded oral oncology agents from the 2014 study period to the 2015 study period. Among the branded agents experiencing growth in the LTC space:

Prescribing for oral oncology products was driven by internal medicine, representing 41% of prescribers. General practice accounted for 33%, and oncologists prescribed 5% of the prescriptions in the oral oncology therapeutic category to LTC residents.

Prescriptions for HIV therapies in the LTC pharmacy market grew by 7% from the 2014 to the 2015 study period. This may reflect the fact that a growing number of people 55 years and older are living with HIV. The Centers for Disease Control and Prevention estimates that persons 55 years and older accounted for 26% of the people living with HIV in the United States in 2011.

 In addition, older Americans are more likely than younger people to be diagnosed with HIV later in the course of their disease, meaning a delayed start to treatment and potentially more damage to their immune system. This represents a potential opportunity for LTC facilities specializing in HIV/AIDS treatment.

Although the average number of specialty prescriptions dispensed per LTC pharmacy per month remained relatively constant from the 2014 to the 2015 study period, the total specialty pharmaceutical spend increased significantly in that time period. This is thought to be driven in large part by the significant increase in HCV drugs, namely Solvaldi (sofosbuvir) and Olysio (simeprevir). It is anticipated that spend of specialty pharmaceuticals within LTC will continue to rise significantly with the addition of Harvoni (ledipasvir and sofobuvir) and Viekira Pak (ombitasvir, paritaprevir, and ritonavir with dasabuvir) to the marketplace (Figure 5.)

In addition, the percentage of prescriptions dispensed with a co-pay for specialty pharmaceutical products within the LTC setting increased slightly from 33% in 2014 to 36% in 2015 (Figure 6). When the patient did experience a co-pay, the average per specialty prescription dispense was found to be $168 in 2014.

Despite challenges such as limited distribution, preferred or narrow specialty pharmacy payer networks, and compliance with Risk Evaluation and Mitigation Strategies program requirements, this data confirm that LTC pharmacies are increasingly providing specialty pharmaceuticals to patients across all LTC settings. Providing high-quality, accessible, specialty pharmacy services to facilities that care for these patients is of the utmost importance as the population in the United States ages. 

The above information is a selective summary of publicly available information and is accurate as of the date of writing. Please consult the sources for complete reference information. The views expressed in this article are those of the authors alone and not of Managed Health Care Associates, Inc.

		MHA Independent Long Term Care Member Study, 2015. Managed Healthcare Associates Inc. Available upon request at MHALongTermCare@mhainc.com.

		Facts and figures: specialty infographic provided by Accredo, Express Scripts: hep C kills 15,000 Americans each year — more than HIV. 

 2014;20(2):109. Published February 2014. Accessed June 3, 2015.

		HIV among people aged 50 and older. Centers for Disease Control and Prevention website. www.cdc.gov/hiv/risk/age/olderamericans/. Published May 12, 2015. Accessed June 3, 2015.

2015 Specialty Trend in Senior Care

As the country's population ages, providing quality care and accessible specialty pharmacy services is of the utmost importance. Here's a review of the key trends and major challenges.

Specialty drug trend is not only increasing in the community setting, but also among those pharmacies that service patients (ie, residents) who live in senior care settings such as long-term care (LTC) facilities. The specialty drug trend is increasing among the senior care population, and important considerations such as regulatory and personnel factors need to be taken into account when dispensing specialty medications to patients residing in LTC facilities.

Senior care is a broad term used to define geriatric patients who reside in a variety of care settings such as adult day care, assisted living, continuum of care retirement communities, LTC facilities (ie, skilled nursing facilities, nursing facilities), rehabilitation centers, and at home. LTC pharmacies are dedicated to serving patients across this spectrum and they are sensitive to the patient needs and interdisciplinary team coordination involved with the care of patients in these settings.

Long-term care lies within the senior care spectrum. By definition, LTC is a variety of services that includes medical and non-medical care for people who have a chronic illness or disability.

 Most long-term care consists of non-medical care such as assistance with activities of daily living like bathing, dressing, using the bathroom, transferring to and from a bed or chair, and eating. The number of seniors needing long-term care is projected to rise to 13.8 million by the year 2030; of those, it is estimated that 5.3 million will reside in nursing homes and other long-term care facilities.

 In 2008, 21 million people had a condition that caused them to need help with medical and non-medical needs and half of them were over the age of 65.3 Although people oftentimes think of skilled nursing facilities when they think of LTC, the reality is that LTC includes care settings beyond geriatric skilled nursing. Other resident populations within LTC include mental health, developmentally disabled, HIV, hospice, and corrections.

INCREASING SPECIALTY DRUG TREND IN SENIOR CARE

The annual 2011 Managed Health Care Associates (MHA) Independent Long Term Care Member Study, an analysis based on 893 closed door LTC pharmacies that encompassed 2.8 million individual patient profiles, was the first to look at specialty product utilization in LTC, and it revealed a double-digit growth of specialty pharmaceuticals from 2010 to 2011. In particular, the study showed a 17% growth in the use of specialty medications used to treat multiple sclerosis (MS) and a 27% increase in specialty medications used to treat inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and psoriasis.

 In addition, a review of dispensing data from pharmacies that service nursing home facilities and assisted living facilities from the first half of 2010 to the first half of 2011 showed an increase in several key metrics when looking at prescription information regarding biologics for inflammatory conditions

• An increase of 29% in the number of patients receiving biologics for inflammatory conditions

• An increase of 39% in the number of practitioners who prescribed biologics for inflammatory conditions

• An increase of 47% in the number of pharmacies that dispensed biologics for inflammatory conditions

• An increase of 36% in the number of assisted living and nursing home residents who received a biologic for inflammatory conditions

• An increase of 42% in the number of prescriptions filled for a biologic for inflammatory conditions

The second annual MHA Independent Long Term Care Member Study to include specialty was released in the first quarter of 2012. It showed a second consecutive year of growth in prescription count among specialty categories within LTC pharmacies, including a 7% growth in the specialty medications to treat MS, a 17% increase in biologics for inflammatory conditions, and a 7% growth in the utilization of oral oncology medications within LTC pharmacies (see Figure 1).

In addition to looking at prescription growth trends, the 2012 MHA Independent Long Term Care Member Study also sought to take a closer look at which physician groups were prescribing specialty medications to LTC patients from 2010 to 2011. The most common type of prescriber for MS, biologics for inflammatory conditions, and oral oncology was physicians identified as practicing internal medicine, and the second most common type of prescriber for these therapies was family practice physicians.

The 2012 MHA Independent Long Term Care Member Study also included a survey component in which 217 independent LTC pharmacies responded to a variety of questions regarding their practice. Respondents reported that 54% of pharmacies had dispensed a biologic for inflammatory conditions to patients residing in assisted living facilities and 51% had dispensed a biologic for inflammatory conditions to patients in a skilled nursing facility. Thirty-two percent of the pharmacies had dispensed a medication used to treat MS to a patient residing in an assisted living facility and 48% of pharmacies had dispensed an MS drug to a skilled nursing facility. Twenty-seven percent of the respondents had dispensed an oral oncolytic drug to patients in an assisted living facility and 45% of the pharmacies had dispensed an oral drug to treat cancer to a patient in a skilled nursing facility (see Figure 2).

In addition, LTC pharmacies have made significant investments in providing specialty services. Thirty-six percent of the respondents have patient education services focused on specialty therapeutic classes, specialty disease states, drug administration, and specialty drug therapy. Twenty-five percent have invested in systems to capture non—claims level data for reporting purposes and 24% of LTC pharmacies who responded to the survey have therapeutic management protocols and programs in place for specialty therapeutic categories.

Based on the data from this study from the past 2 years, we expect growth of specialty to continue at a steep pace based on the increasingly aging population demographics, high adherence to medication regimens in senior care settings, and new products emerging in therapeutic areas with a high prevalence in the senior care demographic, such as gout, lupus, and oncology.

REGULATORY AND PERSONNEL CONSIDERATIONS WITHIN SENIOR CARE 

Due to the varied regulatory environment in senior care and the unique attributes of care provided by LTC and assisted living facilities, there are several considerations that need to be taken into account when dispensing specialty medications to patients who reside in a senior care setting.

One important difference between longterm care and assisted living facilities is that LTC facilities are federally regulated, whereas assisted living facilities are typically state regulated with the regulations varying greatly from state to state. Therefore, while a more standardized approach to dispensing specialty medications can be taken when a patient is a resident in an LTC facility, a more customized approach must be taken from state to state when servicing patients within an assisted living facility.

As it is estimated that Medicare or Medicaid pays for about 70% of the care in US nursing facilities, it is extremely important to understand both programs and their implications in depth. Medicare Part A covers inpatient care in hospitals, skilled nursing facilities (ie, LTC), hospice, and some home health care. A prospective payment system (PPS) is utilized for a skilled nursing home stay and is provided as a per diem to the facility based on Resource Utilization Groups (RUGs). For medications dispensed to the resident under Medicare Part A, LTC pharmacies bill skilled nursing facilities directly. Some LTC pharmacies will enter into a risk-sharing agreement with the skilled nursing facility whereby the LTC pharmacy will charge the skilled nursing facility a per diem rate for Medicare Part A residents based on average medication costs. Certain medications, and in particular high-cost medications, may be carved out of this type of agreement and the pharmacy would charge separately for them. This prospective payment system has put pressure on the skilled nursing facility, medical director, and LTC pharmacy provider to actively manage and reduce, when possible, the costs of medications during a Part A stay. As many specialty drugs are high cost, it is important to consider reimbursement implications of therapy during a Part A stay as well as implications of a patient potentially discontinuing therapy or experiencing a lapse in therapy during this time. Proficiency in dealing with coverage determinations between Medicare Part B and Part D and Medicaid are also important when a resident’s Part A benefits have been exhausted and the patient has now transitioned to other prescription coverage.

LTC facilities are among the most highly regulated industries in the United States, with the goal being to protect vulnerable populations such as elderly patients. These regulations are created and revised by CMS and are published as a document known as the State Operations Manual (SOM). The consultant pharmacist and LTC pharmacy related regulations play an important part in ensuring safe use of medications from the care planning stage to the administration and documentation of the use of medications and their efficacy. It is critical when dispensing a specialty medication to an LTC patient to understand the federal and state regulations that govern medication procurement for these patients.

LTC facilities and some assisted living facilities (dependent upon the state) must obtain both dispensing pharmacy and consulting pharmacy services to fulfill medication needs and regulatory requirements. As per the SOM for LTC facilities, a consultant pharmacist is required to perform a medication regimen review (MRR) for each resident at least once a month. This MRR is focused both on resident-centered activities such as conducting an extensive review of the patient’s medication regimen and their associated care plan, and on facility-centered activities such as implementing and monitoring policies and procedures for safe medication use in the facilities. MRR helps to ensure that the resident’s medications are the most appropriate and most effective, are used correctly, and are the safest possible. MRR also seeks to prevent, identify, resolve, and report medication-related problems that may interfere with achieving the goals of therapy.

Consultant pharmacists may also provide disease assessment and management, MTM services, facility formulary management, drug information, educational programs, medication cost analyses, pharmacokinetic dosing services, medication storage inspections, and other medicationrelated services essential to residents and the facilities. It is important to understand the role of the consultant pharmacist in the senior care setting and ensure that he or she is engaged in and educated about specialty therapies that may be encountered.

It is also important to consider all of the health care personnel—interdisciplinary team&mdash;involved in drug therapy decisions, delivery of medications, and medication administration for patients in LTC facilities when providing specialty medications to patients. The overall approach to a patient’s care within a long-term care facility is centered on coordinated care by the interdisciplinary team. This team may include but is not limited to medical directors, attending physicians, consultant pharmacists, geriatric nurse practitioners,directors of nursing, and the administrator. A medical director provides the overall clinical leadership in the facility and may serve as the attending physician for several patients. The attending physician provides most of the medical care within the facility. Access and availability to consulting physicians, such as specialists, can be variable and often extremely limited. Geriatric nurse practitioners employed directly by the nursing home are increasingly becoming more common, assisting in the daily management of the patient in absence of the physician being on-site. The director of nursing supervises overall nursing services within the facility, whereas the administrator is in charge of the day-to-day operations and overall health and well-being of the patients who reside there.

DISPENSING SPECIALTY MEDICATIONS TO SENIOR CARE PATIENTS

Often when treating patients who reside in senior care settings, there are important clinical and ethical questions that are addressed for each individual patient. One critical question related to specialty medications is determining if the patient should be treated or should continue treatment with a specialty drug or not. The answer is determined by doing an individual assessment of the patient’s circumstances, taking into account overall quality of life, care plan goals, patient comorbidities, and overall life expectancy. Additionally, there is often a focus by the interdisciplinary team on only aggressively treating the major medical issues currently having the highest impact on the patient. Lastly, there are also facility factors such as staffing, medication administration limitations, payer considerations, and access to physician specialists.

All of these specific factors, in addition to federal and state regulations and considerations of medication needs for patients residing in senior care facilities, add up to a unique set of challenges for dispensing complex specialty medications. However, recognizing that specialty drugs and biologics may be the most appropriate clinical choice for a patient, these challenges can be overcome using a team approach. The LTC dispensing pharmacy, together with the consultant pharmacist, should evaluate whether or not the specialty drug is conducive to administration in the specific facility for that particular patient and evaluate the pros and cons of a specific therapy. Pharmacy staff needs to ensure that the nursing staff is familiar with how to properly store and administer the specialty drug, particularly if the product is infused. Pen devices, prefilled syringes, and vials for infusion represent an educational opportunity for the consultant pharmacists with the nursing staff.

Evaluation should also take place for gaps in care. Gaps in care can occur due to transitions of care such as from a patient’s home to the hospital to an LTC facility and can be especially problematic during a Part A stay. Gaps in care for specialty drugs can also occur due to prior authorization challenges and meeting step therapy requirements for payers.

Consultant pharmacists play a critical role in the medication management of senior care patients, and they should be mindful of observing specific monitoring parameters for specialty drugs during medication regimen review. When a resident is taking a specialty drug, it is important to consider signs or indications of infections and whether or not there are any specific immunization recommendations that must be accounted for with co-administration of a biologic product. The consultant pharmacist is also vital to ensuring that any recommended laboratory monitoring for a specialty product is performed and evaluated.

Ongoing assessment of risk versus benefit is also critically important when using specialty medications in the senior care population. Care should be taken to evaluate the impact of the therapy on a patient’s activities of daily living and quality of life. The patient’s clinical status should be continually monitored and assessed and the care team should be involved in discussions of discontinuation if the risk is determined to have outweighed the benefits of continuing therapy with the specialty drug.

One of the most significant challenges that the interdisciplinary team faces is a lack of published research for specialty drugs that focuses specifically on the LTC population and for those patients over 85 years of age. In addition, clear clinical guidance is lacking on evaluating appropriate length of therapy and parameters around discontinuation of therapy for specialty medications for the senior care population.

Another significant challenge that is faced in providing specialty drugs to residents of senior care facilities is limited distribution. It is common business practice in the LTC industry that one pharmacy services the entire LTC facility. LTC pharmacies have the expertise and understanding of the regulations and nuances that accompany servicing nursing home patients. If that LTC dispensing pharmacy is not given access to the specialty drug needed to fulfill an order, significant barriers are created to getting the facility resident the specialty medication in a timely manner and to meeting all the regulations that are set forth by the federal government. In addition, this creates fragmented care that is difficult to manage for the dispensing pharmacy, attending physician, consultant pharmacist, and nurses who are responsible for storage and administration of the medication.

Despite these challenges, specialty drug trend in the senior care population continues to increase. Providing quality, accessible specialty pharmacy services to facilities that care for these patients is of utmost importance as the population in the United States ages. 

		Long term care. US Department of Health and Human Services website. www.medicare.gov/longtermcare/static/home.asp. Published March 25, 2009. Accessed February 2, 2012.

		ASCP Fact Sheet. American Society of Consultant Pharmacists website. www.ascp.com/articles/about-ascp/ascp-fact-sheet. Accessed February 2, 2012.

		National Clearinghouse for Long Term Care Information. US Department of Health and Human Services. www.longtermcare.gov/LTC/Main_Site/Understanding/Definition/Who.aspx. Accessed February 2, 2012.

MHA Independent Long Term Care Member Study, 2011

. Managed Healthcare Associates, Inc; 2011. Available upon request at MHALongTermCare@mhainc.com.

		MHA data on file. Presented during “Biologics for Inflammatory Conditions: A Clinical Primer for Senior Care Pharmacists” at ASCP meeting, November 2011.

MHA Independent Long Term Care Member Study, 2012

. Managed Healthcare Associates, Inc; 2012. Available upon request at MHALongTermCare@mhainc.com.

Consultant Pharmacist Handbook: A Guide for Consulting to Nursing Facilities.

 3rd ed. American Society of Consultant Pharmacists. Revised December 2010.

State Operations Manual, Appendix PP: Guidance to Surveyors for Long Term Care Facilities.

 US Department of Health and Human Services; January 7, 2011. www.cms.gov/manuals/Downloads/som107ap_pp_guidelines_ltcf.pdf. Accessed February 2, 2012.

Stacey Ness, PharmD, MSCS, has worked in both national specialty pharmacy and payer organizations and has experience in clinical management, adherence and persistency programs, as well as chronic disease cost optimization strategies. Dr. Ness is active in the Consortium of Multiple Sclerosis Centers, Academy of Managed Care Pharmacy, National Home Infusion Association, and Hematology and Oncology Pharmacy Association, and has served on the Minnesota Medicaid Drug Formulary Committee since 2008. She is a multiple sclerosis certified specialist and currently serves as the director of specialty clinical services at Managed Health Care Associates, Inc, a health care services organization based in Florham Park, NJ.

Kimberly Binaso, PharmD, RPh, CCP, FASCP, CGP, FASHP, is currently the executive director of clinical services for Managed Healthcare Associates. Dr. Binaso earned her bachelor of science degree from Rutgers University and her doctor of pharmacy degree from the University of Florida. Dr. Binaso is a certified consultant pharmacist in the state of New Jersey, fellow of both the American Society of Consultant Pharmacists and the American Society of Health Systems Pharmacists, and a board-certified geriatric pharmacist. She has held several clinical management positions, working extensively as both a consultant and clinical pharmacist in senior care. Dr. Binaso serves as a national visiting professor and senior care expert presenter contributing posters and articles on a variety of geriatric clinical issues.