Outcomes Literature Library

This specialty pharmacy library is a compilation of literature related to the practice of specialty pharmacy or outcomes of patients prescribed specialty medications. This resource is updated quarterly by the members of the Section of Specialty Pharmacy Practitioners (SSPP) Outcomes and Value SAG using the Pubmed search criteria “specialty pharmacy”[Title/Abstract]. The resources are categorized by the outcome measures they describe. Suggestions for articles to be included here are also welcome and may be submitted via the survey link below:

Please visit the AJHP Specialty Pharmacy Article Collection for additional publications.

Click here to submit a publication to be considered for addition to the Literature Library

Adherence/Persistence

General Specialty

Bagwell A., et al., Advancing Patient Care Through Specialty Pharmacy Services in an Academic Health System. J Manag Care Spec Pharm, 2017;23: 815-20. (MPR)*

Canfield SL, Zuckerman A, Anguiano RH, et al., Navigating the Wild West of Medication Adherence Reporting in Specialty Pharmacy. J Manag Care Spec Pharm. 2019;25:1073-1077. (MPR/PDC)*

Kale HP, Patel AM, Carroll NV. A Comparison of Pharmacy Dispensing Channel Use and Adherence to Specialty Drugs Among Medicare Part D Beneficiaries. J Manag Care Spec Pharm. 2018;24:317-26. (PDC)

Paolella D, Cherry E, Jolly JA, et al., Closing the Gap: Identifying Rates and Reasons for Nonadherence in a Specialty Population. J Manag Care Spec Pharm. 2019;25:1282-88. (PDC)*

Zuckerman AD, DeClercq J, Shah NB, Reynolds VW, Peter ME, Pavlik AM, Choi L. Primary medication nonadherence calculation method specifications impact resulting rates. Res Social Adm Pharm. 2021 Apr 20:S1551-7411(21)00122-4. doi: 10.1016/j.sapharm.2021.03.

Loucks J, Zuckerman AD, Berni A, et al. Proportion of days covered as a measure of medication adherence. Am J Health Syst Pharm. 2021 Oct 12:10.1093/ajhp/zxab392

Cystic Fibrosis
Mehta Z, Kamal KM, Miller R et al. Adherence to cystic fibrosis transmembrane conductance regulator (CFTR) modulators: analysis of a national specialty pharmacy databaseJ Drug Assess. 2021; 10(1):62-67. (PDC)

HCV

Henderson RR, Visaria J, Bridges GG, et al., Impact of specialty pharmacy on telaprevir-containing 3-drug hepatitis C regimen persistence. J Manag Care Spec Pharm, 2014; 20: 1227-34. (MPR)

Visaria J, Frazee SG. Role of pharmacy channel in adherence to hepatitis c regimens. Am J Pharm Benefits. 2013;19:33. (PDC)

HIV

Barnes E, Zhao J, Giumenta, et al., The Effect of an Integrated Health System Specialty Pharmacy on HIV Antiretroviral Therapy Adherence, Viral Suppression, and CD4 Count in an Outpatient Infectious Disease Clinic. J Manag Care Spec Pharm, 2020; 26:95-102. (MPR)*

Idiopathic Pulmonary Fibrosis

Shah NB, Haydek J, Slaughter J, et al., Risk factors for medication nonadherence to self-injectable biologic therapy in adult patients with inflammatory bowel disease. Inflamm Bowel Dis, 2020; 26: 314-20.

Near AM, Burudpakdee C, Effect of a Patient Support Program for Idiopathic Pulmonary Fibrosis Patients on Medication Persistence: A Retrospective Database Analysis. Adv Ther. 2021;38:3888-99.

Inflammatory Bowel Disease

 Shah NB, Haydek J, Slaughter J, et al., Risk Factors for Medication Nonadherence to Self-Injectable Biologic Therapy in Adult Patients With Inflammatory Bowel Disease. Inflamm Bowel Dis, 2020; 26: 314-20. (MPR)*

Multiple Sclerosis

Banks AM, Peter ME, Holder GM, et al., Adherence to Disease-Modifying Therapies at a Multiple Sclerosis Clinic: The Role of the Specialty Pharmacist. J Pharm Pract. 2020;33:605-11. (MPR/PDC)*

Hanson RL, Habibi M, Khamo N, et al., Integrated clinical and specialty pharmacy practice model for management of patients with multiple sclerosis. Am J Health Syst Pharm, 2014; 71: 463-9. (MPR)*

Tan H, Yu J, Tabby D, et al., Clinical and economic impact of a specialty care management program among patients with multiple sclerosis: a cohort study. Mult Scler, 2010; 16; 956-63. (MPR)

Liseno J, Lager B, Miller C, et al. Multiple Sclerosis Patients Treated With Diroximel Fumarate in the Real-World Setting Have High Rates of Persistence and Adherence. Neurol Ther. 2021;10(1):349-360. doi:10.1007/s40120-021-0024. (PDC)

Oncology

Rodday AM, Hackenyos D, Masood R, et al. Assessment of patients' understanding of and adherence to oral anticancer medication (OAM): results of a corss-sectional institutional pilot study. J Oncol Pharm Pract. 2021 Oct;27(7):1569-77.

Academia EC, Mejias-De Jesus CM, Stevens JS, et al. Adherence to oral oncolytic filled through an internal health-system specialty pharmacy compared with external specialty pharmacies. J Manag Car Spec Pharm 2021 Oct (10):1438-46. (MPR/PDC)

Middendorff G, Elsey R, Lounsbery B, et al., Impact of a specialty pharmacy case management service on adherence in patients receiving oral antineoplastic agents. J Oncol Pharm Pract, 2018;24:371-78. (MPR)*

Neuner JM, Fergestrom NM, Laud PW, et al., The association of pharmacy fill synchronization with breast cancer endocrine therapy adherence. Oncology. 2019 Nov 15;125:3960-65. (MPR)*

Tschida S, Aslam S, Lal LS, et al., Outcomes of a Specialty Pharmacy Program for Oral Oncology Medications. The American Journal of Pharmacy Benefits, 2012:4;165-74. (MPR)*

Visaria J, Henderson R, Frazee SG, et al. Specialty Pharmacy Improves Adherence to Imatinib. The American Journal of Pharmacy Benefits, 2013;5:33-39. (PDC)

Pulmonary Arterial Hypertension

Shah NB, Mitchell RE, Proctor ST, et al., High rates of medication adherence in patients with pulmonary arterial hypertension: An integrated specialty pharmacy approach. PLoS One, 2019; 14: e0217798. (PDC)*

Rheumatoid Arthritis

Berger N, Peter M, DeClercq J, et al., Rheumatoid arthritis medication adherence in a health system specialty pharmacy. Am J Manag Care, 2020; 26(12):e380-e387. (PDC)*

Calip GS, Adimadhyam S, Xing S, et al., Medication adherence and persistence over time with self-administered TNF-alpha inhibitors among young adult, middle-aged, and older patients with rheumatologic conditions. Semin Arthritis Rheum, 2017; 47: 157-64. (MPR)

Doshi JA, Pengxiang LI, Ladage VP, et al., Impact of cost sharing on specialty drug utilization and outcomes: a review of the evidence and future directions. Am J Manag Care, 2016;22:188-97. (PDC)

Liu Y, Yang M, Chao J, et al., Greater refill adherence to adalimumab therapy for patients using specialty versus retail pharmacies. Adv Ther. 2010 Aug; 27:523-32. (MRA)*

Stockl KM, Shin JS, Lew HC, et al., Outcomes of a rheumatoid arthritis disease therapy management program focusing on medication adherence. J Manag Care Pharm, 2010;16:593-604. (MPR/PDC)

Peter ME, Zuckerman AD, DeClercq J, et al. Adherence and persistence in patients with rheumatoid arthritis at an integrated health system specialty pharmacy. J Manag Care Spec Pharm 2021 July; 27(7):882-90. (PDC)

Psoriatic Arthritis

Souza AF, Da Silva MR, Dos Santos JB, et al. Medication adherence and persistence of psoriatric arthritis patients treated with biological therapy in a specialty pharmacy in Brazil: a prospective observational study. Pharm Prac (Granada). Apr-Jun 2021;19(2):2312.

Transplant

Hlubocky JM, Stuckey LJ, Schuman AD, et al., Evaluation of a transplantation specialty pharmacy program. Am J Health Syst Pharm, 2012;69:340-7. (CMA)*

Tschida S, Aslam S, Khan TT, et al., Managing specialty medication services through a specialty pharmacy program: the case of oral renal transplant immunosuppressant medications. J Manag Care Pharm, 2013; 19: 26-41.(MPR)

Neurogenic Hypotension

Amjad F, Polenchar B, Favit A. Droxidopa persistence in neurogenic orthostatic hypotension may be affected by titration approach. Int J Gen Med. 2021 Aug 13;14:4485-90.

*Performed by a health-system specialty pharmacy

Clinical/Diagnosis-Related Outcomes

General Specialty

Patel K, Chim YL, Grant J, et al., Development and Implementation of Clinical Outcome Measures for Automated Collection Within Specialty Pharmacy Practice. J Manag Care Spec Pharm. 2020; 26(7): 901 -909. *

Hematology

Katsivalis KV, Thomas J.  Caplacizumab for Acute Thrombotic Thrombocytopenic Purpura. J Adv Pract Oncol. 2021;12(2):211-215. doi:10.6004/jadpro.2021.12.2.8. *

Hemophilia

Blankenship CS, Tortella BJ, Bruno M. BE EMPOWERED, a specialty pharmacy education program for hemophilia B patients, impacts adult joint bleeds and pediatric use of RICE.. J Manag Care Pharm, 2014; 20:151-8.

HCV

Cohen SM, Kwasny MJ, Ahn J. Use of specialty care versus standard retail pharmacies for treatment of hepatitis C, Ann Pharmacother, 2009;43:202-9.

Curry MP, Flamm SL, Milligan S, et al. Prevalence of drug-drug interactions with pangenotypic direct-acting antivirals for hepatitis C and real-world care management in the United States: a retrospective observational study. Am J Manag Care, 2021 Jun 9; 1-10. *

Koren DE, Zuckerman A, Teply R, et al., Expanding Hepatitis C Virus Care and Cure: National Experience Using a Clinical Pharmacist-Driven Model. Open Forum Infect Dis. 2019; July 1;6(7):ofz316. doi: 10.1093/ofid/ofz316. *

Sabourin AA, Fisher-Grant KK, Saulles AR, Mohammad RA. Evaluation of a specialty hepatitis C virus telephone pharmacy service. Am J Health Syst Pharm. 2021;78(Supplement_2):S38-S45. doi:10.1093/ajhp/zxaa423 *

Zaephel M, Cristofaro L, Trawinski A, et al., Evaluation of a hepatitis c patient management program at a university specialty pharmacy. Ann Pharmacother, 2017; 51: 307-314. *

Zuckerman A, Douglas A, Nwosu S, et al., Increasing success and evolving barriers in the hepatitis C cascade of care during the direct acting antiviral era. PLoS One, 2018; 13: e0199174. *

HIV

Barnes E, Zhao J, Giumenta A. et al., The Effect of an Integrated Health System Specialty Pharmacy on HIV Antiretroviral Therapy Adherence, Viral Suppression, and CD4 Count in an Outpatient Infectious Disease Clinic. J Manag Care Spec Pharm, 2020; 26: 95-102. *

Gilbert EM, Gerzenshtein L. Integration of outpatient infectious diseases clinic pharmacy services and specialty pharmacy services for patients with HIV infection. Am J Health Syst Pharm. 2016;73:757-63. *

LDL

Atanda A, Shapiro NL, Stubbings J, et al., Implementation of a New Clinic-Based, Pharmacist-Managed PCSK9 Inhibitor Consultation Service. J Manag Care Spec Pharm. 2017;23:918-25.

Reynolds VW, Chinn ME, Jolly JA, et al., Integrated specialty pharmacy yields high PCSK9 inhibitor access and initiation rates. J Clin Lipidol, 2019;13:254-64. *

Multiple Sclerosis

Habibi M, Kuttab HM. Management of multiple sclerosis and the integration of related specialty pharmacy programs within health systems. Am J Health Syst Pharm, 2016;73:811-9. *

Tan H, Yu J, Tabby D, et al., Clinical and economic impact of a specialty care management program among patients with multiple sclerosis: a cohort study. Mult Scler, 2010;16: 956-63.

Tang J, Bailey J, Chang C, et al., Effects of Specialty Pharmacy Care on Health Outcomes in Multiple Sclerosis. Am Health Drug Benefits. 2016;9:420-29. *

Oncology

Fajardo S, Zook F, Dotson E. Specialty pharmacy for hematologic malignancies. Am J Health Syst Pharm, 2016;73:797-809. *

Virani A, Schlei Z, Gleason C, et al. Impact of an Oncology Clinical Pharmacist Specialist in an Outpatient Multiple Myeloma Clinic. Clin Lymphoma Myeloma Leuk. 2020; 20(9):e543-e546. *

Wang G, Havan T, Dang R. Impact of a pharmacist-led hypertension management program for oral chemotherapy in a specialty pharmacy setting. J Oncol Pharm Pract. 2021 Nov 5; Online ahead of print.

Pulmonary Arterial Hypertension

Shah NB, Mitchell RE, Proctor ST, et al., High rates of medication adherence in patients with pulmonary arterial hypertension: An integrated specialty pharmacy approach. PLoS One, 2019; 14: e0217798. *

Shapiro S, Mandras S, Restrepo-Jaramillo R, et al. Survival and drug persistence in patients receiving inhaled treprostinil at doses greater than 54 mcg (nine breaths) four times daily. Pulm Circ. 2021 Oct 29;11(4): Oct-Dec.

Rheumatoid Arthritis

Stockl KM, Schin JS, Lew HC, et al., Outcomes of a rheumatoid arthritis disease therapy management program focusing on medication adherence. J Manag Care Pharm, 2010; 16: 593-604.

Transplant

Hlubocky JM, Stuckey LJ, Schuman AD, et al., Evaluation of a transplantation specialty pharmacy program. Am J Health Syst Pharm, 2012;69:340-7. *

*Performed by a health-system specialty pharmacy

Financial Outcomes

Out of Pocket Costs

Treatment Related Costs

Total Healthcare Costs

Drug Spending
Doshi, JA et al., Impact of cost sharing on specialty drug utilization and outcomes: a review of the evidence and future directions. Am J Manag Care, 2016; 22: 188-97.

Kay J, Chimonas S, Ohn J, Chen J, Melton R, Kaltenboeck A. Value-based management of specialty drugs: practical considerations and implications for pharmacy. Am J Manag Care. 2021;27(5):195-200. doi:10.37765/ajmc.2021.88633 

Medication Cost

Penington R, Stubbings JA. Evaluation of Specialty Drug Price Trends Using Data from Retrospective Pharmacy Sales Transactions. J Manag Care Spec Pharm. 2016; 22: 1010-7. (cost)

Tschida S, et al., Managing specialty medication services through a specialty pharmacy program: the case of oral renal transplant immunosuppressant medications. J Manag Care Pharm, 2013; 19: 26-41.

Financial Assistance

Revenue
Rim MH, Smith L, Kelly M. Implementation of a patient-focused specialty pharmacy program in an academic healthcare system. Am J Health-Syst Pharm. 2016; 73: 831-8. *

Economic Cost in Pharmacy
De Rijdt T, Ludo Willems L, Simoens S. Economic effects of clinical pharmacy interventions: A literature review. Am J Health System Pharm. 2008; 65:1161-1172. * 

*Performed by a health-system specialty pharmacy

Quality of Care

Medication Errors

Quality of Life

Satisfaction Surveys

Treatment Initiation Rate
Reynolds VW, Chinn ME, Jolly JA, et al., Integrated specialty pharmacy yields high PCSK9 inhibitor access and initiation rates. J Clin Lipidol, 2019; 13: 254-64. *

Safety Monitoring
Carmichel J, Meier J, Robinson A, et al., Leveraging electronic medical record data for population health management in the Veterans Health Administration: Successes and lessons learned. Am J Health System Pharm. 2017:74(18):1447-59. *

Hanson RL, Gannon MJ, Khamo N, et al., Improvement in safety monitoring of biologic response modifiers after the implementation of clinical care guidelines by a specialty pharmacy service in an academic health system. J Manag Care Pharm,2013; 9:49-67. *

Stubbings J, Joshi RA, Hoffman JM. Risk evaluation and mitigation strategies: challenges and opportunities for health-system pharmacists. Am J Health Syst Pharm. 2010; 67: 1547-54. *

*Performed by a health-system specialty pharmacy

Specialty Pharmacy Efficiency

Call Center Metrics
Kappenman AM, Ragsdale R, Rim MH, et al., Implementation of a centralized mail-order pharmacy service, Am J Health Syst Pharm. 2019; 1: S74-S78.

Rim MH, Thomas KC, Chandramouli J, et al., Implementation and quality assessment of a pharmacy services call center for outpatient pharmacies and specialty pharmacy services in an academic health system. Am J Health Syst Pharm. 2018;75:633-41. *

Fill Rate
Kappenman AM, Ragsdale R, Rim MH, et al., Implementation of a centralized mail-order pharmacy service, Am J Health Syst Pharm. 2019; 1: S74-S78.

Prior Authorizations

Time to Therapy

Turnaround Time

Patient Monitoring

Specialty Pharmacy Program Development

Productivity and Staffing

Espinosa AM, Chisholm JM, Kandah HM, Kumor L, Poirier M, Taylor J. Expanding nonclinical roles in specialty pharmacy: How to grow a high-performance specialty pharmacy team. Am J Health Syst Pharm. 2021;78(11):1004-1008. doi:10.1093/ajhp/zxab085. *

Patterson CJ, Best practices in specialty pharmacy management. J Manag Care Pharm, 2013; 19: 42-8. *

Rough S, McDaniel M, Rinehart JR. Effective use of workload and productivity monitoring tools in health-system pharmacy, part 1. Am J Health System Pharm. 2010:67:300-311. *

Rough S, McDaneil M, Rinehart JR. Effective use of workload and productivity monitoring tools in health-system pharmacy, part 2. Am J Health Syst Pharm. 2010;67:380-8.

Sheiner L, Malinovskaya A. Measuring Productivity in Healthcare: an Analysis of the Literature. Hutchins Center on Fiscal and Monetary Policy at Brookings. 2016 May. Published online at https://www.brookings.edu/wp-content/uploads/2016/08/hp-lit-review_final.pdf.

Smith A, Zoller J, Schumock G, et al. Pharmacy staffing, workload, and productivity benchmarks in state psychiatric hospitals. Am J Health Syst Pharm. 2018; 75(8):536-547. *

Program Development and/or Benefit

Bagwell A. Kelly T, Carver A, et al., Advancing Patient Care Through Specialty Pharmacy Services in an Academic Health System. J Manag Care Spec Pharm, 2017; 23: 815-20. *

Canfield SL. Decoding gene therapy: Current impact and future considerations for health-system and specialty pharmacy practice. Am J Health Syst Pharm. 2021;78(11):953-961. doi:10.1093/ajhp/zxab064. *

Cesarz JL, Mott DA, Friestrom ED. A framework for graduate and postgraduate specialty pharmacy training. Am J Health Syst Pharm. 2021;78(11):989-998. doi:10.1093/ajhp/zxab086. *

Jolly JA, Pierson TJ, Pulvermacher A. Turning differentiation into value: How health-system specialty pharmacies can align to an outcomes-focused mission. Am J Health Syst Pharm. 2021;78(11):1009-1014. doi:10.1093/ajhp/zxab087. *

Murray MM, Khaleq F, Wainright AE, Eivazi M, Keller J. Role of the specialty pharmacist in public health: A focus on sharps disposal [published online ahead of print, 2021 Apr 24]. J Am Pharm Assoc (2003). 2021;S1544-3191(21)00170-9. doi:10.1016/j.japh.20. *

Pulvermacher A, Nelson C. Benefits of developing a collaborative, outcomes-based specialty pharmacy program. Am J Health Syst Pharm. 2016; 73: 839-43. *

Rough S, Shane R, Armitstead JA, et al. The high-value pharmacy enterprise framework: Advancing pharmacy practice in health systems through a consensus-based, strategic approach. Am J Health Syst Pharm. 2021;78(6):498-510. doi:10.1093/ajhp/zxaa431. *

Zuckerman AD, Shah NB, Peter ME, Jolly JA, Kelley TN. Development, implementation, and evaluation of a health outcomes and research program at an integrated health-system specialty pharmacy. Am J Health Syst Pharm. 2021;78(11):972-981. doi:10.1093/ajhp/zx. *

Stubbings J, Pedersen Ca, Low K, Chen D. ASHP national survey of health-system specialty pharmacy practice 2020. Am J Health Syst Pharm 2021 Sep 22;78(19):1765-91. *

Abramowitz PW. Future directions in specialty pharmacy. Am J Health System Pharm. 2021 Sep 22;78(19):1743-4.

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