Abstract
With more then three decades of pharmacy practice experience involving biotech-derived drugs, the impact of biologics in community and institution settings for patient care and disease management has never been larger. Preparation, dispensing, and patient education regarding appropriate use of pharmaceuticals are primarily the responsibility of the pharmacist. Traditionally, parenteral products have been available in ready-to-use containers or required appropriate dilution with sterile water or saline prior to use with no other special handling requirements. Hospital pharmacists, in particular, have prepared and dispensed parenteral products for individual patients for many years. While many pharmacists are skilled in handling parenteral products, biotechnology products present additional challenges since they are predominately proteins subject to physical and chemical denaturation and thus require special handling techniques. These challenges will be explained in greater detail in this chapter. Practice issues with biotechnology products may be handled in slightly different ways depending on laws and pharmacy practice standards in each country. This chapter is written primarily from the view of practice in the United States since that is the primary experience of the original chapter authors.
Updated from the 4th Edition chapter authored by Peggy Piascik, Ph. D and Val Adams, PharmD
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References
AbbVie Inc. (2018) Humira® information. Accessed at: https://www.humirapro.com. Accessed 25 May 2018
AHFS (2018) American hospital formulary service drug information. American Society of Health-System Pharmacists. Accessed at: http://www.ahfsdruginformation.com/ahfs-clinical-drug-information/. Accessed 25 May 2018
American Society of Health-System Pharmacists (2017) ASHP guidelines on compounding sterile preparations. Accessed at: https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/compounding-sterile-preparations.ashx. Accessed 25 May 2018
Amgen Inc. (2018a) Epogen® information. Accessed at: http://www.epogen.com/. Accessed 21 May 2018
Amgen Inc. (2018b) Neupogen® information. Accessed at: http://www.neupogenhcp.com. Accessed 21 May 2018
Amgen Inc. (2018c) Prolia® information. Accessed at: https://www.prolia.com/. Accessed 25 May 2018
Amgen Inc. (2018d) Xgeva® information. Accessed at: http://www.xgeva.com/. Accessed 25 May 2018
Artemetrix (2017) 2017 State of specialty management - specialty drug trend report. Accessed at: http://www.psgconsults.com/specialtyreport?gclid=EAIaIQobChMIlaeFxsWh2wIVDv5kCh0VGQENEAAYASAAEgIvDvD_BwE. Accessed 25 May 2018
Bagwell A, Kelley T, Carver A, Lee JB, Newman B (2017) Advancing patient care through specialty pharmacy services in an academic health system. J. Manag Care Spec Pharm 23:815–820
Banga AK, Reddy IK (1994) Biotechnology drugs: pharmaceutical issues. Pharm Times 60:68–76
Bayer HealthCare (2018) Betaseron® full prescribing information. https://www.betaseron.com/. Accessed 21 May 2018
Department of Health and Human Services (2018) CMS manual system, Pub 100–02 Medicare Benefit Policy, Chapter 15. Accessed at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf. Accessed 08 May 2018
Drug Channels (2018) The top 15 specialty pharmacies of 2017: PBMs and payers still dominate. Accessed at: http://www.drugchannels.net/2018/03/the-top-15-specialty-pharmacies-of-2017.html. Accessed 25 May 2018
Finn TE, Nunez AC, Sunde M, Easterbrook-Smith SB (2012) Serum albumin prevents protein aggregation and amyloid formation and retains chaperone-like activity in the presence of physiological ligands. J Biol Chem 28:21530–21540
Genentech (2018a) Pulmozyme® information. Accessed at: https://www.pulmozyme.com/. Accessed 25 May 2018
Genentech (2018b) Activase® information. Accessed at: https://www.activase.com/. Accessed 21 May 2018
HDA Research Foundation (2018) Specialty Pharmaceutical Distribution Facts, Figures and Trends. Accessed at: https://www.hda.org/resources/2017-specialty-pharmaceutical-distribution . Accessed 22 May 2018
King Guide (2018) King guide to parenteral admixture. King Guide Publications, Inc. Accessed at: https://kingguide.net/collections/internet-edition. Accessed 25 May 2018
Managed Care (2014) Provider-administered drugs move to specialty pharmacy benefit. Manag Care 23:49
McDermott DF, Regan MM, Clark JI et al (2005) Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol 23(1):133–141
National Association of Specialty Pharmacy (2018). Accessed at: https://naspnet.org/. Accessed 25 May 2018
Prometheus Therapeutics & Diagnostics (2018) Proleukin® information. Accessed at: https://www.proleukin.com/. Accessed 21 May 2018
Rayfield WJ, Kandula S, Khan H, Tugcu N (2017) Impact of freeze/thaw process on drug substance storage of therapeutics. J Pharm Sci 106:1944–1951
Roche Laboratories (2018) Summary of product characteristics. Accessed at: https://www.roche.com/products/product-details.htm?productId=1c3a82f3-ba8c-48d3-8ab0-dc7bda8e08d0. Accessed 24 May 2018
RxList (2018) Intron® information. Accessed at: https://www.rxlist.com/intron-a-drug.htm#description. Accessed 21 May 2018
Sanofi-Aventis (2018) Leukine® information. Accessed at: http://www.leukine.com/patient. Accessed 21 May 2018
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Sindelar, R.D. (2019). Dispensing Biotechnology Products: Handling, Professional Education, and Product Information. In: Crommelin, D., Sindelar, R., Meibohm, B. (eds) Pharmaceutical Biotechnology. Springer, Cham. https://doi.org/10.1007/978-3-030-00710-2_10
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DOI: https://doi.org/10.1007/978-3-030-00710-2_10
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