Additionally , robust systems will also facilitate accurate billing ( using the new Healthcare Common procedure coding for each product ), reimbursement , medication assistance programs and verifying that drug orders match with administration notes and inventory management .
Pharmacists are also in a position to play a vital role in post-marketing pharmacovigilance systems , which are essential to both detect and assess immunogenicity and other safety issues . As a result , systems that use the correct product coding and lot number at the time of administration will allow for effective tracking of adverse effects and any new safety signals .
Education Clinicians Due to the uniqueness of biologic medicines and biosimilars , healthcare professionals and patients require education , and pharmacists are ideally placed to support clinical colleagues and patients . Much has been written on the concerns of physicians around the use of biosimilars , especially for non-medical switching and general lack of experience of using these drugs compared with the reference products . Clinical pharmacists can help support clinicians through the development of their own educational resources as part of the biosimilar adoption plan , which could provide an explanation of the comparable effectiveness of biosimilars as well as directing colleagues to the various educational resources that have been developed by the FDA 7 and endorsements by professional organizations such as the American Society of Clinical Oncology . 8
Furthermore , pharmacists can direct physicians to the increasing body of evidence that shows switching from reference biologics to biosimilars is safe and does not adversely affect clinical outcomes . This was highlighted in a systematic review of switching studies that included over 14,000 patients , seven different drugs and 14 diseases . The majority of the studies reviewed did not report differences in either efficacy , safety or immunogenicity , each of which are possible concerns for physicians . 9 Furthermore , it would be worth ensuring that the educational information provided to physicians is also disseminated to nurses and advanced practitioners , each of whom come into contact with patients , to ensure consistency of the biosimilar messaging .
Patients There is some evidence that patients are reluctant to use biosimilars 9 and the increasingly recognized nocebo effect , 10 further illustrates the importance of patient education . Although the FDA has produced patient information on biosimilars , 11 because of pharmacists ’ roles in patient counseling , they have an ideal opportunity to help promote understanding of these drugs . Increasingly , patients turn to the internet to search for information but may not be able to correctly understand the information they find . Pharmacist counseling is especially relevant in circumstances where patients have , for example , interpreted that because biosimilars have received approval via an abbreviated pathway , this indicates that the drugs are inferior to the reference product . One potentially useful solution to addressing patient concerns would be to include generic biosimilar fact sheets as part of a biosimilar adoption program to help counsel patients . These fact-sheets should seek to answer common questions such as how biosimilars differ from the reference products , regulatory approval pathways , efficacy and safety issues , cost differences and how this might affect co-pays as well as addressing recognized areas of concern such as non-medical switching . 12
For example , where an organization is undertaking a switch program and the patient is only familiar with the reference product ( for example , Herceptin ), in educating the patient , pharmacists could help alleviate their concerns by explaining how the FDA has approved several biosimilars , and that in this particular hospital , the preferred biosimilar is ( for example ) trastuzumab-anns . Additional advice to lessen a patient ’ s concerns might be the assurance that this particular biosimilar is the preferred option or , at least , accepted by their payer . Hopefully , such tailored information would help in gaining patient acceptance of biosimilars , especially when a patient ’ s drug is changed as part of a switch program .
Conclusions The introduction of biosimilars will lead to organizational cost savings and allow for the treatment of a greater number of patients . Pharmacists who equip themselves with the necessary knowledge have a pivotal role to play in facilitating the uptake and use of biosimilars through a critical evaluation of safety and efficacy , implementing strategies for cost-containment and the provision of educational information directed at physicians and patients . Through effective leadership and expertise , pharmacists can help implement biosimilar adoption in a safe and efficient manner to expedite cost-effective highquality care for patients .
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