Biosimilars: Practical Considerations for Pharmacists

Stevenson, James G.; Popovian, Robert; Jacobs, Ira; Hurst, Susan; Shane, Lesley G

doi:10.1177/1060028017690743

Cited by 29 publications

(22 citation statements)

References 67 publications

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“…At the institutional level, pharmacists have an impact on drug selection through their involvement in interprofessional cancer formulary committees that evaluate clinical data, national guidelines, comparisons of same-class drugs and biosimilars, financial toxicity, and clinical cancer pathways. 5 , 7 Institutional work may also include the creation of standard ordering processes, the implementation of safety checks and other workflows that decrease the likelihood of medication errors, and the development of symptom management protocols. Safe ordering processes for oral oncolytics have been previously addressed by recommendations incorporated into the ASCO/Oncology Nursing Society safety standards and the American Society of Health-System Pharmacists Guidelines on Preventing Medication Errors With Chemotherapy and Biotherapy.…”

Section: Prescribingmentioning

confidence: 99%

2018 Hematology/Oncology Pharmacist Association Best Practices for the Management of Oral Oncolytic Therapy: Pharmacy Practice Standard

Mackler

Segal

Muluneh

et al. 2019

JOP

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PURPOSE: The aim of the current work was to present a pharmacy practice standard from the Hematology/Oncology Pharmacy Association (HOPA) on the management of oral oncolytic therapy. METHODS: The HOPA Standards Committee organized a work group of oncology pharmacist specialists to create a pharmacy practice standard for the management of oral oncolytic therapy that describes the pharmacist’s role on the cancer care team, provides examples of practice tools and resources, summarizes current data related to outcomes, and discusses opportunities to enhance the care of patients with cancer who receive oral oncolytic therapy. We reviewed primary literature, including currently published oral oncolytic guidelines and HOPA’s Scope of Hematology/Oncology Pharmacy Practice. RESULTS: Management of oral oncolytic therapy was divided into the following primary areas: prescribing, education, dispensing and distribution, and monitoring and follow-up. Pharmacists’ roles were summarized in each area with a focus on interprofessional collaboration, communication, patient safety, and quality of patient care. Standards describe the best practices in each area ( Table 1 ). CONCLUSION: Multiple opportunities exist for pharmacists to enhance the care of patients with cancer who receive oral oncolytics through collaboration with oncology care team members. The role of the oncology pharmacist in the care of this patient population is critical given the complexities related to cost, tolerability, and safety of oral oncolytic medications; issues of access; and the monitoring and follow-up of patients receiving this therapy.

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Section: Prescribingmentioning

confidence: 99%

2018 Hematology/Oncology Pharmacist Association Best Practices for the Management of Oral Oncolytic Therapy: Pharmacy Practice Standard

Mackler

Segal

Muluneh

et al. 2019

JOP

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“…The high standards of FDA for approving interchangeable products make sure that healthcare professionals must be confident in the safety and efficiency, similarly as they would be for an FDA-approved reference product. 5,6 Debates in regards to BSMs started in the late 1990s when the patent of some best-selling biopharmaceutical drugs get expired. It was comprehended in 1984 that the Hatch-Waxman Act or Drug Price Competition and Patent Term Restoration Act, an enactment which coordinates the commercialization and extension of generic copies of lowmolecular-weight drugs, did not provide a lawful administrative organizational structure for the endorsement of this particular class in the USA.…”

Section: Introductionmentioning

confidence: 99%

“…It was comprehended in 1984 that the Hatch-Waxman Act or Drug Price Competition and Patent Term Restoration Act, an enactment which coordinates the commercialization and extension of generic copies of lowmolecular-weight drugs, did not provide a lawful administrative organizational structure for the endorsement of this particular class in the USA. 5 Likewise, in Europe or elsewhere globally there was no regulation for the authorization of BSMs. 6 This initiated conversations about the need for commercialization of BSMs in the pharmaceutical market.…”

Section: Introductionmentioning

confidence: 99%

<p>Knowledge, Attitude, and Practice Towards Biosimilars and Interchangeable Products: A Prescriptive Insight by the Pharmacists</p>

Shakeel¹,

Hassali²,

Rehman³

et al. 2020

IJGM

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Background Pharmacists being the drug experts need to be well aware of the applied handling of biosimilar medicines (BSMs). They are an integral educator, trailblazer, and advocate of biosimilar integration across all clinical settings. Therefore, the current study was conducted to assess the pharmacists’ knowledge, attitude, and practices of integrating BSMs into clinical practice. Methods The cross-sectional study was conducted from August 2019 to November 2019. The community pharmacies, clinical and academic settings in Karachi were approached for gathering the responses of pharmacists towards BSMs and interchangeable products using a 30-item survey form. Pearson correlation and independent sample t -test were used to identify the relationship among independent variables and the responses, considering p values <0.05 as statistically significant. Results Overall, there were 305 survey forms used with a response rate of 87.14%. More than 80% of the respondents have good knowledge about the definition, characteristics, safety and efficacy, compatibility, cost issues, and utilization of BSMs. Around half of the respondents (48.9%, [95% CI 46.6–51.2]) were confident in using BSMs in clinical practice. However, they were concerned about the BSM’s safety profile (45.2%, [95% CI 42.1–48.3]), quality (30.2%, [95% CI 28.3–32.1]), and efficacy issues (32.3%, [95% CI 31.2–37.5]). Conclusion The findings revealed that pharmacists were well informed about the BSMs. However, some of the responses to the attitude demonstrated a lack of understanding of the application of that knowledge. The respondents persuaded that advanced patterns of diseases, product marketing stipulations, and need for better patient care drives higher demand for developing BSMs and were enthusiastic about gaining more insight to integrate BSMs into routine clinical practice.

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“…Currently, not only physicians, but also other healthcare professionals, are involved in biosimilar distribution, application and usage. Stevenson et al [ 16 ] believe that pharmacists will play a key role in managing the introduction of biosimilars into healthcare systems. In Poland, hospital pharmacists are specifically responsible for the dispensing of drugs, including biosimilars, their safe storage and documentation.…”

Section: Introductionmentioning

confidence: 99%

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals

et al. 2019

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Introduction There has been a significant increase in the volume of biosimilar medicines recently due to the expiries of patent protections of biologic medicines. Biosimilars are considered new medicines, and their usage in therapy is often associated with uncertainty from the perspectives of physicians, pharmacists and patients. Objectives The purpose of this study was to identify hospital pharmacist opinions towards these new medicines and investigate their usage in practice. Methods A paper-based, self-administered questionnaire was distributed to Polish hospital pharmacists. Results Biosimilars were used in 77% of surveyed hospitals, whereas originator biologics were utilised within 90% of settings. The former medicines were found to consist of less than one-third of the entire course of biological pharmacotherapy used within Polish hospitals. A total of 88% of hospital pharmacists were concerned that the new drugs were not identical with the biologic versions, 48% with their immunogenicity and 44% with other pharmacokinetic properties. The majority of respondents (87%) stated that the most important advantage of biosimilars related to decreased costs. Furthermore, according to participants, pharmacist-led substitution is not appropriate. Conclusion Due to the numerous concerns relating to the usage of biosimilars, their introduction into patient therapy requires special attention from healthcare providers. While pharmacists involved in the distribution of biosimilars are conscious of their impact in decreasing costs of therapy, they do not feel comfortable in recommending their substitution without a physician's permission. There is a need for more precise legal regulations relating to biosimilars, improved communication between physicians and pharmacists, as well as educational initiatives to improve the safe and effective usage of biosimilars.

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Biosimilars: Practical Considerations for Pharmacists

Cited by 29 publications

References 67 publications

2018 Hematology/Oncology Pharmacist Association Best Practices for the Management of Oral Oncolytic Therapy: Pharmacy Practice Standard

2018 Hematology/Oncology Pharmacist Association Best Practices for the Management of Oral Oncolytic Therapy: Pharmacy Practice Standard

<p>Knowledge, Attitude, and Practice Towards Biosimilars and Interchangeable Products: A Prescriptive Insight by the Pharmacists</p>

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals

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