Biosimilars Conceptually, biosimilars are like generic drugs: alternative ver - sions that work like innovator products. The divergence is given away by their name. Unlike generic drugs whose active ingredi - ents are identical to the brand-name product, biosimilars are re- quired to be comparable to the predecessor product. The key difference is that biosimilars, made from natural sources, may be structurally complex, while generic drugs, synthesized from chemical sources are more easily characterized. Due to potential differences in biosimilars, inherent to their complicated compo- sition, FDA often requires more information for these products than they do for generic drugs. The comparability of biosimilars, relative to the brand-name product, is tested using clinical trials, evaluating safety and efficacy, and by undergoing an abbreviated FDA review process. These products must be shown to be safe and effective and may be less expensive than the brand-name medication. (NCI, 2020). Similar to the Orange Book, FDA maintains a database containing information on all FDA-licensed biological products, to include licensed biosimilar, interchangeable products, and their reference Generic substitution Prescribers have the discretion to explicitly prescribe for either brand-name or generic prescription drug products. In most cas - es, prescriptions are then filled and dispensed by pharmacists. The general notion is that whenever possible, generics should be substituted for brand-names in an effort to control the growth of prescription drug expenditures. This process of substitution is governed by two separate types of state laws, with each sort of mandate structured slightly differently. Some jurisdictions have mandatory substitution laws. In these cases, the pharmacist is re - quired to dispense generic products whenever possible as a de - fault practice. The other approach, while different in how the law is written, results in similar practices. In this case, there are pre - sumed consent laws in effect allowing pharmacists to assume that the patient agrees to the substitution. It is important to note, that regardless of which law is in effect, the patient is free to overrule the substitution (Song & Barthold, 2018). Implicit Bias Consideration: Regardless of the laws governing generic substitution, in all cases the choice to allow substitution is ultimately governed by the patient. Nonetheless, the phar- macist, due to their station in the process, may make the incor- rect assumption that all patients prefer to be dispensed generic products. Based on this bias, the pharmacist may make substi- tutions and provide only generic products without consulting the patient. This practice could invalidate a patient’s freedom to choose. Before dispensing a generic or biosimilar product, the pharmacist should confirm that this substitution decision is aligned with patient preference. Self-Assessment Quiz Question #7 The laws governing generic substitution vary from state to state. Despite these inconsistencies, one constant is universal. Out of the potential requirements for generic substitution list- ed below, identify the common prerequisite for appropriate generic substitution. a. The pharmacist must always provide a generic product when available. b. It is appropriate for a pharmacist to assume that a patient always wants to economize by using generic products. c. The patient must always have the last word on generic substitution. d. Prescribers must always direct that generics be dispensed.
products: the Purple Book. Key elements of the Purple Book are listings of products that have been determined by the FDA to be biosimilar to other approved products. Like the Orange Book, it also includes information regarding patent and exclusivity status (FDA, n.d.). Self-Assessment Quiz Question #6 While biosimilars are conceptually similar to generic drug prod- ucts, there are differences. Which of the following distinguishes the two? a. Only generics are required to be safe. b. The review process for both types of products is similar in scope. c. Biosimilars are usually subject to an evaluation of safety and efficacy relative to the branded innovator product. d. Both biosimilars and generics drug products are typically synthesized from readily available chemical precursors. Evidence-based practice! Sacks and investigators recognized that the use of brand-name products, to include biologics, has been the primary source of rising costs associated with prescrip- tion drug spending in the U.S. They also noted that each state is governed by their own laws regulating the practice of generic substitution by pharmacists. In this research, they set out to char - acterize the variation of state drug product selection laws and other factors that impact which version of drug is dispensed. To this end, using a legal database, they examined the laws of all states and Washington DC as of September 2019. Their primary interest was whether substitution was mandatory or permitted, if patient consent was required, and the degree of pharmacist pro - tection from liability due to substitution. Their analyses showed that 19 states required substitution; seven states and Washington DC required patient consent for substitution; 31 states and Wash - ington DC mandated patient notification, and 24 states did not offer pharmacists protection from liability. A total of 45 states had more stringent guidelines for biosimilar than generic substitution, in most cases requiring prescriber notification. In summary, they concluded that there is a need to optimize and harmonize state drug product selection laws in order to further promote generic and biosimilar substitution. They suggest that such efforts would enhance medication compliance and reduce spending on pre- scription drug products (Sacks et al., 2021). As noted by Song & Barthold, despite the pressures to substitute a generic for a brand-name product, the patient is responsible for the ultimate decision. Unfortunately, the question is complex, and as such, likely not one that the average patient is equipped to answer. A recent article published by Harvard Medical School provided a good summary of the pros and cons of generic sub- stitution. While all cases are different and have unique nuances, they offer a generalized answer to the question of generic substi - tution, applicable to most cases. Key points of their argument are provided below: ● Brand-name medications are not always better, and often are more expensive. As a result of high prices, some patients may sometimes skip doses, or not take it all because they cannot afford the product. In such cases, generic substitution may of - fer obvious advantages. ● They estimated that if the practice of generic substitution was increased, drug spending could decrease by as much as $5.9 billion. ● There is little or no definitive evidence that generic medica - tions are less effective or safe than brand-name products. ● Both generic and biosimilar products are highly regulated by the FDA, providing assurance of their quality.
EliteLearning.com/Pharmacy-Technician
Book Code: RPTTX2024
Page 55
Powered by FlippingBook