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. 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. ● While research will continue to be conducted to characterize the performance of generic versus brand-name drugs, most available research demonstrates that the use of generic drugs saves money and provides the same levels of efficacy as brand-name products (Harvard Medical School, 2021). Pharmacists should familiarize themselves with these critical points and use this information to assist their patients in deciding if they should use generic or branded pharmaceutical products. Self-Assessment Quiz Question #8 The decision to use generic or branded medications can be a difficult decision for patients. Which of the following teaching points may be useful for pharmacists when assisting their pa- tients with this decision? a. You get what you pay for; the more expensive branded product is typically of higher quality than the less expensive generics. b. Generic products are safe, effective, and have the potential to save money. c. Due to enhanced FDA regulation of branded products relative to generics, it can be expected that there is an increased risk of adverse events with generic medications. d. Additional research is required to show that generic drugs are able to provide efficacy equivalent to that offered by brand-name products. Healthcare Consideration: Despite all these positives for ge- neric drug usage, when generic substitution is employed, it is critical that healthcare professionals advise their patients to be vigilant for new or worrisome symptoms appearing after switch- ing to a generic. Should this occur, it is important that they dis- cuss these findings with their prescriber, pharmacist, or nurse. In summary, it has been acknowledged that the use of brand- name prescription drug products is expensive, and that there is a need to facilitate the availability and use of cost-effective alter- natives. To this end, laws have been promulgated and a robust generic drug industry has developed to provide these important options to patients. It might be foolish, though, to believe that such a benefit can be delivered without controversy. Arguments made against generic substitution are plentiful. While some may be financially motivated, others provide scientific support. Some examples are provided below. For many years, a longstanding battle centered on concerns re- garding the bioequivalence of generic drugs used to treat epilep- sy. In 2001, the American Academy of Neurology (AAN) publicly
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