Adams Alex J
Former Executive Director, Idaho State Board of Pharmacy, Current Administrator, Idaho Division of Financial Management.
Innov Pharm. 2020 Dec 8;11(4). doi: 10.24926/iip.v11i4.3344. eCollection 2020.
The National Association of Boards of Pharmacy (NABP) recently established a task force to help states develop regulations based on "standards of care" rather than "prescriptive rule-based regulation." This signals a shift in orthodoxy as pharmacy has traditionally been a highly regulated profession. A benchmark report on the pharmacy, nursing, and medical statutes and regulations in Idaho found that pharmacy had a higher overall word count, more overall restrictions, and had to be amended more frequently to keep pace with change.
To identify opportunities to make the transition to a "standard of care" regulatory model in pharmacy law, this manuscript attempts to quantify the regulatory burden for 10 Western U.S. states.
The relevant statutes and regulations were gathered from each of the 10 states, and key measures were extracted, including word count, restrictions, exemptions, and the composition.
States exhibited wide variation in overall regulatory burden as measured by word count (average of 65,882 words, SD=35,057). The top categories of pharmacy law are: 1) professional practice standards (25,249 ± 16,077 words); 2) facility standards (15,230 ± 10,240 words); and 3) licensing (11,412 ± 6,191 words). More than 65% of all pharmacy regulations are in rule adopted by board of pharmacy rather than in statutes passed by the legislature.
States exhibited major variation in total regulatory burden, with the largest contributors to cross-state variation being regulations related to professional practice standards and facility standards. This analysis suggests these two areas should be the primary targets of states looking to decrease regulatory burdens and that regulatory boards have a significant opportunity to remove regulatory burdens even in the absence of legislative action.
美国国家药学委员会协会（NABP）最近成立了一个特别工作组，以帮助各州根据“护理标准”而非“基于规定性规则的监管”来制定法规。这标志着传统观念的转变，因为药学一直是一个受到高度监管的行业。一份关于爱达荷州药学、护理和医学法规的基准报告发现，药学法规的总字数更多，总体限制更多，并且必须更频繁地修订以跟上变化。
为了确定在药事法中向“护理标准”监管模式过渡的机会，本文试图量化美国西部10个州的监管负担。
从这10个州收集相关法规，并提取关键指标，包括字数、限制、豁免和组成部分。
以字数衡量，各州的总体监管负担差异很大（平均65,882字，标准差=35,057）。药事法的主要类别包括：1）专业实践标准（25,249±16,077字）；2）设施标准（15,230±10,240字）；3）许可（11,412±6,191字）。所有药事法规中超过65%是由药学委员会通过的规则，而非立法机构通过的法规。
各州的总体监管负担存在重大差异，导致州际差异的最大因素是与专业实践标准和设施标准相关的法规。该分析表明，这两个领域应成为希望减轻监管负担的州的主要目标，并且即使在没有立法行动的情况下，监管委员会也有很大机会消除监管负担。
