Investigation of Factors Associated With Immunogenicity Labeling Updates and Characteristics of Biologics License Applications.

Immunogenicity, the potential to elicit an antidrug immune response, is a critical concern in developing biological products, but its consequences are difficult to predict with animal studies. The aims of the present study are to investigate the evolution of immunogenicity information in labeling and to identify attributes associated with immunogenicity labeling updates. Biologics License Applications (BLAs) approved by the Center for Drug Evaluation and Research, US Food and Drug Administration between 2008 and 2017 were studied. A majority of BLAs described the incidence/prevalence of antidrug antibodies (ADAs) (94.9%) and neutralizing antibodies (NAbs) (68.4%) in their original labeling documents. However, less than one third of the BLAs mentioned the impact of ADAs/NAbs in the original (20.3%) and most recent (29.1%) labeling documents. BLAs with a priority review status (57.4% vs. 33.3%), orphan designation (61.5% vs. 34.2%), or a mention of ADA impact in the latest label (69.6% vs. 38.9%) had higher percentages of applications with postmarketing requirements (PMRs) directly related to immunogenicity concerns in comparison with applications without those characteristics. Among the BLAs with updated immunogenicity information, the mean time to the first update was 1,077 days, while that for BLAs with accelerated approval was shorter (709.1 ± 492.2 days vs. 1173.8 ± 661.8 days). The results suggest that there is a substantial amount of critical information lacking in the original labeling documents and an overdependence on PMRs for more evidence. Additional efforts should be made to investigate the impact of ADAs to provide timely information for improved patient care.

Compliance With Cannabis Act Regulations Regarding Online Promotion Among Canadian Commercial Cannabis-Licensed Firms.

Importance: As global jurisdictions shift toward cannabis legalization, 2 areas of public health importance relate to exposure to youth and to truthful promotion. Although Canada's Cannabis Act specifies many prohibitions related to cannabis promotion, no systematic monitoring or enforcement among licensed firms exists. Compliance with marketing regulations has effects beyond Canadian citizens because of the global outreach of websites and social media. Objectives: To evaluate compliance among licensed firms with the Cannabis Act and analyze trends among violations regarding promotional material. Design, Setting, and Participants: This cross-sectional study evaluated cannabis-licensed firms after cannabis legalization. Data were extracted from online public platforms, including company websites, Facebook, Instagram, and Twitter, from October 1, 2019, to March 31, 2020. Descriptive statistics, Poisson regression, and logistic regression were used to analyze the associations of covariates with promotion violations. Main Outcomes and Measures: The primary outcome was characterization of type and prevalence of promotion violations. Secondary outcomes were the role of various covariates (namely, licensed firm characteristics and online platforms) in the frequency and probability of violations. Hypotheses were formulated before data collection. Results: Among 261 licensed firms, 211 (80.8%) had an online platform, including 204 (96.7%) with websites, 128 (60.7%) with Facebook, 123 (58.3%) with Instagram, and 123 (58.3%) with Twitter. Of all licensed firms with an online platform, 182 (86.3%) had at least 1 violation. Compared with websites, the risk of violations was significantly higher on Facebook (rate ratio [RR], 1.24; 95% CI, 1.11-1.39) and Instagram (RR, 1.19; 95% CI, 1.05-1.34). The most common violations included lack of age restrictions, brand glamorization, and omission of risk information. With websites as the reference group, lack of age restrictions was approximately 15 times more likely to occur on Facebook (odds ratio [OR], 14.76; 95% CI, 8.06-27.05); the odds of an age restriction violation were also higher on Instagram (OR, 2.48; 95% CI, 1.43-4.32) and Twitter (OR, 4.03; 95% CI, 2.29-7.09). For unsubstantiated claims, the odds of violations were significantly decreased on Facebook (OR, 0.23; 95% CI, 0.11-0.48) and Instagram (OR, 0.28; 95% CI, 0.14-0.57). The odds of glamorization were associated with an increase on Instagram (OR, 2.90; 95% CI, 1.72-4.88). Conclusions and Relevance: In this cross-sectional study, widespread violations were observed in online Canadian cannabis promotion. To protect public health and safety amid legalization, decision-makers should make explicit federal regulation and enforcement regarding promotional activities of cannabis retailers. These results suggest that policy and enforcement of cannabis promotion in Canada would have an international impact, from ease of access to online media and downstream consequences of unregulated promotion.

Access to critical medicines: When are compulsory licenses effective in price negotiations?

Governments of developing countries can be in a vulnerable position with respect to patent protected drugs supplied by foreign firms, if the technology cannot be licensed or independently developed by local firms. In such instances, one possible solution is to negotiate for a price-drop with the patent holder in lieu of issuing a compulsory license. The present paper develops a game theoretic model of such bargaining and shows that while compulsory licenses do not occur under complete information, they can be issued under incomplete information. The model is tested against real episodes of compulsory licenses to derive policy insight.

Accelerating vaccine development and deployment: report of a Royal Society satellite meeting.

The Royal Society convened a meeting on the 17th and 18th November 2010 to review the current ways in which vaccines are developed and deployed, and to make recommendations as to how each of these processes might be accelerated. The meeting brought together academics, industry representatives, research sponsors, regulators, government advisors and representatives of international public health agencies from a broad geographical background. Discussions were held under Chatham House rules. High-throughput screening of new vaccine antigens and candidates was seen as a driving force for vaccine discovery. Multi-stakeholder, small-scale manufacturing facilities capable of rapid production of clinical grade vaccines are currently too few and need to be expanded. In both the human and veterinary areas, there is a need for tiered regulatory standards, differentially tailored for experimental and commercial vaccines, to allow accelerated vaccine efficacy testing. Improved cross-fertilization of knowledge between industry and academia, and between human and veterinary vaccine developers, could lead to more rapid application of promising approaches and technologies to new product development. Identification of best-practices and development of checklists for product development plans and implementation programmes were seen as low-cost opportunities to shorten the timeline for vaccine progression from the laboratory bench to the people who need it.

Prescribing and administering unlicensed medicines.

This article considers the impact on district nurse practice of changes to medicines law introduced by the Medicines (Exemptions And Miscellaneous Amendments) Order 2009 that allows independent nurse prescribers to prescribe unlicensed medicines. These changes include the right to mix medicinal products so that they can be administered together as a single dose in, for example, a syringe driver.

State boards of pharmacy regulation of the supervision of pharmacist interns.

OBJECTIVES: To compare the regulations of state boards of pharmacy for pharmacist intern supervision and review publications of service-learning experiences in pharmacy curricula for methods of supervision. METHODS: Online state pharmacy statutes and board of pharmacy regulations were searched to characterize which states' regulations included provisions for the supervision of pharmacist interns, permitted nonpharmacist supervision for student volunteers, and included provisions on interns participating in the practice of pharmacy. Additionally, a PubMed search was conducted for articles describing the supervision of service-learning experiences of pharmacy students at various colleges and schools of pharmacy. RESULTS: The state boards of pharmacy in all 51 jurisdictions included regulations for the supervision of pharmacist interns. Regulations specifically permitted only pharmacist supervision of interns in 45 (88%) jurisdictions, and 3 (6%) states included provisions allowing nonpharmacist supervision of pharmacist interns. Provisions allowing nonpharmacist supervision on a case-by-case basis existed in 6 (12%) jurisdictions. Among the 32 identified reports of service-learning experiences offered in pharmacy curricula, 14 contained the words "supervision" or "supervise," and 9 indirectly described methods of student supervision. CONCLUSIONS: State boards of pharmacy regulations largely prohibited nonpharmacist supervision of pharmacy students, and reports of pharmacy student service-learning experiences frequently omitted descriptions of student supervision. Boards of pharmacy should consider revising existing regulations to address the growing need for service-learning in pharmacy curricula.

Are regulations more consumer-friendly when boards of nursing are the sole regulators of nurse practitioners?

The widely varied regulations in the 50 states often limit consumer access to nurse practitioners (NPs). In 22 states, the Board of Nursing (BON) must share NP regulatory authority with another profession, usually physicians. This study examines the relationship between the BON as the sole authority regulating NPs or sharing that authority with another profession and the NP regulatory environment. Independent t tests compared the NP regulatory environments for consumer access and choice in states with sole BON regulation with those in states with involvement of another profession. The states' NP regulatory environments were quantified with an 11-measure tool assessing domains of consumer access to NPs, NP patients' access to service, and NP patients' access to prescription medications. BON-regulated states were less restrictive (P < .01, effect size 1.02) and supported NP professional autonomy. Entry into practice regulations did not differ in the two groups of states. Having another profession involved in regulation correlates with more restrictions on consumer access to NPs and more restrictions to the full deployment of NPs.

[Update on the Mali Pharmacy Code: legislative section]. / Essai de mise au point d'un code de la pharmacie au Mali: partie legislative.

Due to colonization (1895-1960) Mali has been submitted, on the legislative and regulation plan to a corpus of numerous and scattered texts relative to pharmacy. It is essentially the Law AN XI of 21 Germinal or the 11 April 1803 Law; the content of Book V of the Public Health Code relative to pharmacy practice, of which some disposals have been extended to Overseas Territories, Togo and Cameroon in 1953; the 1955 Ministerial Order about the dispatching of the Retail Pharmacy in AOF; the 1960 Law creating the Board of Pharmacists in the Federation of Mali etc. After independence, the new Malian State while renewing the pharmacy legislation issued by the old tutor State which was not opposed to the new fundamental Law, has also set up, according to the political orientations of the moment, some new texts. In the framework of this work, we have collected all the legislative and regulation texts that have been allowed in Mali in the pharmacy area and in that of Studies in Pharmacy. We have examined those texts and proceeded to codify the legislative part. The present Code consists of 189 articles divided in 5 titles layed out in chapters and sections.

[Update on the Mali Pharmacy Code: legislative section]. / Essai de Mise au Point D'un Code de la Pharmacie au Mali : Partie Legislative.

Due to colonization (1895-1960) Mali has been submitted, on the legislative and regulation plan to a corpus of numerous and scattered texts relative to pharmacy. It is essentially the Law AN XI of 21 Germinal or the 11 April 1803 Law; the content of Book V of the Public Health Code relative to pharmacy practice, of which some disposals have been extended to Overseas Territories, Togo and Cameroon in 1953; the 1955 Ministerial Order about the dispatching of the Retail Pharmacy in AOF; the 1960 Law creating the Board of Pharmacists in the Federation of Mali etc. After independence, the new Malian State while renewing the pharmacy legislation issued by the old tutor State which was not opposed to the new fundamental Law, has also set up, according to the political orientations of the moment, some new texts. In the framework of this work, we have collected all the legislative and regulation texts that have been allowed in Mali in the pharmacy area and in that of Studies in Pharmacy. We have examined those texts and proceeded to codify the legislative part. The present Code consists of 189 articles divided in 5 titles layed out in chapters and sections.

The potential dual use of online pharmacies.

The technological advances of the 20th century resulted in the creation of the Internet and its introduction into everyday life on a global scale. The Internet provides access to information and the sale and purchase of goods. Medications are also subject to trade. Their sale is conducted by online pharmacies and their global turnover amounts to hundreds of billions of dollars. Medications ordered over the Internet are sent by mail all over the world. Considering the events of recent years, we cannot exclude the risk of a terrorist attack through online pharmacies. Terrorists can establish such companies, legally or illegally, or acquire ones already existing. Parcels, which are highly trusted by the customers of online pharmacies, can, for example, be contaminated with dangerous materials. The sale of online medications in the international system is potentially dangerous and requires international regulation.

The NAPLEX: evolution, purpose, scope, and educational implications.

Since 2004, passing the North American Pharmacist Licensure Examination (NAPLEX) has been a requirement for earning initial pharmacy licensure in all 50 United States. The creation and evolution from 1952-2005 of the particular pharmacy competency testing areas and quantities of questions are described for the former paper-and-pencil National Association of Boards of Pharmacy Licensure Examination (NABPLEX) and the current candidate-specific computer adaptive NAPLEX pharmacy licensure examinations. A 40% increase in the weighting of NAPLEX Blueprint Area 2 in May 2005, compared to that in the preceding 1997-2005 Blueprint, has implications for candidates' NAPLEX performance and associated curricular content and instruction. New pharmacy graduates' scores on the NAPLEX are neither intended nor validated to serve as a criterion for assessing or judging the quality or effectiveness of pharmacy curricula and instruction. The newest cycle of NAPLEX Blueprint revision, a continual process to ensure representation of nationwide contemporary practice, began in early 2008. It may take up to 2 years, including surveying several thousand national pharmacists, to complete.