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Objectives: In the United States, rising rates of overdose deaths and recent outbreaks of hepatitis C virus and HIV infection are associated with injection drug use. We updated a 2014 review of systems-level opioid policy interventions by focusing on evidence published during 2014-2018 and new and expanded opioid policies., Methods: We searched the MEDLINE database, consistent with the 2014 review. We included articles that provided original empirical evidence on the effects of systems-level interventions on opioid use, overdose, or death; were from the United States or Canada; had a clear comparison group; and were published from January 1, 2014, through July 19, 2018. Two raters screened articles and extracted full-text data for qualitative synthesis of consistent or contradictory findings across studies. Given the rapidly evolving field, the review was supplemented with a search of additional articles through November 17, 2019, to assess consistency of more recent findings., Results: The keyword search yielded 535 studies, 66 of which met inclusion criteria. The most studied interventions were prescription drug monitoring programs (PDMPs) (59.1%), and the least studied interventions were clinical guideline changes (7.6%). The most common outcome was opioid use (77.3%). Few articles evaluated combination interventions (18.2%). Study findings included the following: PDMP effectiveness depends on policy design, with robust PDMPs needed for impact; health insurer and pharmacy benefit management strategies, pill-mill laws, pain clinic regulations, and patient/health care provider educational interventions reduced inappropriate prescribing; and marijuana laws led to a decrease in adverse opioid-related outcomes. Naloxone distribution programs were understudied, and evidence of their effectiveness was mixed. In the evidence published after our search's 4-year window, findings on opioid guidelines and education were consistent and findings for other policies differed., Conclusions: Although robust PDMPs and marijuana laws are promising, they do not target all outcomes, and multipronged interventions are needed. Future research should address marijuana laws, harm-reduction interventions, health insurer policies, patient/health care provider education, and the effects of simultaneous interventions on opioid-related outcomes.

In recent years, science studies scholars have critically examined several methods used by the pharmaceutical industry to exert control over knowledge about drugs. Complementary literatures on 'medical neoliberalism' and 'neoliberal science' draw attention to the economic ideas justifying such methods of organizing knowledge, and in so doing suggest that neoliberal thinkers may play an important role in developing them. As yet, the nature of this role remains unexplored. Relying on heretofore-unexamined archival evidence, this article establishes a direct link between the Chicago School of Economics and the mobilization of the pharmaceutical industry in the 1970s. It argues that economists affiliated with the Chicago School of Economics sought to influence pharmaceutical policy and science and constructed institutions to do so. These institutions--most notably the Center for the Study of Drug Development--remain highly influential. This article contributes to a historical understanding of how neoliberal ideas came to assume prominence in pharmaceutical policy, the management of science, and scientific practice.

Harmonizing standards on drug regulation makes sense, but it must protect safety, ensure that only drugs that are truly effective are marketed, and protect a country's ability to act independently. The main driving force behind international harmonization is the International Conference on Harmonization (ICH). When it comes to safety, the ICH has been harmonizing to the lowest common denominator. Examples of harmonization indicate that industry priorities have influenced the direction that Health Canada has taken. Harmonization is also intimately tied in with the policy of smart regulation, changing regulations in a way that enhances the climate for investment. Canada has introduced user fees in concert with other countries, but there are concerns that these may compromise safety standards. When it comes to transparency, Health Canada has chosen to adopt the more restrictive European Union model rather than the more open process used by the United States. Finally, there are a number of areas in which Health Canada has chosen not to harmonize, and in each case the decision is in the direction of lower safety standards. Harmonization could be of benefit to Canada, but the evidence to date suggests that Health Canada been harmonizing down rather than up.

Nongovernmental public action has been effective in influencing global agenda-setting in health and pharmaceutical policies, yet its record in influencing solutions to the problems identified has been notably more limited. While trade policies have been particularly resistant to change, more substantial changes are observable in global health policies and global health governance. However, some of the directions of change may not be conducive to the democratic accountability of global health governance, to the wise use of public resources, to health systems development, or to longer-term access to health care within developing countries. The authors argue that observed changes in global health policies can be understood as accommodating to corporate concerns and priorities. Furthermore, the changing global context and the commercialization of global public action itself pose sharp challenges to the exercise of influence by global nongovernmental public actors. Nongovernmental organizations not only face a major challenge in terms of the imbalance in power and resources between themselves and corporate interest groups when seeking to influence policymaking; they also face the problem of corporate influence on public action itself.

Sales of consumer products over the Internet have grown rapidly, including sales of pharmaceutical products. Online pharmacies mimic mail order pharmacies. To operate legally online, pharmacies must be licensed in every state in which sales occur. Although online pharmacies provide benefits to consumers, when compared with traditional pharmacies patients' safety may be compromised. Purchasing prescription drugs online may pose a risk to consumers because they cannot tell whether the site is offering drugs of the same quality offered by a retail pharmacy. There is also a possibility that prescription drugs purchased online may be counterfeit, illegal, or unapproved. A U.S. General Accounting Office study conducted in June 2004 showed that most counterfeit and unapproved drugs sold online are from non-U.S. pharmacies. The Food and Drug Administration and other government agencies have worked to enforce laws on drug sales over the Internet. The biggest challenge in regulating non-U.S. pharmacies is due to their off-shore location. Unfortunately, given the widespread anonymous and ever-changing nature of the Internet, it is very difficult to close down illegal websites.

Australia has a National Medicines Policy with aims that include quality use of medicines, but policy stakeholders failed to protect Australia from the COX-2 (cyclo-oxygenase-2) inhibitor disaster. Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures on COX-2 inhibitors. Drug companies ran intense and misleading promotional campaigns on COX-2 inhibitors without adequate controls. Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising. Core elements of the National Medicines Policy--in particular the drug approval process, the post-marketing surveillance system, the control of drug promotion, and the quality of independent drug information--require major reappraisal if we want to avoid similar disasters in the future.

Objectives: The primary goals of this study were to assess the propensity for alcohol sales to underage customers and obviously intoxicated customers at community festivals, and to assess the prevalence of alcohol control policies at these events. A secondary goal was to identify server and festival characteristics and festival policies related to the likelihood of illegal alcohol sales., Methods: We conducted pseudo-underage purchase attempts at 43 festivals and pseudo-intoxicated purchase attempts at 50 festivals to assess the likelihood of illegal sales. Research staff made observations at festivals and contacted festival planners by telephone following each event to assess which alcohol policies were implemented. We conducted backwards stepwise multivariate analyses for each purchase attempt outcome to identify policies and characteristics related to likelihood of illegal alcohol sales., Results: Pseudo-intoxicated buyers purchased beer in 89% of 95 attempts (standard deviation [SD]=0.31) and pseudo-underage buyers were able to purchase beer in 50% of 82 attempts (SD=0.50). All festival planners reported having at least two of the 10 alcohol policies we assessed, but no festival had implemented all 10 policies. Server characteristics were not related to either purchase attempt outcome. In the multivariate analyses, having more alcohol control policies was related to a greater likelihood of illegal sales to intoxicated customers; however, having more alcohol control policies was associated with a lesser likelihood of alcohol sales to underage customers. Restricting the number of servings per person was also associated with a lesser likelihood of alcohol sales to underage customers., Conclusions: Propensity for illegal alcohol sales at festivals is very high. Research is needed to identify interventions to prevent illegal alcohol sales at these events.

This article aims to draw attention to the process of harmonization of requirements for drug registration (the so-called ICH process) and to examine how it may affect access to medicines in developing countries. The ICH process, especially when seen in conjunction with the World Trade Organization's Agreement on Technical Barriers to Trade, may create additional barriers to would-be entrants on the global pharmaceutical market, notably large generic manufacturers in developing countries-the very companies that can create credible price competition for the innovative industry and, thus, increase access to medicines. These barriers could help maintain the status quo by insulating well-established companies from competition, thereby forming a further obstacle to lower drug prices and to access to medicines, especially in developing countries. Developing countries should therefore carefully consider the implications of the positioning of ICH standards as global standards, and be vigilant with regard to their possible incorporation, whether explicitly or not, in international trade agreements.

This article examines development in school-based drug prevention policy and programming since the Anti-Drug Abuse Act of 1986. Using data from national surveys and evaluations of school-based programs, it argues, first, that there was really no need for a massive infusion of money into school-based drug prevention in the late 1980s, and, second, that there was little or no evidence to indicate that a "new generation" of effective programs, based on the so-called social influence model, was emerging at this time. Despite the infusion of resources into school-based prevention efforts, adolescent drug use has risen in recent years. Moreover, evaluations continue to show that the effectiveness of social influence programs is very much in the eye of the beholder. Fundamental questions need to be asked of school-based drug prevention--just as they should be asked of other key components of our current drug control policy.

The paper describes the situation of drugs and drug sources found available at the village level in Thailand. It concludes, from village-survey data (N = 195) and village case studies (N = 15), that drugs are available in abundance. A vast variety of drugs, including prescription drugs, are available at various sources, of which the most common ones are grocery stores. The situation reflects the failure of the drug regulation system as well as the influence of commercial pharmaceutical sector in drug provision. This situation hampers attempts to rationalize drug use by consumers.

Although an automatic stop order (ASO) policy is mandated by the Joint Commission on Accreditation of Healthcare Organizations, the policy remains unenforced or exists only "on paper" in some hospitals. Strict enforcement of an ASO can lead to improvement of patient care by requiring physicians and other healthcare professionals to periodically review a patient's drug regimen. Following the approval of an ASO policy by our facility's pharmacy and therapeutics (P&T) committee, an audit of 160 orders of controlled substances revealed that 75 orders (47 percent) were continued for more than one dose without a physician's renewal order. This problem was then brought to the attention of the P&T committee where a decision was made to resolve the situation using a multidisciplinary, collaborative approach. With the help of all of the healthcare professionals involved in this issue, as well as our computer network, a system for strict enforcement of the ASO policy was subsequently implemented and has proven to be successful.

The purpose of this study was to evaluate the implementation of a modified unit dose dispensing system for schedule II controlled substances. Each dose is signed out of stock for the intended patient. Changes in the system required revision of dispensing records and procedures in pharmacy and nursing. After implementation the error rate for controlled substances was reduced to a level equivalent to non-controlled substances. A workload study was conducted in the pharmacy and on two general medical-surgical units. Small increases in workload occurred. Although this system is a modified unit dose system it does provide some of the safety features found in unit dose systems. Patient care benefits may decrease hospital liability in high-risk patients to offset cost factors.

The distribution and control systems for controlled substances were evaluated. A mail survey of other hospitals was conducted to obtain samples of control substance systems and the associated procedures. From these samples of existing programs and previous experiences with the current program, a system was designed to meet the needs of an 800-bed hospital with a decentralized pharmacy distribution system. The new distribution and control system completely replaced the prior system. Therefore, new forms and procedures were generated. The total system was implemented in a stepwise procedure in two-week increments over approximately 14 weeks until the entire hospital was converted. The new system has increased control as well as identified workload, inventory utilization, and problem areas.