Drug shortages pose a serious global public health challenge, affecting China and other countries. Evidence from USA shows that short-supplied drugs demonstrated a very high price growth during and after a shortage. However, the effect of shortages on drug prices in China remains unknown. This paper aims to understand the impact of drug shortages on prices and explore implications for shortage prevention policy.
We collected the purchase prices and delivery rates of 120 drugs from April 2019 to December 2021 across whole China. We examined price progression of affected drugs using linear mixed-effects models and performed subgroup analyses based on the number of manufacturers and the severity of shortage.
Non-shortage cohort had an annual price growth of 11.62% (95% confidence interval [CI] 8.34 to 14.98). Shortage cohort demonstrated an annual price growth of 8.08% (95%CI 0.12 to 16.77) in the period preceding a shortage, 27.57% (95%CI 6.17 to 52.87) during a shortage, and 9.38% (95%CI -12.64 to 36.39) in the post-shortage period. Drug shortages\' impact on prices varied across subgroups. Compared with that of drug markets supplied by a single manufacturer, the price growth rate of markets supplied by more than one manufacture declined more after the shortage resolution.
Shortages resulted in significant price increases of study markets, especially the low-priced markets, while the shortage resolution slowed the growth. The primary shortage driver has shifted from the low price to others drivers, such as unavailability of active pharmaceutical ingredients. For currently sole-supplied drugs, the expedited review of applications from other manufacturers should be considered.

Background: The Pilot Plan of National Centralized Volume-Based Procurement (NCVBP) was adopted to cope with the rapid increase in drug expenditures. This research aimed to quantitatively evaluate the impact of the NCVBP on antiviral medications for the hepatitis B virus. Methods: Data on nucleoside analogs (NAs) medications of hepatitis B virus monthly procurement records in the pilot cities from January 2018 to December 2019 were extracted from the China Drug Supply Information Platform (CDSIP). The impacts of the NCVBP on purchased volumes, expenditures, and pre-defined daily dose costs were evaluated by interrupted time-series (ITS) analysis using Stata 16.0. We constructed two segments with one interruptive point (March 2019). Results: Compared to the same period between pre-and post-intervention, the purchased volume of NAs medications were increased by 92.85%, and selected medications were increased by 119.09%. Analysis of changes in the level of NAs medication followed a decrease in purchased expenditure (coefficient: 5364.88, p < 0.001), meanwhile, the purchased volume was increased with statistical significance (coefficient:605.49, p < 0.001). The Defined Daily Dose cost (DDDc) of NAs medication followed a decrease (coefficient: 8.90, p < 0.001). The NCVBP reform was followed by an increase of 618.41 ten thousand Defined Daily Dose (DDD) (p < 0.001) in purchased volume and a reduction of 5273.84 ten thousand Chinese Yuan (CNY) (p < 0.001) in the purchased expenditure of selected medications in the level. The DDDc of selected medications decreased in the level (coefficient: 9.87, p < 0.001), while the DDDc of alternative medications increased in the slope (coefficient:0.07, p = 0.030). The purchased volume and expenditure of bid-winning products increased by 964.08 ten thousand DDD and 637.36 ten thousand CNY in the level (p < 0.001). An increase of 633.46 ten thousand DDD (p < 0.001) in purchased volume and a reduction of 4285.32 ten thousand CNY (p < 0.001) in the purchased expenditure of generic drugs in the level was observed. Conclusion: The NCVBP reduced the DDDc of NAs medication, improved the utilization of the selected medications, and promoted the usage of generic products.

As one of the major constituents of the cannabis sativa plant, cannabidiol (CBD) is approved for use in medical treatment and cosmetics because of its potential health benefits. With the rapid growth of the CBD market, customers purchase these products, and relevant discussions are becoming more active on social media.
In this study, we aimed to understand the users\' attitudes toward CBD products in various countries by conducting text mining on social media in countries with different substance management policies.
We collected posts from Reddit and Xiaohongshu, conducted topic mining using the latent Dirichlet allocation model, and analyzed the characteristics of topics on different social media. Subsequently, a co-occurrence network of high-frequency keywords was constructed to explore potential relationships among topics. Moreover, we conducted sentiment analysis on the posts\' comments and compared users\' attitudes toward CBD products on Reddit and Xiaohongshu using chi-square test.
CBD-related posts on social media have been rapidly increasing, especially on Xiaohongshu since 2019. A total of 1790 posts from Reddit and 1951 posts from Xiaohongshu were included in the final analysis. The posts on the 2 social media platforms, Reddit and Xiaohongshu, were categorized into 7 and 8 topics, respectively, by the latent Dirichlet allocation model, and these topics on the 2 social media were grouped into 5 themes. Our study showed that the themes on Reddit were mainly related to the therapeutic effects of CBD, whereas the themes on Xiaohongshu concentrated on cosmetics, such as facial masks. Theme 2 (CBD market information) and theme 3 (attitudes toward CBD) on Reddit had more connections with other themes in the co-occurrence network, and theme 3 and theme 1 (CBD therapeutic effects) had a high co-occurrence frequency (22,803/73,865, 30.87%). Meanwhile, theme 1 (CBD cosmetics) on Xiaohongshu had various connections with others (169,961/384,575, 44.19%), and the co-occurrence frequency of theme 4 (CBD ingredients) and theme 1 was relatively prominent (27,128/49,312, 55.01%). Overall, users\' comments tended to be positive for CBD-related information on both Reddit and Xiaohongshu, but the percentage was higher on Xiaohongshu (82.25% vs 86.18%; P<.001), especially in cosmetics and medical health care products.
The CBD market has grown rapidly, and the topics related to CBD on social media have become active. There are apparent differences in users\' attitudes toward CBD in countries with different substance management policies. Targeted CBD management measures should be formulated to suit the prevalence of CBD use of each country.

How PWUD (people who use drugs) live under drug governance is an important research question. This study adopts a qualitative research method to explore how PWUD in China self-manage after perceiving the dilemma of incomplete citizenship and the social pressure brought by drug control arrangements. Through analysis of 130 PWUD\'s files and in-depth interviews with 10 interviewees (from the 24 preliminary interviews), this study found that PWUD developed action strategies of hidden mobility (spatial isolation), disconnection of past experiences (time isolation), instrumental actions, as well as narrative strategies of reframing themselves as ordinary citizens with attempts of reversing identity disadvantages. Further, PWUD\'s self-management strategies manifest as a disengagement model in which the actors (PWUD, not rehabilitation agencies) do not intend to develop integrative positive identities through dispersed, practiced behavioral strategies, but attempt to return to pre-addiction, non-socially exclusionary citizenship experiences. The disengagement model and its negative effect on PWUD\'s social integration help us reflect on the current implementation of rehabilitation projects and institutional settings of drug governance.

OBJECTIVE: In the past two decades, human antibiotic consumption has increased globally, contributing to the emergence and spread of antimicrobial resistance and needing urgent effective actions. Our objectives were to systematically identify and collate studies exploring non-biomedical factors influencing healthcare consumers\' antibiotic use globally, in order to inform future interventions to improve practices in antibiotic use.
METHODS: Data sources were PubMed, EMBASE, PsycINFO, and Cochrane. Study eligibility criteria were original and empirical studies that identified factors for healthcare consumers\' antibiotic use. Participants were healthcare consumers. Assessment of risk of bias used adapted BMJ survey appraisal tools, the Critical Appraisal Skills Programme checklist, and the Mixed Methods Appraisal Tool for quality assessment. Methods of data synthesis employed the Social Ecological Framework and Health Belief Model for data synthesis. We did random-effects meta-analyses to pool the odds ratios of risk factors for antibiotic use.
RESULTS: We included 71 articles for systematic review and analysis; 54 were quantitative, nine were qualitative, and eight were mixed-methods studies. Prevalent non-prescription antibiotic use and irresponsible prescriptions were reported globally, especially in low-to-middle-income countries. Barriers to healthcare-wait time, transportation, stigmatization-influenced people\'s practices in antibiotic use. Further, lack of oversight and regulation in the drug manufacturing and a weak supply chain have led to the use of substandard or falsified antibiotics. Knowledge had mixed effects on antibiotic use behaviours. Meta-analyses identified pro-attitudes towards self-medication with antibiotics, relatives having medical backgrounds, older age, living in rural areas, and storing antibiotics at home to be risk factors for self-medication with antibiotics.
CONCLUSIONS: Non-prescription antibiotic use and irresponsible prescriptions in the community are prevalent in all WHO regions and are driven largely by a mixed collection of non-biomedical factors specific to the respective setting. Future antimicrobial resistance strategies should incorporate an implementation science approach for community-based complex interventions that address drivers of the target behaviours tailored to local contexts.

High drug costs are putting pressures on health care budgets and posing an obstacle for China to achieve universal coverage. Policies such as the direct price ceiling, and the Essential Medicines Program-with the Zero Markup Drug Policy (ZMDP) one key component-were implemented, coming out with limited evidence for a success. As a benchmark of China\'s recent health reform, Sanming city initiated the ZMDP in January 2013; and further piloted the first reference pricing (RP) policy in China in September 2014, with the intention to dis-incentivize the use of costly original drugs. In this study, we used hospital-based drug procurement data of 14 drug substances that were subjected to the RP, from four hospitals in Sanming and a neighbouring city Longyan, between 2012 and 2016. Adopting the difference-in-difference (DID) approach, we evaluated the impacts of the RP together with the ZMDP. On the one hand, we found that the ZMDP had no impact on drugs\' procurement prices, volumes and costs. While on the other hand, we found that the introduction of RP was not associated with changes in unit prices for the 14 drugs in Sanming. However, the RP pilot was associated with a 25.9% [95% confidence interval (CI), 12.9-37.0%] decrease in monthly drug procurement volumes and a 47.7% (95% CI, 33.7-58.7%) decrease in the total drug costs. In particular, it reduced the procurement volumes of original drugs by 56.8% (95% CI, 47.0-64.7%). Subgroup analyses by hospital level and therapeutic class found similar results. We draw lessons for the Chinese government to experiment RP on a larger scale, considering the development and effective regulation of the generic market. This is a first report on the effects of RP in China, Asia and middle-income countries.

Objectives This article assessed the balance between industry and drug policy objectives in the pharmaceutical sector in China. Methods The articles were mainly identified through databases such as Elsevier, Google Scholar, and SpringerLink, among others. Related articles were mainly separated into three categories: studies on drug policies, studies related to China\'s new health-care reform policy, and studies concerning patent policies. Results A relatively healthy environment for continuous innovation and drug patent protection in the pharmaceutical industry has been created in China, and the public\'s drug benefits have also significantly improved. However, the balance between industrial and drug policy objectives in the pharmaceutical sector in China requires additional attention. Discussion and conclusions The results suggest that the government should pay more attention to incentivizing enterprises\' innovation, but the current Essential Medicines System in China has limited innovation. Hence, the mechanism for selecting essential medicines should be reformed, and certain appropriate and reasonably innovative medicines should be included. Additionally, medicine coverage, especially the coverage of essential drugs for primary care should be expanded to improve public health benefits. Furthermore, the pharmaceutical industry should be incorporated into the prospective National Drug Policy to achieve a balance between public benefits and pharmaceutical industry development in the future.

OBJECTIVE: To evaluate essential medicines utilization in community health institutions to identify problems hindering the implementation of the Essential Medicine System at community level in Beijing, China.
METHODS: A total of 20 community health centers in Beijing were surveyed during September 2014 regarding stocking situation and utilization status of essential medicines. Opinions about essential medicines utilization were solicited from clinical staff at these centers. Average outpatient health expenditure was obtained from the Beijing Municipal Health Bureau to evaluate the financial impact.
RESULTS: During our study, an average of 377 species of essential medicines was stocked by the community health institutions, accounting for 53.9% of Beijing Essential Medicine List, and 61.6% of the total medicines in the institutions. First-aid and low-price essential medicines were frequently out of stock. The average expense per outpatient visit increased yearly from 2009 to 2013. Feedback from clinical staff revealed patients\' negative perception of the essential medicines and major concerns about its quality.
CONCLUSIONS: Our study found both the list and supply of essential medicines could not meet the clinical needs of patients at community health centers adequately. Furthermore, some existing drug policies had restricted the service capacity, thus affecting the centers\' function and bringing additional negative impact on essential medicines utilization. Financially, the inadequacy of essential medicine to meet clinical need and poor supply of many low-price drugs contributed much to the rise of average drug expenses, limiting the role of essential medicines to improve the quality of care at the community level.

BACKGROUND: The US Food and Drug Administration (FDA) is responsible for protecting public health. Issuance of a warning letter is the FDA\'s principal means of achieving prompt voluntary compliance with regulations. The objective of this study is to analyze the trends of warning letters issued to medical products about current good manufacturing practices (CGMP) violations during 2007-2014, with a secondary purpose of providing suggestions to manufacturers on how to avoid warning letters.
METHODS: Warning letters were collected from the FDA website, and information about the date of issuance, company, country, and type of medical product was collected from the letters related to medical products about CGMP violations. Descriptive statistics were performed for the analysis.
RESULTS: A total of 997 warning letters were issued to medical products about CGMP violations during 2007-2014. It showed an upward trend in the number of warning letters from 2009 to 2011. In 2011, it reached a maximum and the FDA released 159 letters. Overall, 685 (68.7%) letters were issued to medical devices, 223 (22.4%) to finished pharmaceuticals, followed by active pharmaceutical ingredients (5.7%), biological products (including blood products) (1.8%), and pharmacy compounding (1.4%). Despite a sharp reduction in 2013, the annual number of warning letters released to medical devices was larger than others; conversely, changes in other products remained relatively stable.
CONCLUSIONS: The issuance number of warning letters increased during 2009-2011. Medical device manufacturers received the largest numbers of letters. The issuance number and type of warning letters were greatly influenced by changes in FDA\'s internal enforcement procedures, drug policies and regulations, as well as other departments\' regulations. Manufacturers should comply with regulations voluntarily and respond promptly to policy changes.

Compulsory drug detention is the most frequent way to control drug use in China; however, it has often been criticized. This qualitative study aimed to investigate abstinence self-efficacy and its sources of drug users in a compulsory male drug detention center in Shanghai, China, and the attitudes of the drug users to this form of rehabilitation.
Thirty-six participants were interviewed (semi-structured, in depth) about their history of drug use and rehabilitation, self-evaluation of addiction, motivations to abstain, plans for the future and attitudes toward rehabilitation. A thematic analysis was undertaken of the transcripts with responses to interview questions being coded for content.
Two main types of self-efficacy were found - \"overconfidence\" (n = 16) and \"helplessness\" (n = 17). Overconfident participants underestimated their levels of addiction, overestimated their self-control and held external motivations and attributions. In contrast, helpless participants overestimated their levels of addiction, underestimated their self-control and had internal motivations and attributions. Compared to overconfident participants, helpless participants had more relapse history, and were more inclined to interpret relapse as a failure and attribute relapse to themselves. More helpless participants were abandoned by their family members, and received blame from the family members instead of encouragement, but their family members motivated them to abstain. Helpless participants experienced more negative emotions and had worse physical status. They said compulsory detention was a strong support for them and was the most effective way to abstain; while overconfident participants said compulsory detention was not necessary and not useful.
It is important to increase the motivation of overconfident drug users and the perceived control of helpless drug users. Compulsory drug detention has strengths in supporting drug users who feel helpless to resist drug use. Adjustments and improvements of compulsory drug detention are suggested.