Private sector antimalarial sales a decade after "test and treat": A cross-sectional study of drug shop clients in rural Uganda.

Background: The World Health Organization has promoted "test and treat" guidelines for malaria since 2010, recommending all suspected malaria cases be confirmed with a parasitological test, typically a rapid diagnostic test (RDT), prior to treatment with antimalarial medications. However, many fevers at private drug shops in Uganda continue to be treated presumptively as malaria without diagnostic testing. Methods: The purpose of this study was to document private sector malaria case management in rural Uganda through a cross-sectional survey of drug shop clients in Bugoye sub-county. Drug shop vendors (n = 46) recorded information about sales interactions with clients reporting fever or requesting antimalarials and collected capillary blood samples from clients who purchased medications without an RDT. We estimated the proportion of clients who purchased an RDT, adhered to the RDT result, and received antimalarials without having laboratory-confirmed malaria. Results: Most drug shops were unlicensed (96%) and sold RDTs (98%). Of 934 clients with suspected malaria who visited study drug shops during the data collection period, only 25% bought an RDT. Since some clients reported previous RDTs from the public sector, 40% of clients were aware of their malaria status at the drug shop. Among those with negative tests, 36% still purchased antimalarials. Sixty-five percent of clients who purchased an antimalarial without an RDT subsequently tested negative. Conclusions: Despite national guidelines, drug shop clients who purchase antimalarials from drug shops in Bugoye are often not tested to confirm a malaria diagnosis prior to treatment. Most clients treated presumptively with antimalarials did not have malaria. Interventions are needed to improve malaria case management and rational drug use in the private sector.

"Testing for malaria does not cure any pain" A qualitative study exploring low use of malaria rapid diagnostic tests at drug shops in rural Uganda.

The World Health Organization recommends all suspected malaria cases be confirmed with a parasitological test, typically a rapid diagnostic test (RDT), prior to treatment. Despite recommendations, many fevers presenting at private drug shops are treated presumptively as malaria without diagnostic testing. The purpose of this qualitative study was to describe community perceptions of RDTs and explore ways to improve malaria case management at drug shops in Bugoye, western Uganda. A total of 63 in-depth interviews were conducted between September and December 2021 with 24 drug shop clients, 19 drug shop vendors, 12 community health workers, and 8 health and community officials. Data was analyzed using thematic content analysis and narrative techniques. While drug shop clients valued RDTs, the cost of the test limited their use. Further, mistrust in negative results and fear about treatment options for conditions other than malaria led to nonadherence to negative RDTs. Improvement with antimalarials after a negative RDT, or no RDT at all, was seen as proof an individual had malaria, reinforcing the acceptability of liberal antimalarial use. Drug shop vendors were knowledgeable about malaria case management but financially conflicted between recommending best practices and losing business. While clients viewed drug shop vendors as trusted health professionals, health officials distrusted them as business owners focused on maximizing profits. Study results suggest public-private partnerships that recognize the essential role of drug shops, better incorporate them into the healthcare system, and leverage the high levels of community trust in vendors, could provide greater opportunities for oversight and training to improve private-sector malaria case management. Interventions that address financial barriers to RDT use, emphasize the financial benefits of malaria testing, increase vendor knowledge about illnesses confused with malaria, and improve the quality of vendor-client counseling could increase RDT uptake and improve adherence to RDT results.

Falsified and Substandard Drugs: Stopping the Pandemic.

Falsified and substandard medicines are associated with tens of thousands of deaths, mainly in young children in poor countries. Poor-quality drugs exact an annual economic toll of up to US$200 billion and contribute to the increasing peril of antimicrobial resistance. The WHO has emerged recently as the global leader in the battle against poor-quality drugs, and pharmaceutical companies have increased their roles in assuring the integrity of drug supply chains. Despite advances in drug quality surveillance and detection technology, more efforts are urgently required in research, policy, and field monitoring to halt the pandemic of bad drugs. In addition to strengthening international and national pharmaceutical governance, in part by national implementation of the Model Law on Medicines and Crime, a quantifiable Sustainable Development Goal target and an international convention to insure drug quality and safety are urgent priorities.

Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis.

Importance: Substandard and falsified medicines burden health systems by diverting resources to ineffective or harmful therapies, causing medical complications and prolonging illnesses. However, the prevalence and economic impact of poor-quality medicines is unclear. Objective: To conduct a systematic review and meta-analysis to assess the prevalence and estimated economic burden of substandard and falsified essential medicines in low- and middle-income countries. Data Sources: Five databases (PubMed, EconLit, Global Health, Embase, and Scopus) were searched from inception until November 3, 2017. Study Selection: Publications were assessed to determine whether they examined medicine quality and the prevalence and/or economic burden of substandard and falsified medicines in low- and middle-income countries. Studies with a sample size of 50 or more were included in the meta-analysis. Data Extraction and Synthesis: The study is registered in PROSPERO and reported via the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Study quality was assessed using an adapted Medicine Quality Assessment Reporting Guidelines scoring metric. Multiple reviewers conducted the data extraction and quality assessment independently. Main Outcomes and Measures: Prevalence and/or estimated economic impact of substandard and falsified medicines. Results: Two hundred sixty-five studies that estimated the prevalence of poor-quality essential medicines in low- and middle-income countries were identified. Among 96 studies that tested 50 samples or more (67 839 total drug samples), overall prevalence of poor-quality medicines was 13.6% (95% CI, 11.0%-16.3%), with regional prevalence of 18.7% in Africa (95% CI, 12.9%-24.5%) and 13.7% in Asia (95% CI, 8.2%-19.1%). Of studies included in the meta-analysis, 19.1% (95% CI, 15.0%-23.3%) of antimalarials and 12.4% (95% CI, 7.1%-17.7%) of antibiotics were substandard or falsified. Eight approximations of the economic impact, focused primarily on market size, with poor or undisclosed methods in estimation were identified, ranging from $10 billion to $200 billion. Conclusions and Relevance: Poor-quality essential medicines are a substantial and understudied problem. Methodological standards for prevalence and rigorous economic studies estimating the burden beyond market size are needed to accurately assess the scope of the issue and inform efforts to address it. Global collaborative efforts are needed to improve supply-chain management, surveillance, and regulatory capacity in low- and middle-income countries to reduce the threat of poor-quality medicines. Trial Registration: PROSPERO Identifier: CRD42017080266.

Responding to the pandemic of falsified medicines.

Over the past decade, the number of countries reporting falsified (fake, spurious/falsely labeled/counterfeit) medicines and the types and quantities of fraudulent drugs being distributed have increased greatly. The obstacles in combatting falsified pharmaceuticals include 1) lack of consensus on definitions, 2) paucity of reliable and scalable technology to detect fakes before they reach patients, 3) poor global and national leadership and accountability systems for combating this scourge, and 4) deficient manufacturing and regulatory challenges, especially in China and India where fake products often originate. The major needs to improve the quality of the world's medicines fall into three main areas: 1) research to develop and compare accurate and affordable tools to identify high-quality drugs at all levels of distribution; 2) an international convention and national legislation to facilitate production and utilization of high-quality drugs and protect all countries from the criminal and the negligent who make, distribute, and sell life-threatening products; and 3) a highly qualified, well-supported international science and public health organization that will establish standards, drug-quality surveillance, and training programs like the U.S. Food and Drug Administration. Such leadership would give authoritative guidance for countries in cooperation with national medical regulatory agencies, pharmaceutical companies, and international agencies, all of which have an urgent interest and investment in ensuring that patients throughout the world have access to good quality medicines. The organization would also advocate strongly for including targets for achieving good quality medicines in the United Nations Millennium Development Goals and Sustainable Development Goals.

Risk compensation and vaccination: can getting vaccinated cause people to engage in risky behaviors?

BACKGROUND: Some believe that vaccinating young women against human papillomavirus (HPV) will increase their risky behavior. In more formal terms, vaccination lowers risk perception, and people compensate for their lower perceived risk by reducing other preventive behaviors. PURPOSE: We test several predictions from the risk compensation hypothesis in the context of vaccination behavior. METHODS: We obtained a random sample of adults (N=705), interviewing them by phone just as the Lyme disease vaccine first became available to the public and again 18 months later. Analyses controlled for age, sex, education, and race. RESULTS: Vaccinated respondents were less likely to continue engaging in two of five protective behaviors after vaccination. The frequency of these protective behaviors did not dip below that among the unvaccinated respondents. CONCLUSIONS: We found some evidence of regression (protective behaviors dropping, after vaccination, to levels reported by the unvaccinated cohort). However, we did not find disinhibition (exceeding the risk taking of the unvaccinated cohort), the greater threat to public health. Although we will not know for several years what effect HPV vaccination has on other behaviors, if any, data on other vaccinations can offer critically important information in the interim.

Risk perceptions and their relation to risk behavior.

BACKGROUND: Because risk perceptions can affect protective behavior and protective behavior can affect risk perceptions, the relations between these 2 constructs are complex and incorrect tests often lead to invalid conclusions. PURPOSE: To discuss and carry out appropriate tests of 3 easily confused hypotheses: (a). the behavior motivation hypothesis (perceptions of personal risk cause people to take protective action), (b). the risk reappraisal hypothesis (when people take actions thought to be effective, they lower their risk perceptions), and (c). the accuracy hypothesis (risk perceptions accurately reflect risk behavior). METHODS: Longitudinal study with an initial interview just after the Lyme disease vaccine was made publicly available and a follow-up interview 18 months later. Random sample of adult homeowners (N = 745) in 3 northeastern U.S. counties with high Lyme disease incidence. Lyme disease vaccination behavior and risk perception were assessed. RESULTS: All 3 hypotheses were supported. Participants with higher initial risk perceptions were much more likely than those with lower risk perceptions to get vaccinated against Lyme disease (OR = 5.81, 95% CI 2.63-12.82, p <.001). Being vaccinated led to a reduction in risk perceptions, chi2(1, N = 745) = 30.90, p <.001, and people vaccinated correctly believed that their risk of future infection was lower than that of people not vaccinated (OR =.44, 95% CI.21-.91, p <.05). CONCLUSIONS: The behavior motivation hypothesis was supported in this longitudinal study, but the opposite conclusion (i.e., that higher risk led to less protective behavior) would have been drawn from an incorrect test based only on cross-sectional data. Health researchers should take care in formulating and testing risk-perception-behavior hypotheses.

Risk perceptions regarding ticks and Lyme disease: a national survey.

BACKGROUND: Lyme disease (LD) is caused by the tickborne bacterium Borrelia burgdorferi and, in 2000, accounted for >90% of all reported cases of vectorborne illness in the United States. Aside from anecdotal and indirect evidence, little empirical evidence exists regarding what the U.S. public knows, says, or does about preventing LD. OBJECTIVES: To examine knowledge, perceptions, and practices regarding prevention of tick bites and LD. METHODS: In 1998, a random-digit-dial frame was used to collect a cross-sectional sample (n =1500) from the 48 coterminous states plus the District of Columbia, and an over-sample (n =250) from six states with the highest incidence of LD. RESULTS: Forty percent of respondents reported doing something to avoid being bitten by ticks. Less than half (41%) used insect repellent. Ninety-two percent of those who had heard about LD stated their likelihood of ever getting the disease was

Pre-West Nile virus outbreak: perceptions and practices to prevent mosquito bites and viral encephalitis in the United States.

Mosquitoes can transmit over 100 of the viruses that can cause encephalitis, meningitis, and hemorrhagic disease in humans (Chin 2000; Gubler 1996; Monath 1989). While much is known about the ecology, epidemiology, and clinical manifestations of the arboviral encephalitides (Campbell et al. 2002; Centers for Disease Control and Prevention 1997; Gubler 1998; Hayes 1989; Hubálek and Halouzka 1999), little empirical research exists regarding the U.S. population's knowledge of mosquitoes and arboviral encephalitis, particularly prior to the U.S. outbreak of West Nile virus (WNV) in 1999. A nationally representative 55-item survey instrument was successfully administered to 1,500 adults in the United States and an additional 250 adults in six states in the Northeast (Connecticut, Delaware, New Jersey, New York, Pennsylvania, and Rhode Island) regarding mosquitoes and mosquito-borne viral encephalitis. A summary outcome measure for mosquito bite prevention was created. Analyses revealed that the following were statistically significant predictors of behaviors taken to prevent mosquito bites: being concerned about being bitten by mosquitoes, perceived effectiveness of staying indoors in late afternoon and early evening was protective, perceived effectiveness that mosquito repellent is not harmful to health, owning dogs and/or cats as pets, being married, and being > or = 18-44 years old. Being concerned about being bitten by mosquitoes was the most robust predictor of behavioral action to prevent mosquito bites (OR = 7.3; 95% CI = 4.3, 12.2). Observed misperceptions and inadequate knowledge regarding insect repellents suggest increased promotion of the safety and efficacy of DEET-containing insect repellents is warranted.