In this issue of AJPH, the article "Global Policy Surveillance: Creating and Using Comparative National Data on Health Law and Policy" by Kavanagh et al. (p. 1805) is an excellent and important ...overview of what is required to map and evaluate laws of public health significance. Surveillance, the systematic collection and analysis of public health- related laws, is designed to enable research on "the implementation and health impact of laws, their spread, and their political determinants." This is an ambitious project in which the evaluation of health impact has been dubbed "legal epidemiology." The entire enterprise surveyed by the authors requires a truly transdisciplinary effort in evaluating global health information and its effect. This ecosystem at the nexus of law, policy, and health is complex, and, in my view, such monitoring and evaluation as the authors suggest similarly requires the coalescence of disciplines that normally may not interact. Moreover, all the policy surveillance and legal epidemiology in the world will not matter if the disparities in social determinants of health remain as they are. The field requires concerted political action.
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CEKLJ, DOBA, FSPLJ, IZUM, KILJ, NUK, ODKLJ, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
The ongoing policy debate about the value of communications technology in promoting development objectives is diverse. Some view computer/web/phone communications technology as insufficient to solve ...development problems while others view communications technology as assisting all sections of the population. This paper looks at evidence to support or refute the idea that fixed and mobile telephones is, or could be, an effective healthcare intervention in developing countries.
A Web-based and library database search was undertaken including the following databases: MEDLINE, CINAHL, (nursing & allied health), Evidence Based Medicine (EBM), POPLINE, BIOSIS, and Web of Science, AIDSearch (MEDLINE AIDS/HIV Subset, AIDSTRIALS & AIDSDRUGS) databases.
Evidence can be found to both support and refute the proposition that fixed and mobile telephones is, or could be, an effective healthcare intervention in developing countries. It is difficult to generalize because of the different outcome measurements and the small number of controlled studies. There is almost no literature on using mobile telephones as a healthcare intervention for HIV, TB, malaria, and chronic conditions in developing countries. Clinical outcomes are rarely measured. Convincing evidence regarding the overall cost-effectiveness of mobile phone " telemedicine" is still limited and good-quality studies are rare. Evidence of the cost effectiveness of such interventions to improve adherence to medicines is also quite weak.
The developed world model of personal ownership of a phone may not be appropriate to the developing world in which shared mobile telephone use is important. Sharing may be a serious drawback to use of mobile telephones as a healthcare intervention in terms of stigma and privacy, but its magnitude is unknown. One advantage, however, of telephones with respect to adherence to medicine in chronic care models is its ability to create a multi-way interaction between patient and provider(s) and thus facilitate the dynamic nature of this relationship. Regulatory reforms required for proper operation of basic and value-added telecommunications services are a priority if mobile telecommunications are to be used for healthcare initiatives.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
High out-of-pocket expenditures (OOPE) increases the probability that households will become impoverished or will forgo needed care. The aim of this paper is to study household medicines expenditure ...and its associated determining factors to develop policies to protect households from financial hardship. The present cross-sectional and population-level study used the Bangladesh 2016-17 National Household Income and Expenditure Survey (HIES). The final sample size was 46,080 households. We analyzed the probability of OOPE for medicines, the share of total OOPE due to medicines out of total OOPE in health (reported as a ratio between zero and one), the OOPE amount for medicines reported (in United States Dollars), and the share of OOPE amount on medicines out of total household expenditure (reported as a ratio between zero and one). Predictors of analyzed outcomes were identified using three regression models. Out of those households who spent on healthcare, the probability of having any OOPE on medicines was 87.9%. Of those who spent on medicines, the median monthly expenditure was US$3.03. The poorest households spent 9.97% of their total household expenditure as OOPE on medicines, nearly double that of the wealthiest households (5.86%). The characteristic which showed the most significant correlation to a high OOPE on medicines was the presence of chronic diseases, especially cancer. Twenty six percent of all surveyed households spend more than 10% of their OOPE on medicines. Our study shows that financial protection should be targeted at the poorest quintiles and such protection should include enrollment of rural households. Further, outpatient medicines benefits should include those for non-communicable diseases (NCDs).
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Cardiovascular diseases (CVD) represent the highest burden of disease globally. Medicines are a critical intervention used to prevent and treat CVD. This review describes access to medication for CVD ...from a health system perspective and strategies that have been used to promote access, including providing medicines at lower cost, improving medication supply, ensuring medicine quality, promoting appropriate use, and managing intellectual property issues. Using key evidence in published and gray literature and systematic reviews, we summarize advances in access to cardiovascular medicines using the 5 health system dimensions of accessavailability, affordability, accessibility, acceptability, and quality of medicines. There are multiple barriers to access of CVD medicines, particularly in low- and middle-income countries. Low availability of CVD medicines has been reported in public and private healthcare facilities. When patients lack insurance and pay out of pocket to purchase medicines, medicines can be unaffordable. Accessibility and acceptability are low for medicines used in secondary prevention; increasing use is positively related to country income. Fixed-dose combinations have shown a positive effect on adherence and intermediate outcome measures such as blood pressure and cholesterol. We have a new opportunity to improve access to CVD medicines by using strategies such as efficient procurement of low-cost, quality-assured generic medicines, development of fixed-dose combination medicines, and promotion of adherence through insurance schemes that waive copayment for long-term medications. Monitoring progress at all levels, institutional, regional, national, and international, is vital to identifying gaps in access and implementing adequate policies.
This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing ...the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. ...This phenomenon, pejoratively known as "evergreening", can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market.
We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration's Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product's device patents and medicine patents.
Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3-15.2 years).
Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes "evergreening" depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic improvements in the standard of care, which is highly debatable.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
New innovation ecosystems are emerging that challenge the complex intellectual property and regulatory landscape surrounding drug development in the United States (US). A prime example is an ...initiative known as the Open Insulin Project. The goal of the project is to sidestep patents and enable generic manufacturers to produce cheaper insulin. However, the US regulatory environment, not patent exclusivity, is the main barrier to insulin affordability. If the Open Insulin Project succeeds in releasing an open protocol for insulin manufacturing, follow-on work could enable a number of new insulin production ecosystems, including ‘home-brewed’ insulin. Regulators will need to consider how to proceed in a future where commercial pharmaceuticals remain unaffordable, but patients are empowered to produce drugs for their personal use.
New innovation ecosystems for drug discovery and development are emerging.
Members of the ‘do-it-yourself biology’ community, sometimes called ‘biohackers,’ are contributing to this new frontier by experimenting with the development of medical treatments and devices.
An initiative known as the Open Insulin Project is working to develop a protocol for insulin production in order to sidestep intellectual property.
Follow-on work could contribute to a number of different insulin distribution structures, including ‘home-brewed’ insulin for personal use.
The current regulatory system is incongruous with emerging innovation ecosystems such as the Open Insulin Project.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Elderly patients and those with comorbid conditions are at high risk for poor outcomes after Clostridium difficile infection (CDI) but outcomes in a healthier, nonelderly population are not well ...described. We sought to investigate gastrointestinal diagnoses and CDI during hospitalizations in the 24 to 36 months after an initial episode of CDI in nonelderly patients in a cohort with an overall low prevalence of comorbid conditions. We performed a retrospective analysis of hospital admissions from 2010-2013 using the Truven MarketScan database of employment-based private insurance claims. Subjects <65 years of age and their adult dependents (> = 18 years old); a CDI diagnosis in 2011 (index date); at least 12 months of pre-index continuous enrollment; and 24-36 months of continuous post-index enrollment were included. The 12 months of each subject's enrollment prior to the index date for a CDI served as the reference period for the analyses of that subject's post-CDI time periods. Hospital claims during the follow-up period were evaluated for gastrointestinal diagnoses and/or CDI ICD-9 codes. The risk of gastrointestinal diagnoses was assessed using Cox proportional hazards models adjusted for a pre-specified set of baseline demographic and clinical factors. During 2011, 5,632 subjects with CDI met the inclusion criteria for our study. The risk of gastrointestinal diagnoses in patients with a CDI diagnostic code for the same admission was almost 8-fold higher 3 months post-CDI (hazard ratio (HR) = 7.56; 95% confidence interval (CI): 2.97-19.19) than for subjects without CDI and remained statistically significant until month 24 (HR = 1.47; 95% CI = 1.04-2.08). After CDI, patients remained at risk for gastrointestinal symptoms with CDI for up to two years. There is an important, long-term healthcare burden after CDI in this population.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract Objective Review the literature on the impact of policies designed to enhance uptake of generic medicines in low and middle income countries (LMICs). Methods We searched for publications ...related to generic medicines policies (January 2000–March 2010) and did a bibliometric, descriptive analysis of the dataset in addition to an analysis of studies evaluating the impact of pro-generic policies. We repeated a subset of this larger search in January 2012. Results Of the 4994 articles screened, 315 (6.3%) full-text publications were related to generic medicines policies. Of these 315, 236 (75%) dealt with generic medicine policies in high-income countries, and 79 (25%) with policies in LMICs. In total, we found only 10 evaluation studies looking at the impact of competition, trade, pricing and prescribing policies on generic medicine price and/or volume. Key barriers to implementing generic medicine policies in LMICs are negative perceptions of stakeholders (e.g., generics are of lower quality) plus perverse private sector financial incentives to sell products with the highest profit margin. Other relevant barriers are legal/regulatory, such as the absence of generic substitution regulations. There also exists a general difficulty in promoting generics due to a lack of transparency in the pharmaceutical supply and distribution system, for example, a lack of price information provided by health care provider organizations to physicians. Conclusion There is little policy evaluation to determine which pro-generic policies increase generic medicines utilization in LMICs. Ensuring a functioning medicines regulation authority, creating a reasonably robust market of generic medicines and aligning incentives for physicians, consumers and drug sellers are necessary prerequisites for increasing the uptake and use of generic medicines.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Insurances in high-income countries (HIC) often contract with private community pharmacies to dispense medicines to outpatients. In contrast, dispensing of medicines in low- and middle-income ...countries (LMICs) often lacks such contractual arrangements. Furthermore, many LMICs lack sufficient investment in supply chains and financial and human resources to guarantee stock levels and services at public medicine-dispensing institutions. Countries striving to achieve universal health coverage (UHC) can, in principle, incorporate retail pharmacies into their supply chains to expand access to essential medicines (EMs). The objectives of this paper are (a) to identify and analyze key considerations, opportunities and challenges for public payers when contracting out the supply and dispensing of medicines to retail pharmacies and (b) to provide examples of strategies and policies to address these challenges.
A targeted literature strategy was used to conduct this scoping review. We created an analytical framework of key dimensions: (1) governance (including medicine and pharmacy regulation); (2) contracting (3) reimbursement; (4) medicine affordability (5) equitable access; and (6) quality of care (including 'patient-centered' pharmaceutical care). Using this framework, we selected a mix of three HIC and four LMIC case studies and analyzed the opportunities and challenges encountered when contracting retail pharmacies.
From this analysis, we identified a set of opportunities and challenges that should be considered by public payers considering public-private contracting: (1) balancing business viability with medicine affordability; (2) incentivizing equitable access to medicines; (3) ensuring quality of care and delivery of services; (4) ensuring product quality; (5) task-sharing from primary care providers to pharmacies and (6) securing human resources and related capacity constraints to ensure sustainability of the contract.
Public-private partnerships offer opportunities to improve access to EMs. Nonetheless, managing these agreements is complex and is influenced by a variety of factors. For effective contractual partnerships, a systems approach is needed in which business, industry and regulatory contexts are considered in tandem with the health system. Special attention should be devoted to rapidly changing health contexts and systems, such as changes in patient preferences and market developments brought about by the COVID-19 pandemic.
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