Dataset Information

Public reporting on pharmaceutical industry-led access programs: alignment with the WHO medicine programs evaluation checklist.

ABSTRACT:

Background

There has been increased demand for greater public accountability and transparency of private sector-led global health partnership programs. This study critically reviews and pilot tests the World Health Organization (WHO) medicine program checklist as a framework for public reporting and assessing of programs.

Methods

We reviewed each question on the WHO checklist for clarity and usability. Next, we pilot tested the subset of checklist questions focused on program assessment. We extracted and analyzed publicly available information on one randomly selected program from each of the 20 largest research-based biopharmaceutical companies. For each program, we assessed whether publicly available information allowed for an assessment of each relevant question in the checklist.

Results

Checklist questions fit in four main categories: [1] national health and development plans, needs, capacity, laws and policies; [2] financial, performance, and public accountability; [3] risk management and mitigation strategies; and [4] long-term sustainability. Nearly all (21 of 22) questions in the checklist require information best provided by companies; one question requires information best provided by governments.Programs frequently reported on the public health needs of their programs (100%), program objectives and activities (100%) and the actual or expected program outputs (95%). There was less information on program alignment with country plans and capacity (50%), detailed program monitoring and evaluation plan (20%), risks mitigation strategies (5%), program needs assessment (5%), and additional resources required from or contributed by government (0%).

Conclusion

The WHO checklist of key considerations for evaluating proposals for access to medicine programs could be a useful framework for public reporting of program information as most of checklist questions ask for data that should be available to those leading the program. Further revisions of the WHO checklist will help refine it to improve clarity and content validity.

SUBMITTER: Umeh CA

PROVIDER: S-EPMC7098075 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Public reporting on pharmaceutical industry-led access programs: alignment with the WHO medicine programs evaluation checklist.

Umeh Chukwuemeka A CA Rockers Peter C PC Laing Richard R Wagh Ovi O Wirtz Veronika J VJ

Journal of pharmaceutical policy and practice 20200326

<h4>Background</h4>There has been increased demand for greater public accountability and transparency of private sector-led global health partnership programs. This study critically reviews and pilot tests the World Health Organization (WHO) medicine program checklist as a framework for public reporting and assessing of programs.<h4>Methods</h4>We reviewed each question on the WHO checklist for clarity and usability. Next, we pilot tested the subset of checklist questions focused on program asse ...[more]

PMID: 32226630

Similar Datasets

Project description:BackgroundDrug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination.ObjectiveThis study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe.MethodsThe case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses.ResultsA total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were 'change in administration setting to hospital' (374%, p<0.0001), 'addressing unmet needs' (69%, p<0.05), 'reformulations belonging to Group 3'-that is, change in administration route (117%, p<0.001), and being a repurposed product with the 'same brand name' as the original product (65%, p<0.05).ConclusionWe found that the ability of the repurposed product to address unmet needs, a reformulation where the target product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in the USA, in particular. Although a change of administration from ambulatory to hospital setting seemed to be significantly correlated with a price increase for the target product, only one case was retrieved for this parameter; as such, it was not possible to infer a firm correlation between this parameter and a change in price.

Project description:ObjectiveThis article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health.MethodsIt considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians' website (Medycyna Praktyczna) between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland.ResultsThe majority of respondents (96.8%) said that they had talked with pharmaceutical sales representatives (PSRs) in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3%) said they trusted the information provided by PSRs. Over one third of respondents (36.4%) claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law.ConclusionsThe study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency and strengthen the ethical guidelines surrounding the physician-pharmaceutical industry relationship in Poland. The present findings also have implications for public health policy.

Project description:To investigate whether adverse effects data for the sponsor's product are presented more favourably in pharmaceutical industry-funded studies than in non-industry-funded studies.We conducted a systematic review of methodological evaluations that had assessed the relationship between industry funding and the reported risk of adverse effects. Searches were undertaken in 10 databases and supplemented with other sources of information such as handsearching, citation searching, checking conference proceedings and discussion with experts. Two reviewers independently screened the records and carried out data extraction for potentially relevant papers. We included studies that compared the results and interpretation of the adverse effects data according to funding source (e.g. adverse effects data in pharmaceutical industry research vs. data from nonprofit organizations, or from one manufacturer vs. another). Methodological evaluations were excluded if categories of funding source were not explicitly specified by the researchers, and if we were uncertain that industry-funded studies were present in the evaluation.The search strategy yielded 4,069 hits, of which six methodological evaluations met our inclusion criteria. One survey of 370 trials covering a wide range of topics found that trials with industry sponsors had more complete reporting of adverse effects compared with non-industry-funded trials, whereas another survey of 504 inhaled corticosteroid studies showed no apparent difference after confounding factors were adjusted for. In contrast, we found evidence from post hoc subgroup analyses involving two products where the likelihood of harm was of a lower magnitude in manufacturer-funded studies compared with nonmanufacturer-funded studies. There is also evidence from four methodological evaluations that authors with industry funding were more likely than authors without pharmaceutical funding to interpret and conclude that a drug was safe, even among studies that did find a statistically significant increase in adverse effects for the sponsored product.Our review indicates that industry funding may not be a major threat to bias in the reporting of the raw adverse effects data. However, we are concerned about potential bias in the interpretation and conclusions of industry-funded authors and studies.

Project description:Although corporate social responsibility (CSR) activities are common in the pharmaceutical industry, there is little empirical evidence on consumer responses to CSR practices. We investigated public awareness, preferences, and expectations regarding social contribution of the pharmaceutical industry's CSR activities, and identified the factors associated with such activities. We conducted an online survey with 1,298 respondents comprising two groups: healthy individuals (546) and patients (752). Most respondents (78%) expressed interest in CSR activities undertaken by pharmaceutical companies. However, they reported a lack of awareness and experience thereof; only 26.9% were aware of and 7.9% had experience with such activities. Among our six CSR activity categories, both survey groups showed the highest preference for the "promoting public health" (healthy group: 6.34/10; patient group: 6.37/10) and "emergency disaster relief support" (6.31 and 6.35) categories. Among sub-categories, activities related to "development of innovative drugs in untreated areas" (6.63 and 6.82) and "support for research on new drug development" (6.59 and 6.84) received the highest scores. The mean expectation score of social contribution of all CSR activities was slightly higher than the mean preference score (6.37 and 6.06, respectively). The patient group exhibited a larger difference between the highest and lowest expectation scores than the healthy group (1.11 and 0.64, respectively). The results of the regression analysis revealed that being a patient, being male, and having positive attitudes toward CSR and its expected effects significantly and positively affected public preferences regarding CSR activities. We can conclude that CSR activities with high public preference might be an effective strategy to improve public awareness of the pharmaceutical industry's CSR activities. Furthermore, the highest preference for CSR activities relates to new drug development, indicating that our society believes the pharmaceutical industry's key CSR activity should be to pursue its intrinsic mission: to fulfill unmet medical needs by developing new drugs.

Project description:BackgroundMedicinal products that have been developed and approved for one disease may be the object of additional clinical development in other disease areas or of additional pharmaceutical development for new and different formulations. The newly developed products can be named as repositioned or reformulated products, respectively. Market access of repositioned or reformulated products in Europe and the United States is an interesting object of study as it may provide clarity about which parameters are assessed and considered to bring added value, other than the molecule itself. As such, we aim to evaluate if the added value of repositioned or reformulated medicinal products can be systematically described, quantified, and predicted. As a first step toward investigating the impact of market access on drug research and development trends for repositioned and reformulated products, it is necessary to have consistency in the designations for the case studies evaluated in this project. In an attempt to achieve that consistency, the current study aims to propose harmonized definitions for the repositioning and reformulation strategies and to propose a taxonomy for the medicinal products derived thereof.MethodsA systematic literature review was conducted to collect information on existing cases of repositioning or reformulation. A search strategy was developed by defining the search objectives, targeted data sources, search keywords, and inclusion/exclusion criteria for the retrieved documents.ResultsA total of 505 publications were retrieved through a search of the main data sources. The screenings and the ad hoc search led to a total of 56 publications to be used for the case study data extraction. In total, 87 repositioning and/or reformulation cases were found described in the literature, 23 of which presented different definitions and/or classifications by different authors.ConclusionGiven the disparity and inconsistency of terminologies and classifications in the literature, a harmonized nomenclature for drug repositioning, reformulation, and combination cases will allow for a robust analysis of the added value and market access conditions attributed for each strategy and case type as assessed by regulators and payors in Europe and the United States. After evaluation of the existing terminologies and given the absence of clear and consistent definitions for drug reformulation and repositioning in the literature, we propose a global terminology and taxonomy in order to cover all of the previously unclear definitions and classifications for repositioned and reformulated products.

Dataset Information

Public reporting on pharmaceutical industry-led access programs: alignment with the WHO medicine programs evaluation checklist.

Background

Methods

Results

Conclusion

Publications

Public reporting on pharmaceutical industry-led access programs: alignment with the WHO medicine programs evaluation checklist.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets