Racha Fadlallah

A Call for a Backward Design to Knowledge Translation

Despite several calls to support evidence-informed policy-making, variations in uptake of evidence into policy persist. This editorial brings together and builds on previous Knowledge Translation (KT) frameworks and theories to present a simple, yet, holistic approach for promoting evidence-informed policies. The proposed conceptual framework is characterized by its impact-oriented approach and its view of KT as a continuum from the evidence synthesis stage to uptake and evaluation, while highlighting capacity and resource requirement at every step. A practical example is given to guide readers through the different steps of the framework. With a growing interest in strengthening evidence-informed policy-making, there is a need to continuously develop theories to understand and improve the science of KT and its implementation within the field of policy-making.

Legislative, educational, policy and other interventions targeting physicians’ interaction with pharmaceutical companies: a systematic review

Background Pharmaceutical company representatives likely influence the prescribing habits and professional behaviour of physicians. Objective The objective of this study was to systematically review the effects of interventions targeting practising physicians’ interactions with pharmaceutical companies. Eligibility criteria We included observational studies, non-randomised controlled trials (non-RCTs) and RCTs evaluating legislative, educational, policy or other interventions targeting the interactions between physicians and pharmaceutical companies. Data sources The search strategy included an electronic search of MEDLINE and EMBASE. Two reviewers performed duplicate and independent study selection, data abstraction and assessment of risk of bias. Appraisal and synthesis methods We assessed the risk of bias in each included study. We summarised the findings narratively because the nature of the data did not allow a meta-analysis to be conducted. We assessed the quality of evidence by outcome using the GRADE methodology. Results Of 11 189 identified citations, one RCT and three observational studies met the eligibility criteria. All four studies specifically targeted one type of interaction with pharmaceutical companies, that is, interactions with drug representatives. The RCT provided moderate quality evidence of no effect of a ‘collaborative approach’ between the pharmaceutical industry and a health authority. The three observational studies provided low quality evidence suggesting a positive effect of policies aiming to reduce interaction between physicians and pharmaceutical companies (by restricting free samples, promotional material, and meetings with pharmaceutical company representatives) on prescription behaviour. Limitations We identified too few studies to allow strong conclusions. Conclusions Available evidence suggests a potential impact of policies aiming to reduce interaction between physicians and drug representatives on physicians’ prescription behaviour. We found no evidence concerning interventions affecting other types of interaction with pharmaceutical companies.

Association between physicians’ interaction with pharmaceutical companies and their clinical practices: A systematic review and meta-analysis

Background Pharmaceutical company representatives likely influence the prescribing habits and professional behaviors of physicians. The objective of this study was to systematically review the association between physicians’ interactions with pharmaceutical companies and their clinical practices. Methods We used the standard systematic review methodology. Observational and experimental study designs examining any type of targeted interaction between practicing physicians and pharmaceutical companies were eligible. The search strategy included a search of MEDLINE and EMBASE databases up to July 2016. Two reviewers selected studies, abstracted data, and assessed risk of bias in duplicate and independently. We assessed the quality of evidence using the GRADE approach. Results Twenty articles reporting on 19 studies met our inclusion criteria. All of these studies were conducted in high-income countries and examined different types of interactions, including detailing, industry-funded continuing medical education, and receiving free gifts. While all included studies assessed prescribing behaviors, four studies also assessed financial outcomes, one assessed physicians’ knowledge, and one assessed their beliefs. None of the studies assessed clinical outcomes. Out of the 19 studies, 15 found a consistent association between interactions promoting a medication, and inappropriately increased prescribing rates, lower prescribing quality, and/or increased prescribing costs. The remaining four studies found both associations and lack of significant associations for the different types of exposures and drugs examined in the studies. A meta-analysis of six of these studies found a statistically significant association between exposure and physicians’ prescribing behaviors (OR = 2.52; 95% CI 1.82–3.50). The quality of evidence was downgraded to moderate for risk of bias and inconsistency. Sensitivity analysis excluding studies at high risk of bias did not substantially change these results. A subgroup analysis did not find a difference by type of exposure. Conclusion There is moderate quality evidence that physicians’ interactions with pharmaceutical companies are associated with their prescribing patterns and quality.

Interventions to combat or prevent drug counterfeiting: a systematic review

Objective Drug counterfeiting has serious public health and safety implications. The objective of this study was to systematically review the evidence on the effectiveness of interventions to combat or prevent drug counterfeiting. Data sources We searched multiple electronic databases and the grey literature up to March 2014. Two reviewers completed, in duplicate and independently, the study selection, data abstraction and risk of bias assessment. Study eligibility criteria, participants and interventions We included randomised trials, non-randomised studies, and case studies examining any intervention at the health system-level to combat or prevent drug counterfeiting. Outcomes of interest included changes in failure rates of tested drugs and changes in prevalence of counterfeit medicines. We excluded studies that focused exclusively on substandard, degraded or expired drugs, or that focused on medication errors. Appraisal and synthesis We assessed the risk of bias in each included study. We reported the results narratively and, where applicable, we conducted meta-analyses. Results We included 21 studies representing 25 units of analysis. Overall, we found low quality evidence suggesting positive effects of drug registration (OR=0.23; 95% CI 0.08 to 0.67), and WHO-prequalification of drugs (OR=0.06; 95% CI 0.01 to 0.35) in reducing the prevalence of counterfeit and substandard drugs. Low quality evidence suggests that licensing of drug outlets is probably ineffective (OR=0.66; 95% CI 0.41 to 1.05). For multifaceted interventions (including a mix of regulations, training of inspectors, public-private collaborations and legal actions), low quality evidence suggest they may be effective. The single RCT provided moderate quality evidence of no effect of ‘two extra inspections’ in improving drug quality. Conclusions Policymakers and stakeholders would benefit from registration and WHO-prequalification of drugs and may also consider multifaceted interventions. Future effectiveness studies should address the methodological limitations of the available evidence. Trial registration number PROSPERO CRD42014009269.

Knowledge, beliefs and attitudes of physicians in low and middle-income countries regarding interacting with pharmaceutical companies: a systematic review

BackgroundUnderstanding the perceptions and attitudes of physicians is important. This knowledge assists in the efforts to reduce the impact of their interactions with the pharmaceutical industry on clinical practice. It appears that most studies on such perceptions and attitudes have been conducted in high-income countries. The objective was to systematically review the knowledge, beliefs and attitudes of physicians in low and middle-income countries regarding interactions with pharmaceutical companies.MethodsEligible studies addressed any type of interaction between physicians and pharmaceutical companies. The outcomes of interest included knowledge, beliefs and attitudes of practicing physicians. The search strategy covered MEDLINE and EMBASE databases. Two reviewers completed in duplicate and independently study selection, data abstraction, and assessment of methodological features. The data synthesis consisted of a narrative summary of the findings stratified by knowledge, beliefs and attitudes.ResultsWe included ten reports from nine eligible studies, each of which had a number of methodological limitations. Four studies found that the top perceived benefits of this interaction were receiving information and rewards. In five out of eight studies assessing the perception regarding the impact of the interaction on the behavior of physician prescription, the majority of participants believed it to be minor. In one of these studies, participants perceived that impact to be lesser when asked about their own behavior. The attitudes of physicians towards information and rewards provided by pharmaceutical company representatives (PCRs) (assessed in 5 and 2 studies respectively) varied across studies. In the only study assessing their attitudes towards pharmaceutical-sponsored Continuing Medical Education, physicians considered local conferences to have higher impact. Their attitudes towards developing policies restricting physicians’ interactions with PCRs were positive in two studies. In one study, the majority of participants did not mind the public knowing that physicians were receiving gifts and awards from drug companies.ConclusionsThis review identified few studies conducted in low and middle-income countries. While physicians generally perceived the impact of interactions on their behavior to be minor, their attitudes toward receiving information and rewards varied across studies.

Knowledge, Beliefs and Attitudes of Patients and the General Public towards the Interactions of Physicians with the Pharmaceutical and the Device Industry: A Systematic Review

Objective To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry. Methods We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country. Results Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians’ disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies. Conclusion The awareness of participants was low for physicians’ receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness, less concern and more acceptance of surgeon-device industry interactions relative to physician-pharmaceutical industry interactions. We discuss the implications of the findings at the patient, provider, organizational, and systems level.

The SPARK Tool to prioritise questions for systematic reviews in health policy and systems research: development and initial validation

BackgroundGroups or institutions funding or conducting systematic reviews in health policy and systems research (HPSR) should prioritise topics according to the needs of policymakers and stakeholders. The aim of this study was to develop and validate a tool to prioritise questions for systematic reviews in HPSR.MethodsWe developed the tool following a four-step approach consisting of (1) the definition of the purpose and scope of tool, (2) item generation and reduction, (3) testing for content and face validity, (4) and pilot testing of the tool. The research team involved international experts in HPSR, systematic review methodology and tool development, led by the Center for Systematic Reviews on Health Policy and Systems Research (SPARK). We followed an inclusive approach in determining the final selection of items to allow customisation to the user’s needs.ResultsThe purpose of the SPARK tool was to prioritise questions in HPSR in order to address them in systematic reviews. In the item generation and reduction phase, an extensive literature search yielded 40 relevant articles, which were reviewed by the research team to create a preliminary list of 19 candidate items for inclusion in the tool. As part of testing for content and face validity, input from international experts led to the refining, changing, merging and addition of new items, and to organisation of the tool into two modules. Following pilot testing, we finalised the tool, with 22 items organised in two modules – the first module including 13 items to be rated by policymakers and stakeholders, and the second including 9 items to be rated by systematic review teams. Users can customise the tool to their needs, by omitting items that may not be applicable to their settings. We also developed a user manual that provides guidance on how to use the SPARK tool, along with signaling questions.ConclusionWe have developed and conducted initial validation of the SPARK tool to prioritise questions for systematic reviews in HPSR, along with a user manual. By aligning systematic review production to policy priorities, the tool will help support evidence-informed policymaking and reduce research waste. We invite others to contribute with additional real-life implementation of the tool.

Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness

BackgroundA recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation.ObjectiveThe aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting.MethodsWe conducted an extensive search, including an electronic search of 14 databases. We included studies examining the efficiency, feasibility, reliability, and economic outcomes of the interventions, as well as barriers and facilitators to their implementation. Two reviewers selected eligible studies and abstracted data in duplicate and independently. We synthesized the results narratively, stratified by type of intervention.ResultsOf 10,220 captured citations, 19 met our inclusion criteria. The findings suggest that the following may strengthen regulatory measures (e.g., registration): minimizing drug diversion, enhancing lines of communications, ensuring feedback on drug quality, and promoting strict licensing criteria. There is evidence that onsite quality surveillance and inspection systems may be efficient and cost-effective for preliminary testing of large samples of drugs. Laws and legislation need to be specific to counterfeit drugs, include firm penalties, address online purchasing of drugs, and be complemented by education of judges and lawyers. Public awareness and education should rely on multiple platforms and comprehensive and dedicated content. While product authentication technologies may be efficient and reliable in detecting counterfeit drugs in the supply chain, they require a strong information system infrastructure. As for pharmacovigilance systems, it is critical to tackle the issue of underreporting, to enhance their chances of success.ConclusionSeveral factors are critical to the successful design and implementation of systems-level interventions to combat or prevent drug counterfeiting. Policymakers need to take these into consideration to ensure success of these interventions.

Pharmacists’ views and reported practices in relation to a new generic drug substitution policy in Lebanon: a mixed methods study

BackgroundGovernments in both developed and developing countries have adopted generic drug substitution policies to decrease pharmaceutical expenditures and improve access to medicine. In August 2015, the Ministry of Public Health (MOPH) in Lebanon introduced generic drug substitution and a unified medical prescription form as policy instruments to promote generic drug use. The objective of this exploratory study was to examine the attitudes of community pharmacists and the reported practices in relation to the implementation of the new generic drug substitution policy.MethodsWe used a cross-sectional mixed methods approach composed of self-administered questionnaires and semi-structured interviews. The study population consisted of community pharmacists in Lebanon. We randomly approached one pharmacy personnel from each selected community pharmacy. We conducted descriptive analyses to assess responses to questionnaire and regression analyses to understand associations between responses and respondent demographics. We analyzed qualitative data thematically.ResultsOut of 204 invited community pharmacies, 153 pharmacies participated (75% response rate). The majority of respondents (64%) were in favor of generic drug substitution; however, less than half (40%) indicated they have substituted brand drugs for generic equivalents. Moreover, 57% indicated that the existing pricing system discourages them from performing generic drug substitution. Most respondents indicated that physicians are overusing the “non-substitutable” option (84%) and that there are technical problems with processing the new prescription form (78%). Less than half (47%) reported that the MOPH is performing regular audits on the forms collected by the pharmacy. While 45% of the respondents indicated that consumers have accepted most of the generic substitutions, 21% perceived the increase in generic drug dispensing to be significant. Findings suggested a potentially significant association between being informed about generic drugs and respondents’ support of the policy. Suggested strategies to address implementation challenges included strengthening stewardship function of MOPH, securing full commitment of health care providers, conducting educational and awareness campaigns about generic drugs and generic drug substitution, and aligning incentive systems of the key stakeholders.ConclusionsThe majority of community pharmacists were supportive of generic drug substitution in general but not of the current implementation of the policy in Lebanon. Findings revealed implementation challenges at the provider, patient, and system level which are hindering attainment of the policy objectives. The key lessons derived from this study can be used for continuous improvement of the policy and its implementation.

Systematic reviews addressing identified health policy priorities in Eastern Mediterranean countries: a situational analysis

BackgroundSystematic reviews can offer policymakers and stakeholders concise, transparent, and relevant evidence pertaining to pressing policy priorities to help inform the decision-making process. The production and the use of systematic reviews are specifically limited in the Eastern Mediterranean region. The extent to which published systematic reviews address policy priorities in the region is still unknown. This situational analysis exercise aims at assessing the extent to which published systematic reviews address policy priorities identified by policymakers and stakeholders in Eastern Mediterranean region countries. It also provides an overview about the state of systematic review production in the region and identifies knowledge gaps.MethodsWe conducted a systematic search of the Health System Evidence database to identify published systematic reviews on policy-relevant priorities pertaining to the following themes: human resources for health, health financing, the role of the non-state sector, and access to medicine. Priorities were identified from two priority-setting exercises conducted in the region. We described the distribution of these systematic reviews across themes, sub-themes, authors’ affiliations, and countries where included primary studies were conducted.ResultsOut of the 1,045 systematic reviews identified in Health System Evidence on selected themes, a total of 200 systematic reviews (19.1%) addressed the priorities from the Eastern Mediterranean region. The theme with the largest number of systematic reviews included was human resources for health (115) followed by health financing (33), access to medicine (27), and role of the non-state sector (25). Authors based in the region produced only three systematic reviews addressing regional priorities (1.5%). Furthermore, no systematic review focused on the Eastern Mediterranean region. Primary studies from the region had limited contribution to systematic reviews; 17 systematic reviews (8.5%) included primary studies conducted in the region.ConclusionsThere are still gaps in the production of systematic reviews addressing policymakers’ and stakeholders’ priorities in the Eastern Mediterranean region. Efforts should be directed towards better aligning systematic review production with policy needs and priorities. Study findings can inform the agendas of researchers, research institutions, and international funding agencies of priority areas where systematic reviews are required.