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OBJECTIVE: To explore pharmacy users' perceptions of current and future provision of community pharmacy services in England. METHODS: Qualitative, reconvened focus groups were conducted with community pharmacy users. An initial focus group explored preliminary views. Participants were then given an evidence brief describing community pharmacy before a reconvened focus group two weeks later. Transcripts were analysed using inductive thematic analysis. KEY FINDINGS: Eleven individuals participated across two reconvened focus groups. Participants valued community pharmacies and staff, but lacked awareness of their services and roles: ' I don't think the general public is aware of all of this it gives you a very different perspective'. Urgent care and long-term conditions management were identified as suitable for future development, facilitated by training, closer collaboration with general practices, shared access to health records, and premises with more space and confidentiality: 'I still think of it as a retail space more than as a health service'. Concerns were expressed about working conditions in community pharmacy and unplanned closures: 'doesn't sound like a great place to work'. Participants anticipated greater use of technology but did not want this to replace face-to-face contact with pharmacy staff: 'I am not saying it's inaccurate, it is so remote and impersonal'. CONCLUSIONS: Pharmacy users would value a greater role for community pharmacy in addressing the challenges currently faced by the health service in England, provided that their concerns on a range of issues are addressed.
Subject(s)
Community Pharmacy Services , Pharmacies , Pharmacy , Humans , Focus Groups , Motivation , Pharmacists , EnglandABSTRACT
INTRODUCTION: Although hospitals are key health service providers, their financial ties to drug companies are little understood. We examine non-research pharmaceutical industry payments to English National Health Service (NHS) trusts-hospital groupings providing secondary and tertiary care. METHODS: We extracted data from the industry-run Disclosure UK database, analysing it descriptively and using the Jonckheere-Terpstra test to establish whether a statistically significant time trend existed in the median values of individual payments. We explained payment value and number per trust with random effects models, using selected trust characteristics as predictors. RESULTS: Drug companies reported paying £60,253,421 to 234 trusts, representing between 90.0% and 92.0% of all trusts in England between 2015 and 2018. As a share of payments to all healthcare organisations, the number of payments rose from 38.6% to 39.5%, but their value dropped from 33.0% to 23.6%. The number of payments for fees for service and consultancy and contributions to costs of events increased by 61.5% and 29.4%. The median payment value decreased significantly for trusts overall (from £2,250.8 to £1,758.5), including those with lower autonomy from central government; providing acute services; and from half of England's regions. The random effects model showed that acute trusts received significantly more money on average than trusts with all other service profiles; and trusts from East England received significantly less than those from London. However, trusts enjoying greater autonomy from government did not receive significantly more money than others. Trusts also received significantly less money in 2018 than in 2015. CONCLUSION: NHS trusts had extensive pharmaceutical industry ties but were losing importance as payment targets relative to other healthcare organisations. Industry payment strategies shifted towards events sponsorship, consultancies, and smaller payments. Trusts with specific service and geographical profiles were prioritised. Understanding corporate payments across the health system requires more granular disclosure data.
Subject(s)
Disclosure , State Medicine , Conflict of Interest , England , Drug IndustryABSTRACT
OBJECTIVES: To explore the views of professional stakeholders on the future of community pharmacy services in England. Specific objectives related to expectations of how community pharmacy services will be provided by 2030 and factors that will influence this. DESIGN: Qualitative, using semistructured interviews in person or via telephone/Skype. The topic guide was informed by a recent policy review that used the Walt and Gilson policy framework. Transcripts were analysed using inductive thematic analysis. SETTING: England. PARTICIPANTS: External stakeholders were representatives of non-pharmacy organisations, including policy-makers, commissioners and representatives of healthcare professions. Internal stakeholders were community pharmacists or pharmacy organisation representatives. Interviewees were identified using stakeholder mapping RESULTS: In total, 25 interviews were completed (7 external stakeholders and 18 internal stakeholders, of which 10 were community pharmacists). Community pharmacy was recognised as having a key role in expanding health system capacity (' pharmacy is the obvious person to take on those roles '), particularly for long-term condition management (eg, adherence, reducing polypharmacy, monitoring), urgent care (eg, minor illnesses) and public health (including mental health). For these contributions to be developed and optimised, greater integration and collaboration with general practices will be needed (' there is no room for isolationism in pharmacy anymore '), as well as use of technology in a patient-centred way and full access to health records. These changes will require workforce development together with appropriate commissioning and contractual arrangements. Community pharmacy is currently undervalued (' the complete misunderstanding by senior Government officials is very scary') and recent investment in general practice pharmacists rather than community pharmacy was seen as a missed opportunity. CONCLUSIONS: Community pharmacy as a sector could and should be developed to increase health service capacity to address its current challenges. Numerous modifications are required from a range of stakeholders to create the environment in which these changes can occur.
Subject(s)
Community Pharmacy Services , Pharmacies , Pharmacy , Humans , Motivation , England , Pharmacists/psychology , Professional RoleABSTRACT
Background: An increased role for community pharmacy might bring considerable value to healthcare systems, for example by relieving workload elsewhere in primary care through the provision of medicines-related services. This requires support from appropriate policy. Objectives: To explore the representation of community pharmacy in governmental and professional health policies in England (2008-2017) using the Walt and Gilson policy framework. Methods: Relevant policies were identified using a systematic search. The content of these policies was analysed using thematic analysis. The transparency of evidence use during the policymaking process was scored in four keys areas using a recognised tool: diagnosis; proposal; implementation; testing and evaluation. Key actors involved in the development of each policy were summarised. Results: 18 governmental policies and 7 pharmacy profession policies were included. Convergence between governmental and professional policy content was identified in 6 areas: healthcare workforce; behaviour and collaborations; utilising technology; urgent care; long-term health conditions; service provision. Divergence was identified in 5 areas: enquiry-driven culture; quality in healthcare; cancer care; mental health care; commissioning. Professional policies were less transparent in their use of evidence and had less documentation of the involvement of key actors, such as professionals and the public. Conclusions: The profession has limited influence and/or representation in governmental policies. This may be because professional policies did not reflect concerns expressed in governmental policies and had low credibility due to limited stakeholder involvement and transparency about evidence use.
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BACKGROUND: Self-regulation of payment disclosure by pharmaceutical industry trade groups is a major global approach to increasing transparency of financial relationships between drug companies and healthcare professionals and organisations. Nevertheless, little is known about the relative strengths and weaknesses of self-regulation across countries, especially beyond Europe. To address this gap in research and stimulate international policy learning, we compare the UK and Japan, the likely strongest cases of self-regulation of payment disclosure in Europe and Asia, across three dimensions of transparency: disclosure rules, practices, and data. RESULTS: The UK and Japanese self-regulation of payment disclosure had shared as well unique strengths and weaknesses. The UK and Japanese pharmaceutical industry trade groups declared transparency as the primary goal of payment disclosure, without, however, explaining the link between the two. The rules of payment disclosure in each country provided more insight into some payments but not others. Both trade groups did not reveal the recipients of certain payments by default, and the UK trade group also made the disclosure of some payments conditional on recipient consent. Drug company disclosure practices were more transparent in the UK, allowing for greater availability and accessibility of payment data and insight into underreporting or misreporting of payments by companies. Nevertheless, the share of payments made to named recipients was three times higher in Japan than in the UK, indicating higher transparency of disclosure data. CONCLUSIONS: The UK and Japan performed differently across the three dimensions of transparency, suggesting that any comprehensive analysis of self-regulation of payment disclosure must triangulate analysis of disclosure rules, practices, and data. We found limited evidence to support key claims regarding the strengths of self-regulation, while often finding it inferior to public regulation of payment disclosure. We suggest how the self-regulation of payment disclosure in each country can be enhanced and, in the long run, replaced by public regulation to strengthen the industry's accountability to the public.
Subject(s)
Disclosure , Self-Control , Humans , Japan , Drug Industry , United KingdomABSTRACT
OBJECTIVES: To examine the characteristics of pharmaceutical payments to healthcare and patient organisations in the four UK countries. Compare companies spending the most; types of organisations receiving payments and types of payments in the four countries. Measure the extent to which companies target payments at the same recipients in each country and whether it differs depending on the type of recipient. DESIGN: Cross-sectional comparative and social network analysis. SETTING: England, Scotland, Wales, Northern Ireland. PARTICIPANTS: 100 donors (pharmaceutical companies) reporting payments to 4229 recipients (healthcare organisations and patient organisations) in 2015. MAIN OUTCOME MEASURES: For each country: payment totals and distribution; average number of common recipients between companies; share of payments to organisations fulfilling different roles in the health ecosystem and payments for different activities. RESULTS: Companies prioritised different types of recipient and different types of activity in each country. There were significant differences in the distribution of payments across the four countries, even for similar types of recipients. Recipients in England and Wales received smaller individual payments than in Scotland and Northern Ireland. Overall, targeting shared recipients occurred most frequently in England, but was also common in certain pockets of each country's health ecosystem. We found evidence of reporting errors in Disclosure UK. CONCLUSIONS: Our findings suggest a strategic approach to payments tailored to countries' policy and decision-making context, indicating there may be specific vulnerabilities to financial conflicts of interest at subnational level. Payment differences between countries may be occurring in other countries, particularly those with decentralised health systems and/or high levels of independence across its decision-making authorities. We call for a single database containing all recipient types, full location details and published with associated descriptive and network statistics.
Subject(s)
Ecosystem , Social Network Analysis , Humans , Cross-Sectional Studies , Drug Industry , Conflict of Interest , Disclosure , England , Pharmaceutical PreparationsABSTRACT
OBJECTIVE: To assess financial conflicts of interest (COI) and nonfinancial COI among psoriatic arthritis (PsA) clinical practice guideline (CPG) authors in Japan and the US, and to evaluate the quality of evidence and strength of recommendations of PsA CPGs. METHODS: We performed a retrospective analysis using payment data from major Japanese pharmaceutical companies and the US Open Payments Database from 2016 to 2018. All authors of PsA CPGs issued by the Japanese Dermatological Association (JDA) and American College of Rheumatology (ACR) were included. RESULTS: Of 23 CPG authors in Japan, 21 (91.3%) received at least 1 payment, with a combined total of $3,335,413 between 2016 and 2018. Regarding 25 US authors, 21 (84.0%) received at least 1 payment, with a combined total of $4,081,629 during the same period. The 3-year combined mean ± SD payment per author was $145,018 ± $114,302 in Japan and $162,825 ± $259,670 in the US. A total of 18 authors (78.3%) of the JDA PsA CPG and 12 authors (48.0%) of the ACR PsA CPG had undisclosed financial COI worth $474,663 and $218,501, respectively. The percentage of citations with at least 1 CPG author relative to total citations was 3.4% in Japan and 33.6% in the US. In sum, 71.4% and 88.8% of recommendations for PsA in the JDA and ACR were supported by low or very low quality of evidence. CONCLUSION: More rigorous cross-checking of information disclosed by pharmaceutical companies and self-reported by physicians and more stringent and transparent COI policies are necessary.
Subject(s)
Arthritis, Psoriatic , Conflict of Interest , Humans , United States , Retrospective Studies , Japan , Arthritis, Psoriatic/diagnosis , Arthritis, Psoriatic/drug therapy , Authorship , Financial Support , Pharmaceutical Preparations , DisclosureABSTRACT
BACKGROUND: Financial relationships between healthcare institutions and pharmaceutical companies can lead to conflicts of interest (COIs), potentially compromising patients' care. In Japan, scholarship donations, unique type of payments made to healthcare institutions and their subunits by pharmaceutical industries without restricting their use including non-educational or research purpose, may often have implicit promotional purposes. However, detailed information about these payments remains scarce. METHODS: This study employed a cross-sectional design to analyse the extent and distribution of all scholarship donations made by all 73 pharmaceutical companies belonging to the Japan Pharmaceutical Manufacturers Association (JPMA) to healthcare institutions in 2017. Data were obtained from publicly available sources from the companies, and the total number of payments, their distributions across various institutions and specialties were analysed. RESULTS: A total of 27 007 payment contracts amounting to $178 703 721 in scholarship donations were made to 4839 specific departments and laboratories at 251 different institutions by 67 pharmaceutical companies. National universities received 50.8% of total payments. All universities setting medical school in Japan received one or more payments. Domestic pharmaceutical companies contributed to $137 797 302 (77.1%) in total. Clinical medicine departments received 89.6% ($160 113 147) with 6.2% ($11 011 946) and 2.0% ($3 600 456) allocated to basic medicine and social medicine specialties, respectively. CONCLUSION: This study provided a comprehensive overview of scholarship donations from pharmaceutical companies to healthcare institutions in Japan, revealing significant financial support primarily directed to national universities and clinical medicine departments. Japanese policy-makers should consider implementing regulations that promote transparency and mitigate potential COIs arising from scholarship donations, which may be useful in other countries with similar schemes.
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Delivery of Health Care , Fellowships and Scholarships , Humans , Cross-Sectional Studies , Japan , Pharmaceutical PreparationsABSTRACT
Pharmaceutical industry funding of patient organizations raises ethical challenges related to patient engagement in healthcare due to fears of commercial agendas influencing patient advocacy and creating industry-driven inequalities across patient organizations. We contribute to an international body of knowledge on patient organization-industry relations by analyzing all payments reported by companies in Denmark over a six-year period, 2014-2019. We performed descriptive analyses calculating the number, value, and distribution of payments for various units of analysis: all companies and patient organizations; individual companies and patient organizations; and the broader disease area (e.g., cancer) and narrower disease (e.g., breast cancer). Fifty-one companies reported paying 8,826,916 to 84 patient organizations. As in previously studied countries, the funding was dominated by a relatively small number of funders and recipients, and commercially high-profile diseases attracted most of the funding. Nevertheless, our study also highlighted the arguably concerning dominance of one company in Denmark, both at the level of overall funding and in funding specific patient organizations, during a time of great policy contention surrounding one of its drugs, the world's top-selling medicine; i.e., switching patients to cheaper biosimilars to save big money for the healthcare system. Patient organizations have reasons to rethink some collaborations with companies, especially during policy contentions, and governments should ensure equitable funding to counteract risks posed by the concentration of industry funding.
Subject(s)
Biosimilar Pharmaceuticals , Patient Advocacy , Humans , Drug Industry , Organizations , DenmarkABSTRACT
This paper explores policy mechanisms behind New Zealand's remarkable track record of cost containment in public pharmaceutical spending, contrasting with most other advanced economies. We drew on a review of official policy documents and 28 semi-structured expert interviews. We found that decision making in pricing and reimbursement policy was dominated by a small group of managers at the Pharmaceutical Management Agency (PHARMAC), the country's drug reimbursement and Health Technology Assessment Agency, who negotiated pharmaceutical prices on behalf of the public payer. In formal negotiation over patented pharmaceutical prices these managers applied an array of pricing strategies, most notably, 'bundling' consisting of discounted package deals for multiple pharmaceuticals, and 'play-off tenders', whereby two or more pharmaceutical companies bid for exclusive contracts. The key pricing strategy for generic drugs, in contrast, was 'blind-tenders' taking the form of an annual bidding process for supply contracts. An additional contextual condition on bargaining over pharmaceutical prices was an indirect strategy that involved the cultivation of the PHARMAC's 'negotiation leverage'. We derived two cost containment mechanisms consisting in the relationship between pricing strategy options and various reimbursement actors. Our findings shed light on aspects of the institutional design of drug reimbursement that may promote the effective use of competitive negotiations of pharmaceutical prices, including specific pricing strategies, by specialist public payer institutions. On this basis, we formulate recommendations for countries seeking to develop or reform policy frameworks to better meet the budgetary challenge posed by pharmaceutical expenditure.
Subject(s)
Drug Costs , Negotiating , Cost Control , Drugs, Generic , Humans , New ZealandABSTRACT
BACKGROUND: Creating new therapies often involves drug companies paying healthcare professionals and institutions for research and development (R&D) activities, including clinical trials. However, industry sponsorship can create conflicts of interest (COIs). We analysed approaches to drug company R&D payment disclosure in European countries and the distribution of R&D payments at the country and company level. METHODS: Using documentary sources and a stakeholder survey we identified country- regulatory approaches to R&D payment disclosure. We reviewed company-level descriptions of disclosure practices in the United Kingdom, a country with a major role in Europe's R&D. We obtained country-level R&D payment data from industry trade groups and public authorities and company-level data from eurosfordocs.eu, a publicly available payments database. We conducted content analysis and descriptive statistical analysis. RESULTS: In 32 of 37 studied countries, all R&D payments were reported without named recipients, following a self-regulatory approach developed by the industry. The methodological descriptions from 125 companies operating in the United Kingdom suggest that within the self-regulatory approach companies had much leeway in deciding what activities and payments were considered as R&D. In five countries, legislation mandated the disclosure of R&D payment recipients, but only in two were payments practically identifiable and analysable. In 17 countries with available data, R&D constituted 19%-82% of all payments reported, with self-regulation associated with higher shares. Available company-level data from three countries with self-regulation suggests that R&D payments were concentrated by big funders, and some companies reported all, or nearly all, payments as R&D. CONCLUSION: The lack of full disclosure of R&D payments in countries with industry self-regulation leaves considerable sums of money unaccounted for and potentially many COIs undetected. Disclosure mandated by legislation exists in few countries and rarely enhances transparency practically. We recommend a unified European approach to R&D payment disclosure, including clear definitions and a centralised database.
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Conflict of Interest , Research Design , Humans , Databases, Factual , Drug Industry , Europe , United KingdomABSTRACT
Pharmaceutical companies regularly fund patient organizations. It is important for patient organizations' credibility that there be transparency regarding this financial support. In Europe, the pharmaceutical industry promises to deliver transparency through self-regulation, as opposed to legally binding provisions, but self-regulation's effectiveness is contested. We compared the industry's transparency of funding in four Nordic countries that, given their general reputation for high transparency, offered a critical test of self-regulation's ability to deliver on its transparency promise. For 2017-2019, we compared: national rules regarding funding disclosure; disclosure practices as evidenced by the availability, accessibility, and format of company transparency reports; and disclosure data, including payment descriptions and sums. Transparency problems differed in kind and magnitude between countries. In Norway and Finland, unlike in Sweden and Denmark, data on funding were difficult to access and analyze and sometimes seemed incomplete or missing. We explain that a key factor allowing for country differences is the freedom given to a country's pharmaceutical industry trade associations to form self-regulatory rules, provided they do not fall below the weak, European-level minimum requirements. Transparency could be improved by aligning rules and practices with the FAIR data principles: that is, corporate disclosures should be findable, accessible, interoperable, and reusable.
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Disclosure , Self-Control , Conflict of Interest , Drug Industry , Financial Support , HumansABSTRACT
We examined the minimum extent of dependency of UK patient organisations on pharmaceutical industry funding using drug company disclosure reports and patient organisation financial accounts from 2012 to 2016. We used linear regression to explain the overall share of industry funding ('general dependency') and top donor funding ('company-specific dependency') in organisations' income. Predictors included patient organisations' goal; having members and volunteers; geographical scope of activity; headquarter location; expenditure/income ratio; and disease area. The prevalent low levels of general dependency (IQR, 0.1%-6.0%) and company-specific dependency (IQR, 0.1%-4.3%) made a widespread capture of patient organisations unlikely, though only if one excludes the possibility of significant payment under-reporting. However, organisations with considerably higher dependency than others might be more prone to co-optation by industry. Of the 398 organisations, 18 (4.5%) and 8 (2.0%) had general and company-specific financial dependency over 50%, respectively. However, the shares of outliers exceeding the third quartile plus 1.5 times IQR were 51 (12.8%) and 56 (14.1%) for each dependency type. Certain characteristics including activity profile (advocacy) or indicating limited access to resources (remote location) made organisations vulnerable to developing financial dependency. Future research should examine both financial and non-financial links between the two sides and their impact on patient organisations' activity.
Subject(s)
Conflict of Interest , Disclosure , Drug Industry , Humans , Organizations , United KingdomABSTRACT
Although there has been extensive research on pharmaceutical industry payments to healthcare professionals, healthcare organisations with key roles in health systems have received little attention. We seek to contribute to addressing this gap in research by examining drug company payments to General Practices in England in 2015. We combine a publicly available payments database managed by the pharmaceutical industry with datasets covering key practice characteristics. We find that practices were an important target of company payments, receiving £2,726,018, equivalent to 6.5% of the value of payments to all healthcare organisations in England. Payments to practices were highly concentrated and specific companies were also highly dominant. The top 10 donors and the top 10 recipients amassed 87.9% and 13.6% of the value of payments, respectively. Practices with more patients, a greater proportion of elderly patients, and those in more affluent areas received significantly more payments on average. However, the patterns of payments were similar across England's regions. We also found that company networks-established by making payments to the same practices-were largely dominated by a single company, which was also by far the biggest donor. Greater policy attention is required to the risk of financial dependency and conflicts of interests that might arise from payments to practices and to organisational conflicts of interests more broadly. Our research also demonstrates that the comprehensiveness and quality of payment data disclosed via industry self-regulatory arrangements needs improvement. More interconnectivity between payment data and other datasets is needed to capture company marketing strategies systematically.
Subject(s)
Delivery of Health Care/economics , Drug Industry/economics , Financial Support/ethics , General Practice/economics , Health Personnel/economics , Organizations/economics , Social Network Analysis , Conflict of Interest , Cross-Sectional Studies , Delivery of Health Care/legislation & jurisprudence , Disclosure , England , HumansABSTRACT
OBJECTIVES: To examine the accessibility and quality of drug company payment data in Europe. DESIGN: Comparative policy review of payment data in countries with different regulatory approaches to disclosure. SETTING: 37 European countries. PARTICIPANTS: European Federation of Pharmaceutical Industries and Associations, its trade group and their drug company members; eurosfordocs.eu, an independent database integrating payments disclosed by companies and trade groups; regulatory bodies overseeing payment disclosure. MAIN OUTCOME MEASURES: Regulatory approaches to disclosure (self-regulation, public regulation, combination of the two); data accessibility (format, structure, searchability, customisable summary statistics, downloadability) and quality (spectrum of disclosed characteristics, payment aggregation, inclusion of taxes, recipient or donor identifiers). RESULTS: Of 30 countries with self-regulation, five had centralised databases, with Disclosure UK displaying the highest accessibility and quality. In 23 of the remaining countries with self-regulation and available data, disclosures were published in the portable document format (PDF) on individual company websites, preventing the public from understanding payment patterns. Eurosfordocs.eu had greater accessibility than any industry-run database, but the match between the value of payments integrated in eurosfordocs.eu and summarised separately by industry in seven countries ranged between 56% and 100% depending on country. Eurosfordocs.eu shared quality shortcomings with the underlying industry data, including ambiguities in identifying payments and their recipients. Public regulation was found in 15 countries, used either alone (3), in combination (4) or in parallel with (8) self-regulation. Of these countries, 13 established centralised databases with widely ranging accessibility and quality, and sharing some shortcomings with the industry-run databases. The French database, Transparence Santé, had the highest accessibility and quality, exceeding that of Disclosure UK. CONCLUSIONS: The accessibility and quality of payment data disclosed in European countries are typically low, hindering investigation of financial conflicts of interest. Some improvements are straightforward but reaching the standards characterising the widely researched US Open Payments database requires major regulatory change.
Subject(s)
Disclosure , Policy , Delivery of Health Care , Drug Industry , Europe , HumansABSTRACT
For two decades, New Zealand has been placed consistently at the foot of OECD rankings for state expenditure on pharmaceuticals. In this article, we explore New Zealand's containment of pharmaceutical spending as a 'divergent' case of pharmaceutical policy in a liberal democracy. To elucidate the likely institutional mechanisms and interests behind this phenomenon, we conducted a case study of New Zealand's drug reimbursement policy. In doing so, we derived sensitising concepts from major accounts of pharmaceutical policymaking (Corporate Bias Theories and Reputational Theory) and theories of the western state (Historical Institutionalism and Corporate Domination Theory). Drawing on 28 expert interviews and documentary analysis, we identified three main mechanisms of spending containment. First, New Zealand's state bureaucracy use pricing strategies that rely on a spending containment strategy coordinated by bureaucratic managers. Second, these managers shape the policy preferences of expert committees involved in scientific drug assessment. Third, on a meta-level, conditions for spending containment are enabled by the judicial-legislative arena. As such, we find support for Historical Institutionalism and Reputational Theory and more limited support for Corporate Bias Theory and Corporate Domination Theory. Our explanation posits further conceptual linkages between the macro/societal and meso-organisational theoretical levels.