Healthcare clinic and pharmacy chains in Kenya and Nigeria: A qualitative exploration of the opportunities and risks they present for healthcare regulatory systems.

BACKGROUND: Regulating fragmented healthcare markets is a major challenge in low- and middle-income countries. Although a recent transformation towards consolidation could improve regulatory efficiency, there are concerns over risks to client safety and market functioning. We investigated market consolidation through the emergence of clinic and pharmacy chains in Kenya and Nigeria and explored resultant regulatory opportunities and risks. METHODS: The study was conducted in Nairobi Kenya and Abuja Nigeria. Data were collected through document reviews and 26 interviews with chain operators, professional associations and regulators between September and December 2018. A thematic analysis was conducted. RESULTS: We characterised two broad types of chains: organic chains that started as single business locations and expanded gradually, and investor-driven chains that expanded rapidly following external capital injection. In both countries, chains and independents were regulated similarly, with regulators failing to both capitalize on opportunities and guard against risks. For instance, chains' brand visibility and centralised management systems made them easier to regulate and more suitable for self-regulation. On the other hand, chains were perceived to pose the risks of market dominance, commercialisation of healthcare, and regulatory capture. CONCLUSION: As healthcare chains expand, regulators should build on opportunities presented and guard against emerging risks.

Availability, Prices and Affordability of Antibiotics Stocked by Informal Providers in Rural India: A Cross-Sectional Survey.

Providers without formal training deliver healthcare and antibiotics across rural India, but little is known about the antibiotics that they stock. We conducted a cross-sectional survey of such informal providers (IPs) in two districts of West Bengal, and assessed the availability of the antibiotics, as well as their sales volumes, retail prices, percentage markups for IPs and affordability. Of the 196 IPs that stocked antibiotics, 85% stocked tablets, 74% stocked syrups/suspensions/drops and 18% stocked injections. Across all the IPs, 42 antibiotic active ingredients were stocked, which comprised 278 branded generics from 74 manufacturers. The top five active ingredients that were stocked were amoxicillin potassium clavulanate (52% of the IPs), cefixime (39%), amoxicillin (33%), azithromycin (25%) and ciprofloxacin (21%). By the WHO's AWaRe classification, 71% of the IPs stocked an ACCESS antibiotic and 84% stocked a WATCH antibiotic. The median prices were in line with the government ceiling prices, but with substantial variation between the lowest and highest priced brands. The most affordable among the top five tablets were ciprofloxacin, azithromycin, cefixime and amoxicillin (US$ 0.8, 0.9, 1.9 and 1.9 per course), and the most affordable among the syrups/suspensions/drops were azithromycin and ofloxacin (US$ 1.7 and 4.5 per course, respectively), which are mostly WATCH antibiotics. IPs are a key source of healthcare and antibiotics in rural communities; practical interventions that target IPs need to balance restricting WATCH antibiotics and expanding the basket of affordable ACCESS antibiotics.

Cheaper Medicines for the Better Off? A Comparison of Medicine Prices and Client Socioeconomic Status Between Chain and Independent Retail Pharmacies in Urban India.

BACKGROUND: The growth of chain pharmacies in India, and other low- and middle-income countries (LMICs), is challenging the status quo of pharmacy retail markets which have historically been dominated by independent pharmacies. This raises the question of whether such organisations will have a positive impact on affordability and access to medicines. METHODS: This paper draws on a standardised patient (SP) survey to measure the prices of medicines and expenditure on consultations for two tracer conditions (suspected tuberculosis [TB] in an adult and diarrhoea in an absent child) at a random sample of 230 chain and independent pharmacies in Bengaluru. Asset data were collected from 808 exit interviews with pharmacy customers to determine socioeconomic profiles of clients. Results: Chain pharmacies were found to provide lower priced medicines for patients seeking care for diarrhoea and TB, with expenditure also lower for diarrhoea patients, compared to independent pharmacies. This was seemingly driven by lower prices rather than number of medicines dispensed or prescribing habits. Despite the availability of cheaper medicines, chains served wealthier clients, compared to independent pharmacies. CONCLUSION: The findings indicate the potential for chains to contribute to improving medicine affordability as they expand. However, any attempt to leverage this organisational model for public health good would need to take account of the current client-mix of these pharmacies and be accompanied by appropriate regulatory constraints in order to realise the potential benefits for poorer groups.

When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries.

The recent growth of medicine sales online represents a major disruption to pharmacy markets, with COVID-19 encouraging this trend further. While e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in low-income and middle-income countries (LMICs). Public health concerns associated with e-pharmacy include the sale of prescription-only medicines without a prescription and the sale of substandard and falsified medicines. There are also non-health-related risks such as consumer fraud and lack of data privacy. However, e-pharmacy may also have the potential to improve access to medicines. Drawing on existing literature and a set of key informant interviews in Kenya, Nigeria and India, we examine the e-pharmacy regulatory systems in LMICs. None of the study countries had yet enacted a regulatory framework specific to e-pharmacy. Key regulatory challenges included the lack of consensus on regulatory models, lack of regulatory capacity, regulating sales across borders and risks of over-regulation. However, e-pharmacy also presents opportunities to enhance medicine regulation-through consolidation in the sector, and the traceability and transparency that online records offer. The regulatory process needs to be adapted to keep pace with this dynamic landscape and exploit these possibilities. This will require exploration of a range of innovative regulatory options, collaboration with larger, more compliant businesses, and engagement with global regulatory bodies. A key first step must be ensuring that national regulators are equipped with the necessary awareness and technical expertise to actively oversee this e-pharmacy activity.

Quality of tuberculosis care by pharmacies in low- and middle-income countries: Gaps and opportunities.

Pharmacies hold great potential to contribute meaningfully to tuberculosis (TB) control efforts, given their accessibility and extensive utilisation by communities in many high burden countries. Despite this promise, the quality of care provided by pharmacies in these settings for a range of conditions has historically been poor. This paper sets out to conceptualise the key issues surrounding quality of TB care in the low- and middle-income country pharmacy setting; examine the empirical evidence on quality of care; and review the interventions employed to improve this. A number of quality challenges are apparent in relation to anti-TB medicine availability, pharmacopeial quality of anti-TB medicines stocked, pharmacy workers' knowledge, and management of patients both prior to and following diagnosis. Poor management practices include inadequate questioning of symptomatic patients, lack of referral for testing, over-the-counter sale of anti-TB medication as well as unnecessary and harmful medicines (e.g., antibiotics and steroids), and insufficient counselling. Interventions to improve pharmacy practice in relation to TB control have all fallen under the umbrella of public-private mix (PPM) initiatives, whereby pharmacies are engaged into national TB programmes to improve case detection. These interventions all involved training of pharmacists to refer symptomatic patients for testing and have enjoyed reasonable success, although achieving scale remains a challenge. Future interventions would do well to expand their focus beyond case detection to also improve counselling of patients and inappropriate medicine sales. The lack of pharmacy-specific global guidelines and the regulatory environment were identified as key areas for future attention.

'A smile is most important.' Why chains are not currently the answer to quality concerns in the Indian retail pharmacy sector.

Chain pharmacies are expanding in many low and middle-income countries (LMICs). Historically practices of independent pharmacies in these settings have been poor, and there is a need to understand how these new organisational arrangements are affecting the functioning of pharmacies, and the implications for public health. Drawing on economics literature, we develop a set of hypotheses as to how chains could address the quality failures that typify LMIC retail pharmacy markets, and explore these hypotheses using a set of 38 in-depth interviews, conducted in Bengaluru, India between 2014 and 2015. We look specifically at how being organised in a chain affects several key behaviours: employment of qualified staff; the ability of government authorities to focus regulation on central management structures; the propensity for firms to self-regulate; and the impact of the potentially lower-powered incentives faced by chain employees compared to independent owners. In practice, few differences were identified between chain and independent organisations in these areas. Not all chains were operating with a qualified pharmacist (akin to independent shops). Drug control authorities did not take advantage of the existing chain architecture to enforce regulation. Chains did heavily self-regulate but their focus was on customer service, rather than aspects of quality relevant to health outcomes. Additionally, widespread bribery in the sector was a barrier to effective drug control. Finally, the incentives faced by chain employees were not low-powered due to rewarding sales targets and pressure to increase sales. We observed that chains exerted strong influence over their staff but the potential to exploit this to improve quality of care is not currently being realised. A shift in focus from customer satisfaction to outcomes of public health concern is unlikely without either financial incentives or strengthened external regulation.

Quality of tuberculosis care by Indian pharmacies: Mystery clients offer new insights.

For many patients in India, pharmacies are their first point of contact, where most drugs, including antibiotics, can be purchased over-the-counter (OTC). Recent standardised (simulated) patient studies, covering four Indian cities, provide new insights on how Indian pharmacies manage patients with suspected or known tuberculosis. Correct management of the simulated patients ranged from 13% to 62%, increasing with the certainty of the TB diagnosis. Antibiotics were frequently dispensed OTC to patients, with 16% to 37% receiving such drugs across the cases. On a positive note, these studies showed that no pharmacy dispensed first-line anti-TB drugs. Engagement of pharmacies is important to not only improve TB detection and care, but also limit the abuse of antibiotics.

Do chain pharmacies perform better than independent pharmacies? Evidence from a standardised patient study of the management of childhood diarrhoea and suspected tuberculosis in urban India.

INTRODUCTION: Pharmacies and drug stores are frequently patients' first point of care in many low-income and middle-income countries, but their practice is often poor. Pharmacy retailing in India has traditionally been dominated by local, individually owned shops, but recent years have seen the growth of pharmacy chains. In theory, lower-powered profit incentives and self-regulation to preserve brand identity may lead to higher quality in chain stores. In practice, this has been little studied. METHODS: We randomly selected a stratified sample of chain and independent pharmacies in urban Bengaluru. Standardised patients (SPs) visited pharmacies and presented a scripted case of diarrhoea for a child and suspected tuberculosis (TB). SPs were debriefed immediately after the visit using a structured questionnaire. We measured the quality of history taking, therapeutic management and advice giving against national (Government of India) and international (WHO) guidelines. We used Pearson's χ2 tests to examine associations between pharmacy type and case management. FINDINGS: Management of childhood diarrhoea and suspected TB was woefully substandard. History taking of the SP was limited; unnecessary and harmful medicines, including antibiotics, were commonly sold; and advice giving was near non-existent. The performance of chains and independent shops was strikingly similar for most areas of assessment. We observed no significant differences between the management of suspected TB in chains and independents. 43% of chains and 45% of independents managed the TB case correctly; 17% and 16% of chains and independents, respectively, sold antibiotics. We found that chains sold significantly fewer harmful antibiotics and antidiarrhoeals (35% vs 48%, p=0.029) and prescription-only medicines (37% vs 49%, p=0.048) for the patient with diarrhoea compared with independent shops. Not a single shop managed the patient with diarrhoea correctly according to guidelines. CONCLUSION: Our results from Bengaluru suggest that it is unlikely that chains alone can solve persisting quality challenges. However, they may offer a potential vehicle through which to deliver interventions. Future intervention research should consider recruiting chains to see whether effectiveness of interventions differ among chains compared with independents.

Physicochemical properties of dietary phytochemicals can predict their passive absorption in the human small intestine.

A diet high in phytochemical-rich plant foods is associated with reducing the risk of chronic diseases such as cardiovascular and neurodegenerative diseases, obesity, diabetes and cancer. Oxidative stress and inflammation (OSI) is the common component underlying these chronic diseases. Whilst the positive health effects of phytochemicals and their metabolites have been demonstrated to regulate OSI, the timing and absorption for best effect is not well understood. We developed a model to predict the time to achieve maximal plasma concentration (Tmax) of phytochemicals in fruits and vegetables. We used a training dataset containing 67 dietary phytochemicals from 31 clinical studies to develop the model and validated the model using three independent datasets comprising a total of 108 dietary phytochemicals and 98 pharmaceutical compounds. The developed model based on dietary intake forms and the physicochemical properties lipophilicity and molecular mass accurately predicts Tmax of dietary phytochemicals and pharmaceutical compounds over a broad range of chemical classes. This is the first direct model to predict Tmax of dietary phytochemicals in the human body. The model informs the clinical dosing frequency for optimising uptake and sustained presence of dietary phytochemicals in circulation, to maximise their bio-efficacy for positively affect human health and managing OSI in chronic diseases.

Drinks containing anthocyanin-rich blackcurrant extract decrease postprandial blood glucose, insulin and incretin concentrations.

Blackcurrants are rich in polyphenolic glycosides called anthocyanins, which may inhibit postprandial glycemia. The aim was to determine the dose-dependent effects of blackcurrant extract on postprandial glycemia. Men and postmenopausal women (14M, 9W, mean age 46 years, S.D.=14) were enrolled into a randomized, double-blind, crossover trial. Low sugar fruit drinks containing blackcurrant extract providing 150-mg (L-BE), 300-mg (M-BE) and 600-mg (H-BE) total anthocyanins or no blackcurrant extract (CON) were administered immediately before a high-carbohydrate meal. Plasma glucose, insulin and incretins (GIP and GLP-1) were measured 0-120min, and plasma 8-isoprostane F2α, together with arterial stiffness by digital volume pulse (DVP) was measured at 0 and 120min. Early plasma glucose response was significantly reduced following H-BE (n=22), relative to CON, with a mean difference (95% CI) in area over baseline (AOB) 0-30min of -0.34mmol/l.h (-0.56, -0.11, P<.005); there were no differences between the intermediate doses and placebo. Plasma insulin concentrations (AOB 0-30min) were similarly reduced. Plasma GIP concentrations (AOB 0-120min) were significantly reduced following H-BE, with a mean difference of -46.6ng/l.h (-66.7, -26.5, P<.0001) compared to CON. Plasma GLP-1 concentrations were reduced following H-BE at 90min. There were no effects on 8-isoprostane F2α or vascular function. Consumption of blackcurrant extract in amounts roughly equivalent to 100-g blackcurrants reduced postprandial glycemia, insulinemia and incretin secretion, which suggests that inclusion of blackcurrant polyphenols in foods may provide cardio-metabolic health benefits. This trial was registered at clinicaltrials.gov as NCT01706653.

Comparative environmental impact assessment of herbicides used on genetically modified and non-genetically modified herbicide-tolerant canola crops using two risk indicators.

Canola (Brassica napus L.) is the third largest field crop in Australia by area sown. Genetically modified (GM) and non-GM canola varieties released or being developed in Australia include Clearfield® (imidazolinone tolerant), TT (triazine tolerant), InVigor® (glufosinate-ammonium tolerant), Roundup Ready® - RR® (glyphosate tolerant) and Hyola® RT® (tolerant to both glyphosate and triazine). We used two risk assessment approaches - the Environmental Impact Quotient (EIQ) and the Pesticide Impact Rating Index (PIRI) - to compare the environmental risks associated with herbicides used in the canola varieties (GM and non-GM) that are currently grown or may be grown in the future. Risk assessments found that from an environmental impact viewpoint a number of herbicides used in the production of TT canola showed high relative risk in terms of mobility and ecotoxicity of herbicides. The EIQ field use rating values for atrazine and simazine in particular were high compared with those for glyphosate and trifluralin. Imazapic and imazapyr, which are only used in Clearfield® canola, had extremely low EIQ field use rating values, likely reflecting the very low application rates used for these chemicals (0.02 to 0.04kg/ha) compared with those used for atrazine and simazine (1.2 to 1.5kg/ha). The PIRI assessment showed that irrespective of the canola variety grown, trifluralin posed a high toxicity risk to fish (Rainbow trout, Oncorhynchus mykiss), algae and Daphnia sp. While the replacement of trifluralin with propyzamide had little effect on the mobility score, it greatly decreased the ecotoxicity score to fish, algae and Daphnia sp. due to the lower LC50 values for propyzamide compared with trifluralin. This study has shown that based on likelihood of off-site transport of herbicides in surface water and potential toxicity to non-target organisms, the GM canola varieties have no advantage over non-herbicide tolerant (non HT) or Clearfield® canola.

Performance of retail pharmacies in low- and middle-income Asian settings: a systematic review.

In low- and middle-income countries (LMIC) in Asia, pharmacies are often patients' first point of contact with the health care system and their preferred channel for purchasing medicines. Unfortunately, pharmacy practice in these settings has been characterized by deficient knowledge and inappropriate treatment. This paper systematically reviews both the performance of all types of pharmacies and drug stores across Asia's LMIC, and the determinants of poor practice, in order to reflect on how this could best be addressed. Poor pharmacy practice in Asia appears to have persisted over the past 30 years. We identify a set of inadequacies that occur at key moments throughout the pharmacy encounter, including: insufficient history taking; lack of referral of patients who require medical attention; illegal sale of a wide range of prescription only medicines without a prescription; sale of medicines that are either clinically inappropriate and/or in doses that are outside of the therapeutic range; sale of incomplete courses of antibiotics; and limited provision of information and counselling. In terms of determinants of poor practice, first knowledge was found to be necessary but not sufficient to ensure correct management of patients presenting at the pharmacy. This is evidenced by large discrepancies between stated and actual practice; little difference in the treatment behaviour of less and more qualified personnel and the failure of training programmes to improve practice to a satisfactory level. Second, we identified a number of profit maximizing strategies employed by pharmacy staff that can be linked to poor practices. Finally, whilst the research is relatively sparse, the regulatory environment appears to play an important role in shaping behaviour. Future efforts to improve the situation may yield more success than historical attempts, which have tended to concentrate on education, if they address the profit incentives faced by pharmacy personnel and the regulatory system.

What happens when GPs engage in commissioning? Two decades of experience in the English NHS.

OBJECTIVE: To review the evidence on commissioning schemes involving clinicians in the United Kingdom National Health Service, between 1991 and 2010; report on the extent and impact of clinical engagement; and distil lessons for the development of such schemes both in the UK and elsewhere. METHODS: A review of published evidence. Five hundred and fourteen abstracts were obtained from structured searches and screened. Full-text papers were retrieved for UK empirical studies exploring the relationship between commissioners and providers with clinician involvement. Two hundred and eighteen published materials were reviewed. RESULTS: The extent of clinical engagement varied between the various schemes. Schemes allowing clinicians to act autonomously were more likely to generate significant engagement, with 'virtuous cycles' (experience of being able to make changes feeding back to encourage greater engagement) and 'vicious cycles' (failure to influence services generating disengagement) observed. Engagement of the wider general practitioner (GP) membership was an important determinant of success. Most impact was seen in GP prescribing and the establishment of services in general practices. There was little evidence of GPs engaging more widely with public health issues. CONCLUSION: Evidence for a significant impact of clinical engagement on commissioning outcomes is limited. Initial changes are likely to be small scale and to focus on services in primary care. Engagement of GP members of primary care commissioning organizations is an important determinant of progress, but generates significant transaction costs.

Butyrylated starch intake can prevent red meat-induced O6-methyl-2-deoxyguanosine adducts in human rectal tissue: a randomised clinical trial.

Epidemiological studies have identified increased colorectal cancer (CRC) risk with high red meat (HRM) intakes, whereas dietary fibre intake appears to be protective. In the present study, we examined whether a HRM diet increased rectal O(6)-methyl-2-deoxyguanosine (O(6)MeG) adduct levels in healthy human subjects, and whether butyrylated high-amylose maize starch (HAMSB) was protective. A group of twenty-three individuals consumed 300 g/d of cooked red meat without (HRM diet) or with 40 g/d of HAMSB (HRM+HAMSB diet) over 4-week periods separated by a 4-week washout in a randomised cross-over design. Stool and rectal biopsy samples were collected for biochemical, microbial and immunohistochemical analyses at baseline and at the end of each 4-week intervention period. The HRM diet increased rectal O(6)MeG adducts relative to its baseline by 21% (P < 0.01), whereas the addition of HAMSB to the HRM diet prevented this increase. Epithelial proliferation increased with both the HRM (P < 0.001) and HRM + HAMSB (P < 0.05) diets when compared with their respective baseline levels, but was lower following the HRM + HAMSB diet compared with the HRM diet (P < 0.05). Relative to its baseline, the HRM + HAMSB diet increased the excretion of SCFA by over 20% (P < 0.05) and increased the absolute abundances of the Clostridium coccoides group (P < 0.05), the Clostridium leptum group (P < 0.05), Lactobacillus spp. (P < 0.01), Parabacteroides distasonis (P < 0.001) and Ruminococcus bromii (P < 0.05), but lowered Ruminococcus torques (P < 0.05) and the proportions of Ruminococcus gnavus, Ruminococcus torques and Escherichia coli (P < 0.01). HRM consumption could increase the risk of CRC through increased formation of colorectal epithelial O(6)MeG adducts. HAMSB consumption prevented red meat-induced adduct formation, which may be associated with increased stool SCFA levels and/or changes in the microbiota composition.

Primary care-led commissioning: applying lessons from the past to the early development of clinical commissioning groups in England.

BACKGROUND: The current reorganisation of the English NHS is one of the most comprehensive ever seen. This study reports early evidence from the development of clinical commissioning groups (CCGs), a key element in the new structures. AIM: To explore the development of CCGs in the context of what is known from previous studies of GP involvement in commissioning. DESIGN AND SETTING: Case study analysis from sites chosen to provide maximum variety across a number of dimensions, from September 2011 to June 2012. METHOD: A case study analysis was conducted using eight detailed qualitative case studies supplemented by descriptive information from web surveys at two points in time. Data collection involved observation of a variety of meetings, and interviews with key participants. RESULTS: Previous research shows that clinical involvement in commissioning is most effective when GPs feel able to act autonomously. Complicated internal structures, alongside developing external accountability relationships mean that CCGs' freedom to act may be subject to considerable constraint. Effective GP engagement is also important in determining outcomes of clinical commissioning, and there are a number of outstanding issues for CCGs, including: who feels 'ownership' of the CCG; how internal communication is conceptualised and realised; and the role and remit of locality groups. Previous incarnations of GP-led commissioning have tended to focus on local and primary care services. CCGs are keen to act to improve quality in their constituent practices, using approaches that many developed under practice-based commissioning. Constrained managerial support and the need to maintain GP engagement may have an impact. CONCLUSION: CCGs are new organisations, faced with significant new responsibilities. This study provides early evidence of issues that CCGs and those responsible for CCG development may wish to address.

The impact of the catechol-O-methyltransferase genotype on vascular function and blood pressure after acute green tea ingestion.

SCOPE: Evidence for the benefits of green tea catechins on vascular function is inconsistent, with genotype potentially contributing to the heterogeneity in response. Here, the impact of the catechol-O-methyltransferase (COMT) genotype on vascular function and blood pressure (BP) after green tea extract ingestion are reported. METHODS AND RESULTS: Fifty subjects (n = 25 of the proposed low-activity [AA] and of the high-activity [GG] COMT rs4680 genotype), completed a randomized, double-blind, crossover study. Peripheral arterial tonometry, digital volume pulse (DVP), and BP were assessed at baseline and 90 min after 1.06 g of green tea extract or placebo. A 5.5 h and subsequent 18.5 h urine collection was performed to assess green tea catechin excretion. A genotype × treatment interaction was observed for DVP reflection index (p = 0.014), with green tea extract in the AA COMT group attenuating the increase observed with placebo. A tendency for a greater increase in diastolic BP was evident at 90 min after the green tea extract compared to placebo (p = 0.07). A genotypic effect was observed for urinary methylated epigallocatechin during the first 5.5 h, with the GG COMT group demonstrating a greater concentration (p = 0.049). CONCLUSION: Differences in small vessel tone according to COMT genotype were evident after acute green tea extract.

A qualitative study of HIV testing and referral practices of private hospital doctors treating patients with TB in Chennai, India.

OBJECTIVE: In India, 50%-80% of patients with tuberculosis (TB) seek private care. This study set out to explore HIV testing and referral practices of private hospital doctors treating patients with TB. METHODS: Interviews were conducted with private hospital doctors (n = 15). Interviews covered HIV testing, linking HIV-positive patients with TB to HIV care, and coordination of care for co-infected patients. RESULTS: Doctors did not routinely refer patients with TB to government HIV testing facilities as per national policy guidance. If deemed appropriate, then testing was conducted privately. Testing was more common when a facility guideline mandated testing or a public-private initiative for TB management was in place. Otherwise, testing was based on doctors' judgement. Patients accustomed to private care who could not afford treatment were reportedly reluctant to shift to public facilities. A lack of communication between public and private doctors was found to undermine co-management. CONCLUSIONS: In this sample, private provider practices were influenced by both the social and the health systems contexts in which they operated. An understanding of patient perceptions of HIV, private doctors concerns for retaining patients, and the contrasting philosophies of private medicine versus public health objectives was found to be critical to explain HIV testing and referral behaviours. The government has proposed to scale up HIV testing and treatment among patients with TB, yet operationalising this will require engagement with the realities of a large, diverse private sector. It will also require considering what role government policies can have on shaping private practice and how to potentially integrate public and private care.

A preliminary investigation of the impact of catechol-O-methyltransferase genotype on the absorption and metabolism of green tea catechins.

PURPOSE: Green tea is thought to possess many beneficial effects on human health. However, the extent of green tea polyphenol biotransformation may affect its proposed therapeutic effects. Catechol-O-methyltransferase (COMT), the enzyme responsible for polyphenolic methylation, has a common polymorphism in the genetic code at position 158 reported to result in a 40% reduction in enzyme activity in in vitro studies. The current preliminary study was designed to investigate the impact of COMT genotype on green tea catechin absorption and metabolism in humans. METHODS: Twenty participants (10 of each homozygous COMT genotype) were recruited, and plasma concentration profiles were produced for epigallocatechin gallate (EGCG), epigallocatechin (EGC), epicatechin gallate (ECG), epicatechin (EC) and 4'-O-methyl EGCG after 1.1 g of Sunphenon decaffeinated green tea extract (836 mg green tea catechins), with a meal given after 60 min. RESULTS: For the entire group, EGCG, EGC, EC, ECG and 4'-O-methyl EGCG reached maximum concentrations of 1.09, 0.41, 0.33, 0.16 and 0.08 µM at 81.5, 98.5, 99.0, 85.5 and 96.5 min, respectively. Bimodal curves were observed for the non-gallated green tea catechins EGC and EC as opposed to single-peaked curves for the gallated green tea catechins EGCG and ECG. No significant parametric differences between COMT genotype groups were found. CONCLUSIONS: In conclusion, the COMT Val(158/108)Met does not appear to have a dramatic influence on EGCG absorption and elimination. However, further pharmacokinetic research is needed to substantiate these findings.