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Objective: Access to highly priced anticancer medications usually requires insurance coverage. A first step towards coverage of such medications is their inclusion in reimbursement lists. We assessed listing for reimbursement in China between 2009 and 2018 of anticancer medications on the WHO’s Essential Medicines List. Setting and study design: Using publicly available data, we assessed which anticancer medications listed in the 20th WHO Model List of Essential Medicines (EML) were included in China’s National Reimbursement Drug List (NRDL). For five targeted anticancer medications on the WHO EML, we also assessed inclusion in the 31 Chinese Provincial Reimbursement Drug Lists (PRDLs). Logistic regression was used to test whether inclusion of targeted anticancer medications was associated with provincial economic levels. Primary outcome measures: Inclusion of five targeted anticancer medications in the NRDL and PRDLs before and after 2017. Results: The 2017 NRDL included all anticancer medications on the WHO EML (except for one not approved in China at the time), and by 2018, all 31 PRDLs listed the targeted anticancer medications except for nilotinib; four provinces had covered all five targeted medications before the 2017 NRDL coverage mandate. Provincial economic level and regional incidence of specific cancers seemed unrelated to the inclusion of five targeted anticancer medications in PRDLs. Conclusion: Our findings suggest that by including medications in the national and provincial reimbursement lists, China has taken an important first step in promoting access to targeted anticancer medications. Further research is needed to determine whether inclusion in PRDLs improved the availability, appropriate use and affordability of highly priced targeted anticancer medications in China. [ABSTRACT FROM AUTHOR]

Purpose: This study aims to illustrate the prevalence and patterns of medication use among pregnant women in mainland China. Patients and methods: Hospital and drugstore service data for a nationally representative sample of basic medical insurance (BMI) beneficiaries in 2015 were obtained from the China Health Insurance Association (CHIRA) database. A total of 7946 women who had singleton deliveries in 2015, aged between 12 and 54, and whose records in the CHIRA database covered at least one trimester were included in this study. We conducted descriptive analyses of sample characteristics, medication use prevalence, and number and types of medications used. Results: We found that 11.7% of women used at least one medication during the course of pregnancy (median number of medications used = 6.7). Medication use was more common among those who were older, residing in Eastern China, or employed. Most commonly used medication groups by the Anatomical Therapeutic Chemical Classification System were B (Blood and blood forming organs, 49.3%), A (Alimentary tract and metabolism, 48.1%), G (Genito urinary system and sex hormones, 38.1%) and J (Antiinfectives for systemic use, 31.6%). Intravenous solutions, vitamins and minerals, progestogens, and beta-lactam antibacterials were the most frequently used medications from each of these four ATC groups, respectively. Moreover, 7.1% used at least one medication contraindicated in pregnancy. Conclusion: This study showed that around one in 10 women used medication during pregnancy in mainland China and found possible cases of inappropriate or unsafe medication use. [ABSTRACT FROM AUTHOR]

Background In October 2012, the Chinese government established maximum retail prices for specific products, including 30 antineoplastic medications. Three years later, in June 2015, the government abolished price regulation for most medications, including all antineoplastic medications. This study examined the impacts of regulation and subsequent deregulation of prices of antineoplastic medications in China. Methods Using hospital procurement data and an interrupted time series with comparison series design, we examined the impacts of the policy changes on relative purchase prices (Laspeyres price index) and volumes of and spending on 52 antineoplastic medications in 699 hospitals. We identified three policy periods: prior to the initial price regulation (October 2011 to September 2012); during price regulation (October 2012 to June 2015); and after price deregulation (July 2015 to June 2016). Results During government price regulation, compared with price-unregulated cancer medications (n=22, mostly newer targeted products), the relative price of price-regulated medications (n=30, mostly chemotherapeutic products) decreased significantly (β=−0.081, p<0.001). After the government price deregulation, no significant price change occurred. Neither government price regulation nor deregulation had a significant impact on average volumes of or average spending on all antineoplastic medications immediately after the policy changes or in the longer term (p>0.05). Conclusion Compared with unregulated antineoplastics, the prices of regulated antineoplastic medications decreased after setting price caps and did not increase after deregulation. To control the rapid growth of oncology medication expenditures, more effective measures than price regulation through price caps for traditional chemotherapy are needed. [ABSTRACT FROM AUTHOR]

Background: Supportive supervision has been found to be more effective than corrective fault-oriented inspections. Uganda's Ministry of Health in 2012 implemented a comprehensive strategy (SPARS) to build medicines management capacity in public sector health facilities. The approach includes supportive supervision. This structured observational study assesses supportive supervision competency among medicines management supervisors (MMS). Method: The study used structured observations of two groups of five purposely selected MMS-one group supervising facilities with greater medicines management improvement during one year of SPARS and one group with less improvement, based on quantitative metrics. We observed and scored behaviors and skills of supervisors in 11 categories deemed critical for effective and supportive supervision. Results: Supportive supervision was not evenly or adequately implemented, with the median supportive supervision competency score for all observed supervisors being 38%. Supervisor's main strengths were problem identification, data interpretation, education, and providing constructive feedback (45%-47%). Their weakest areas were assuring continuity and setting targets (17%) and most MMS were fair to strong in effective communication, use of tools and problem solving. MMS of facilities with little improvement in medicines management over time were weak in setting targets and promoting participation. There was a 33 percentage point difference in the median supportive supervision competency scores between MMS of facilities with more versus less improvement (57%-24%) and a 77 percentage point difference in competency between the highest and lowest scoring MMS (77%-0%). We did not find a relationship between MMS experience (number of visits implemented) and their supportive supervision competency or facility improvement in medicines management. However, there is a likely relationship between supportive supervision competency and facility improvement. Conclusion: Competency of MMS in supportive supervision among the sampled MMS was generally weak, but with much individual variation. Our results suggest that MM'S supportive supervision competency is positively related to the SPARS effectiveness scores of the facilities they supervise. We recommend strategies to strengthen supportive supervision behaviors and skills. [ABSTRACT FROM AUTHOR]

Background: Uganda introduced a multipronged intervention, the supervision, performance assessment, and recognition strategy (SPARS), to improve medicines management (MM) in public and not-for-profit health facilities. This paper, the first in a series, describes the SPARS intervention and reports on the MM situation in Uganda before SPARS (baseline). Methods: To build MM capacity at health facilities, health workers were trained as MM supervisors to visit health facilities, assess MM performance, and use the findings to provide support and standardize MM practices. Performance is assessed based on 25 MM indicators covering five domains: dispensing quality (7 indicators), prescribing quality (5), stock management (4), storage management (5) and ordering and reporting (4). From the end of 2010 to 2013, MM supervisors assessed baseline MM performance of 1384 government (85 %) and private not-for-profit facilities at all levels of care in about half of Uganda's districts. Results: The overall MM baseline median score was 10.3 out of a maximum of 25 with inter-quartile range (IQR) of 8.7-11. 7. Facility domain scores (out of a maximum of 5) were as follows: storage management, median score of 2.9 (IQR 2.3-3.4); stock management 2.3 (IQR 2.0-2.8), ordering and reporting 2.2 (IQR 1.3-2.5), and dispensing quality 2.1 (IQR 1.7-2.7). Performance in prescribing quality was 0.9 (IQR 0.4-1.4). Significant regional differences were found: overall scores were highest in the Northern region (10.7; IQR 9.2-12.4) and lowest in the Eastern region (9.6; (IQR 7.8-11.2) (p<0.001). Overall scores did not differ by facility ownership; however, government facilities scored lower in dispensing and storage and higher in ordering and reporting. Hospitals scored higher overall and in domains other than prescribing and stock management. Districts classified a priori as having high capacity for implementing SPARS had higher scores at baseline compared to lower-capacity districts. Conclusion: Assessing and building national capacity in MM is needed in both private not-for-profit and government facilities at all levels of care. The indicator-based, multipronged SPARS assessment has been described here, while the strategy's impact has yet to be documented. [ABSTRACT FROM AUTHOR]

Background: Evidence of global progress in treating acute paediatric infections is lacking. Objectives: To assess progress over two decades in prescribing for childhood infections and interventions to improve treatment by reviewing empirical evidence in developing and transitional countries. Methods: Data were systematically extracted on the use of medicines for diarrhoea, respiratory infections and malaria from published and unpublished studies (1990–2009) in children under 5 years of age. Medians of each indicator were calculated across studies by study year, geographic region, sector, country income level and prescriber type. To estimate intervention effects from studies meeting methodologically accepted design criteria [randomised controlled trials (RCTs), pre-post with control, and time series studies], the medians of the median effect sizes (median MES) were calculated across outcome measures. Results: Data were extracted from 344 studies conducted in 78 countries with 394 distinct study groups in public (64%), private (22%) and other facilities to estimate trends over time. Of 226 intervention studies, only the 44 (19%) with an adequate study design were used to estimate intervention effects. Over time, use of anti-diarrhoeals for acute diarrhoea decreased significantly (P<0·01). However, treatment of malaria and acute respiratory infection remained largely sub-optimal. Multi-component interventions resulted in larger improvements than single-component ones. The median MES indicated a 28% improvement with community case-management, an 18% improvement with provider education combined with consumer education, but only 9% improvement with provider education alone. Conclusions: While diarrhoea treatment has improved over the last 20 years, treatment of other childhood illnesses remains sub-optimal. Multi-component interventions demonstrated some success in improving management of acute childhood illness. [ABSTRACT FROM AUTHOR]

Objective: Differences between women and men in political and economic empowerment, education, and health risks are well-documented. Similar gender inequities in access to care and medicines have been hypothesized but evidence is lacking. Methods: We analyzed 2002 World Health Survey data for 257,922 adult respondents and 80,932 children less than 5 years old from 53 mostly low and middle-income countries. We constructed indicators of need for, access to, and perceptions of care, and we described the number of countries with equal and statistically different proportions of women and men for each indicator. Using multivariate logistic regression models, we estimated effects of gender on our study outcomes, overall and by household poverty. Findings: Women reported significantly more need for care for three of six chronic conditions surveyed, and they were more likely to have at least one of the conditions (OR 1.41 [95% CI 1.38, 1.44]). Among those with reported need for care, there were no consistent differences in access to care between women and men overall (e.g., treatment for all reported chronic conditions, OR 1.00 [0.96, 1.04]) or by household poverty. Of concern, access to care for chronic conditions was distressingly low among both men and women in many countries, as was access to preventive services among boys and girls less than 5 years old. Conclusions: These cross-country results do not suggest a systematic disadvantage of women in access to curative care and medicines for treating selected chronic conditions or acute symptoms, or to preventive services among boys and girls.

More than two billion people in low- and middle-income countries (LMIC) lack adequate access to essential medicines. In this paper, we make strong public health, human rights and economic arguments for improving access to medicines in LMIC and discuss the different roles and responsibilities of key stakeholders, including national governments, the international community, and non-governmental organizations (NGOs). We then establish a framework of pharmaceutical firms’ corporate responsibilities - the “must,” the “ought to,” and the “can” dimensions - and make recommendations for actionable business strategies for improving access to medicines. We discuss controversial topics, such as pharmaceutical profits and patents, with the goal of building consensus around facts and working towards a solution. We conclude that partnerships and collaboration among multiple stakeholders are urgently needed to improve equitable access to medicines in LMIC.

Objective: In 2001, Thailand implemented the Universal Coverage Scheme (UCS), a public insurance system that aimed to achieve universal access to healthcare, including essential medicines, and to influence primary care centres and hospitals to use resources efficiently, via capitated payment for outpatient services and other payment policies for inpatient care. Our objective was to evaluate the impact of the UCS on utilisation of medicines in Thailand for three non-communicable diseases: cancer, cardiovascular disease and diabetes. Design: Interrupted time-series design, with a non-equivalent comparison group. Setting: Thailand, 1998–2006. Data: Quarterly purchases of medicines from hospital and retail pharmacies collected by IMS Health between 1998 and 2006. Intervention: UCS implementation, April–October 2001. Outcome measures Total pharmaceutical sales volume and percent market share by licensing status and National Essential Medicine List status. Results: The UCS was associated with long-term increases in sales of medicines for conditions that are typically treated in outpatient primary care settings, such as diabetes, high cholesterol and high blood pressure, but not for medicines for diseases that are typically treated in secondary or tertiary care settings, such as heart failure, arrhythmias and cancer. Although the majority of increases in sales were for essential medicines, there were also postpolicy increases in sales of non-essential medicines. Immediately following the reform, there was a significant shift in hospital sector market share by licensing status for most classes of medicines. Government-produced products often replaced branded generic or generic competitors. Conclusions: Our results suggest that expanding health insurance coverage with a medicine benefit to the entire Thai population increased access to medicines in primary care. However, our study also suggests that the UCS may have had potentially undesirable effects. Evaluations of the long-term impacts of universal health coverage on medicine utilisation are urgently needed.

Background: Several low and middle-income countries are implementing electronic health records (EHR). In the near future, EHRs could become an efficient tool to evaluate healthcare performance if appropriate indicators are developed. The aims of this study are: a) to develop quality of care indicators (QCIs) for type 2 diabetes (T2DM) in the Mexican Institute of Social Security (IMSS) health system; b) to determine the feasibility of constructing QCIs using the IMSS EHR data; and c) to evaluate the quality of care (QC) provided to IMSS patients with T2DM. Methods We used a three-stage mixed methods approach: a) development of QCIs following the RAND-UCLA method; b) EHR data extraction and construction of indicators; c) QC evaluation using EHR data from 25,130 T2DM patients who received care in 2009. Results: We developed 18 QCIs, of which 14 were possible to construct using available EHR data. QCIs comprised both process of care and health outcomes. Several flaws in the EHR design and quality of data were identified. The indicators of process and outcomes of care suggested areas for improvement. For example, only 13.0% of patients were referred to an ophthalmologist; 3.9% received nutritional counseling; 63.2% of overweight/obese patients were prescribed metformin, and only 23% had HbA1c <7% (or plasma glucose ≤130 mg/dl). Conclusions: EHR data can be used to evaluate QC. The results identified both strengths and weaknesses in the electronic information system as well as in the process and outcomes of T2DM care at IMSS. This information can be used to guide targeted interventions to improve QC.

Background: Access to antiretroviral therapy has dramatically expanded in Africa in recent years, but there are no validated approaches to measure treatment adherence in these settings. Methods: In 16 health facilities, we observed a retrospective cohort of patients initiating antiretroviral therapy. We constructed eight indicators of adherence and visit attendance during the first 18 months of treatment from data in clinic and pharmacy records and attendance logs. We measured the correlation among these measures and assessed how well each predicted changes in weight and CD4 count. Results: We followed 488 patients; 63.5% had 100% coverage of medicines during follow-up; 2.7% experienced a 30-day gap in treatment; 72.6% self-reported perfect adherence in all clinic visits; and 19.9% missed multiple clinic visits. After six months of treatment, mean weight gain was 3.9 kg and mean increase in CD4 count was 138.1 cells/mm3. Dispensing-based adherence, self-reported adherence, and consistent visit attendance were highly correlated. The first two types of adherence measure predicted gains in weight and CD4 count; consistent visit attendance was associated only with weight gain. Conclusions: This study demonstrates that routine data in African health facilities can be used to monitor antiretroviral adherence at the patient and system level.

Background: The current health care reform in China launched in 2009 tackles the problem of access to appropriate medicines for its 1.3 billion people by focusing on providing essential medicines to all. To provide evidence for the reform process, we investigated the manufacturing, purchasing, and prescribing of essential medicines in two provinces. Methods: We conducted surveys in 2007 of all manufacturers (n = 253) and of 59 purposively selected retail and 63 hospital pharmacies in Shandong and Gansu provinces to assess production and supply of products on the 2004 National Essential Medicines List (NEML), as well as factors underlying decision making about production and supply. We also reviewed prescriptions (n = 5456) in health facilities to calculate standard indicators of appropriate medicines use. Results: Overall, manufacturers in Shandong and Gansu produced only 62% and 50%, respectively, of the essential medicines they were licensed to produce. Of a randomly selected 10% of NEML products, retail pharmacies stocked up to 60% of Western products. Median availability in hospital pharmacies ranged from 19% to 69%. Manufacturer and retail pharmacy managers based decisions on medicines production and stocking on economic considerations, while hospital pharmacy managers cited clinical need. Between 64% and 86% of prescriptions contained an essential medicine. However, overprescribing of antibiotics (34%-77% of prescriptions) and injectables (22%-61%) for adult non-infectious outpatient consultations was common. Conclusions: We found that manufacturers, retail pharmacies, and hospital pharmacies paid limited attention to China's 2004 NEML in their decisions to manufacture, purchase, and stock essential medicines. We also found that prescribing of essential medicines was frequently inappropriate. These results should inform strategies to improve affordable access to essential medicines under the current health care reform.

Objectives: The 2004 International Conference on Improving Use of Medicines recommended that emerging and expanding health insurances in low-income countries focus on improving access to and use of medicines. In recent years, Community-based Health Insurance (CHI) schemes have multiplied, with mounting evidence of their positive effects on financial protection and resource mobilization for healthcare in poor settings. Using literature review and qualitative interviews, this paper investigates whether and how CHI expands access to medicines in low-income countries. Methods: We used three complementary data collection approaches: (1) analysis of WHO National Health Accounts (NHA) and available results from the World Health Survey (WHS); (2) review of peer-reviewed articles published since 2002 and documents posted online by national insurance programs and international organizations; (3) structured interviews of CHI managers about key issues related to medicines benefit packages in Lao PDR and Rwanda. Results: In low-income countries, only two percent of WHS respondents with voluntary insurance belong to the lowest income quintile, suggesting very low CHI penetration among the poor. Yet according to the WHS, medicines are the largest reported component of out-of-pocket payments for healthcare in these countries (median 41.7%) and this proportion is inversely associated with income quintile. Publications have mentioned over a thousand CHI schemes in 19 low-income countries, usually without in-depth description of the type, extent, or adequacy of medicines coverage. Evidence from the literature is scarce about how coverage affects medicines utilization or how schemes use cost-containment tools like co-payments and formularies. On the other hand, interviews found that medicines may represent up to 80% of CHI expenditures. Conclusion: This paper highlights the paucity of evidence about medicines coverage in CHI. Given the policy commitment to expand CHI in several countries (e.g. Rwanda, Lao PDR) and the potential of CHI to improve medicines access and use, systematic research is needed on medicine benefits and their performance, including the impacts of CHI on access to, affordability, and use of medicines at the household level.

Background: Studies carried out in the community enable researchers to understand access to medicines, affordability, and barriers to use from the consumer's point of view, and may stimulate the development of adequate medicines policies. The aim of the present article was to describe methodological and analytical aspects of quantitative studies on medicine utilization carried out at the household level. Methods: Systematic review of original papers with data collected in studies in which the household was a sampling unit, published between 1995 and 2008. The electronic review was carried out in Medline/Pubmed, Scielo and Lilacs. The reference lists of the papers identified were examined, as well as other publications by their authors. Studies on the utilization of specific pharmacological groups, or those including only respondents with a given disease were excluded. Results: Out of 4852 papers initially identified in the literature search, 61 fulfilled our inclusion criteria. Most studies were carried out in Europe and North America and used a cross-sectional approach. More than 80% used face-to-face interviews for data collection, and the most frequently used recall period for assessing medicine utilization was 14–15 days. In 59% of the studies, interviewers were trained to request the packaging of the medicines reported by the subjects; medical prescriptions were requested less frequently (15% of the studies). Conclusion: These data will be useful for updating researchers on what methods their peers are currently using. Such information may help overcome challenges in the planning and analyses of future studies. Moreover, this publication may contribute to the improvement of the quality of medicine use data obtained in household surveys.

Background: Hypertension is the number one attributable risk factor for death throughout the world and a major contributor to morbidity, mortality, and increasing health care expenditures in the Philippines. Lack of access to outpatient antihypertensive medicines leads to avoidable disease progression and costly inpatient admissions. We estimated the cost to the Philippine Health Insurance Corporation (PhilHealth), which generally does not cover outpatient medicines, for inpatient care for hypertension and its sequelae. Methods: Using PhilHealth inpatient claims for discharges between July 1, 2002 and December 31, 2005, we describe costs to PhilHealth for hospitalizations classified by primary discharge diagnoses into hospitalizations for hypertension; hypertensive heart and/or renal disease; other definite; and other possible consequences of untreated hypertension and assess disease trajectory for patients with more than one admission. Results: PhilHealth reimbursed US $56 million for 444,628 hospitalizations for hypertension-related diagnoses incurred by 360,016 patients during 3.5 years; 42% of admissions were for essential or secondary hypertension; 19% for hypertensive heart or renal disease; and 39% for other consequences of untreated hypertension. Among 60,659 patients admitted during the first 18 months of the study with a diagnosis of essential or secondary hypertension, 9% were hospitalized again for treatment of sequelae; older individuals (vs. =< 40 years old), men, dependents (vs. members), and those who were employed (vs. in the private membership category) were more likely to be hospitalized again; as were those whose first admission during the study period was for consequences of hypertension (vs. essential or secondary hypertension). Conclusion: Inpatient care for hypertension and its sequelae is expensive. Since many hospitalizations may be avoided with antihypertensive pharmacologic therapy, an outpatient medicines benefit may be one cost-effective policy option for PhilHealth.

A strong pharmaceutical sector is a precondition for effective and efficient health care and financing systems, and thus for achieving the best possible health of a population. Supported by visionary, long-term donor funds, in conjunction with mutual trust, the USAID-funded Securing Ugandans Rights to Essential Medicines (SURE) and Uganda Health Supply Chain (UHSC) program engaged in a close, more than 10 year-long (in 2018) collaboration with the Ministry of Health of Uganda. Over time, the partnership implemented numerous multi-pronged comprehensive changes in the pharmaceutical sector and conducted research to document successes and failures. We describe the evolution and key characteristics of the SURE/UHSC interventions. [ABSTRACT FROM AUTHOR]