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Increased outsourcing and importation of drugs from different parts of the world to the Latin America and the Caribbean (LAC) region result in the proliferation of substandard and fake medicines, posing a threat to public health. The presence of substandard and fake medications in LAC regions is a source of public health concern and causes an economic burden to the governments in these regions. Whereas testing and detecting medication quality can easily be achieved in developed countries, the situation is different in developing countries such as LAC. This paper aims to examine the public health challenges faced by LAC regarding substandard, fake and counterfeit medicines and how the region can tackle these challenges.

Databases such as Scopus, PubMed, ScienceDirect, Embase, HINARI, EBSCOhost, Google Scholar, unpublished data, conference abstracts and papers from World Health Organization, Pan-American Health Organization and electronic newspapers were searched concerning medicine quality and in LAC.

Drug treatment improves the quality of life while decreasing morbidity and mortality among diseased populations. Absence of or inadequate testing laboratories, old and ineffective legislature, lack of enforcement or willpower and lack of effective surveillance are challenges in LAC for the proliferation of substandard and falsified medicines (SFMs).

The most significant limitation of this study was the need for the reviewers to have used articles written in other languages besides English. The LAC region has a large population in non-English-speaking countries, and many articles are written using local languages. Hence, excluding those articles is a limitation worthy of note in this review. The articles accessed needed to provide adequate information on SFM markets and illegal pharmacies or hospitals but did not. Future reviews may focus on providing illegal substandard and falsified medicines markets in the region and how they can be minimized or eliminated.

This review highlights the challenges faced by LAC countries regarding substandard, fake and counterfeit medicines. The sources, prevalence and consequences of substandard and falsified drugs were identified to suggest the measures needed to curb the infiltration of low-quality medicines in LAC.

The purpose of this paper is to explore physical environmental, medical environmental, and individual factors in a sample of ethnic minority adults with or at-risk for type 2 diabetes (T2D) on the Atlantic Coast of Nicaragua.

The study used a cross-sectional descriptive design guided by a community-based participatory research framework. Three coastal communities in the South Atlantic Autonomous Region (RAAS) of Nicaragua were sampled. Inclusion criteria were: lay adult with or at-risk for T2D, ⩾21 years of age, self-identification as Creole or Miskito, and not pregnant. Convenience sampling procedures were followed. Data were collected via objective (A1C, height, and weight) and self-report (Pan American Health Organization surveys, Diabetes Care Profile subscales, and Medical Outcomes Survey Short Form-12 (MOS SF-12) measures. Univariate and bivariate statistics were computed according to level of measurement.

The sample (N=112) was predominately comprised of Creoles (72 percent), females (78 percent), and mid-age (M=54.9, SD±16.4) adults with T2D (63 percent). For participants with T2D, A1C levels, on average, tended to be elevated (M=10.6, SD±2.5). Those with or at-risk for T2D tended to be obese with elevated body mass indices (M=31.7, SD±8.1; M=30.2, SD±6.0, respectively). For many participants, fresh vegetables (63 percent) and fruit (65 percent) were reported as ordinarily available but difficult to afford (91 and 90 percent, respectively). A majority reported that prescribed medication(s) were available without difficulty (56 percent), although most indicated difficulty in affording them (73 percent). A minority of participants with T2D reported receipt of diabetes education (46 percent). A1C levels did not significantly vary according to diabetes education received or not (M=10.9, SD±2.9; M=10.4, SD±2.5; t=−0.4, p=0.71). Participants at-risk for T2D were infrequently instructed, by a provider, to follow an exercise program (4.8 percent) or meal plan (4.8 percent) and receive diabetes education (2.38 percent). MOS SF-12 findings revealed participants with T2D (M=41.84, SD=8.9; M=37.8, SD±8.5) had significantly poorer mental and physical health quality of life relative to at-risk participants (M=45.6, SD±8.4; M=48.1, SD±9.5) (t=−2.9, p<0.01; t=−2.5, p=0.01).

Salient physical environmental, medical environmental, and individual factors were identified in a sample of adults with or at-risk for T2D on Nicaragua’s Atlantic Coast.

Findings informed the development of community-based clinics to address the problem of T2D locally.

The community-based clinics, housed in trusted church settings, provide culturally competent care for underserved ethnic minority populations with or at-risk for T2D.

This is the first quantitative assessment of the T2D problem among diverse ethnic groups in Nicaragua’s underserved RAAS.

The purpose of this paper is to describe the current situation in relation to restrictive interventions, and some actions that could be taken to reduce them. The quality of care provided by inpatient services for people with intellectual disabilities has come under increasing scrutiny in recent years – from Winterbourne View in 2011 to Whorlton Hall in 2019, there has been increasing concern that admission to hospital does not always result in a good outcome for the patients. For some people, it has resulted in further deterioration in their physical and mental health, separation from families and supports and reduced probability of living as part of their community. This is in spite of knowledge and evidence of what good practice looks like.

This paper examines the extent to which inpatient services deliver good practice in treatment and care and, where this is not happening, the extent to which they are subject to effective governance.

People admitted to inpatient services can be at risk of poor-quality care and the overuse of restrictive interventions. There is guidance available that addresses what should be in place for them to receive high-quality care and treatment, and this clearly is available to many people. However, others can find themselves placed in increasingly restrictive environments and in circumstances where their human rights are at risk of being breached. There is increasing evidence that these services do not follow good practice guidance in terms of staff skills, development and implementation of effective care plans and governance arrangements that address these issues. Regulators, commissioners and managers could, and should, focus on these issues to ensure that the most vulnerable receive the care and treatment they need while in hospital.

Service providers are aware of the difficulties in developing alternative community services. This places even more importance on the need to ensure that care and treatment in hospital is of a good standard, and that the use of restrictive interventions is minimised. McGill et al. (this issue) describe the features of a capable environment and it may be that hospitals consider that the requirements are unlikely to be implemented effectively in a ward/unit setting. However, a shift of focus in doing this could result in a reduction in restrictive interventions and a better experience – potentially for both the staff and the patients. And families could have some reassurance that their relative was receiving the best quality care and treatment, and that their human rights were being upheld.

The study compares how distinct mechanisms that connect pre-established policy objectives to professionals' practices, and the health policy implementation context influenced different approaches to frontline staff participation. The authors analysed 26 teams in six cities from two Brazilian states, during the last cycle of the National Program for Improving Access and Quality of Primary Care (PMAQ).

About 172 in-depth interviews were conducted with frontliners – community health workers (78), nurses (37), doctors (30) – and managers (27). Interview guides were based on key issues identified in the implementation and pay-for-performance (P4P) literature. Drawing on thematic analysis and synthesis of the literature, three types of participation mechanisms were identified: relational, motivational and incremental learning. They were analysed considering distinct contexts at the local level to understand how they influenced different forms of participation: mere adherence, result-oriented and transformative.

Administrations with stronger institutional organizational structures were able to control work processes and reduce professional discretion. However, sustained participation was more likely where there was greater integration between management and frontline health care teams. Motivation based only on financial incentives could not bring about transformative participation. This depended on the degree of professional's ideational motivation towards primary care. Finally, contexts with unfavourable working conditions tend to demotivate professionals, but incremental learning helps teams cope with these obstacles.

The study overcomes gaps in the literature in relation to PMAQ's implementation process. Overall, the study delves into which/how mechanisms alter frontliners participation in performance-oriented health programs.

The purpose of this study is to enhance the understanding of the complete process of framing and implementing operational excellence in the pharmaceutical industry to ensure higher regulatory compliance.

A literature search was conducted using preferred reporting items for systematic reviews and meta-analyses guidelines. Strategies were set with different keywords and certain assessment criteria for the inclusion and exclusion of articles. A total of 46 articles were considered for a full review.

This study describes the impact of implementing operational excellence in day-to-day operations and the driving forces to achieve the same. Seven commonly used enablers are described can be used in combination to develop and validate an assessment model. Case studies are summarized to schematize operational excellence programs for the scope of their industry.

This study is limited to Indian pharmaceutical manufacturers. It is implied toward small-scale manufacturers. It can be further extended to manufacturers from other regions.

This study guides quality assurance managers, regulatory agencies and other top management to implement operational excellence to ensure higher regulatory compliance. It guides to develop a roadmap to operational excellence in their scope. This study is applicable to any manufacturing industry bound to comply with pharmaceutical regulatory standards.

To the best of the authors’ knowledge, at the time of publication, there are regulatory guidelines and some articles on various key enablers to achieve operational excellence. There is no published systematic review on achieving regulatory compliance by using operational excellence.

Medication adherence contributes significantly to symptom remission, recovery and wellbeing in mental illnesses. We evaluated how medication adherence correlates with clinico-demographic factors and quality of life (QoL) in a sample of Nigerians with schizophrenia. This descriptive cross-sectional study involved 160 randomly selected participants with confirmed diagnosis of schizophrenia based on MINI International Neuropsychiatric Interview. Data on socio-demographic and clinical characteristics of participants were collected with a questionnaire. Medication adherence was assessed with Morisky Medication Adherence Questionnaire, and participants completed the World Health Organization Quality of Life Scale-BREF. The mean age of participants was 38.54 (±11.30) years, and all the participants were on antipsychotics, but only 45% were adherent to their medication. Out of all the participants, 45 (28.2%) considered their overall QoL to be good, 97 (60.6%) considered theirs to be fair, while 18 (11.2%) reported poor QoL. Medication non-adherence correlated negatively with good QoL across multiple dimensions including overall QoL (r=−0.175), health satisfaction (r=-0.161), physical (r=-0.186) and psychological domain (r=-0.175). Again, participant's age (r=−0.190) and age of onset of illness (r=-0.172) correlated negatively with medication non-adherence, and a trend towards relapse delay with medication adherence was also observed (r=-0.155). The effect size of these correlations were however small. Our findings suggest a link between medication adherence and QoL in schizophrenia, such that strategy that addresses medication non-adherence and its determinants may have potential benefits on wellbeing. Further hypotheses-driven studies are desirable.

A high proportion of people with learning disabilities receive psychotropic medications such as antipsychotics, antidepressants, antianxiety drugs including benzodiazepines, buspirone and beta blockers, mood stabilisers such as lithium and some antiepileptic medications, psychostimulants, opioid antagonists and also vitamins and diets. Many receive these for behaviour problems for which these medications have not been indicated. Apart from a few exceptions of recent good quality randomised controlled trials (RCTs) of risperidone on the management of behaviour problems among children and adults with learning disabilities with and without autism, most of the evidence for the effectiveness of medication for the management of behaviour problems comes from non‐controlled or non‐randomised observational studies. The lack of evidence does not automatically mean that there is evidence that these medications are not effective. Current guidelines suggest that a thorough assessment of the cause and effect of the behaviour problems should be carried out before prescribing medications. A formulation should document the assessment and rationale for use of medications. Non‐medication based interventions should always be considered along with medication and where appropriate behavioural and psychological interventions should be employed either instead of or along with the medication. People with learning disabilities and their carers should be involved in the decision‐making process all along. Where necessary other relevant professionals should also be involved. At the outset the time, method and people involved with the follow‐up assessment should be determined. Follow up should involve an objective assessment of target behaviours but, more importantly, an assessment of the quality of life of the person and their carers. At each follow up a reformulation should be carried out along with consideration of non‐medication based management and the possibility of withdrawing medication. Important issues such as capacity, consent and legal issues should always be borne in mind. Medications should be used with some caution because of their adverse effects.

This study aimed to assess the sleep quality and its associated factors among patients with type 2 diabetes mellitus (T2DM) in a private hospital in Yangon, Myanmar.

A cross-sectional study was conducted. A total of 289 T2DM patients were interviewed using a structured questionnaire. An English version of the Pittsburgh Sleep Quality Index (PSQI) was translated into Myanmar and used for assessing sleep quality.

Approximately 48.4% of T2DM patients had poor sleep quality (PSQI score > 5). The mean ± SD of the PSQI global score was 5.97 ± 3.45. About 36.0% of participants reported the presence of diabetes complications, and 14.9% used sleep medication. About 27.7% had depression and 8.3% had poor family relationships. Multiple logistic regression analysis revealed that the presence of complications (AOR = 1.86; 95%CI; 1.04–3.35), poor family relationships (AOR = 5.09; 95%CI; 1.55–16.68) and depression (AOR = 7.52; 95%CI; 3.83–14.76) were significantly associated with poor sleep quality.

The prevalence of poor sleep quality is rather high among T2DM patients. Healthcare personnel and hospital administrators should focus on the complication status, family relationships and depression status of T2DM patients by providing regular screening for sleep quality and depression and by providing a program of sleep health education and counselling at diabetic clinics

The purpose of this paper is to examine how clinical handoffs affect clinical information quality (IQ) and medication administration quality.

A case study was conducted in a US hospital. The authors applied a business process management (BPM) perspective to analyze an end‐to‐end medication administration process and related handoffs, and accounting control theory (ACT) to examine the impact of handoffs on IQ and medication errors.

The study reveals how handoffs can lead to medication errors (by passing information that is not complete, accurate, timely or valid) and can help reduce errors (by preventing, detecting and correcting information quality flaws or prior clinical mistakes).

The paper reports on one case study on one hospital unit. Future studies can investigate the impact of clinical IQ on patient safety across the multitude of health information technologies (e.g. computerized provider order entry (CPOE), electronic medication administration records (EMAR), and barcode medication administration systems (BCMA)) and approaches to process design and support (e.g. use of clinical pathways and checklists).

The findings can contribute to more successful design, implementation and evaluation of medication administration and other clinical processes, ultimately improving patient safety.

The paper's main contribution is the use of accounting control theory to systematically focus on IQ to evaluate and improve end‐to‐end medical administration processes.