Regulation of biosimilar medicines and current perspectives on interchangeability and policy.

Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability. Interchangeability is an important issue for healthcare professionals but different definitions and regulatory frameworks exist in the USA and Europe. In the USA, an interchangeable biological product is a biosimilar which may be substituted by a pharmacist, subject to local State policies. The interchangeability of a biosimilar with its reference medicine will be evaluated by the United States Food and Drug Administration (FDA) in cases where approval as an 'interchangeable product' is sought. In contrast, the European Medicines Agency (EMA) does not assess or make recommendations on interchangeability, therefore, in Europe, interchangeability does not mean substitution but is generally physician-led or driven by national policy. This paper provides an overview of the regulation of biosimilar medicines. Challenges associated with the demonstration of interchangeability and practical considerations relating to switching are also discussed. Finally, we present policies that have been adopted to date in several European countries, the USA and Australia, which aim to promote the use of biosimilar medicines.

MyD88 adaptor-like (Mal) functions in the epithelial barrier and contributes to intestinal integrity via protein kinase C.

MyD88 adapter-like (Mal)-deficient mice displayed increased susceptibility to oral but not intraperitoneal infection with Salmonella Typhimurium. Bone marrow chimeras demonstrated that mice with Mal-deficient non-hematopoietic cells were more susceptible to infection, indicating a role for Mal in non-myeloid cells. We observed perturbed barrier function in Mal(-/-) mice, as indicated by reduced electrical resistance and increased mucosa blood permeability following infection. Altered expression of occludin, Zonula occludens-1, and claudin-3 in intestinal epithelia from Mal(-/-) mice suggest that Mal regulates tight junction formation, which may in part contribute to intestinal integrity. Mal interacted with several protein kinase C (PKC) isoforms in a Caco-2 model of intestinal epithelia and inhibition of Mal or PKC increased permeability and bacterial invasion via a paracellular route, while a pan-PKC inhibitor increased susceptibility to oral infection in mice. Mal signaling is therefore beneficial to the integrity of the intestinal barrier during infection.

A review of national health policies in seven countries in the WHO African Region.

OBJECTIVES: This paper proposes an analytical framework for assessing compliance of national health policies with WHO/AFRO guidelines. DATA SOURCES: Data for this study was obtained from the national health policies of Botswana, Eritrea, Liberia, Namibia, Swaziland, Gambia, and Uganda. STUDY SELECTIONS: National health policies of seven of the 19 Anglophone countries of the WHO African region were selected for review using simple random sampling method. These include: Botswana, Eritrea, Liberia, Namibia, Swaziland, Gambia, and Uganda. DATA EXTRACTION: An analytical framework derived from WHO/AFRO guidelines for developing national health policies and plans was used in the review. It identifies components which are pertinent for appropriate national health policy formulation. DATA SYNTHESIS: It appears that aspects related to policy content are well addressed. In relation to the process, there is need for improving the mapping of stakeholders and specifying their roles and aspects of collaboration; and the implications for meeting broad service and impact targets. CONCLUSION: Development of health policies needs to focus on all aspects of the analytical framework with emphasis on improving the articulation for mapping out stakeholders and specifying their roles and aspects of collaboration; and the implications for meeting broad service and impact targets.

Status of health sector strategic plans in five countries of the WHO African Region.

OBJECTIVES: To assess the adequacy of the existing strategic plans and compare the format and content of health sector strategic plans with the guidelines in selected countries of the African region. DATA SOURCE: The health strategic plans for Gambia, Liberia, Malawi, Tanzania and Uganda, which are kept at the WHO/AFRO, were reviewed. DATA EXTRACTION: All health strategic plans among the Anglophone countries (Gambia, Ghana, Kenya, Liberia, Malawi, Mauritius, Tanzania, Uganda, Zambia and Zimbabwe) that were developed after the year 2000 were eligible for inclusion. Fifty percent of these countries that fitted this criterion were randomly selected. They included Gambia, Liberia, Malawi, Tanzania and Uganda. The analysis framework used in the review included situation analysis; an assessment of appropriateness of strategies that are selected; well developed indicators for each strategy; the match between the service and outcomes targets with available resources; and existence of a clear framework for partnership engagement for implementation. DATA SYNTHESIS: Most of the strategic plans identify key ill health conditions and their contributing factors. Health service and resource gaps are described but not quantified in the Botswana, Gambia, Malawi, Tanzania strategic documents. Most of the plans selected strategies that related to the situational analysis. Generally, countries' plans had clear indicators. Matching service and outcome targets to available resources was the least addressed area in majority of the plans. Most of the strategic plans identified stakeholders and acknowledged their participation in the implementation, providing different levels of comprehensiveness. CONCLUSION: Some of the areas that are well addressed according to the analysis framework included: addressing the strategic concerns of the health policies; identifying key partners for implementation; and selection of appropriate strategies. The following areas needed more emphasis: quantification of health system gaps; setting targets that are cognisant of the local resource base; and being more explicit in what stakeholders' roles are during the implementation period.

A rapid assessment of district health systems in six countries of the WHO African Region.

OBJECTIVES: This paper reviews the adequacy of inputs and processes at district level to support outputs and outcomes of service delivery at district level using a rapid assessment. The outputs included in this study are those considered essential for the attainment of the Health related Millennium Development Goals (MDGs). DATA SOURCES: A questionnaire based rapid District Health Systems assessment was conducted among six African countries during the year 2007. STUDY SELECTIONS: The study took place in a random sample of six out of 19 English speaking countries of the WHO African region. These countries are Ghana, Liberia, Namibia, Nigeria, Sierra Leone and Uganda. DATA EXTRACTION: The data was extracted from the questionnaires, entered and analysed in Excel spreadsheet. DATA SYNTHESIS: In spite of the variability in quality and completeness of reporting on the selected parameters, this paper does indicate that according to country norms and standards, the inputs and processes are insufficient to lead to acceptable outputs and outcomes, especially those related to the MDGs. An important point to note is that comparability across countries is made on the basis of individual country norms and standards. Implicit in this assessment is that country norms and standards are reasonable and are appropriate for the attainment of the MDGs. However reasonable the country norms and standard are, it is unlikely that the low resource base as well as weak organisational and managerial capacities in most countries will support effectively the attainment of the MDGs. CONCLUSION: Most countries manage to offer the essential health services at all levels of care despite the relatively low level of inputs. However, their level of quality and equity is debatable. The general trend is that provision of the essential health services is more at the higher levels of care prompting concerns for the populations served at lower levels of care. There is also a tendency to have wide variations in the performance of service delivery geographically as well as at the different levels of the health systems. This paper recommends further exploration of the impact of focusing on improving quality of existing health services while increasing quantity of service delivery points to achieve higher coverage of essential health services.

Monitoring and evaluation of health sector reforms in the WHO African Region.

OBJECTIVES: To describe a comprehensive analytical framework for assessing health sector reforms and demonstrates use of the analysis framework using cost-recovery mechanisms as a case study in the WHO African Region. DATA SOURCES: Health sector reforms published literature review. STUDY SELECTION: No selection involved. DATA EXTRACTION: This paper draws from previous published literature to describe a comprehensive framework to assess the performance of health sector reforms in the African region. Using this framework, it goes on to illustrate how it may be used to analyze cost recovery reforms as a case study. The major elements for the analysis include a description of the context, design, process and intended results. DATA SYNTHESIS: In terms of context and design of the cost recovery reform, there were gaps in the stewardship role of governments as evidenced by the lack of appropriate policies and information to monitor and/or influence the process. Regarding the cost recovery implementation, it is not clear from the literature reviewed in this paper that there was a comprehensive stakeholder coordination mechanism that catered for all who were involved. Concerning results of the expected results of implementing cost recovery reforms such as improved quality of health services; equitable service utilisation; social sustainability through active community participation; and gains in efficiency were not always realised. CONCLUSIONS: Given that the aspects of the analysis framework described in this paper are interrelated, reviewing one without another provides an answer to a specific question but is insufficient for a comprehensive assessment.

Effecting change in outpatient failed appointments.

The problem of failed appointments was addressed in a family practice clinic. This study borrows an approach toward increasing clinic attendance that has had consistent and positive results in mental health settings: pretherapy induction. The previsit induction was intended to prepare the patient for entry into a medical system, altering erroneous and unrealistic expectations of the patient, which, if left unaddressed, can lead to patient frustration and subsequent noncompliance. Four hundred sixty patients were each randomly assigned to one of three groups. One group viewed a 20-minute videotape introducing the clinic, its staff, and services, and how to utilize the staff during and outside office hours. A second experimental group received the same information in pamphlet form. The control group received no information about clinic function except that which was requested by the patient. Eleven months after onset of the study all patient charts were reviewed. Compared with both the no-treatment control group and the pamphlet experimental group, significantly fewer new patients viewing the induction videotape missed subsequent scheduled appointments (P less than .025). This same group had a significantly lower number of missed appointments during the study period (P less than .05).