Pharmacovigilance and biosimilars: considerations,needs and challenges

Introduction: Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007, biosimilars have been approved for use in patients in the European Union (EU) and other regions. European experience provides several lessons as the United States (US) healthcare system prepares for biosimilar approvals. These lessons emphasize the need for adequate efficacy and safety studies, post-marketing surveys and a robust pharmacovigilance system that can accurately track and trace biologics, including biosimilars and their reference products, from the patient to the manufacturer.

Areas covered: We review the EU experience with biosimilar pharmacovigilance and discuss the implications for biosimilar pharmacovigilance in the USA. Furthermore, we review several aspects of biosimilar pharmacovigilance, including cohort event monitoring, traceability, biosimilar interchangeability, pharmacovigilance system development, nomenclature and counterfeit tracking.

Expert opinion: The availability of biosimilars as lower-cost biologics must carefully consider issues of safety, efficacy and traceability. Stringent pharmacovigilance procedures are required to detect potential differences in safety signals between biosimilars and their reference products. Pharmacovigilance of biologics should include processes that are easily used by prescribing practitioners to ensure that data are consistent and new safety signals are properly reported and assigned to the correct product.     

Universal influenza virus vaccines: what needs to happen next?

Introduction: Influenza occurs worldwide and causes significant disease burden in terms of morbidity, associated complications, hospitalizations, and deaths. Vaccination constitutes the primary approach for controlling influenza. Current influenza vaccines elicit a strain-specific response yet occasionally exhibit suboptimal effectiveness. This review describes the limits of available immunization tools and the future prospects and potentiality of universal influenza vaccines.

Areas covered: New ‘universal’ vaccines, which are presently under development, are expected to overcome the problems related to the high variability of influenza viruses, such as the need for seasonal vaccine updates and re-vaccination. Here, we explore vaccines based on the highly conserved epitopes of the HA, NA, or extracellular domain of the influenza M2 protein, along with those based on the internal proteins such as NP and M1.

Expert opinion: The development of a universal influenza vaccine that confers protection against homologous, drifted, and shifted influenza virus strains could obviate the need for annual reformulation and mitigate disease burden. The scientific community has long been awaiting the advent of universal influenza vaccines; these are currently under development in laboratories worldwide. If such vaccines are immunogenic, efficacious, and able to confer long-lasting immunity, they might be integrated with or supplant traditional influenza vaccines.     

Accessibility needs and challenges of a mHealth system for patients with dexterity impairments

Purpose State: An innovative mobile health system called iMHere (interactive Mobile Health and Rehabilitation) has been developed at the University of Pittsburgh to support self-care and adherence to self-care regimens for patients with chronic conditions. The goal of this study is to explore and to identify the accessibility needs and preferences of individuals with dexterity impairments when they use the iMHere system. Method: Participants were asked to perform tasks after a one-week field trial. The time for a participant to complete each task, the number of possible errors a participant made and the number of errors a participant was able to self-correct were recorded and analyzed. The Telehealth Usability Questionnaire was collected to rate participants' experiences. Results: Nine participants with various levels of dexterity abilities were included in the study. A statistically significant negative correlation was identified between participants' dexterity levels and their error ratios by using a Pearson product-moment correlation (r?=??0.434, n?=?36, p?=?0.004). Approximately 51% of errors detected was self-corrected without any help, but other errors called for resolution from a researcher. Conclusions: Due to the diversity of participants' dexterity impairments, their needs and preferences differ one from another. Personalized design may be the key to approaching these challenges in improving accessibility.

• Implications for Rehabilitation

• An innovative mobile health system called iMHere has been developed to support self-care and adherence to self-care regimens as part of rehabilitation for patients with chronic conditions.

• Before populations with these limitations can harness the potential of mHealth, accessibility of mHealth has to be addressed to ensure its quality and value.

• Dexterity limitations are commonly associated with chronic disease, accidents or aging. The study presented here identified the potential issues and barriers to accessibility related to user interface components for persons with dexterity impairments. The findings should be of interest for those working with mobile health, accessibility, smartphone apps, wellness and self-care.

     

Technical challenges in designing post-marketing eCRFs to address clinical safety and pharmacovigilance needs

To identify key challenges and propose technical considerations in designing electronic case report form (eCRF) for post-marketing studies, the author undertakes a comprehensive literature review of peer reviewed and grey literature to assess the key aspects, processes, standards, recommendations, and best practices in designing eCRFs based on industry experience in designing and supporting electronic data capture (EDC) studies. Literature search using strings on MEDLINE and PUBMED returned few papers directly related to CRF design. Health informatics and general practice journals were searched and results reviewed. Many conference, government commission, health professional and special interests group websites provide relevant information from practical experience — summarization of this information is presented. Further, we presented a list of concrete technical considerations in dealing with EDC technology/system limitations based on literature assessment and industry implementation experience. It is recognized that cross-functional teams be involved in eCRF design process and decision making. To summarize the keys in designing eCRFs to address post-market study safety and pharmacovigilance needs, the first is to identify required data elements from the study protocol supporting data analyses and reporting requirements. Secondly, accepted best practices, CDASH & CDISC guidelines, and company internal or therapeutic unit standard should be considered and applied. Coding (MedDRA & WHODD) mapping should be managed and implemented as well when possible. Finally, we need to be on top of the EDC technologies, challenge the technologies, drive EDC improvement via working with vendors, and utilize the technologies to drive clinical effectiveness.     

Adapt use of physician extenders for your needs

Know the scope of practice for all physician extenders--not only for those who work solely in your department but for other hospital specialties. The Joint Commission on Accreditation of Healthcare Organizations requires you explicitly follow the bylaws of your medical staff concerning allied practitioners. You can create a more limited scope of practice than outlined by the state but not a more expansive one. Make sure a mechanism is in place for checking the privileges of extenders in the ED who come from other departments.     

Advances and challenges in the therapeutic use of stem cells

In spite of the monumental challenges, supporters of stem cell research remain convinced of its benefits to future generations. This article outlines what stem cells are and discusses their current therapeutic applications, current research, new potential uses, and the scientific and ethical challenges that these present.     

Caring for family with Alzheimer's disease and Parkinson's disease: needs, challenges and satisfaction

A convenience sample of 40 family members caring for an individual with either Alzheimer's disease (AD) or Parkinson's disease (PD) completed the Caregiver Assistance Measure (CAM) to identify the types of assistance that would be most helpful in caring for a family member at home. The CAM measures three categories or types of assistance: care knowledge and skills, self-care, and resource acquisition. Caregivers also completed open-ended questions about the difficulties and the satisfactions of caregiving. The PD and AD caregivers agreed on the importance of 75% of the assistance items on the CAM. In addition, both groups of caregivers identified issues related to care knowledge and skills and selfcare as the most difficult aspects of caregiving. These findings suggest many caregiver needs may be common across chronic illness populations and provide initial support for the development and testing of standardized interventions for caregivers.     

Cultural mistrust and use of hospice care: challenges and remedies

Cultural mistrust is a prominent barrier to the involvement of African Americans in hospice care. While disavowing the theory that cultural mistrust has its origin in any single factor or event, it is argued that there needs only to exist the cultural construct of community for cultural mistrust to perpetuate itself among any ethnic group. The attitudes toward hospice care are advanced as illustrative of the relationship between African Americans and the health care system, and many other institutions of American society. From a perspective that accepts the existence of the phenomenon of cultural mistrust, suggestions for structuring training for cultural competence are discussed. These suggestions are relevant for workers in institutions that serve the African American community in critical health care areas in general, and administrators and staff of hospices in particular.