Medicines and drug testing in the workplace

Drug testing at work is rapidly becoming the standard in the United States. For drug testing to fulfill its promise as a vital part of the effort to end the drug abuse epidemic, it is essential that the tests be reliable so that people who are not using drugs are not falsely accused and that legitimate medical use of controlled substances not expose employees to harassment or labeling as drug abusers. To merit employee confidence, workplace drug testing needs to be made part of a program that includes these basic elements: (1) a clear and comprehensive policy; (2) secure collection; (3) chain-of-custody procedures; (4) retained positive samples; (5) an initial screening test; (6) a sophisticated confirmatory test; (7) a medical review officer; (8) a retest of retained positive samples in disputed cases; and (9) a system of quality control. In addition, this drug testing program needs to be built on a solid foundation that distinguishes between legitimate use of prescribed medicines and nonmedical drug use. This differentiation is the primary responsibility of the medical review officer.     

Opportunities and responsibilities for pharmacists to improve their effectiveness in addressing medication adherence through culturally sensitive collaborations with community health workers

ObjectivesDespite progress in addressing health disparities among vulnerable populations, minority populations are at risk for chronic health conditions associated with multiple determinants of health, which affects their health status and access to care. We offer a potential solution, which creates an unconventional medical team between a pharmacist and a community health worker (CHW). We explore weaknesses and challenges in our medication use system in the context of adherence as a drug therapy problem, the role of culture in shaping medication use, and finally offer a unique paradigm for a collaborative interprofessional team consisting of CHWs and pharmacists.SummaryMedication adherence is far from optimal, especially in minority ethnic populations. Members of an ethnic group may acquire beliefs about illness consistent with their culture’s shared customs. These findings intimate that ethnocultural minority groups may have their own remedies for illness that shape their decision to use medications as prescribed. An interprofessional team in which CHWs and pharmacists collaborate offers an opportunity to improve the effectiveness of pharmacists to address adherence-related problems, especially among minority populations in which culturally determined beliefs can shape medication use decisions.This approach holds promise because CHWs are usually embedded within the community in which their patients live, having experienced the same life experiences. These shared experiences may lead CHWs to uncover medication use practices that pharmacists are not able to discover on their own because the relationship with their patients is often not authentic, which, for many minority patients, can only be established through shared experiences.ConclusionThis paper argues that creating teams of CHWs and pharmacists will help address challenges in achieving health equity and health disparities among vulnerable populations in the medication use system.     

Challenges and opportunities in conducting health services research through international collaborations: A review of personal experiences

There is increasing attention to international collaborations in health services research with a number of benefits. For developing and nurturing international collaboration, a growing number of funding opportunities are available globally. Having observed and experienced the growth of international collaborations in the global health research field, the authors reflect upon their own experiences in international collaboration between the United Kingdom and many different countries in the process of health services and educational research and discuss challenges and opportunities to conduct impactful research in international settings. The commentary also highlights key issues and strategies for learning and achieving more impact from global health research, including: communication, co-creation, strong leadership and sustainability.     

Pharmacogenetics: data, concepts and tools to improve drug discovery and drug treatment

Variation in the human genome is a most important cause of variable response to drugs and other xenobiotics. Susceptibility to almost all diseases is determined to some extent by genetic variation. Driven by the advances in molecular biology, pharmacogenetics has evolved within the past 40 years from a niche discipline to a major driving force of clinical pharmacology, and it is currently one of the most actively pursued disciplines in applied biomedical research in general. Nowadays we can assess more than 1,000,000 polymorphisms or the expression of more than 25,000 genes in each participant of a clinical study -- at affordable costs. This has not yet significantly changed common therapeutic practices, but a number of physicians are starting to consider polymorphisms, such as those in CYP2C9, CYP2C19, CYP2D6, TPMT and VKORC1, in daily medical practice. More obviously, pharmacogenetics has changed the practices and requirements in preclinical and clinical drug research; large clinical trials without a pharmacogenomic add-on appear to have become the minority. This review is about how the discipline of pharmacogenetics has evolved from the analysis of single proteins to current approaches involving the broad analyses of the entire genome and of all mRNA species or all metabolites and other approaches aimed at trying to understand the entire biological system. Pharmacogenetics and genomics are becoming substantially integrated fields of the profession of clinical pharmacology, and education in the relevant methods, knowledge and concepts form an indispensable part of the clinical pharmacology curriculum and the professional life of pharmacologists from early drug discovery to pharmacovigilance.     

Strengthening pandemic preparedness through pharmacy and public health collaborations: Findings from a facilitated discussion exercise

BackgroundCommunity pharmacists are key partners to public health agencies during pandemics and other emergencies. Community pharmacy and public health agencies can establish memoranda of understanding (MOUs) for dispensing and administering medical countermeasures and providing related services to affected population(s) during a public health incident.ObjectiveThe objective of this facilitated discussion exercise was to identify the strengths and opportunities associated with the activation of a statewide pharmacy–public health agencies MOU with community pharmacists on the basis of a simulated pandemic influenza event.MethodsA facilitated discussion exercise was held in the Puget Sound region of the State of Washington in May 2017. The participants included pharmacists from 2 community pharmacy organizations, emergency preparedness officials from 2 local health departments and the state health department, staff of the state pharmacy association, and faculty from a school of pharmacy. The evaluators recorded the discussions and observations, augmented by a postexercise telephone call with participants from each of the participating community pharmacy organizations. Key themes from the exercise are reported.ResultsFive themes were identified during the facilitated discussion exercise. Two themes described the strengths of the MOU and its operational plan: (1) collaboration strengthens preparedness and response planning, and (2) an MOU provides a framework for effective collaboration. Three themes acknowledged the opportunities to optimize activation of the existing MOU: (1) early and active engagement between health department personnel and community pharmacists, (2) establishing pharmacy policies and procedures to support readiness and response, and (3) addressing the training or other educational needs of community pharmacists.ConclusionThis exercise provided community pharmacists and public health agency personnel an opportunity to better plan for responding to a pandemic. The open dialogue in this facilitated discussion allowed the exercise participants to identify the strengths, priorities, and perspectives as well as the gaps in the MOU operational plan. The lessons learned in this exercise can inform the community pharmacy and public health response to the coronavirus disease pandemic.     

Biomarkers in drug discovery and development: from target identification through drug marketing

Biomarkers of disease play an important role in medicine and have begun to assume a greater role in drug discovery and development. The challenge for biomarkers is to allow earlier, more robust drug safety and efficacy measurements. Their role in drug development will continue to grow for the foreseeable future. For biomarkers to assume their rightful role, greater understanding of the mechanism of disease progression and therapeutic intervention is needed. In addition, greater understanding of the requirements for biomarker selection and validation, biomarker assay method validation and application, and clinical endpoint validation and application is needed. Biomarkers need to be taken into account while the therapeutic target is still being identified and the concept is being formulated. Biomarkers need to be incorporated into a continuous cycle that takes what is learned from the discovery and development of one series of biomarkers and translates it into the next series of biomarkers. Optimum biomarker development and application will require a team approach because of the multifaceted nature of biomarker selection, validation, and application, using such techniques as pharmacoepidemiology, pharmacogenetics, pharmacogenomics, and functional proteomics; bioanalytical method development and validation; disease process and therapeutic intervention assessments; and pharmacokinetic/pharmacodynamic modeling and simulation to improve and refine drug development. The potential for biomarkers in medicine and drug development will be limited by the least effective component of the processes. The team approach will minimize the potential for the least effective component to be fatal to the rest of the process. As scientific/regulatory foundations for biomarkers in medicine and drug development begin to be established, successes and applications will need to be effectively communicated with all of the stakeholders, including not only internal and external drug developers and regulators but also the medical community, to ensure that biomarkers are totally integrated into drug discovery and development as well as the practice of medicine.     

Weak links: Instabilities and areas for improvement in the drug supply chain

ObjectiveTo evaluate the current pharmaceutical supply chain, from both a regulatory and market perspective, to identify instabilities as well as propose methods to ensure consistent drug quality and access.Data sourcesData sources include publicly available Food and Drug Administration (FDA) databases.SummaryRecent recalls of important drugs such as angiotensin receptor blockers, heparin, epinephrine, and acyclovir highlight the importance of ensuring access to essential medications. However, the current drug supply chain has multiple weaknesses from both regulatory and market perspectives. A lack of adequate inspection and quality standards means that quality issues often go unfound, but when they are found, disruptions to the supply chain are amplified by a dependence on India and China for active pharmaceutical ingredients. The mutual recognition agreement, India Pilot Program, and increased number of FDA foreign inspectors were steps in the right direction, but more must be done to ensure access.ConclusionEnsuring drug quality and access is not possible without first providing greater transparency into the drug supply chain. This allows both health care consumers and the FDA to respond to drug quality issues. Additionally, extra steps including broadening the scope of the mutual recognition agreement, encouraging increased self-regulation in China and India, and mandating unannounced inspections of foreign manufacturers may help in providing a more stable supply chain.     

Monitoring service delivery in a drug and alcohol regional program

Monitoring is an important component in the planning, development and evaluation of service delivery in the drug and alcohol field. This paper describes a preliminary study of professional activities undertaken by staff in a Queensland regional program. A modified WHO daily log book was used to record activities for a one month period. Some difficulties experienced with this measure are discussed and directions for future monitoring presented.     

Recent national and regional drug reforms in Sweden: implications for pharmaceutical companies in Europe

With an aging population and increased prevalence of chronic diseases, such as obesity and diabetes mellitus, drug reforms are needed across Europe to ensure the continued provision of comprehensive healthcare. It is also a challenge, with the limited resources available, to fund new innovative drugs that significantly improve patient health.Recent national and regional reforms in Sweden have moderated the rate of increase in drug expenditure, despite increased volumes of drug use and the launch of new, expensive drugs. National reforms include the adoption of economic principles when assessing the value and subsequent reimbursement of new and existing drugs, as well as reforms to obtain low prices for generic drugs. Regional reforms aim to encourage the rational use of medicines through the establishment of drug and therapeutic committees, development of guidelines, academic detailing, continuous benchmarking of prescribing patterns, and financial incentives.Some of these reforms provide examples to other European countries, whilst others duplicate existing measures. As such, we believe other European countries can benefit from an analysis of the Swedish reforms. We believe the pharmaceutical industry can also benefit from this analysis by working with key regional payers involved with developing and implementing the reforms as they moderate and refine their future activities, including finding acceptable ways of introducing new expensive drugs.     

Pneumatic dry granulation: potential to improve roller compaction technology in drug manufacture

INTRODUCTION: Solid dosage form manufacture still remains the most common in the production of pharmaceutical products. Established granulation processes can benefit from novel technical improvements, which can in turn enhance the behavior and properties of the process intermediates, that is, granules. These improvements in the manufacturing process can ultimately shorten development times, provide processing solutions for challenging materials and improve quality of drug delivery systems. AREAS COVERED: The aim of this review is to give the reader an overview of the latest trends in research with regard to roller compaction technology. Pneumatic dry granulation is also discussed as a new development with the potential to improve and extend the use of dry granulation processes, which can result in a substantial contribution to drug delivery system development and drug product manufacture. EXPERT OPINION: Dry granulation techniques, and more specifically roller compaction, can provide many advantages over the more established wet granulation techniques. There are still problems with roller compaction such as high amounts of fines and poor flow of granulate. Technical innovations that improve existing processes will have a considerable impact on development times and contribute to improved material processability and behavior of the end product. Pneumatic dry granulation has the potential to provide such alternatives.     

Converting a peptide into a drug: strategies to improve stability and bioavailability

The discovery of peptide hormones, growth factors and neuropeptides implicated in vital biological functions of our organism has increased interest in therapeutic use of short peptides. However, the development of peptides as clinically useful drugs is greatly limited by their poor metabolic stability and low bioavailability, which is due in part to their inability to readily cross membrane barriers such as the intestinal and blood-brain barriers. The aim of peptide medicinal chemistry is, therefore, to develop strategies to overcome these problems. Recent progress in chemical synthesis and design have resulted in several strategies for producing modified peptides and mimetics with lower susceptibility to proteolysis and improved bioavailability, which has increased the probability of obtaining useful drugs structurally related to parent peptides. This review describes different experimental approaches to transforming a peptide into a potential drug and provides examples of the usefulness of these strategies.