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Drug shortage

Adam C Fisher, Sau L Lee, Daniel P Harris, Lucinda Buhse, Steven Kozlowski, Lawrence Yu, Michael Kopcha, Janet Woodcock
Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality...
October 20, 2016: International Journal of Pharmaceutics
Michail Alevizakos, Marios Detsis, Christos A Grigoras, Jason T Machan, Eleftherios Mylonakis
BACKGROUND: Medication shortages are frequent and have clinical and financial ramifications; however, their effect on drug prices remains unknown. OBJECTIVE: To examine price progression of medications affected by a shortage. METHODS: We collected prices of medications covered under Medicare Part B, reflective of general market prices, and data on clinically relevant shortages for the period 2005-16. We used linear mixed-effects models to examine the price growth of affected medications...
October 21, 2016: Drugs
Henry Zakumumpa, Sara Bennett, Freddie Ssengooba
BACKGROUND: Uganda implemented a national ART scale-up program at public and private health facilities between 2004 and 2009. Little is known about how and why some health facilities have sustained ART programs and why others have not sustained these interventions. The objective of the study was to identify facilitators and barriers to the long-term sustainability of ART programs at six health facilities in Uganda which received donor support to commence ART between 2004 and 2009. METHODS: A case-study approach was adopted...
October 18, 2016: BMC Health Services Research
Masayuki Shimoda, Shinichi Matsumoto
Allogeneic islet transplantation has become a viable option for the treatment of unstable type 1 diabetes; however, donor shortage and the necessity for immunosuppressive drugs are two major drawbacks of this treatment. Microencapsulated porcine islets can solve both of these drawbacks, and clinical trials have been conducted. Previous clinical trials demonstrated the safety and marginal efficacy of this treatment; therefore, it is necessary to improve its efficacy. The production of microencapsulated porcine islets consists of pancreas procurement, islet isolation, and microencapsulation...
2017: Methods in Molecular Biology
Masayuki Shimoda, Shinichi Matsumoto
Allogeneic islet transplantation has become a viable treatment for patients with unstable type 1 diabetes; however, donor shortage and the necessity for immunosuppressive drugs are the major drawbacks of this approach. Microencapsulated porcine islet xenotransplantation could solve these drawbacks. Clinical porcine islet xenotransplantation as well as microencapsulated islet transplantation has been conducted without significant side effects. However, these transplantations are not as efficacious as allogeneic naked islet transplantation...
2017: Methods in Molecular Biology
Khaled S Abdelkawy, Kelsey Lack, Fawzy Elbarbry
Up-regulation of arginase activity in several chronic disease conditions, including cancer and hypertension, may suggest new targets for treatment. Recently, the number of new arginase inhibitors with promising therapeutic effects for asthma, cancer, hypertension, diabetes mellitus, and erectile dysfunction has shown a remarkable increase. Arginase inhibitors may be chemical substances, such as boron-based amino acid derivatives, α-difluoromethylornithine (DMFO), and Nω-hydroxy-nor-L-arginine (nor-NOHA) or, of plant origin such as sauchinone, salvianolic acid B (SAB), piceatannol-3-O-β-D-glucopyranoside (PG) and obacunone...
October 12, 2016: European Journal of Drug Metabolism and Pharmacokinetics
Éverton da Silva Santos, Francielle Pelegrin Garcia, Priscila Miyuki Outuki, Jaqueline Hoscheid, Paulo Roberto Nunes de Goes, Lúcio Cardozo-Filho, Celso Vataru Nakamura, Mara Lane Carvalho Cardoso
Currently, leishmaniasis is difficult to manage owing to the limited choice and high toxicity of available drugs, and emergence of drug-resistant protozoa. Medicinal plants, which produce various bioactive molecules, can help counter this global shortage. In this study, we prepared Pterodon pubescens fruit extracts, which show antileishmanial activity, and developed a nanoemulsion of the optimized extract to improve its performance. The extracts were prepared using conventional methods and a supercritical fluid method and were tested for activity against Leishmania amazonensis promastigotes and amastigotes...
October 7, 2016: Experimental Parasitology
C Malone, J R Acheson, J D Hinds, M H McComiskey
The aim was to assess the efficacy of Syntometrine (®) (500 micrograms ergometrine with 5 units oxytocin) as an appropriate alternative first-line uterotonic for use in elective caesarean section (CS) during a national shortage of UK-licensed IV oxytocin from April-June 2014. An observational study was performed involving 2 groups of 22 women undergoing elective CS in a UK DGH during this period. Primary endpoints included mean estimated blood loss (EBL), haemoglobin drop post-operatively and transfusion requirement...
September 2016: Ulster Medical Journal
Abhay B Kadam, Karen Maigetter, Roger Jeffery, Nerges F Mistry, Mitchell G Weiss, Allyson M Pollock
BACKGROUND: Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India's pharmaceutical industry and its large export market makes the problem more acute. METHODS: The focus of this study is a case study of Maharashtra, which has 29% of India's manufacturing units and 38% of its medicines exports...
April 27, 2016: International Journal of Health Policy and Management
Linnéa Schmidt, Sathishkumar Baskaran, Patrik Johansson, Narendra Padhan, Damian Matuszewski, Lydia C Green, Ludmila Elfineh, Shimei Wee, Maria Häggblad, Ulf Martens, Bengt Westermark, Karin Forsberg-Nilsson, Lene Uhrbom, Lena Claesson-Welsh, Michael Andäng, Ida-Maria Sintorn, Bo Lundgren, Ingrid Lönnstedt, Cecilia Krona, Sven Nelander
Glioblastoma multiforme (GBM, astrocytoma grade IV) is the most common malignant primary brain tumor in adults. Addressing the shortage of effective treatment options for this cancer, we explored repurposing of existing drugs into combinations with potent activity against GBM cells. We report that the phytoalexin pterostilbene is a potentiator of two drugs with previously reported anti-GBM activity, the EGFR inhibitor gefitinib and the antidepressant sertraline. Combinations of either of these two compounds with pterostilbene suppress cell growth, viability, sphere formation and inhibit migration in tumor GBM cell (GC) cultures...
September 28, 2016: Oncotarget
Daudi Simba, Deodatus Kakoko, Innocent Semali, Anna Kessy, Martha Embrey
INTRODUCTION: Private sector drug shops are an important source of medicines in Tanzania. In 2003, the government introduced the accredited drug dispensing outlet (ADDO) program to improve access to good-quality medicines in rural and peri-urban areas that have frequent drug shortages in public health facilities and few or no registered pharmacies. However, increasing access may also contribute to antimicrobial resistance (AMR) due to the potential overuse and misuse of drugs. METHODS: We conducted a cross-sectional household survey in four regions in mainland Tanzaniato characterize consumer care-seeking habits and medicines use and to determine the extent to which members of the community are knowledgeable about antimicrobials and AMR...
2016: PloS One
Francisco J Mercado-Martinez, Denise Guerreiro V da Silva, Mauricio E Correa-Mauricio
Renal replacement therapy is the indicated treatment for individuals with chronic kidney disease (CKD) to survive. However, not all sick people have access to the same treatment. This study compares renal care in two developing countries with different health systems. Specifically, it explores hemodialysis treatment from the perspective of low-income individuals. A qualitative, comparative study was performed in Brazil and Mexico. Using purposive sampling, the research was based on open-ended interviews with nineteen participants with kidney failure undergoing hemodialysis treatment in public hospitals and ten relatives...
September 27, 2016: Nursing Inquiry
May Griffith, Mohammad M Islam, Joel Edin, Georgia Papapavlou, Oleksiy Buznyk, Hirak K Patra
Biomaterials are now being used or evaluated clinically as implants to supplement the severe shortage of available human donor organs. To date, however, such implants have mainly been developed as scaffolds to promote the regeneration of failing organs due to old age or congenital malformations. In the real world, however, infection or immunological issues often compromise patients. For example, bacterial and viral infections can result in uncontrolled immunopathological damage and lead to organ failure. Hence, there is a need for biomaterials and implants that not only promote regeneration but also address issues that are specific to compromised patients, such as infection and inflammation...
2016: Frontiers in Bioengineering and Biotechnology
Parvaneh Mohammadi, Khalil Kass Youssef, Nasser Aghdami, Saeed Abbasalizadeh, Hossein Baharvand
Billions of dollars are annually invested in pharmaceutical industry and cosmetic sector with intent to develop new drugs and treatment strategies for alopecia. Because the hair looks an important characteristic of humans - an effective appendage in perception, expression of beauty, and preservation of self-esteem - the global market for hair loss treatment products is exponentially increasing. However, current methods to treat hair loss endure yet multiple challenges, such as unfavorable outcomes, non-permanent and patient-dependent results as well as unpredictable impacts, which limit their application...
September 21, 2016: Stem Cells and Development
Clara T Nicolas, Raymond D Hickey, Harvey S Chen, Shennen A Mao, Manuela Lopera Higuita, Yujia Wang, Scott L Nyberg
Donor organ shortage is the main limitation to liver transplantation as a treatment for end-stage liver disease and acute liver failure. Liver regenerative medicine may in the future offer an alternative form of therapy for these diseases, be it through cell transplantation, bioartificial liver (BAL) devices, or bioengineered whole organ liver transplantation. All three strategies have shown promising results in the past decade. However, before they are incorporated into widespread clinical practice, the ideal cell type for each treatment modality must be found, and an adequate amount of metabolically active, functional cells must be able to be produced...
September 19, 2016: Stem Cells
Xi Tan, Fabian Camacho, Vincent D Marshall, Joseph Donohoe, Roger T Anderson, Rajesh Balkrishnan
BACKGROUND: Appalachia is a largely rural, mountainous, poor and underserved region of the United States. Adherence to adjuvant endocrine therapy among Appalachian women with breast cancer is suboptimal. OBJECTIVES: To explore small-area geographic variations and clustering patterns of breast cancer patient adherence to adjuvant endocrine therapy and associated factors in Appalachia. METHODS: In this retrospective study, we analyzed Medicare claims data linked with cancer registries from four Appalachian states (PA, OH, KY, and NC) in 2006-2008...
August 25, 2016: Research in Social & Administrative Pharmacy: RSAP
Gabriela Fagundez, Hugo Perez-Freixo, Juan Eyene, Juan Carlos Momo, Lucia Biyé, Teodoro Esono, Marcial Ondó Mba Ayecab, Agustín Benito, Pilar Aparicio, Zaida Herrador
Equatorial Guinea has one of the highest burden of tuberculosis (TB) in Africa. Incomplete adherence to TB treatment has been identified as one of the most serious remaining problem in tuberculosis control. The following study is aimed at determining the adherence to anti-tuberculosis treatment in Equatorial Guinea and its determinants, as well as at assessing the knowledge of the people about the disease. In this cross-sectional study, participants were recruited by non-probabilistic consecutive sampling amongst patients who attended the reference units for TB in Bata and Malabo between March and July 2015...
2016: PloS One
Gunilla Skoog, Charlotta Edlund, Christian G Giske, Sigvard Mölstad, Christer Norman, Pär-Daniel Sundvall, Katarina Hedin
BACKGROUND: In 2014 the Swedish government assigned to The Public Health Agency of Sweden to conduct studies to evaluate optimal use of existing antibiotic agents. The aim is to optimize drug use and dosing regimens to improve the clinical efficacy. The present study was selected following a structured prioritizing process by independent experts. METHODS: This phase IV study is a randomized, open-label, multicenter study with non-inferiority design regarding the therapeutic use of penicillin V with two parallel groups...
2016: BMC Infectious Diseases
Georges Danhoundo, Mary E Wiktorowicz, Sanni Yaya
Although malaria in pregnancy predisposes women to increased perinatal mortality and morbidity, complex issues underlie its persistence. To develop a better understanding of the factors affecting women's access to Intermittent Preventive Treatment in Benin, we used the theoretical lens of "sensemaking" to clarify policymakers', health professionals', and women's perspectives concerning preventive policies and barriers to access. Several assumptions were found to underlie Benin's malaria preventive policy that contribute to the unintended effect of deterring pregnant women in poverty from accessing preventive treatment...
September 12, 2016: Health Care for Women International
Anna Helova, Eliud Akama, Elizabeth A Bukusi, Pamela Musoke, Wafula Z Nalwa, Thomas A Odeny, Maricianah Onono, Sydney A Spangler, Janet M Turan, Iris Wanga, Lisa L Abuogi
Current WHO guidelines recommend lifelong antiretroviral therapy (ART) for all HIV-positive individuals, including pregnant and breastfeeding women (Option B+) in settings with generalized HIV epidemics. While Option B+ is scaled-up in Kenya, insufficient adherence and retention to care could undermine the expected positive impact of Option B+. To explore challenges to the provision of Option B+ at the health facility level, we conducted forty individual gender-matched in-depth interviews with HIV-positive pregnant/postpartum women and their male partners, and four focus groups with thirty health care providers at four health facilities in western Kenya between September-November 2014...
September 10, 2016: Health Policy and Planning
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