Perspectives of pharmaceutical stakeholders on determinants of medicines accessibility at the primary care level.

BACKGROUND: Equitable access to essential medicines of maintained efficacy, safety, quality, and cost-effectiveness must be ensured by a well-functioning health system. This study aims to identify the determinants of patients' access to medicines at the primary health care (PHC) level from the perspectives of various (internal and external) stakeholders of the pharmaceutical system. METHODS: The study employed both quantitative and qualitative components. Quantitative component applied a descriptive a cross-sectional design and qualitative component applied an in-depth interview design. It was a health system research conducted at two (PHC) facilities (one urban and the other rural) in Egypt. It inquired upon political, economic, and managerial aspects of the pharmaceutical system utilizing the "Health System Assessment Approach: a How-To Manual" and the "WHO operational package for assessing, monitoring and evaluating country pharmaceutical situations." RESULTS: Analysis of the quantitative data extracted from the cross-sectional component with external stakeholders (patients) revealed that about one-third of patients in both facilities were unable to pay for the medicine. Patients in both settings took less than an hour to reach the PHC facility. The Percent of patients who believe that the private pharmacies' medicine is better than the PHC one was significantly higher in rural than urban group (24% and 10% respectively) and the percent of medicines dispensed was 50% and 66.7% in rural and urban groups respectively. Analysis of the qualitative data extracted from in-depth interviews with internal stakeholders (key informants from regulatory agencies, pharmaceutical industry, academia, pharmacists, and physicians) were summarized utilizing Strengths-Weaknesses-Opportunities-Challenges (SWOC) analysis approach. Various viewpoints toward the determinants of patients' access to medicines were disclosed. CONCLUSIONS: The Percent of medicines dispensed was insufficient in both rural and urban facilities. There is a need to invest in building trust in generic medicine quality in the government health facilities focusing on improving medicine availability and ensuring enough amounts of high-quality drugs. Although there are drug committees in the two studied PHC facilities for demonstrating the prescribing and dispensing policies, yet the system required to enforce these policies is still deficient.

Rhabdomyolysis associated with the use of a mislabeled "acai berry" dietary supplement.

INTRODUCTION: This case report describes a patient who developed rhabdomyolysis temporally associated with the use of a mislabeled acai berry dietary supplement. METHODS AND RESULTS: The authors describe a 22-year-old man presenting with rhabdomyolysis approximately 2 weeks after starting a weight-loss dietary supplement. His medical history was significant only for hypertension treated with amlodipine. The diagnosis of rhabdomyolysis was confirmed (creatine kinase, 84,000 IU/L, positive urine myoglobin) with other potential causes ruled out. The signs and symptoms of the patient gradually resolved and he was discharged on hospital day 5. Assessment using the Naranjo Adverse Drug Reaction Probability Scale yielded a score of 3, indicating a possible relationship between the supplement and rhabdomyolysis. Although the product was labeled and promoted as containing acai berry and additional ingredients, there was no acai berry found on analysis. CONCLUSION: Clinicians should be aware that all dietary supplements may vary in uniformity and contain unknown contaminants.

Etravirine: A novel nonnucleoside reverse transcriptase inhibitor for managing human immunodeficiency virus infection.

PURPOSE: The pharmacology, efficacy, and safety of etravirine and its clinical utility with respect to the available alternative human immunodeficiency virus (HIV) treatment options are reviewed. SUMMARY: While single mutations confer resistance to earlier nonnucleoside reverse transcriptase inhibitors (NNRTIs), etravirine exhibited an increased barrier to resistance by requiring multiple mutations for resistance to occur in preclinical studies. Randomized controlled trials have demonstrated the efficacy of etravirine in achieving HIV RNA viral loads of <50 copies/ mL and a significant increase in baseline CD4+ lymphocyte count in treatment-experienced patients. There has been a trend toward increased rates of death, progression to acquired immunodeficiency syndrome, and opportunistic infections in patients using placebo during Phase III trials. Baseline patient characteristics that correlate with changes in etravirine efficacy are reported. Mild-to-moderate rash and nausea are the most common adverse effects of etravirine. If rash is suspected, etravirine should be discontinued and rechallenge should be avoided due to the risk of severe and possibly fatal skin reactions. Unlike some antiretrovirals, increased risks of hepatic, lipid, or neuropsychiatric abnormalities are not correlated with its use. Several drug interactions are expected with etravirine use, and some may require dosage adjustment or substitution of concurrent drugs. No dosage adjustments are recommended for patients with mild-to-moderate hepatic or renal impairment. CONCLUSION: Etravirine, a second-generation NNRTI, is efficacious in achieving viral suppression and improving the immune function in treatment-experienced HIV-infected patients.

Emerging lipid-lowering drugs: squalene synthase inhibitors.

BACKGROUND: Lapaquistat was the only squalene synthase inhibitor in Phase III clinical trials in Europe and the United States, but was recently discontinued from clinical development. Unlike statins, the inhibition of de novo cholesterol biosynthesis by lapaquistat does not deplete mevalonate, a precursor of isoprenoids. Isoprenoids are critical in cell growth and metabolism. OBJECTIVE: The present review will focus on the chemistry, pharmacology, and lipid-lowering effects of novel squalene synthase inhibitors. METHODS: A search of Pubmed, IPA, and GoogleScholar for studies (animal and human) and review articles published in English between 1990 and April 2008, using the search terms "squalene synthase inhibitors" or "lapaquistat". All clinical trials identified were then cross-referenced for their citations. All literature identified was then complied for this analysis. RESULTS/CONCLUSION: Lapaquistat mainly targets LDL-C, but may have some effect on HDL-C and TG. Preliminary reports on Phase II and Phase III associated lapaquistat 100 mg with elevated hepatic enzymes. Hepatotoxicity, possible drug-drug interaction with statins, and the investigation of a statin/coenzyme Q10 combination are among the few challenges that impeded lapaquistat's clinical development.