The Evolution of Supply and Demand in Markets for Generic Drugs.

Policy Points Much concern about generic drug markets has emerged in recent policy debates. Important changes in regulations, the structure of purchasing, and the length of the drug supply chain have affected generic drug markets. Effective price competition remains the rule in generic markets for large-selling drugs. Smaller markets and those for injectable products often have less price competition and are more susceptible to supply disruptions. CONTEXT: The image of generic drugs as a commodity sold in competitive markets is an oversimplification, as evidenced by increasing accounts of price spikes, sustained high price-cost margins, and market disruptions. The mismatch between the canonical economic model of generic drug markets and reality motivated our empirical project. METHODS: To explore recent changes in those factors impacting the supply and demand for generic drugs, we studied, from a variety of sources, the data on price, competition, supply disruptions and recalls, changes to the supply chain, and buy-side concentration. We examined quarterly data through 2018 for a cohort of 77 molecules that lost patent protection during the so-called patent cliff between 2010 and 2013. FINDINGS: On the supply side, we found that for large-market oral solids, generic entry and price declines were consistent with past studies showing a significant number of market entrants and substantial reductions in the average price of a molecule. In smaller markets for oral solids and injectable products, we observed fewer entrants, higher rates of exit, smaller price reductions, and, in some cases, considerable price instability. The number of reported shortages increased across all generic market types over time, with the rate of shortage increases especially pronounced in markets for injectable products. The number of product recalls also rose over our study period. Although we did not estimate causal effects, we did find several changes in the market environment for generic drugs that may contribute to these phenomena. The demand side for generics has become more concentrated. Supply chains rely more on producers outside the United States (particularly from China and India). Contracting practices have undergone changes that may inhibit competition in product supply. FDA regulatory scruitiny has increased. CONCLUSIONS: Competition in generic drug markets varies widely by market size and product form. Recent changes in demand-side market structure imply more downward pressure on prices stemming from buy-side concentration. The FDA's greater regulatory oversight puts upward pressure on costs, and the lengthening of the supply chain increases production uncertainty for producers. Demand and supply-side changes point to further market instabilities across all generic markets due to producers' changing economic position.

Outcomes of a multicomponent safe surgery intervention in Tanzania's Lake Zone: a prospective, longitudinal study.

BACKGROUND: Evidence-based strategies for improving surgical quality and patient outcomes in low-resource settings are a priority. OBJECTIVE: To evaluate the impact of a multicomponent safe surgery intervention (Safe Surgery 2020) on (1) adherence to safety practices, teamwork and communication, and documentation in patient files, and (2) incidence of maternal sepsis, postoperative sepsis, and surgical site infection. METHODS: We conducted a prospective, longitudinal study in 10 intervention and 10 control facilities in Tanzania's Lake Zone, across a 3-month pre-intervention period in 2018 and 3-month post-intervention period in 2019. SS2020 is a multicomponent intervention to support four surgical quality areas: (i) leadership and teamwork, (ii) evidence-based surgery, anesthesia and equipment sterilization practices, (iii) data completeness and (iv) infrastructure. Surgical team members received training and mentorship, and each facility received up to a $10 000 infrastructure grant. Inpatients undergoing major surgery and postpartum women were followed during their stay up to 30 days. We assessed adherence to 14 safety and teamwork and communication measures through direct observation in the operating room. We identified maternal sepsis (vaginal or cesarean delivery), postoperative sepsis and SSIs prospectively through daily surveillance and assessed medical record completeness retrospectively through chart review. We compared changes in surgical quality outcomes between intervention and control facilities using difference-in-differences analyses to determine areas of impact. RESULTS: Safety practices improved significantly by an additional 20.5% (95% confidence interval (CI), 7.2-33.7%; P = 0.003) and teamwork and communication conversations by 33.3% (95% CI, 5.7-60.8%; P = 0.02) in intervention facilities compared to control facilities. Maternal sepsis rates reduced significantly by 1% (95% CI, 0.1-1.9%; P = 0.02). Documentation completeness improved by 41.8% (95% CI, 27.4-56.1%; P < 0.001) for sepsis and 22.3% (95% CI, 4.7-39.8%; P = 0.01) for SSIs. CONCLUSION: Our findings demonstrate the benefit of the SS2020 approach. Improvement was observed in adherence to safety practices, teamwork and communication, and data quality, and there was a reduction in maternal sepsis rates. Our results support the emerging evidence that improving surgical quality in a low-resource setting requires a focus on the surgical system and culture. Investigation in diverse contexts is necessary to confirm and generalize our results and to understand how to adapt the intervention for different settings. Further work is also necessary to assess the long-term effect and sustainability of such interventions.

Decline In New Starts Of Psychotropic Medications During The COVID-19 Pandemic.

COVID-19 interrupted delivery of mental health care in the US. During the initial course of the COVID-19 pandemic new starts of antidepressants declined by 7.5 percent, anxiolytics by 5.6 percent, and antipsychotics by 2.6 percent compared with expected levels. Our findings suggest that there is large unmet need for mental health treatment in the US due to COVID-19.