Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.

The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and challenges to brand-name drugs' patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation. It also should consider whether the law should be amended so that some of its provisions are brought more in line with recently enacted legislation governing approval of so-called biosimilars, or the corollary for biologics of generic competition for small-molecule drugs.

Percutaneous Revision of a Testicular Prosthesis is Safe, Cost-effective, and Provides Good Patient Satisfaction.

Office-based percutaneous revision of a testicular prosthesis has never been reported. A patient received a testicular prosthesis but was dissatisfied with the firmness of the implant. In an office setting, the prosthesis was inflated with additional fluid via a percutaneous approach. Evaluated outcomes included patient satisfaction, prosthesis size, recovery time, and cost savings. The patient was satisfied, with no infection, leak, or complication after more than 1 year of follow-up, at significantly less cost than revision surgery. Percutaneous adjustment of testicular prosthesis fill-volume can be safe, inexpensive, and result in good patient satisfaction.

A framework for revising preservice curriculum for nonphysician clinicians: The mozambique experience.

Mozambique, with approximately 0.4 physicians and 4.1 nurses per 10,000 people, has one of the lowest ratios of health care providers to population in the world. To rapidly scale up health care coverage, the Mozambique Ministry of Health has pushed for greater investment in training nonphysician clinicians, Tιcnicos de Medicina (TM). Based on identified gaps in TM clinical performance, the Ministry of Health requested technical assistance from the International Training and Education Center for Health (I-TECH) to revise the two-and-a-half-year preservice curriculum. A six-step process was used to revise the curriculum: (i) Conducting a task analysis, (ii) defining a new curriculum approach and selecting an integrated model of subject and competency-based education, (iii) revising and restructuring the 30-month course schedule to emphasize clinical skills, (iv) developing a detailed syllabus for each course, (v) developing content for each lesson, and (vi) evaluating implementation and integrating feedback for ongoing improvement. In May 2010, the Mozambique Minister of Health approved the revised curriculum, which is currently being implemented in 10 training institutions around the country. Key lessons learned: (i) Detailed assessment of training institutions' strengths and weaknesses should inform curriculum revision. (ii) Establishing a Technical Working Group with respected and motivated clinicians is key to promoting local buy-in and ownership. (iii) Providing ready-to-use didactic material helps to address some challenges commonly found in resource-limited settings. (iv) Comprehensive curriculum revision is an important first step toward improving the quality of training provided to health care providers in developing countries. Other aspects of implementation at training institutions and health care facilities must also be addressed to ensure that providers are adequately trained and equipped to provide quality health care services. This approach to curriculum revision and implementation teaches several key lessons, which may be applicable to preservice training programs in other less developed countries.