JCAHO posts 2005 National Patient Safety Goals

The Joint Commission on Accreditation of Healthcare Organizations has posted its 2005 National Patient Safety Goals for hospitals on the organization’s web site.

The goals, effective Jan. 1, 2005, include five of the 2004 goals as well as two new sets of requirements aimed at improving medication safety and reducing the risk of patient falls. The Joint Commission Board of Commissioners approved the goals at its July 9-10 meeting.

Here is a new requirement relating to medications:

• Under the goal of improving the safety of using medications, this requirement has been added: Identify and, at a minimum, annually review a list of look-alike/sound-alike drugs used in the organization, and take action to prevent errors involving the interchange of these drugs.

The two new goals, with their requirements are as follows:

Goal: Accurately and completely reconcile medications across the continuum of care.

• During 2005, for full implementation by January 2006, develop a process for obtaining and documenting a complete list of the patient’s current medications upon the patient’s admission to the organization and with the involvement of the patient. This process includes a comparison of the medications the organization provides to those on the list.

• A complete list of the patient’s medications is communicated to the next provider of service when it refers or transfers a patient to another setting, service, practitioner, or level of care within or outside the organization.

Goal: Reduce the risk of patient harm resulting from falls.

• Assess and periodically reassess each patient’s risk for falling, including the potential risk associated with the patient’s medication regimen, and take action to address any identified risks.

ISDA appeals to lawmakers for antibiotic development

To avert a looming public health crisis with a unique set of underlying causes, Congress and the administration, including federal public health agencies, must act quickly to reinvigorate pharmaceutical investment in antibiotic research and development (R&D), according to a new report given to lawmakers by the Infectious Diseases Society of America (IDSA) in Alexandria, VA.

Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates . . . A Public Health Crisis Brews, is the product of a year’s worth of research by some of the country’s top infectious disease physicians, the society says.

Bad Bugs, No Drugs explains the antibiotic resistance problem with data, charts, and graphs. It identifies the obstacles that pharmaceutical companies face in developing new antibiotics, and it proposes a range of specific, innovative policy and administrative measures designed to head off the impending health crisis.

The report includes recommendations for Congress, the FDA, and the National Institute of Allergy and Infectious Diseases (NIAID), as well as funding increases for the Centers for Disease Control and Prevention and other programs.

Highlights of proposed policy and administrative actions in the report include the following:

  • Establish an independent Commission to Prioritize Antimicrobial Discovery. This commission would decide which infectious pathogens to target using legislative incentives and administrative solutions.
  • Create a new type of "wild-card" patent extension. A company that develops and receives approval for a priority antibiotic could extend the market exclusivity period of another FDA-approved drug as long as the company commits to invest a portion of the profits derived during the extension period back into antibiotic R&D.
  • Provide tax incentives for R&D of priority antibiotics.
  • Establish measured liability protections similar to those that exist for childhood vaccines.

The report can be accessed and downloaded from the IDSA home page at www.idsociety.org.

HHS gives details of Medicare reform proposal

Department of Health and Human Services Secretary Tommy G. Thompson announced the proposed regulations for the voluntary prescription drug benefit under Medicare. The benefit is a key element of the Medicare Modernization Act that was signed into law on Dec. 8, 2003.

The prescription drug benefit will allow all Medicare beneficiaries to enroll in drug coverage through a prescription drug plan or Medicare health plan with Medicare paying for 75% of the premium. Additional benefits for Medicare beneficiaries who have limited means will cover, on average, 95% of their drug costs. The new benefits also will provide new protections for retirees who currently receive drug coverage through their employers or unions. All the new Medicare benefits are voluntary as seniors can choose to keep their existing traditional coverage.

The Centers for Medicare & Medicaid Services also proposed rules to implement another element of the law: strengthening and improving the Medicare Advantage program, including making regional PPOs available to all Medicare beneficiaries. These provisions will give beneficiaries broad and more access to coordinated-care health plans that provide additional benefits and significantly lower out-of-pocket costs.

The rule was published in the Federal Register on Aug. 3. The comment period on the proposed regulations lasts 60 days, closing on Oct. 4. Final rules are to be issued early in 2005. Enrollment for the new prescription drug plans will begin in the fall of 2005 for benefits starting on Jan. 1, 2006.

FDA establishes new cancer office, program

The FDA has announced plans to make significant changes to its organizational structure to provide for a stronger and more consistent approach to the review process for drugs and most therapeutic biologics used to diagnose, treat, and prevent cancer.

The FDA will create a new oncology office, called the Office of Oncology Drug Products (ODP), to be housed in the Center for Drug Evaluation and Research (CDER). This new office will be a consolidation of three existing areas within CDER responsible for the review of drugs and therapeutic biologics used to diagnose, treat, and prevent cancer. This new office also will include drugs and certain therapeutic biologics used in medical imaging, many of which are used to detect, treat, or monitor cancer.

The ODP will contain three review divisions. The therapeutic biologic products that will be included in this new office include recombinant therapeutic proteins and monoclonal antibodies.

This office will also provide technical consultation between CDER and other FDA components including the FDA’s Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Food Safety and Applied Nutrition (CFSAN).

To support this oncology office, and coordinate work performed throughout the FDA Centers (CDER, CBER, CDRH, and CFSAN) related to the prevention, diagnosis, and treatment of cancer, the FDA also is creating an Oncology Program to be housed within the oncology office, that will facilitate cross-agency expert consultation, provide a forum to discuss and develop regulatory policy and standards, and serve as a focal point for agency interaction and collaboration with the oncology professional societies, National Cancer Institute, and other important stakeholders. In addition, this program will coordinate crosscutting training and oncology educational activities.