PUBLIC HEALTH PROGRAMS
ACCESS TO HEALTH CARE
The National Health Service Corps
The evaluation of the effectiveness of the National Health Service Corps (NHSC) focused on mechanisms for training and recruiting providers, placement in underserved areas, and retainment in primary care and related professions. The findings showed that NHSC:
- needs to focus more sharply on the loan repayment program to meet the needs of underserved populations, based on findings that the loan repayment program has greater impact in achieving NHSC objectives.
- achieves better outcomes in rural communities, because they may enable young clinicians to make relatively important contributions in a short period, enhancing their professional gratification.
- should strategically manage the mix of health professionals it supports in response to both community requirements and NHSC health service delivery objectives.
The study concluded that underserved areas continue to need NHSC placements if they are to provide basic health care to a growing and diverse population. NHSC helps extend and expand access to basic health care services and improves the health care delivery system in underserved communities.
DRUG APPLICATION AND REVIEW
Evaluation of Written Prescription Information Provided in Community Pharmacies: An 8-State Study
This evaluation assessed the quality of written prescription information provided voluntarily to individuals receiving new prescription medicines in community pharmacies. The study tested whether fictitious patients as observers were given any written prescription information by pharmacists whom they asked for drugs prescribed (in addition to the labels and stickers on their medication containers). The quality of written information was also assessed. This pilot study produced encouraging results for consumers:
- nearly 87% of new prescriptions were dispensed with some written prescription information in addition to the label and stickers on the medication container, suggesting that the provision of written prescription information is becoming a routine practice in community pharmacies.
- expert panelists found that most written information sheets were accurate and unbiased in content and tone. They included necessary details for monitoring and interpreting adverse reactions and appeared legible and comprehensible to consumers.
The study raised several concerns: most patient information was rated low on identifying precautions, their significance, and how to avoid them, and storage instructions and general information. The study will be repeated nationally in 2001 and the results will be used to identify areas for improvement in consumer communication of prescription information.
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FY 2000 Performance Report to Congress for the Prescription Drug User Fee Act of 1992
The Prescription Drug User Fee Act (PDUFA) authorized FDA to collect fees from companies that produce human drug and biological products. The PDUFA annual performance report to Congress for FY 2000 focuses on the Agency's performance toward the agreed-upon numeric goals for reviewing and acting on submissions and responding to sponsors' pre-submission requests. The major accomplishments to report are:
- FDA continued to exceed nearly all the review performance goals in FY 2000increasing numbers of applications filed; higher quality applications; quicker approvals for products with the requisite data; and outcomes that result in more quality products reaching American practitioners and consumers faster.
- application filings and quality remain high by historic standards and approval times continue to drop;
- compared to the approval rates for all new drug applications, there is a smaller increase in approval rates for new molecular entities (NMEs), unique new drugs that are approved for the first time by FDA.
- median total approval time (i.e., time from the initial submission of a marketing application to the issuance of an approval letter) for priority applications submitted in FY 99 was 6 months, less than half the median approval times for priority applications submitted in the early PDUFA years.
The FDA performance report states that since the passage of PDUFA there has been a shift in the pattern of NME introductions with more American patients now receiving the benefits of important new drugs before they are available to citizens of other countries. This shift requires that FDA be increasingly vigilant in its post-market surveillance efforts.
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Infant Immunization with Acellular Pertussis Vaccines in the US: Assessment of the First Two Years Data from the Vaccine Adverse Events Reporting System (VAERS)
The evaluation objective was to assess the safety of infant immunization with acellular pertussis vaccines in the United States. In 1996, the FDA approved the first acellular pertussis vaccine for use in infants in the United States. The study examined adverse events in the US after infant immunization with pertussis-containing vaccines, using the Vaccine Adverse Event Reporting System (VAERS), a national surveillance system. The overall findings showed that:
- the annual number of reported events categorized as nonfatal serious (defined as events involving initial hospitalization, prolongation of hospitalization, life-threatening illness, or permanent disability) to VAERS for all pertussis-containing vaccines declined between 1995 and 1998.
- the annual number of less serious reports to VAERS for pertussis-containing vaccines also declined.
- this evaluation did not identify any new safety concerns of the vaccine based on an analysis of VAERS data for acellular pertussis vaccines, with regards to adverse events identified in a 1991 Institute of Medicine report on the safety of diphtheria-tetanus-pertussis vaccine.
The study findings support the safety of marketed acellular pertussis vaccines. In addition, the VAERS data, although subject to the limitations of passive surveillance, support the prelicensure data with regard to the safety of the US-licensed acellular pertussis vaccines evaluated in this study.
FOOD SAFETY AND NUTRITION
Consumer Attitudes Toward Potential Changes in Food Standards of Identity
As part of the 1995Regulatory Reinvention Initiative, FDA evaluated federal food standards of identity regulations (intended to assist consumers with the identity, quality, and fill of containers for standardized foods) to guide policy decisions about which standards should be retained, revised, or revoked. Consumer attitude data toward standards of identity regulations, collected in eight focus group discussions with household grocery shoppers, were analyzed. The principal findings showed that the focus group participants:
- those who think standards are bad believe that truth-in-labeling laws are adequate protection for consumers;
- supported standards in a philosophical sense;
- did not think their choices were being unduly restricted by standards;
- had concerns about the time it takes them to find products they like in the grocery store than about a lack of product choice.
Overall, the focus group participants were wary of trying to draw generalizations about when standards would be bad, and instead, they felt that evaluating and revising standards could only be done on a case-by-case basis. Furthermore, participants felt that FDA should get input from consumers about standards and not rely on industry.
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Status of Nutrition Labeling, Health Claims, and Nutrient Context Claims on Processed Foods - 1997 Food Label and Package Survey (FLAPS)
This evaluation study analyzed data to determine the status of food labels three years after nutrition labeling rules were implemented in 1994. FDA conducted the 1997 Food Labels and Package Survey (FLAPS) as an ongoing effort to monitor the food industrys response to the food labeling regulations. FLAPS allows FDA to characterize various aspects of the labeling of processed, packaged food products, including the prevalence and accuracy of nutrition labeling, health claims, and nutrient content claims. Product classes representing 80 percent of the sales in each of 58 product groups were included in the sample. From each product class, FDA selected the 3 top- selling product brans and randomly selected follower brands. Based on label information from a final sample of 1,267 food products and weighting by food market data, FDA determined the percentage of products sold that bearNutrition Fact labels, health claims, and nutrient content claims. The major findings of the survey were that:
- Nutrition-labeled products accounted for an estimated 96.5 percent of the annual sales of processed, packaged foods.
- An additional 3.4 percent of products sold were exempt from labeling regulations.
- Nutrient content claims and health claims appeared on a estimated 39 percent, and 4 percent respectfully, of the products sold.
The 1997 FLAPS collected sufficient product label information to estimate the prevalence of nutrition labels for most processed, packaged foods in the US. Although regulation for nutrition labeling have changed since the surveys start in 1976, the FLAPS data collected allow for analysis of consistent patterns and trends in food labeling practices.
Report of the Panel to Evaluate the U.S. Standard Certificates and Reports
TheNational Vital Statistics System is the Nations capacity to collect data maintain statistics on birth, deaths, fetal deaths, marriages, and divorces. These data come from State vital registration systems where standardize certificates are filed. The evaluation purpose was to assess current certificates for usefulness and quality for statistical and legal purposes; identify unmet data needs and determine whether the standard certificates should be changed; make recommendations for a standard vital statistics data base. Based on survey data from State vital registration and statistics executives and representative national health organizations and the work of an expert panel, the study found that:
- substantial changes were needed for the standard birth certificate, particularly the medical portion;
- additional data items are needed on the mothers health which could linked to other health data sources;
- changes are recommended for the standard certificates on death and fetal deaths to include data items that could permit linkages to other health data systems and would improve the quality of cause-of-death data.
INFECTIOUS DISEASE PREVENTION
Evaluation of Effectiveness of Group B Streptococcal Disease Prevention Guidelines
Group B Streptococcus (GBS) is the leading cause of bacterial infection in newborns in the United States. To address the problem CDC developed prevention guidelines in collaboration with the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) and published the guidelines in the Morbidity and Mortality Weekly Report in 1996. This evaluation assessed the management of GBS disease in the United States, looking at the extent to which the guidelines were followed and factors associated with poor compliance. Results showed that:
- implementation of the new GBS prevention guidelines was successful at the test site (Group Health Cooperative of Puget Sound) and was accomplished in a short time period;
- more complete compliance with GBS guidelines helped to improve clinical outcomes for mothers with GBS infections; and
- a cost benefit analysis showed that the costs of delivering antibiotics is minimal compared with the potential health and economic benefits from reduced infant mortality.
This population-based evaluation is a good example of collaboration between managed care organizations and public health agencies to determine the impact of national disease prevention guidelines on health care providers.
Evaluation of National Center for Injury Prevention and Control (NCIPC) Injury Control Recommendations for Bicycle Helmets
In 1995, NCIPC published recommendations on the use of bicycle helmets in preventing head injuries, including information on the magnitude of related head injuries, potential impact of increased helmet use, helmet standards and crash performance, barriers to increased helmet use by the public, and approaches to increase community-level bicycle helmet use. The evaluation purpose was to measure effective use of the recommendations by NCIPCs injury prevention constituents (state and local health officials and national bicycle safety advocate organizations) and access the process of developing the recommendations. The studys survey of constituents showed that:
- ninety percent of respondents found the recommendations useful for their efforts to increase bicycle helmet use, such as directing a bicycle helmet promotion program, advocating for a injury prevention program, and disseminating information to other injury prevention constituents; and
- eighty percent of respondents said that CDC should develop additional recommendations to address prevention service problems.
The evaluative survey results on bicycle helmets have helped CDC to improve the development and dissemination of injury control recommendations.
MATERNAL AND CHILD HEALTH
Effect of Healthy Start on Infant Mortality and Birth Outcomes
TheHealthy Start program was launched in 1991 by the Health Resources and Services Administration (HRSA) of the U.S. Public Health Service to demonstrate innovative ways to reduce infant mortality in some of the areas with the highest infant mortality rates in the country. Strategies used in the selected fifteen high-risk communities included outreach, case management, public information campaigns, support services, health education, and enhanced clinical services. Thirteen of the fifteen sites were urban. This evaluation analyzed the effects ofHealthy Start on pregnancy- related outcomes by comparing the original fifteenHealthy Start sites with comparison communities from 1991 thorough 1996. Infant mortality related outcomes prenatal care utilization, pre-term birth rate, incidence of low and very low birth weight infants, and infant mortality ratesfor the fifteenHealthy Start communities were compared with two comparison communities pre site for fourteen of the sites. Conclusions of the study suggest thatHealthy Start communities showed:
- increased use of any prenatal care in five project sites;
- increases in first trimester care in three communities;
- improved adequacy of prenatal care in eight communities;
- increases in the adequacy of prenatal care in four projects;
- improved adequacy of the number of prenatal care visits in nine projects; and
- and improvements in all prenatal care measures in three of the project areas.
As for health outcomes, Healthy Start was associated with lower pre-term births in four sites; reductions in low birth weight in three project areas; and reductions in infant mortality rates, neonatal mortality, and post neonatal mortality in two sites each.
PUBLIC HEALTH INFRASTRUCTURE
Evaluation of the National Electronic Telecommunication System for Surveillance
The National Telecommunications System for Surveillance (NETSS) is a computerized public health surveillance system that assembles, analyzes and disseminates weekly data on about 50 nationally notifiable diseases, provided by state and territorial health agencies and transmitted to CDC's Epidemiology Program Office (EPO). Providers, clinical laboratories, and public health officials collect NETSS data at the state and local level. The evaluation purpose was to examine the effective use of communicable disease data transmitted to CDC over NETSS by state and local public health officials, as well as CDC officials. Identification of barriers to effective use and ways to make improvements was and another study objective. The results showed that:
- state health officials said they are making effective use of NETSS data to track trends in communicable diseases, detect epidemiological patterns, and compare observed levels of disease to expected levels;
- these officials had encountered some technical barriers to the use of NETSS data; and
- some major problems identified concerned outdated computer technology or incompatibilities with other electronic disease surveillance systems, including unresolved software malfunctions.
The state epidemiologists recommended that disease data from other states be available for analysis.