Healthy People 2000 Consortium Meeting November 7, 1997

Summary of Breakout Group Discussion Concerning Priority Area 12: Food and Drug Safety

The facilitator welcomed workgroup participants and explained the purposes of the afternoon session. First to be addressed were the Healthy People 2000 objectives for food safety and it was noted that supporting data in this area are often scanty, when not lacking altogether. Participants made further observations and suggestions, as follows:

• In objective 12.1, consider adding other organisms to the list of those tracked, e.g., cryptosporidium. Also, broaden the field to include waterborne, as well as foodborne, illnesses, or add a separate objective for this (IFIC).
• In light of the 2010 goal to eliminate disparities, seek to enhance cultural sensitivity when collecting, analyzing, and reporting data (FDA).
• In pursuit of the foregoing, FDA, CDC, and USDA should jointly publish materials on food consumption and handling in multiple languages. Also, data sources should be developed on use of consumer materials in other languages (IFIC).
• Contamination of food by bovine feces is a factor that should be taken into account, as recent studies have shown (CDC).
• The facilitator noted that no sentiment was expressed to modify objective 12.2.
• Expand objective 12.3 to reflect the aims of the Partnership for Food Safety Education with respect to hand washing, avoidance of cross-contamination, cooking temperatures, and food storage (IFIC).
• Initiate or expand public education campaigns about consumption of raw seafood and unpasteurized cider and other juices (FDA).
• IFIC offered to assist in getting the message across to States and territories about implementation of Food Guide 1993 (objective 12.4).
• Seek greater involvement of the private sector in developing and disseminating information to the public about food handling practices (FDA).
• Integrate safe food handling messages into Dietary Guidelines for Americans and Food Guide Pyramid publications (IFIC).

Turning to the objectives for drug safety, several participants addressed shortcomings of objective 12.5 (linking dispensary systems to provide alerts to potential drug reactions) as it is written. They noted that the concept works better in theory than in actuality (NCPA); that third-party reimbursers employ it more to avoid billing discrepancies than for its essential purpose (NCPIE) (FDA) (NCPA); and that expanding drug conglomerates have not assured that their component parts can communicate sufficiently well with one another (ASHP). Other observations and suggestions regarding objectives in this portion of Chapter 12 were as follows:

• Separate objective 12.5 into two separate objectives, inasmuch as it addresses two different issues. A suggested rewording is, "Increase to ___ the proportion of pharmacies and other dispensers within integrated systems that use linked systems to facilitate information sharing between different components of health care." The second objective would seek to increase the proportion of pharmacies and dispensers that utilize systems to detect potential drug misadventures (e.g., drug interactions, as well as dosing errors). These are suggestions of the ASHP representative, who noted that the Society had conducted two national surveys that might provide data useful in tracking these objectives.
• The NCPA representative largely concurred with the foregoing suggestions and also observed that data reported as baseline for objective 12.5 is not particularly useful, in that it does not adequately address either of the suggested reworkings. NCPA would further revise the objective to specify its purpose as communication of drug interactions or other medical information between pharmacy benefit managers (PBM’s) or other integrated systems.
• Regarding objective 12.6, the facilitator observed that the phrase "other dispensers of medicine" was added later to "proportion of primary care providers" in the revision of the objective, but that data are insufficient to support the change.
• ASHP and NCPA favored deletion of "other" in the wording, as it makes it appear that physicians are the primary dispensers of medicine. ASHP may be able to assist in filling the data gap.
• Responsibility should shift to the consumer in greater measure (NCPIE).
• Track the number of patients who take the initiative to request information (ASHP).
• Make more use of avenues of community outreach, such as shops, hospitals, and ethnic associations (FDA).
• Reword objective 12.7 to achieve greater clarity. Important information may not be getting reported because what is regarded as a "serious" adverse event is a matter of interpretation. Furthermore, measurability is a problem since recorded national totals are usually extrapolations (ASHP).
• It is important to develop information faster and to define safety considerations as quickly as possible. Managed care plans should be exploited as an additional information resource (FDA).
• Use information from the private-sector Keystone Initiative, which was accepted earlier this year by the Secretary, to enhance the effectiveness of objective 12.8 (NCPIE) (ASHP).
• Ensure that data are published in a timely manner. An update for 12.8 using 1996 data on the proportion of people receiving written information from dispensers was reported publicly by FDA in early 1997, but not included in Healthy People 2000 Review 1997 (NCPIE).

Participants concluded their deliberations in the workgroup session by discussing 2010 development and proposing new or replacement objectives for food and drug safety. Their observations and suggestions included the following:

• Consider adding an objective to increase the number of food safety education materials available to consumers, with attention to culturally competent variations (e.g., languages and modes of delivery) (IFIC).
• Develop an objective to follow up on Operation Clean Hands, which increased awareness of the importance of hand washing after toileting.
• Increase to at least 50 percent the proportion of consumers who ask their pharmacist or primary care provider for oral counseling with new prescriptions (NCPIE).
• In general, raise Healthy People 2010 targets from the year 2000 levels (IFIC).
• Contrary to the general drift of opinion as expressed in the morning session, there is a need for objectives for special populations, particularly the elderly (NCPIE) (ASHP).
• Develop an objective for drug safety parallel to the goals of the Partnership for Food Safety (NCPIE).
• Consider replacing objective 12.5 with "Increase the proportion of integrated health systems that use an integrated electronic medical record system." These systems utilize physician order entry and should decrease the potential for drug mishaps. This was suggested by ASHP, which conducts a national survey of pharmacy practice that will provide data that can be used for tracking.
• Add an objective to increase the pace and efficiency of the application to practice of new information about adverse drug reactions (FDA).
• For "adverse drug reactions" substitute the term "medication misadventures," which carries no connotation of blame and better captures the array of events that can go wrong in drug therapy, including errors in prescribing, errors in the process of bringing the product to the ultimate user, idiosyncratic responses, and patient adherence (ASHP).
• Seek to reduce the number of medication misadventures by targeting specific populations, as in "Decrease the proportion of elderly patients who receive drugs that should generally be avoided in this population (see the list by Beers in Archives of Internal Medicine, 1991)." Identification of the percentage of patients over 65 who have been prescribed such drugs may be possible from a current AHRQ Medical Expenditure Panel Survey that will be repeated periodically (ASHP).
• On all fronts, seek to improve the capacity and speed of computer software available for tracking objectives (ASHP) (FDA).
• Develop an objective to alter prescribing practices so as to moderate the impact of increasing drug resistance in disease organisms (ODPHP).
• Increase the proportion of health care providers who routinely monitor patient adherence to drug therapy. This new objective could be listed under key disease states, e.g., hypertension, diabetes, tuberculosis, stroke, AIDS (ASHP).
• Objectives to address antimicrobial resistance may fit best in the infectious diseases priority area. Rates of resistance are currently being tracked by several national surveillance systems, including Project ICARE, a CDC and Emory University Initiative, and SCOPE, a surveillance program coordinated by the University of Iowa. Possible objectives include: "Increase the proportion of patients with tuberculosis who receive directly observed therapy"; "Decrease the proportion of patients who are prescribed antibiotics for the common cold"; "Decrease the proportion of patients who inappropriately receive antibiotics for otitis media (AHRQ has some baseline data)"; and "Increase the proportion of health systems that routinely use culture and sensitivity data for formulary drug management." (ASHP)

Because of the composition of the workgroup, drug safety received relatively more attention in this session than did food safety. The recorder offered participants the chance to submit additional or expanded comments later by electronic mail and some of them availed themselves of the opportunity.

Participants

Peter Rheinstein, Facilitator, Food and Drug Administration
Ellis Davis, Recorder, Office of Disease Prevention and Health Promotion
April Bell, Centers for Disease Control and Prevention
Robert Earl, International Food Information Council
Douglas Hoey, National Community Pharmacists Association
Leslie Dotson Jaggers, American Society of Health-System Pharmacists
Lee Rucker, National Council on Patient Information and Education

Breakout Session List