Mass immunization programs: principles and standards.

Mass immunization involves delivering immunizations to a large number of people at one or more locations in a short interval of time. Good mass immunization programs apply planning and quality standards that maximize return on resources invested and provide the greatest individual benefits when immunizing many people in a short period of time. These programs can be used to counter contagious outbreaks, adopted as a repeated means of sustained healthcare delivery, or applied where many people move through a specific place in a short interval of time. Relevant quality standards address appropriate facilities and supplies, training of professional and paraprofessional staff, education of potential vaccinees and methods to screen them for contraindications to immunization, safeguards against anaphylaxis and syncope, documentation, safety surveillance, and a quality-improvement program. Successful mass immunization programs require early planning that builds on existing competencies. As the number of available vaccines increases, prioritizing which vaccines to administer during mass campaigns requires consideration of effectiveness, safety, and a cost-benefit equation from both the individual and community perspectives. Mass immunization campaigns aim to maximize the health of a population, but such campaigns need to be customized based on individual contraindications to immunization. Mass immunization programs need to be conducted ethically, with considerations of benefit versus risk and the need for detailed education of healthcare workers and vaccinees.

Comprehensive immunization delivery in conjunction with influenza vaccination.

All patients and employees presenting for influenza A and B vaccination were studied for the need for other immunizations or tests, based on criteria of the Immunization Practices Advisory Committee. More than 72% of patients and employees needed at least one other vaccine or test. During a 4 1/2-month period, 1,353 doses of influenza virus vaccine, bivalent, types A and B, were prescribed. Health care providers ordered doses of diphtheria and tetanus toxoids (adult) for 36.8% of these recipients, pneumococcal vaccine, polyvalent 23, for 42.1%, and a tuberculin skin test for 36.3%. Determinations of hepatitis B titers or hepatitis B vaccine doses were ordered for 140 individuals. Patients older than 60 years needed additional immunizations with greater frequency. Rates of delayed adverse reactions (35.9%) and subsequent self-medication (11.7%) were recorded. The systemic adverse reaction rate was 17.3%. Annual influenza vaccination programs are valuable public health opportunities to determine immunizations needed by patients who might not otherwise receive a comprehensive, individualized review of the status of their immunization protection.

Patterns of antihypertensive use among patients in the US Department of Defense database initially prescribed an angiotensin-converting enzyme inhibitor or calcium channel blocker.

The US Department of Defense recently assembled electronic records of outpatient prescriptions dispensed through the Uniformed Services Prescription Database Project (USPDP) going back to 1990. The objectives of this portion of a larger study were: (1) to examine longitudinally the patterns of antihypertensive drug use during the first year of therapy in patients whose initial therapy was with an angiotensin-converting enzyme (ACE) inhibitor or a calcium channel blocker (CCB); (2) to determine continuous and noncontinuous users of antihypertensive drugs; and (3) to estimate the direct medication costs for each pattern of medication use. Filtering criteria for patient and prescription identification were developed, because the USPDP contains no records of confirmatory diagnoses of hypertension. Once data filters were implemented, information for 771 patients was analyzed. An ACE inhibitor was the initial therapy for 328 patients, accounting for 1935 antihypertensive medication prescription fills, and a CCB was the initial therapy for 443 patients, accounting for 2459 fills (including refills). Slightly more than half of the patients (n = 401, 52.0%) were classified as continuous users (> or = 80% medication-possession ratio [supply of medication in days divided by the number of days in the 12-month study period]). In the first year, 177 of these continuous users (44.1%) had no change in therapy in the first year, 49 (12.2%) had an increase in dose, 8 (2.0%) had a decrease in dose, 15 (3.7%) had a change to a different therapeutic class of antihypertensive medication, 14 (3.5%) were changed to a different medication in the same therapeutic class, 20 (5.0%) had a new medication added to the regimen, and 118 (29.4%) had complex regimens involving more than one change. For continuous users, the mean medication supply in days was 354.6, and the average time before a medication change was 152.1 days for those continuous users who had one change in therapy. The overall average wholesale price (AWP) and average manufacturer price (AMP) for continuous users during 1 year of therapy were $471.31 and $378.51, respectively. For those patients whose therapy was changed to an ACE inhibitor/CCB combination and who were continuous users, the average AWP was $598.47 per year ($492.05 AMP). Once the change from monotherapy to an ACE inhibitor/CCB combination occurred in continuous users, AWP costs per member per month increased by approximately $22.00 ($18.00 AMP). Over half of the patients whose initial therapy was an ACE inhibitor or CCB had at least one change in their first year of therapy. Research into the reasons for these changes and their outcomes is needed.

Status and future of vaccines for adults.

The current status and future prospects of vaccines for adults are discussed. For every child in America who dies of a vaccine-preventable disease, about 400 adults die of such a disease. Evidence of the merit of influenza vaccination continues to accumulate, yet < 30% of high-risk people younger than 65 have been vaccinated. Use of pneumococcal vaccine lags behind that of influenza vaccine. Serious discrepancies in immunization levels exist among different segments of U.S. adult society. A vaccination status assessment is now recommended for everyone reaching the age of 50. New vaccines are available to prevent varicella, hepatitis A, and typhoid fever. There are now two formulations of hepatitis A virus vaccine; adult users of these vaccines include travelers, people relocating to areas with poor sanitation, military personnel, laboratory workers, and hemophiliacs. New rabies vaccines may be the next vaccines to be used primarily in adults. Vaccines against pertussis, Lyme disease, cholera, herpes simplex, malaria, other infectious diseases, and cancer are in various stages of development. For health care personnel in areas where there is a strong likelihood of Mycobacterium tuberculosis transmission and infection, BCG vaccination is recommended. The risk of immunization to a person infected with the human immunodeficiency virus is likely outweighed by the protection offered against other health threats. Health systems should select tetanus-diphtheria toxoids adsorbed for their formularies for immunizing adults, not monovalent tetanus toxoid. Vaccines are available to prevent a growing list of infectious diseases but are underused in adults.

Health-system pharmacists' role in immunizing adults against pneumococcal disease and influenza.

The role of pharmacists in immunizing adults against pneumococcal disease and influenza is discussed. Pneumococcal disease and influenza each cause up to 40,000 deaths annually in the United States. Vaccination against these diseases is encouraged for all people 65 years of age or older and for those with certain chronic diseases or immunosuppression. Influenza virus vaccine should also be given to residents of long-term-care facilities, many pregnant women, and health care workers. Pneumococcal vaccine is usually given once in a lifetime; influenza virus vaccine is given annually in the fall. Advocacy of immunization is consistent with the precepts of pharmaceutical care, and pharmacists can promote immunization by assuming the roles of educator, facilitator, and immunizer. Despite lack of specific mention of it in accreditation standards, health-system personnel have a duty to vaccinate adults, just as they do pediatric patients. Pharmacists should review immunization records with patients periodically and at the time of immunization. As with other drug products, formulary decisions and the distribution, storage, and handling of vaccines are important pharmacist responsibilities. Pharmacoeconomic studies have demonstrated the value of pneumococcal and influenza virus vaccines. Medicare covers these vaccines under Part B. Pharmacists have an important role to play in promoting adult immunizations against pneumococcal disease and influenza.

Immunization outreach using individual need assessments of adults at an army hospital.

A comprehensive assessment of the immunization status of 2,451 adults was carried out at Walter Reed Army Medical Center's Allergy-Clinical Immunology Service, Washington, DC, during an influenza immunization program from October 1985 through February 1986. More than 66 percent of those screened needed either immunization other than for influenza, or an immunologic test, a decline from 72 percent noted during a 1984-85 influenza immunization program. The mean number of interventions was 2.00 per patient in the 1985-86 program and 2.26 during the previous program. Of patients screened in the period 1985-86, 20.5 percent received diphtheria-tetanus toxoids, 15.7 percent received pneumococcal vaccine, and 23.1 percent received a tuberculin skin test. Vaccination or titers for measles were ordered for 10.4 percent, for rubella for 10.9 percent, and for hepatitis B for 20.3 percent. Assessment of those who came to the clinic for influenza vaccination in the second program demonstrated that the needs of some patients had been met in the first program. However, a general lack of immune protection existed in the majority of patients screened in the second program. In both programs, those older than 59 years needed pneumococcal vaccine and diphtheria-tetanus toxoids more frequently than the general population. The means of the numbers of interventions and the percentages of patients needing intervention other than influenza vaccine declined from the first program to the second, suggesting progress in meeting some individual immunization needs in a large and changing ambulatory population.

A comparison of drug products available in Germany and the United States.

Health-care professionals practicing with the U.S. European Command frequently encounter drug products of their host nation. Confusion about the identity or use of these medications can slow emergency treatment or mislead the medical management of patients. This article compares drug products available in the Federal Republic of Germany (FRG) with those of the United States of America. Differences in nomenclature used for generic drug names are described, as well as prescription practices unique to the FRG, such as unusual drug combinations, additional dosage forms, and divergent labeling practices. Military pharmacies are effective resources for translation of host nation drug products.

Review of the 1995 Food and Drug Administration/National Institutes of Health Public Forum on informed consent in clinical research conducted in emergency circumstances.

We describe some of the deliberations and questions raised by the recent Food and Drug Administration/National Institutes of Health Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. Consent will have to be waived in emergency medical research if such research is to be conducted, because it is virtually impossible to obtain meaningful informed consent in emergency circumstances. There is clearly a conflict between research subject autonomy and society's perceived need for answers about emergency medical care. Who will resolve this dilemma and how it will be resolved are important questions for modern medicine.

Prescribed medication use among troops deploying to Somalia: pharmacoepidemiologic analysis.

To describe the frequency of chronic ambulatory prescriptions dispensed to troops, pharmacists analyzed records of soldiers deploying to Somalia for Operation Restore Hope. Prescriptions recorded in the Fort Drum pharmacy data base for soldiers deploying between November 24, 1992, and January 12, 1993, were compared to the roster of troops deployed. Among 3,701 deploying soldiers, 273 patients (7.4%) received 425 prescriptions. For each 1,000 troops, 114.8 prescriptions were dispensed. Of 333 presumptive diagnoses, the most common diagnostic groups were contraceptive, musculoskeletal, dermatologic, respiratory, and cardiovascular. Of 425 prescriptions, the most common therapeutic classes of medication dispensed were oral contraceptives, anti-inflammatory drugs, acne treatments, and beta-adrenergic agonists. Generically, the common prescribed substances were contraceptives, ibuprofen, pirbuterol, temazepam, piroxicam, and beclomethasone. Although women represented 6.8% of troops, women represented 31.5% of prescription recipients and received 29.4% of prescriptions. Women were 6.5 times as likely to receive a prescription as men (p < 0.0001); this relative risk was 3.4 if contraceptives were omitted from analysis (p < 0.0001). Two hospitalizations in Somalia may have been related to medication use.

Pharmacoepidemiology and military medical automation: opportunity for excellence.

Fielding of the Composite Health Care System (CHCS) brings an unparalleled opportunity for medical research. This sophisticated automated medical record system promises pharmacoepidemiologic research of a quality and quantity never before possible. Pharmacoepidemiology provides answers about the validity of beneficial and adverse drug events and aids in individualizing drug therapy. When CHCS eventually encompasses an estimated 9.1 million patients at 166 military hospitals and 588 clinics around the world, it will provide a database capable of supporting sophisticated automated research. In addition to the unprecedented size of this resource, advantages of pharmacoepidemiology performed with the CHCS database include integration of inpatient and outpatient care records, the completeness of prescription and medical records, and the wide socioeconomic spectrum covered in a defined population. Limitations and potential biases of such a database include separate drug formularies at each medical treatment facility, only limited information about nonprescription drug use and single-dose drug orders in clinics, and the mobility of military service members and their families. Pharmacoepidemiology is a tool that will benefit individual members of the military family, as well as advancing the sciences of pharmacy and medicine. Using the CHCS database for this form of research is in the best tradition of military medical research.

The average daily dose of fluoride: a model based on fluid consumption.

The quantity of fluoride needed to prevent caries but avoid dental fluorosis is unknown. To estimate the desired daily dose of fluoride, we analyzed fluid consumption data from a stratified random sample of 7,345 children studied during the 1977-78 US Department of Agriculture Nationwide Food Consumption Survey and applied it to Dean's observations of optimally fluoridated communities in the 1940s. The average daily fluoride intake per kilogram body weight from optimally fluoridated tap water was highest (0.080 mg/kg/d) from 7 to 9 months of age, and declined linearly to 0.034 mg/kg/d at 12.5 to 13 years of age. The mean was 0.068 +/- 0.008 mg/kg/d from birth to age 7 years, and 0.042 +/- 0.006 mg/kg/d from age 7 to 13 years. The American Academy of Pediatrics supplementation schedule delivers fluoride dosage rates that are below our findings of the average daily dose of fluoride after the third month of life, although the two curves are within 0.006-0.013 mg/kg/d from 3 months to 16 years of age. While supplementation alone does not exceed the average daily dose of fluoride, the cumulative effects of fluoride from tap water, processed foods, ingested toothpaste, and dental treatments after the third birthday should be evaluated for their role in the increased prevalence of fluorosis.

What I need to know about anthrax today.

The US Department of Defense has been concerned about the use of anthrax as a biological weapon by an enemy on US troops for a number of years. This is the reason why the military has embarked on a vaccination program for its forces deployed to regions of the world, which are considered high-risk areas. These areas have been in the Southwest Asia-Persian Gulf region as well as the Korean Peninsula. Many intelligence personnel have also been concerned about the possibility of biological agents being used by terrorists in the Continental United States. The recent anthrax incidents in Florida and elsewhere in the United States have significantly heightened concerns along these lines, especially following the terrorist attacks on the World Trade Center and the Pentagon on September 11th. The death of a Florida businessman, identification of infection in one of his co-workers, evidence of exposure and in some instances, cutaneous infection in some others, as well as evidence of contamination in their buildings, raised further concerns of the possibility of terrorist activity using biological warfare in this country. It is somewhat ironic that a disease that you probably haven't heard about since medical school has become the focus of national attention. Our goal in this communication is to refresh your understanding of what anthrax is and what you need to know about it today since anthrax is counted among the weapons of mass destruction. As a member of the medical profession, you will need to know what to look for in patients and how to treat them if they are contaminated with this biological agent. You will also have to serve as the "front line" of the public health system and alert the police and public health agencies.

A century of pneumococcal vaccination research in humans.

Sir Almroth Wright coordinated the first trial of a whole-cell pneumococcal vaccine in South Africa from 1911 to 1912. Wright started a chain of events that delivered pneumococcal vaccines of increasing clinical and public-health value, as medicine advanced from a vague understanding of the germ theory of disease to today's rational vaccine design. Early whole-cell pneumococcal vaccines mimicked early typhoid vaccines, as early pneumococcal antisera mimicked the first diphtheria antitoxins. Pneumococcal typing systems developed by Franz Neufeld and others led to serotype-specific whole-cell vaccines. Pivotally, Alphonse Dochez and Oswald Avery isolated pneumococcal capsular polysaccharides in 1916-17. Serial refinements permitted Colin MacLeod and Michael Heidelberger to conduct a 1944-45 clinical trial of quadrivalent pneumococcal polysaccharide vaccine (PPV), demonstrating a high degree of efficacy in soldiers against pneumococcal pneumonia. Two hexavalent PPVs were licensed in 1947, but were little used as clinicians preferred therapy with new antibiotics, rather than pneumococcal disease prevention. Robert Austrian's recognition of high pneumococcal case-fatality rates, even with antibiotic therapy, led to additional trials in South Africa, the USA and Papua New Guinea, with 14-valent and 23-valent PPVs licensed in 1977 and 1983 for adults and older children. Conjugation of polysaccharides to proteins led to several pneumococcal conjugate vaccines licensed since 2000, enabling immunization of infants and young children and resultant herd protection for all ages. Today, emergence of disease caused by pneumococcal serotypes not included in various vaccine formulations fuels research into conserved proteins or other means to maximize protection against more than 90 known pneumococcal serotypes.