Francis B. Palumbo

Incidence and characteristics of antibiotic use in aged nursing home patients

Objective. To measure the prevalence, incidence, types, and certain characteristics of antibiotics prescribed in nursing homes.

Practice management guidelines for prophylactic antibiotic use in penetrating abdominal trauma: the EAST Practice Management Guidelines Work Group.

Fullen et al. first described the role for antibiotics in patients sustaining penetrating abdominal injuries. They retrospectively reviewed 295 patients who underwent celiotomy after sustaining penetrating abdominal wounds and categorized patients according to the timing of their first antibiotic dose: preoperative, n 5 16; intraoperative, n 5 98; and postoperative, n 5 81. The reported rate of trauma-related infections (incisional and intra-abdominal abscess) were 7%, 33%, and 30%, respectively. Individuals with colon injuries had postoperative infection rates of 11%, 57%, and 70% for each group, respectively. These rates remained constant even when the data were analyzed for additional risk factors, including the number of associated intra-abdominal organs injured, frequency of shock, and need for transfusion of blood products. The average time from hospital admission to laparotomy was the same for all three groups. Regardless of whether the observed difference was caused by the intraoperative or postoperative groups having a longer interval between injury and antibiotic administration or that the preoperative group had antibiotics circulating at the time of incision, this was the first study to suggest that the timing of antibiotic administration can impact the development of injury-related infections in patients with penetrating abdominal injuries. The importance of broad-spectrum antibiotic coverage for these patients was demonstrated by Thadepalli et al. in 1973. This study was a prospective, randomly assigned comparison of kanamycin and cephalothin to kanamycin and clindamycin. Both antibiotic combinations were administered preoperatively. The clindamycin group had a significantly lower rate of infection in the postoperative period compared with the cephalothin group (10% vs. 27%). They further demonstrated that the difference was caused by significantly more anaerobic infections in the cephalothin group (21%) compared with the clindamycin group (2%). These two studies demonstrated a significantly lower rate of infection when antibiotics providing aerobic and anaerobic coverage are administered before operative treatment. Prophylactic antibiotics for patients sustaining penetrating abdominal injuries with intestinal contamination have a role for reducing the rate of incisional wound infection subjected to gastrointestinal soiling. A single dose providing sufficient concentration within the wound during the vulnerable period is optimal. The other aspect of prophylactic antibiotic administration in trauma is the potential therapeutic role. The problem is to define the time period when contamination of the abdominal cavity becomes an established infection. At celiotomy, the intestinal wound is closed, eliminating further contamination and soiling of the peritoneal cavity. Thus, no further antibiotic should be necessary. Surgeons have concluded that “prophylactic antibiotics” in penetrating abdominal trauma can reduce the incidence of postoperative infectious complications. Since the mid-1970s, no study has included a placebo control group because of the high incidence of infectious complications after intestinal injury. However, many studies in the past 2 decades have compared various antibiotic regimens to evaluate single agents versus combination regimens, duration of administration, and, more recently, the pharmacokinetics and cost implications of single versus combination therapy.

Probiotics: Finding the Right Regulatory Balance

Some products marketed as drugs should be excused from Phase I trials, but safety and efficacy claims for dietary supplements should be more tightly regulated. Initial findings of the Human Microbiome Project (HMP), funded by the U.S. National Institutes of Health (NIH), raise important questions about the role and variation of microorganisms within individuals and across populations (1). One related area of growing research and commercial interest is the development and use of probiotics, substances containing live microorganisms that have a beneficial effect when taken in sufficient quantities (2) and “designed to intentionally manipulate microbiome and host properties” (3). We offer observations about the regulatory process for probiotics and potential areas for reform.

The Effect of Managed Care on Prescription Drug Costs and Benefits

This review discusses the approaches to prescription drug payment practices taken by managed care to influence drug use and costs, and presents the research evidence supporting these interventions.In the US, drugs were infrequently covered as an ambulatory benefit under fee-for-service indemnity insurance; however, health maintenance organisations almost always provide outpatient drugs and consequently have developed approaches to influence drug use and manage its costs.Managed care as a set of tools and as an organisational form is moving toward more restrictions on direct access to pharmaceuticals as a covered benefit. Options for influencing drug use and cost may address access, ingredient costs, dispensing fees and cost sharing. The formulary process is the foundation for a managed pharmacy benefit and integrates these options.The limited empirical evidence for an effect of managed care on drug costs and use is reviewed. A proposed research agenda includes evaluation of the effects of restrictive formularies, capitation, disease management and other programmes to influence the cost and use of pharmaceuticals.

Antiparkinson Drug Adherence and Its Association with Health Care Utilization and Economic Outcomes in a Medicare Part D Population

OBJECTIVES We examine the associations of adherence to antiparkinson drugs (APDs) with health care utilization and economic outcomes among patients with Parkinsons disease (PD). METHODS By using 2006-2007 Medicare administrative data, we examined 7583 beneficiaries with PD who filled two or more APD prescriptions during 19 months (June 1, 2006, to December 31, 2007) in the Part D program. Two adherence measures--duration of therapy (DOT) and medication possession ratio (MPR)--were assessed. Negative binomial and gamma generalized linear models were used to estimate the rate ratios (RRs) of all-cause health care utilization and expenditures, respectively, conditional upon adherence, adjusting for survival risk, sample selection, and health-seeking behavior. RESULTS Approximately one-fourth of patients with PD had low adherence (MPR < 0.80, 28.7%) or had a short DOT (≤ 400 days, 23.9%). Increasing adherence to APD therapy was associated with decreased health care utilization and expenditures. For example, compared with patients with low adherence, those with high adherence (MPR = 0.90-1.00) had significantly lower rates of hospitalization (RR = 0.86), emergency room visits (RR = 0.91), skilled nursing facility episodes (RR = 0.67), home health agency episodes (RR = 0.83), physician visits (RR = 0.93), as well as lower total health care expenditures (-

Recruitment of Long‐Term Care Facilities for Research

2242), measured over 19 months. Similarly, lower total expenditure (-

Policy implications of drug importation

6308) was observed in patients with a long DOT versus those with a short DOT. CONCLUSIONS In this nationally representative sample, higher adherence to APDs and longer duration of use of APDs were associated with lower all-cause health care utilization and total health care expenditures. Our findings suggest the need for improving medication-taking behaviors among patients with PD to reduce the use of and expenditures for medical resources.

Improving regulation of microbiota transplants

We report the successful recruitment of a stratified random sample of nursing homes in the state of Maryland into three research studies funded by the National Institute on Aging. These studies examine the prevalence of infections and urinary tract instrumentation and the incidence of antimicrobial use in nursing home residents. Following selection of a facility, the administrator was telephoned and a meeting at the home was requested. At this meeting, the project was explained in detail using a packet of promotional information which included a project summary, a listing of project staff and their qualifications, and letters of support from influential organizations. A total of 61 eligible facilities were contacted in order to achieve a group of 53 participating homes with approximately 5000 beds. One hundred percent cooperation was achieved from all strata except small (≤50 beds) proprietary comprehensive care facilities, and homes with both comprehensive and domiciliary beds. A direct, personal approach, backed by carefully prepared study information and the support of medical and nursing home organizations resulted in successful recruitment of 53 (87%) of 61 homes sampled.

CRITERIA TO REQUEST PHARMACOECONOMIC DATA AND DATA SOURCES FOR HOSPITAL FORMULARY DECISIONS

BACKGROUND Importation of prescription drugs into the United States has been a major health policy issue for some time. The original objective of personal importation was to allow patients to have access to drugs that were not available to them in the United States either for continuation of therapy begun in another country or when all US Food and Drug Administration (FDA)-approved drug options for their condition had been exhausted. An increasing proportion of personally imported drugs are currently marketed in the United States, but imported drugs are presumably available at a lower cost to the consumer. As US consumers opt for importation through Internet sites and other means of purchase from other countries, potential risks of exposure to counterfeit products have increased, presenting challenges to both the US regulatory system and pharmaceutical companies. OBJECTIVE This commentary summarizes the current state of importation of prescription drugs into the United States. CONCLUSIONS Regulators and policymakers are under increasing pressure to address the high cost of branded drugs in the United States and the desires of many US patients to purchase less expensive formulations of these products through importation. In many cases, the historical policies surrounding personal importation of prescription drugs that are not sold in the United States have been blatantly ignored, leaving the FDA in a quandary. While current legislative proposals would allow for greater access to drugs directly to consumers from other countries, they do not address the fact that the FDA has no ability to monitor the safety and efficacy of imported products. As such, the possibility of the entry of counterfeit medications and the related potential harm remain concerns.

A proposed definition of microbiota transplantation for regulatory purposes

Policy should balance safety, efficacy, access, and research The Human Microbiome Project and similar research has generated great interest in potential health benefits of microbiota transplantations (MTs). The use of fecal microbiota transplantation (FMT), the transfer of stool from a human donor to a human recipient, for recurrent Clostridium difficile infection (CDI) is considered by many to be standard-of-care therapy, and data on its safety and effectiveness are accumulating (1–3). Yet, although some physicians are practicing FMT using stool from donors known to the physician or patient, stool is inconsistently screened for infectious pathogens. The use of prescreened stool obtained from a stool bank and shipped to the physician is increasing, but the stool banks are not regulated. Patients who self-administer FMT using unscreened stool sourced from family or friends is also widely described. In consideration of these and other particular characteristics and challenges of MT, and the nascent regulatory landscape, we convened human microbiome researchers, legal experts, and others to explore regulatory pathways for MT (4). We believe our proposed approach is an improvement on the U.S. Food and Drug Administrations (FDA) current and proposed scheme and could provide a model for other countries that are contemplating regulatory frameworks for FMT.