Clinical effectiveness and quality of life with ranitidine vs placebo in gastroesophageal reflux disease patients: a clinical experience network (CEN) study.

BACKGROUND: Gastroesophageal reflux disease (GERD), often characterized as heartburn, is a highly common presenting complaint to family physicians. This study is the first large, prospective, nationwide family practice outpatient evaluation of the effectiveness of the histamine (H2)-receptor antagonist ranitidine as medical therapy for this disorder. METHODS: This randomized, double-blind, placebo-controlled, parallel group, 6-week study was designed to evaluate the effect of ranitidine on clinical outcomes and quality of life in patients with GERD. Eligible patients included those who were at least 18 years old and had at least a 3-month history of heartburn or heartburn therapy and a minimum of 4 days with at least one heart-burn episode in the week preceding the baseline visit. Quality-of-life effects were measured using a general health status instrument and a previously validated heartburn-specific questionnaire. RESULTS: Ranitidine treatment conferred clinically and statistically significant reductions in mean heartburn pain scores within the first 24 hours (P < or = .001) and mean number of heartburn episodes within the first 48 hours (P < or = .001). These reductions were maintained throughout the 6-week trial, during both daytime and nighttime. Compared with patients receiving placebo, patients treated with ranitidine also used significantly fewer doses of antacids (P < or = .003). Further, both ranitidine-treated patients' and their physicians' global assessments of decreases in heartburn severity, as well as clinical improvement on ranitidine, proved superior to those of controls (P < or = .001). The rate of adverse events associated with ranitidine and placebo was low and similar. Ranitidine-treated patients had more favorable scores on the general health status dimensions of physical functioning, bodily pain, and vitality (P < .05), and more favorable scores on all dimensions of the heartburn-specific questionnaire (P < .05). CONCLUSIONS: Twice-daily treatment with ranitidine 150 mg is a valuable therapy for GERD in a typical family practice setting. It reduces the frequency and severity of symptoms within the first 24 to 48 hours of treatment and diminishes the use of nonprescription antacids while improving the quality of life as measured by both a general health status instrument and a disease-specific instrument.

Pharmacotherapy specialty certification examination. IV. 1992 results and process modifications, including recertification. The 1992 Specialty Council on Pharmacotherapy, Board of Pharmaceutical Specialties.

Certification of pharmacotherapy specialists is proceeding smoothly. Modifications to the examination process, which include reapportioning domains, offering the examination at several sites, and establishing the recertification process, have occurred. The guidelines for petitioners and structure of specialization continue to receive the attention and interest of prospective candidates, pharmacy organizations, and the BPS. To date, 674 specialists have been certified in the approved specialties: 175 nuclear pharmacists, 236 nutrition pharmacists, and 263 pharmacotherapy specialists.

Diet and exercise and gemfibrozil therapy for the management of dyslipidemia: a CEN study. Clinical Experience Network.

BACKGROUND: Dyslipidemia constitutes a serious health problem that should be diagnosed and treated by the family physician. Little is known about the efficacy of typical dietary therapy for patients with abnormal cholesterol levels. This study was the first large prospective family practice evaluation of the effectiveness of diet-and-exercise therapy followed by a pharmacologic intervention for those patients who remained dyslipidemic. METHODS: Patients who met standard criteria for cardiovascular disease risk based on lipid analysis were enrolled in a typical 6-week physician-directed diet-and-exercise program. Those patients who were still dyslipidemic after that period were started on 12 weeks of pharmacologic treatment with gemfibrozil. RESULTS: Of the 2992 patients screened, 1193 were eligible for participation in the study. The diet-and-exercise program led to a modest change in lipid values (average decrease in total cholesterol of 4.1%). Only 2% of the patients achieved desirable levels of all lipid values. Seven hundred thirty-nine subjects qualified for further therapy and were treated with gemfibrozil. Seventy patients discontinued drug therapy because of adverse effects. Those who completed 12 weeks of pharmacologic therapy had an additional 5.4% reduction in total cholesterol, 3.9% reduction in low-density lipoprotein cholesterol, 30.6% reduction in triglycerides, and a 17.2% increase in high-density lipoprotein cholesterol. CONCLUSIONS: These findings suggest that in a typical clinical setting, a nonpharmacologic intervention of diet and exercise may not produce the desired overall lipid changes in the majority of dyslipidemic patients.

Antimicrobial formulary management: meeting the challenge in the community hospital.

We established a casework approach to develop an antibiotic formulary for a large community hospital. The program consists of a combination of comprehensive clinical and administrative strategies designed to reduce antimicrobial expenditures and improve the quality of antibiotic prescribing. Strategies included a background document summarizing each pharmacologic group of antimicrobial drugs and formulary preferences, presentations to medical and surgical departments, development of drug use evaluation strategies that complement the development of the formulary, and a monitoring program for nonformulary antibiotic use. The development of a customized microbiologic/antibiotic susceptibility report card specific to the institution's inpatient and outpatient microflora was an integral part of the program. This tool also allowed for the continuous compilation of comparison data and development of prescribing tips. Predetermined criteria were established providing physicians with microorganism susceptibility reports and preferred treatment alternatives linked to pharmacoeconomic concerns. These strategies can be implemented with or without direct clinical pharmacotherapy specialist involvement at the individual patient care level.

Adult immunization in a network of family practice residency programs.

A substantial proportion of morbidity and mortality associated with vaccine-preventable diseases occurs among adults. Teaching residents about disease prevention is mandated in the curriculum guidelines for family practice programs. A cooperative study among the Kansas City family practice residency programs was begun to look at immunization behaviors in these teaching programs. A retrospective audit of medical records and a prospective survey of residents and faculty were performed. From the medical records of 400 patients seen for health maintenance examinations, the frequency of tetanus-diphtheria immunizations recorded was 4.75%. The pooled immunization rate recorded for pneumococcal vaccine was 25%, and for influenza vaccine, 24%. Although 93% of respondents knew patients need tetanus-diphtheria immunization every 10 years, on a written questionnaire giving clinical examples, they were less likely to elect to immunize older patients eligible for tetanus-diphtheria vaccine. The following immunization criteria were listed by respondents: for pneumococcal vaccine, age over 65 years (86%); for influenza vaccine, age over 65 years (85%), chronic diseases (69%), residence in a chronic care facility (7%), and being a health care worker (28%). Educational interventions stressing the appropriate criteria and involvement of the patient are planned at the separate programs.

Cost-effective drug regimen review program for home health care patients.

A prospective longitudinal study of a home health agency-based drug regimen review program was completed. A consultant pharmacist working collaboratively with home health nurses and physicians reduced medication utilization and costs to homebound patients. Within a 12 month period, medication utilization in 840 homebound patients was reduced by 27%. Projected total net medication cost saving per annum was $183,379.20 (e.g., $218.31 per patient reviewed). Implementation of similar drug regimen review programs in home-health agencies could improve patient care, prevent adverse drug reactions, and achieve cost-effective medication utilization.

Endocrine metabolic emergencies.

Endocrine metabolic emergencies are common clinical entities seen by most health care professionals in acute care medicine. Except for cardiopulmonary arrest, few situations require such rapid institution of immediate drug therapy to reverse life-threatening metabolic imbalances. To safely guide patients through these situations, the physician requires a basic knowledge and familiarity with the approaches, indications, and limitations of drug therapy as a component of care.

Treatment of osteomyelitis.

The etiology, pathophysiology, and treatment of osteomyelitis are reviewed. Osteomyelitis may result from hematogenous bacterial emboli from a distant source lodging in the bone, the contiguous spread of an adjoining soft-tissue infection, or direct bacterial inoculation secondary to trauma or surgery. Hematogenous osteomyelitis most commonly occurs in children, and it usually is caused by a single organism, Staphylococcus aureus. Adults are most commonly affected by contiguous-spread osteomyelitis, and many infections occur in adults with vascular insufficiency. Staphylococcus aureus is the most common organism, but unlike hematogenous osteomyelitis, multiple organisms (including gram-negative bacteria) generally are involved. Successful treatment is predicated upon accurate classification of the disease, identification of the offending organism(s), surgical debridement if necessary, and prompt initiation of antibiotic therapy. Adults with acute osteomyelitis usually are given a penicillinase-resistant penicillin, ampicillin, or cephalosporin in doses of 8-12 g/day for four to six weeks. Carefully monitored oral drug therapy following initial injectable antibiotic therapy has been shown to be effective in children. Chronic osteomyelitis requires both surgery to remove infected tissue and high-dose injectable antibiotic therapy for four to six weeks; it is recommended that follow-up oral antibiotic therapy be continued for one to two months, or possibly as long as two years. Home antibiotic administration programs, oral antibiotic therapy, and investigational injectable antibiotics with once-daily dosing may allow patients with osteomyelitis who previously were hospitalized for prolonged periods to be treated at home in the future.

Shuttlebox avoidance in rhesus monkeys: effects on plasma cortisol and beta-endorphin.

Groups of monkeys either extensively pretrained to avoid shocks in a shuttlebox or with minimal prior experience were compared for plasma cortisol and beta-endorphin levels immediately following: (1) an exposure to the box with no shock, (2) the box providing repeated inescapable shocks or (3) a re-exposure to the box, again with no shock presentation. Mere exposure to the unfamiliar box elevated plasma cortisol just as much as exposure + shock did when inexperienced monkeys were tested. However, animals with a history of previously successful shock avoidance showed smaller elevations when exposed to the box alone, than they did when inescapable shock was received. Plasma beta-endorphin levels following shuttlebox exposure showed only a sporadic pattern of elevations in either inexperienced or pretrained monkeys. However, levels of beta-endorphin as determined under control conditions in the home cage were lower in pretrained animals, as were plasma levels of cortisol. The results indicate that behavioral factors may effect plasma cortisol and beta-endorphin following both acute and chronic shuttlebox experience.

Double-blind study to investigate methods to prevent cephalothin-induced phlebitis.

Methods which might be useful in preventing cephalothin-induced phlebitis following intravenous administration of the buffered drug were investigated. One hundred and twenty adult orthopedic patients were assigned randomly to either a control group or one of five treatment groups. The treatment regimens studied were: addition of hydrocortisone phosphate 10 mg to each liter of intravenous fluid; addition of heparin 1,000 units to each liter of intravenous fluid; addition of heparin 500 units and hydrocortisone phosphate 1 mg to each liter of intravenous fluid; addition of heparin 1,000 units and hydrocortisone phosphate 10 mg to each liter of intravenous fluid; and filtration of intravenous solutions through a 0.22-mum inline filter. All patients in the study received intravenous buffered cephalothin at a dosage of 1 g every six hours for a minimum of 48 hours. Phlebitis was assessed every 12 hours according to predetermined criteria. Significant differences were found in the incidence of phlebitis at 48 hours between the control group and the last three study groups (see above). It is concluded that postinfusion phlebitis following cephalothin administration can be reduced by the concomitant addition of heparin and hydrocortisone to the intravenous solution or by the use of an inline 0.22-mum final filter.

Pharmacist's role in management of hypertensive patients in an ambulatory care clinic.

A program involving a pharmacist in the management of ambulatory hypertensive patients is discussed. A hypertension monitoring protocol was developed by a physician and a pharmacist. The protocol provided for initial patient assessment and treatment by the physician, counseling and education of the patient by the pharmacist, patient follow-up by the pharmacist every one to two months and follow-up by the physician every four to six months. In the first four months of the program, 28 of 75 newly diagnosed hypertensive patients were referred by the physician to the pharmacist for follow-up.