Health and disease management: what is it and where is it going? What is the role of health and disease management in hypertension?

Health and disease management, a clinical improvement process that integrates best practice principles in a comprehensive manner throughout the entire continuum of care, is likely to be the dominant style of health care delivery in the future. The goal of these programs is to eliminate or reduce unacceptable variations in cost and quality between various providers by developing guidelines that will achieve measurable outcomes for specific diseases. These protocols also emphasize wellness and disease prevention, coordinate resources across the entire continuum of care, and define interventions for the entire duration of the disease. Conditions most suited to this management strategy include diseases that are of high volume and cost, complex to manage, and present chronically over a long period of the patient's life. Such programs are developed by a multidisciplinary team that is also charged with obtaining buy-in and championing the program to their peers. Among the many components of a comprehensive health and disease management program, intensive education for patients and families and altering physician behavior to obtain compliance are key areas on which to focus. Hypertension is an ideal condition to manage in this way. It is frequently the most common reason for patients to be seen by a primary care provider, is an expensive disease to treat, and is an important cause of major organ damage from inadequate treatment. Successfully adopting a disease management model for hypertension treatment that will integrate all health care providers and offer intensive education of patients and providers to encourage adherence to the highly effective therapies currently available should afford a major opportunity for a dramatic reduction in complications and costs, with enhanced clinical outcomes and quality of life for these patients.

Disease management: partnering for better patient care.

Disease management is having a profound effect on the evolution of health care delivery toward an integrated system. Management strategies include coordinating professional services, empowering patients, and analyzing outcomes data. The managed care approach to disease management has expanded, to some degree, across all models of HMOs in an effort to document cost-containment efforts and improved outcomes. Pharmaceutical manufacturers and pharmacy benefit management companies are highly active in developing programs. The author discusses 10 steps toward implementing a successful disease management program through partnering with other organizations.

Health care informatics: the key to successful disease management.

Health services integration and disease state management (DSM) require improved health care informatics systems. Accurate, comprehensive patient information and an integrated data infrastructure are needed for all stages of DSM, from development and implementation of programs to evaluation and continuous program improvement. The lack of an integrated information infrastructure is one of the leading obstacles to achieving a comprehensive electronic patient data system. This article examines initiatives underway to make the computer-based patient record a reality.

Stability of cefpirome sulfate in the presence of commonly used intensive care drugs during simulated Y-site injection.

The stability of cefpirome sulfate during simulated Y-site injection with drugs commonly used in the intensive care unit was studied. Cefpirome sulfate was constituted and diluted to 50 mg/mL with 0.9% sodium chloride injection, 0.45% sodium chloride injection, 5% dextrose injection, and lactated Ringer's injection. Each cefpirome sulfate solution was mixed 1:1 (simulating Y-site injection) with amikacin 5.0 mg/mL (as the sulfate salt), amphotericin B 0.1 mg/mL, cefazolin 10 mg/mL (as the sodium salt), clindamycin 12.0 mg/mL (as the phosphate ester), dexamethasone phosphate 4.0 mg/mL (as the sodium salt), dopamine hydrochloride 0.8 mg/mL, epinephrine 0.1 mg/mL (as the hydrochloride salt), fluconazole 2.0 mg/mL, gentamicin 1.0 mg/mL (as the sulfate salt), and vancomycin 5.0 mg/mL (as the hydrochloride salt). All the drug combinations were prepared in triplicate and maintained at 23 degrees C. The combinations were observed visually at intervals up to eight hours, pH was measured, and samples were tested for drug concentration by high-performance liquid chromatography. Cefpirome was stable in the presence of each of the secondary drugs throughout the study period. All the secondary drugs except amphotericin B were stable in the presence of cefpirome. There were no visual phenomena indicating incompatibility. Changes in pH were minimal. Cefpirome 50 mg/mL (as the sulfate salt) in four different diluents was stable in the presence of each of 10 commonly used intensive care drugs for at least eight hours during simulated Y-site administration. Amphotericin B 0.1 mg/mL was not stable in the presence of cefpirome sulfate.

Stability of ramipril in water, apple juice, and applesauce.

The stability of ramipril in water, in apple juice, and in applesauce was studied. The contents of a single capsule each of ramipril 1.25, 2.5, and 5 mg were mixed in glass beakers with 120 mL of deionized and filtered water, apple juice, or applesauce. Each mixture was apportioned into 10 120-mL amber polyethylene terephthalate (PET) containers. Five of the containers in each set were stored at 23 degrees C, and samples were taken at 0, 1, 2, 6, 12, and 24 hours. The other five containers were stored at 3 degrees C, and samples were taken at 4, 8, 12, 24, and 48 hours. The samples were analyzed for ramipril concentration by stability-indicating high-performance liquid chromatography (HPLC). The quantity of drug remaining in the PET container after "administration" was determined by mixing the contents of single 5-mg ramipril capsules with 60 mL of apple juice, pouring the mixture into a waste receptacle, rinsing the PET container three separate times with 10 mL of water, and analyzing the pooled fluid from these rinses for ramipril concentration by HPLC. Under no condition did the percentage of ramipril remaining drop below 90%. No peaks for degradation products appeared in the chromatograms. The mean +/- S.D. quantity of ramipril remaining in the PET containers after draining was 0.3 +/- 0.3% for the apple juice. Ramipril from 1.25-, 2.5-, and 5-mg capsules mixed in water, in apple juice, and in applesauce was stable for 24 hours at 23 degrees C and for 48 hours at 3 degrees C.

Stability of cephalexin monohydrate suspension in polypropylene oral syringes.

The stability of cephalexin monohydrate suspension in plastic oral syringes was studied. Commercially available cephalexin monohydrate powder for oral administration was reconstituted according to the manufacturer's instructions and stored in the original containers or drawn into 5-mL clear polypropylene oral syringes. The original containers and syringes were divided into groups and stored at -20, 4, 25, 40, 60, or 80 degrees C. Powder from two additional lots was similarly reconstituted and packaged; these original containers and syringes were stored at 80 degrees C only to assess interlot variability. Immediately after reconstitution and at specified times during storage, three syringes and the corresponding three original containers stored at each temperature were removed, and their contents were analyzed for cephalexin concentration using the standard USP iodometric assay for antibiotics. The stability-indicating nature of the assay was documented. Cephalexin monohydrate followed a first-order rate of degradation at temperatures of 40, 60, and 80 degrees C. At temperatures of -20, 4, and 25 degrees C, cephalexin monohydrate exhibited no appreciable degradation during the 90-day study period. Cephalexin monohydrate suspension reconstituted from powder as a suspension and repackaged in clear polypropylene oral syringes was stable for 90 days when stored under ambient, refrigerated, and frozen conditions.

Stability of dicloxacillin sodium oral suspension stored in polypropylene syringes.

The stability of dicloxacillin sodium in oral suspension stored in clear polypropylene oral syringes was studied. Commercially available dicloxacillin sodium powder for oral suspension from a single lot was reconstituted according to the manufacturer's instructions and drawn into 5-mL clear polypropylene oral syringes. The syringes were divided into groups and stored at -20, 4, 25, 40, 60 or 80 degrees C. Two additional lots were similarly reconstituted, repackaged, and stored at 80 degrees C only to assess interlot variability. Powder in the original containers was similarly reconstituted according to the manufacturer's instructions, and the containers were divided into groups and stored with the syringes. Immediately after reconstitution and at specified times during storage, three syringes and the original containers at each storage temperature were removed, and their contents were analyzed for dicloxacillin sodium concentration using the Standard USP Iodometric Assay. Dicloxacillin sodium follows a first-order rate of degradation at temperatures of 40, 60, and 80 degrees C. The rate of degradation changes to a zero-order process at temperatures of 25, 4, and -20 degrees C. At all temperatures, degradation occurred more rapidly when the drug was repackaged into unit dose polypropylene oral syringes than in the manufacturer's original container. Dicloxacillin sodium reconstituted from powder as oral suspension and repackaged in clear polypropylene syringes was stable for no longer than 7, 10, and 21 days when stored under ambient, refrigerated, and frozen conditions, respectively.

Stability of ampicillin trihydrate suspension in amber plastic oral syringes.

The stability of ampicillin trihydrate oral suspension stored in amber plastic oral syringes was studied. Commercially available ampicillin trihydrate powder for oral suspension was reconstituted according to manufacturer's instructions and drawn into 5-mL amber polypropylene plastic oral syringes. The syringes were divided into groups and stored at -20, 4, 25, 60, or 80 degrees C. Powder from two additional lots was similarly reconstituted and packaged and stored at 80 degrees C only to assess interlot variability. Immediately after reconstitution and at specified times during storage, three syringes at each storage temperature were removed and their contents analyzed for ampicillin trihydrate concentration by a spectrophotometric assay. Samples stored at frozen (-20 degrees C) or refrigerated (4 degrees C) temperature retained at least 90% of the initial ampicillin concentration throughout the 47-day study period. Samples stored at room temperature retained at least 90% of the initial ampicillin concentration for 30 days and exhibited an apparent zero-order degradation rate. Samples stored at heated temperatures (60 and 80 degrees C) exhibited an apparent first-order degradation process, with the concentration of ampicillin decreasing to less than 90% of initial concentration within two hours. Reconstituted ampicillin trihydrate powder for oral suspension is stable for at least 30 days when stored at room, refrigerated, or frozen temperature in the amber plastic oral syringes studied. The expiration dates recommended by the manufacturer for ampicillin trihydrate suspension stored in its original container can also be used for reconstituted suspension stored in these amber plastic syringes.

In vitro and in vivo characteristics of some commercial phenobarbital tablets.

Using an incompletely randomized crossover study design, the oral bioavailability characteristics of 7 different brands of phenobarbital tablets, USP, 100 mg was investigated in 5 adult, male volunteers. From plasma drug concentration-time data, best estimates for the bioavailability parameters of peak plasma phenobarbital concentration (Cmax) and time to peak concentration (tmax) were obtained by curve fitting and area under the plasma drug concentration-time curve (AUC) computed with the trapezoid rule. No significant difference in Cmax or normalized AUC was seen for the 7 products investigated. Additionally, a difference in tmax was observed between 2 preparations (A and E) only (p less than or equal to 0.05). All drug products met USP requirements for weight variation and tablet disintegration and all but one product (D) exhibited reasonably good and similar dissolution characteristics in simulated gastric fluid. No correlation between various in vitro dissolution parameters and in vivo bioavailability of phenobarbital could be found for the 7 phenobarbital products studied.