Q and A from the Pharmaceutical Care Project in Minnesota.
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Drug Monitoring↗
Biomedical subjects
L M Strand
Publications and source records attributed to L M Strand.
Levels of pharmaceutical care: a needs-based approach.
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Humans↗
Drug-related problems: their structure and function.
In order to better focus the role of the pharmacist on patient need and patient outcome, a means of categorizing drug-related problems (DRPs) is presented. A DRP exists when a patient experiences or is likely to experience either a disease or symptom having an actual or suspected relationship with drug therapy. Eight different categories of DRPs are described and examples of each category are offered. This categorization serves a number of functions, such as: (1) to illustrate how adverse drug reactions form but one category of extant DRPs, (2) to make tangible the pharmacist's role for the future, (3) to serve as a focus for developing a systematic process whereby the pharmacist contributes significantly to the overall positive outcome of patients, (4) to bring to pharmacy practice a vocabulary consistent with that of other healthcare professionals, and (5) to aid in the development of standards of practice for pharmacists.
Diagnostic Errors↗
Opportunities and responsibilities in pharmaceutical care.
Pharmacy's opportunity to mature as a profession by accepting its social responsibility to reduce preventable drug-related morbidity and mortality is explored. Pharmacy has shed the apothecary role but has not yet been restored to its erst-while importance in medical care. It is not enough to dispense the correct drug or to provide sophisticated pharmaceutical services; nor will it be sufficient to devise new technical functions. Pharmacists and their institutions must stop looking inward and start redirecting their energies to the greater social good. Some 12,000 deaths and 15,000 hospitalizations due to adverse drug reactions (ADRs) were reported to the FDA in 1987, and many went unreported. Drug-related morbidity and mortality are often preventable, and pharmaceutical services can reduce the number of ADRs, the length of hospital stays, and the cost of care. Pharmacists must abandon factionalism and adopt patient-centered pharmaceutical care as their philosophy of practice. Changing the focus of practice from products and biological systems to ensuring the best drug therapy and patient safety will raise pharmacy's level of responsibility and require philosophical, organizational, and functional changes. It will be necessary to set new practice standards, establish cooperative relationships with other health-care professions, and determine strategies for marketing pharmaceutical care. Pharmacy's reprofessionalization will be completed only when all pharmacists accept their social mandate to ensure the safe and effective drug therapy of the individual patient.
Costs and Cost Analysis↗
Integrated patient-specific model of pharmacy practice.
The deficiencies of traditional models for the provision of clinical pharmacy services are discussed, and a patient-specific model that integrates drug distribution and clinical pharmacy functions is proposed. Traditional models have either designated specific individuals as providers of clinical pharmacy services or have combined distributive and supportive services with clinical services. In both cases, clinical services have been of secondary importance. Such models have resulted in inconsistent clinical services for which the patient is not necessarily the primary focus and have made it difficult for pharmacists to understand their mission. The lack of a well-defined primary clinical role for pharmacists has confused health-care providers and created problems for managers attempting to evaluate pharmacists and justify clinical services. The integrated patient-specific model is based on the ethical imperative that the patient must be central to any health-care endeavor. Under this model, clinical pharmacy services are of central importance and distributive services are integrated as a secondary but still very important aspect of comprehensive institutional pharmacy services. Critical elements of the integrated model include a patient-centered philosophy of practice, a definition of clinical pharmacy work, and a managerial framework. The integrated patient-specific model of pharmacy practice puts pharmacists in a professional relationship with patients and explicitly defines clinical services and priorities.
Institutional Practice↗
Isotretinoin therapy for acne: a population-based study.
The use of isotretinoin over a 2-year period was retrospectively studied in Saskatchewan. The database of the Saskatchewan Prescription Drug Plan was used to obtain the names of physicians who prescribed isotretinoin as well as the names of patients for whom it was prescribed. Of the 861 such patients 161 had been instructed to use the drug for at least 4 months by 42 physicians. Questionnaires were returned by 86 of the 161 patients and 22 of the 42 physicians. The responses confirmed that isotretinoin therapy is highly effective for acne. However, at least half of the patients for whom the agent was prescribed apparently did not complete a full 4- to 5-month course of treatment, and of the 34 women (average age 28 years) who responded to the questionnaire 12 (35%) did not use a method of contraception, which is a matter of concern in view of isotretinoin's teratogenic effects.
Acne Vulgaris↗
Fatal upper gastrointestinal hemorrhage or perforation among users and nonusers of nonsteroidal anti-inflammatory drugs in Saskatchewan, Canada 1983.
We report a cohort study of fatal upper GI hemorrhage and/or perforation in relation to use of nonsteroidal anti-inflammatory drugs (NSAIDs) among the one million residents of Saskatchewan Canada in 1983. All hospitalized cases of GI hemorrhage and/or perforation with a fatal outcome were identified using the records linkage system of the Saskatchewan Department of Health. Discharge summaries and autopsy records were reviewed to select the cases of upper GI hemorrhage or upper GI perforation and to exclude cases in which known risk factors were present. The 134,060 residents who filled one or more prescriptions for an NSAID in 1983 were identified and individually linked to their hospital records by patient identification number. The age- and gender-specific incidence of fatal upper GI hemorrhage and/or perforation in the absence of risk factors in users was compared to that in nonusers, controlling for recent history of upper GI disease. Fatal upper GI hemorrhage or perforation in temporal association with NSAIDs is extremely rare in persons younger than 75 years of age. No temporally-related cases occurred in male NSAID users age 75 and older, but NSAID usage in this group was limited. Among women age 75 and older, the rate in users was higher than in nonusers, with the highest rate being in female NSAID users age 75 and older with a recent history of upper GI disease. Total mortality among women age 75 and older was slightly lower among users than among nonusers. Physicians who prescribe NSAIDs to patients age 75 and older should be aware of the potential risks, particularly in those with predisposing factors such as a history of upper GI disease.
Adult↗
Documenting the clinical pharmacist's activities: back to basics.
The profession of pharmacy has applied the term "documentation" to count activities that more closely approximate descriptive protocols or administrative reports. This extended nonclinical use of the term documentation has resulted in the profession losing sight of a necessary step in the development, justification, and successful implementation of clinical pharmacy services. An instrument that helps to standardize the documentation of a clinical pharmacist's database, patient-care activities, and therapeutic plans is presented. This process, the pharmacist's workup of drug therapy (PWDT), consists of the following six interrelated steps: (1) establish a comprehensive patient-specific database; (2) identify patient-specific, drug-related problems; (3) describe desired therapeutic outcomes; (4) list all therapeutic alternatives that might produce the desired outcomes; (5) select the drug recommendation(s) that most likely will result in the desired outcomes; and (6) establish a plan for therapeutic drug monitoring that documents that desired effects occur and undesired effects are minimized. A formative method of documenting the clinical pharmacist's activities such as the PWDT must be functional on a daily basis in order to generate meaningful summative management reports.
Documentation↗
Functional and structural prerequisites for clinical pharmacy services.
Pharmacy directors and pharmacists in charge of clinical services at 46 medium-sized hospitals were surveyed to identify possible explanations for previously documented inconsistency in the implementation of clinical pharmaceutical services. There were three study objectives: to determine the extent to which basic structural and functional management prerequisites have been implemented at these institutions; to determine whether a relationship exists between the kind and number of clinical services offered and implementation of these prerequisites; and to identify discrepancies between responses of the pharmacy director and the pharmacist in charge of clinical services at the same hospital to the same questions. One hundred hospitals providing clinical pharmaceutical services were randomly selected from a master list of 190 hospitals that had been grouped into nine geographic areas. Of 17 functional and structural prerequisites studied, 4 to 13 of them had been implemented at the hospitals surveyed. Only 24% of the hospitals had implemented the basic functional prerequisites of unit dose drug distribution and decentralized pharmaceutical services. Of nine clinical pharmaceutical services, one to eight were being delivered. A weak correlation between the number of prerequisites implemented and the number of clinical services provided was found. Significant disagreement was found between the directors and their pharmacists about which prerequisites and clinical services were being implemented. This pilot study suggests that pharmacy directors and clinical pharmacists need to assess how effectively basic management prerequisites are being put into practice in the delivery of clinical pharmaceutical services.
Medication Systems, Hospital↗
Intrapatient variation in aminoglycoside disposition in cystic fibrosis.
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Adolescent↗
Cost comparison of two systems for intermittent intravenous administration of small-volume injections.
Pharmacy department costs for preparing and administering intermittent i.v. drug doses using a piggyback bottle system and a syringe pump system were predicted and compared. Centralized i.v. admixture service personnel time for preparation of small-volume injections in piggyback bottles was recorded for 14 days. After a four-week orientation of personnel to the syringe pump system, personnel time for preparation of doses in this system was recorded for 14 days. Material costs were itemized for each system and annual costs were predicted. Costs were calculated on the basis of the previous year's purchasing data, assuming that 80% of intermittent i.v. drug doses could be given by the syringe pump system. Syringe pump system costs were calculated for administration of one to eight drug doses through each secondary infusion set; 5-mL and 10-mL syringes were used. Preparation time was slightly longer for the syringe pump system than for the piggyback bottle system; the annualized personnel cost difference was $0.012 per dose. Based on one dose per secondary infusion set, material costs were higher for the syringe pump system. Based on administration of four doses through each secondary infusion set, overall costs were lower for the syringe pump system. Lower material acquisition costs for the syringe pump system could result in pharmacy department cost savings if at least four intermittent i.v. drug doses were administered through each secondary administration set.
Costs and Cost Analysis↗
Two approaches to cost containment in hospital pharmacy.
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Cost Control↗
Wide interpatient variations in gentamicin dose requirements for geriatric patients.
Substantial interpatient variations were demonstrated in the daily doses required to obtain therapeutic gentamicin sulfate serum concentrations in 417 elderly patients. Dosages ranged from 0.3 to 22.0 mg/kg/day in patients with a normal serum creatinine level. Twenty-five percent of these patients required daily doses higher than the standard regimen of 5 mg/kg/day, and 33% required less than 3 mg/kg/day. The drug half-lives in these patients ranged from 0.3 to 32.7 hours, compared with previous reports of 2.5 to four hours. The distribution volumes of these patients ranged from 0.07 to 0.53 L/kg, compared with reported values of 0.20 to 0.25 L/kg. These wide variations in kinetic variables in elderly patients and the need to obtain narrow ranges in serum concentrations required measuring serum concentrations and individually calculating each patient's dosage requirement early in the treatment course. Doing this consistently produced optimal peak and trough serum levels. Ototoxicity did not occur in any of the patients, and nephrotoxicity may have been drug related in 2% of the elderly patients.
Aged↗
Gentamicin dosing errors with four commonly used nomograms.
Four methods for calculating gentamicin sulfate dosage requirements were evaluated in 96 patients and compared with an individualized method. The pharmacokinetic parameters of gentamicin were determined from serum concentration time data and used to calculate individualized dosage regimens. Doses were determined in each patient using the "predictive methods" (Sarubbi-Hull, Dettli, "rule of eights," and Chan). Resultant serum concentrations were calculated from doses arrived at by each method. These dosing methods resulted in a large proportion of patients with subtherapeutic or potentially toxic concentrations, or both. The Dettli and Chan methods produced therapeutic concentrations in more patients than the Sarubbi-Hull and rule of eights methods. Desired therapeutic concentrations were attained in significantly more patients with the individualized method than with the predictive methods, and, in addition, larger doses were required. The use of predictive dosage methods should be followed with serum concentration determinations and dosage adjustment to ensure therapeutic concentrations early in treatment.
Adolescent↗
Saliva-serum theophylline concentrations: substantial intrapatient and interpatient variation in predicting serum concentrations.
The relationships between serum and saliva concentrations were evaluated in 18 patients after single doses of three theophylline preparations. Simultaneous multiple saliva and serum samples were obtained after theophylline ingestion and were analyzed for theophylline content by the modified Schack and Waxler spectrophotometric method. Significant variability was observed in the data for those saliva/serum ratio sets obtained within 30 min of dosage. The mean correlation coefficient for saliva/serum sample sets obtained at and after 30 min was 0.86. Pearson product moment correlation coefficients determined for saliva/serum ratios at 2,4,6, and 8 hr ranged from 0.84 to 0.89, leaving 26% of the variance unexplained. Serum concentrations were calculated from a randomly selected saliva/serum ratio for each patient. Predicted serum concentrations were +/- 2 micrograms/ml of measured concentrations in only 143 of the 196 determinations (73%). Therefore, the use of saliva concentrations to predict serum values has substantial error in specific patients and may lead to incorrect dosage adjustments.
Adult↗
Cost of developing a computerized drug file.
The personnel time and costs involved in manually developing a master drug file are described. This system was designed independently by the pharmacy personnel of a 550-bed medical center to support the computer programs for drug purchasing, inventory control, outpatient services, i.v. admixture services, and pharmacy management reports. The master drug file was created to contain data on every drug and nondrug line item used in the pharmaceutical services of the medical center. The process of manually developing the drug file and entering the data into the computer system required six weeks, 732 pharmacy staff hours, 120 hours of supervision by administrative pharmacy personnel, 50 hours of program planning and organization of computerized programs, and cost a total of $8451. The drug file contains 1138 drug formulary line items; 0.88 hours were consumed per line item, at a development cost of $7.43 per line item. Although a commercially available drug file could have provided 35,000 records at half the cost, it was concluded that the independent development of the master drug file was justified in terms of meeting this medical center's specific information needs.
Computers↗
Determination of theophylline bioavailability using saliva theophylline concentrations.
Substantial error occurs when individual saliva theophylline concentrations are used to predict serum theophylline concentrations. However, the use of saliva theophylline concentrations to determine product bioavailability has never been evaluated. Subjects in this study were 18 stable patients (20-51 yr) with a history of chronic obstructive pulmonary disease. Three preparations--a capsule (Elixophyllin 400 mg), elixir (Elixophyllin 373 mg), and tablet (Theolair 375 mg)--were administered in a randomized crossover design. Serum and saliva samples were obtained pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 8 hours after theophylline administration. The saliva AUC0-infinity and serum AUC0-infinity were highly associated for the elixir (r = 0.84) tablet (r = 0.89), and capsule (r = 0.89). The bioavailability of the tablet and capsule calculated from elixir saliva and elixir serum AUC0-infinity were not significantly different (p = 0.2). The bioavailability of the tablet calculated from saliva and serum was 93% and 102%, respectively. The bioavailability of the capsule calculated from saliva and serum was 113% and 102% respectively. Our data suggests that theophylline bioavailability can be reliably estimated from saliva theophylline concentrations. However, study designs that include larger sample sizes and more frequent sampling may be necessary when determining bioavailability from saliva.
Adult↗
Practice functions necessary for the delivery of pharmaceutical care.
Pharmaceutical care is a concept outlining the responsibilities of individual pharmacists to individual patients. Although widely accepted on a philosophical basis, there is a lack of comprehensive information about the functions and responsibilities pharmacists undertake when providing pharmaceutical care. Pharmacy educators and practitioners at the faculty of pharmacy, University of Toronto, developed and informally tested a process that details the practice functions required of pharmacists when providing pharmaceutical care as originally defined.
Humans↗