OBJECTIVE:To compare point-of-care (POC) glycosylated hemoglobin (A1C) and random plasma glucose (RPG) as a POC screening tool for prediabetes and diabetes in migrant farm workers of eastern North Carolina.DESIGN:Prospective, observational, single-center study.SETTING:Federally qualified community health center in eastern North Carolina, from August to October 2011.PARTICIPANTS:Migrant farm workers 18 years or older who resided in a migrant camp in eastern North Carolina.INTERVENTION:Diabetes screening using POC A1C and RPG via fingerstick followed by venipuncture A1C and basic metabolic panel in individuals with a positive screening.MAIN OUTCOME MEASURES:Positive predictive value (PPV) of POC A1C and RPG, incidence of positive screening, incidence of confirmed diagnosis, concordance rate of the screening tools, and correlation between POC A1C and laboratory A1C.RESULTS:206 workers participated in the screenings; screening identified 39 individuals with a POC A1C greater than 5.7% and 1 individual with both an RPG of 200 mg/dL or more and a POC A1C greater than 5.7%. Of the 39 individuals found to have a positive screening, 24 presented to Carolina Family Health Centers, Inc., for follow-up venipuncture; however, 1 participant did not have a venipuncture A1C, leaving 23 individuals with complete data. Two participants were diagnosed with diabetes and 17 with prediabetes. POC A1C had a PPV of 82.6%; however, the PPV of RPG could not be calculated due to the number of participants lost to follow-up. POC A1C correlated well with laboratory A1C regardless of time to follow-up.CONCLUSION:POC A1C should be considered for diabetes screening in high-risk populations. If the screening had been performed with RPG alone, 38 individuals would have gone undetected. Early identification of individuals with elevated blood glucose will likely decrease the risk of long-term complications.
OBJECTIVE To summarize the start-up experience with patients identified as eligible during the first four quarters of the Iowa Pharmaceutical Case Management (PCM) program and to characterize the extent of the services proved by pharmacists in the program. DESIGN Prospective pharmaceutical care intervention project. SETTING One hundred seventeen community pharmacies in Iowa. PATIENTS Medicaid patients at high risk for drug-related problems based on using 4 or more nontopical medications and having 1 of 12 specific disease states. INTERVENTION To become eligible to provide PCM services, licensed pharmacists had to undergo training and submit five care plans to the Iowa Department of Human Services. Community pharmacists were provided names of newly eligible patients each calendar quarter for 1 year. For each patient, pharmacists were asked to indicate by fax whether they had met with the patient, performed a written work-up of the patient, sent recommendations to the patient's physician, and whether the physician replied. When pharmacists were unable to provide the service, they were asked to state the reason. Both the pharmacist and the physician receive $75 for the initial assessment, with additional payments after each follow-up visit performed. MAIN OUTCOME MEASURES An intensity score and the percentage of eligible patients for whom all steps were completed were calculated for each pharmacy. RESULTS Fax survey results were returned for 2,834 (96.7%) of the 2,931 patients eligible for PCM services. Pharmacists met with 943 (33.3%), worked up 763 (26.9%), sent recommendations to physicians for 500 (17.6%), and received replies from physicians for 327 (11.5%) patients. Pharmacists were unable to provide PCM services for 1,891 (66.7%) patients. The primary reasons given for this inability to provide services were patient access issues for 438(23.2%) patients, pharmacy staffing or start-up issues for 419(22.2%) patients, or no reason specified for 575(30.4%) patients. A PCM intensity score was developed to represent the scope of services provided and the number of patients served. A higher intensity score indicated pharmacies that provided PCM to more patients and/or that offered higher levels of care (e.g., provided a written set of recommendations to the physician rather than simply assessing the patient without preparing or sending recommendations). Future evaluations will determine the validity of the score on the basis of patient outcomes. CONCLUSION Some pharmacies implemented PCM services very effectively. However, 40% to 60% of the pharmacies provided little or no PCM services within 3 months of notification of patient eligibility. Future investigations will evaluate the quality of prescribing and quality of life for patients who received PCM services.
OBJECTIVES To develop guidelines for the documentation elements that need to be included in any record of pharmacist-provided care to allow the quality of the care to be assessed and to describe the use of these guidelines to improve the quality of pharmacist documentation. DESIGN An initial list of 85 potential documentation elements, developed through a review of the literature, was validated by a group of pharmacy practitioners. Then, through three rounds of a Delphi process and a group meeting, a panel of experts reached consensus on a refined list of 27 documentation data elements. RESULTS The documentation elements were formatted into a one-page Tool for Evaluation of Documentation (TED). The TED is a checklist for assessing the completeness of the documentation of pharmacist-provided care. CONCLUSION The TED and the consensus-building methodology used in the development of this tool can serve as cornerstones of a quality assessment process for documentation of pharmacist-provided care, enable further assessment of the quality of care, and, ultimately, be used to measure the impact of pharmacist-provided care on patient outcomes. Our results should provide guidance both to pharmacists providing care and to organizations that assess the quality of that care.
OBJECTIVETo demonstrate whether a community pharmacist can be successful in identifying and referring patients with elevated blood pressure and/or increased risk of stroke.SETTINGAn independent community pharmacy and well-elderly housing facility in rural Iowa.PRACTICE DESCRIPTIONThe pharmacy had dedicated space for patient care activities, had a community pharmacy practice resident, and served as a clerkship site for a local school of pharmacy. One of three well-elderly housing facilities in the same community was used as a screening site for the stroke prevention program.PRACTICE INNOVATIONAll adults entering the pharmacy duringthe time the blood pressure project was underway were offered a free blood pressure screening. If readings were elevated, patients were referred to their primary care provider. For stroke prevention, a screening using the American Heart Association stroke risk assessment protocol was held at the pharmacy and the well-elderly housing facility.MAIN OUTCOME MEASURESBlood pressure categories and stroke risk (normal, mild, moderate, and high) categories obtained during the screening.RESULTSA total of 351 patients werescreened for hypertension. Of these, 216 (62%) had readings greater than 140/90 mm Hg. Of the 121 patients referred to their physician, 43 (36%) had a regimen change. A total of 50 patients were screened for stroke risk. Results of the risk assessments for patients screened were normal, 4%; mild, 26%; moderate, 32%; high, 38%.CONCLUSIONThese projects demonstrated that, through ongoing screening programs, community pharmacists are in an ideal position to screen patients at risk for cardiovascular and cerebrovascular disease and refer patients to their physicians for further evaluation.
OBJECTIVES:To present current information about trends development and marketing of over-the-counter (OTC) medications and dietary supplement products and describe new products, delivery systems, home monitoring devices, and home accessories in these markets that are likely generating questions from or posing potential problems for patients.DATA SOURCES:Recently published clinical and pharmaceutical industry literature.STUDY SELECTION:By the authors.DATA EXTRACTION:By the authors.DATA SYNTHESIS:Last year witnessed the first effort of the Food and Drug Administration (FDA) to remove a dietary supplement from the U.S. market. Ephedra, because of its imminent danger when used for weight reduction and athletic enhancement, was the target of FDA action. FDA has issued a final rule implementing this ban, which prohibits the sale of dietary supplements containing ephedrine alkaloids (e.g., ephedra). Two newer diet-aid products are being actively promoted with little or no safety and effectiveness data. Thus, pharmacist's vigilance is important along with sensible advice on how to lose weight safely and effectively. Further, two independent organizations have created certification programs for dietary supplements that ensure product purity, active ingredient strength, and compliance with good manufacturing practices. In addition, through recent changes in federal legislation, consumers are now able to obtain reimbursement for their nonprescription purchases through flexible spending accounts. Information is presented in this article about selected products in these OTC, home care, and dietary supplement categories: heartburn (proton pump inhibitors), allergy (second-generation antihistamines), constipation (laxatives), diabetes mellitus (blood glucose monitoring systems), home testing (fertility monitoring), nicotine addiction (smoking cessation products), otic disorders (ear syringes), contraceptives and sexual aids (condoms and lubricants), and dermatology (wart removal).CONCLUSION:Patients continue to increase their reliance on self-care. To assist them, pharmacists must remain up-to-date on trends and have an understanding of the nuances of consumers' behavior and thinking in relation to OTC products and their use.
OBJECTIVES:To discuss the current procedures and processes by which viral safety is ensured for intravenous immunoglobulins (IVIGs), to place in context the current increase in clinical indications for IVIGs, and to describe the safety issues that have led to product shortages.DATA SOURCES:Articles on viral safety retrieved from MEDLINE using the search terms gamma globulin, intravenous, adverse reaction, and infection and information from the manufacturers' literature and Food and Drug Administration package inserts.STUDY SELECTION AND DATA EXTRACTION:Studies that specifically addressed the areas of major concern or advancement in viral safety of IVIGs, including donor selection, plasma screening, and other quality control procedures to ensure safety of source plasma; detection of viruses that may have escaped antibody screening tests through the use of polymerase chain reaction-based assays, which are capable of detecting small amounts of viral genomic material (e.g., hepatitis C virus, hepatitis B virus, and human immunodeficiency virus [HIV]) in small plasma pools; and industrial-scale, validated viral inactivation methods, such as pasteurization and solvent/detergent treatment, that have been incorporated into the manufacturing processes of immunoglobulins to further minimize the risk of viral transmission.DATA SYNTHESIS:In addition to the treatment of primary immunodeficiency disorders, the clinical uses of IVIGs have expanded to include treatment of Kawasaki's syndrome, idiopathic thrombocytopenic purpura, infection following bone marrow transplantation, secondary immunologic disorders (e.g., pediatric HIV infection), hematologic disorders (e.g., chronic lymphocytic leukemia), and neurologic indications (e.g., Guillain-Barré syndrome). Although IVIG preparations are derived from human plasma, they have a long safety record and a low risk for transmitting viral infections.CONCLUSION:Viral validation studies demonstrated that the processes discussed herein differ in their capabilities to inactivate lipid-enveloped and nonlipid-enveloped viruses.
OBJECTIVE To develop a questionnaire for measuring patient satisfaction with pharmaceutical care and to establish its factorial composition. DESIGN Single intervention, noncomparative, 20-item self-administered questionnaire. SETTING Iowa. PARTICIPANTS Seven hundred seventy-five prescription patrons of eight community pharmacies whose pharmacists had received training in pharmaceutical care but who had not yet implemented it. INTERVENTIONS An instrument originally developed to measure patient satisfaction with traditional community pharmacy services was modified to focus on the elements of pharmaceutical care. This revised questionnaire was mailed to participants. MAIN OUTCOME MEASURES Participant responses to items in the questionnaire. RESULTS The survey response rate was 55%. Factor analysis and item analysis identified two dimensions of pharmaceutical care. We labeled the dimensions Friendly Explanation (including items related to friendliness of care, the setting of care, and medication counseling) and Managing Therapy (items dealing with the concept of pharmaceutical care-managing drug therapy and solving therapy problems). Respondents scored items on the Managing Therapy scale lower than they did items on the Friendly Explanation scale. The scales were highly correlated. Two other hypothesized dimensions of care-Consideration/Caring Relationships and Setting-were subsumed in the final scale of Friendly Explanation. CONCLUSION The instrument provides information on patients' satisfaction with two dimensions of pharmacy services. The instrument may be useful to practicing pharmacists, but it should be used cautiously until it is tested among patrons of pharmacies known to provide different levels of care.
Increased access to sterile syringes has been shown to reduce HIV risk among people who inject drugs (PWID). Where syringe services programs (SSPs) are limited, pharmacies are an important sterile syringe source. We assessed factors associated with using pharmacies as the primary source of syringes among PWID from 20 US cities.PWID ages ≥18 years were recruited for the 2015 National HIV Behavioral Surveillance using respondent-driven sampling. Using generalized estimating equation (GEE) models, we assessed demographic characteristics independently associated with participant-reported primary syringe source: pharmacies vs. SSPs. We calculated associations between primary syringe source and various behavioural outcomes, adjusted for participant characteristics.PWID who were <30 years old, female, white, and less frequent injectors were more likely have used pharmacies as their primary syringe source. Accessing syringes primarily from pharmacies, as compared to SSPs, was associated with receptive syringe sharing and unsafe syringe disposal; using sterile syringes, recent HIV testing and participation in an HIV behavioural intervention were negatively associated with primary pharmacy use.Pharmacies can play an important role in comprehensive HIV prevention among PWID. Linkage to HIV interventions and syringe disposal services at pharmacies could strengthen prevention efforts for PWID who cannot access or choose not to utilize SSPs.
OBJECTIVE:To identify factors influencing pharmacists' decisions about selling syringes to injection drug users (IDUs). DESIGN:Audiotaped interviews. SETTING:Denver, Colorado. PARTICIPANTS:Thirty-two pharmacists at 24 pharmacies. INTERVENTION:One-hour semistructured interviews. MAIN OUTCOME MEASURES:Practices regarding syringe sales to IDUs and factors influencing the practices. RESULTS:Of the 32 pharmacists interviewed, 16 indicated that they sold syringes to all customers ("pro-sell"), 11 refused to sell unless shown proof of diabetic status ("no-sell"), and 5 were "undecided." Several factors influenced the decision to sell. A perceived conflict between prevention of disease and prevention of drug abuse most clearly distinguished the three categories, with pro-sell pharmacists more likely than others to prioritize disease prevention and believe that syringe sales would not increase drug abuse. Business concerns, such as the effect of the presence of IDUs on other customers and the possibility of discarded syringes around the store, were especially prevalent among no-sell and undecided pharmacists. Seventeen pharmacists did not know about Colorado laws governing syringe sales. Four no-sell pharmacists used the laws to justify their decision not to sell, and two undecided pharmacists said they used the law when they did not want to sell syringes to IDU. All pharmacists supported syringe exchange programs. CONCLUSION:One-half of the pharmacists sold syringes to IDUs, and several more indicated that they would do so if certain concerns were addressed. These data suggest that improved syringe disposal options, continuing education programs, and clarification of existing laws and regulations would encourage more pharmacists in Denver to sell syringes to IDUs.
OBJECTIVES To summarize the prevalence, quality of life (QOL) implications, cost of illness, and pharmacotherapy of overactive bladder (OAB), and to describe the pharmacist's role in the management of patients with OAB. DATA SOURCES Articles published between 1990 and 2001 identified through a MEDLINE search using the terms overactive bladder, unstable bladder, urinary incontinence, prevalence, cost of illness, quality of life, drug therapy, pharmacist, and pharmacy in various combinations. STUDY SELECTION All studies providing information on OAB or urinary incontinence were retrieved. DATA EXTRACTION By the authors. DATA SYNTHESIS Published prevalence and cost studies focus primarily on urinary incontinence, which is only one possible symptom of OAB. Reported prevalence rates of urge and mixed incontinence in the United States range from 3% to 8% and 5% to 37%, respectively, and the highest prevalence has been found in geriatric and psychogeriatric populations. Associated costs are substantial. Total costs of OAB in the United States were estimated to be $12.6 billion in 2000. Patients with OAB score lower than the general population in QOL assessments. All aspects of QOL can be compromised by OAB, as physical, social, occupational, domestic, and sexual activities are often limited in OAB patients. The pharmacist is instrumental in improving an individual's QOL through ensuring safe and effective treatment for OAB. Oxybutynin and tolterodine (Detrol-Pharmacia) have been the mainstays of pharmacotherapy for OAB, but frequent adverse effects (including dry mouth) often prevent patients from adhering to treatment. Tolterodine, now available in a new long-acting formulation, has been proven safe and efficacious in the treatment of OAB, with fewer adverse effects and better tolerability than existing agents. CONCLUSION Pharmacists can play an active role in helping identify and recommending interventions for OAB that can ultimately improve an individual's QOL.
Drotrecogin alfa (activated) is a recombinant form of human activated protein C that has been shown to reduce mortality in severely septic patients with a high risk of death. Given the complexity of the inclusion and exclusion criteria, the stability and unique duration of infusion, and the cost of treatment, therapy with this agent should be carefully considered to ensure its appropriate use.
