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Interesting Articles in 2001 Aug - Dec



From
American Journal of Health-System Pharmacy
August 1, 2001 (Volume 58, Number 15)

Potential Risks and Prevention, Part 3: Drug-Induced Threats to Life

Marcellino K, Kelly WN
Am J Health Syst Pharm. 2001;58:1399-1405

This article is the third in a series of 4 articles describing adverse drug events (ADEs) and focuses on events that, given no medical intervention, would have led to patient death. The objectives of this study included the identification of case reports of drug-induced life threats, development of a rational database of the events identified, analysis of database for identifiable trends and risk factors, and identification of events that may have been preventable.

Case reports of ADEs were identified from Clin-Alert. Reported ADEs were separated into 3 categories: definite, probable, and possible. Each ADE was reviewed for patients, drug, and event variables. Once the variables were accounted for, each ADE was examined to determine whether it could have been prevented. A series of 8 questions were used to determine whether the event could have been prevented. For preventable ADEs, a list of mechanisms for prevention of ADEs was compiled following the review of the case reports. For this study, life threats were defined based on information from emergency medicine texts, a list of critical laboratory values, and a list of symptoms reviewed by an internal medicine physician.

A total of 846 cases were identified over a 20-year period from 1977 to 1997. Of these, 11% were assessed as definite life threats, 63% as probable life threats, and 26% as possible life threats. Almost half of the identified cases (45%) involved the use of either a central nervous system agent or an antimicrobial. The majority of patients (89%) had received doses that were considered to be usual or lower-than-usual doses. Almost 50% of the identified cases could have been prevented, half of these by pharmacist intervention.

Editor's Comment

This series of articles can provide a starting point for any healthcare organization that is struggling with where to begin with an ADE program as well as serve as a checkpoint for organizations with active programs. The understanding of what has happened globally with medication misadventures is as important as understanding what has happened at your institution. Programs aimed at prevention must understand the types of errors and events that have already occurred.

Abstract
Full text (membership required)

Related Resource Center:
-- Medication Errors/Adverse Drug Reactions



From
American Journal of Health-System Pharmacy
September 15, 2001 (Volume 58, Number 18)

Program to Remove Incorrect Allergy Documentation In Pediatric Medical Records

Bouwmeester M-C, Laberge N, Bussières J-F, Lebel D, Bailey B
Am J Health-Syst Pharm. 2001;58:1722-1727

Identification and clarification of patient allergies is an important step in providing quality healthcare to hospitalized patients. In this prospective cohort study, children admitted to a university hospital over a 46-day period were included. Identification of patients occurred during daily rounds of medical wards. If an allergy was noted for the patient, he/she was included in the study.

A standardized questionnaire was used to collect data about the allergy; if the patient was 12 years of age or younger, the tool was administered to the parents. Following data collection, the allergies were labeled as true allergy, undetermined allergy, or incorrectly reported allergy. Data collected about the allergy, information about the study, and a copy of the consent form were faxed to the patient's primary physician and pharmacy.

A total of 186 drug allergies were included in the analysis from the 1591 medical charts that were reviewed. This included 26 true allergies (14%), 103 undetermined allergies (55%), and 57 incorrectly reported allergies (31%). A label of drug intolerance was given to 29/57 incorrectly reported allergies, and 24 of these allergies were completely removed from the patient chart. The majority of incorrectly reported allergies that were removed from the records involved antimicrobial agents. The calculated cost of this intervention was $119 per incorrectly reported allergy removed.

Editor's Comment

Although very important, this article highlights the difficulties associated with clarification of reported drug allergies in today's healthcare environment. Time is difficult to stretch to include gathering information in the detail outlined in this report. It is the right thing to do, however, and organizations must think out of the box to come up with creative solutions to allow for cost-effective and time-efficient methods of evaluating reported allergies. The benefit can be avoidance of high-cost or higher-risk medication use in the future.

Abstract
Full text



September 1, 2001 (Volume 58, Number 17)

Developing A Service Excellence System for Ambulatory Care Pharmacy Services

Craig S, Crane VS, Hayman JN, Hoffman R, Hatwig CA
Am J Health-Syst Pharm. 2001;58:1597-1606

Competition for patients is driving the change in focus in pharmacy departments from product-only to product plus patient service. One large teaching hospital redesigned its ambulatory care service to modify existing environmental conditions. The environmental conditions present at the hospital included crowding, congestion, and lengthy turnaround time for service.

The hospital dispenses approximately 1.5 million ambulatory care prescriptions yearly. A "service excellence" program, defined as providing consistent outstanding service from the patient's perspective, was initiated. The program consisted of 4 steps, including the development of a patient survey designed to define patient expectations, identification of key performance indicators, increased involvement and education for staff to alter attitudes and processes, and measurement of improvement.

After implementation of the service excellence program, overall measured patient satisfaction increased from 72% to 93% at the main campus pharmacy. Smaller sites also noted improvements in patients' satisfaction, from 85% to 95%. No increases in pharmacy staff were required to initiate the changes.

Editor's Comment

In today's competitive healthcare environment, any improvement that leads to increased patient satisfaction with the encounter is beneficial. This report describes one organization's success with using patient satisfaction as a quality indicator and improving services. Note that this organization first determined patient-described indicators of satisfaction rather than dictating what should make patients more satisfied from a professional point of view.

Full text

Related Articles:
-- Learning From the Pros: Health Plans Go to Customer Satisfaction School
-- Book Review - Clinical Excellence Strategies 2001




From
Pharmacotherapy
August 2001 (Volume 21, Number 8)

Use of Point-of-Service Health Status Assessments by Community Pharmacists to Identify and Resolve Drug-Related Problems in Patients With Musculoskeletal Disorders

Ernst ME, Doucette WR, Dedhiya SD, et al.
Pharmacotherapy. 2001;21:988-997

A 12-month, prospective, multicenter demonstration project was designed to determine whether community pharmacists could use point-of-service assessments of health status to help identify drug-related problems (DRPs) in ambulatory patients with musculoskeletal disorders. The impact of DRPs on the health status of this patient population was also addressed in the study.

Twelve community pharmacies that were part of the Outcomes Pharmaceutical Care Network in eastern Iowa participated in the study. Either new or existing patients with a musculoskeletal disorder were included in the study. Health status assessments and monitoring for DRPs were conducted during quarterly pharmacy visits. A computerized, touch-screen system was used to capture patient specific visit information. Health status was assessed using the Short Form-36 (SF-36) general health survey, used by the Health Care Financing Administration to track the health status of Medicare beneficiaries in the Health of Seniors project. Following patient completion of the computerized survey, the pharmacist received computerized reports that highlighted clinically important indicators of functional status, health resource utilization, and graphed the patients' SF-36 scores with age- and gender-adjusted population norms and the patients' previous scores. Reports were then reviewed with the patient and DRPs were addressed as necessary.

During the 6-week enrollment period, 461 patients were recruited and completed the baseline visit. A total of 926 DRPs were identified during the 12-month study. The need for additional therapy (32.8%), adverse drug reaction (17.3%), subtherapeutic dosing (15.1%), and compliance problems (15.9%) were the most common DRPs identified. More than half of the DRPs were related to the musculoskeletal disorder. Pharmacists took action to resolve the DRPS in 96.8% of identified DRPs. Drug therapy regimens were changed in 20.9% of cases and nonprescription medications were added in 17% of cases. At 12 months, 70.7% of identified DRPs with a reported outcome were resolved or improved. An additional 27.6% were reported as either stable or unchanged.

Editor's Comment

The results of this study support the continued need for pharmacist intervention at the pharmacy service level. It would appear from this study that patients' medication regimens are complex and contain problems. Intervention at the point-of-service can benefit patients and in turn improve quality of life and help reduce overall medical expenditures. Pharmacists need to continue to be proactive at the point-of-service; pharmacists not currently providing services to patients beyond dispensing need to evaluate ways to implement patient-centered services in their practice settings.

Related Resource Center:
-- Medication Errors/Adverse Drug Reactions



From
American Journal of Health-System Pharmacy
October 1, 2001 (Volume 58, Number 19)

Abuse of Coricidin HBP Cough & Cold Tablets: Episodes Recorded by A Poison Center

Banerji SN, Anderson BA
Am J Health-Syst Pharm. 2001;58:1811-1814

Supratherapeutic doses of dextromethorphan can result in euphoric effects; the recreational abuse of cough and cold products containing dextromethorphan has been reported. Most recently, the abuse of Coricidin HBP Cough & Cold tablets among teenagers seeking a euphoric effect has been noted. This trend prompted the California Poison Control System (CPCS) to retrospectively review all reported ingestions of Coricidin HBP Cough & Cold tablets over a 9-month period. Computerized records were selected for review if patients were older than 5 years of age and if the reason for the call was for an ingestion other than a therapeutic error.

During the review period, the CPCS received approximately 240,000 calls. One hundred charts involving Coricidin were identified; 92 charts met inclusion criteria and were evaluated further. The reason for ingestion was classified as abuse in 65 patient charts (71%). An additional 8 cases (9%) were attributed to a suicide attempt, and the reason for ingestion was unknown in 16 patient charts (17%). Coricidin was the only agent consumed in 80% of the cases. Seventy-eight (85%) of the cases involved children between the ages of 13 and 17 years. Most of these patients intended to abuse the drug. Between 8 and 16 tablets were ingested in the majority of cases involving intended abuse. Ingestion was commonly associated with tachycardia, hypertension, lethargy, mydriasis, agitation, and dizziness. Sixty-six percent of patients reported an alteration in mental status. More than half of the reported cases resulted in an emergency room visit; 11 patients were admitted to the hospital.

Editor's Comment

Poison centers are an important source of information and are often the first to identify trends of abuse. Dextromethorphan abuse, especially among the teenage population, is a growing concern. This study offers pharmacists an important opportunity to provide public outreach information and education regarding the trends and dangers of ingestion. Because dextromethorphan is available in many over-the-counter products, clinicians should keep an eye out for potential problems and report concerns to health departments and the Board of Pharmacy.

Abstract
Full text (requires Adobe Acrobat Reader)

Related Resource Centers:
-- Toxicology
-- Addiction



From
The Annals of Pharmacotherapy
September 2001 (Volume 35, Number 9)

Barriers to Use of Electronic Adherence Monitoring in an HIV Clinic

Wendel CS, Mohler MJ, Kroesen K, Ampel NM, Gifford AL, Coons SJ
Ann Pharmacother. 2001;35:1010-1015

Optimization of highly active antiretroviral therapy (HAART) is important in the management of HIV. This requires high adherence to prescribed regimens on the part of the patient. The Medication Event Monitoring System (MEMS) is one currently available method of assessing adherence. MEMS does its measurement electronically through a microprocessor located inside a novel medication container cap. The processor records the date and time of up to 1800 openings.

A cross-sectional descriptive study was conducted at a Veterans Affairs (VA) health clinic. All patients had been stable on their current HAART regimens for at least 30 days. One of the medications in the HAART regimen was selected per protocol to have a MEMS device placed on the container. Participants returned to the study center 30 days after receiving their prescriptions.

A total of 64 men completed MEMS monitoring. Decanting (removing medication to pill boxes or sorters) was established in 42% (27/64) of the study subjects; 10 of these patients did not stop this process once MEMS monitoring commenced. Thirteen percent (n = 8) of participants felt that MEMS interfered with their ability to be adherent. Only 6 participants reported that MEMS served as a reminder.

Editor's Comment

This study provides interesting insight into one method of adherence measurement. As health professionals, we are often presented with adherence issues. Technology is frequently offered as a method of increasing adherence. This study suggests that there are patient behaviors, such as decanting, that contribute to compliance and may make the use of technology to assess or increase adherence difficult. The MEMS system certainly can provide substantial information about adherence patterns in many patients, but as with many of our tool kits, it cannot be universally applied.

Abstract
Full text (requires Adobe Acrobat Reader)

Related articles:
-- A Team Approach to Address Antiretroviral Therapy Adherence Barriers in a Managed Care Organization
-- Enhancing Adherence to HAART: A Pilot Program of Modified Directly Observed Therapy
-- Starting Therapy: Adherence Is Key to Success When CD4+ Counts Are Very Low
-- Adherence to Antiretrovirals in HIV Disease



From
Hospital Pharmacy
September 2001 (Volume 36, Number 9)

Stability of a Baclofen and Clonidine Hydrochloride Admixture for Intrathecal Administration

Godwin DA, Kim N-H, Zuniga R
Hosp Pharm. 2001;36:950-954

For some patients with chronic pain, a satisfactory balance between adequate pain control and the occurrence of adverse events is not achievable. In these instances, intrathecal delivery of analgesic agents can provide a positive response. Implantable pumps are often used for intrathecal drug administration. Intrathecal baclofen is used for the management of severe spasticity of spinal cord or cerebral origin. Intrathecal clonidine produces a dose-dependent analgesia when administered epidurally. When these 2 agents are used together, the effects appear to be additive.

This study was designed to determine the stability of an admixture of baclofen (1000 mcg/mL) and clonidine hydrochloride (200 mcg/mL) in 0.9% sodium chloride. Three formulations were prepared for this study; each agent by itself and the combination of the 2 drugs. Powders were weighed and diluted in volumetric flasks with 0.9% sodium chloride to the desired concentrations. Samples were obtained from the prepared solutions and stored in the absence of light at 37° C for 10 weeks. A stability-indicating high-performance liquid chromatography (HPLC) assay was used to determine the stability of the stored samples at the end of the study period.

Using a definition for stability as the concentration of the solution > 90% of the original concentration, all of the samples were stable at the studied temperature for a 10-week period. All solutions remained colorless over the study period.

Editor's Comment

The management of chronic pain remains a challenge for providers and patients. Pain management often requires the use of agents with different mechanisms of action to provide adequate pain control with a minimum of side effects. The results of this study indicate that 2 agents with different mechanisms of action are chemically stable for a given period. Whether the combination is therapeutically stable will require additional study.

Related Resource Center:
-- Pain Management



From
Journal of Managed Care Pharmacy
September/October 2001 (Volume 7, Number 5)

Evaluation of Resources Used to Treat Adverse Events of Selective Serotonin Reuptake Inhibitor Use

Rascati K, Godley P, Pham H
J Managed Care Pharm. 2001;7:402-406

Adverse events associated with prescribed therapies can account for additional prescriptions and/or medical visits. To measure these events associated with the use of selective serotonin reuptake inhibitors (SSRIs) in patients being treated for depression, one integrated healthcare network used data from prescription medical records and electronic medical records. The network has more than 170,000 members in several cities and more than 1 million patient visits are recorded during a 1-year period.

For this study, data were pulled from 1998-1999 prescription claims. Patients with a prescription for an SSRI in the last quarter of 1998 were identified. Medical records were obtained and reviewed for patients meeting inclusion criteria. Two researchers reviewed approximately 10% of these records to assess inter-rater reliability.

A total of 464 patients met all inclusion criteria (>/= 18 years of age, continuous enrollment, new prescription for SSRI in 1998). Of these patients, only 73% (n = 337) had a diagnosis of depression listed in the medical record. Approximately 40% (137/337) had experienced at least 1 documented adverse event in the 6 months following initiation of an SSRI. Ninety-six patients (28.5%) had 101 changes in their medications because of adverse events; 32 patients visited their physician's office as a result of an adverse event associated with their SSRI therapy. Direct medical costs associated with adverse events ranged from $11 to $17 per patient.

Editor's Comment

This study suggests that the costs associated with the management of adverse events in patients treated with SSRIs are not excessive. However, the retrospective nature of this study and the reliance on a complete medical record may significantly underestimate these costs. Compared with the significant costs associated with untreated depression, though, the use of SSRIs would seem to be a good investment for healthcare organizations.

Full text (requires Adobe Acrobat Reader)

Related Resource Center:
-- Medication Errors/Adverse Drug Reactions



From
Pharmacotherapy
September 2001 (Volume 21, Number 9)

A Prospective and Retrospective Analysis of the Nephrotoxicity and Efficacy of Lipid-Based Amphotericin B Formulations

Cannon JP, Garey KW, Danziger LH
Pharmacotherapy. 2001;21:1107-1114

The increased number of immunocompromised patients in today's society is associated with an increased frequency of invasive fungal infections. There has been a corresponding increase in the use of antifungal agents, in particular amphotericin B. This observational study was conducted to determine the usage patterns of lipid-based amphotericin B formulations at a large urban teaching medical center in Illinois. In addition, the observed nephrotoxicity and the efficacy of the formulations were measured. Two lipid formulations (amphotericin B lipid complex [Abelcet] and liposomal amphotericin B [AmBisome]) and amphotericin B deoxycholate were available for use; amphotericin B lipid complex was designated as the formulary lipid formulation.

Data on the use of amphotericin B lipid complex from December 1996 to July 1999 were collected prospectively; prospective data on the use of liposomal amphotericin B were collected between August 1998 and July 1999. The charts of patients for whom liposomal amphotericin B was prescribed prior to August 1998 were reviewed retrospectively.

Sixty-seven patients met the predefined criteria for inclusion in the analysis. Forty-six patients received the Abelcet and the remaining 21 patients received AmBisome. The use of lipid-based formulations occurred mainly in oncology patients. The most common reasons for using amphotericin B lipid complex included documented fungal infection (50%) and neutropenic fever (33%). Liposomal amphotericin B was prescribed most often in the treatment of neutropenic fever (62%) and documented fungal infection (29%). Patients were most often prescribed a lipid formulation because they were considered refractory to other antifungal agents. Nephrotoxicity occurred in 2 patients who received amphotericin B lipid complex (4.3%) and 4 patients who received liposomal amphotericin B (19%). Concomitant nephrotoxins were used in all but 1 of these patients. Eighty-seven percent of patients with a documented fungal infection who were treated with amphotericin B lipid complex and 80% of those treated with liposomal amphotericin B had a complete or partial response to therapy. Significant differences in toxicity or efficacy were not observed between the treatments.

Editor's Comment

While the number of patients treated in this study is not large, the data do not support the use of one lipid-based formulation over another. In addition, a third amphotericin lipid formulation product is available (amphotericin colloidal dispersion [Amphotec]). This product is associated with infusion-related toxicity that is not noted with the other 2 lipid-based products. Until definitive study data indicate the superiority of either amphotericin B lipid complex or liposomal amphotericin B, the choice of lipid-based product will most likely be determined by costs and institution preference.

Abstract

Related articles:
-- New Insights in Medical Mycology: Focus on Fungal Infections



From
American Journal of Health-System Pharmacy
December 1, 2001 (Volume 58, Number 23)

Automated Medication Distribution Systems and Compliance With Joint Commission Standards

Garrelts JC, Koehn L, Snyder V, et al.
Am J Health-Syst Pharm. 2001;58:2267-2272

The use of automated medication distribution (AMD) systems in the delivery of pharmaceuticals has increased over the last decade. When used correctly, the addition of automation can help decrease medication errors and increase efficiency. This report describes the use of an automated medication delivery system at a regional medical center with regard to compliance with Joint Commission of Healthcare Organizations (JCAHO) compliance. The medical center is comprised of 3 separate facilities serving a total patient population of more than 700 patients. The AMD system used at the medical center interfaces with the pharmacy information system and contains patient specific medication profiles. The AMD unit will not release a medication until an order has been reviewed by the pharmacy. The system became fully operational at the medical center during the summer of 2000.

JCAHO has increased the scrutiny of AMD systems as their use has increased. The survey process has been adapted to address the use of automation. Specific questions addressing the use of an AMD system are now included in the survey. At this particular medical system, the pharmacists and nurses began addressing JCAHO compliance issues as soon as the AMD system was selected. The AMD system is now used for about 90% of all medication storage and is the primary component of the medication-use system. The pharmacy department maintains the supply of medications within the AMD and reviews the contents to ensure appropriateness. Additional safety checks have been used to prevent restocking errors. Restocking codes and monthly pharmacy inspections of AMD contents are used. The use of override codes that allow nurses to bypass the pharmacist review of a medication order is rarely used at the medical center. Each unit can be programmed to allow or prevent an override. Adequate staff education and training were important aspects that helped with the transition to an AMD system.

Editor's Comment

This article offers a good overview of the process that was involved in the implementation of an AMD. In addition, it addresses specific JCAHO standards that need to be addressed when such a system is implemented. More and more hospitals are moving toward the use of automated devices; as practitioners look at different systems, particular attention needs to be focused on the provision of safe and efficient care without compromising either the patient or healthcare professional.

Abstract (requires registration)
Full text (requires Adobe Acrobat Reader and registration)

Related Articles:
-- Carmenates J, Keith MR. Impact of automation on pharmacist interventions and medication errors in a correctional health care system. Am J Health-Syst Pharm. 2001;58:779-783.
-- Sparks M. Preparing for a successful JCAHO visit. Medscape Nursing. 2001.
-- Wellman GS, Hammond RL, Talmage R. Computerized controlled-substance surveillance: application involving automated storage and distribution cabinets. Am J Health-Syst Pharm. 2001;58:1830-1835.



From
The Annals of Pharmacotherapy
November 2001 (Volume 35, Number 11)

Nonprescription Drug-Related Problems and Pharmacy Interventions

Westerlund LT, Marklund BG, Handl WH, Thunberg ME, Allebeck P
Ann Pharmacother. 2001;35:1343-1349

In Sweden, nonprescription medications are sold only in pharmacies. The pharmacy may have a staffed self-serve department specifically for these over-the-counter (OTC) medications or the medications may be kept behind a pharmacist counter. This study, conducted in 45 pharmacies, documented the number and types of drug-related problems (DRPs) identified in customers purchasing OTC medications. In addition, the authors sought to describe the DRPs according to gender, age, class of drug, and underlying ailment. The number and type of intervention made by pharmacy staff was also noted.

A total of 1425 DRPs were identified during the study period. Approximately 300 practitioners recorded interventions. The variation in DRP documentation varied 20-fold among participating pharmacies. Individual practitioners reported a wide range of individual problems, from 1 to 89. DRP documentation was approximately 60% higher in pharmacies selling OTC medications from the counter rather than in self-serve, staffed departments. The most prevalent DRPs included uncertainty about the indication for the drug (33.5%) and therapy failure (19.5%). Therapy failure was more common among men than among women. The most common specified symptom was dyspepsia, occurring in 11.4% of the study population. Identified problems were attributed to OTC medications in 83% of the documented reports.

In an attempt to solve identified DRPs, pharmacy practitioners reported 2040 interventions. The most common intervention was customer drug counseling (61.1%). Referral to a physician was suggested more than 25% of the time. The medications chosen by customers were switched in more than 4 out of 10 cases.

Editor's Comment

This study, conducted in a more professionally influenced OTC market than the US market, raises again the questions about the OTC market in the United States. A large number of DRPs were identified in the study above. There were significantly more DRPs in the self-serve pharmacies. Imagine what we might find were we to survey individuals purchasing OTC medications in a local grocery store or warehouse setting?

Abstract

Related Resource Center:
-- Medication Errors/Adverse Drug Reactions



From
Hospital Pharmacy
November 2001 (Volume 36, Number 11)

Performance Measurement of a Pharmacist-Directed Anticoagulation Management Service

Schommer JC, Mott DA, Schneider PJ, et al.
Hosp Pharm. 2001;36:1164-1169

Although documentation exists that describes decreases in costs and improved patient outcomes with the use of pharmacist-directed anticoagulation programs, the organizational performance of these services has not been described. A performance-driven organizational change framework can be used to describe the achievement of specific objectives by an organization in a manner that is efficient. The authors of this study used this type of framework to evaluate the efficiency of care provided in one university-affiliated anticoagulation clinic.

Staff at the clinic collected and recorded data on 286 consecutive patient encounters over a 2-month period. This included demographics, clinical outcomes, regimen adherence, and the amount of time the staff spent on the patient encounter.

Over the study period there was an average of 3.2 encounters per patient. The average number of prescription and nonprescription medications (in addition to warfarin) taken by each patient was 7 per day. Each patient encounter required an average of 10.7 minutes of staff time. This included 4.2 minutes of pharmacist time and 6.5 minutes of technician time. Patients requiring the most time per encounter were those with regimen adherence problems. The International Normalized Ratio (INR) was within a specified range in 56% of the encounters. Patients with adherence problems were 9.9 times more likely to be outside of the specified INR range than those patients without adherence problems.

Editor's Comment

Today's healthcare environment dictates that new patient care services not only provide high-quality care but also provide the service in a manner that is efficient. This study provides some insight into the organizational performance of one anticoagulation service. Expanding this information to include other services would be helpful in the development of benchmark figures that could help with justification for initiating these services as well as providing a framework for performance improvement initiatives.

Related Articles:
-- Aldridge MA, Ito MK. Fenofibrate and warfarin interaction. Pharmacotherapy. 2001;21:886-889.
-- Chamberlain MA, Sageser NA, Ruiz D. Comparison of anticoagulation clinic patient outcomes with outcomes from traditional care in a family medicine clinic. J Am Board Fam Pract. 2001;14:16-21.
-- Ravnan SL, Locke C. Levofloxacin and warfarin interaction. Pharmacotherapy. 2001;21:884-885.



From
Journal of Managed Care Pharmacy
November/December 2001 (Volume 7, Number 6)

Medical and Pharmacy Cost and Utilization Outcomes of a Quantity Limit on the 5-HT1 Agonists (Triptans) by a Managed Care Organization

Culley EJ, Wanovich RT
J Managed Care Pharm. 2001;7:468-475

The 5-HT1 agonists (triptans) have provided a breakthrough in acute relief of migraine headache. However, the availability of these medications has also led to increased costs and misuse. In this study, the impact of a quantity limit for the 5 triptan products was evaluated.

Quantity limits were established based on the maximum doses for each product that would be required to treat 4 migraine headaches per month. Patients who presented with a prescription for one of these agents that exceeded the established limit had their prescription denied at the point of sale. The adjudication screen prompted the dispensing pharmacist to call the managed care organization (MCO). The prescribing physician was contacted by an MCO pharmacist to determine whether changes needed to be made to the prescription quantity. Exclusion was made for patients presenting with an acute migraine.

Costs of care were collected including medical claims data, primary care physician visits, emergency room visits, neurologist consultations, and hospitalizations, as well as costs for prophylactic medications and acute relief medications.

Of 11,200 patients who had a prescription filled for a triptan during the 6-month study period, 25% required review by the MCO because of the quantity limit. Before and after cost analysis demonstrated that the MCO spent $582,988 less on triptans during the 6-month period after initiation of the quantity limit. An increase of $74,780 was noted after implementation of the quantity limit in medical claims, physician visits, and hospitalizations. Overall, a $12.25 cost savings per member per month was realized.

Editor's Comment

Migraine headaches affect more than 23 million Americans. Despite the existence of some guidelines, the treatment of migraine varies greatly. Patients suffering from significant pain often take more medication than is prescribed. In many areas of the country, prophylactic medications are only minimally used. Programs such as this one may do much to educate the healthcare professional as well as the patient about the most effective use of this group of medications.

Full text (requires Adobe Acrobat Reader)

Related Resource Center:
-- Migraine Pain



From
Pharmacotherapy
November 2001 (Volume 21, Number 11)

Prevalence and Risk of Thrombocytopenia with Valproic Acid: Experience at a Psychiatric Teaching Hospital

Conley EL, Coley KC, Pollock BG, Dapos SV, Maxwell R, Branch RA
Pharmacotherapy. 2001;21:1325-1330

Valproic acid has been used as an antiepileptic agent for many years. More recently, it has also been used in the treatment of mood disorders and treatment-resistant schizophrenia. Thrombocytopenia and liver toxicity are known adverse effects related to valproic acid therapy. The incidence of these adverse effects differs depending upon the population tested. In this retrospective study, the incidence of thrombocytopenia in hospitalized psychiatric patients was evaluated.

All patients admitted to a university psychiatric center over a 5-year period who received valproic acid or divalproex and had at least 1 platelet count measured during their hospital stay were included in the analysis. Patients with an underlying blood disorder, human immunodeficiency virus, low platelet counts not corresponding with valproic acid therapy, or those receiving antineoplastic agents were excluded from review. Thrombocytopenia was defined by platelet counts and divided into mild (101-150 x 103/mm3), moderate (40-100 x 103/mm3), and severe (< 40 x 103/mm3).

Of the 264 patients who were admitted and received valproic acid during the 5-year period, 172 had at least 1 recorded platelet count. Platelet counts were not decreased significantly or were normal in 129 patients. Thirty-one patients met the criteria for thrombocytopenia; 12% incidence overall (31 of 264). The thrombocytopenia was mild in 25 patients and moderate in the remaining 6 patients. There were no clinical complications associated with the thrombocytopenia. The likelihood of clinically significant thrombocytopenia was nearly double in patients older than 65 years compared with a younger population (P = .02). Increased dosages of valproic acid were also associated with the development of thrombocytopenia (P < .001). Ten percent of patients receiving dosages of up to 1 g/day developed thrombocytopenia compared with 35% in those patients receiving up to 2 g/day and 55% in those receiving more than 2 g/day. The incidence of thrombocytopenia did not correlate with serum valproic acid concentrations.

Editor's Comment

Adverse effects are important limiting factors for any medication therapy. Valproic acid has long been known to cause clinically significant adverse effects. Based on the results of this study, it appears that elderly patients and those patients receiving doses of valproic acid greater than 1 g/day are more likely to be at risk for developing thrombocytopenia. While none of these patients suffered clinically significant consequences associated with the development of thrombocytopenia, the potential for harm remains. It would be interesting to expand this study to evaluate the incidence of hepatic effects. Valproic acid is now being used in multiple diagnoses, and care must be taken to continue to monitor the incidence of adverse effects associated with its use.

Abstract

Related Resource Centers:
-- Medication Errors/Adverse Drug Reactions
-- Schizophrenia: Wellness Center
-- Epilepsy



From
The Annals of Pharmacotherapy
December 2001 (Volume 35, Number 12)

Risk of Extrapyramidal Syndromes with Haloperidol, Risperidone, or Olanzapine

Schillevoort I, de Boer A, Herings RMC, et al.
Ann Pharmacother. 2001;35:1517-1522

Extrapyramidal syndromes (EPS) associated with the use of antipsychotic agents include parkinsonism, akathisia, dystonia, and tardive dyskinesia. Clinical trials have shown the newer atypical antipsychotic agents such as risperidone and olanzapine to be as efficacious as older antipsychotic agents. These atypical agents are associated with a lower frequency of EPS. This study was conducted to compare the risk of EPS in patients receiving haloperidol in clinical practice with patients receiving risperidone or olanzapine.

In The Netherlands, almost all patients designate a single pharmacy to fill prescriptions. A database of these records was obtained from 11 Dutch cities. Through this system, patients aged 15-54 years were identified if they received any one of the study drugs for the first time during a 5.5-year period. Records were also reviewed for the first use of any drug indicated for the treatment of EPS at any time in the 90 days following initiation of study drug. If the antipsychotic agent and the EPS treatment were started on the same day, the case was not reviewed.

A total of 848 patients were identified, including 424 patients who were initiated on haloperidol, 243 who started with risperidone, and 181 who started with olanzapine. Users of risperidone and olanzapine more frequently had prior use of an antipsychotic agent plus an antiparkinsonian agent than users of haloperidol (36.2%, 40.3%, 4.5%, respectively; P < .001). The relative risk of EPS was generally lower in the patients receiving olanzapine and risperidone (RR 0.03-0.22) than in patients receiving haloperidol with one exception. Patients who received risperidone who had experienced EPS in the past did not experience a lower risk of EPS (RR, 1.3; 95% CI, 0.24-7.18).

Editor's Comment

The authors of this article are quick to point out the limitations of observational information and tried to alleviate some of the bias inherent in an observational study. The investigators stratified the patients as to past EPS symptoms to account for instances when prescribing might be slanted toward the newer agents in patients who had previously experienced EPS. This study presents results that may help clinicians who are trying to select the best agent for a patient in need of an antipsychotic agent. The findings, however, must be corroborated by evidence from a randomized controlled trial.

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From
Journal of the American Pharmaceutical Association
November/December 2001 (Volume 41, Number 6)

Pharmaceutical Care in Chain Pharmacies: Beliefs and Attitudes of Pharmacists and Patients

Amsler MR, Murray MD, Tierney WM, et al.
J Am Pharm Assoc. 2001;41:850-855

Chain pharmacies currently are the largest provider of prescription services in the United States. One of the larger chain pharmacies conducted focus groups, which included both pharmacy practitioners and their patients with reactive airways disease, to evaluate a pharmaceutical care program for patients with this disease. The intent was to develop a program that was practical and acceptable to pharmacists and their patients.

Separate focus groups were formed; the 2 pharmacist groups included 11 pharmacists from 6 stores, the patient groups included 13 adult patients identified by prescription audit and confirmed by telephone. All participants received dinner in exchange for their participation. In addition, patient participants each received $25.00.

The focus groups, designed to be 60-90 minutes in duration, were led by an experienced facilitator who was trained to use open-ended questions. The sessions were audiotaped and notes were taken. The audiotapes were later transcribed verbatim.

Counseling was viewed by pharmacists as an important component of their job, yet they cited insufficient time as a barrier to performing patient counseling. They also reported that physicians were difficult to reach and that they felt that many physicians resented their input.

According to the patient focus group participants, the most effective way of getting information about their medications was through pharmacist counseling. They also wanted written information to take with them. They view the physician as the person primarily responsible for their healthcare and see the pharmacist as supporting the physician and preventing errors.

Editor's Comment

Within the profession of pharmacy, pharmaceutical care has become an expected part of everyday patient care. However, in many practice settings, staffing, reimbursement issues, individual professional commitment, and knowledge limit the ability to provide pharmaceutical care. The use of focus groups can provide insight into the patients' perception of the pharmacist responsibility. Programs can then be designed to address at least some aspects of pharmaceutical care within the current healthcare system.

Abstract

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From
Pharmacotherapy
December 2001 (Volume 21, Number 12)

Impact of the Cost of Prescription Drugs on Clinical Outcomes in Indigent Patients With Heart Disease

Schoen MD, DiDomenico RJ, Connor SE, Dischler JE, Bauman JL
Pharmacotherapy. 2001;21:1455-1463

Indigent patients are often unable to successfully obtain outpatient prescription medications because the out-of-pocket expenses are too steep. Many of these indigent patients are often elderly and/or disabled and are afflicted with chronic diseases that require long-term medications. At a large university hospital, poor adherence with cardiovascular regimens due to cost was identified as a major problem for patients treated at the inner-city medical center. As a result of this poor adherence, poor control of cardiovascular disease was evident in this patient population. To help with drug coverage issues, a mechanism was developed that provided cardiovascular patients, followed in the ambulatory clinics, free medications and assistance with identifications of potential pharmacy benefit options. Clinical outcomes were then measured after 6 months to determine whether the outcomes improved when the cost burden of medications was minimized. Cardiovascular outcomes measures included international normalized ratio (INR), blood pressure, low density lipoprotein cholesterol (LDL), and hospitalizations.

A total of 170 patients were identified and enrolled in the program between October 1996 and April 1998. Baseline data were available for 163 patients. Of these patients, 66% were Medicare beneficiaries without supplemental insurance and 24% had no kind of health insurance coverage. After entering the program, 67% of patients received medications directly from drug companies, 63% received sample medications, 49% received state-funded coverage, and 11% received Medicaid. Hypertension and hyperlipidemia were the most common cardiovascular diseases present in this patient population.

Mean INR increased from 2.44 +/- 0.64 at baseline to 2.61 +/- 0.53 at the 6-month end point, P < .05. Mean blood pressure also decreased; a significant decrease was observed only in the diastolic measurement, P < .05. Mean LDL decreased from 126 +/- 39 mg/dL to 108 +/- 38 mg/dL (P < .001) and medication adherence increased from 48.5% to 72.7% (P < .001) over the study period.

Editor's Comment

Poor medication adherence in patients with chronic disease can lead to increased morbidity and mortality. Indigent patients are at high risk for medical complications because of their inability to acquire preventative medications. The ultimate impact of the lack of medication coverage places increased stressors on the healthcare system because of the associated increases in morbidity and mortality. The data from this study can be used to help support increased medication coverage and availability for elderly and disabled patients.

Full text

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