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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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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?
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.
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.
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.
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.
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.
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.
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