Both Researchers and Journals are to Blame for Inconsistent Disclosure
of Conflicts of Interest
Researchers who combed through one year's worth of stent research say
conflict-of-interest disclosures are the exception, not the rule--in
some cases, authors disclosed conflicts in one paper, but not others.
Effect of Pharmacists on Medication Errors in an Emergency Department
Could pharmacists be a key to reducing drug errors in the ED?
Am J Health-Syst Pharm 65(4) 2008
Both Researchers and Journals are to Blame for Inconsistent Disclosure of Conflicts of Interest
Heartwire 2008. ©2008 Medscape
May 7, 2008 - Researchers are inconsistent
about disclosing financial conflicts of interests, and journals are
inconsistent in how they use or publish disclosure information, a novel
study suggests [1
]. The findings call into
question the whole purpose and efficacy of a process intended to
preserve integrity and eliminate bias in medical literature,
"The system of disclosures that we have for the professional
literature in medicine is not as extensive as we'd hoped," lead author Dr Kevin P Weinfurt
(Duke University, Durham, NC) told heartwire
. "I think people are under the impression that disclosures are more consistent and frequent than they actually are."
The results appear online May 6, 2008 in PLoS ONE
For their study, researchers at Duke University searched for studies
about stents published in 2006, then compared prevalence, nature, and
consistency of financial disclosures across the papers. They report
that of 746 papers by 2985 authors, only 17% had a disclosure statement
for any author, and only 6% of authors had disclosure statements.
Strikingly, in one-third of the studies, no disclosure statement was
provided, despite the fact that one or more authors had disclosed
conflicts of interest in other papers.
In an interview, Weinfurt explained that it is difficult to tease
out from the analysis whether authors were intentionally failing to
disclose a conflict, whether they were unsure what constituted a
"relevant" conflict, or whether it was the journals not requesting
information or not publishing disclosure information.
"Disclosure is sort of like a new drug that's been proposed to solve
a health problem," Weinfurt suggested. "In the journals, we're sort of
in a situation where people are using this drug very inconsistently and
not at the same dose, and very few people are giving the drug. We're
asking the question, how effective is the drug? But the problem is,
we're really not seeing a consistent use of the drug so that we can
evaluate whether it's working or not."
Lack of Disclosure Policies vs Failure to Disclose?
In their review, Weinfurt et al found that the more renowned medical journals (journals that endorsed International Committee of Medical Journal Editors
guidelines or that have a "higher impact factor") were the most likely
to include disclosure information. More surprising statistics from the
study are below.
Disclosure-Statement Information in Stent-Research Papers in 2006
|No disclosure statement in article
|Declaration of "no conflicts of interest" in article
|Disclosure of conflict of interest in article
|Proportion of authors with articles with disclosure statements
|For authors of multiple papers: no disclosure statements vs declarations of no conflicts of interest
|For authors of multiple papers: no disclosure statements vs specific disclosures
|For authors of multiple papers: specific disclosures vs no conflict of interest
But the numbers don't tell the full story. According to Weinfurt,
when he and his colleagues conducted an informal Google search of
authors' names who had expressly listed "no conflicts," they found that
some were advisory board members for stent manufacturers or consulted
for stent companies or for companies that made drugs used during or
after stenting. One person had even founded a company that makes
stents, yet had not disclosed that information.
While some authors may have intentionally withheld information, Weinfurt gives them the benefit of the doubt.
"Investigators may be getting only very vague directions from the
journals and doing their best to comply with them, but perhaps not
including information that the public might think is appropriate. If
the journal says, please disclose any relative conflicts of interest,
and if my article is evaluating the effectiveness of stents, I
sincerely might not believe that the consulting work I do for a major
manufacturer of medical interventions would be a conflict. So part of
the problem might be a lack of awareness on the part of investigators
as to what might constitute a conflict and what might be perceived as a
Of note, just 1.3% of the research papers included in the analysis
(623 papers) included information on "author contributions" (the extent
to which individual authors contributed to the research and writing of
the paper)--something the authors argue is a valuable corollary to
understanding conflicts of interest. "If one purpose of financial
disclosures is to allow readers to assess the influence of the
financial interests on the overall study, presumably readers would also
need to know the role played by the authors with the financial
interests," they write.
Across the Board
Weinfurt said he and his coauthors chose to look specifically at
stents, within a one-year period, partly because of the controversies
around drug-eluting stents in the past few years and partly because it
is a very active area of scholarship, where people "are really looking
to the research to figure out what to do."
The results of stent research will have a major influence on public
health, on the multibillion-dollar stent industry, and on
products/strategies that are alternatives to stents, he said.
"I think problems with disclosure are across the board, but I think
the finances involved with stents and other devices do make them ripe
territory for problems with conflicts of interests," he told heartwire
The complete contents of Heartwire, a professional news service of WebMD, can be
found at www.theheart.org, a Web site for cardiovascular healthcare
- Weinfurt KP, Seils DM, Tzeng JP, et al. Consistency of
financial interest disclosures in the biomedical literature: The case
of coronary stents. PLoS ONE 2008; 3:e2128. Available at: http://www.plosone.org.
Effect of Pharmacists on Medication Errors in an Emergency Department
Jamie N. Brown; Connie L. Barnes; Beth Beasley; Robert Cisneros; Melanie Pound; Charles Herring
Am J Health-Syst Pharm. 2008;65(4):330-333. ©2008 American Society of Health-System Pharmacists
Abstract and Introduction
Purpose: The frequency of medication errors in an emergency department (ED)
before and after an ED pharmacist was assigned to check medication
orders was studied.
Methods: A retrospective chart review was
conducted for any patient admitted to the ED of a large rural hospital
between November 6, 2005, and December 6, 2005 (control group), or
between November 6, 2006, and December 6, 2006 (intervention group).
For the control group, no pharmacist was present in the ED to check
drug orders; for the intervention group, a pharmacist was present.
Potential errors in medication orders were identified and validated.
Results: A total of 490 medication orders written for 198 patients were evaluated for errors. The control group (n = 94) and the intervention group (n = 104) did not differ significantly with respect to age, sex, race, or
number of medication orders. A total of 37 and 14 medication errors
were identified for the control and intervention groups, respectively.
The rate of errors was 16.09 per 100 medication orders for the control
group compared with 5.38 per 100 orders for the intervention group, a
66.6% difference (p = 0.0001). The ED pharmacists made 183 recommendations, of which 98.6% were accepted.
Conclusion: The rate of medication errors in the ED decreased significantly when pharmacists prospectively reviewed ED medication orders.
Since 1999, when the Institute of Medicine published "To Err Is Human: Building a Safer Health System," there have been remarkable developments in the measurement and analysis of patient safety and medication errors. Medication errors have historically been defined as occurrences of inappropriate use of medications, regardless of outcomes. This broad definition encompasses all adverse drug events (ADEs)
related to medication use, including potentially harmful events that
have been prevented from reaching the patient. Such errors have been
documented in almost all areas of the health care system, with
emergency departments (EDs) having the highest rate of preventable ADEs
The nation's EDs treated over 114 million patients in 2003. This large number of patients, in combination with a sometimes chaotic
environment, makes the ED an ideal setting for pharmacist interventions
to reduce medication errors. The Joint Commission, in an effort to
minimize the risks associated with medication errors, now requires a
review of "all medication orders in hospitals unless a licensed
practitioner controls the ordering, preparation, and administration of
the medication." This requirement does not mandate that a
pharmacist be present in the ED, but recent evidence from other
practice settings suggests that an ED-based pharmacist may reduce
medication errors.[1,6,7] Also, it has consistently been
shown that pharmacist participation in a hospital ED offers the
potential for substantial cost savings.[1,8-11]
60% of medication errors are the result of the prescriber's lack of
knowledge about the drug, lack of information about the patient,
transcription errors, or memory lapses during drug ordering and
delivery. Having a clinically trained pharmacist present
in the ED allows for multiple layers of patient protection, reducing
the potential for errors to occur or to reach the patient. A literature search revealed no studies quantifying the impact of an ED-based pharmacist on medication errors in that setting.
purpose of this study was (1) to determine the frequency of medication
errors in an ED before and after pharmacists were assigned to
prospectively review medication orders and (2) to evaluate physician
acceptance of the pharmacists' recommendations.
study was conducted in the ED of a 426-bed tertiary care hospital in
rural North Carolina. A clinical pharmacist was assigned to the ED for
consultation with and other assistance to the health care providers
during all hours of each shift. The pharmacists' duties in the ED
included clinical consultation, patient education, order screening,
staff education, and emergency preparedness.
The ED is divided
into two units, one for adults and one for children. The adult unit
officially has 44 assigned rooms but frequently operates over capacity.
The pediatric unit has 13 designated beds. The average combined daily
census is 250-270 patients. Usual staffing includes 15-18 registered
nurses in the adult unit and 4-6 registered nurses in the pediatric
unit; 4 physicians and 2 physician assistants are responsible for both
units per shift. The adult unit admits approximately 20% of patients
and the pediatric unit less than 5%. The average time in the ED is four
hours for patients who are subsequently discharged and not admitted to
the hospital. For patients who are admitted, the average time in the ED
is seven to eight hours.
Pharmacists in this health system are
responsible for reporting all clinical interventions through the
computer system (Siemens Corp., Malvern, PA). The use of the Siemen's
program was implemented in the hospital in October 2004 and was adopted
as an institutionwide medication-order-review system. This program
provides pharmacists with the means to document interventions and is
accessible only through a personal computer with network access. The
program provides data on the number and type of pharmacist
recommendations and the percentage of recommendations accepted.
medication error was defined as any preventable event that may lead to
inappropriate medication use or patient harm while the medication is in
the control of the health care professional. Categories
of medication errors were omission of dose, omission of information,
unauthorized drug, wrong dose, extra dose, wrong route, wrong form,
wrong technique, and wrong time.
study protocol was approved by the hospital's institutional review
board. The study was designed as a retrospective review of the charts
of all patients, regardless of age, who were admitted to the ED between
November 6, 2005, and December 6, 2005 (control group) or between
November 6, 2006, and December 6, 2006 (intervention group). For the
control group, no pharmacist was present in the ED to check drug
orders; for the intervention group, a pharmacist was present. Patient
records were selected by convenience sampling by the medical
information department. Patients with incomplete charts or no
medication orders were excluded.
All medication errors were
identified by an independent evaluator who reviewed the medical
records, including all progress notes, drug orders, and laboratory test
results, using the chart-review techniques described by Flynn et al. To document the errors, the evaluator used a structured form that was
organized and analyzed with Microsoft Access (Microsoft Corp., Redmond,
Each drug order was analyzed for medication errors. A
medication error, if generalized to include more than one medication
order (as when drug allergy information was missing), was documented
only once and not multiple times. After the evaluator identified
medication errors, a blinded panel of three pharmacists assessed each
one for validity. A majority decision was necessary to validate an
Data on the number and types of pharmacist recommendations
and the percentage accepted were provided by computer. The ED
pharmacists completed a report describing each recommendation that
might have led to a change in a medication order.
study was designed to have an 80% power to detect a 66% relative risk
reduction (RRR) in the rate of medication errors historically occurring
in at least 10% of ED medication orders.[6,15] Sample-size
calculations showed that 56 chart reviews, or 224 medication orders,
were required per study group to find a 66% RRR at the two-tailed
significance level of 0.05. Historical estimates were
used for medication error frequency because of a lack of relevant
documentation at the health care facility.
The chi-square test
was used to compare the groups with respect to sex, race, and
medication error rates. Differences in age and number of medications
were analyzed with Student's t test and analysis of variance,
respectively. Descriptive statistics were used to assess pharmacist
recommendations. All statistical analyses were performed with JMP,
version 6.0.3 (SAS Institute Inc., Cary, NC).
A total of 490 medication orders written for 198 patients were evaluated for errors. The control group (n
= 94) and the intervention group (n
= 104) did not differ significantly with respect to age, sex, race, or number of medication orders ( Table 1
total of 37 and 14 medication errors were identified for the control
and intervention groups, respectively. The rate of errors was 16.09 per
100 medication orders for the control group and 5.38 per 100 orders for
the intervention group, a 66.6% difference (p
The pharmacists made 183 recommendations ( Table 2
). Practitioners accepted 72 (98.6%) of 73 recommendations documented
by the pharmacists; 110 recommendations were undocumented as accepted
or declined. The most common recommendations involved dosage
calculations (29%); inappropriate dosages, drugs, routes, or schedules
(26%); order clarifications (16%); and drug allergies (12%).
results of this study suggest that pharmacists assigned to an ED played
a role in reducing the rate of medication errors by two thirds. This
reduction is consistent with the 66-78% rate reductions observed in
previous studies in other hospital settings.[6,7] Almost all
the pharmacists' recommendations were accepted by other health care
professionals. The 99% acceptance rate in this study was higher than
the acceptance rates reported for the EDs at other institutions but
similar to the rates reported for other settings at other institutions.[6,8,17,18]
study has several limitations. First, the evaluator was not blinded to
the intervention group; this was considered impractical because of the
ubiquitous presence of date identifiers in the medical records.
However, a structured form with standard definitions of medication
errors was used for documentation to increase the objectivity of the
analysis. Also, a panel of pharmacists was used to assess the clinical
validity of each potential medication error. The panel was blinded to
the intervention group, reducing the potential impact of investigator
bias. A second limitation is the absence of a concurrent control group.
The decision to omit a concurrent control group was based on the lack
of a comparable unit without a pharmacist's presence. A third
limitation is the use of patient medical records for detection of
medication errors. Since direct observation has been shown to be more
efficient and accurate than chart review, the rate of medication errors
detected may have underrepresented the true rate. Finally, the study was limited to patients admitted to the ED; the results may not be generalizable to other specialty units.
rate of medication errors in an ED decreased significantly when
pharmacists prospectively reviewed ED medication orders. Virtually all
of the pharmacists' recommendations were accepted by other health care
||Control Group (n = 94)
||Intervention Group (n = 104)
|Mean ? S.D. age, yr
||32.3 ? 23.1
||37.0 ? 21.3
|Race, no. (%) pts
| African American
|Sex, no. (%) pts
|Total no. medications ordered
|Mean ? S.D. no. medications per pt
||2.44 ? 1.36
||2.46 ? 1.60
|Admitted to hospital, no. (%) pts
ap not significant for any comparison.
|Type of Recommendation
||No. Intervention (%)
|Inappropriate dosage, drug, route, or schedule
|Identification of drug allergy
|Miscellaneous or unspecified
|Approval of nonformulary medication
|Identification of duplicate therapy
|Clarification of medication history
|Identification of drug interaction
LT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer
health system. Washington, DC: National Academy Press; 1999.
- Fairbanks RJ, Hays DP, Webster DF et al. Clinical pharmacy services in an emergency department. Am J Health-Syst Pharm. 2004; 61:934-7.
P, Wolcott J, Bootman JL et al. Preventing medication errors:
qualitychasm series. Washington, DC: National Academy Press; 2006.
- Cobaugh DJ, Schneider SM. Medication use in the emergency department: why are we placing patients at risk? Am J Health-Syst Pharm. 2005; 62:1832-3.
- McCaig LF, Burt CW. National hospital ambulatory medical care survey: 2003 emergency department summary. Adv Data. 2003; 358:1-38.
LL, Cullen DJ, Clapp MD et al. Pharmacist participation on physician
rounds and adverse drug events in the intensive care unit. JAMA. 1999; 281:267-70.
SN, Peters M, Mlynarek M et al. Pharmacists on rounding teams reduce
preventable adverse drug events in hospital general medicine units. Arch Intern Med. 2003; 163:2014-8.
- Ling JM, Mike LA, Rubin J et al. Documentation of pharmacist interventions in the emergency department. Am J Health-Syst Pharm. 2005; 62:1793-7.
ST, Hennenfent JA, Ritchie DJ et al. A prospective, randomized trial to
assess the cost impact of pharmacist-initiated interventions. Arch Intern Med. 1999; 159:2306-9.
K, Collette D, Dang M et al. Transformation of a pharmacy department:
impact on pharmacist interventions, error prevention, and cost. Jt Comm J Qual Improv. 2002; 28:324-30.
- Lada P, Delgado G Jr. Documentation of pharmacists’ interventions in an emergency department and associated cost avoidance. Am J Health-Syst Pharm. 2007; 64:63-8.
- Leape LL, Bates DW, Cullen DJ et al. Systems analysis of adverse drug events. JAMA. 1995; 274:35-43.
Coordinating Counsel for Medication Error Reporting and Prevention.
What is a medication error? www.nccmerp.org/aboutMedErrors.html
(accessed 2006 Aug 25).
- Flynn EA, Barker KN, Pepper GA et al.
Comparison of methods for detecting medication errors in 36 hospitals
and skilled-nursing facilities. Am J Health-Syst Pharm. 2002; 59:436-47.
- Barker KN, Flynn EA, Pepper GA et al. Medication errors observed in 36 health care facilities. Arch Intern Med. 2002; 162:1897-903.
R. Inference for proportions: comparing two independent samples.
Power/sample size calculator.
http://newton.stat.ubc.ca/~rollin/stats/ssize/b2.html (accessed 2006
- Lee AJ, Boro MS, Knapp KK et al. Clinical and economic
outcomes of pharmacist recommendations in a Veterans Affairs medical
center. Am J Health-Syst Pharm. 2002; 59:2070-7.
- Sayles TJ. Documentation of pharmacists’ interventions and associated cost savings. Am J Health-Syst Pharm. 2004; 61:838, 840. Letter.
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