ArticlePDF Available

Use of tracking drugs for the search of intra-hospital adverse reactions: a pharmacovigilance study

Authors:

Abstract and Figures

Objective: To estimate the incidence of potential in-hospital adverse reactions with the use of alert drugs in a general hospital in southern Brazil. Method: Cross-sectional study, carried out in a hospital in southern Brazil. The electronic medical records (TASY®) of patients hospitalized between January and August 2020, who were prescribed one of the drugs earmarked for tracking adverse drug reactions, were evaluated: the drugs included flumazenil, fexofenadine hydrochloride, naloxone, promethazine, diphenhydramine and loperamide. Results: A total of 13,476 medical records were reviewed and 204 (1.5%) were included in the study in which tracker use was indicated in the management of adverse drug reactions. In this study a total of 18 different signs or symptoms were found in medical records, with pruritus/hyperemia/urticaria being the most reported symptoms (n = 76). Among the drug classes that caused most adverse drug reactions, opioids were the most mentioned (n = 44). It should be noted that in 49 medical records the information on which drug caused the adverse events was not reported. Regarding the cause of hospitalization of patients who used creening drugs, cancer was the most frequent (n = 37). Conclusions: This study indicates that the use of trackers can be a tool to estimate the occurrence of adverse drug reactions and to establish adverse events related to the use of medications, which should be reported to the pharmacovigilance service, with a view to patient safety.
Content may be subject to copyright.
Farmacia Hospitalaria
lEARLY ACCESS INDEXING l
Farmacia
HOSPITALARIA
Órgano o ficial de expre sión cientí fica de la Socie dad Española d e Farmacia Hospitalaria
Los artículos publicados en esta revista se distribuyen co n la licencia
Articles published in this jo urnal are licensed with a
Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
http://creativecommons.org/licenses/by-nc-sa/4.0/
La revista Farmacia no cobra tasas por el envío de trabajos,
ni tampoco por la publicación de sus ar tículos.
Kely Corrêa Benedet Baesso et al.
ORIGINALS
Bilingual edition English/Spanish
Use of tracking drugs for the search of intra-hospital
adverse reactions: a pharmacovigilance study
Uso de fármacos alertantes para la detección
de reacciones adversas intrahospitalarias:
estudio de farmacovigilancia
Kely Corrêa Benedet Baesso1, Diego Zapelini do Nascimento2,
Alessandra de Sá Soares2, Fabiana Schuelter-Trevisol2,3
1Univers idade do Sul d e Santa Cat arina, Curs o de Medicina, Tu barão (Sant a Catarin a). Brazil. 2Programa de Pós-Graduação em Ciências da Saúde. Universidade
do Sul de Santa Catarina, Tubarão (Santa Cat arina). Brazil. 3Hospital Nossa Senhora da Conceição, Centro de Pesquisas Clínicas, Tubarão (Santa Catarina),
Brazil.
Author of correspondence
Fabiana Schuelter-Trevisol
Avda. José Acácio Moreira, 787
Bairro: Dehon
88704-900. Tubarão (Santa Catarina).
Brazil.
Email:
fastrevisol@gmail.com
Resumen
Objetivo: Estimar la incidencia de potenciales reacciones adversas
intrahospitalarias con el uso de prescripciones alertantes en un hospital
general del sur de Brasil.
Método: Estudio transversal, realizado en un hospital del sur de Brasil.
Se evaluaron las historias clínicas electrónicas (TASY®) de los pacientes
hospitalizados entre enero y agosto de 2020, a los que se les prescribió
uno de los medicamentos destinados al seguimiento de reacciones adver-
sas a medicamentos: los medicamentos incluían flumazenil, clorhidrato
de fexofenadina, naloxona, prometazina, difenhidramina y loperamida.
Resultados: Se revisaron 13.476 historias clínicas y se incluyeron 204 (1,5%)
en el estudio en el que se indicó el uso de prescripciones alertantes en el
manejo de reacciones adversas a medicamentos. En este estudio se encontró un
total de 18 signos o síntomas diferentes en las historias clínicas, siendo el prurito,
la hiperemia y la urticaria los síntomas más reportados (n = 76). Entre las clases
de fármacos que causaron la mayoría de las reacciones adversas a medica-
mentos, los opioides fueron los más mencionados (n = 44). Cabe señalar que
en 49 historias clínicas no se reportó la información sobre qué fármaco causó
los eventos adversos. En cuanto a la causa de hospitalización de los pacientes
que utilizaron prescripciones alertantes, el cáncer fue la más frecuente (n = 37).
Abstract
Objective: To estimate the incidence of potential in-hospital adverse
reactions with the use of alert drugs in a general hospital in southern
Brazil.
Method: Cross-sectional study, carried out in a hospital in southern
Brazil. The electronic medical records (TASY®) of patients hospitalized
between January and August 2020, who were prescribed one of the
drugs earmarked for tracking adverse drug reactions, were evaluated:
the drugs included flumazenil, fexofenadine hydrochloride, naloxone, pro-
methazine, diphenhydramine and loperamide.
Results: A total of 13,476 medical records were reviewed and 204
(1.5%) were included in the study in which tracker use was indicated in the
management of adverse drug reactions. In this study a total of 18 different
signs or symptoms were found in medical records, with pruritus/hypere-
mia/urticaria being the most reported symptoms (n = 76). Among the drug
classes that caused most adverse drug reactions, opioids were the most
mentioned (n = 44). It should be noted that in 49 medical records the
information on which drug caused the adverse events was not reported.
Regarding the cause of hospitalization of patients who used screening
drugs, cancer was the most frequent (n = 37).
Received 19 October 2021;
Accepted 17 December 2021.
Early Access date (04/26/2022).
DOI: 10.7399/fh.13039
KEYWORDS
Drug-Related Side Effects and Adverse Reactions;
Pharmacy Service, Hospital; Drug Utilization; Patient Safety;
Pharmacovigilance.
PALABRAS CLAVE
Efectos colaterales y reacciones adversas relacionadas
con medicamentos; Servicio de Farmacia, utilización de
medicamentos; Seguridad del paciente; Farmacovigilancia.
13039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 113039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 1 25/4/22 12:5525/4/22 12:55
Farmacia Hospitalaria
l EARLY ACCESS INDEXING lKely Corrêa Benedet Baesso et al.
Introduction
In the hospital setting, due to the complexity of clinical conditions, it
is common to use extensive pharmacotherapy to manage the signs and
symptoms presented by patients. In health institutions, the drug can have
different purposes, and can be used for treatment (cure or palliative), or
for prophylactic and diagnostic purposes1. In addition, it is common that
hospitalized patients have multiple comorbidities and be prescribed one or
more medications2,3.
Clinically important adverse drug events (ADE) can affect an average of
10% to 20% of hospitalized patients, and out of these, 7% can die2,3. Inten-
sive care units (ICU) usually have a higher number of ADE when compared
to wards, as they have more complex illnesses, take care of critically ill
patients and because of the number and type of medication administered.
The ICU, pediatric and geriatric sectors, polytherapy, patients with impaired
renal function and female gender increase the risk of drug-related ADE,
which corresponds to adverse drug reactions (ADR) and medication errors
(ME)4.
It is observed that ADRs are among the ten leading causes of death in
the United States and generate a great economic impact on the health
systems5. According to the patient’s age, ADRs can account for 0.16% to
15.7% of hospital admissions5,6. ADRs in the hospital setting are the cause of
numerous illnesses, disabilities and deaths6. In this way, the trackers proved
to be useful for detecting suspected ADR. It is extremely important that the
early detection of ADR and ME be carried out by a qualified and experien-
ced professional, especially for elderly patients, who compose the group
that experiences most these adverse events and, in most cases, make use
of different medications. Patients with ADR have a longer average length
of stay compared to patients without ADR and have furthermore severe
conditions in greater proportions than the other patients, which means a
burden for the health system and increased risks for the patient in the hos-
pital setting5,6.
ADRs correspond to approximately 7.0% of hospitalizations in health
systems, resulting in 840,000 cases/year, increasing health costs7, 8 .
Different methods and approaches are increasingly used to discover sus-
pected ADRs. Reporting such suspicions is considered an accessible and
cost-effective strategy. However, underreporting, low quality of reports
and difficulty in estimating frequencies and rates of suspected ADRs are
some of the health systems’ shortcomings9,10. In addition, other potential
obstacles to the notification of ADRs are pointed out, such as the short
time to notify, fear of the consequences of notification, lack of return of
notifications made by the health professional, uncertainties about what to
notify and the questions about the notifications may impact on positive
changes11.
Due to the characteristics of these ADEs, there is a need to monitor the
processes related to medications in the hospital setting12 and the develop-
ment of actions that can predict and prevent these ADEs. In this connection,
with patient safety as a priority, the use of alert drugs is one of the methods
that enables the early identification of ADR occurrence in patients6. The use
of these alert drugs acts as a “trigger” tool, showing great sensitivity and
specificity for the detection of ADRs when compared to existing measures
that assess the harm to the patient per se13. The “trigger” tool technique is
performed through the retrospective review of the prescriptions of all patients
using alert drugs, to identify possible ADRs related to patient care, or pros-
pectively from the identification of the alert drug when the prescription is
delivered to the pharmacist at the hospital pharmacy14.
The Institute for Healthcare Improvement (IHI) developed, from the review
of medical records, trackers with the objective of monitoring ADE in hospi-
tals15. Trackers are defined as data or clues in the patient’s medical record
that warns about potential harm6 and their presence allows directing the
investigation to determine the occurrence and measurement of ADE16.
There are some medications that are frequently used as trackers, such
as antidotes and antihistamines17. Antidotes are used to reverse or mini-
mize ADE conditions because they are safer or because they cause fewer
side effects and antihistamines are used to block the action of histamine,
which is an important amine in mediating anaphylactic reactions18,19. The
IHI listed 19 potential medications, previously tested and selected using
the retrospective medical record review technique, as ADE alert medi-
cines. Some examples include: diphenhydramine, vitamin K, flumazenil,
droperidol, ondansetron, promethazine, hydroxyzine, trimethobenzamide,
prochlorperazine, metoclopramide, naloxone, sodium polystyrene, cor-
ticosteroids, glucose 10-50%, glucose-insuline, norepinephrine. These
medications can be used to manage clinical situations such as hypoglyce-
mia, hematological and coagulation alterations, elevation of serum crea-
tinine, excessive sedation, lethargy, fall, rash, among other effects that
characterize ADRs20.
In addition to identifying ADRs, it is necessary to create prevention,
treatment and notification processes within the health institutions. Automating
these procedures, active search and follow-up, increasingly help detecting
events more than passive communications. In this framework, the analysis
of signs and symptoms and the identification of the use of alert drugs are
the safest practices, as they act as warning signs for adverse events and
are used in the hospital setting in a prospective and retrospective way in
intervention studies or in emergency studies21.
Given the above, this study aims to evaluate the incidence of potential
in-hospital ADRs by using alert drugs in a general hospital in southern Brazil
between January and June 2020.
Methods
A cross-sectional epidemiological study was carried out in a general
hospital in southern Santa Catarina. The study population consisted of medi-
cal records of patients hospitalized between January and June 2020, who
received a prescription for one of the drugs considered to be ADR trackers17.
The sample was selected by convenience, according to the alert drug use
as reported in the medical record during the study period. The convenience
sample was selected by the Clinical Pharmacy service of the hospital. For
each drug considered an alert drug, the review of the chart was performed
to investigate the ADR. The Clinical Pharmacy service does not take place
full-time in the hospital, and for this reason, the convenience sampling system
was adopted.
The hospital under study is located in Southern of Brazil. Its a general,
private and philantropic hospital, with 400 inpatient beds. The hospital
currently has 30 ICU beds and 10 neonatal ICU beds, being State refe-
rence for median and high complexity in general service. In addition, it has
a cancer care center. The population attended is 80% of patients Unified
Health Systems (SUS), the public health care of Brazil.
The medical records of patients of any age and of both genders who
were prescribed one of the following alert drugs were considered. The
drugs used included flumazenil (injectable), fexofenadine hydrochloride,
naloxone (injectable), promethazine (injectable), diphenhydramine or lope-
ramide. These drugs were selected because they are part of the hospital’s
drug standards. The medicines choosen as alert drugs for ADR, were selec-
ted based on scientific studies and defined by the Hospital Pharmacy Com-
mittee, as a pilot project study in the researched hospital.
To start data collection, the Information Technology (IT) Department was
asked to provide a report on the dispensing of these drugs by the Hospital
Pharmacy within the defined period. The report included the patient’s ser-
vice number, enabling access to the electronic medical record. With the
report at hand, the electronic medical chart was revised by the hospital cli-
nic pharmacist to define the case and collect the study variables of interest,
such as: gender, age group, length of stay, prescribed tracking drug, doses
Conclusiones: Este estudio indica que el uso de alertadores puede ser
una herramienta para estimar la incidencia de reacciones adversas a medi-
camentos y establecer eventos adversos relacionados con el uso de
medicamentos, los cuales deben ser reportados al servicio de farmacovigi-
lancia, con miras a la seguridad del paciente.
Conclusions: This study indicates that the use of trackers can be a tool
to estimate the occurrence of adverse drug reactions and to establish
adverse events related to the use of medications, which should be repor-
ted to the pharmacovigilance service, with a view to patient safety.
13039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 213039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 2 25/4/22 12:5525/4/22 12:55
Farmacia Hospitalaria
l EARLY ACCESS INDEXING lUse of tracking drugs for the search of intra-hospital adverse reactions: a pharmacovigilance study
of tracking drug used, patient’s clinical outcome, hospitalization diagnosis,
identified ADR and potential ADR-causing drug.
ADR was defined when the tracker was used in-hospital and a sign and
symptom resulting from a medication emerged, whether this medication was
indicated in the medical record or not. When the tracker was previously
used or its indication of use was determined without connection to ADR, the
case was excluded.
In the description of the data, absolute (n) and relative (%) frequencies
were used for qualitative variables and measures of central tendency and
dispersion for quantitative variables. The Microsoft Office Excel program
was used to prepare the database and charts and the SPSS v.21 software
(IBM, Armonk, New York, USA) for data analysis.
This study was approved by the Research Ethics Committee of the Univer-
sidade do Sul de Santa Catarina under opinion 4,135,024, dated July4,
2020.
Results
Between January and June 2020, 13,476 medical records of the diffe-
rent patients (some number of patients as medical charts) containing a pres-
cription for one of the six alert drugs selected in this study were evaluated.
Out of 13,476 medical records reviewed, 204 (1.5%) were included in the
study considering the use of the tracker associated with the management
of ADR (Table 1).
The hospitalization diagnoses of patients who used alert drugs in the
management of ADR were: cardiovascular disease (29), surgery (28), diges-
tive tract diseases (27), orthopedics (18), urinary tract diseases (14), neuro-
logy (11), pneumology (8), infections (7), chronic pain (6), dermatology (4),
intoxication (2), hematology (2), gynecology and obstetrics (2), endocrino-
logy (2), metabolic disease (2), burns (1), and fever of unknown origin (1).
Table 2 shows the demographic and clinical characteristics of patients
who used alert drugs.
It is noteworthy that the median age of respondents was 58.5 years
(P25: 42.0; P75: 67.0 years) and ranged between zero and 94 years of
age. The median length of stay was 7 days (P25: 2.0; P75: 15.0 days) and
ranged between zero and 125 days.
The evaluation of the types of ADR showed that 185 (91.6%) patients
had one symptom, 15 (7.4%) patients had two concomitant symptoms, and
two (1.0%) patients had three concomitant symptoms (data not shown in
the table).
Figure 1 shows a total of 18 different symptoms among 204 medical
records assessed. The category called pruritus/hyperemia/urticaria was the
most frequently mentioned (n = 76).
Figure 2 shows the drugs that potentially caused ADR. Among the drugs
classes with available information, opioids were the most mentioned (n =
44). It should be noted that in 49 medical records the information on which
drug caused the adverse event was not reported, which corresponds to
24% of all medications evaluated.
Table 1. Distribution of tracking medication information across medical records and drugs included in the survey.
January to June 2020
Triggers Medical records evaluated Medical records included Percentage of evaluated medical
records (%)
Naloxone 784 42 5.4
Flumazenil 774 25 3.2
Promethazine 3,968 62 1.6
Fexofenadine 2,325 34 1.4
Diphenhydramine 3,249 29 0.9
Loperamide 2,376 12 0.5
Total 13,476 204 1.5
Table 2. Distribution of demographic and clinical characteristics
of patients and drugs used as tracers in the management
of adverse drug reactions. January to June 2020
Variables n %
Gender
Male 106 52.0
Female 98 48.0
Age (years)
0-19 9 4.5
20-39 39 19.1
40-59 55 26.9
60-94 101 49.5
Length of hospitalization (days)
0-7 108 52.9
8-15 48 23.5
16-29 29 14.2
≥ 30 20 9.4
Triggers
Fexofenadine 34 16.7
Naloxone 42 20.6
Flumazenil 25 12.3
Promethazine 62 30.4
Loperamide 12 5.9
Diphenhydramine 29 14.2
Number of doses used
1 154 75.5
2-6 37 18.1
7-16 13 6.4
Outcome
Discharge 173 84.8
Death 24 11.8
Transfer to another clinical care 7 3.4
13039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 313039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 3 25/4/22 12:5525/4/22 12:55
Farmacia Hospitalaria
l EARLY ACCESS INDEXING lKely Corrêa Benedet Baesso et al.
Discussion
The incidence rate found in this study was 1.5% for adverse drug reac-
tions based on the use of alert drugs for drug reactions identification. ADR
incidence rates may vary according to the literature, depending on the
characteristics of the hospital and the strategies used to identify and search
for reactions. While Lima et al.21 also found 1.5% of ADR in the patients
evaluated, Nóbrega et al.22 identified a 12.9% rate.
The identification of ADRs is complex and can be characterized under
different aspects, such as type, severity, causality, among others. The pre-
sent study showed a total of 18 different adverse reactions in the 204eva-
luated medical records; the most common ADRs were those related to
dermatological aspects such as pruritus/hyperemia/urticaria, followed by
lowered level of consciousness/chest discomfort. All ADRs were described
in the electronic evolution history of the patient. Because they are visible and
acutely uncomfortable, the most commonly identified ADRs are those seen
on the skin and defined as allergic, characterized by itching, rash and skin
hyperemia5. A prospective review of medical records was carried out at a
tertiary care hospital in North India from August 2010-May 2011 conclu-
ding that the major risk factors associated with ADR included the number of
drugs, length of hospitalization and number of diagnosis23. Based on the
findings a rigorous study is recommended to determine the burden and iden-
tify the risk factors of ADR to target interventions23. In two medical units of
an Indian teaching hospital, the total cost of 154 ADRs in 140 patients was
Indian rupees (Rs). 1,490,803 with an average of Rs. 1,070 per patient.
The preventable cost for 57/154 ADR was Rs. 96,31024.
Most ADR identified cases affected the elderly, which suggests that
those cases are associated with age and greater vulnerability to ADE. In
the aging process, senescence reduces immunity, making the patient more
Figure 1. Description of cases evaluated according to the types of adverse reactions to identified drugs.
Adverse drug reactions*
010 20 30 40 50 60 70 80
*Some patients had more than one type of reaction.
Other
Dysphasia
Changes in heart beat
Hypotension
Rash
Diarrhea
Erythema/Hyperemia
Respiratory distress
Edema
Altered level of consciousness
Itching
Drug causing adverse reaction
Anticholinergic
Antihypertensive
Corticosteroid
Vaccine
Antiemetic
Anesthetic
Non-steroidal anti-inammatory drugs
Antiarrhythmic
Non-opioid analgesic
Benzodiazepine
Chemotheraphy
Antibiotic
Opioid
Unknown
010 20 30 40 50 60
Figure 2. Description of cases evaluated according to the types of drugs causing adverse reactions.
13039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 413039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 4 25/4/22 12:5525/4/22 12:55
Farmacia Hospitalaria
l EARLY ACCESS INDEXING lUse of tracking drugs for the search of intra-hospital adverse reactions: a pharmacovigilance study
susceptible to allergic processes, and reduces the vital functions affecting
the pharmacokinetics. Furthermore, physiological changes due to the aging
process affect different systems in these patients, such as a reduction in the
renal filtration rate, resulting in potential intoxication, lower liver metabolism
and pharmacodynamic particularities21. In line with the literature, Nagai
etal. explained that the elderly, for the most part, take several medications
(polytherapy) for having numerous simultaneous chronic diseases in a higher
percentage when compared to younger populations6. Polytherapy conside-
rably increases the risk of drug interactions and adverse effects since several
drugs, of different classes and pharmacological effects are being admi-
nistered concurrently, sometimes at the same time of the day22. Therefore,
reducing the amount of medication used by the patient should be a concern
of the healthcare team that allows for the reduction of drug interactions and
healthcare costs24. An alternative that allows the reduction of the number
of drugs administered is the use of non-pharmacological and preventative
measures against the occurrence of health problems25.
No matter as there is a growing increase in ADR in hospital institutions
and that research on this subject has been developing18, its complexity and
the scarcity of studies that address this issue, makes it difficult to find reliable
scientific evidence showing the dimensions of morbidities related to ADR26,
especially in Brazil. A systematic review and meta-analysis assessed the
frequency of adverse drug reactions in hospitalized patients and concluded
the wide variation in methodologies was one of the most important mode-
rators of heterogeneity. Therefore, it is important standardize methodologies
to reduce bias27
.
Neoplasms were the most frequent cause of hospitalization among
patients who were identified with ADR, followed by diseases of the car-
diovascular system. Patients with neoplastic diseases normally make use
of different antineoplastic drugs, sometimes in combinations, which can
cause different ADRs. According to Pérez-Ricart et al.28, in 2019, the main
therapeutic groups involved in adverse drug events were antineoplastic
agents (21.3%). In addition, other aspects may increase the chance of these
patients developing ADR, such as the use of polytherapy, affected immune
system20, and prescription of morphine that is used for the treatment of neo-
plastic pain, and which may be responsible for the increase in the onset of
ADR as it triggers histamine release26,28.
A study conducted in a tertiary hospital used medications as “triggers”
to search for ADRs, and it was found that analgesics and antibiotics were
the drug classes that caused the most ADRs in hospitalized patients21. These
findings corroborate the present study, in which hypnoanalgesics and anti-
biotics occupied first and second position, respectively, in the drug classes
identified as causing ADR28.
The drug alert chosen for this study were determined using standardized
medications at the hospital studied. The most frequently used tracker was
naloxone with 5.4% efficacy. This efficacy is measured by anesthesiologists
who reported that with the administration of naloxone, sedation was redu-
ced. Naloxone can be considered a good tracker because it is used as an
opioid antidote, neutralizing ADRs, narcotic intoxication and its side effects,
such as respiratory depression29.
Decreased level of consciousness, chest discomfort, and drowsiness
were the adverse events found as a result of the excessive use of prescri-
bed opioids and benzodiazepines. For this reason, naloxone once again
appeared as an effective tracker, as well as flumazenil, which can block the
central effects of substances that are active on benzodiazepine receptors30.
Flumazenil is classified as an antidote drug by Anatomical Therapeutic Che-
mical (ATC), and its prescription is indicated to reverse sedative action after
anesthesia, as well as in the treatment of acute overdose of benzodiaze-
pines6. In this context, it was observed that this tracker was 3.2% effective
and, together with naloxone, was considered the most effective tracker as
ADR indicator30.
The recording of information in connection with the use of medications is
essential to safely monitor the use of this technology, in addition to allowing
the identification of ADRs or ME, which may have underestimated the reac-
tions in the period under study. Among the limitations of the study, the use of
electronic medical records is highlighted, which did not justify or detail the
process of dispensing and administering the medication, only the prescrip-
tion. The evolutions assessed were not always complete to understand the
temporality of the events, in order to properly track the ADR and the drug
that caused such an event. The research hospital is in the process of imple-
menting the Clinical Pharmacy service, therefore Naranjo or Karch-Lasagna
were not used to identified ADR. This research became a pilot Project for
the needs of pharmacovigilance, and relevant area to Clinical Pharmacy. It
would be extremely necessary and useful to know which specific drugs are
the most frequently involved in each category that follows in table 1, howe-
ver, as this study is cross-sectional retrospective, it is impossible to accurately
identify which drugs are the most frequent to develop adverse reactions,
requiring the use of alert drugs. So, this is another limitation on this study.
Therefore, in this study, the search for adverse events caused by alert drugs
was performed. It is noteworthy that this strategy, although already used, is
being carried out for the first time in the service in question and may help
to monitor cases, helping the clinical pharmacy and patient safety service.
It is important that the healthcare team gets involved in developing phar-
macovigilance actions aimed at preventing and reducing ADRs, bringing
together different professionals and creating multidisciplinary teams that can
contribute both to patient safety and to reducing healthcare costs. The use
of trackers, in addition to estimating the incidence of ADR, allows us to verify
the profile of the most vulnerable patients and the therapeutic classes most
related to the events. However, further research is also suggested regarding
interventions and the minimization of ADRs, so that hospitals can adapt their
institutions and capacitate their health team involved.
Funding
No funding.
Acknowledgements
To the Clinical Pharmacy sector of the Hospital Nossa Senhora da
Conceição
Conflict of interest
No conflict of interest.
Contribution to the scientific literature
There are some drugs that are frequently used to reverse or mini-
mize adverse events because they are safer or cause fewer associated
effects. These medications can be used as trackers or triggers in iden-
tifying adverse drug reactions (ADR). The use of trackers to estimating
the prevalence of adverse drug reactions allows us to verify the profile
of the most vulnerable patients and the therapeutic classes most related
to the events. This is very important for patient safety during inpatient
healthcare. Considering that the incidence and magnitude of adverse
drug reactions in the hospital environment is unknown, the importance
of this study is evident, which aims to reduce risks to the patient through
the surveillance of adverse events. As results, it is possible to reduce
costs and time of hospital stay. The healthcare team can be involved in
developing pharmacovigilance actions aimed at preventing and redu-
cing adverse drug reactions, bringing together different professionals
and creating multidisciplinary teams that can contribute both to patient
safety and to reducing healthcare costs.
Bibliography
1. Lombardo M, Eserian JK. A análise da qualidade de medicamentos e o papel do
laboratório oficial no co ntexto da saúde pública. Re. Adm Saúde. 2017;17(67):1-14.
DOI: 10.23973/ras.67.28
2. Duarte SCM, Stipp MAC, Silva MM, Oliveira FT. Adverse events and safety
in nursing care. Rev Bras Enferm. 2015;68(1):136-46. DOI: 10.1590/0034-
7167.2015680120
13039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 513039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 5 25/4/22 12:5525/4/22 12:55
Farmacia Hospitalaria
l EARLY ACCESS INDEXING lKely Corrêa Benedet Baesso et al.
3. Al-Tajir GK, Kelly WN. Epidemiology, comparative methods of detection, and pre-
ventability of adverse drug events. Ann Pharmacother. 2005;39(7-8):1169-74. DOI:
10.1345/a p h .1E5 59
4. Mota DM, Vigo A, Kuchenbecker RS. Reações adversas a medicamentos no sis-
tema de farmacovigilância do Brasil, 2008 a 2013: estudo descritivo. Cad Saúde
Pública. 2019;35(8):e00148818. DOI: 10.1590/0102-311X00148818
5. Fattinger K, Roos M, Vergeres P, Holenstein C, Kind B, Masche U, et al. Epidemio-
logy of drug exposure and adverse drug reactions in two Swiss departments of
internal medicine. Br J Clin Pharmacol. 2000;49(2):158-67. DOI: 10.1046/j.1365-
2125.2000.00132.x
6. Nagai KL, Takahashi PSK, Pinto LMO, Romano-Lieber NS, Nagai KL, Takahashi
PSK, et al. Uso de rastreadores para busca de reações adversas a medicamen-
tos como motivo de admissão de idosos em pronto-socorro. Cien Saude Colet.
2018;23 (11):3 997- 4 0 06. D O I: 10.159 0/1413-81232 0182311.27022016
7. Reis AMM, Alves CPB, Figueredo TP, Barroso SCC, Nascimento MMG. Reação
adversa a medicamentos como fator contribuinte para a internação hospitalar
de idosos. Rev Bras Farm Hosp Serv Saúde. 2017;8(3):8-13. DOI: 10.30968/
rbfhss.2017.083.002
8. Ramos S, Perdigão P, Oliveira RP. Erros relacionados aos medicamentos. En: Souza
P, Mendes W. Segurança do Paciente: criando organizações de saúde seguras.
Río de Janeiro: FIOCRUZ; 2019. p. 161-88.
9. Lima EC, Matos GC, Vieira JML, Gonçalves ICCR, Cabral LM, Turner MA. Sus-
pected adverse drug reactions reported for Brazilian children: cross-sectional study.
JPediatr. 2019;95(6):682-8. DOI: 10.1016/j.jped.2018.05.019
10. Yu A, Flott K, Chainani N, Fontana G, Darzi A. Patient Safety 2030 [Internet].
NIHR Imperial Patient Safety Translational Research Centre. London; 2016
[accessed 08/23/2021]. Available at: http://www.imperial.ac.uk/media/
imperial-college/institute-of-global-health-innovation/centre-for-health-policy/
Patient-Safety-2030-Report-VFinal.pdf
11. Leite MS, Leuschle VCKN, Deuschle RAN. Eventos adversos a medicamentos em
ambiente hospitalar. Rev Esp Cien Saúde. 2016; 4(1):82-91.
12. Lim D, Melucci J, Rizer MK, Prier BE, Weber RJ. Dete ction of adverse drug events using
an electronic trigger tool. Am J Health Syst Pharm. 2016;73(17Suppl4):S112-20.
DOI: 10. 214 6/ajhp150481
13. Carnevali L, Krug B, Amant F, Van Pee D, Gérard V, De Béthune X, et al. Perfor-
mance of the adverse drug event trigger tool and the global trigger tool for iden-
tifying adverse drug events: experience in a Belgian hospital. Ann Pharmacother.
2013;47(11):1414-9. D OI: 10.1177/106002801350 0939
14. Griffin FA, Resar RK. IHI Global Trigger Tool for Measuring Adverse Events. Cam-
bridge: Institute for Healthcare Improvement; 2009.
15. Fabretti SC, Brassica SC, Cianciarullo MA, Romano-Lieber NS. Rastreadores para
a busca ativa de eventos adversos a medicamentos em recém-nascidos. Cad
Saúde Pública. 2018;34(9):e00069817. DOI: 10.1590/0102-311X00069817
16. Saavedra PAE, Soares L, Nascimento SB, Oliveira JVL, Areda CA, Cunha KB, etal.
Os rastreadores de eventos adversos a medicamentos se aplicam a pacientes
hospitalizados por queimaduras? Rev Bras Queimaduras. 2018;17(1):20-7.
17. Steinman MA, Lund BC, Miao Y, Boscardin WJ, Kaboli PJ. Geriatric conditions,
medication use, and risk of adverse drug events in a predominantly male, older
veteran population. Am Geriatr Soc. 2011;59(4):615-21. DOI: 10.1111/j.1532-
5415.2011.03331
18. Sales VBS, Teles Filho AAM, Verolla BD, Morais BAS, Diniz CG, Iachinski JS, et al.
Anafilaxia: diagnóstico e tratamento. En: Carvalho Júnior FF. Alergia e Imunologia:
abordagens clínicas e prevenções. 186-99. DOI 10.37885/210404162
19. Giordani F, Rozenfeld S, Oliveira DFM, Versa GLGS, Terencio JS, Caldeira LF, et al.
Vigilância de eventos adversos a medicamentos em hospitais: aplicação e desem-
penho de rastreadores. Rev Bras Epidemiol. 2012;15(3):455-67. DOI: 10.1590/
S0034-8910.2013047004735
20. Rozenfeld S, Giordani F, Coelho S. Eventos adversos a medicamentos em hospital
terciário: estudo piloto com rastreadores. Rev Saúde Pública. 2013;47(6):1102-11.
DO I: 10.1590/S 0034-8910.2013047004735
21. Lima TJV, Garbini CAS, Araújo PC, Garbini AJI, Saliba TA, Saliba O. Reações
adversas a medicamentos entre idosos institucionalizados: prevalência e fato-
res associados. Arch Health Invest. 2017;6(3):129-35. DOI: /10.21270/archi.
v6i3 .19 21
22. Nóbrega LC, Sousa LBD, Gomes VP, Galvão TF. Medicamentos Rastreadores Na
Identificação de Reações Adversas em um Hospital. Rev Bras Farm Hosp Serv
Saúde. 2016;7(3):42-5.
23. Haile DB, Ayen WY, Tiwari P. Prevalence and assessment of factors contributing to
adverse drug reactions in wards of a tertiary care hospital, India. Ethiop J Health
Sci. 2013;23(1):39-48.
24. Doshi MS, Patel PP, Shah SP, Dikshit RK. Intensive monitoring of adverse drug
reactions in hospitalized patients of two medical units at a tertiary care teaching
hospital. J Pharmacol Pharmacother. 2012;3(4):308-13. DOI: 10.4103/0976-
500X.103687
25. Costa AJR, Ghidetti CA, Macedo RF, Godoy JSR, Teixeira CAB. Non-pharmacolo-
gical treatment of arterial hypertension in primary care: An integrative review. Res
Soc Dev. 2021;10(7): e46110716644. DOI: 10.33448/rsd-v10i7.16644
26. Reis CT, Martins M, Laguardia J. A segurança do paciente como dimensão da qua-
lidade do cuidado de saúde: um olhar sobre a literatura. Ciênc Saúde Coletiva.
2013;18(7 ):2029 -36 . D O I: 10.159 0/ S1413 - 81232 013 0 0 070 0 018
2 7. Miguel A, Azevedo LF, Araújo M, Pereira AC. Frequency of adverse drug reactions
in hospitalized patients: a systematic review and meta-analysis. Pharmacoepide-
miol Drug Saf. 2012;21(11):1139-54. DOI: 10.1002/pds.3309.
28. Pérez-Ricart A, Gea-Rodríguez E, Roca-Montañana A, Gil-Máñez E, Pérez-Feliu
A. Integrating pharmacovigilance into the routine of pharmacy department:
experience of nine years. Farm Hosp. 2019;43(4):128-33. DOI: 10.7399/
f h .1116 9
29. Andrade PA. Efecto de la dexmedetomidina y morfina intratecal como coadyu-
vantes en anestesia obstétrica. Rev Cient Cienc Méd. 2020;23(2):184-91. DOI:
10.515 81/rccm.v23i 2.12
30. Imbeloni LE. Naloxona: Estado atual. Rev Bras Anestesiol. 1989;39(2):133-41.
13039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 613039_Uso de farmacos alertadores para la deteccion de reacciones adversas_ING.indd 6 25/4/22 12:5525/4/22 12:55
... Group C patients (10) received saline instead of FLU and placebo tablets instead of oxazepam for 8 days [28]. FLU immediately reversed BZD effects on balance tasks and significantly reduced withdrawal symptoms in comparison with oxazepam and placebo on both self-reported and observer-rated withdrawal scales [29,30,31]. The partial agonist also reduced craving scores during the detoxification procedure. ...
Article
Full-text available
Introduction: The use of benzodiazepines (BDZ) is notoriously associated with significant long-term problems and it is estimated that the long-term users (LTU) in Italy are over 3 million people, including many elderly people. Unfortunately, 40 to 80% of the LTUs develop dependence and many also have tolerance, with the need for a progressive increase in the daily dosage up to the point of tolerating daily megadoses. In recent years, the off-label use of continuous infusion subcutaneous flumazenil has established itself as a viable approach for rapid hospital detoxification of these sometimes very complex clinical cases. The purpose of the article is, starting from the pharmacological and biochemical bases, to describe the mechanism of action, the areas of applicability and the possible criticalities by analyzing the Italian data. Materials and Methods: A computerized research was carried out for the articles to be inserted through use of international databases PUBMED and RESEARCHGATE by typing in keywords such as “flumazenil, high dose benzodiazepine users, use of flumazenil for benzo detoxification” and related articles. We also used the PUBCHEM database to describe some chemical and pharmacological characteristics of flumazenil. Both Italian and international research articles have been selected, starting from 1980 to today. Discussion and Conclusions: The use of flumazenil in slow infusion remains off-label but, for almost 20 years, it has been in use (in Italy and beyond) to detoxify, in about a week of hospitalization, patients with equivalent daily doses of diazepam greater than 50 mg / day for more than 6 months (with a description of cases up to 350 mg / day of diazepam-equivalent). This would allow the GABA-Argic receptor resensitization in a short time and with minimal or absent withdrawal symptoms, being able to suspend megadoses of BDZ in a very short time. In Italy this approach is still used to a limited extent and it cannot be said that it is absolutely the best method but the analysis of various endpoints in published studies, such as acute withdrawal discomfort, discharge without prescription of benzodiazepines and relapses in the first 6-12 months of discharge, certainly makes us reflect on the possibility of extending this approach to various territorial hospitals
Article
Full-text available
Background Pharmaceutical management is a new frontier subject between pharmacy, law and management, and related research involves the whole process of drug development, production, circulation and use. With the development of medical systems and the diversification of patients’ drug needs, research in the field of pharmaceutical management is becoming increasingly abundant. To clarify the development status of this field, this study conducted a bibliometric analysis of relevant literature in the field based on the knowledge graph method for the first time and explored the evolutionary trends of research hotspots and frontiers. Methods Literature was obtained from the Web of Science Core Collection database. CiteSpace 6.2.R4 (Advanced), VOSViewer, Scimago Graphica, Pajek and the R programming language were used to visualize the data. Results A total of 12,771 publications were included in the study. The publications in the field of pharmaceutical management show an overall increasing trend. In terms of discipline evolution, early research topics tended to involve the positioning of pharmacists and pharmaceutical care and the establishment of a management system. From 2000 to 2005, this period tended to focus on clinical pharmacy and institutional norms. With the development of globalization and the market economy, research from 2005 to 2010 began to trend to the fields of drug markets and economics. From 2010 to 2015, research was gradually integrated into health systems and medical services. With the development of information technology, after 2015, research in the field of pharmaceutical management also began to develop in the direction of digitalization and intelligence. In light of the global pandemic of COVID-19, research topics such as drug supply management, pharmaceutical care and telemedicine services under major public health events have shown increased interest since 2020. Conclusion Based on the knowledge mapping approach, this study provides a knowledge landscape in the field of pharmaceutical management research. The results showed that the reform of pharmacy education, the challenge of drug management under the COVID-19 pandemic, digital transformation and the rise of telemedicine services were the hot topics in this field. In addition, the research frontier also shows the broad prospects of the integration of information technology and pharmaceutical management, the practical value of precision pharmaceutical services, the urgent need of global drug governance, and the ethical and legal issues involved in the application of artificial intelligence technology in drug design, which points out the direction for the future development of pharmaceutical practice.
Article
Full-text available
El uso de coadyuvantes en anestesia obstétrica es útil para disminuir la dosis de los anestésicos locales. En boga la adición de un nuevo fármaco como es la dexmedetomidina espinal que abarca de 5 μg a 10 μg en el reporte mundial. Objetivos: Comparar el efecto de la administración espinal de la dexmedetomidina y morfina, más bupivacaina pesada en pacientes sometidas a cesárea. Métodos: Ensayo clínico, doble ciego y prospectivo de 99 pacientes randomizados en 3 grupos: grupo D2 (fentanilo 10 μg, bupivacaina 9 mg y dexmedetomidina 2 μg); grupo D3 (fentanilo 10 μg, bupivacaina 9 mg y dexmedetomidina 3 μg) y grupo M (fentanilo 10 μg, bupivacaina 9 mg y morfina 100 μg). Evaluación de parámetros hemodinámicos, duración de bloqueo motor, necesidad de vasopresores y complicaciones. Análisis estadístico: ANOVA para variables cuantitativas, para variables nominales se empleó chi cuadrado. Valor de p
Article
Full-text available
Objective: To describe our pharmacovigilance program and to analyze the reported adverse drug reactions. Method: Observational longitudinal study conducted from 2008 to 2016. The Pharmacy Department leads the pharmacovigilance program and performs prospective, retrospective, intensive, and spontaneous reporting of inpatients and outpatients (emergencies, day hospital, external consultations, and nursing homes). Each adverse drug reaction is incorporated in the electronic health record of the patient along with an alert. Results: A total of 2,631 adverse drug reactions were reported in 2,436 patients. Of these patients, 52% were men with a mean age of 63.3 (0-98) years. A total of 92.8% drug events were reported by the pharmacists and 7.2% by doctors, nurses, and technicians. A total of 63.7% were reported in inpatients, 19.2% in emergencies, 10.6% in external consultations, 6.2% in the day hospital, and 0.3% in diagnostic radiology. There was an increase in adverse drug reactions detected by prospective and intensive pharmacovigilance. Principal therapeutic groups involved in adverse drug events were antineoplastic agents (21.3%), antibacterials (12.3%), antithrombotics (7.7%), analgesics (6.7%), corticosteroids (5.2%), psycholeptics (5.2%), diuretics (4.9%), antivirals (4.9%), antiinflammatories and antirheumatics (4.2%), and immunosupressants (3.3%). Adverse drug reactions mainly affected the skin and appendages (19.7%) and gastrointestinal tract (19.1%). Adverse drug reactions were mild (38.7%), severe (30.8%), and moderate (30.5%). In total, 60.9% of patients recovered from drug events and 31.7% were in recovery. The most frequent response was treatment interruption in 65% of cases and the patients received additional specific treatment in 56% of cases. Conclusions: The incorporation of the pharmacovigilance program within the daily routine of the hospital pharmacist provides added value to the safety and pharmacotherapy of the patient.
Article
Full-text available
Resumo: Analisam-se as suspeitas de reações adversas a medicamentos notificadas no sistema de farmacovigilância do Brasil (Notivisa-medicamento) entre 2008 e 2013. Trata-se de estudo descritivo cujas unidades de análises da base de dados foram as notificações e os pares medicamento-reação adversa. Foi identificado um total de 26.554 notificações, o que produziu uma taxa de notificação de 22,8 milhões de habitantes/ano. As notificações referentes ao sexo feminino (60,5%) prevaleceram, assim como a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de reações adversas a medicamentos ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 registros de pares de medicamento-reação adversa, em que prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). Os medicamentos mais frequentes nas reações adversas a medicamentos graves pertenceram aos grupos L - agentes neoplásicos e imunomodulares (32,1%) e J - anti-infeciosos gerais para uso sistêmico (27%), ao passo que o sistema-órgão-classe mais afetado foi o relacionado a afecções da pele e distúrbios afins (23,7%). O Notivisa-medicamento é relevante recurso para a produção de sinais de alertas e hipóteses sobre a segurança de medicamentos comercializados no Brasil. No entanto, a taxa de notificação por milhão de habitantes/ano mostrou-se muito inferior àquela descrita por países de média e alta renda.
Article
Full-text available
O objetivo foi verificar a aplicação e o desempenho dos rastreadores para a busca ativa de eventos adversos a medicamentos em recém-nascidos hospitalizados. Trata-se de um estudo de coorte prospectivo. A pesquisa foi realizada em um hospital universitário, nas unidades de cuidado neonatal, durante o período de março a setembro de 2015. Uma lista de rastreadores foi desenvolvida para ser utilizada na identificação de eventos adversos a medicamentos nessa população. A lista contemplou rastreadores antídotos, clínicos e laboratoriais. Foram incluídos 125 recém-nascidos que utilizaram medicamentos durante a internação. Os prontuários dos recém-nascidos eram avaliados, a fim de detectar a existência de um rastreador. Se o rastreador fosse encontrado, seguia-se com uma revisão à procura de possíveis eventos adversos a medicamentos ocorridos. O rendimento de cada um dos rastreadores para identificar eventos adversos a medicamentos foi calculado e depois categorizado de acordo com o desempenho. Novecentos e vinte e cinco rastreadores identificaram 208 suspeitas de eventos adversos a medicamentos. A taxa de rendimento geral dos rastreadores foi de 22,5%. Os rastreadores mais identificados nos prontuários foram: queda da saturação de oxigênio, aumento da frequência de evacuação, suspensão de medicamento e vômito. Os rastreadores de alto desempenho na identificação de eventos adversos a medicamentos foram: aumento da creatinina, aumento da ureia, enterocolite necrosante, prescrição de flumazenil, hipercalcemia, hipercalemia, hipernatremia, hipersedação. Os rastreadores elencados com base neste estudo podem ser utilizados para a busca de eventos adversos a medicamentos em instituições de saúde de perfil semelhante, devendo ser considerados aqueles que obtiveram melhor desempenho e menor carga de trabalho para serem identificados.
Article
Full-text available
Objective: To assess spontaneous reports of suspected adverse drug reactions (ADRs) in children aged 0-12 years from the Brazilian Health Regulatory Agency between 2008 and 2013. Methods: A cross-sectional study on suspected ADR reports related to medicines and health products in children was carried out for a six-year period (2008-2013). Year of report, origin of report by Brazilian state, gender, age, suspected drug, adverse reaction description and seriousness were included in the analysis. The data obtained was compared to the number of pediatric beds in health services and to global data from the VigiBase (WHO). Results: A total of 3330 ADRs were reported in children in Brazil in the investigated period (54% were in boys). About 28% of suspected ADR reports involved 0 to 1-year-old children. Almost 40% of reports came from the Southeast region. Approximately 60% were classified as serious events. There was death in 75 cases. Nearly 30% of deaths involved off-label use; 3875 medicines (465 active substances) were considered suspected drugs. Anti-infective (vancomycin, ceftriaxone, oxacillin, and amphotericin), nervous system (metamizole) and alimentary tract and metabolism medicines were more frequent in reports. Conclusions: The distribution of suspected ADR reports by sex and age group corresponded to the profile of children hospitalized in Brazil. Data about seriousness and medicines reported may be useful to encourage regulatory actions and improve the safe use of medicines in children.
Article
Full-text available
Introdução: O aumento da expectativa de vida e o envelhecimento populacional estão associados a uma maior prevalência de doenças crônicas e o aumento do número de medicamentos utilizados. Nesse contexto, a ocorrência de reações adversas a medicamentos (RAM) em idosos é maior em relação aos demais indivíduos devido a vulnerabilidade do seu organismo.Objetivo: determinar a prevalência de reações adversas a medicamentos (RAM) relacionadas à farmacoterapia domiciliar que contribuíram para internação hospitalar de idosos. Métodos: Estudo transversal com idosos (60 anos ou mais), internados em enfermaria de clínica médica. A variável dependente do estudo foi a ocorrência de RAM relacionada a medicamentos de uso domiciliar. A causalidade das RAM foi verificada empregando-se o Algoritmo de Naranjo. Realizou-se análise univariada. Resultados: O estudo abrangeu 183 idosos, destes 22 (12%) apresentaram pelo menos uma RAM relacionada a medicamentos de uso domiciliar. Foram identificadas 26 RAM, sendo as mais frequentes intoxicação digitálica (n=4; 15,4%), elevação do RNI (n=2; 7,7%) e bradicardia (n=2; 7,7%). Os principais medicamentos relacionados às RAM foram digoxina (n=4), varfarina (n=4) e amiodarona (n=3). Em relação à causalidade 21 (80,7%) das RAM eram prováveis e 5 (19,3%) eram possíveis. A análise univariada demonstrou associação estatisticamente significativa com polifarmácia (OR: 3,05; IC95%1,14–8,21; p=0,021). Conclusão: A ocorrência de RAM representa um problema importante para a saúde dos idosos e pode contribuir para a internação. A ocorrência de RAM apresentou associação positiva com polifarmácia.
Article
Full-text available
Adverse drug events (ADE) are important causes of impairment of the quality of care for inpatients and therefore should be identified and characterized. Thus, lists of triggers were developed, including the proposal by the Institute for Healthcare Improvement. We analyzed the application of these triggers in a university hospital, with the cooperation of pharmacy and medical students, field training, standardized forms and manuals. Here, we present the process of application and performance of these triggers in a teaching hospital. The information on the triggers and ADE were collected through a retrospective chart review of patients discharged from January to June 2008. Four hundred and ninety-seven triggers were identified in 177 charts, and each chart had 2.33 (SD = 2.7) triggers on average. The most frequent triggers were: "antiemetic" (72.1/100 charts), "abrupt cessation of medication" (70.0/100 charts) and "over-sedation, drowsiness, numbness, lethargy, hypotension and fall" (34.6/100 charts). The most effective triggers for capturing ADE were "benzodiazepine antagonist", "antidiarrheal" and "rash", which, when identified in charts, were related to an event. The ADE most commonly found were related to the triggers, "abrupt cessation of medication" (8.3/100 charts), "antiemetic" (4.6/100 charts), "rash" and "anti-allergy" (2.1/100 charts). These results may help to decide which triggers are more useful in each situation.
Article
Full-text available
To estimate the frequency of and to characterize the adverse drug events at a terciary care hospital. A retrospective review was carried out of 128 medical records from a hospital in Rio de Janeiro in 2007, representing 2,092 patients. The instrument used was a list of triggers, such as antidotes, abnormal laboratory analysis results and sudden suspension of treatment, among others. A simple random sample of patients aged 15 and over was extracted. Oncologic and obstetric patients were excluded as were those hospitalized for less than 48 hours or in the emergency room. Social and demographic characteristics and those of the disease of patients who underwent adverse events were compared with those of patients who did not in order to test for differences between the groups. Around 70.0% of the medical records assessed showed at least one trigger. Adverse drug events triggers had an overall positive predictive value of 14.4%. The incidence of adverse drug events was 26.6 per 100 patients and 15.6% patients suffered one or more event. The median length of stay for patients suffering an adverse drug event was 35.2 days as against 10.7 days for those who did not (p < 0.01). The pharmacological classes most commonly associated with an adverse drug event were related to the cardiovascular system, nervous system and alimentary tract and metabolism. The most common active substances associated with an adverse drug event were tramadol, dypirone, glibenclamide and furosemide. Over 80.0% of events provoked or contributed to temporary harm to the patient and required intervention and 6.0% may have contributed to the death of the patient. It was estimated that in the hospital, 131 events involving drowsiness or fainting 33 involving falls, and 33 episodes of hemorrhage related to adverse drug effects occur annually. Almost one-sixth of in-patients (16,0%) suffered an adverse drug event. The instrument used may prove useful as a technique for monitoring and evaluating patient care results. Psycothropic therapy should be critically appraised given the frequency of associated events, such as excessive sedation, lethargy, and hypotension.
Article
Full-text available
Medication-related harm can be detected using the adverse drug event (ADE) trigger tool and the medication module of the Global Trigger Tool (GTT) developed by the Institute for Healthcare Improvement (IHI). In recent years, there has been some controversy on the performance of this method. In addition, there are limited data on the performance of the medication module of the GTT as compared with the ADE trigger tool. To evaluate the performance of the ADE trigger tool and of the medication module of the GTT for identifying ADEs. The methodology of the IHI was used. A random sample of 20 adult admissions per month was selected over a 12-month period in a teaching hospital in Belgium. The ADE trigger tool was adapted to the Belgian setting and included 20 triggers. The positive predictive value (PPV) of each trigger was calculated, as well as the proportion of ADEs that would have been identified with the medication module of the GTT as compared with the ADE trigger tool. A total of 200 triggers and 62 ADEs were found, representing 26 ADEs/100 admissions. Nineteen ADEs (31%) were found spontaneously without the presence of a trigger. Three triggers never occurred. The PPVs of other triggers varied from 0 to 0.67, with half of them having PPVs less than 0.20. If we had used the medication triggers included in the GTT (n = 11), we would have identified 77% of total ADEs and 67% of preventable ADEs. Applying the trigger tool method proposed by the IHI to a Belgian hospital led to the identification of one ADE out of 4 admissions. To increase performance, refining the list of triggers in the ADE trigger tool and in the medication module of the GTT would be needed. Recording nontriggered events should be encouraged.
Article
Purpose: Implementation and refinement of an integrated electronic "trigger tool" for detecting adverse drug events (ADEs) is described. Methods: A three-month prospective study was conducted at a large medical center to test and improve the positive predictive value (PPV) of an electronic health record-based tool for detecting ADEs associated with use of four "trigger drugs": the reversal agents flumazenil, naloxone, phytonadione, and protamine. On administration of a trigger drug to an adult patient, an electronic message was transmitted to two pharmacists, who reviewed cases in near real time (typically, on the same day) to detect actual or potential ADEs. In phase 1 of the study, any use of a trigger drug resulted in an alert message; in subsequent phases, the alerting criteria were narrowed on the basis of clinical criteria and laboratory data with the goal of refining the trigger tool's PPV. Results: A total of 87 drug administrations were reviewed during the three-month study period, with 27 ADEs detected. PPV values in phases 1, 2, and 3 were 0.33, 0.21, and 0.36, respectively. The relatively low overall PPV of the trigger tool was largely attributable to false-positive trigger messages associated with phytonadione use (such messages were reduced from 35 in phase 1 to 7 in phase 3). Conclusion: Evaluation and refinement of an electronic trigger tool based on detecting the use of the reversal agents flumazenil, naloxone, phytonadione, and protamine found an overall PPV of 0.31 during a three-month study period.