WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Attitude is an important factor impacting pharmacists' reporting of adverse drug events (ADE) to pharmacovigilance centres.
• However, little is known about ...United States (US) pharmacists' attitudes with respect to ADE reporting. No known study has assessed US pharmacists' attitude to report serious ADEs to the FDA.
WHAT THIS STUDY ADDS
• This study results suggest that pharmacists hold favourable attitudes toward reporting serious ADEs to the FDA and there is an association between pharmacists' attitude and intention to report serious ADEs.
• Pharmacists' beliefs that reporting serious ADEs was time consuming and disrupted the normal workflow impact on reporting intentions.
• Pharmacists' attitudes towards reporting need to be improved in order to enhance patient and drug safety.
AIM To investigate the influence of pharmacists' attitudes on intention to report serious adverse drug events (ADEs) to the Food and Drug Administration (FDA).
METHODS This cross‐sectional study used a mail survey to collect data from hospital and community pharmacists practicing in Texas, United States. Three and 16 items were used to measure intention and attitudes, respectively, using a seven‐point bipolar scale. Pharmacists' demographic and practice characteristics, and past reporting were also measured.
RESULTS The response rate was 26.4% (n= 377/1500 pharmacists). Most pharmacists intended (n= 297, 78.8%) to report serious ADEs that they will encounter to the FDA through MedWatch. Overall, pharmacists held favourable attitudes towards reporting serious ADEs (mean = 24.5, SD = 6.7, possible range 1–49, neutral = 16). Pharmacists intending to report serious ADEs had more favourable attitudes than those who did not (P < 0.001). About 90% of the pharmacists believed that reporting serious ADEs would improve patient safety. However, 72.6% indicated that reporting serious ADEs was time consuming and over half (55.5%) of the respondents believed that reporting serious ADEs disrupted the normal workflow. Non‐intenders held stronger beliefs that ADE reporting would disrupt the normal workflow and was time consuming compared with intenders. Years of experience, number of hours worked and practice setting were associated with pharmacists' attitudes towards reporting (P < 0.05).
CONCLUSIONS Most pharmacists held moderately favourable attitudes and high intentions toward reporting serious ADEs to the FDA. This study's findings contribute to an increased understanding of individual factors that influence pharmacists' attitude and intention towards reporting serious ADEs to the FDA.
Abstract
Background
Older patients using antihypertensive medication may experience Adverse Drug Events (ADEs), and thus benefit from deprescribing. The lack of a practical protocol may hamper ...deprescribing. Therefore, we aimed to develop a deprescribing protocol, based on a review of literature, combined with a feasibility test in a small number of patients.
Methods
A deprescribing protocol for general practitioners was drafted and tested in older patients using multiple antihypertensive medication in a single arm intervention. Patients were included if they were 75 years or older, were using two or more antihypertensives, had at least one ADE linked to antihypertensive medication and deprescribing was considered to be safe by their general practitioner. The primary outcome was the percentage of patients for whom one or more antihypertensive drugs were stopped or reduced in dose after 12 months of follow up while maintaining safe blood pressures. Secondary outcomes were the proportion of patients reporting no ADEs after 12 months and the number of deprescribed antihypertensives. Patient’s opinions on deprescribing and enablers and barriers for study participation were also collected.
Results
Nine general practitioners included 14 patients to deprescribe antihypertensive medication using the deprescribing protocol. After 12 months antihypertensive drug use was lowered in 11 patients (79%). These patients had a mean systolic blood pressure increase of 16 mmHg and a mean diastolic blood pressure increase of 8 mmHg. Nine patients (64%) reported experiencing no ADEs anymore after twelve months. The mean number of deprescribed antihypertensives was 1.1 in all patients and 1.4 (range: 0.5 to 3.5) in patients who successfully lowered their medication.
At baseline, being able to use less medication was the most frequently mentioned enabler to participate in this study. The most frequently mentioned positive experience at the end of the study was using less medication, which was in line with the most mentioned enabler to participate in this study.
Conclusion
A protocol for deprescribing antihypertensives in older patients was considered feasible, as it resulted in a substantial degree of safe deprescribing in this pilot study. Larger studies are needed to demonstrate the effect and safety of deprescribing antihypertensives in older patients.
Purpose The purpose of this study is to evaluate the clinical safety and usefulness of the Prosure®300 in contrast-enhanced abdominal CT. Materials and Methods This prospective study was approved by ...our center's Institutional Review Board. This study included 727 patients in four hospitals who underwent contrast-enhanced abdominal CT using Prosure®300 from December 2010 to June 2011. Adverse events were classified into minor and major adverse events. Logistic regression analysis was used to evaluate the relationship between adverse events and patient gender, age, underlying disease, and amount of injected contrast agent. Two radiologists independently evaluated imaging quality as poor, insufficient, sufficient, good, or very good. Results One hundred seventy-six out of 727 patients complained of adverse events, but most of them were minor adverse events. Five patients complained of dyspnea and one patient had hoarseness, but recovered without treatment. The rate of adverse events was significantly higher in men (p = 0.011), and a greater amount of injected contrast agent was related to a higher rate of adverse events (p = 0.000). Imaging quality was evaluated as ‘good’ or ‘very good’ in all cases. Conclusion Prosure®300, a generic CT contrast agent developed in South Korea, can be used in contrast-enhanced abdominal CT.
According to so many previous studies, lack of sufficient information during prescribing steps may lead to medication errors. Thus, the presence of the clinical pharmacist during routine rounding ...process in the ward with intervention of patient care plan may reduce the probability of adverse drug events (ADEs).This study evaluate role of the clinical pharmacists, as a member of medical team with the physician, on ADEs and report their interventions in the internal medicine unit. This study was designed to compare between two groups of patients, those receiving care from a rounding team (physician, nurse, and clinical pharmacist) (study or intervention group with 51 patient); and those receiving care from a rounding team (physician and nurse, but without any pharmacist) (control group with 49 patient). The primary outcome measure was preventable ADEs and secondary one involves the time of staying in the hospital and onset of response to therapy. Patients were randomly selected, followed a single-blind design, and evaluated by a senior physicians and clinical pharmacists who document their medical interventions.Specialist physicians accepted (60) of (77) recommendations (i.e. do modifications in drug therapy depending on clinical pharmacist interventions). The most common intervention was recommending dosage or frequency of medication (32.4%), followed by addition of medication (19.5%).The rate of preventable ordering ADEs in the study unit was 77% lower than in the control unit (P<0.05). There was no significant difference (p>0.05) in the cost of drug therapy between patient groups. Patients with ADEs in the control group had an average of 1.5 day longer staying period at the hospital; which was not differ significantly (p>0.05) from the study group.In summary, presence of clinical pharmacist during tour as a full member of the patient care team in internal medicine ward was associated with a substantially lowered rate of ADEs which caused by prescribing errors. Types of errors indicate the need for activation of the clinical pharmacist's interventions. Key words: adverse drug events (ADEs), clinical pharmacist.
Background:
The rapid increase in prescribing and use of opioids for noncancer pain has coincided with an increase in opioid-related adverse drug events (ADEs). The objective of our study was to ...describe ADEs related to tapentadol and oxycodone/naloxone spontaneously reported to the Australian Therapeutic Goods Administration (TGA).
Methods:
Public case detail reports for tapentadol (September 2013–March 2017) and oxycodone/naloxone (April 2011–March 2017) were sourced from the TGA. The total number of public case detail reports for tapentadol were 104 and 249 for oxycodone/naloxone. Demographic characteristics of patients, concomitant medications, causality assessment and outcome were described for each opioid according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class.
Results:
The most prevalent ADEs for tapentadol were nervous system disorders (n = 52, 50%), psychiatric (n = 34, 32.7%), gastrointestinal (n = 18, 17.3%), and general disorders and administration site conditions (n = 21, 20.2%). Sixteen (23.2%) of 69 nervous system disorders reaction terms were consistent with serotonin syndrome of which 14 (87.5%) involved documented coadministration with another serotonergic medication. The most prevalent ADEs for oxycodone/naloxone were psychiatric disorders (n = 78, 31.3%), gastrointestinal (n = 73, 29.3%), general disorders and administration site conditions (n = 87, 35%), and nervous system disorders (n = 62, 24.9%). There were 40 (16%) public case detail reports for oxycodone/naloxone with the MedDRA reaction terms ‘drug withdrawal syndrome’ and ‘withdrawal syndrome’.
Conclusion:
The profiles of spontaneous ADE reports for tapentadol and oxycodone/naloxone are largely consistent with their premarketing randomized controlled studies and profiles of opioids in general. Further research into the risk of serotonin syndrome with tapentadol use is warranted. The ADEs suggest clinicians should be cautious when switching patients to oxycodone/naloxone from other opioids.
Background
Sacubitril, a neprilysin inhibitor in the combination molecule sacubitril/valsartan, slows down degradation of endogenous natriuretic peptides, thereby enhancing their beneficial ...cardiovascular effects. However, sacubitril might also promote neuronal dysfunction and cognitive impairment in patients with chronic heart failure (CHF) treated with sacubitril/valsartan, due to possible neprilysin inhibition at the level of Central Nervous System.
Methods
A retrospective cohort study was undertaken to detect the effects exerted by sacubitril/valsartan on cognitive function in CHF patients. The patients’ clinical data were examined for information provided in the Mini-Mental State Examination (MMSE), which was routinely administered during clinical visits at two centers from 15 March to 31 October 2017. Patients in the sacubitril/valsartan group had a clinical history of at least 3 months of continuous sacubitril/valsartan administration. The control group comprised CHF patients on conventional therapy not taking sacubitril/valsartan. In the between-group comparison, patients were matched for mean age, educational level, sex, NYHA class, and comorbidities. In the present retrospective study only patients in NYHA class II-III were enrolled.
Results
The mean MMSE score was 22.72 ± 2.68 (mean ± standard deviation SD) in the sacubitril/valsartan group (
n
= 51 patients) vs. 21.96 ± 2.73 (mean ± SD) in the control group (
n
= 51;
p
= 0.1572, independent samples
t
-test). Thus, a similar mild-to-moderate impairment in cognitive performance was found in the comparison between the two groups.
Conclusion
In our study, we did not find any evidence of the alleged harmful influence of sacubitril/valsartan on cognitive function. Patients taking sacubitril/valsartan for at least 3 months had similar mean MMSE scores to control subjects.
OBJECTIVESThe aims of the study were to investigate the prevalence of hospital visits associated with medication-related problems (MRPs, i.e., adverse drug events ADEs, adverse drug reactions ADRs, ...nonadherence NA to medication, and medication error) and to identify the medications involved in hospital visits associated with MRPs in outpatient departments (OPDs).
METHODSA prospective observational study was carried out in OPD of 11 hospitals in the lower northern region of Thailand. Patients visiting OPDs were screened for suspected MRPs by clinical pharmacists using medical record review supplemented by patient interview. Three experts evaluated suspected MRPs using the following 3 criteriacausality, severity, and preventability.
RESULTSOf the 3069 patients who visited the OPDs during the study period, 113 (3.7%) were deemed to have causal MRPs. Nearly half of the causal MRPs (n = 49, 43.4%) were preventable. The following 4 types of causal MRPs were identifiedADEs (n = 112, 3.7%), ADRs (n = 65, 2.1%), NA to medications (n = 48, 1.6%), and medication errors (n = 1, 0.03%). In nonelective patients (n = 764), 35 patients (4.6%) were judged to have causal MRPs. Of the nonelective patients who experienced causal MRPs, 25 (71.4%) were preventable. The medications commonly associated with ADEs and NA to medication were those targeting the cardiovascular system (especially enalapril, amlodipine, and hydrochlorothiazide), whereas the medications involving ADRs involved the cardiovascular and endocrine systems (especially, enalapril, amlodipine, and metformin).
CONCLUSIONSOutpatient department visits associated with MRPs, particularly in nonelective patients, were preventable. Effective strategies are needed for reducing visits to hospital OPD associated with preventable MRPs.
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•We demonstrate significant improvement over a baseline approach to identifying ADEs from MEDLINE indexing.•This approach mitigates some of the inherent limitations of MEDLINE ...indexing for pharmacovigilance.•ADEs extracted from MEDLINE indexing are complementary to, not a replacement for, other sources.
Traditional approaches to pharmacovigilance center on the signal detection from spontaneous reports, e.g., the U.S. Food and Drug Administration (FDA) adverse event reporting system (FAERS). In order to enrich the scientific evidence and enhance the detection of emerging adverse drug events that can lead to unintended harmful outcomes, pharmacovigilance activities need to evolve to encompass novel complementary data streams, for example the biomedical literature available through MEDLINE.
(1) To review how the characteristics of MEDLINE indexing influence the identification of adverse drug events (ADEs); (2) to leverage this knowledge to inform the design of a system for extracting ADEs from MEDLINE indexing; and (3) to assess the specific contribution of some characteristics of MEDLINE indexing to the performance of this system.
We analyze the characteristics of MEDLINE indexing. We integrate three specific characteristics into the design of a system for extracting ADEs from MEDLINE indexing. We experimentally assess the specific contribution of these characteristics over a baseline system based on co-occurrence between drug descriptors qualified by adverse effects and disease descriptors qualified by chemically induced.
Our system extracted 405,300 ADEs from 366,120 MEDLINE articles. The baseline system accounts for 297,093 ADEs (73%). 85,318 ADEs (21%) can be extracted only after integrating specific pre-coordinated MeSH descriptors and additional qualifiers. 22,889 ADEs (6%) can be extracted only after considering indirect links between the drug of interest and the descriptor that bears the ADE context.
In this paper, we demonstrate significant improvement over a baseline approach to identifying ADEs from MEDLINE indexing, which mitigates some of the inherent limitations of MEDLINE indexing for pharmacovigilance. ADEs extracted from MEDLINE indexing are complementary to, not a replacement for, other sources.
Objectives:
The initial phase of infection of a foot ulcer in a person with diabetes is often categorized as mild. Clinicians usually treat these infections with antimicrobial therapy, often applied ...topically. Some experts, however, believe that mild diabetic foot ulcer infections will usually heal with local wound care alone, without antimicrobial therapy or dressings.
Methods:
To evaluate the potential benefit of treatment with a topical antibiotic, we performed a single-center, investigator-blinded pilot study, randomizing (1:1) adult patients with a mild diabetic foot ulcer infection to treatment with a gentamicin–collagen sponge with local care versus local care alone. Systemic antibiotic agents were prohibited.
Results:
We enrolled a total of 22 patients, 11 in the gentamicin–collagen sponge arm and 11 in the control arm. Overall, at end of therapy, 20 (91%) patients were categorized as achieving clinical cure of infection, and 2 (9%) as significant improvement. At the final study visit, only 12 (56%) of all patients achieved microbiological eradication of all pathogens. There was no difference in either clinical or microbiological outcomes in those who did or did not receive the gentamicin–collagen sponge, which was very well tolerated.
Conclusion:
The results of this pilot trial suggest that topical antibiotic therapy with gentamicin–collagen sponge, although very well tolerated, does not appear to improve outcomes in mild diabetic foot ulcer infection.
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