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American Journal of Ophthalmology Case... Sep 2020Many consumer products and non-ophthalmic medications are packaged in plastic "eye dropper" bottles, posing a risk of accidental ocular chemical injury when these...
PURPOSE
Many consumer products and non-ophthalmic medications are packaged in plastic "eye dropper" bottles, posing a risk of accidental ocular chemical injury when these substances are mistaken for eye drops.
OBSERVATIONS
We present the case of an elderly glaucoma patient who mistook blue stamper ink for the glaucoma medication Combigan®, and suffered ocular injury as a result.
CONCLUSIONS AND IMPORTANCE
The packaging of non-ophthalmic products in plastic "eye dropper" bottles poses a significant risk of accidental ocular chemical injury. Elderly individuals with low vision and/or cognitive deficits may be at particular risk of accidental injury. Ophthalmologists have been calling for a greater distinction between the packaging of ophthalmic and non-ophthalmic products for over 35 years, but to date little progress has been made in this regard.
PubMed: 32566800
DOI: 10.1016/j.ajoc.2020.100773 -
Sensors (Basel, Switzerland) Apr 2020A common problem for healthcare providers is accurately tracking patients' adherence to medication and providing real-time feedback on the management of their medication...
A common problem for healthcare providers is accurately tracking patients' adherence to medication and providing real-time feedback on the management of their medication regimen. This is a particular problem for eye drop medications, as the current commercially available monitors focus on measuring adherence to pills, and not to eye drops. This work presents an intelligent bottle sleeve that slides onto a prescription eye drop medication bottle. The intelligent sleeve is capable of detecting eye drop use, measuring fluid level, and sending use information to a healthcare team to facilitate intervention. The electronics embedded into the sleeve measure fluid level, dropper orientation, the state of the dropper top (on/off), and rates of angular motion during an application. The sleeve was tested with ten patients (age ≥65) and successfully identified and timestamped 94% of use events. On-board processing enabled event detection and the measurement of fluid levels at a 0.4 mL resolution. These data were communicated to the healthcare team using Bluetooth and Wi-Fi in real-time, enabling rapid feedback to the subject. The healthcare team can therefore monitor a log of medication use behavior to make informed decisions on treatment or support for the patient.
Topics: Algorithms; Glaucoma; Health Personnel; Humans; Machine Learning; Medication Adherence; Ophthalmic Solutions
PubMed: 32344754
DOI: 10.3390/s20082435 -
Pediatrics Apr 2020The albuterol dropper bottle used to prepare solutions for continuous nebulization contains the preservative benzalkonium chloride (BAC). BAC, by itself, has been shown...
BACKGROUND AND OBJECTIVES
The albuterol dropper bottle used to prepare solutions for continuous nebulization contains the preservative benzalkonium chloride (BAC). BAC, by itself, has been shown to cause bronchospasm. We hypothesized that BAC would decrease the therapeutic efficacy of albuterol in patients with acute asthma exacerbations.
METHODS
We performed a retrospective cohort study comparing the clinical outcomes of patients <18 years of age receiving continuous nebulized albuterol with and without BAC. For the primary end point (duration of continuous albuterol nebulization), we compared the 2 groups with Kaplan-Meier estimate of survival curves, conducted a log-rank test of difference, and adjusted for baseline characteristics using multivariable Cox regression. A value <.05 was considered significant.
RESULTS
A total of 477 patients were included in the analysis (236 exposed to BAC and 241 controls). The duration of continuous nebulization was significantly longer in the BAC group than in the control group (median of 9 vs 6 hours; 15.7% required continuous nebulization compared to 5.8% of controls at 24 hours). The control group was 79% more likely to stop continuous nebulization at any particular point in time (hazard ratio 1.79; 95% confidence interval: 1.45 to 2.22; < .001) and 43% more likely to stop additional respiratory support (hazard ratio 1.43; 95% confidence interval: 1.16 to 1.75; < .001).
CONCLUSIONS
BAC is a functional albuterol antagonist associated with a longer duration of continuous albuterol nebulization treatment and additional respiratory support, suggesting that preservative-free albuterol formulations are safer for use in continuous nebulization.
Topics: Administration, Inhalation; Adolescent; Albuterol; Asthma; Benzalkonium Compounds; Bronchodilator Agents; Child; Child, Preschool; Disease Progression; Drug Interactions; Female; Humans; Infant; Infant, Newborn; Kaplan-Meier Estimate; Linear Models; Male; Preservatives, Pharmaceutical; Regression Analysis; Retrospective Studies
PubMed: 32165556
DOI: 10.1542/peds.2019-0107 -
Translational Vision Science &... May 2019We developed and evaluated an eye dropper bottle sensor system comprising motion sensor with automatic motion waveform analysis using deep learning (DL) to accurately...
PURPOSE
We developed and evaluated an eye dropper bottle sensor system comprising motion sensor with automatic motion waveform analysis using deep learning (DL) to accurately measure adherence of patients with antiglaucoma ophthalmic solution therapy.
METHODS
We enrolled 20 patients with open-angle glaucoma who were treated with either latanoprost ophthalmic solution 0.005% or latanoprost-timolol maleate fixed combination ophthalmic solution in both eyes. An eye dropper bottle sensor was installed at patients' homes, and they were asked to instill the medication and manually record each instillation time for 3 days. Waveform data were automatically collected from the eye dropper bottle sensor and judged as a complete instillation by the DL instillation assessment model. We compared the instillation times captured on the waveform data with those on each patient's record form. In addition, we also calculated instillation movement duration from Waveform data.
RESULTS
The developed eye bottle sensor detected all 60 instillation events (100%). Mean difference between patient and eye bottle sensor recorded time was 1 ± 1.22 (range, 0-3) minutes. Additionally, mean instillation movement duration was 16.1 ± 14.4 (range, 4-43) seconds. Two-way ANOVA revealed a significant difference in instillation movement duration among patients ( < 0.001) and across days ( < 0.001).
CONCLUSION
The eye dropper bottle sensor system developed by us can be used for automatic monitoring of instillation adherence in patients with glaucoma.
TRANSLATIONAL RELEVANCE
We believe that our eye dropper bottle sensor system will accurately measure adherence of all glaucoma patients as well as help glaucoma treatment.
PubMed: 31293810
DOI: 10.1167/tvst.8.3.55 -
PeerJ 2018Polyhexamethylene biguanide (PHMB) eye drops are a frequently used medication to treat Acanthamoeba keratitis. In the absence of marketed PHMB eye drops,...
BACKGROUND
Polyhexamethylene biguanide (PHMB) eye drops are a frequently used medication to treat Acanthamoeba keratitis. In the absence of marketed PHMB eye drops, pharmacy-compounding units are needed to prepare this much needed treatment, but the lack of validated PHMB stability data severely limits their conservation by imposing short expiration dates after preparation. In this study we aim to assess the physicochemical and microbiological stability of a 0.2 mg/mL PHMB eye drop formulation stored in two kinds of polyethylene bottles at two different temperatures.
METHODS
A liquid chromatography coupled with diode array detector stability-indicating method was validated to quantify PHMB, using a cyanopropyl bonded phase (Agilent Zorbax Eclipse XDB-CN column 4.6 × 75 mm with particle size of 3.5 μm) and isocratic elution consisting of acetonitrile/deionized water (3/97 v/v) at a flow rate of 1.3 mL/min. PHMB eye drops stability was assessed for 90 days of storage at 5 and 25 °C in ethylene oxide sterilized low density polyethylene (EOS-LDPE) and gamma sterilized low density polyethylene (GS-LDPE) bottles. The following analyses were performed: visual inspection, PHMB quantification and breakdown products (BPs) screening, osmolality and pH measurements, and sterility assessment. PHMB quantification and BP screening was also performed on the drops emitted from the multidose eyedroppers to simulate in-use condition.
RESULTS
The analytical method developed meets all the qualitative and quantitative criteria for validation with an acceptable accuracy and good linearity, and is stability indicating. During 90 days of storage, no significant decrease of PHMB concentration was found compared to initial concentration in all stored PHMB eye drops. However, BP were found at day 30 and at day 90 of monitoring in both kind of bottles, stored at 5 and 25 °C, respectively. Although no significant variation of osmolality was found and sterility was maintained during 90 days of monitoring, a significant decrease of pH in GS-LDPE PHMB eye drops was noticed reaching 4 and 4.6 at 25 °C and 5 °C respectively, compared to initial pH of 6.16.
DISCUSSION
Although no significant decrease in PHMB concentration was found during 90 days of monitoring in all conditions, the appearance of BPs and their unknown toxicities let us believe that 0.2 mg/mL PHMB solution should be conserved for no longer than 60 days in EOS-LDPE bottles at 25 °C.
PubMed: 29682408
DOI: 10.7717/peerj.4549 -
Eye (London, England) Oct 2017PurposeTo assess the safety and efficacy of an eye drop combining osmoprotectants, carboxymethylcellulose and hyaluronic acid (O/CMC/HA) in reducing symptomatic,... (Randomized Controlled Trial)
Randomized Controlled Trial
PurposeTo assess the safety and efficacy of an eye drop combining osmoprotectants, carboxymethylcellulose and hyaluronic acid (O/CMC/HA) in reducing symptomatic, moderate to severe dry eye, compared with HA.MethodsIn this investigator-masked, randomised study, patients instilled 1-2 drops/eye of O/CMC/HA or HA (2-6 times/day) for 3 months. Primary endpoint: mean change in Global Ocular Staining Score (GOSS) from baseline at day 35. Noninferiority of O/CMC/HA was tested in the per-protocol population; if achieved, superiority was tested in the intent-to-treat population. Secondary efficacy endpoints: mean change from baseline in GOSS, Ocular Surface Disease Index (OSDI), Schirmer score, tear break-up time (TBUT), corneal/conjunctival staining, conjunctival hyperaemia, symptoms, and patient/investigator assessments.ResultsBaseline characteristics were comparable between groups (n=40 each). O/CMC/HA was noninferior (and not superior) to HA based on similar GOSS reductions from baseline at day 35 and month 3 in both groups (P=0.778, day 35, per-protocol population). Overall, O/CMC/HA and HA provided similar reductions in OSDI, Schirmer score, TBUT, corneal staining and hyperaemia from baseline at 35 days (P≥0.155). More patients reported less severe stinging/burning, sandiness/grittiness, and painful/sore eyes at month 3 with O/CMC/HA (P≤0.039), and more rated the dropper bottle easy to use (87.5%), compared with HA (46.2%; P=0.002). Other patient and investigator assessments were similar between groups. O/CMC/HA and HA were well tolerated.ConclusionsO/CMC/HA is noninferior to HA in improving objective signs of dry eye, with potential advantages for subjective symptoms and patient acceptance.
Topics: Carboxymethylcellulose Sodium; Dose-Response Relationship, Drug; Drug Administration Schedule; Dry Eye Syndromes; Female; Humans; Hyaluronic Acid; Male; Middle Aged; Ophthalmic Solutions; Osmosis; Severity of Illness Index; Tears; Treatment Outcome; Viscosupplements
PubMed: 28452989
DOI: 10.1038/eye.2017.73 -
Respiratory Medicine Case Reports 2017Nebulized bronchodilator solutions are available in the United States as both nonsterile and sterile-filled products. Sulfites, benzalkonium chloride (BAC), or...
Paradoxical bronchospasm from benzalkonium chloride (BAC) preservative in albuterol nebulizer solution in a patient with acute severe asthma. A case report and literature review of airway effects of BAC.
Nebulized bronchodilator solutions are available in the United States as both nonsterile and sterile-filled products. Sulfites, benzalkonium chloride (BAC), or chlorobutanol are added to nonsterile products to prevent bacterial growth. Bronchoconstriction from inhaled BAC is cumulative, prolonged, and correlates directly with basal airway responsiveness. The multi-dose dropper bottle of albuterol sulfate solution contains 50 μg BAC per/2.5 mg of albuterol, which may be below or at the lower limit of the threshold dose for bronchoconstriction. However, with repeated albuterol nebulization, the effect can be additive and cumulative, often exceeding the bronchoconstriction threshold. We report a case of a 17 years old patient, who received 32 mg of BAC via nebulization over a period of 3.5 days that probably caused persistent bronchospasm evidenced by failure to improve clinically and to increase peak expiratory flow rate (PEFR) from 125 L/min (27% of predicted value) to 300 L/min (68% of predicted value) within 2 hours of withdrawing BAC. The patient's respiratory status and PEFR improved dramatically once the nebulization solution was switched to BAC free lev-albuterol solution. The pediatric providers, particularly the emergency department physicians, intensivists and pulmonologists need to be aware of this rare albeit possible toxicity to the respiratory system caused by BAC used as a preservative in albuterol nebulizer solution.
PubMed: 28377880
DOI: 10.1016/j.rmcr.2017.03.005 -
The Journal of Pediatric Pharmacology... 2016The US Food and Drug Administration industry guidelines for manufacturers of oral, over-the-counter, liquid medications recommend that these products be packaged with...
OBJECTIVES
The US Food and Drug Administration industry guidelines for manufacturers of oral, over-the-counter, liquid medications recommend that these products be packaged with dosage-delivery devices. This study describes the prevalence of these devices and instructions packaged with prescription, oral, liquid medications.
METHODS
This was a descriptive study of prescription oral-liquid medications dispensed during a 6-month period at a community pharmacy. Product information was obtained from the National Library of Medicine's DailyMed database and from the products themselves. Endpoints included provision of a measuring device, the type of device, the maximum dose measurable and intervals on the provided device, and inclusion of instructions to the pharmacist.
RESULTS
A total of 382 liquid prescription medications were included in the study. Forty-nine of the 382 products (12.8%) were packaged with a measuring device. The most commonly provided device was a calibrated dropper (n = 18; 36.7%), followed by an oral syringe with a bottle adaptor (n = 9, 18.4%). Specific instructions on proper use of the provided measuring device were included with 20 products (40.8%). Among the products that did not provide a measuring device, only 70 of the 333 package inserts (21%) included instructions to the pharmacist regarding counseling the patient on proper administration.
CONCLUSIONS
Packaging of prescription oral-liquid medications is inconsistent and leaves room for vast variability in patient or parent administration practices. In the future, patterns of actual dispensing practices among pharmacies and pharmacists would help determine the true incidence of dispensing of measuring devices.
PubMed: 26997931
DOI: 10.5863/1551-6776-21.1.75 -
BMC Pregnancy and Childbirth Dec 2015Infections are responsible for 30-40 % of 4 million neonatal deaths annually. Use of chlorhexidine (CHX), a broad-spectrum topical antiseptic with strong residual... (Randomized Controlled Trial)
Randomized Controlled Trial
Trial of improved practices approach to explore the acceptability and feasibility of different modes of chlorhexidine application for neonatal cord care in Pemba, Tanzania.
BACKGROUND
Infections are responsible for 30-40 % of 4 million neonatal deaths annually. Use of chlorhexidine (CHX), a broad-spectrum topical antiseptic with strong residual activity, for umbilical cord cleansing has been shown to reduce infections during the neonatal period. However, the challenge remains with regard to selection of best mode of CHX delivery. As a part of formative research, we undertook a qualitative study in Pemba Island as a pilot to explore the attitudes; beliefs and practices of the community and health workers related to delivery, newborn and cord care. During the second phase of formative research, we used Trials of Improved Practices (TIPs) methodology to explore the acceptance and impediments, for the three possible modes of chlorhexidine application- 100 ml bottle with cotton swab, 10 ml single use dropper bottle and 3 g single application squeeze tube containing gel, as an umbilical cord care intervention.
METHODS
In this pilot study, 204 mother-newborn pairs were enrolled from hospital and community setting in Pemba, Tanzania using a randomized three period crossover design. Mothers/guardians, Trained Birth Attendants (TBA)/ medical staff and community health workers (CHWs) were requested to try three different modes of CHX application for cord cleaning. All participants were demonstrated the method of cord cleaning using all three modes of delivery; each delivery mode was used for 3 days and an interview was conducted on day 10 to collect summary of their experience. Acceptance and preference scores were calculated based on feedback from the participants.
RESULTS
Of 204 mother-newborn pairs, 27 were lost to follow up. 177 mothers performed the intervention and applied CHX to the newborn cord for all 9 days. Mothers rated 10 ml dropper bottle (49.7 %) as most convenient in terms of ease and application. They selected 10 ml dropper bottle (44.6 %) as their first choice; gel tube (33.9 %) and 100 ml bottle (21.5 %) as their second and third choice. TBAs, medical staff and CHWs also preferred 10 ml dropper bottle (43.3 %) over 100 ml bottle (12.9 %) and gel (38.8 %).
CONCLUSIONS
Overall acceptability of CHX application for cord cleansing was high. 10 ml single use dropper bottle was given highest preference for CHX application. An understanding of the attitudes, beliefs and cultural practices in the community and selection of the most acceptable mode of CHX delivery is essential to the design and implementation of the intervention trials examining the efficacy of CHX cord care in reducing neonatal mortality and subsequent implementation in the programs.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01528852 Registered February 3, 2012.
Topics: Anti-Infective Agents, Local; Chlorhexidine; Delivery, Obstetric; Female; Humans; Infant; Infant Mortality; Infant, Newborn; Patient Acceptance of Health Care; Pilot Projects; Pregnancy; Qualitative Research; Sepsis; Tanzania; Umbilical Cord
PubMed: 26711437
DOI: 10.1186/s12884-015-0760-4 -
Medicine Feb 2015The aim of this study was to compare the percentage of contamination of multiuse eyedrops applied by glaucoma patients at home and by the medical personnel at the... (Comparative Study)
Comparative Study Observational Study
The aim of this study was to compare the percentage of contamination of multiuse eyedrops applied by glaucoma patients at home and by the medical personnel at the outpatient department, the ward, and the operating room of our Department of Ophthalmology. Eyedrops were collected over a period of 11 months. Samples were taken from the dropper tip (smear), drops, and the residual fluid inside the bottle and cultivated on blood agar. Colony forming units were counted and identified by mass spectrometry. The percentage of contamination was significantly higher in eyedrops applied by the patients (29/119; 24.4%, P < 0.01), used in the ward (26/133; 19.5%, P < 0.01), and in the outpatient unit (6/35; 17.1%, P = 0.036) compared with that in the operating room (6/113; 5.3%). The median period of use was 1 week in the operating room compared with 4 weeks in the other groups (P < 0.01). Glaucoma medications were significantly more frequently contaminated than antibiotic and anesthetic eyedrops (P < 0.05). For eyedrops applied by the patients, the tip was more frequently contaminated than the drops and the residual internal fluid. For eyedrops from the ward, the opposite was true. Pathogenic strains (Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter lwoffii, Stenotrophomonas maltophilia, and Staphylococcus aureus) were found only in 6 bottles (1.5%), whereas most of the detected microbes belonged to human or environmental flora. This study underlines the importance of hygienic handling of eyedrops and raises the question of whether single-use glaucoma medication might be preferred to reduce the risk of contamination.
Topics: Academic Medical Centers; Ambulatory Care; Drug Contamination; Glaucoma; Humans; Ophthalmic Solutions
PubMed: 25715262
DOI: 10.1097/MD.0000000000000583