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Biomedica : Revista Del Instituto... Sep 2020Eye burns due to the accidental application of pharmacological or nonpharmacological substances packaged in plastic dropper bottles have been described for more than...
Eye burns due to the accidental application of pharmacological or nonpharmacological substances packaged in plastic dropper bottles have been described for more than three decades and continue to occur. These burns can cause potentially serious corneal injuries. We report the case of a patient who mistakenly applied salicylic acid to the right eye after confusing it with an eye lubricant, which caused him a severe corneal burn. Fortunately, after aggressive medical and surgical management (including oxygen therapy and amniotic membrane grafting), the visual results were good. We suggest conducting educational campaigns and taking legislative measures in our country to avoid packaging corrosive substances in this type of dropper bottle to reduce the risk of accidental burns.
Topics: Antifungal Agents; Corneal Injuries; Drug Labeling; Drug Packaging; Eye Burns; Humans; Lubricant Eye Drops; Male; Middle Aged; Ophthalmic Solutions; Plastics; Salicylic Acid
PubMed: 33030823
DOI: 10.7705/biomedica.5284 -
Scientific Reports Oct 2021In this study, we examined the rate of contamination of multi-dose ophthalmic solutions in the operating theatre and the underlying risk for infection by examining the...
In this study, we examined the rate of contamination of multi-dose ophthalmic solutions in the operating theatre and the underlying risk for infection by examining the microbiological load on the tips of the dispenser bottles. A total of 245 samples of eye drop bottles were collected and analysed between June 2018 and January 2019. All were collected in the operating theatre of the University Eye Hospital Hamburg-Eppendorf. Contamination of the dropper tip occurred in 2% of the samples. Although the prevalence of contamination was low, the results of this study reveal the possibility of contamination of multi-dose eyedrops even when used by health care professionals in the controlled environment of an operating theatre. Following these results, we recommend the use of single-dose eyedrops in the pre- and intraoperative context.
PubMed: 34645913
DOI: 10.1038/s41598-021-99892-8 -
Clinical and Experimental Vaccine... Apr 2023Sublingual immunotherapy is currently promoted by various companies, with administration schedules variable in the different products even though almost all are...
PURPOSE
Sublingual immunotherapy is currently promoted by various companies, with administration schedules variable in the different products even though almost all are standardized immunologically. So, this study was planned to examine the efficacy of simple nondaily dosing of sublingual immunotherapy instead of the widely used daily schedule.
MATERIALS AND METHODS
Fifty-two patients with allergic rhinitis and bronchial asthma were enrolled. Sublingual immunotherapy (manufactured at the allergen immunotherapy preparation unit at Mansoura University) was given in suitable bottles with a dropper mechanism that permits comfortable dosing under the tongue. The physician recommended that the patient put the drops under his/her tongue and leave the drops beneath the tongue for 2 minutes before swallowing. This was repeated every 3 days, with the drop number and concentration gradually rising.
RESULTS
After 2 months of follow-up, 65.8% responded partially to the symptom score and 26.3% responded completely to the medication score. There was a significant decline in the symptom and medication scores from the baseline scores (p<0.0001). After 4 months of follow-up, 95.8% responded partially to symptom scores and no one has not responded; 54.2% responded completely to medication scores; and 81% of studied patients had no side effects. However, the most frequent side effect was a sore throat.
CONCLUSION
Our nondaily schedule of sublingual immunotherapy is tolerable, safe, and effective in patients with allergic rhinitis and bronchial asthma.
PubMed: 37214147
DOI: 10.7774/cevr.2023.12.2.121 -
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 -
Healthcare (Basel, Switzerland) Jan 2023(1) Background: Water is necessary for the preparation of some medicines found in pharmacies where the local water source does not meet the required purity. This study...
(1) Background: Water is necessary for the preparation of some medicines found in pharmacies where the local water source does not meet the required purity. This study aimed to investigate the presence of coliform contamination in water used for drug reconstitution in community pharmacies in Jordan. (2) Methods: Two water samples from 50 randomly selected community pharmacies representing all Jordanian governorates were filtered and then cultured in plate count agars to determine total microbial count, and in m-Endo Agar Les and Eosin Methylene Blue (EMB) agar to cultivate (). The presence of was further characterized with gram stains, biochemical tests, and Polymerase chain reaction (PCR). Antibiotic susceptibility of isolated was tested against a variety of standard antibiotics. (3) Results: Community pharmacies used droppers filled with water from coolers (62%), bottled water (20%), boiled tap water (16%) and tap water (2%). The majority of the sampled water contained coliform bacteria (88%), and was isolated from 26% of all samples. Statistical analysis showed no significant difference in the percentage of contaminated water samples based on its source location. Nonetheless, the results showed a tendency for higher proportions of contamination in droppers filled from boiled tap water (37.5%; SE: 17.1), followed by water from water coolers (25.8%; SE: 7.9), and then from bottled water (20%; SE: 12.7). All of the isolated were sensitive to gentamycin, ciprofloxacin and levofloxacin. The susceptibility of the isolates to ceftazidime, doxycycline, tetracycline, azithromycin and amoxicillin/clavulanic acid were 92%, 61%, 46%, 23% and 15%, respectively. (4) Conclusions: This study confirms the widespread presence of multidrug-resistant bacteria in water intended for reconstituting drugs in local pharmacies. These findings expose an alarming situation that needs special attention by the acting pharmacists and competent authorities. Higher levels of personal hygiene in the pharmacies coupled with regular inspection of water quality may reduce the risk of microbial contamination in compounded products, especially multidrug-resistant strains of and other index microorganisms.
PubMed: 36766874
DOI: 10.3390/healthcare11030299 -
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 -
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 -
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 -
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 -
Clinical Ophthalmology (Auckland, N.Z.) May 2010To investigate the influence of container structures and content solutions on the time of dispensing from eye dropper bottles.
PURPOSE
To investigate the influence of container structures and content solutions on the time of dispensing from eye dropper bottles.
METHODS
Eye dropper bottle models, solution models (filtrate water/surfactant solution) and a dispensing time measuring apparatus were prepared to measure the dispensing time.
RESULTS
With filtrate water and pressure thrust load of 0.3 MPa, the dispensing time significantly increased from 1.1 +/- 0.5 seconds to 4.6 +/- 1.1 seconds depending on the decrease of inner aperture diameters from 0.4 mm to 0.2 mm (P < 0.0001). When using the bottle models with inner aperture diameters of 0.4 mm or larger, the dispensing time became constant. The dispensing time using surfactant solution showed the same tendency as above. When pressure thrust load was large (0.07 MPa), the solution flew out continuously with inner aperture diameters of 0.4 mm or larger and the dispensing time could not be measured. The inner aperture diameter most strongly explained the variation of the dispensing time in both the content solutions in the multiple linear regression analysis (filtrate water: 46%, R(2) = 0.462, surfactant solution: 56%, R(2) = 0.563).
CONCLUSIONS
Among content solutions and container structures, the dispensing time was mostly influenced by the diameter of the inner aperture of bottles.
PubMed: 20535225
DOI: 10.2147/opth.s10804