-
Journal of the American Geriatrics... Dec 2014To identify the practical problems that older people experience with the daily use of their medicines and their management strategies to address these problems and to...
OBJECTIVES
To identify the practical problems that older people experience with the daily use of their medicines and their management strategies to address these problems and to determine the potential clinical relevance thereof.
DESIGN
Qualitative study with semistructured face-to-face interviews.
SETTING
A community pharmacy and a geriatric outpatient ward.
PARTICIPANTS
Community-dwelling people aged 70 and older (N = 59).
MEASUREMENTS
Participants were interviewed at home. Two researchers coded the reported problems and management strategies independently according to a coding scheme. An expert panel classified the potential clinical relevance of every identified practical problem and associated management strategy using a 3-point scale.
RESULTS
Two hundred eleven practical problems and 184 management strategies were identified. Ninety-five percent of the participants experienced one or more practical problems with the use of their medicines: problems reading and understanding the instructions for use, handling the outer packaging, handling the immediate packaging, completing preparation before use, and taking the medicine. For 10 participants, at least one of their problems, in combination with the applied management strategy, had potential clinical consequences and 11 cases (5% of the problems) had the potential to cause moderate or severe clinical deterioration.
CONCLUSION
Older people experience a number of practical problems using their medicines, and their strategies to manage these problems are sometimes suboptimal. These problems can lead to incorrect medication use with clinically relevant consequences. The findings pose a challenge for healthcare professionals, drug developers, and regulators to diminish these problems.
Topics: Aged; Aged, 80 and over; Disease Management; Drug Labeling; Drug Packaging; Female; Humans; Interviews as Topic; Male; Pharmaceutical Preparations; Qualitative Research
PubMed: 25516030
DOI: 10.1111/jgs.13126 -
Anesthesiology Mar 2012
Topics: Administration, Oral; Benzoates; Borates; Cocaine; Drug Packaging; History, 20th Century; Humans; Menthol; Pharyngitis
PubMed: 22354244
DOI: 10.1097/ALN.0b013e31824e551f -
Journal of Pharmaceutical and... Nov 2023Prefilled plastic packaging is time- and cost-effective in hospital pharmacy because it prevents waste, preparation errors, dosage errors, microbial contamination and...
Development of a generic approach for monitoring leachable compounds in hospital pharmacy-prepared prefilled plastic packaging by ultrahigh-performance liquid chromatography coupled to high-resolution mass spectrometry with postcolumn infusion.
Prefilled plastic packaging is time- and cost-effective in hospital pharmacy because it prevents waste, preparation errors, dosage errors, microbial contamination and accidents. This packaging mostly includes prefilled syringes (PFS), intravenous (IV) bags and vials intended for long-term storage that can be used for immediate treatment. There is a rising availability in the market for prefilled drug products due to their practical approach. Leachable compounds could be evaluated in hospital pharmacy-prepared prefilled drug solutions. The Pharmacy Department at the Lausanne University Hospital has developed an innovative, highly sensitive, and generic method by postcolumn infusion based on ultrahigh-performance liquid chromatography coupled to high-resolution mass spectrometry (LC-HRMS) for the analysis of plastic additives in hospital pharmacies. The postcolumn infusion solution was developed with 2% ammonium hydroxide in methanol on a representative set of 30 candidate compounds with different physical-chemical properties, such as log P and molecular structure, to represent the most important categories of additives. The LODs obtained for all compounds ranged from 0.03 to 7.91 ng/mL with linearity up to 250 ng/mL. Through this screening method, plastic additives can be rapidly identified due to the combined use of retention time, exact mass (including isotopic pattern) and MS/MS spectra. In addition, the users can screen for vast categories of plastic additives, including plasticizers, epoxy monomers, antioxidants, UV stabilizers, and others. The screening is facilitated by assessments of a complex in-house-built database for extractable and leachable trace assessment (DELTA), containing 205 compounds for unambiguous identification. Relative response factors were established for all analytes to obtain a semiquantitation of compounds. Moreover, the database also contains valuable estimative toxicology information, which was obtained through calculating their permissible dose exposure threshold; thus, estimative toxicology assessment can be performed for identified compounds in prefilled drug products. This method and the database were applied to a hospital pharmacy-prepared prefilled vancomycin syringe for paediatric use. Ultrasound-assisted dispersive liquid-liquid microextraction (UA-DLLME) was used to prepare the samples for leachable analysis. As a result, 17 plastic additives were formally identified, and their concentrations were estimated. A toxicology assessment was performed by comparing their concentrations with their theoretical PDE thresholds. In conclusion, the prefilled drug solution released a negligible amount of known leachables that appeared to be safe for use in neonates and children.
Topics: Infant, Newborn; Humans; Child; Tandem Mass Spectrometry; Pharmacy Service, Hospital; Chromatography, Liquid; Drug Packaging; Chromatography, High Pressure Liquid
PubMed: 37683372
DOI: 10.1016/j.jpba.2023.115640 -
The Cochrane Database of Systematic... Apr 2005Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly.
OBJECTIVES
To summarize the effects of unit-dose packaged treatment on cure and treatment adherence in people with uncomplicated malaria.
SEARCH STRATEGY
We searched the Cochrane Infectious Diseases Group Specialized Register (November 2004), CENTRAL (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to November 2004), EMBASE (1980 to November 2004), LILACS (November 2004), conference proceedings, and reference lists of articles. We also contacted pharmaceutical companies, organizations, and researchers in the field.
SELECTION CRITERIA
Randomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs, and controlled before-and-after studies of unit-dose packaged drugs for treating uncomplicated malaria.
DATA COLLECTION AND ANALYSIS
We independently assessed study eligibility and methodological quality, and extracted data for an intention to treat analysis, where possible. We combined binary data using relative risk (RR) and the fixed-effect model, and presented them with 95% confidence intervals (CI). We attempted to contact study authors for additional information.
MAIN RESULTS
Three quasi-RCTs (895 participants) and one cluster-RCT (6 health facilities) met the inclusion criteria. Trials were of poor methodological quality, and none adequately assessed treatment failure. Unit-dose packaged drugs (in conjunction with prescriber training and patient information) appeared to be associated with higher participant-reported treatment adherence in all trials.A meta-analysis of two trials (596 participants) showed that participant-reported treatment adherence was higher with blister-packed tablets compared with tablets in paper envelopes (RR 1.18, 1.12 to 1.25). Two trials using tablets in sectioned polythene bags as the intervention also noted an increase in participant-reported treatment adherence: the cluster-RCT (6 clusters) compared it with tablets in paper envelopes, and the other trial compared it with syrup in bottles (RR 2.15, 1.76 to 2.61; 299 participants).
AUTHORS' CONCLUSIONS
There is insufficient evidence to determine the effect of unit-dose packaged antimalarial drugs on treatment failure. Unit-dose packaging supported by prescriber training and patient information appears to improve participant-reported treatment adherence, but these data come from trials with methodological limitations.
Topics: Antimalarials; Drug Packaging; Humans; Malaria; Patient Compliance; Randomized Controlled Trials as Topic
PubMed: 15846723
DOI: 10.1002/14651858.CD004614.pub2 -
Revista Brasileira de Anestesiologia 2011Glass ampoules have been widely used in packaging injection drugs. Glass has important characteristics that allow it to be widely used in fabrication of recipients for...
BACKGROUND AND OBJECTIVES
Glass ampoules have been widely used in packaging injection drugs. Glass has important characteristics that allow it to be widely used in fabrication of recipients for drugs and other sterile substances. However, contamination of solutions with glass microparticles on breaking open glass ampoules, the presence of metals, percutaneous injury, and biological contamination justify the need of educational materials to orient the manipulation of ampoules.
CONTENTS
Glass microparticles generated in the snap-opening of ampoules, as well as metals that contaminate their contents can be aspirated and injected through several routes. Exogenous contaminations by glass and metals can reach several sites in the organism. They trigger organic reactions that may give rise to injuries. Opening ampoules can expose professionals to the risk of percutaneous injuries. These lesions increase the biological risk as they are the gateway for viruses and bacteria. Ampoules opening systems (VIBRAC and OPC) have been developed to reduce the incidence of such accidents. Alternative materials to glass may represent an interesting strategy to increase safety. The use of prefilled syringes may represent an evolution regarding safety.
CONCLUSIONS
Team training and information provided by the pharmaceutical industry on the use of ampoules are fundamental in the prophylaxis of accidents and contaminations. The search for safer materials to replace glass is also important.
Topics: Drug Contamination; Drug Packaging; Glass; Health Personnel; Occupational Injuries; Risk Factors; Risk Management
PubMed: 21724014
DOI: 10.1016/S0034-7094(11)70059-9 -
European Journal of Hospital Pharmacy :... Sep 2022To develop a science and risk based strategy to qualify a prefillable autoclavable cyclic olefin polymer (COP) syringe as a container for multiple drug products in a...
OBJECTIVES
To develop a science and risk based strategy to qualify a prefillable autoclavable cyclic olefin polymer (COP) syringe as a container for multiple drug products in a hospital pharmacy setting METHODS: Different extraction studies were performed with different solution characteristics: phosphate buffer batches (NaHPO / NaHPO in NaCl 0.9%) at different pH values, NaCl 0.9% batches, isopropyl alcohol (IPA) 5% in water and batches with Water For Injections (WFI) at different pH values. The filled syringes were terminally sterilised. The syringes were stored at room temperature (20°C±5°C).Following different monographs of the European Pharmacopoeia several tests were performed on the different batches. Analyses were performed at t=0, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 and 36 months for the general tests. For the subvisible particles, sterility and closure integrity a bracketing scheme was applied during 36 months.
RESULTS
Low levels of extractables were measured for the different solutions. The test for subvisible particles, sterility and closure integrity all met predefined requirements. In the 5mL and 50mL syringes different concentrations of silicon were measured. Overall higher silicon concentrations were measured for the 50mL syringes.
CONCLUSIONS
The chosen strategy for the qualification program provided an adequate understanding about the extractables that could leak from the syringes. The cyclic olefin polymer syringes including stopper and tip cap were found to be suitable as primary packaging materials for the production of water based products.
Topics: Cycloparaffins; Drug Packaging; Humans; Infertility; Polymers; Silicon; Sodium Chloride; Syringes; Water
PubMed: 33504510
DOI: 10.1136/ejhpharm-2020-002333 -
American Journal of Preventive Medicine Jun 2019Flow restrictors are child-resistant packaging innovations designed to limit the amount of liquid dispensed from a medication bottle. In 2011, flow restrictors were... (Observational Study)
Observational Study
INTRODUCTION
Flow restrictors are child-resistant packaging innovations designed to limit the amount of liquid dispensed from a medication bottle. In 2011, flow restrictors were added to pediatric liquid single-ingredient acetaminophen formulations. The hypothesis of this study is that implementation would be associated with reduced volume and severity of pediatric acetaminophen exposures reported to the U.S. National Poison Data System.
METHODS
This study describes accidental unsupervised ingestions of acetaminophen in children aged <6 years. Exposures were grouped into pre-implementation (pre-period; January 4, 2010-July 17, 2011); transition (July 18, 2011-July 15, 2012); and post-implementation (post-period; July 16, 2012-December 25, 2016) periods. Cumulative and annual rates of change per million units (i.e., bottles) sold were calculated for the pre- and post-periods for acetaminophen and pediatric liquid ibuprofen (comparator without flow restrictors). Pre- to post-period rate ratios were used to compare products and to estimate the potential effect on other over-the-counter medications. Analysis was conducted in 2017 and 2018.
RESULTS
The pre- and post-period cumulative acetaminophen exposure rate was 507.2 (95% CI=481.1, 534.6) and 325.6 (95% CI=305.8, 346.7) per 1 million units sold, respectively. Declines in the pre- versus post-period rate ratios were seen for exposures with any effect (0.642, 95% CI=0.591, 0.696) and with clinically significant outcomes (0.728, 95% CI=0.581, 0.913). In the post-period, acetaminophen exposures decreased faster than ibuprofen with a rate of change ratio of 0.936 (95% CI=0.912, 0.960) for all exposures and 0.939 (95% CI=0.909, 0.970) for exposures with any effect.
CONCLUSIONS
The addition of flow restrictors to pediatric liquid acetaminophen was associated with a reduction in the number and severity of exposures. Application of flow restrictors to other liquid medications should be considered.
Topics: Accidents; Acetaminophen; Age Factors; Antitussive Agents; Child, Preschool; Diphenhydramine; Drug Overdose; Drug Packaging; Female; Humans; Ibuprofen; Infant; Male; Nonprescription Drugs; Poison Control Centers; Seasons; United States
PubMed: 31003808
DOI: 10.1016/j.amepre.2018.12.015 -
Scientific Reports Dec 2019The pharmaceutical industry has made improvements to mitigate protein degradation during the drug manufacturing process, storage, and transportation. However, there is...
The pharmaceutical industry has made improvements to mitigate protein degradation during the drug manufacturing process, storage, and transportation. However, there is less quality control after the manufacturer releases the drug. Previous research has shown that drop shock due to mishandling and accidental dropping of therapeutic vials may cause cavitation, aggregation, and particle formation. In this study, the cavitation behavior of Deionized (DI) water and 10mM L-Histidine buffer solution which were subjected to drop shock by hand dropping were investigated to study the effects of vial materials, solutions, fill volumes, drop heights, and internal vial geometries. A Phantom v7 high-speed camera was used to record images at a rate of 66,700 frames per second of the vials as they underwent drop shock. These videos were then reviewed to find the angle of impact, and to determine if there was cavitation. The results indicate that decreasing fill height by using a smaller fill volume or larger diameter vials were found to mitigate cavitation across drop heights. Secondly, results indicate there is a significant difference between the cavitation behavior of glass and plastic vials, and plastic had more cavitation cases. Lastly, there was not a significant difference in the occurrence of cavitation between DI water and L-Histidine buffer solution.
Topics: Chemistry, Pharmaceutical; Drug Industry; Drug Packaging; Glass; Surface Properties; Water
PubMed: 31844126
DOI: 10.1038/s41598-019-55668-9 -
CMAJ : Canadian Medical Association... Jan 1989
Topics: Advertising; Drug Packaging; Ontario; Postal Service
PubMed: 2910390
DOI: No ID Found -
Anaesthesia Aug 2002
Topics: Accidents, Occupational; Anesthetics, Intravenous; Drug Packaging; Finger Injuries; Humans; Medical Staff, Hospital; Propofol
PubMed: 12182151
DOI: 10.1046/j.1365-2044.2002.02752_22.x