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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 -
Yakugaku Zasshi : Journal of the... 2015Patients and consumers have desired high quality drug information in their pharmacotherapy, and are entitled to receive it. It is desirable that the information should... (Review)
Review
Patients and consumers have desired high quality drug information in their pharmacotherapy, and are entitled to receive it. It is desirable that the information should be aimed at shared decision-making between patients and healthcare professionals about medications. The quality of drug information available to patients should also be assured. With an aim to improve the quality of "Drug Guide for Patients", we investigated Patient Information Leaflets (PILs) which are approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) with regard to the criteria of development and user testing for assuring the quality of the PILs. In the European Union (EU), these are called Package Leaflets (PLs). PILs have been a legal requirement in the UK since 1999 for all medications. The user testing of PILs has been implemented as evidence since 2005 so that people can rely on the information provided in the leaflet. Execution of PILs which follow the guidance of the user testing, according to the guidance of this user testing, would reflect the views of patients. Here, we introduce the development process and implementation of user testing of PILs. In terms of readability, accessibility and understandability of drug information for patients, we need to discuss involving the public in decisions on how its quality should be assured and how it can be made easily be comprehensible for patients, in order to make effective use of "Drug Guide for Patients" in the future in Japan.
Topics: Decision Making; Drug Information Services; Drug Packaging; European Union; Risk Management
PubMed: 25747226
DOI: 10.1248/yakushi.14-00232-2 -
The American Journal of Tropical... Jul 2018This study evaluated a newly developed paper analytical device (PAD) for screening amoxicillin samples in Blantyre urban townships. Covert shoppers attempted to buy...
This study evaluated a newly developed paper analytical device (PAD) for screening amoxicillin samples in Blantyre urban townships. Covert shoppers attempted to buy amoxicillin from a geographically stratified selection of private pharmacies ( = 22 out of 26) and drug stores ( = 23 out of 103) in the township area. According to the PAD results, all 42 samples obtained by the shoppers contained amoxicillin and none contained suspicious filler materials. Next, the products were assayed using high-performance liquid chromatography. Consistent with the PAD results, all samples contained the correct amount of amoxicillin with no unexpected ingredients. However, one sample was purchased as amoxicillin and contained that ingredient, but was packaged in capsules that are normally used to package ampicillin. Almost every sample failed a simple packaging analysis. Nine in 10 samples were missing their original packaging and/or inserts (52.4% repackaged capsules and 35.7% repackaged blister packs). Only 33.3% of the packages had expiry dates, 16.7% had batch numbers, and 47.6% had the manufacturer's name. Dispensing practices were likewise unsatisfactory. Ninety-five percentage of the sellers sold the amoxicillin without a prescription, even though this medicine is regulated as prescription-only in Malawi. Although the chemical analysis showed that amoxicillin quality was good, our market survey revealed poor adherence to prescription-only medicine dispensing of antibiotics, which threatens antimicrobial stewardship efforts. Furthermore, the wide prevalence of repackaging deprives medicines of important information needed during patient's use, regulatory investigations, and pharmacovigilance reporting.
Topics: Amoxicillin; Anti-Bacterial Agents; Chromatography, High Pressure Liquid; Commerce; Drug Labeling; Drug Packaging; Drug Utilization; Drug and Narcotic Control; Humans; Malawi; Pharmacies
PubMed: 29692302
DOI: 10.4269/ajtmh.18-0003 -
Tobacco Control May 2020Plain packaging and minimum pack size legislation for tobacco products was introduced in the UK in May 2016, with a 1-year sell-off period until May 2017, during which...
BACKGROUND
Plain packaging and minimum pack size legislation for tobacco products was introduced in the UK in May 2016, with a 1-year sell-off period until May 2017, during which both fully branded and plain packs of various sizes were legally available. This study investigates trends in prices of roll-your-own tobacco (RYO) before, during and after implementation of this legislation, and compares trends with those observed in the cigarette market.
METHODS
We used Nielsen Scantrack data for the period from March 2013 to June 2018 to describe trends in UK inflation-adjusted prices and volumes of both RYO and cigarettes, and linear regression to estimate changes in prices associated with the introduction of plain packaging and the minimum pack sizes of 30 g RYO and 20 cigarettes.
RESULTS
In contrast to a downward trend in cigarette sales volumes, RYO volumes rose throughout the study period. By the time plain packs accounted for 75% or more of sales, the average price of products sold in equivalent pack sizes had increased, relative to average prices in the year before implementation and with adjustment for tax changes, from 34.9 to 38.8 pence per gram for RYO (mean difference 4.26, 95% CI 3.99 to 4.53 pence, 12% increase), and from 38.6 to 41.13 pence for cigarettes (mean difference 2.53, 95% CI 2.24 to 2.83 pence, 7% increase) per cigarette.
CONCLUSIONS
New legislation resulted in higher prices for RYO and manufactured cigarettes. However, sales volumes of RYO continued to increase throughout the study period, perhaps because RYO remains a less expensive means of smoking tobacco.
Topics: Cigarette Smoking; Commerce; Consumer Behavior; Drug Packaging; Health Behavior; Health Policy; Health Promotion; Humans; Legislation, Drug; Marketing; Product Packaging; Taxes; Nicotiana; Tobacco Industry; Tobacco Products; Tobacco Smoking; Tobacco Use; United Kingdom
PubMed: 31073097
DOI: 10.1136/tobaccocontrol-2018-054734 -
Tobacco Control Mar 2015This study examined the impact of pictorial cigarette-warning labels, warning-label message framing and plain cigarette packaging, on young adult smokers' motivation to... (Comparative Study)
Comparative Study Randomized Controlled Trial
OBJECTIVE
This study examined the impact of pictorial cigarette-warning labels, warning-label message framing and plain cigarette packaging, on young adult smokers' motivation to quit.
METHODS
Smokers aged 18-30 years (n=740) from a consumer research panel were randomised to one of four experimental conditions where they viewed online images of four cigarette packs with warnings about lung disease, cancer, stroke/heart disease and death, respectively. Packs differed across conditions by warning-message framing (gain vs loss) and packaging (branded vs plain). Measures captured demographics, smoking behaviour, covariates and motivation to quit in response to cigarette packs.
RESULTS
Pictorial warnings about lung disease and cancer generated the strongest motivation to quit across conditions. Adjusting for pretest motivation and covariates, a message framing by packaging interaction revealed gain-framed warnings on plain packs generated greater motivation to quit for lung disease, cancer and mortality warnings (p<0.05), compared with loss-framed warnings on plain packs.
CONCLUSIONS
Warnings combining pictorial depictions of smoking-related health risks with text-based messages about how quitting reduces risks, may achieve better outcomes among young adults, especially in countries considering or implementing plain packaging regulations.
Topics: Adolescent; Adult; Attitude to Health; Drug Labeling; Drug Packaging; Female; Health; Humans; Lung Diseases; Male; Motivation; Neoplasms; Product Labeling; Risk; Smoking; Smoking Cessation; Smoking Prevention; Tobacco Products; Tobacco Use Disorder; Young Adult
PubMed: 24420310
DOI: 10.1136/tobaccocontrol-2013-051234 -
PloS One 2021Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the...
INTRODUCTION
Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.
METHODS
A total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out.
RESULTS
The samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements.
CONCLUSION
This study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.
Topics: Chromatography, High Pressure Liquid; Drug Labeling; Drug Packaging; Hydrogen-Ion Concentration; Kenya; Quality Control; Reference Standards; Suspensions; Trimethoprim, Sulfamethoxazole Drug Combination
PubMed: 34551002
DOI: 10.1371/journal.pone.0257625 -
AAPS PharmSciTech Feb 2021Current trends in the pharmaceutical industry led to a demand for more flexible manufacturing processes with smaller batch sizes. Prepackaged nested vials that can be...
Current trends in the pharmaceutical industry led to a demand for more flexible manufacturing processes with smaller batch sizes. Prepackaged nested vials that can be processed as a unit were introduced into the market to fulfill this need. However, vial nests provide a different thermal environment for the vials compared to a hexagonal packaging array and could therefore influence product temperature profiles, primary drying times, and product quality attributes. Polymer caps with the possibility of vial closure inside the freeze-drying chamber were developed to remove the risks and need of a crimping process. A general concern with the use of such caps is the possibility of an increase in resistance to water vapor flow out of the vial. This case study investigated the effect of the LyoSeal and PLASCAP polymer caps and EZ-fill nests on the freeze-drying process. Amorphous and partially crystalline model formulations were freeze-dried. Process data and product quality attributes were compared for regularly stoppered vials and vials with polymer caps as well as vials in a hexagonal packaging array and nested vials. The results indicated no increased resistance or impeded water vapor flow by the polymer caps. Differences in the macro- and microscopic appearances of products and a trend towards lower product temperatures were observed for the investigated nest type compared to a regular hexagonal packaging array. Consequently, the polymer caps could be used as an alternative to regular stoppers without affecting freeze-drying process data or product quality attributes, while the different thermal environment of nested vials should be considered.
Topics: Desiccation; Drug Industry; Drug Packaging; Freeze Drying; Polymers; Temperature
PubMed: 33624199
DOI: 10.1208/s12249-021-01953-8 -
Journal of Medical Internet Research Feb 2011For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a...
BACKGROUND
For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging.
OBJECTIVE
The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging.
METHODS
During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States.
RESULTS
Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms.
CONCLUSIONS
Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.
Topics: Drug Labeling; Drug Packaging; Humans; Internet; Pharmaceutical Preparations; Pharmaceutical Services
PubMed: 21324833
DOI: 10.2196/jmir.1441 -
PloS One 2019To evaluate the labeling preferences of medication users and characterize their perceptions of the comprehensibility and readability of medication labels. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To evaluate the labeling preferences of medication users and characterize their perceptions of the comprehensibility and readability of medication labels.
METHODS
We conducted a population-based cross-sectional study of medication users aged 18 years or older in 10 Brazilian capital cities. Perceptions of the comprehensibility and readability of medication labels in relation to sociodemographic characteristics were evaluated by Poisson regression models with robust variance. Labeling preferences were assessed through questions addressing possible improvements and through the use of digitally simulated packages.
RESULTS
Of 6,255 medication users interviewed, more than half found it difficult or very difficult to read (50.8%) and/or understand (52.0%) medication labels. Difficulties were more pronounced for participants aged 40 years or older, with lower levels of education, and non-whites. Increasing the font size (93.7%), describing the indications for use (95.9%) and contraindications (95.6%) on the label, and highlighting the expiration date (96.3%) were the most widely accepted improvements. In the evaluation of simulated packages, users preferred factors that improved readability, such as increased font size, use of graphic elements and color to highlight the concentration of the active ingredient, and contrast between the font color and background. The new simulated package design, with increased font size, color to highlight the concentration and contrast between the font color and background, was preferred over the standard design by 77.0% of participants.
CONCLUSION
Based on users' perceptions, increased font size and use of graphic elements and color to emphasize critical information, such as expiration date and concentration, are factors that contribute to making medication labels clearer to users. Pharmaceutical industries and policy makers should consider these items when developing labels and defining policies on this issue.
Topics: Adolescent; Adult; Age Factors; Aged; Brazil; Comprehension; Cross-Sectional Studies; Drug Labeling; Drug Packaging; Female; Humans; Male; Middle Aged; Patient Preference; Reading; Visual Perception
PubMed: 30794574
DOI: 10.1371/journal.pone.0212173 -
European Journal of Hospital Pharmacy :... May 2022
Topics: Drug Labeling; Drug Packaging; Electronics
PubMed: 34301744
DOI: 10.1136/ejhpharm-2021-002960