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Bulletin of the World Health... Dec 2004Adequate adherence to medication regimens is central to the successful treatment of communicable and noncommunicable disease. Fixed-dose combination pills and... (Review)
Review
Adequate adherence to medication regimens is central to the successful treatment of communicable and noncommunicable disease. Fixed-dose combination pills and unit-of-use packaging are therapy-related interventions that are designed to simplify medication regimens and so potentially improve adherence. We conducted a systematic review of relevant randomized trials in order to quantify the effects of fixed-dose combination pills and unit-of-use packaging, compared with medications as usually presented, in terms of adherence to treatment and improved outcomes. Only 15 trials met the inclusion criteria; fixed-dose combination pills were investigated in three of these, while unit-of-use packaging was studied in 12 trials. The trials involved treatments for communicable diseases (n = 5), blood pressure lowering medications (n = 3), diabetic patients (n = 1), vitamin supplementation (n = 1) and management of multiple medications by the elderly (n = 5). The results of the trials suggested that there were trends towards improved adherence and/or clinical outcomes in all but three of the trials; this reached statistical significance in four out of seven trials reporting a clinically relevant or intermediate end-point, and in seven out of thirteen trials reporting medication adherence. Measures of outcome were, however, heterogeneous, and interpretation was further limited by methodological issues, particularly small sample size, short duration and loss to follow-up. Overall, the evidence suggests that fixed-dose combination pills and unit-of-use packaging are likely to improve adherence in a range of settings, but the limitations of the available evidence means that uncertainty remains about the size of these benefits.
Topics: Drug Combinations; Drug Packaging; Humans; Patient Compliance; Randomized Controlled Trials as Topic; Self Administration; Tablets; Treatment Outcome
PubMed: 15654408
DOI: No ID Found -
Anaesthesia Apr 2015
Topics: Anesthetics, Local; Bupivacaine; Color; Drug Packaging; Humans; Levobupivacaine; Medication Errors; Sodium Chloride
PubMed: 25764407
DOI: 10.1111/anae.13055 -
Tidsskrift For Den Norske Laegeforening... Dec 2014
Topics: Drug Packaging; Female; Foreign Bodies; Humans; Peritonitis
PubMed: 25492319
DOI: 10.4045/tidsskr.14.1300 -
BMC Health Services Research Sep 2023Many medicine quality problems are detected after they arrive at health facilities. Thus, critically defective medicines that may pose health risks to patients need to...
BACKGROUND
Many medicine quality problems are detected after they arrive at health facilities. Thus, critically defective medicines that may pose health risks to patients need to be withheld or recalled.
AIMS
To investigate the withheld and recalled medicines in relation to the types of defects, their total numbers, therapeutic categories, pharmaceutical dosage forms, and country of manufacturer during the study period.
METHODS
A retrospective review was performed on withheld and recalled medicines published on the publicly available National Medicines Regulatory Authority (NMRA) official website in Sri Lanka between June 2018 and August 2021. Details on substandard medicines (SM) were extracted and documented. Each record of SM was individually reviewed to determine the type of defect, subsequent action taken by NMRA, therapeutic category, pharmaceutical dosage form, and country of manufacturer.
RESULTS
A total of 163 defects were identified in 143 defective medicines, among which the most common types of defects were contamination (n = 59, 36.2%), stability defects (n = 41, 25.2%), packaging and labelling defects (n = 27, 16.6%) and active pharmaceutical ingredient defects (n = 26, 15.9%). Out of 143 total defective medicines identified, anti-infectives accounted for 41.9%, while parenteral preparations (44.0%) were found to be frequently defective. Nearly 70% of the recalled and withheld medicines were of Indian origin, and some manufacturers were identified to be repeatedly involved.
CONCLUSIONS
This study revealed that contamination was the most frequent cause of defective medicines, while parenteral preparations and anti-infectives were the most susceptible pharmaceutical dosage form and therapeutic category found to be substandard, respectively. In addition, the findings show that some manufacturers were accountable for repetitive withholdings and recalls, which reflects the ignorance of quality control measures and weak regulatory inspections as a violation of Good Manufacturing Practice (GMP).
Topics: Humans; Sri Lanka; Retrospective Studies; Commerce; Drug Packaging; Pharmaceutical Preparations
PubMed: 37700302
DOI: 10.1186/s12913-023-09995-3 -
Nature Communications Sep 2023Filamentous bacteriophages package their circular, single stranded DNA genome with the major coat protein pVIII and the minor coat proteins pIII, pVII, pVI, and pIX....
Filamentous bacteriophages package their circular, single stranded DNA genome with the major coat protein pVIII and the minor coat proteins pIII, pVII, pVI, and pIX. Here, we report the cryo-EM structure of a ~500 Å long bacteriophage M13 mini variant. The distal ends of the mini phage are sealed by two cap-like complexes composed of the minor coat proteins. The top cap complex consists of pVII and pIX, both exhibiting a single helix structure. Arg33 of pVII and Glu29 of pIX, located on the inner surface of the cap, play a key role in recognizing the genome packaging signal. The bottom cap complex is formed by the hook-like structures of pIII and pVI, arranged in helix barrels. Most of the inner ssDNA genome adopts a double helix structure with a similar pitch to that of the A-form double-stranded DNA. These findings provide insights into the assembly of filamentous bacteriophages.
Topics: Bacteriophage M13; Cryoelectron Microscopy; Inovirus; DNA, Single-Stranded; Drug Packaging
PubMed: 37669979
DOI: 10.1038/s41467-023-41151-7 -
AAPS PharmSciTech Dec 2010The preparation of sterile parenteral products requires careful control of all ingredients, materials, and processes to ensure the final product has the identity and... (Review)
Review
The preparation of sterile parenteral products requires careful control of all ingredients, materials, and processes to ensure the final product has the identity and strength, and meets the quality and purity characteristics that it purports to possess. Contamination affecting these critical properties of parenteral products can occur in many ways and from many sources. The use of closures supplied by manufacturers in a ready-to-use state can be an effective method for reducing the risk of contamination and improving the quality of the drug product. This article will address contamination attributable to elastomeric container closure components and the regulatory requirements associated with container closure systems. Possible contaminants, including microorganisms, endotoxins, and chemicals, along with the methods by which these contaminants can enter the product will be reviewed. Such methods include inappropriate material selection, improper closure preparation processes, compromised container closure integrity, degradation of closures, and leaching of compounds from the closures.
Topics: Drug Contamination; Drug Industry; Drug Packaging; Elastomers; Infusions, Parenteral; Risk; Sterilization
PubMed: 21057904
DOI: 10.1208/s12249-010-9531-8 -
Age and Ageing Mar 2022the ageing global population is living longer with complex health conditions addressed by multiple medications. Little is known about how older people manage these...
BACKGROUND
the ageing global population is living longer with complex health conditions addressed by multiple medications. Little is known about how older people manage these medications and associated packaging at home.
OBJECTIVES
to explore how older people manage the use of multiple medication and associated packaging in their process of self-care.
METHODS
fifteen older, home-dwelling participants (mean age = 76.2 years) participated in this study. All participants used three or more daily medications and resided in Southern Sweden. Data were collected using photographs and written diaries completed by each participant over seven consecutive days, complemented by researcher-led interviews. Interviews and diary data were analysed using thematic analysis.
RESULTS
six major themes emerged and are discussed: systematic organisation of medication, design of medication packaging, design of tablets, ease of package opening, emotional response to the need for medication, and environmental waste.
CONCLUSION
packaging plays an important role in protecting products and enabling easy storage, product longevity and transportation. Medication packaging is no exception. However, the design of medication packaging poses challenges for older people managing medications for their chronic health conditions at home. There is a need to facilitate the systematic management of multiple medications, especially for new medication regimes or changes in treatment. Design of both packaging and medication should be consistent for older users to avoid potential errors; difficulties opening packaging can potentially hinder adherence to treatment. This study highlights the need for patient-centred solutions and involvement of older people in a co-design process for medication and packaging design.
Topics: Aged; Drug Packaging; Health Status; Humans; Medication Adherence; Self Care; Sweden
PubMed: 35258519
DOI: 10.1093/ageing/afac050 -
Biologicals : Journal of the... Sep 2011To share the experience of reviewing clinical data required for the licensing of follow-on biologic products (biosimilar products and similar biotherapeutical products... (Review)
Review
To share the experience of reviewing clinical data required for the licensing of follow-on biologic products (biosimilar products and similar biotherapeutical products as EU and WHO terminology, respectively) in Japan, the data packages of two follow-on biologics, "Somatropin BS s.c. [Sandoz] (Omnitrope®)" and "Epoetin alfa BS [JCR]", which have been recently approved in Japan according to the "Guidelines for the Quality, Safety and Efficacy Assurance of Follow-on Biologics" published on March 4th 2009, are described. The clinical data package and indication of Somatropin BS/Omnitrope(®) were different in each country. In case of Epoetin alfa BS [JCR], non-clinical and clinical data-package was different from those of erythropoietin biosimilar products approved in EU. Submission of post-marketing surveillance plans for both products was required. Even though there seem to be differences in data requirements by each national regulatory authority, the accumulation of experience will provide the rationale and consensus on how to design the clinical trials for follow-on biologics.
Topics: Drug Evaluation; Drug Packaging; Erythropoietin; Female; Follow-Up Studies; Guidelines as Topic; Human Growth Hormone; Humans; Japan; Male; Product Surveillance, Postmarketing; Recombinant Proteins
PubMed: 21917473
DOI: 10.1016/j.biologicals.2011.08.006 -
European Journal of Clinical... Jan 2024In Europe, most medicines are taken orally and primarily packaged as single solid oral dosage forms (SODF) in blister chambers (alveoli) arranged on blister cards....
PURPOSE
In Europe, most medicines are taken orally and primarily packaged as single solid oral dosage forms (SODF) in blister chambers (alveoli) arranged on blister cards. Blister cards are constructed as multilayer laminates of aluminum (Al) foils and/or various plastic polymers bonded together, forming the alveoli, which are separated by more or less large gaps. We calculated the amount of packaging material (and thus waste) generated annually for the packaging of the most commonly prescribed SODF in Germany and estimated how much waste could be saved by rearranging the alveoli.
METHODS
For this purpose, we analysed the SODF of the 50 most frequently prescribed medicines that were packaged in alveoli (N = 45; 13 of aluminum-aluminum blisters, 32 of mixed materials), measured and weighed their packaging material and content, calculated the annual amount of waste produced from them, and estimated how much waste could be saved if the alveoli were optimally positioned on the blister cards. In addition, we examined the variability of the blister packaging of eight groups of commonly prescribed generics of the same strength.
RESULTS
Detailed analysis of the blister cards revealed that most of the material (69%) was used for the space between blisters and that aluminum-aluminum alveoli were more than four times larger than the packaged SODF. The (conservatively) estimated annual amount of composite waste generated for the primary packaging of these SODF was 3868 t (and extrapolated to the entire German pharmaceutical market 8533 t), of which an optimized arrangement of the blister chambers, i.e., a 2-mm sealing area around each alveolus and the arrangement of the SODF in 2 rows, would save approximately 37%.
CONCLUSION
Considering that other ecological strategies are not yet mature, the optimal arrangement of blister chambers would be a captivatingly simple and, above all, immediately implementable strategy to avoid large amounts of avoidable waste.
Topics: Humans; Blister; Aluminum; Drug Packaging; Tablets; Europe
PubMed: 37978998
DOI: 10.1007/s00228-023-03594-1 -
Journal of Psychoactive Drugs 2018State legalization and regulation of cannabis, despite continued federal illegality, is a massive shift in regulatory approach. Manufactured cannabis, including...
State legalization and regulation of cannabis, despite continued federal illegality, is a massive shift in regulatory approach. Manufactured cannabis, including concentrates, extracts, edibles, tinctures, topicals and other products, has received less attention than more commonly used dried flower, but represents emerging regulatory challenges due to additives, potency, consumption methods, and abuse and misuse potential. In November 2017, the California Department of Public Health (CDPH) released initial cannabis manufacturing regulations as part of a new state regulatory structure. As the largest U.S. medical cannabis market (and largest legal adult use market in the world beginning in 2018), California's regulatory approach will potentially influence national and global policy. Comparing CDPH's initial regulations to tobacco control best practices reveals that, while the regulations recognize the need to protect public health, prioritizing public health over business interests requires stronger approaches to labeling, packaging, and product formulations. Based on tobacco best practices, we recommend that cannabis regulations incorporate large and proportionately sized informational labels, a prominent universal cannabis symbol, rotating and pictorial health warnings, mandatory plain packaging, a comprehensive ban on characterizing flavors and addictive additives, and strict limits on the potency of inhalable products and those easily confused with non-cannabis products.
Topics: Adult; California; Drug Labeling; Drug Packaging; Humans; Industry; Medical Marijuana; Product Labeling; Product Packaging; Public Health; Tobacco Industry
PubMed: 29438634
DOI: 10.1080/02791072.2017.1422816