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Journal of Pharmaceutical and... Mar 2019In recent years, there has been a very active debate about the stability of drug products especially after exceeding the expiry dates. The regulatory authorities require...
In recent years, there has been a very active debate about the stability of drug products especially after exceeding the expiry dates. The regulatory authorities require comprehensive stability data for market approval. The shelf-life obtained determines the expiry date, which is typically between 1 and 5 years and commonly set in a conservative manner. Conducting stability studies is a resource- and time-consuming matter for the pharmaceutical manufacturer. Short shelf-lives of drug products are also a challenge for managers of hospitals, nursing homes, and strategic national stockpile agencies which have to dispose of large quantities of outdated medicines every year. This conflict raises the question whether shelf-lives are often longer than the labeled one. In the past years, the FDA has launched several programs for shelf-life extension in order to defer replacement costs and to prevent drug shortages due to supply disruption. The aim of this review was to bring together the available literature of expired drug products as well as historical pharmaceutical relicts with an age of more than 80 years and to discuss the actual shelf-life with regard to the respective dosage form and the affiliation of the drug class. It seems to be reasonable for a large portion of drugs to extend the expiry dates far beyond five years.
Topics: Dosage Forms; Drug Labeling; Drug Stability; Pharmaceutical Preparations; Quality Control; Time Factors
PubMed: 30660807
DOI: 10.1016/j.jpba.2019.01.016 -
Preventive Medicine Feb 2017We aimed to investigate the effects of special packaging (child-resistant, adult-friendly) and tamper-resistant packaging on health and behavioral outcomes in order to... (Review)
Review
OBJECTIVE
We aimed to investigate the effects of special packaging (child-resistant, adult-friendly) and tamper-resistant packaging on health and behavioral outcomes in order to identify research gaps and implications for packaging standards for tobacco products.
METHODS
We searched seven databases for keywords related to special and tamper-resistant packaging, consulted experts, and reviewed citations of potentially relevant studies. 733 unique papers were identified. Two coders independently screened each title and abstract for eligibility. They then reviewed the full text of the remaining papers for a second round of eligibility screening. Included studies investigated a causal relationship between type of packaging or packaging regulation and behavioral or health outcomes and had a study population composed of consumers. Studies were excluded on the basis of publication type, if they were not peer-reviewed, and if they had low external validity. Two reviewers independently coded each paper for study and methodological characteristics and limitations. Discrepancies were discussed and resolved.
RESULTS
The review included eight studies: four assessing people's ability to access the contents of different packaging types and four evaluating the impact of packaging requirements on health-related outcomes. Child-resistant packaging was generally more difficult to open than non-child-resistant packaging. Child-resistant packaging requirements have been associated with reductions in child mortality.
CONCLUSIONS
Child-resistant packaging holds the expectation to reduce tobacco product poisonings among children under six.
Topics: Humans; Product Packaging; Social Control, Formal; Nicotiana
PubMed: 27939602
DOI: 10.1016/j.ypmed.2016.11.013 -
JAMA Sep 2014Medication nonadherence, which has been estimated to affect 28% to 31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic... (Review)
Review
IMPORTANCE
Medication nonadherence, which has been estimated to affect 28% to 31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic medication packaging (EMP) devices (adherence-monitoring devices incorporated into the packaging of a prescription medication).
OBJECTIVES
To investigate whether EMP devices are associated with improved adherence and to identify and describe common features of EMP devices.
EVIDENCE REVIEW
Systematic review of peer-reviewed studies testing the effectiveness of EMP systems in the MEDLINE, EMBASE, PsycINFO, CINAHL, International Pharmaceutical Abstracts, and Sociological Abstracts databases from searches conducted to June 13, 2014, with extraction of associations between the interventions and adherence, as well as other key findings. Each study was assessed for bias using the Cochrane Handbook for Systematic Reviews of Interventions; features of EMP devices and interventions were qualitatively assessed.
FINDINGS
Thirty-seven studies (32 randomized and 5 nonrandomized) including 4326 patients met inclusion criteria (10 patient interface-only "simple" interventions and 29 "complex" interventions integrated into the health care system [2 qualified for both categories]). Overall, the effect estimates for differences in mean adherence ranged from a decrease of 2.9% to an increase of 34.0%, and the those for differences in the proportion of patients defined as adherent ranged from a decrease of 8.0% to an increase of 49.5%. We identified 5 common EMP characteristics: recorded dosing events and stored records of adherence, audiovisual reminders to cue dosing, digital displays, real-time monitoring, and feedback on adherence performance.
CONCLUSIONS AND RELEVANCE
Many varieties of EMP devices exist. However, data supporting their use are limited, with variability in the quality of studies testing EMP devices. Devices integrated into the care delivery system and designed to record dosing events are most frequently associated with improved adherence, compared with other devices. Higher-quality evidence is needed to determine the effect, if any, of these low-cost interventions on medication nonadherence and to identify their most useful components.
Topics: Drug Packaging; Electronics; Humans; Medical Informatics; Medication Adherence; Prescription Drugs; Randomized Controlled Trials as Topic; Reminder Systems
PubMed: 25247520
DOI: 10.1001/jama.2014.10059 -
The Annals of Pharmacotherapy Nov 2015Problematic prescription drug labeling has been cited as a root cause of patient misunderstanding, medication errors, and nonadherence. Although numerous studies have... (Review)
Review
OBJECTIVE
Problematic prescription drug labeling has been cited as a root cause of patient misunderstanding, medication errors, and nonadherence. Although numerous studies have recently been conducted to identify and test labeling best practices, the last systematic review on this topic was conducted a decade ago. The objective of this review was, therefore, to examine, summarize, and update best practices for conveying written prescription medication information and instructions to patients.
DATA SOURCES
English-language articles published from June 2005 to June 2015 were identified in MEDLINE and CINAHL by searching the following text words: 'medication OR prescription OR drug' AND 'label OR leaflet OR brochure OR pamphlet OR medication guide OR medication insert OR drug insert OR medication information OR drug information OR instructions' AND 'patient OR consumer.' Reference mining and secondary searches were also performed.
STUDY SELECTION AND DATA EXTRACTION
A total of 31 articles providing evidence on how to improve written, prescription drug labeling for patient use were selected. Two reviewers independently screened articles, rated their quality, and abstracted data.
DATA SYNTHESIS
Identified best practices included the use of plain language, improved formatting and organization, and more explicit instructions to improve patient comprehension. The use of icons had conflicting findings, and few studies tested whether practices improved knowledge or behaviors with patients' actual prescribed regimens.
CONCLUSIONS
Future studies are needed to determine how specific modifications and improvements in drug labeling can enhance patient knowledge and behavior in actual use. Synthesizing best practices across all patient materials will create a more useful, coordinated system of prescription information.
Topics: Comprehension; Drug Labeling; Humans; Medication Adherence; Medication Errors; Patient Education as Topic; Prescription Drugs
PubMed: 26354048
DOI: 10.1177/1060028015602272 -
Current Medical Research and Opinion Jan 2015Inadequate medication adherence is a widespread problem that contributes to increased chronic disease complications and health care expenditures. Packaging interventions... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Inadequate medication adherence is a widespread problem that contributes to increased chronic disease complications and health care expenditures. Packaging interventions using pill boxes and blister packs have been widely recommended to address the medication adherence issue. This meta-analysis review determined the overall effect of packaging interventions on medication adherence and health outcomes. In addition, we tested whether effects vary depending on intervention, sample, and design characteristics.
RESEARCH DESIGN AND METHODS
Extensive literature search strategies included examination of 13 computerized databases and 19 research registries, hand searches of 57 journals, and author and ancestry searches. Eligible studies included either pill boxes or blister packaging interventions to increase medication adherence. Primary study characteristics and outcomes were reliably coded. Random-effects analyses were used to calculate overall effect sizes and conduct moderator analyses.
RESULTS
Data were synthesized across 22,858 subjects from 52 reports. The overall mean weighted standardized difference effect size for two-group comparisons was 0.593 (favoring treatment over control), which is consistent with the mean of 71% adherence for treatment subjects compared to 63% among control subjects. We found using moderator analyses that interventions were most effective when they used blister packs and were delivered in pharmacies, while interventions were less effective when studies included older subjects and those with cognitive impairment. Methodological moderator analyses revealed significantly larger effect sizes in studies reporting continuous data outcomes instead of dichotomous results and in studies using pharmacy refill medication adherence measures compared with studies with self-report measures.
CONCLUSIONS
Overall, meta-analysis findings support the use of packaging interventions to effectively increase medication adherence. Limitations of the study include the exclusion of packaging interventions other than pill boxes and blister packs, evidence of publication bias, and primary study sparse reporting of health outcomes and potentially interesting moderating variables such as the number of prescribed medications.
Topics: Drug Packaging; Humans; Medication Adherence
PubMed: 25333709
DOI: 10.1185/03007995.2014.978939 -
Infection and Drug Resistance 2022The use of poor quality drugs will have multiple consequences with an extended hazard of growing drug-resistant strains. (Review)
Review
BACKGROUND
The use of poor quality drugs will have multiple consequences with an extended hazard of growing drug-resistant strains.
PURPOSE
The review aimed to provide the quality status of antimalarial drugs in East Africa.
DATA SOURCE
PubMed, Scopus, Web of Science, and Google Scholar were searched from September 5 to September 12, 2021.
STUDY SELECTION
The review included articles available as original research targeted at evaluating the quality of antimalarial drugs. For inclusion, data on at least one of the following quality control parameters were required: packaging and labeling, hardness, friability, weight variation/uniformity of weight, disintegration, dissolution, and assay/percentage purity. Mendeley citation manager version 1.19.4 was used to avoid duplication and organize references, and titles and abstracts were primarily used for screening.
DATA EXTRACTION
The sample collection site, drug name, and the quality control parameters tested were retrieved from the selected studies.
DATA SYNTHESIS
Totally, 300 antimalarial drug samples from Ethiopia, Kenya and Tanzania were included in this review. No antimalarial drug tested failed the identification and disintegration test. However, 15.93% (36/226), 5.00% (15/300), and 1.90% (3/158) of antimalarial samples failed the dissolution, assay and mass uniformity test, respectively. Moreover, amodiaquine and sulfadoxine/pyrimethamine samples failed dissolution and assay tests. In addition, amodiaquine samples failed the mass uniformity test. However, artemether/lumefantrine and quinine passed all quality control parameters tested. Overall, 19.67% (59/300) of antimalarial drug samples did not meet at least one quality control parameter. And the higher faller rate was reported for sulfadoxine/pyrimethamine accounting for 52.86% (37/70).
CONCLUSIONS
An unneglected amount of antimalarial drug failed to meet at least one quality control parameter. Strengthening pharmaceutical management systems, including post-marketing surveillance, and providing the resources required for medication quality assurance, are recommended.
PubMed: 36277242
DOI: 10.2147/IDR.S373059 -
The American Journal of Forensic... Mar 2019A systematic review of the literature regarding drug packaging methods in body packing and materials used is presented, with the aim (a) to summarize data regarding the...
A systematic review of the literature regarding drug packaging methods in body packing and materials used is presented, with the aim (a) to summarize data regarding the packaging methods adopted by drug trafficking organizations, (b) to support forensic pathologists and police forces to classify and describe drug packages, (c) to propose a new classification for drug packaging techniques, and (d) to better clarify the impact of packaging methods on radiological detectability.Packaging methods have been described in 2981 cases, permitting us to summarize the different materials used and to propose a new classification for packaging method based on the materials used. Information concerning the affiliation of body packers and pushers with major (or not) drug trafficking organizations and techniques used to reduce the radiological detectability of the concealed drugs have also been collected.Besides the packaging methods described over the years, our study suggests a standardized approach for the description of drug packages based on the use of different materials and packaging procedures, which provide a possible insight to the type of drug trafficking organization involved.
Topics: Body Packing; Drug Packaging; Drug Trafficking; Foreign Bodies; Forensic Medicine; Humans; Illicit Drugs
PubMed: 30308547
DOI: 10.1097/PAF.0000000000000436 -
British Journal of Clinical Pharmacology Oct 2022Use of immunomodulating therapeutics for immune-mediated inflammatory diseases may cause disease-drug-drug interactions (DDDIs) by reversing inflammation-driven... (Review)
Review
AIM
Use of immunomodulating therapeutics for immune-mediated inflammatory diseases may cause disease-drug-drug interactions (DDDIs) by reversing inflammation-driven alterations in the metabolic capacity of cytochrome P450 enzymes. European Medicine Agency (EMA) and US Food and Drug Administration (FDA) guidelines from 2007 recommend that the DDDI potential of therapeutic proteins should be assessed. This systematic analysis aimed to characterize the available DDDI trials with immunomodulatory drugs, experimental evidence for a DDDI risk and reported DDDI risk information in FDA/EMA approved drug labelling.
METHOD
For this systematic review, the EMA list of European Public Assessment Reports of human medicine was used to select immunomodulating monoclonal antibodies (mAbs) and tyrosine kinase inhibitors (TKIs) marketed after 2007 at risk for a DDDI. Selected drugs were included in PubMed and Embase searches to extract reported interaction studies. The Summary of Product Characteristics (SPCs) and the United States Prescribing Information (USPIs) were subsequently used for analysis of DDDI risk descriptions.
RESULTS
Clinical interaction studies to evaluate DDDI risks were performed for 12 of the 24 mAbs (50%) and for none of the TKIs. Four studies identified a DDDI risk, of which three were studies with interleukin-6 (IL-6) neutralizing mAbs. Based on (non)clinical data, a DDDI risk was reported in 32% of the SPCs and in 60% of the USPIs. The EMA/FDA documentation aligned with the DDDI risk potential in 35% of the 20 cases.
CONCLUSION
This systematic review reinforces that the risk for DDDI by immunomodulating drugs is target- and disease-specific. Drug labelling information designates the greatest DDDI risk to mAbs that neutralize the effects of IL-6, Tumor Necrosis Factor alfa (TNF-α) and interleukin-1 bèta (IL-1β) in diseases with systemic inflammation.
Topics: Antibodies, Monoclonal; Drug Approval; Drug Interactions; Drug Labeling; Humans; Immunomodulating Agents; Inflammation; Interleukin-1beta; Interleukin-6; Pharmaceutical Preparations; Protein Kinase Inhibitors; Risk Assessment; Tumor Necrosis Factor-alpha; United States; United States Food and Drug Administration
PubMed: 35484780
DOI: 10.1111/bcp.15372 -
Revista de Saude Publica 2015OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use. METHODS We conducted a systematic literature review between 2008... (Review)
Review
OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use. METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords "Readability and Package Leaflet" and "Readability and Package Insert" in the academic search engine Biblioteca do Conhecimento Online, comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded. RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions. CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.
Topics: Comprehension; Consumer Health Information; Drug Labeling; Drug Packaging; Humans; Language
PubMed: 25741660
DOI: 10.1590/s0034-8910.2015049005559 -
American Journal of Preventive Medicine Aug 2021Literature suggests that cannabis legalization may increase fatal motor vehicle collisions. However, evidence on the effectiveness of interventions to prevent drugged... (Review)
Review
CONTEXT
Literature suggests that cannabis legalization may increase fatal motor vehicle collisions. However, evidence on the effectiveness of interventions to prevent drugged driving is limited.
EVIDENCE ACQUISITION
MEDLINE, PsycINFO, Web of Science, Embase, SafetyLit, Criminal Justice Database, Transport Research International Documentation, bibliographies, and relevant gray literature were searched systematically through May 2020. Randomized and nonrandomized studies of preventive interventions measuring drugged driving outcomes were included. Evidence certainty was judged per Grading of Recommendations Assessment, Development, and Evaluation guidelines to designate quality ratings from very low to high.
EVIDENCE SYNTHESIS
The search identified 11 RCTs and 17 nonrandomized studies conducted predominantly among youth (aged 15-25 years; n=33,711 of 37,117 active research participants). In the public, cannabis packaging with health warnings increases the knowledge about drugged driving effects (high certainty); roadside drug testing can reduce drugged driving among cannabis users (moderate certainty); media campaigns may increase deterrent attitudes and knowledge (low certainty); and state sanctions, including traffic offense criminalization, license withdrawal, and per se drugged driving laws, may have little or no effect on drug-related fatalities or injuries (very low-low certainty). For youth or previous offenders, motivational interviewing can prevent drugged driving and driver education programs can increase knowledge (moderate certainty), whereas drug abuse prevention, substance abuse treatment, and driver rehabilitation may prevent drugged driving (very low certainty).
CONCLUSIONS
Overall, there is evidence to support the interventions that may improve drugged driving knowledge, attitudes, and behaviors. However, the impact of such interventions on measures of drugged driving-related morbidity and mortality is uncertain. Further research is urgently required to address these gaps in knowledge.
Topics: Accidents, Traffic; Adolescent; Automobile Driving; Cannabis; Humans; Licensure; Pharmaceutical Preparations
PubMed: 34099354
DOI: 10.1016/j.amepre.2021.03.012