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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 -
International Journal of Pharmaceutics Mar 2021Prefilled dual chamber devices (DCDs) are combination products containing freeze-dried drug and diluent in two separate chambers of the device. DCDs provide high... (Review)
Review
Prefilled dual chamber devices (DCDs) are combination products containing freeze-dried drug and diluent in two separate chambers of the device. DCDs provide high stability and convenience to patients and doctors, thus significantly improving product quality, patient compliance and market competitiveness. DCDs should also provide seal integrity, sterility and compatibility with biopharmaceuticals and avoid leachability and needle stick injuries. DCDs are promising alternatives to traditional containers or devices for biopharmaceuticals. The regulatory and medical practice to choose plastic DCDs as better alternatives over well-established glass syringes will be addressed here. The impact and major issues during processing, manufacturing, and storage of DCDs are also highlighted. Further discussion clears its business potential, composition, stability testing, and quality standard requirements to deal with market competition. It also covers major role of extractables and leachables in storage stability of the product.
Topics: Drug Contamination; Drug Delivery Systems; Drug Packaging; Freeze Drying; Humans; Pharmaceutical Preparations; Syringes
PubMed: 33540011
DOI: 10.1016/j.ijpharm.2021.120314 -
Tidsskrift For Den Norske Laegeforening... May 2020
Topics: Drug Packaging; Humans
PubMed: 32463183
DOI: 10.4045/tidsskr.20.0427 -
Expert Opinion on Drug Delivery Nov 2014Confinement of biomolecules in structured nanoporous materials offers several desirable features ranging from chemical and thermal stability, to resistance to... (Review)
Review
INTRODUCTION
Confinement of biomolecules in structured nanoporous materials offers several desirable features ranging from chemical and thermal stability, to resistance to degradation from the external environment. A new generation of mesoporous materials presents exciting new possibilities for the formulation and controlled release of biological agents. Such materials address niche applications in enteral and parenteral delivery of biologics, such as peptides, polypeptides, enzymes and proteins for use as therapeutics, imaging agents, biosensors, and adjuvants.
AREAS COVERED
Mesoporous silica Santa Barbara Amorphous-15 (SBA-15), with its unique, tunable pore diameter, and easily functionalized surface, provides a representative example of this new generation of materials. Here, we review recent advances in the design and synthesis of nanostructured mesoporous materials, focusing on SBA-15, and highlight opportunities for the delivery of biological agents to various organ and tissue compartments.
EXPERT OPINION
The SBA-15 platform provides a delivery carrier that is inherently separated from the active biologic due to distinct intra and extra-particle environments. This permits the SBA-15 platform to not require direct modification of the active biological therapeutic. Additionally, this makes the platform universal and allows for its application independent of the desired methods of discovery and development. The SBA-15 platform also directly addresses issues of targeted delivery and controlled release, although future challenges in the implementation of this platform reside in particle design, biocompatibility, and the tunability of the internal and external material properties. Examples illustrating the flexibility in the application of the SBA-15 platform are also discussed.
Topics: Animals; Biosensing Techniques; Chemistry, Pharmaceutical; Drug Delivery Systems; Drug Packaging; Humans; Pharmaceutical Preparations; Porosity; Silicon Dioxide
PubMed: 25016923
DOI: 10.1517/17425247.2014.938636 -
Anaesthesia Nov 1999
Topics: Anesthesia, Spinal; Anesthetics, Intravenous; Drug Packaging; Fentanyl; Humans; Sterilization
PubMed: 10541713
DOI: 10.1046/j.1365-2044.1999.01186.x -
BMC Pharmacology & Toxicology Aug 2021Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may...
BACKGROUND
Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure and development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. To ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market.
METHODS
This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All sampled ARVs were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV's that failed screening test or yielded doubtful results and 10 % (10 %) of all that complied with the screening test requirements were selected for full quality control testing. Quality control testing was conducted at the Tanzania Medicines and Medical Devices Authority (TMDA) laboratory a World Health Organisation prequalified. Samples collected from the medicine distribution outlets were also, subjected to product information review.
RESULTS
A total of 2,630 samples were collected, of which 83.7 % (2200/2630) were from port of entry (POEs). All sampled ARVs were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27 % (7/2630) and lamivudine/zidovudine/nevirapine 0.27 % (7/2630) that failed the disintegration test. Out of the 100 samples selected for full quality control testing, 3 % of them failed to comply with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2 % (2/100) and 1 % (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6 %) versus specification limits (90 -110 %). Out of the 430 samples which were subjected to product information review, 25.6 % (110/430) failed to comply with the TMDA packaging and labelling requirements.
CONCLUSIONS
The quality of majority of ARVs circulating on the Tanzania Mainland market was good, even so, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania Mainland market.
Topics: Anti-HIV Agents; Drug Combinations; Drug Labeling; Drug Packaging; Quality Control; Tanzania
PubMed: 34446094
DOI: 10.1186/s40360-021-00514-w -
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 -
BMJ Clinical Evidence Sep 2015Adherence to medication is generally defined as the extent to which people take medications as prescribed by their healthcare providers. It can be assessed in many ways... (Review)
Review
INTRODUCTION
Adherence to medication is generally defined as the extent to which people take medications as prescribed by their healthcare providers. It can be assessed in many ways (e.g., by self-reporting, pill counting, direct observation, electronic monitoring, or by pharmacy records). This overview reports effects of prompting mechanisms on adherence to cardiovascular medications, however adherence has been measured.
METHODS AND OUTCOMES
We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of prompting mechanisms to improve adherence to long-term medication for cardiovascular disease in adults? We searched Medline, Embase, The Cochrane Library, and other important databases up to May 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review).
RESULTS
At this update, searching of electronic databases retrieved 174 studies. After deduplication and removal of conference abstracts, 80 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 45 studies and the further review of 35 full publications. Of the 35 full articles evaluated, one RCT was added at this update. We performed a GRADE evaluation of seven PICO combinations.
CONCLUSIONS
In this systematic overview, we categorised the efficacy for seven comparisons based on information relating to the effectiveness and safety of prompting mechanisms, alone and in combination with reminder packaging or patient education.
Topics: Cardiovascular Agents; Cardiovascular Diseases; Drug Packaging; Humans; Medication Adherence; Patient Education as Topic; Reminder Systems
PubMed: 26389860
DOI: No ID Found -
Therapeutic Delivery Nov 2011
Topics: Drug Delivery Systems; Drug Design; Drug Packaging; Drug Stability; Drug Storage; Humans; Space Flight
PubMed: 22826869
DOI: 10.4155/tde.11.115 -
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