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Journal of Basic and Clinical Pharmacy Dec 2013Self-medication is a global phenomenon and potential contributor to human pathogen resistance to antibiotics. The adverse consequences of such practices should always be... (Review)
Review
Self-medication is a global phenomenon and potential contributor to human pathogen resistance to antibiotics. The adverse consequences of such practices should always be emphasized to the community and steps to curb it. Rampant irrational use of antimicrobials without medical guidance may result in greater probability of inappropriate, incorrect, or undue therapy, missed diagnosis, delays in appropriate treatment, pathogen resistance and increased morbidity. This review focused on the self-medication of allopathic drugs, their use, its safety and reason for using it. It would be safe, if the people who are using it, have sufficient knowledge about its dose, time of intake, side effect on over dose, but due to lack of information it can cause serious effects such as antibiotic resistance, skin problem, hypersensitivity and allergy. There is need to augment awareness and implement legislations to promote judicious and safe practices. Improved knowledge and understanding about self-medication may result in rationale use and thus limit emerging microbial resistance issues. Articles which were published in peer reviewed journals, World Self-Medication Industry and World Health Organization websites relating to self-medication reviewed.
PubMed: 24808684
DOI: 10.4103/0976-0105.128253 -
Respiratory Medicine 2019Smart inhalers, connected to smartphones, can provide real-life objective information about the patterns of a patient's adherence and their inhaler technique during... (Review)
Review
Smart inhalers, connected to smartphones, can provide real-life objective information about the patterns of a patient's adherence and their inhaler technique during routine use. The e-modules contain the battery and measuring sensors. Many of these are add-on modules attached externally whilst others are integrated inside the inhaler. Smart inhalers that identify a dose has either been actuated or prepared do not confirm the dose was inhaled but they can send missed dose reminders and clinical studies have highlighted their potential to improve adherence and outcomes. The e-modules that measure an inhalation profile confirm a dose has been inhaled together with providing useful information about the inhaler technique. Studies confirm that the sensors are accurate and confirm their usefulness to provide information about real-life inhaler use. Add-on e-modules are generic whereas integrated smart inhalers can be approved containing active agents and, therefore, prescribed and instructed under healthcare guidance. Real-life studies need to be carried out to demonstrate their potential to improve disease control and prevent exacerbations to justifying their increased cost.
Topics: Female; Humans; Male; Nebulizers and Vaporizers; Patient Compliance
PubMed: 31563027
DOI: 10.1016/j.rmed.2019.09.008 -
ERJ Open Research Oct 2020Adherence to treatment for tuberculosis (TB) has been a concern for many decades, resulting in the World Health Organization's recommendation of the direct observation... (Review)
Review
Adherence to treatment for tuberculosis (TB) has been a concern for many decades, resulting in the World Health Organization's recommendation of the direct observation of treatment in the 1990s. Recent advances in digital adherence technologies (DATs) have renewed discussion on how to best address nonadherence, as well as offering important information on dose-by-dose adherence patterns and their variability between countries and settings. Previous studies have largely focussed on percentage thresholds to delineate sufficient adherence, but this is misleading and limited, given the complex and dynamic nature of adherence over the treatment course. Instead, we apply a standardised taxonomy - as adopted by the international adherence community - to dose-by-dose medication-taking data, which divides missed doses into 1) late/noninitiation (starting treatment later than expected/not starting), 2) discontinuation (ending treatment early), and 3) suboptimal implementation (intermittent missed doses). Using this taxonomy, we can consider the implications of different forms of nonadherence for intervention and regimen design. For example, can treatment regimens be adapted to increase the "forgiveness" of common patterns of suboptimal implementation to protect against treatment failure and the development of drug resistance? Is it reasonable to treat all missed doses of treatment as equally problematic and equally common when deploying DATs? Can DAT data be used to indicate the patients that need enhanced levels of support during their treatment course? Critically, we pinpoint key areas where knowledge regarding treatment adherence is sparse and impeding scientific progress.
PubMed: 33263043
DOI: 10.1183/23120541.00315-2020 -
European Journal of Endocrinology May 2022Growth hormone (GH) replacement therapy in patients with adult growth hormone deficiency (AGHD) is individually titrated due to variable dose-responses among patients.... (Clinical Trial)
Clinical Trial
OBJECTIVE
Growth hormone (GH) replacement therapy in patients with adult growth hormone deficiency (AGHD) is individually titrated due to variable dose-responses among patients. The aim of this study was to provide clinical guidance on dosing and titration of the novel long-acting GH derivative somapacitan based on analyses of somapacitan dose-insulin-like growth factor I (IGF-I) responses in AGHD patients.
DESIGN
Analyses of dosing information, 4364 somapacitan concentration samples and 4880 IGF-I samples from 330 AGHD patients treated with somapacitan in three phase 3 trials.
METHODS
Pharmacokinetic/pharmacodynamic modelling was used to evaluate starting dose groups by age and oral oestrogen therapy, characterise the dose-IGF-I response in the overall AGHD population and patient subgroups, predict the IGF-I response to dose changes and simulate missed dosing.
RESULTS
The analyses supported the clinical recommendations of higher starting doses for younger patients and women on oral oestrogen replacement therapy. For patients switching from daily GH treatment, the mean maintenance dose ratio between somapacitan (mg/week) and somatropin (mg/day) was predicted to be 8.2 (observed interquartile range of 6.7-9.1). Simulations of IGF-I SDS profiles confirmed the appropriate time for IGF-I sampling to be 3-4 days after somapacitan dosing and supported somapacitan administration with up to 3 days delay in case of missed dosing. Subgroup analyses characterised the dose-exposure-IGF-I response in patient subgroups and indicated that dose requirements are mainly influenced by sex and oral oestrogen treatment.
CONCLUSIONS
This study extends the knowledge of the somapacitan dose-IGF-I response and provides information on clinical dosing of once-weekly somapacitan in patients with AGHD.
Topics: Adult; Dwarfism, Pituitary; Estrogens; Female; Histidine; Human Growth Hormone; Humans; Insulin-Like Growth Factor I; Mannitol; Phenol; Pituitary Hormones, Anterior
PubMed: 35521713
DOI: 10.1530/EJE-21-1167 -
The Journal of Pharmacy Technology :... Apr 2022When medications dispensed from a hospital inpatient pharmacy aren't able to be found at their intended destination (ie, a missing dose), this can result in delayed...
When medications dispensed from a hospital inpatient pharmacy aren't able to be found at their intended destination (ie, a missing dose), this can result in delayed medication administration and rework to redispense the medication. Technology advancements in the medication use process have led to development of dose-tracking software that has the capability to track medication doses throughout the medication use cycle and document a medication's location to its destination. The primary objective of this study was to evaluate the impact of dose-tracking software on the number of inpatient pharmacy redispenses and nursing requests for missing medications. Secondary objectives included pharmacy staff satisfaction with dose-tracking software, its impact on workflow and patient safety, and compliance with dose-track scanning. The study design was a prospective, pre-post implementation to compare the requests for missing doses and associated dispenses of injectable medications during the set evaluation period. Dose-track scanning compliance data was collected and evaluated. A survey was also administered to staff to evaluate employee perception and satisfaction with usability and value of the software. During the preimplementation period, 40 021 injectable doses were dispensed, and 9841 (24.6%) were documented as redispensed doses. After dose-tracking implementation, 42 975 total injectable doses were dispensed with 9839 (22.9%) being redispensed. The count of medication messages was 10 661 in the preperiod and 11 475 in the postperiod. The data were normalized using case mix index (CMI) and patient days to account for variation in severity of illness. Implementation of dose-tracking software showed a decrease in the percentage of redispensed injectable medications.
PubMed: 35571343
DOI: 10.1177/87551225211069001 -
Epidemics Dec 2022This dose response assessment combines data from 6 human challenge studies and 44 outbreaks to determine infectivity and pathogenicity of several serotypes of nontyphoid...
This dose response assessment combines data from 6 human challenge studies and 44 outbreaks to determine infectivity and pathogenicity of several serotypes of nontyphoid Salmonella. Outcomes focus on the major serotypes Salmonella Enteritidis and Typhimurium, showing that Typhimurium is less infectious and has a lower probability of causing acute illness in infected subjects. The dose response relation of Salmonella Enteritidis is less steep than that of Typhimurium, indicating greater heterogeneity in infectivity and pathogenicity. This study revisits an older study with less flexible methods that could not combine the widely different outcomes of challenge studies and outbreaks, and had limited capability for dealing with missing information. Reported outcomes are in a format that allows use in calculations of uncertainty for quantitative risk assessment.
Topics: Humans; Salmonella typhimurium; Salmonella enteritidis; Serogroup; Virulence; Disease Outbreaks
PubMed: 36436317
DOI: 10.1016/j.epidem.2022.100653 -
Australian Prescriber Apr 2015Long-term treatment with warfarin is recommended for patients with atrial fibrillation at risk of stroke and those with recurrent venous thrombosis or prosthetic heart... (Review)
Review
Long-term treatment with warfarin is recommended for patients with atrial fibrillation at risk of stroke and those with recurrent venous thrombosis or prosthetic heart valves. Patient education before commencing warfarin - regarding signs and symptoms of bleeding, the impact of diet, potential drug interactions and the actions to take if a dose is missed - is pivotal to successful use. Scoring systems such as the CHADS2 score are used to determine if patients with atrial fibrillation are suitable for warfarin treatment. To rapidly achieve stable anticoagulation, use an age-adjusted protocol for starting warfarin. Regular monitoring of the anticoagulant effect is required. Evidence suggests that patients who self-monitor using point-of-care testing have better outcomes than other patients.
PubMed: 26648615
DOI: 10.18773/austprescr.2015.016 -
MMWR. Morbidity and Mortality Weekly... Mar 2021In December 2020, two COVID-19 vaccines (Pfizer-BioNTech and Moderna) received Emergency Use Authorization from the Food and Drug Administration.* Both vaccines require...
In December 2020, two COVID-19 vaccines (Pfizer-BioNTech and Moderna) received Emergency Use Authorization from the Food and Drug Administration.* Both vaccines require 2 doses for a completed series. The recommended interval between doses is 21 days for Pfizer-BioNTech and 28 days for Moderna; however, up to 42 days between doses is permissible when a delay is unavoidable. Two analyses of COVID-19 vaccine administration data were conducted among persons who initiated the vaccination series during December 14, 2020-February 14, 2021, and whose doses were reported to CDC through February 20, 2021. The first analysis was conducted to determine whether persons who received a first dose and had sufficient time to receive the second dose (i.e., as of February 14, 2021, >25 days from receipt of Pfizer-BioNTech vaccine or >32 days from receipt of Moderna vaccine had elapsed) had received the second dose. A second analysis was conducted among persons who received a second COVID-19 dose by February 14, 2021, to determine whether the dose was received during the recommended dosing interval, which in this study was defined as 17-25 days (Pfizer-BioNTech) and 24-32 days (Moderna) after the first dose. Analyses were stratified by jurisdiction and by demographic characteristics. In the first analysis, among 12,496,258 persons who received the first vaccine dose and for whom sufficient time had elapsed to receive the second dose, 88.0% had completed the series, 8.6% had not received the second dose but remained within the allowable interval (≤42 days since the first dose), and 3.4% had missed the second dose (outside the allowable interval, >42 days since the first dose). The percentage of persons who missed the second dose varied by jurisdiction (range = 0.0%-9.1%) and among demographic groups was highest among non-Hispanic American Indian/Alaska Native (AI/AN) persons (5.1%) and persons aged 16-44 years (4.0%). In the second analysis, among 14,205,768 persons who received a second dose, 95.6% received the dose within the recommended interval, although percentages varied by jurisdiction (range = 79.0%-99.9%). Public health officials should identify and address possible barriers to completing the COVID-19 vaccination series to ensure equitable coverage across communities and maximum health benefits for recipients. Strategies to ensure series completion could include scheduling second-dose appointments at the first-dose administration and sending reminders for second-dose visits.
Topics: Adolescent; Adult; Aged; COVID-19; COVID-19 Vaccines; Female; Health Services Accessibility; Humans; Immunization Schedule; Male; Middle Aged; Time Factors; United States; Vaccination Coverage; Young Adult
PubMed: 33735162
DOI: 10.15585/mmwr.mm7011e2 -
Medicina (Kaunas, Lithuania) Aug 2022Preconception counseling is an essential tool for preventing adverse pregnancy outcomes associated with thyroid dysfunction. The high prevalence of thyroid disease among... (Review)
Review
Preconception counseling is an essential tool for preventing adverse pregnancy outcomes associated with thyroid dysfunction. The high prevalence of thyroid disease among women of reproductive age, and the increased risk of adverse pregnancy outcomes associated with thyroid dysfunction, emphasize the necessity for well-established screening and treatment criteria in the preconception period. We therefore conducted a literature review for relevant information on the screening, diagnosis and treatment of subclinical and overt hypothyroidism in women seeking pregnancy. While screening for thyroid disease is recommended only in the presence of risk factors, iodine supplementation should be recommended in most regions, with higher doses in areas with severe deficiency. Known hypothyroid women should be counseled about increasing their levothyroxine dose by 20-30% in the case of suspected or confirmed pregnancy (missed menstrual cycle or positive pregnancy test). Treating subclinical hypothyroidism appears to be beneficial, especially in the presence of autoimmunity or in patients undergoing artificial reproductive techniques. Regarding the management of TPOAb negative SCH women or euthyroid women with positive TPOAb, further research is necessary in order to make evidence-based recommendations.
Topics: Autoimmunity; Counseling; Female; Humans; Hypothyroidism; Pregnancy; Thyroid Diseases; Thyroxine
PubMed: 36013589
DOI: 10.3390/medicina58081122 -
Allergologie Select 2019Phase II studies on allergen immunotherapy (AIT) should define the dose with the best balance between efficacy and safety ("optimal dose"). Their key role is based on... (Review)
Review
Phase II studies on allergen immunotherapy (AIT) should define the dose with the best balance between efficacy and safety ("optimal dose"). Their key role is based on dose selection for subsequent pivotal studies (phase III, field studies). Since products for AIT differ in composition and unit definitions, phase II trials are mandatory for new products and preparations being developed according to the German Therapy Allergen Ordinance ("Therapie-Allergeneverordnung", TAV) due to current EMA guidelines since 2009. The latter permit various in-vivo models and endpoints for phase II studies, e.g., AIT-induced changes in skin test, nasal, conjunctival or bronchial provocation, or in exposure chamber or field trials. Selection and graduation of the doses, minimization of placebo effects, and sufficient numbers of patients are a challenge. Effort, required time, and costs are important variables for the initiators of phase II trials. Risks are characterized by e.g., a) too small doses without relevant differences compared to placebo, b) missing true dose-response relationships, c) strong placebo effect and consequently small "therapeutic window", d) large heterogeneity and missing distinct differences (compared to placebo), e) too small effects in field studies due to low allergen exposure, f) missing dose-related increase (in case of too high doses). In the view of the Paul-Ehrlich-Institute, the unambiguous phase II trials with TAV products performed until today were not able to confirm the marketed doses for AIT. Regardless of the utilized model, more raw and single data should illustrate the individual outcome of AIT during phase II trials, facilitating an improved and more intuitive interpretation of the data (placebo effects? scattering?). In the medium term, evidence regarding AIT efficacy will considerably increase due to phase II trials as a prerequisite for subsequent phase III field studies. This affects all manufacturers offering AIT products in Germany and Europe.
PubMed: 32176223
DOI: 10.5414/ALX02033E