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- Prescription for COVID-19 by non-medical professionals during the pandemic
in Colombia: a cross-sectional study
Authors: Maria Jose Nino-Orrego, Daniela Baracaldo-Santamaría, Claudia Patricia Ortiz, Heyde Patricia Zuluaga, Sthefany Alejandra Cruz-Becerra, Franklin Soler, Andrés M. Pérez-Acosta, Daniel Ricardo Delgado, Carlos-Alberto Calderon-Ospina
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Background:The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, and hydroxychloroquine that are not useful for preventing or treating COVID-19 and could expose patients to unnecessary adverse drug reactions (ADRs), drug-drug interactions (DDIs), disease masking, and antibiotic resistance.Rationale:SM with drugs advertised for COVID-19 can have consequences, and people should be aware of approved uses, potential contraindications, and ADRs. Thus, the aim of this study was to know the drug therapies including natural products and homeopathic drugs offered by Colombian pharmaceutical establishments for the prevention and treatment of COVID-19, as well as the information provided on the safe use of the product.Methods:An observational, cross-sectional mystery shopping study was carried out to determine the pharmaceutical alternatives for the management of COVID-19 offered by pharmaceutical establishments (drugstores, pharmacies, homeopathic pharmacies, and nutritional supplements stores) in Colombia, and information related to the safe use of the product. The study included 482 pharmaceutical establishments from 16 Colombian departments. Data collection was done through telephone calls to each of the establishments following an interview protocol pretending to be a patient who presents symptoms related to COVID-19.Results:About 57.3% (276) of the establishments recommended a product for the treatment of COVID-19 infection, 66.6% (321) asked whether the caller had COVID-19 symptoms and what they are, and 44.2% (213) suggested taking a COVID-19 test. Of 59 drugs suggested by pharmacies, the most recommended were azithromycin, ivermectin, acetaminophen, ibuprofen, and ASA (aspirin). From the establishments that recommended a product, dosage was indicated in 85.5% (236) of the pharmaceutical establishments and 14.5% (40) of the establishments reported the most common adverse effects of this substance. About 9.4% (26) of the establishments reported possible interactions of the recommended drugs and substances with food, beverages, or supplements.Conclusion: Pharmaceutical establishments in Colombia seem to have significantly contributed to self-medication for COVID-19 in Colombia during the pandemic. This behavior is inappropriate, since the mild forms of the disease do not have a specific treatment.Plain Language SummarySelf-medication induced by pharmaceutical establishments in Colombia during the COVID-19 pandemicBackground: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, hydroxychloroquine among others, which are not useful for preventing or treating COVID-19 and could expose patients to unnecessary side effects and interactions with other medications. People should be aware of the approved and non-approved uses, and potential side effects of these drugs. Rationale: The aim of this study was to know the drugs, including natural products and homeopathic drugs, offered by Colombian pharmaceutical establishments for the prevention and treatment of COVID-19, as well as the information provided on the safe use of the product. Methods: The study was done using the mystery shopping method, collecting data through telephone calls to each of the establishments by a trained individual pretending to be a patient with COVID-19 symptoms. The study included 482 pharmaceutical establishments from 16 Colombian departments. Results: Of 59 drugs suggested by pharmacies, the most recommended were azithromycin, ivermectin, acetaminophen, ibuprofen, and aspirin. The recommended dose was indicated in 85.5% (236) of the pharmaceutical establishments, and 14.5% (40) of them reported the most common adverse effects of the recommended product. About 9.4% (26) of the establishments reported possible interactions of the recommended drugs and substances with food, beverages, or supplements. Conclusion: The majority of the pharmaceutical establishments included in the study promoted inadequate self-medication for COVID-19 in Colombia during the pandemic.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-05-25T06:40:35Z
DOI: 10.1177/20420986221101964
Issue No: Vol. 13 (2022)
- Analysis of drug-induced hand–foot syndrome using a spontaneous
reporting system database
Authors: Yu Yoshida, Sayaka Sasaoka, Mizuki Tanaka, Kiyoka Matsumoto, Misaki Inoue, Riko Satake, Kazuyo Shimada, Ririka Mukai, Takaaki Suzuki, Mari Iwata, Fumiya Goto, Takayuki Mori, Koki Mori, Tomoaki Yoshimura, Mitsuhiro Nakamura
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Purpose:The aim of our study was to assess the clinical features of hand–foot syndrome (HFS) associated with certain systemic chemotherapeutic drugs in a real-world setting using the Japanese Adverse Drug Event Report (JADER) database.Methods:HFS was defined using the preferred terms from the Medical Dictionary for Regulatory Activities. We used several indices, such as the reporting odds ratios (RORs) at 95% confidence interval (CI), the time-to-onset profile of HFS, and cluster analysis.Results:Of 646,779 reports (submission period: April 2004 to September 2020), 1814 reported HFS events. The RORs (95% CI) for axitinib, capecitabine, lapatinib, regorafenib, sorafenib, and sunitinib were 14.9 (11.1–20.1), 54.6 (49.2–60.6), 130.4 (110.7–153.6), 63.3 (55.2–72.6), 29.0 (25.8–32.7), and 13.9 (11.7–16.5), respectively. The analysis of time-to-onset profiles revealed that the median values (interquartile range: 25.0–75.0%) of drug-induced HFS caused by capecitabine, cisplatin, docetaxel, everolimus, regorafenib, sorafenib, and trastuzumab were 21.0 (13.0–42.0), 15.0 (10.0–82.0), 6.0 (3.0–25.0), 86.5 (67.0–90.5), 9.0 (6.0–14.0), 9.0 (6.0–14.0), and 70.0 (15.0–189.0) days, respectively. The number of clusters was set to 4. Among these, one cluster, which included capecitabine, regorafenib, and lapatinib, exhibited a higher reporting ratio and ROR of drug-induced HFS than other drugs.Conclusions:The RORs and results of time-to-onset analysis obtained in this study indicated the potential risk of HFS associated with chemotherapeutic drugs. Our results suggest that health care professionals must be aware of the potential onset of drug-induced HFS with docetaxel, regorafenib, and sorafenib for at least 4 weeks; therefore, careful observation is recommended.Plain Language SummaryElucidation of the relationship between cancer drugs and risk of hand–foot syndromePurpose: Hand–foot syndrome (HFS) is an adverse effect of some cancer drugs, which is characterized by symptoms such as redness, swelling, blistering, and pain in the area of palms and soles. HFS reduces the quality of life of patients and can sometimes interfere with anticancer treatment plans. It is important to understand the clinical manifestations of HFS and gain knowledge that will allow for early intervention by clinicians.Methods: In this study, we used a large-scale side effect database of real-world cases for a comprehensive investigation of anticancer-drug-induced HFS. The database contained 646,779 adverse event reports from April 2004 to September 2020; among which, we identified 1814 HFS events. Using these data, we could obtain information on the relationship between 19 types of anticancer drugs and HFS, and the onset time of HFS and HFS prognosis related to each anticancer drug. Results: Our results suggest that clinicians should monitor the risk of HFS with docetaxel, regorafenib, and sorafenib for at least the first 4 weeks after drug administration. Conclusion: These findings are crucial for improving the management of the adverse effects caused by anticancer drugs.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-05-25T06:37:14Z
DOI: 10.1177/20420986221101963
Issue No: Vol. 13 (2022)
- A case report of drug-induced liver injury due to the infliximab
biosimilar CT-P13 on switching from original infliximab in a patient with
Crohn’s disease
Authors: Shin Kashima, Koji Sawada, Kentaro Moriichi, Mikihiro Fujiya
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Inflammatory bowel diseases (IBDs) are chronic immune disorders of unclear etiology. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A large number of clinical trials of infliximab biosimilar (CT-P13) have suggested that the administration of biosimilars provides high efficacy and safety similar to that of the originators, with a lower cost, so switching from the original to a biosimilar is considered an acceptable treatment. While several abnormalities of blood examination have been observed in patients with CT-P13 administration, no cases of drug-induced liver injury (DILI) caused by CT-P13 has been reported. A 23-year-old woman had been diagnosed with Crohn’s disease and was treated with original infliximab (O-IFX) for 9 years. She developed severe jaundice 1 month after switching from O-IFX to CT-P13. Serologic tests of autoimmune and hepatitis viruses were negative, and ultrasonography, computed tomography, and magnetic resonance cholangiopancreatography revealed no abnormalities. A liver biopsy showed prominent pericentral canalicular cholestasis, without features of steatosis or sclerosing cholangitis, which was consistent with drug-induced cholestasis. The cholestasis improved 10 weeks after the discontinuation of CT-P13, and no DILI redeveloped even after re-switching from CT-P13 to O-IFX. This is the first report of DILI due to switching from O-IFX to CT-P13. While the efficacy and safety of CT-P13 are considered equal to those of O-IFX, clinicians need to be alert for certain severe DILIs when switching from O-IFX to CT-P13 with careful monitoring and appropriate treatment.Plain Language SummaryA case report of drug-induced liver injury due to switch from original infliximab to infliximab biosimilarInflammatory bowel disease (IBD) is characterized by chronic inflammation of the entire gastrointestinal tract, although its etiology has largely been unclear. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A biological medicinal product that contains a version of the active substance of an already authorized biological medicinal product. Biosimilars of TNF inhibitors, such as CT-P13, are thought to possess equal efficacy and safety to the original with a lower cost, so switching from the original to a biosimilar considered an acceptable treatment. While several serious adverse reactions of TNF inhibitors have been reported, drug-induced liver injury (DILI) is uncommon, and liver dysfunction due to the administration of CT-P13 has not been reported in IBD patients. We herein report the first case of DILI due to CT-P13 after switching from original infliximab (O-IFX) in a patient with Crohn’s disease. While the efficacy and safety of CT-P13 are considered equal to those of O-IFX, clinicians need to be alert for certain severe DILIs when switching from O-IFX to CT-P13 with careful monitoring and appropriate treatment.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-05-25T06:33:37Z
DOI: 10.1177/20420986221100118
Issue No: Vol. 13 (2022)
- Trends in potentially inappropriate opioid prescribing and associated risk
factors among Korean noncancer patients prescribed non-injectable opioid
analgesics
Authors: Yoojin Noh, Kyu-Nam Heo, Yun Mi Yu, Ju-Yeun Lee, Young-Mi Ah
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Introduction:The aim of this study was to investigate trends in the prevalence of potentially inappropriate opioid prescribing (PIOP) and identify potential risk factors among Korean noncancer patients.Methods:We conducted a cross-sectional study of annual national patient sample data from the Korean Health Insurance Review and Assessment Service (HIRA-NPS) for the period 2012–2018. Noncancer patients who were prescribed non-injectable opioid analgesics (NIOAs) at least once were included. The proportion of patients with at least one PIOP in terms of concurrent use of benzodiazepines or gabapentinoids, substance use disorder, treatment duration, and dosage was evaluated. Multivariable logistic regression was performed to identify the risk factors associated with PIOP.Results:Of the 9,772,503 noncancer patients, 1,583,444 (16.2%) were prescribed NIOAs at least once. Among them, 15.7% were exposed to PIOP, and the prevalence was much higher (31.6%) in the elderly group (age: ⩾65 years). The prevalence of PIOP increased 1.1-fold over 7 years (14.8–16.8%) among the total NIOA users and was more pronounced in non-tramadol NIOA users (a 1.5-fold increase, from 13.2% to 19.4%). Multivariable logistic regression indicated that older age, beneficiaries of medical aid or national meritorious service, exposure to polypharmacy, psychological disorder, chronic pain indication, and concomitant sedative use were independently associated with higher odds of PIOP.Discussion and Conclusion:We found that the prevalence of PIOP was 15.7% among Korean noncancer patients, and it increased over the 7-year study period. This increasing trend is alarming because it was more drastic with non-tramadol NIOAs compared with that with tramadol. Several patient-level risk factors associated with PIOP would be useful in targeted management strategies for the safe use of opioids.Plain Language SummaryPotentially inappropriate opioid prescribing and related risk factors among noncancer patients prescribed non-injectable opioids in KoreaIn Korea, the prevalence of non-injectable opioid analgesic (NIOA) use in noncancer patients steadily increased from 15.3% in 2012 to 17.1% in 2018.Also, the prevalence of potentially inappropriate opioid prescribing (PIOP) increased from 14.8% in 2012 to 16.8% in 2018.The following factors were associated with a markedly increased risk of PIOP: age, beneficiaries of medical aid or national meritorious service, polypharmacy, psychological disorder, chronic pain, and concomitant medications.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-04-30T12:44:22Z
DOI: 10.1177/20420986221091001
Issue No: Vol. 13 (2022)
- Drug safety of frequently used drugs and substances for self-medication in
COVID-19
Authors: Daniela Baracaldo-Santamaría, Santiago Pabón-Londoño, Luis Carlos Rojas-Rodriguez
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
During the COVID-19 pandemic, the behavior of self-medication has increased. The dissemination of misleading information regarding the efficacy of certain drugs or substances for the prevention and treatment of COVID-19 has been the major contributing factor for this phenomenon. Alongside with the increase in self-medication behavior, the inherent risks to this act such as drug–drug interactions, adverse events, drug toxicity, and masking of symptoms have also increased. Self-medication in the context of COVID-19 has led to drug misuse leading in some cases to the development of fatal adverse drug reactions. It is important that during this ongoing pandemic drugs with potential clinical efficacy against COVID-19 are adequately analyzed regarding their efficacy, safety, and monitoring. The aim of this review is to describe the available evidence regarding the efficacy, safety, and monitoring of the drugs and substances that have been shown to be frequently used for self-medication in patients with COVID-19 (hydroxychloroquine, non-steroidal anti-inflammatory drugs, ivermectin, azithromycin, vitamins, aspirin, and chlorine dioxide) to adequately characterize their risks, safe use, monitoring strategies, and to reinforce the concept that these substances should not be used for self-medication and require a medical prescription.Plain Language SummaryDrug safety of frequently used drugs and substances for self-medication in COVID-19Dissemination of information about potential COVID-19 treatments has led individuals to self-medicate and expose themselves to risks such as drug–drug interactions, side effects, antibiotic resistance, and misdiagnosis. There is a need to review the medical literature to evaluate the safety and efficacy of the drugs and substances commonly used by the population for the treatment and prevention of SARS CoV-2 infection. In this review, we included drugs that are frequently used for self-medication and commonly advertised such as ivermectin, hydroxychloroquine, chlorine dioxide, azithromycin, and non-steroidal anti-inflammatory drugs, among others. A brief introduction of the drug and its mechanism of action, followed by a summary of the efficacy in COVID-19 and safety, will be described for each drug in order to promote their responsible use.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-04-21T12:14:21Z
DOI: 10.1177/20420986221094141
Issue No: Vol. 13 (2022)
- The response to the COVID-19 pandemic trusted in pharmacovigilance to
diminish communication risk
Authors: Gustavo A. Quintero
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-03-29T09:54:16Z
DOI: 10.1177/20420986221088650
Issue No: Vol. 13 (2022)
- Neurodevelopmental outcomes in children exposed prenatally to
levetiracetam
Authors: Bshra A. Alsfouk
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Some old antiseizure medications (ASMs) pose teratogenic risks, including major congenital malformations and neurodevelopmental delay. Therefore, the use of new ASMs in pregnancy is increasing, particularly lamotrigine and levetiracetam. This is likely due to evidence of low risk of anatomical teratogenicity for both lamotrigine and levetiracetam. Regarding neurodevelopmental effects, lamotrigine is the most frequently investigated new ASM with information available for children up to 14 years of age. However, fewer data are available for the effects of levetiracetam on cognitive and behavioral development, with smaller cohorts and shorter follow-up. The aim of the present review was to explicate neurodevelopmental outcomes in children exposed prenatally to levetiracetam to support clinical decision-making. The available data do not indicate an increased risk of abnormal neurodevelopmental outcomes in children exposed prenatally to levetiracetam. Findings demonstrated comparable outcomes for levetiracetam versus controls and favorable outcomes for levetiracetam versus valproate on global and specific cognitive abilities, and behavioral problems. In addition, the available evidence shows no significant dose-effect association for levetiracetam on neurodevelopmental outcomes. However, this evidence cannot be determined definitively due to the limited numbers of exposures with relatively short follow-up. Therefore, further research is required.Plain Language SummaryAntiseizure medications (ASMs) are medicines that inhibit the occurrence of seizures. Levetiracetam is a new ASM. Some old ASMs are linked with an increased risk of physical birth abnormalities and adverse effects on the child’s brain development. Therefore, the use of new ASMs in pregnancy is increasing, especially lamotrigine and levetiracetam. This is likely due to evidence of low risk of birth abnormalities for both lamotrigine and levetiracetam. Regarding effects on development of the brain, lamotrigine is the most frequently examined new ASM with information available for children up to 14 years of age. However, fewer data are available for the effects of levetiracetam on cognitive and behavioral development. Also, levetiracetam studies were smaller and shorter compared with studies investigating lamotrigine effects. The aim of this article was to review the child’s brain development effects after exposure to levetiracetam during pregnancy. The available data do not suggest an increased risk of the child having learning or thinking difficulties. Findings demonstrated comparable outcomes for levetiracetam versus controls (i.e. children unexposed to levetiracetam), and favorable outcomes for levetiracetam versus valproate. In addition, the available evidence shows no link between the higher dose of levetiracetam and an increased risk of adverse effects on the child’s brain development. However, this evidence cannot be determined definitively due to the limited numbers of children exposed to levetiracetam with relatively short duration of follow-up. Therefore, further research is required.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-03-29T09:53:18Z
DOI: 10.1177/20420986221088419
Issue No: Vol. 13 (2022)
- Corrigendum
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-03-17T12:03:00Z
DOI: 10.1177/20420986221090074
Issue No: Vol. 13 (2022)
- Alkalising agents in urinary tract infections: theoretical
contraindications, interactions and synergy
Authors: Oisín N. Kavanagh
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Introduction:Alkalising agents have the potential to enhance the efficacy of many antimicrobial agents used in the treatment of Urinary Tract Infections; they also have the potential to cause significant patient harm if used incorrectly. This work seeks to illustrate and quantify these risks and synergies by modelling drug solubility and supersaturation against pharmacokinetic data for commonly used antibiotic agents.Methods:Solubility-pH relationships are employed to quantify the crystalluria risk for compounds which may be reasonably expected to be co-prescribed—or co-administered—with urinary alkalisers (amoxicillin, nitrofurantoin, trimethoprim, sulfamethoxazole and ciprofloxacin). These results are correlated against reports of crystalluria in the literature and in the EU Adverse Drug Reaction database.Results and Discussion:We find a correlation between the maximum theoretical supersaturation attainable and crystalluria reports for sulfamethoxazole, amoxicillin and ciprofloxacin. Shifts in urine pH which can be induced by alkalising agents may produce supersaturated states (and thus induce crystalluria) and may also affect antimicrobial efficacy. The importance of employing biorelevant media to improve predictive capacity of this analysis is also discussed.Conclusion:Despite their widespread use, alkalising agents have significant effects on the pharmacokinetics of the most common drugs used to treat UTIs. With self-care set to increase, all OTC products should be critically re-evaluated to ensure patient safety, particularly within contexts where healthcare professionals are not involved in treatment selection. This analysis suggests a need for consistency across patient and healthcare professional documents to improve clarity.Plain Language SummaryOTC Alkalising agents need additional warning informationAlkalising agents (e.g., sodium and potassium citrate) can be purchased in many locations without the supervision of a healthcare professional.Although they are thought as innocuous agents, alkalisers can greatly influence the way some antibiotics behave in the body and this can potentially cause patient harm.This work illustrates these risks and synergies by modelling drug solubility and supersaturation against pharmacokinetic data for commonly used antibiotic agents.Manufacturers and patients should be aware that the use of alkalising agents with these drugs (and potentially many others) may cause unintended consequences.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-03-16T12:53:38Z
DOI: 10.1177/20420986221080794
Issue No: Vol. 13 (2022)
- Ten-year trends in adverse drug reaction–related hospitalizations
among people with dementia
Authors: Anum Saqib Zaidi, Gregory M. Peterson, Luke R.E. Bereznicki, Colin M. Curtain, Mohammed S. Salahudeen
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Aim:Trends in the incidence of adverse drug reaction (ADR)–related hospitalizations have been studied in the general population, but not specifically in people with dementia. This study aimed to investigate trends in the incidence of ADR-related hospitalizations among people with dementia, and identify the most commonly implicated drugs and diagnoses in these admissions.Methods:This study utilized the administrative data of all adults admitted to the four major public hospitals of Tasmania, Australia, with a primary or secondary diagnosis of dementia from July 2010 to December 2019. ADR-related hospitalizations were identified by using diagnosis-based and external cause codes. The Cochran–Armitage test was used to examine trends in the incidence of ADR-related hospitalizations.Results:Of the 7552 people with dementia admitted to the hospital at least once within the study period, 1775 (23.5%) experienced at least one ADR-related hospitalization. The estimated annual incidence of ADR-related hospitalizations increased 18% (1484–1760 per 100,000 population with dementia, p for trend
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-03-11T12:02:21Z
DOI: 10.1177/20420986221080796
Issue No: Vol. 13 (2022)
- Self-medication and the ‘infodemic’ during mandatory preventive
isolation due to the COVID-19 pandemic
Authors: Andrés Gaviria-Mendoza, Danny Alberto Mejía-Mazo, Carolina Duarte-Blandón, Juan Daniel Castrillón-Spitia, Manuel Enrique Machado-Duque, Luis Fernando Valladales-Restrepo, Jorge Enrique Machado-Alba
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Aim:Quarantine due to the COVID-19 pandemic altered the supply and demand of health services. This, together with the ‘infodemic’ and generalized panic, could alter the patterns of self-medication in the population. The objective was to characterize the patterns of self-medication in four cities of Colombia during mandatory preventive isolation in 2020.Methods:This was a cross-sectional study done in four Colombian cities during mandatory national preventive isolation between June and September 2020. A sample of 397 adults who responded to an online survey, based on the Instrument for Systematic Data Collection for Self-medication (Instrumento de Recolección Sistemática de Datos para la Automedicación–IRIS-AM), was obtained. The use of social networks (including WhatsApp) as the source of information about medications was explored.Results:The 397 people surveyed had a median age of 31.0 years, and 58.2% were women. The prevalence of self-medication during lockdown was 34.3% (n = 136). Medications targeting the nervous system (n = 117; 86.0% of those participants with self-medication) and the musculoskeletal system (n = 68; 50.0%) were the most commonly used. Ten (7.4%) of the self-medicated patients reported doing so to prevent COVID-19, and 15 (11.0%) named social networks as the source of information.Conclusion:More than one-third of the participants reported self-medication during COVID-19 lockdown, mainly with analgesic-type nervous system medications. People who reported self-medication to prevent COVID-19 often got their information from social networks, the Internet, and WhatsApp.Plain Language SummarySelf-medication during mandatory COVID-19 isolationIntroduction: Self-medication refers to the use of medications to treat self-diagnosed disorders or symptoms, and it can lead to health problems. This habit is widely practiced by the people, especially in low- and middle-income countries. The objective was to characterize the patterns of self-medication in four cities of Colombia during mandatory preventive isolation in 2020 due the quarantine by COVID-19 explored pandemic. Methods: We made a cross-sectional study between June and September 2020, and a sample of 397 adults who responded to an online survey. The use of social networks (including WhatsApp) as the source of information about medications was explored. Results: The prevalence of self-medication during lockdown was 34.3% (n = 136). Medications targeting the nervous system (n = 117; 86.0% of those participants with self-medication) and the musculoskeletal system (strategies n = 68; 50.0%) were the most commonly used. Conclusion: People who reported self-medication to prevent COVID-19 often got their information from social networks, the Internet, and WhatsApp. These findings raise the possibility of designing pedagogical strategies on this topic.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-02-26T06:33:22Z
DOI: 10.1177/20420986221072376
Issue No: Vol. 13 (2022)
- Use of an electronic medication management support system in patients with
polypharmacy in general practice: study protocol of a quantitative process
evaluation of the AdAM trial
Authors: Robin Brünn, Dorothea Lemke, Kiran Chapidi, Juliane Köberlein-Neu, Alexandra Piotrowski, Sara Söling, Wolfgang Greiner, Petra Kellermann-Mühlhoff, Nina Timmesfeld, Marjan van den Akker, Christiane Muth
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Background:Interventional studies on polypharmacy often fail to significantly improve patient-relevant outcomes, or confine themselves to measuring surrogate parameters. Interventions and settings are complex, with many factors affecting results. The AdAM study’s aim is to reduce hospitalization and death by requiring general practitioners (GPs) to use a computerized decision-support system (CDSS). The study will undergo a process evaluation to identify factors for successful implementation and to assess whether the intervention was implemented as intended.Objective:To evaluate our complex intervention, based on the Medical Research Council’s guideline dimensions.Research Questions:We will assess implementation (reach, fidelity, dose, tailoring) by asking: (1) Who took part in the intervention (proportion of GPs using the CDSS, proportion of patients enrolled in them)' Information on GPs’ and patients’ characteristics will also be collected. (2) How many and which medication alerts were dealt with' (3) Was the intervention implemented as intended' (4) On what days did GPs use the intervention tool'Methods:The process evaluation is part of a stepped-wedge cluster-randomized controlled trial. Characteristics of practices, GPs and patients using the CDSS will be compared with the non-participating population. CDSS log data will be analyzed to evaluate how the number of medication alerts changed between baseline and 2 months later, and to identify the kind of alerts that were dealt with. Comparison of enrolled patients on weekdays versus weekends will shed light on GPs’ use of the CDSS in the absence or presence of patients. Outcomes will be presented using descriptive statistics, and significance tests will be used to identify associations between them. We will conduct subgroup analyses, including time effects to account for software improvements.Discussion:This study protocol is the basis for conducting analyses of the quantitative process evaluation. By providing insight into how GPs conduct medication reviews, the evaluation will provide context to the trial results and support their interpretation. The evaluation relies on the proper documentation by GPs, potentially limiting its explanatory power.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-01-22T10:23:14Z
DOI: 10.1177/20420986211073215
Issue No: Vol. 13 (2022)
- Safety of dipeptidyl peptidase-4 inhibitors in older adults with type 2
diabetes: a systematic review and meta-analysis of randomized controlled
trials
Authors: Katharina Doni, Stefanie Bühn, Alina Weise, Nina-Kristin Mann, Simone Hess, Andreas Sönnichsen, Dawid Pieper, Petra Thürmann, Tim Mathes
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Registration:PROSPERO: CRD42020210645Introduction:We aimed to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older patients with type 2 diabetes with inadequate glycaemic control.Methods:We included randomized controlled trials (RCTs) in older (⩾65 years) patients with type 2 diabetes. The intervention group was randomized to treatment with any DPP-4 inhibitors. A systematic search in MEDLINE and Embase was performed in December 2020. For assessing the risk of bias, RoB 2 tool was applied. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. We pooled outcomes using random effects meta-analyses.Results:We identified 16 RCTs that included 19,317 patients with a mean age of greater than 70 years. The mean HbA1c level ranged between 7.1 and 10.0 g/dl. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly [risk ratio (RR) 1.04; 95% confidence interval (CI) 0.89–1.21]. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia (RR 1.08; 95% CI 1.01–1.16), but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas (RR 0.88; 95% CI 0.75–1.04). DPP-4 inhibitors probably reduce the risk for hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis.Conclusion:There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase hypoglycaemia risk. Second-line therapy in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case second-line treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas.Plain language summarySafety of dipeptidyl peptidase-4 inhibitors in older adults with type 2 diabetesIntroduction:We performed the review to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older type 2 diabetes patients with blood sugar outside the normal level.Methods:To answer the question, we searched various electronic databases. We included studies in older (⩾65 years) patients with type 2 diabetes that assessed the safety of DPP-4 inhibitors. The data from the different studies were quantitatively summarized using statistical methods. We assessed the quality of the data to judge the certainty of the findings.Results:We identified 16 studies that included 19,317 patients with a mean age greater than 70 years. The average blood sugar level of patients in the included studies was slightly or moderately increased. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia, but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas. DPP-4s probably reduce the risk of hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis.Conclusion:There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase the risk that blood sugar falls below normal. Adding DPP-4 inhibitorss to standard care in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case additional treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-01-21T08:46:43Z
DOI: 10.1177/20420986211072383
Issue No: Vol. 13 (2022)
- The 5th European pharmacovigilance congress: speaker abstracts
Abstract: Therapeutic Advances in Drug Safety, Volume 13, Issue , January-December 2022.
Citation: Therapeutic Advances in Drug Safety
PubDate: 2022-01-04T12:05:43Z
DOI: 10.1177/20420986211068914
Issue No: Vol. 13 (2022)
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