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1.
J Orthop Trauma ; 36(Suppl 4): S6-S11, 2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-35994302

RESUMO

SUMMARY: Negative pressure wound therapy (NPWT) with reticulated open cell foam is used commonly in orthopaedic trauma, particularly in the management of complex open fracture wounds. This article reviews the literature to date regarding this adjunctive treatment, particularly in regard to removal of infectious material, temporary management of wounds pending soft tissue reconstruction, combat wounds, and over split-thickness skin grafts. Mechanism of action is also reviewed, including stabilization of the wound environment, edema control, macrodeformation, and microdeformation effects. Use of NPWT as an adjunct in management of open fractures along with operative debridement, systemic antibiotics, and early soft tissue reconstruction are the highest yield interventions for managing open fracture wounds with infection. NPWT as an adjunct therapy in the protocol for open fractures seems to add additional clinical benefit for patients with severe open fracture wounds not amenable to primary, immediate closure.


Assuntos
Fraturas Expostas , Tratamento de Ferimentos com Pressão Negativa , Extremidades/cirurgia , Fraturas Expostas/cirurgia , Humanos , Tratamento de Ferimentos com Pressão Negativa/métodos , Transplante de Pele , Cicatrização
2.
Front Public Health ; 10: 723229, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35387181

RESUMO

Background: Coronavirus disease-2019 (COVID-19) is caused by severe acute respiratory syndrome-coronavirus (SARS-CoV) and represents a major public health threat that aggressively promotes increased morbidity and mortality. Changes in public behavior were more common during the pandemic to protect against the infection. Suboptimal behavioral practices for a specific disease would increase the susceptibility of the public to infection. This study aimed to determine changes in behaviors of the general public during the COVID-19 pandemic. Methods: A cross-sectional study was conducted using an online questionnaire survey to determine the extent of public behavioral changes in Saudi Arabia during the COVID-19 pandemic. Data were collected with a self-reported survey, and analysis was conducted using Statistical Package for the Social Sciences version 26 (SPSS). A chi-square test was performed to determine the association among variables. A P ≤ 0.05 was considered statistically significant. Results: Of 348 respondents, 244 (70.1%) were male, and 270 (77.6%) had a university degree. Approximately 48% used social media to seek COVID-19 information, and 36% (n = 124) avoided large gatherings. Approximately one-fourth of the respondents always avoided public transportation, while 65.8% reported avoiding traveling to infected areas. Of the participants, 33% always washed their hands, while 36% always used an alcohol-based sanitizer. There was a significant association between age group and employment status with respect to hand washing frequency (p < 0.05). There was also a significant association between age group (p < 0.0001) and employment status and wearing of face masks (p < 0.048). Conclusion: This study highlights changes in the public's behaviors in Saudi Arabia during the COVID-19 pandemic for protection against the infection and reports acceptable preventative practices against COVID-19 in the Saudi community. Furthermore, continuous awareness of recommended protective measures for COVID-19 is still warranted.


Assuntos
COVID-19 , Pandemias , COVID-19/epidemiologia , Estudos Transversais , Humanos , Masculino , Pandemias/prevenção & controle , SARS-CoV-2 , Arábia Saudita/epidemiologia
3.
Adv Sci (Weinh) ; 9(14): e2103241, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35289122

RESUMO

Lymphoid follicles (LFs) are responsible for generation of adaptive immune responses in secondary lymphoid organs and form ectopically during chronic inflammation. A human model of ectopic LF formation will provide a tool to understand LF development and an alternative to non-human primates for preclinical evaluation of vaccines. Here, it is shown that primary human blood B- and T-lymphocytes autonomously assemble into ectopic LFs when cultured in a 3D extracellular matrix gel within one channel of a two-channel organ-on-a-chip microfluidic device. Superfusion via a parallel channel separated by a microporous membrane is required for LF formation and prevents lymphocyte autoactivation. These germinal center-like LFs contain B cells expressing Activation-Induced Cytidine Deaminase and exhibit plasma cell differentiation upon activation. To explore their utility for seasonal vaccine testing, autologous monocyte-derived dendritic cells are integrated into LF Chips. The human LF chips demonstrate improved antibody responses to split virion influenza vaccination compared to 2D cultures, which are enhanced by a squalene-in-water emulsion adjuvant, and this is accompanied by increases in LF size and number. When inoculated with commercial influenza vaccine, plasma cell formation and production of anti-hemagglutinin IgG are observed, as well as secretion of cytokines similar to vaccinated humans over clinically relevant timescales.


Assuntos
Vacinas contra Influenza , Influenza Humana , Estruturas Linfoides Terciárias , Animais , Anticorpos Antivirais , Humanos , Influenza Humana/prevenção & controle , Dispositivos Lab-On-A-Chip , Estações do Ano , Vacinação
5.
Front Public Health ; 9: 785568, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34957036

RESUMO

Background and Objectives: Blood is an essential body fluid primarily required for regulating the body's systems and maintaining homeostasis. In developed and developing countries, concern about the demand and supply for blood is increasing. The current study aims to assess the beliefs, behaviors, and opinions of the public toward blood donation. Methods: This was a cross-sectional study in which a self-created questionnaire with 17-items was used for data collection. The self-administered questionnaire was disseminated between November 2019 and January 2020 through social media (WhatsApp© and Facebook©). Data was analyzed using SPSS program version 26. Results: A total of 356 questionnaires were completed with a response rate of 89%. The majority of participants were male 253 (71.1%), 336 (94.4%) considered blood donation important, 350 (98.3%) believed that blood donation saves lives, and 254 (71.3%) agreed to receive blood from voluntary donors. One-hundred sixty-seven (49.4%) were willing to donate blood voluntarily. The barriers to blood donation were fear of needles 86 (24.2%), fear of contracting a chronic disease 84 (23.6%), and lack of time 40 (11.2%). One day off (91.9%) and receiving a token 73.6% were common motivational factors for blood donation. Overall, 57% of the participants had favorable attitudes toward blood donation and 41.9% were knowledgeable. Favorable attitudes were significantly associated with being married (P = 0.018) and having university level of education (P = 0.005). Younger participants (18-29 years) had a statistically significant better knowledge than older participants (≥30 years). Conclusion: The respondents displayed positive beliefs, opinions, and motivation toward blood donation. Additionally, most of them considered blood donation an important act and a national duty of every individual and are willing to donate in the future.


Assuntos
Doadores de Sangue , Conhecimentos, Atitudes e Prática em Saúde , Estudos Transversais , Feminino , Humanos , Índia , Masculino , Transtornos Fóbicos
6.
Artigo em Inglês | MEDLINE | ID: mdl-34886434

RESUMO

The aim of this study was to assess the adequacy of dietary folate intake and perceptions of pill burden among Saudi patients on maintenance hemodialysis (MHD). This was a cross-sectional study of adults (>18 years) on MHD (>3 months) attending the dialysis unit at King Saud University Medical City. Patient demographics, dietary folic acid intake, and perceptions of pill burden were collected. Fifty-four patients met the eligibility criteria, with a mean age of 57 ± 15.5 years. The majority were females (63%), and the most prevalent comorbidities were diabetes (43%) and hypertension (76%). The average number of medications/patients was 11 ± 2.9, and most patients were receiving folate supplementation (68.5%). The average dietary folate intake was 823 ± 530 mcg/day. Pill burden was bothersome, primarily due to taking too many medications (57%) while taking medications at the workplace was the least bothersome burden (17%). The reported high pill burden and adequate dietary folate intake by Saudi patients on MHD indicates that the omission of folate supplementation may be advantageous for this special population.


Assuntos
Ácido Fólico , Diálise Renal , Adulto , Idoso , Estudos Transversais , Suplementos Nutricionais , Ingestão de Alimentos , Feminino , Humanos , Pessoa de Meia-Idade , Arábia Saudita/epidemiologia
7.
Risk Manag Healthc Policy ; 14: 4235-4241, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34675717

RESUMO

OBJECTIVE: The aim of this study was to validate the Arabic version of General Medication Adherence Scale (GMAS) in Sudanese patients with type 2 diabetes mellitus (T2DM). METHODS: A 3-month cross-sectional study was conducted among patients with T2DM at Al-Daraja Health Center, located in Wad Medani, Sudan. A convenient sample of patients was selected, and the study sample size was calculated using the item response ratio. Factorial, known group, and construct validities were determined. Internal consistency and reliability were also determined. RESULTS: Responses were provided by 500 patients. The average medication adherence score was 30 (median 31). The normed fit index (NFI) was 0.950, the comparative fit index (CFI) was 0.963, the incremental fit index (IFI) was 0.963, and the root-mean-square error of approximation (RMSEA) was 0.071. The results from these fit indices indicated a good model. Factorial, known group and construct validities were all established. A significant association was found between adherence score and age (P = 0.03) since a larger proportion of older patients were found to have high adherence compared to patients in other age groups. The reliability (α) of the questionnaire was 0.834. CONCLUSION: The Arabic version of GMAS was validated in Sudanese patients with T2DM making it a suitable scale to be used in this population.

8.
Saudi Pharm J ; 29(6): 527-532, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34194259

RESUMO

INTRODUCTION: Oral isotretinoin is an effective agent for the treatment of severe cystic acne. Isotretinoin is a teratogen; there is an increased risk of congenital defects in infants exposed to the drug in the uterus. The Saudi Food and Drug Authority (SFDA) has implemented a pregnancy prevention program (PPP) to protect females from those teratogenic effects. OBJECTIVES: To investigate the awareness of women, of reproductive age who were using Isotretinoin or used it previously, about isotretinoin use and the SFDA-approved PPP in Riyadh, Saudi Arabia. METHODS: This cross-sectional study was conducted during the period from June to October 2019. A questionnaire was developed based on the published literature and the PPP recommendations. The study was carried out online among female patients who were on Isotretinoin therapy or have used it previously in Riyadh city. The Statistical Package for Social Sciences (SPSS for Windows, version 24) was used to analyze the study data. RESULTS: During the study period, 483 patients participated in the study. Among them, 97.3% reported that they used the drug based on a doctor's prescription, 94.6% were aware of Isotretinoin's teratogenic effect, and 30.6% confirmed their awareness of the PPP. Amongst the participants, 9.1% (n = 44) used Isotretinoin while being married or planning to get married within a one-month period after using it. Concerning the use of two contraceptive methods according to the PPP guidelines, of the participants, 43.2% reported that they have been informed by their healthcare providers to use two contraceptive methods before starting the medication. Also 43.2% reported that they have been informed to use two contraceptive methods while using the medication, and 50% reported that they have been informed to use two contraceptive methods for one month after stopping the medication. Regardless of the information they had, participants' actual practice, was as follow: 15.9% used two contraceptive methods before starting the medication, 15.9% used two contraceptive methods during the treatment, and 13.6% used two contraceptive methods for one month after stopping the medication. CONCLUSIONS: Although this study revealed that the vast majority of participants were aware of isotretinoin's teratogenic effect, still a considerable number of them had no idea about the PPP. This issue needs to greatly be addressed to minimize the risk of teratogenicity.

9.
PLoS One ; 16(3): e0247295, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33657129

RESUMO

PURPOSE: The aim of this study was to gather data from female students studying in both health and non-health colleges at Imam Abdulrahman Bin Faisal University and report the prevalence, reasons, and determinants of dietary supplements use. METHODS: A month-long cross-sectional study was conducted in health and non-health colleges affiliated to Imam Abdulrahman Bin Faisal University in Dammam, Saudi Arabia. Convenient sampling was employed, and the data was gathered through an online survey using the English and Arabic versions of the Dietary Supplement Questionnaire (DSQ). The data was analyzed using SPSS version 23 and Medcalc. The study was approved by an ethics committee. RESULTS: Data from 545 participants was collected. The overall prevalence of dietary supplement use was 32.7% (95% CI: 29.06%- 36.51%). The prevalence was 29.77% (95% CI: 25.29%- 34.56%) among students at all health colleges combined and, it was 37.50% (95% CI: 31.36%- 43.96%) among students at all non-health colleges. Most students used a brand product, spent a monthly cost of SAR 286 (USD 76.3) on supplements and agreed that supplements were good for health (N = 392, 71.9%). Students from non-health- colleges agreed that dietary supplements are good for health in greater numbers as compared to non-health college students (p < 0.001). Students aged ≥ 20 years, studying in a non-health college and up to 3rd year of study, were more 2 times more likely to agree that dietary supplements are good for health. CONCLUSION: Supplements were commonly used among female students at this university however, it was quite low as compared to students from other local and regional universities. Prevalence was higher in non-health colleges as compared to health colleges and the most commonly used supplements were brand products and, multivitamins, used for general health and well-being. This highlights the inclination of students towards supplement use.


Assuntos
Suplementos Nutricionais , Educação de Graduação em Medicina , Estudantes , Universidades , Adolescente , Adulto , Feminino , Humanos , Prevalência , Arábia Saudita , Adulto Jovem
10.
Saudi Pharm J ; 28(9): 1055-1061, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32922135

RESUMO

PURPOSE: The study aimed to translate and validate the Arabic version of General Medication Adherence Scale (GMAS) in Saudi patients with chronic diseases. METHODS: A multi-center cross sectional study was conducted for a month in out-patient wards of hospitals in Khobar, Dammam, Makkah, and Madinah, Saudi Arabia. Patients were randomly selected from a registered patient pools at hospitals and the item-subject ratio was kept at 1:20. The tool was assessed for factorial, construct, convergent, known group and predictive validities as well as, reliability and internal consistency of scale were also evaluated. Sensitivity, specificity, and accuracy were also evaluated. Data were analyzed using SPSS v24 and MedCalc v19.2. The study was approved by concerned ethics committees (IRB-129-25/6/1439) and (IRB-2019-05-002). RESULTS: A total of 282 responses were received. The values for normed fit index (NFI), comparative fit index (CFI), Tucker Lewis index (TLI) and incremental fit index (IFI) were 0.960, 0.979, 0.954 and 0.980. All values were >0.95. The value for root mean square error of approximation (RMSEA) was 0.059, i.e., <0.06. Hence, factorial validity was established. The average factor loading of the scale was 0.725, i.e., >0.7, that established convergent validity. Known group validity was established by obtaining significant p-value <0.05, for the associations based on hypotheses. Cronbach's α was 0.865, i.e., >0.7. Predictive validity was established by evaluating odds ratios (OR) of demographic factors with adherence score using logistic regression. Sensitivity was 78.16%, specificity was 76.85% and, accuracy of the tool was 77.66%, i.e., >70%. CONCLUSION: The Arabic version of GMAS achieved all required statistical parameters and was validated in Saudi patients with chronic diseases.

11.
Front Pharmacol ; 11: 60, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32153397

RESUMO

OBJECTIVE: The study aimed to evaluate the association between disease knowledge and medication adherence in patients with type 2 diabetes mellitus. METHODS: A cross-sectional study was conducted for three months, in patients with type 2 diabetes who visited three community pharmacies located in Khobar, Saudi Arabia. Patients' disease knowledge and their adherence to medications were documented using Arabic versions of the Michigan Diabetes Knowledge Test and the General Medication Adherence Scale respectively. Data were analyzed through SPSS version 23. Chi-square test was used to report association of demographics with adherence. Spearman's rank correlation was employed to report the relationship among HbA1c values, disease knowledge and adherence. Logistic regression model was utilized to report the determinants of medication adherence and their corresponding adjusted odds ratio. Study was approved by concerned ethical committee (IRB-UGS-2019-05-001). RESULTS: A total of 318 patients consented to participate in the study. Mean HbA1c value was 8.1%. A third of patients (N = 105, 33%) had high adherence and half of patients (N = 162, 50.9%) had disease knowledge between 51% - 75%. A significantly weak-to-moderate and positive correlation (ρ = 0.221, p < 0.01) between medication adherence and disease knowledge was reported. Patients with >50% correct answers in the diabetes knowledge test questionnaire were more likely to be adherent to their medications (AOR 4.46, p < 0.01). CONCLUSION: Disease knowledge in most patients was average and half of patients had high-to-good adherence. Patients with better knowledge were 4 to 5 times more likely to have high adherence. This highlights the importance of patient education and awareness regarding medication adherence in managing diabetes.

12.
Risk Manag Healthc Policy ; 13: 55-61, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32158290

RESUMO

AIM: The aim of this study was to determine and compare the level of knowledge and perception of ADRs reporting and pharmacovigilance among interns and hospital pharmacists in different health-care settings in Saudi Arabia. METHODS: A cross-sectional study was conducted among pharmacists and pharmacy interns in different hospitals in Saudi Arabia. A total of 315 participants completed the self-administered and validated questionnaire during the period from August 2018 to March 2019. RESULTS: There was poor perception and knowledge of pharmacovigilance and ADRs reporting among pharmacists as well as intern pharmacists. However, pharmacists had better knowledge score compared to interns (P=0.043). Most of the respondents believed that ADRs reporting is important. The majority of both interns and pharmacists stated that they did not receive adequate education about pharmacovigilance during their undergraduate or internship program. CONCLUSION: There is a gap in knowledge and perception about pharmacovigilance among practicing pharmacists and new pharmacy graduates. Drug safety fundamentals and policies should be taught to undergraduate pharmacy students in Saudi Arabia.

13.
Artigo em Inglês | MEDLINE | ID: mdl-31947942

RESUMO

Although symptom burden and symptom profile severity are independent predictors of post-concussion symptom duration, few studies have examined their effects on prolonged recovery simultaneously. This study examined differences in symptom burden and symptom profile scores between concussed children with prolonged recovery and those with typical recovery. We conducted a retrospective case-control study of concussed children aged 10-18 years. Prolonged recovery was defined as symptom duration beyond 28 days post-injury. Symptom burden was measured as total symptom score (TSS) at injury. Symptom profiles included: (1) vestibular, (2) ocular, (3) cognitive/fatigue, (4) migraine, and (5) anxiety. A total of 4380 unique concussions sustained by 3777 patients were included; 80.3% white, 60.0% male, and 44.0% aged 13-15 years. The prolonged recovery group had a significantly higher TSS and greater number of symptoms than the typical recovery group (p < 0.001 and p < 0.001, respectively). The prolonged recovery group had significantly higher scores on all five symptom profiles, including vestibular (p < 0.001), ocular (p < 0.001), cognitive/fatigue (p < 0.001), migraine (p < 0.001) and anxiety (p < 0.001), than the typical recovery group, even after adjusting for number of symptoms and other covariates. Further studies using prospective cohort designs are needed to better understand the influence of symptom burden and profiles on pediatric concussion recovery.


Assuntos
Concussão Encefálica/reabilitação , Síndrome Pós-Concussão/fisiopatologia , Adolescente , Estudos de Casos e Controles , Criança , Feminino , Humanos , Masculino , Meio-Oeste dos Estados Unidos , Síndrome Pós-Concussão/classificação , Síndrome Pós-Concussão/etiologia , Recuperação de Função Fisiológica , Estudos Retrospectivos
14.
Saudi Pharm J ; 28(12): 1635-1647, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33424256

RESUMO

OBJECTIVE: The primary objective was to assess beverage consumption pattern and calorie intake among undergraduate students on weekly and daily basis. Secondary objectives were to determine the relationship between demographic variables and beverage intake, assess mean differences in calorie intake between students' groups and, report the predictors of beverage consumption. METHODS: A cross-sectional study was conducted for 3 months (January-March 2019) among currently enrolled undergraduate students studying in 8 colleges of a public sector university in Dammam, Saudi Arabia. The study used the Arabic version of Beverage Frequency Questionnaire (BFQ) and collected data through purposive stratified sampling. Total intake in ml and calories in kcals were calculated. Data was analyzed through SPSS version 23 and the study was approved from ethics committee of the university (IRB-2019-05-021). RESULTS: A total of 507 students responded to the survey. The average volume of sugar sweetened beverages (SSBs), caffeine containing beverage (CCBs) and carbonated beverages (CarBs) consumed was 4.2 L, 4 L and 1.5 L per week and 650.6 ml, 575.2 ml and 224.6 ml per day, respectively. Average daily calorie intake from SSBs, CCBs and CarBs was 187.6 kcals, 87.6 kcals and 52.5 kcals, respectively. Body mass index (BMI) was significantly related to CCB (ρ = 0.130) and CarBs (ρ = 0.100) intake (mL) (p < 0.05). Mean difference in calorie intake was mostly significant (p < 0.05) when accounted for students' demographics, gender, BMI, residence, illness and, examination time, in case of SSBs, CCBs, CarBs and, all beverages. Averge % contribution towards total daily energy expenditure (TDEE) for SSBs, CCBs and CarBs were 10.2%, 6.3% and 2.8%, respectively. Year of study, BMI, residence and illness were predictors of SSBs consumption while BMI, residence and examination time were predictors of CCBs consumption. Gender and BMI were predictors of CarBs intake. CONCLUSION: There was a high consumption of beverages in students that was related to their demographic characteristics. There is a need to create awareness among the students regarding the detrimental effects of chronic consumption of these beverages.

15.
Front Pharmacol ; 10: 633, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31231222

RESUMO

Objective: The aim was to validate the General Medication Adherence Scale (GMAS) (English version) in Saudi patients with chronic disease. Methods: A month-long study was conducted in the out-patient department of tertiary care hospitals in three cities of Saudi Arabia that collected data from a randomized sample of Saudi patients with chronic disease. The study aimed to achieve an item-to-subject ratio greater than 1:10. Factor analyses were conducted and fit indices calculated. Convergent, discriminant, known group, and concurrent validities were analysed. Internal consistency was determined using test-retest reliability using Cronbach's alpha (α), McDonald's coefficient omega (ω t ), and Pearson's correlation coefficient (ρ). Sensitivity analysis was conducted. Data were analysed through Statistical Package for Social Sciences (SPSS) version 23. The study was ethically approved (i.e., IRB-129-26/6/1439). Results: The survey gathered responses from 171 patients with a response rate of 85.5%. An item-to-subject ratio of 1:15 was achieved. Factor analysis revealed a three-factor structure with acceptable fit indices (i.e., normed fit index (NFI) = 0.93, Tucker-Lewis index (TLI) = 0.99, and comparative fit index (CFI) = 0.99), i.e., greater than 0.9. The value of root mean square error of approximation (RMSEA) was 0.01, i.e., less than 0.08. The tool established construct validity, i.e., convergent and discriminant validities. Known group and concurrent validities were also established. An α value of 0.74 and ω t value of 0.92 were reported. Test-retest reliability ρ = 0.82, p < 0.001. The tool had high sensitivity (>75%) and specificity (>80%). Conclusion: The GMAS-English was successfully validated in Saudi patients with chronic disease.

16.
Am J Pharm Educ ; 83(2): 6528, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30962640

RESUMO

Objective. To explore the opinions and recommendations of university and health care professional experts regarding the Advanced Pharmacy Practice Experiences (APPE) curriculum at the King Saud University College of Pharmacy. Methods. Forty-eight health care professionals of different backgrounds participated in a roundtable discussion during a 1-day meeting. The discussion revolved around three predefined themes: the doctor of pharmacy (PharmD) program learning outcomes, regulations and responsibilities and APPE activities and syllabi, non-clinical rotations, and assessment. The discussion was transcribed verbatim. Discussion of each theme was summarized and incorporated in the result. Results. Discussion regarding the PharmD program learning outcomes emphasized clinical outcomes with an additional focus on basic sciences. The regulations and responsibilities table incorporated guidance toward developing student professionalism. APPE activities and syllabi, non-clinical rotations and assessment recommendations encompassed crucial issues such as effective communication among the college, preceptors, and students, scheduled site visits, financial reimbursement for preceptors, student preparatory workshops, and non-clinical rotations. Conclusion. This roundtable discussion identified many of the concerns and recommendations previously encountered or currently being addressed in many of the previous studies and current accreditation standards. International candidates should consider these recommendations when applying for certification.


Assuntos
Acreditação/normas , Educação de Pós-Graduação em Farmácia/normas , Preceptoria/normas , Humanos , Estudantes de Farmácia , Universidades
18.
Ther Clin Risk Manag ; 14: 803-809, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29750038

RESUMO

PURPOSE: To analyze and compare the signals of bleeding from the use of direct-acting oral anticoagulants (DOACs) in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database over 5 years. METHODS: Reports of bleeding and of events with related terms submitted to the FAERS between October 2010 and September 2015 were retrieved and then analyzed using the reporting odds ratio (ROR). The signals of bleeding associated with DOAC use were compared with the signals of bleeding associated with warfarin use utilizing the FAERS databases. RESULTS: A total of 1,518 reports linked dabigatran to bleeding, accounting for 2.7% of all dabigatran-related reports, whereas 93 reports linked rivaroxaban to bleeding, which accounted for 4.4% of all rivaroxaban-related reports. The concurrent proportion of bleeding-related reports for warfarin was 3.6%, with a total of 654 reports. The association of bleeding and of related terms with the use of all three medications was significant, albeit with different degrees of association. The ROR was 12.30 (95% confidence interval [CI] 11.65-12.97) for dabigatran, 15.61 (95% CI 14.42-16.90) for warfarin, and 18.86 (95% CI 15.31-23.23) for rivaroxaban. CONCLUSIONS: The signals of bleeding varied among the DOACs, and the bleeding signal was higher for rivaroxaban and lower for dabigatran compared to that for warfarin.

19.
BMJ Open ; 8(5): e019101, 2018 05 05.
Artigo em Inglês | MEDLINE | ID: mdl-29730617

RESUMO

OBJECTIVE: To investigate the epidemiology of medication errors and error-related adverse events in adults in primary care, ambulatory care and patients' homes. DESIGN: Systematic review. DATA SOURCE: Six international databases were searched for publications between 1 January 2006 and 31 December 2015. DATA EXTRACTION AND ANALYSIS: Two researchers independently extracted data from eligible studies and assessed the quality of these using established instruments. Synthesis of data was informed by an appreciation of the medicines' management process and the conceptual framework from the International Classification for Patient Safety. RESULTS: 60 studies met the inclusion criteria, of which 53 studies focused on medication errors, 3 on error-related adverse events and 4 on risk factors only. The prevalence of prescribing errors was reported in 46 studies: prevalence estimates ranged widely from 2% to 94%. Inappropriate prescribing was the most common type of error reported. Only one study reported the prevalence of monitoring errors, finding that incomplete therapeutic/safety laboratory-test monitoring occurred in 73% of patients. The incidence of preventable adverse drug events (ADEs) was estimated as 15/1000 person-years, the prevalence of drug-drug interaction-related adverse drug reactions as 7% and the prevalence of preventable ADE as 0.4%. A number of patient, healthcare professional and medication-related risk factors were identified, including the number of medications used by the patient, increased patient age, the number of comorbidities, use of anticoagulants, cases where more than one physician was involved in patients' care and care being provided by family physicians/general practitioners. CONCLUSION: A very wide variation in the medication error and error-related adverse events rates is reported in the studies, this reflecting heterogeneity in the populations studied, study designs employed and outcomes evaluated. This review has identified important limitations and discrepancies in the methodologies used and gaps in the literature on the epidemiology and outcomes of medication errors in community settings.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Prescrição Inadequada/estatística & dados numéricos , Erros de Medicação/estatística & dados numéricos , Segurança do Paciente , Assistência Ambulatorial , Humanos , Incidência , Atenção Primária à Saúde , Fatores de Risco
20.
Saudi Pharm J ; 22(5): 411-8, 2014 11.
Artigo em Inglês | MEDLINE | ID: mdl-25473329

RESUMO

OBJECTIVE: To assess community pharmacists' knowledge, behaviors and experiences relating to Adverse Drug Reaction (ADR) reporting in Saudi Arabia. METHODS: A cross-sectional study was conducted using a validated self-administered questionnaire. A convenience sample of 147 community pharmacists working in community pharmacies in Riyadh, Saudi Arabia. RESULTS: The questionnaire was distributed to 147 pharmacists, of whom 104 responded to the survey, a 70.7% response rate. The mean age of participants was 29 years. The majority (n = 101, 98.1%) had graduated with a bachelorette degree and worked in chain pharmacies (n = 68, 66.7%). Only 23 (22.1%) said they were familiar with the ADR reporting process, and only 21 (20.2%) knew that pharmacists can submit ADR reports online. The majority of the participants (n = 90, 86.5%) had never reported ADRs. Reasons for not reporting ADRs most importantly included lack of awareness about the method of reporting (n = 22, 45.9%), misconception that reporting ADRs is the duty of physician and hospital pharmacist (n = 8, 16.6%) and ADRs in community pharmacies are simple and should not be reported (n = 8, 16.6%). The most common approach perceived by community pharmacists for managing patients suffering from ADRs was to refer him/her to a physician (n = 80, 76.9%). CONCLUSION: The majority of community pharmacists in Riyadh have poor knowledge of the ADR reporting process. Pharmacovigilance authorities should take necessary steps to urgently design interventional programs in order to increase the knowledge and awareness of pharmacists regarding the ADR reporting process.

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