Traditional remedies have gained recognition for their effectiveness in treating various conditions such as diabetes,arthritic pain,liver disease,cough and cold,memory enhancement,and immunological stimulation.Their p...Traditional remedies have gained recognition for their effectiveness in treating various conditions such as diabetes,arthritic pain,liver disease,cough and cold,memory enhancement,and immunological stimulation.Their perceived safety has led to the increasing use of herbs by people without prescriptions.These therapies remain significant in areas with limited access to modern drugs or cultural preferences for traditional treatments.With a long history of use,traditional medicines have been the primary method of pain management.This review article explores natural and herb-based analgesics,their origins,and potential benefits,along with the growing scientific evidence supporting their effectiveness.Studies have examined their efficacy in treating musculoskeletal pain,neuropathic pain,and migraines.Rather than being seen as separate therapies,traditional medicines should be considered supplementary or alternative options that can be integrated into comprehensive pain management regimens.However,some studies have reported adverse drug reactions associated with herbal formulations and plants.Therefore,there is a need for pharmacovigilance in traditional medicine to ensure patient safety and promote evidence-based practices.Although pharmacovigilance in this field is still developing,it faces challenges due to the wide availability of herbal medicines without on-site medical supervision.This paper discusses the complex challenges of herbal pharmacovigilance,provides insights on recent advancements,and offers recommendations for improving the safety monitoring of traditional medications in the future.展开更多
BACKGROUND Pharmacovigilance(PV)is the activities and scientific studies conducted to detect,evaluate,understand or prevent adverse reactions and other drug-related problems.AIM To define the awareness and experiences...BACKGROUND Pharmacovigilance(PV)is the activities and scientific studies conducted to detect,evaluate,understand or prevent adverse reactions and other drug-related problems.AIM To define the awareness and experiences of the clinicians on PV and adverse drug reactions(ADRs)in Turkey.METHODS The study was cross-sectional and analytical.Data were obtained through a questionnaire.The questionnaire was sent via e-mail.The survey was sent to 2030 physicians and 670 participated.RESULTS The most appropriate definition of PV was correctly defined by 53.9%of the participants.The most important goal of PV was correctly defined by 54.9%of the participants,and 27.3%of the participants were aware of the Turkish Pharmacovigilance Center.Nonsurgical physicians had better PV knowledge than surgical physicians.A total of 80.9%of the physicians who encountered ADRs,filled in the ADR notification form,and 8.8%received training on how to fill in the form.PV knowledge of the clinicians was not sufficient.Although half of the physicians encountered ADRs,the rates of seeing and filling in the ADR form were low.CONCLUSION Few of the physicians followed the current information about PV.The results provide more comprehensive data on PV practices and ADR reporting at a national level.展开更多
Background: The inappropriate, irrational use or misuse of antibiotics is observed in all health systems and in all patients’ groups worldwide, especially for children, where antibiotics continue to be the drugs most...Background: The inappropriate, irrational use or misuse of antibiotics is observed in all health systems and in all patients’ groups worldwide, especially for children, where antibiotics continue to be the drugs most commonly prescribed. Methods: A cross-sectional study was conducted in all public pediatric clinics in the Republic of Cyprus, from April to May 2015. A questionnaire was distributed to pediatricians in order to identify the antibiotic prescription practices in common childhood diseases and attitudes towards Pharmacovigilance. The SPSS 19.0 was used for the statistical analysis. In total 42 pediatricians and pediatric residents filled out the questionnaire. Results: A significant percentage of the respondents administered empirical therapy for possible group A streptococcus infection (59.5%), they implemented the “watchful waiting” tactic in acute otitis media (66.7%), whereas 11.9% of them administered antibiotics for the prevention of secondary respiratory tract infections. The majority of physicians did not feel diagnostic uncertainty leading to antibiotics prescribing (90.2%) and their prescribing habits were not influenced by parental demand (80.5%). Although 23.1% of physicians observed often/very often Adverse Drug Reactions (ADRs) after antibiotic administration during their clinical practice, however, 47.6% of the pediatricians declared that they did not report them. Conclusion: Health professionals’ continuing education on the use of therapeutic guidelines and protocols and the development of Pharmacovigilance programs could significantly contribute to the avoidance of the misuse of antibiotics in hospital care as well as to health professionals’ awareness on rational prescribing.展开更多
Objectives:To evaluate the impact of educational intervention on knowledge,attitude,and practice(KAP)regarding pharmacovigilance(PV)and adverse drug reaction(ADR)reporting among nursing officers.Materials and Methods:...Objectives:To evaluate the impact of educational intervention on knowledge,attitude,and practice(KAP)regarding pharmacovigilance(PV)and adverse drug reaction(ADR)reporting among nursing officers.Materials and Methods:A pre-and post-single-arm interventional study was conducted at All India Institute of Medical Sciences(AIIMS),Nagpur from May 2021 to October 2021 among 48 nursing officers.Data related to KAP were obtained through validated questionnaires before and after 3 months of educational intervention.Results:The mean knowledge score among nursing officers significantly improved from 11.05±3.09 to 16.77±2.07 after training session(P<0.001).The mean score regarding attitude was significantly upgraded from 21.16±5.6 to 23.79±2.97(P<0.001).At baseline,the mean practice score was poor(2.41±2.89),which was improved after training session,but the difference is not significant.Conclusion:Educational intervention had a significant impact on knowledge and attitude toward ADR reporting.The practice of detecting and reporting an ADR to the treating consultant is improved,but it is not transformed into reporting an ADR to the PV center to a significant extent.Hence,it is recommended to streamline ADR reporting process by implementing such training modules more frequently.展开更多
Objective: To assess the perception of pharmacovigilance by healthcare professionals practicing at the University Teaching Hospital of Cocody (Ivory Coast) in 2017. Methodology: A descriptive and analytic cross-sectio...Objective: To assess the perception of pharmacovigilance by healthcare professionals practicing at the University Teaching Hospital of Cocody (Ivory Coast) in 2017. Methodology: A descriptive and analytic cross-sectional survey has been conducted in 2017 at the University Teaching Hospital of Cocody. This survey involved a sample of healthcare professionals practicing in 17 services who are prescribing medications and gave their oral consent. Results: A response rate of 54.08% (106/196) among physicians versus 43.87% (86/196) for the nurses and 27.61% (21/76) for the mid-wives. 57.94% (62/107) of paramedics versus 94.33% (100/106) of physicians had already heard about pharmacovigilance, during their basic training (40.18% of paramedics versus 73.58% of doctors). However, the main obstacles to the practice of pharmacovigilance were it teaching hours considered insufficient (94.39% of paramedics versus 75.47% of physicians), the lack of knowledge on the location of the pharmacovigilance unit (80.37% of paramedics versus, 40% of physicians) and the reporting of the adverse drug reactions to a hierarchical supervisor (60.60% of paramedics versus 37.25% of physicians). A regular visit of pharmacovigilance monitors in the hospital services (34.57% of paramedics versus 29.24% of physicians) and the availability of reporting forms (30.84% of paramedics versus 27.35% of physicians) could improve the perception of pharmacovigilance by the healthcare professionals. Conclusion: Our investigational survey has highlighted some factors that may influence the perception of pharmacovigilance by the healthcare professionals in Ivory Coast.展开更多
Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conduc...Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.展开更多
Background: Pharmacovigilance of biological medicines is crucial because it ensures that medicines meet the World Health Organization (WHO) standards. In Zambia, there is little information on healthcare professionals...Background: Pharmacovigilance of biological medicines is crucial because it ensures that medicines meet the World Health Organization (WHO) standards. In Zambia, there is little information on healthcare professionals’ familiarity, knowledge and practices on the pharmacovigilance of biological and biosimilar medicines. Therefore, this study investigated the familiarity, knowledge, and practices related to the pharmacovigilance (PV) of biological and biosimilar medicines at selected hospitals in Lusaka, Zambia. Methods: The study was an analytical questionnaire-based cross-sectional study conducted among healthcare professionals (HCPs) at the Adult hospital, Cancer Diseases hospital, Paediatrics hospital and Women and New Born Hospital in Lusaka. Data were collected over four weeks in May and June 2021 and subsequently analysed using IBM SPSS version 21. The statistical significance was set at a 95% confidence interval. Results: Of 245 participants, only 115 (48.9%) of the HCPs were familiar with biological medicines to a basic understanding. Regarding the term biosimilars, most of the HCPs (40.9%) never heard of this word. The mean score for knowledge regarding the PV considerations of biological medicines was 4.1 out of 8 questions. Most HCPs used non-proprietary names (44.2%) when prescribing, dispensing, or administering biological medicines. Additionally, more than half (57.3%) of HCPs did not record batch numbers when dispensing or administering biological medicines. Conclusion: Healthcare professionals were more familiar with the term biological medicines than biosimilars. Healthcare professionals generally scored poorly when their knowledge regarding the PV considerations of biological medicines was assessed. Thus, there is a need to provide adequate training and continuous professional development among healthcare professionals on the pharmacovigilance of biological and biosimilar medicines.展开更多
Objective: To assess the perception on pharmacovigilance by the nurses and midwives at the University Teaching Hospital (CHU) of Cocody in 2017. Methodology: Descriptive and analytic cross-sectional study conducted in...Objective: To assess the perception on pharmacovigilance by the nurses and midwives at the University Teaching Hospital (CHU) of Cocody in 2017. Methodology: Descriptive and analytic cross-sectional study conducted in 17 services of the University Teaching Hospital (CHU) of Cocody using an anonymized and standardized questionnaire. Results: The response rate was 39.33% for the 86 nurses and 21 midwives with at least 10 years of professional experience (50.6%). 57.94% of the respondents (n = 62) have already heard about pharmacovigilance during their basic training (40.18%, n = 43). However, only 19.63% (21/107) of the respondents knew about the existence of a pharmacovigilance unit which they wrongly located to the pharmacy (11/21) of the CHU of Cocody. 40.18% of respondents (n = 43) had previously experienced an adverse drug reaction that was reported (76.74%, n = 33) to a hierarchical supervisor (60.60%, n = 20). The causes of non-reporting were either the frequent occurence (4/10) or the benign nature (2/10) of the adverse drug reaction. Specific actions to be taken (37.38%, n = 40) and a feedback (28.97%, n = 31) were the respondents’ main expectations for the stimulation of the reporting system. They also wanted the pharmacovigilance monitors to regularly visit their services (34.57%, n = 37) and to provide them with the reporting forms (30.84%, n = 33). Conclusion: Our study has allowed us to highlight the lack of knowledge of the pharmacovigilance and to identify certain factors that could improve the perception of the pharmacovigilance by the nurses and the midwives in Ivory Coast.展开更多
With the widespread concern about the safety of Chinese materia medica, China urgently needs to build a Chinese materia medica pharmacovigilance system that conforms to the national development policy and has the char...With the widespread concern about the safety of Chinese materia medica, China urgently needs to build a Chinese materia medica pharmacovigilance system that conforms to the national development policy and has the characteristics of traditional Chinese medicine(TCM). A good job of pharmacovigilance of Chinese materia medica not only helps Chinese pharmaceutical companies to control their risks, but also guides them to use drugs safely and rationally. And it is also of great significance to the national drug regulatory work. Based on the monitoring of herbal safety in WHO pharmacovigilance system, the establishment of a Chinese materia medica pharmacovigilance system was explored in order to provide a valuable reference for the risk control of Chinese pharmaceutical companies, the clinical use of Chinese materia medica, and the national drug regulatory work.展开更多
Objective To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus(BGZP)related with hepatobiliary adverse drug reactions(ADR),in order to rein...Objective To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus(BGZP)related with hepatobiliary adverse drug reactions(ADR),in order to reinforce pharmacovigilance.Methods A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December 2016.Serious and general ADRs were analyzed and assessed.Results There were 355 cases of hepatobiliary ADR related to BGZP.Both the amount of cases and the proportion of serious ADR showed an increasing growth by years(P<0.05).It was found that 10.43%of 355 cases may be involved with irrational drug use,including overdose,repeated medication,and combination of multiple drugs.There were 190 cases which used BGZP(non-combination),and they were mainly for common in diseases caused by abnormal immune activation(accounting for 40.53%of the total cases).Especially at the age group with the most cases with age of 41–50 years,the cases associated with immunological diseases of female were obviously more than that of male(P<0.05).The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days,and the median latency was 27.5 days,along with the range of cumulative dose(0.45–520.02 g)as well as the daily dose(0.09–2.64 g/d)after the conversion.Conclusions Cases of hepatobiliary ADR related to BGZP showed significant individual differences,and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary ADR.It may be similar with idiosyncratic drug-induced liver injury,and recommended that BGZP should be used with more caution under monitoring liver function,especially in female patients with immunological diseases.展开更多
Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 ...Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas(subdistricts)of 26 districts(these include VL,PKDL,treatment failure,and relapse VL and cutaneous leishmaniasis cases).This study aimed to investigate the feasibility of using focused pharmacovigilance for VL(VLPV)in Bangladesh’s National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions(ADRs).Methods:This activity has been going on since December 2014.Activity area includes secondary public hospital or Upazila health complex(UHC)in hundred sub districts and Surya Kanta Kala-azar Research Center(SKKRC)in Mymensingh District,a specialized center for management of complicated VL and PKDL cases.Communicable Disease Control(CDC)of the Directorate General of Health Services(DGHS)assigned twenty five of hundred UHCs and SKKRC(total 26)as treatment centers depending on their suitable geographical location.This was implemented for better management of VL cases with Liposomal Amphotericin B(AmBisome®)to ensure patient convenience and proper utilization of this expensive donated drug.A VLPV expert committee and a UHC VLPV team were established,an operational manual and pharmacovigilance report forms were developed,training and refresher training of health personnel took place at UHCs and at the central level,collected information such as patient data including demographics,treatment history and response,adverse events were analyzed.This report includes information for the period from December 2014 to December 2016.Results:From December 2014 to December 2016,1327 leishmaniasis patients were treated and 1066(80%)were available for VLPV.Out of these,57,33,9,and 1%were new VL,PKDL,VL relapse,and other cases,respectively.Liposomal amphotericin B was mostly used(82%)for case management,followed by miltefosine(20%)and paromomycin(3%).Out of the 1066 patients,26%experienced ADRs.The most frequent ADR was fever(17%,176/1066),followed by vomiting(5%,51/1066).Thirteen serious adverse events(SAEs)(eight deaths and five unexpected SAEs)were observed.The expert committee assessed that three of the deaths and all unexpected SAEs were possibly related to treatment.Out of the five unexpected SAEs,four were miltefosine-induced ophthalmic complications and the other was an AmBisome^(■)-induced avascular necrosis of the nasal alae.The Directorate General of the Drug Administration entered the ADRs into the World Health Organization Uppsala Monitoring Centre(WHO-UMC)VigiFlow database.Conclusions:This study found that VLPV through NKEP is feasible and should be continued as a routine activity into the public health system of Bangladesh to ensure patient safety against anti-leishmanial drugs.展开更多
AIM: To inform clinicians on the level of hepatotoxicrisk among antimycotics in the post-marketing setting,following the marketing suspension of oral ketocon-azole for drug-induced liver injury(DILI).METHODS: The publ...AIM: To inform clinicians on the level of hepatotoxicrisk among antimycotics in the post-marketing setting,following the marketing suspension of oral ketocon-azole for drug-induced liver injury(DILI).METHODS: The publicly available international FAERSdatabase(2004-2011) was used to extract DILI cases(including acute liver failure events), where antimycot-ics with systemic use or potential systemic absorptionwere reported as suspect or interacting agents. The re-porting pattern was analyzed by calculating the report-ing odds ratio and corresponding 95%CI, a measure ofdisproportionality, with time-trend analysis where ap-propriate.RESULTS: From 1687284 reports submitted over the8-year period, 68115 regarded liver injury. Of these,2.9% are related to antimycotics(1964 cases, of which 112 of acute liver failure). Eleven systemic antimycotics(including ketoconazole and the newer triazole deriva-tives voriconazole and posaconazole) and terbinafine(used systemically to treat onychomicosis) generated a significant disproportionality, indicating a post-market-ing signal of risk.CONCLUSION: Virtually all antimycotics with systemic action or absorption are commonly reported in clinically significant cases of DILI. Clinicians must be aware of this aspect and monitor patients in case switch is con-sidered, especially in critical poly-treated patients under chronic treatment.展开更多
The aged population is constantly growing, thus fostering an increase in age-dependent diseases. Among these, diabetic retinopathy (DR) along with age-related macular degeneration entails progressive vision loss. Sinc...The aged population is constantly growing, thus fostering an increase in age-dependent diseases. Among these, diabetic retinopathy (DR) along with age-related macular degeneration entails progressive vision loss. Since such conditions are associated with the proliferation of novel vessels, their pharmacotherapeutic management consists of the intravitreal injection of anti-vascular endothelial growth factor drugs, able to hinder the driving of vascular proliferation prompted by vascular endothelial growth factor. The humanized anti-vascular endothelial growth factor monoclonal antibody ranibizumab provided evidence for efficacy in several trials, hence earning approval by the US Food and Drug Administration for therapeutic use in all the stages of DR. Due to the lack of epidemiologic and pharmacoeconomic evaluation in the local Calabria Region context, the present retrospective observational study focused on prevalence of DR and age-related macular degeneration, treatment and cost of therapy with ranibizumab in 870 patients arriving to clinical observation at the "Mater Domini” University Hospital in Calabria, Italy from January 2014 to June 2017. Data were extracted from the database of ophthalmology ward and subjected to statistical analysis. The results suggest that the most frequent retinal diseases are age-related macular degeneration and DR and that the use of ranibizumab has been decreasing over the 4-year study period together with the associated cost per patient which was similar for both disorders. Therefore, appropriateness of treatment with drugs other than ranibizumab needs to be assessed in this setting and deep monitoring of pharmacologic treatment for retinal diseases is necessary to prevent or delay visual acuity decrease and complete vision loss. Study procedures were performed in accordance with the "Mater Domini” University Hospital ethical standards of the responsible committee on human experimentation.展开更多
In recent years,the popularity increased for nutritional supplements and herbal products.Prescription drugs,but not herbal therapies are paid by health insurances.They are sold over-the-counter(OTC)on the patients’ow...In recent years,the popularity increased for nutritional supplements and herbal products.Prescription drugs,but not herbal therapies are paid by health insurances.They are sold over-the-counter(OTC)on the patients’own expense.However,there are potential risks of self-medication,e.g.incorrect self-diagnosis,severe adverse reactions,dangerous drug interactions,risk of addiction etc.They are often used by patients at their own discretion without knowledge of and control by their physicians.Certain users are at risk of intoxication.Multiple medications taken by older patients increase the risk for adverse drug reactions,drug-drug interactions,and compliance problems for this age group(polypharmacy).Herbals should be discontinued prior to operations to avoid interactions with anesthetics or anticoagulants.Herbal preparations may also be carcinogenic or interfere with cancer treatments.Pregnant women use various OTC preparations.However,in many cases,it is unclear whether their use is safe for mother or baby.Self-medication with herbals is also largely distributed among anxious and depressive patients,and patients with other conditions and symptoms.The popularity of herbal products has also brought concerns on quality,efficacy and safety.Cases of botanical misidentification,contaminations with heavy metals,pesticides,radioactivity,organic solvents,microbials as well as adulteration with chemical drugs necessitate the establishment of international quality control standards.Hepatotoxic effects have been reported for more than 300 plant species,and some commonly used herbs have been demonstrated to interact with Western medication.Health care professionals have a critical responsibility assessing the self-care ability of their patients.Databases are available for pharmacists with information on action,side effects and toxicities as well as herbdrug interactions.There is a need for established guidelines regarding the correct use of nutritional supplements and herbal OTC preparations(phytovigilance).Physicians,pharmacists,and other health care professionals have to counsel patients and the general public on the benefits and risks associated with herbal drugs.Information centers for consumers and general practitioners are needed,and convincing evidence on safety and efficacy of herbal products has to be demonstrated in placebo-controlled,double blind and randomized clinical trials.展开更多
Even though randomized controlled clinical trials(RCTs)have been accepted as the gold standard for official assessment of novel interventions,there is a substantial gap between the efficacy observed in RCTs and the im...Even though randomized controlled clinical trials(RCTs)have been accepted as the gold standard for official assessment of novel interventions,there is a substantial gap between the efficacy observed in RCTs and the impact on clinical practice and in terms of patient benefit.While real-world studies(RWS)are emerging to confer valuable complementing evidence in this regard and beyond,the evolving role of RWS is yet to be agreed.This article delineates an updated profile of RWS covering effectiveness verification,rare adverse effects discovery,indication repurposing,to name a few.RWS tends not only to improve the efficiency of clinical investigations for regulatory approval,but also optimizes the whole-life cycle evaluation of biomedical/pharmaceutical products.展开更多
Coronavirus disease 2019(COVID-19)consists of a systemic disease that can present many complications.The infection presents broad clinical symptoms and a high rate of transmissibility.In addition to severe acute respi...Coronavirus disease 2019(COVID-19)consists of a systemic disease that can present many complications.The infection presents broad clinical symptoms and a high rate of transmissibility.In addition to severe acute respiratory syndrome,the patients manifest complications beyond the respiratory system.The frequency of liver damage in COVID-19 patients ranges from 14.8% to 53% of patients.One should pay attention to drug-induced liver injury(DILI)in patients with COVID-19,especially considering the off-label use of drugs in prophylactic and therapeutic regimens applied on large scales.This review aims to present relevant information on the medication used so far in COVID-19 patients and its possible hepatotoxicity.We reviewed liver damage in patients with COVID-19 on PubMed and Virtual Health Library to investigate DILI cases.Four studies were selected,involving the medicines remdesivir,tocilizumab and a pharmacovigilance analysis study.The hepatotoxicity profile of drugs presented in the literature considers use in accordance to usual posology standards for treatment.However,drugs currently used in the management of COVID-19 follow different dosages and posology than those tested by the pharmaceutical industry.The deficiency of uniformity and standardization in the assessment of hepatotoxicity cases hinders the publication of information and the possibility of comparing information among healthcare professionals.It is suggested that severe liver injury in COVID-19 patients should be reported in pharmacovigilance institutions,and physicians should pay attention to any considerable abnormal liver test elevation as it can demonstrate unknown drug hepatotoxicity.Liver disorders in COVID-19 patients and the use of several concomitant off-label medications—with a potential risk of further damaging the liver-should at least be a warning sign for rapid identification and early intervention,thus preventing liver damage from contributing to severe impairment in patients.展开更多
BACKGROUND The antidepressant escitalopram is widely prescribed for the treatment of depression.It is generally well-tolerated,and cholestasis is not mentioned in its summary of product characteristics(Sm PC).We prese...BACKGROUND The antidepressant escitalopram is widely prescribed for the treatment of depression.It is generally well-tolerated,and cholestasis is not mentioned in its summary of product characteristics(Sm PC).We present a case of cholestatic and cytolysis liver injury due to escitalopram and a Vigi Base?study.CASE SUMMARY A 68-year-old man was admitted to our emergency unit due to clinical jaundice associated with hepatitis,pruritus and dark urine.We tested the patient for the most common etiologies of jaundice,including hemolysis,viral hepatitis,cirrhosis,carcinoma,cholangitis,cholelithiasis and intrahepatic or extrahepatic obstruction.The etiological study was negative,and an adverse drug reaction was the sole possible explanation.The patient was receiving treatment with escitalopram.Two days after its withdrawal,pruritus was resolved.Ten days after withdrawal,clinical jaundice disappeared.It took a month and three weeks after withdrawal for the patient to have normalized liver function tests.To our knowledge,this is the first reported case of cholestasis where treatment with escitalopram was the only possible cause,with a highly probable causality.In addition,we determined whether escitalopram is associated with hepatotoxicity and cholestasis by performing a disproportionality analysis.All cases of hepatobiliary disorders induced by escitalopram and reported in the World Health Organization pharmacovigilance database(Vigi Base?)were analyzed to characterize this toxicity.We found that patients treated with escitalopram had an increased risk of hepatitis[odds ratio(OR)=1.938(1.186-3.166)]and cholestasis[OR=1.866(1.279-2.724)][OR(95%confidence interval)].The median duration between the introduction of escitalopram and the occurrence of acute hepatitis and/or cholestasis was ten days+/-seven days.CONCLUSION Although extremely rare,this case report,the review of the literature and the pharmacovigilance update confirm that escitalopram can cause drug-induced hepatotoxicity and cholestasis,generally within a week after initiation.Thus,escitalopram should be withdrawn immediately if an iatrogenic cause cannot be excluded.If its responsibility is ascertained,escitalopram should be consequently contraindicated.In addition,serotoninergic antidepressants in patients with nonsevere depression are ineffective and harmful.Finally,the Sm PC of escitalopram should be updated to alert for this risk and give clear clinical guidelines.展开更多
Objective:To examine the frequency and profile of spontaneous reports of adverse drug reactions(ADRs)sent to Ethiopia's pharmacovigilance(PV)database system.Methods:The descriptive and retrospective study analysed...Objective:To examine the frequency and profile of spontaneous reports of adverse drug reactions(ADRs)sent to Ethiopia's pharmacovigilance(PV)database system.Methods:The descriptive and retrospective study analysed spontaneous ADR complaints reported to the PV database by healthcare professionals between 2013 and 2018.Spontaneous ADR reports that reached the PV center and met the minimum reporting criteria were identified and assessed in terms of reporting rate,patient characteristics,type of ADRs,suspected drugs,report sources,and reporters’profession.Results:A total of 657 spontaneous ADR reports were filed to the PV center between 2013 and 2018.During the study period,the reporting pattern of ADRs changed dramatically.The number of reports increased from 2013(n=12)and peaked in 2015(n=205),and then declined from 2016 to 2018(n=144,142 and 65 in 2016,2017 and 2018,respectively).Females had a higher percentage of reported cases(56.3%)than males(43.7%).The highest number of ADRs was reported in the age categories of 15-64 years(475,72.3%),followed by 0-14 years(154,23.4%),and 65 years and above(21,3.2%).Pharmacists reported the majority of ADRs(81.7%),followed by health officers(7.2%),nurses(5.8%),and physicians(5.2%).Skin and subcutaneous tissue abnormalities were the most commonly reported ADRs.The anatomical therapeutic chemicals code class"anti-infective for systemic use"was the most usually suspected medication.Trimethoprim with sulfamethoxazole as a combination ADRs was the most commonly reported drug that cause ADRs(14.2%).Conclusions:The number of ADRs reported in Ethiopia was small and unpredictable compared to developed countries,indicating the performance of PV system and level of awareness of health care professionals towards ADR reporting was not satisfactory.In order to increase the frequency of spontaneous reports,more efficient PV methods and public policies must be implemented.展开更多
AIM: To detect ophthalmic adverse drug reactions(ADRs), that occurred in Portugal from 2000 to 2009, through the utilization of administrative hospital databases. We also intended to compare the results of this method...AIM: To detect ophthalmic adverse drug reactions(ADRs), that occurred in Portugal from 2000 to 2009, through the utilization of administrative hospital databases. We also intended to compare the results of this methodology with spontaneous reporting.METHODS: We conducted a retrospective nationwide study using hospital administrative databases, which included all inpatients and outpatients in all public hospitals in Portugal, from 2000 to 2009. We used International Classification of Diseases- 9th Revision- Clinical Modification(ICD-9-CM) coding data that allowed the detection of ADRs. We used WHO's definition for ADR. We searched all of ICD-9-CM terms in Ophthalmology for codes that included "drug-induced", "iatrogenic", "toxic" and all other that could signal an ADR, such as "362.55- toxic maculopathy" or "365.03- steroid responders", and also "E" codes(codes from E930 to E949.9, that exclude intoxications and errors).RESULTS: From 11944725 hospitalizations or ambulatory episodes within that period of time, we identified 1524 probable ophthalmic ADRs(corresponding to a frequency of 1.28 per 10000 episodes) and an additional 100 possible ophthalmic ADRs. We used only 4 person-hours in the application of this methodology. A total of 113 spontaneous reports arose from ophthalmic ADRs from 2000 to 2009 in Portugal(frequency of 0.095 per 10000 episodes).To our knowledge, this was the first estimate of the frequency of ophthalmic ADRs through the use of databases, and the first nationwide estimate of ophthalmic ADRs, in Portugal. We identified 1524 probable ADRs and 100 possible ADRs. CONCLUSION: This database methodology adapted for Ophthalmology may represent a new approach for the detection of ophthalmic ADRs, since these codes exist in the ICD-9-CM classification. Its performance was clearly superior to spontaneous reporting.展开更多
Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured...Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Objective: To assess the safety of TransferonTM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with TransferonTM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with TransferonTM (MD 1.9, IQR 1.7 - 2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with TransferonTM, and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: TransferonTM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.展开更多
文摘Traditional remedies have gained recognition for their effectiveness in treating various conditions such as diabetes,arthritic pain,liver disease,cough and cold,memory enhancement,and immunological stimulation.Their perceived safety has led to the increasing use of herbs by people without prescriptions.These therapies remain significant in areas with limited access to modern drugs or cultural preferences for traditional treatments.With a long history of use,traditional medicines have been the primary method of pain management.This review article explores natural and herb-based analgesics,their origins,and potential benefits,along with the growing scientific evidence supporting their effectiveness.Studies have examined their efficacy in treating musculoskeletal pain,neuropathic pain,and migraines.Rather than being seen as separate therapies,traditional medicines should be considered supplementary or alternative options that can be integrated into comprehensive pain management regimens.However,some studies have reported adverse drug reactions associated with herbal formulations and plants.Therefore,there is a need for pharmacovigilance in traditional medicine to ensure patient safety and promote evidence-based practices.Although pharmacovigilance in this field is still developing,it faces challenges due to the wide availability of herbal medicines without on-site medical supervision.This paper discusses the complex challenges of herbal pharmacovigilance,provides insights on recent advancements,and offers recommendations for improving the safety monitoring of traditional medications in the future.
文摘BACKGROUND Pharmacovigilance(PV)is the activities and scientific studies conducted to detect,evaluate,understand or prevent adverse reactions and other drug-related problems.AIM To define the awareness and experiences of the clinicians on PV and adverse drug reactions(ADRs)in Turkey.METHODS The study was cross-sectional and analytical.Data were obtained through a questionnaire.The questionnaire was sent via e-mail.The survey was sent to 2030 physicians and 670 participated.RESULTS The most appropriate definition of PV was correctly defined by 53.9%of the participants.The most important goal of PV was correctly defined by 54.9%of the participants,and 27.3%of the participants were aware of the Turkish Pharmacovigilance Center.Nonsurgical physicians had better PV knowledge than surgical physicians.A total of 80.9%of the physicians who encountered ADRs,filled in the ADR notification form,and 8.8%received training on how to fill in the form.PV knowledge of the clinicians was not sufficient.Although half of the physicians encountered ADRs,the rates of seeing and filling in the ADR form were low.CONCLUSION Few of the physicians followed the current information about PV.The results provide more comprehensive data on PV practices and ADR reporting at a national level.
文摘Background: The inappropriate, irrational use or misuse of antibiotics is observed in all health systems and in all patients’ groups worldwide, especially for children, where antibiotics continue to be the drugs most commonly prescribed. Methods: A cross-sectional study was conducted in all public pediatric clinics in the Republic of Cyprus, from April to May 2015. A questionnaire was distributed to pediatricians in order to identify the antibiotic prescription practices in common childhood diseases and attitudes towards Pharmacovigilance. The SPSS 19.0 was used for the statistical analysis. In total 42 pediatricians and pediatric residents filled out the questionnaire. Results: A significant percentage of the respondents administered empirical therapy for possible group A streptococcus infection (59.5%), they implemented the “watchful waiting” tactic in acute otitis media (66.7%), whereas 11.9% of them administered antibiotics for the prevention of secondary respiratory tract infections. The majority of physicians did not feel diagnostic uncertainty leading to antibiotics prescribing (90.2%) and their prescribing habits were not influenced by parental demand (80.5%). Although 23.1% of physicians observed often/very often Adverse Drug Reactions (ADRs) after antibiotic administration during their clinical practice, however, 47.6% of the pediatricians declared that they did not report them. Conclusion: Health professionals’ continuing education on the use of therapeutic guidelines and protocols and the development of Pharmacovigilance programs could significantly contribute to the avoidance of the misuse of antibiotics in hospital care as well as to health professionals’ awareness on rational prescribing.
文摘Objectives:To evaluate the impact of educational intervention on knowledge,attitude,and practice(KAP)regarding pharmacovigilance(PV)and adverse drug reaction(ADR)reporting among nursing officers.Materials and Methods:A pre-and post-single-arm interventional study was conducted at All India Institute of Medical Sciences(AIIMS),Nagpur from May 2021 to October 2021 among 48 nursing officers.Data related to KAP were obtained through validated questionnaires before and after 3 months of educational intervention.Results:The mean knowledge score among nursing officers significantly improved from 11.05±3.09 to 16.77±2.07 after training session(P<0.001).The mean score regarding attitude was significantly upgraded from 21.16±5.6 to 23.79±2.97(P<0.001).At baseline,the mean practice score was poor(2.41±2.89),which was improved after training session,but the difference is not significant.Conclusion:Educational intervention had a significant impact on knowledge and attitude toward ADR reporting.The practice of detecting and reporting an ADR to the treating consultant is improved,but it is not transformed into reporting an ADR to the PV center to a significant extent.Hence,it is recommended to streamline ADR reporting process by implementing such training modules more frequently.
文摘Objective: To assess the perception of pharmacovigilance by healthcare professionals practicing at the University Teaching Hospital of Cocody (Ivory Coast) in 2017. Methodology: A descriptive and analytic cross-sectional survey has been conducted in 2017 at the University Teaching Hospital of Cocody. This survey involved a sample of healthcare professionals practicing in 17 services who are prescribing medications and gave their oral consent. Results: A response rate of 54.08% (106/196) among physicians versus 43.87% (86/196) for the nurses and 27.61% (21/76) for the mid-wives. 57.94% (62/107) of paramedics versus 94.33% (100/106) of physicians had already heard about pharmacovigilance, during their basic training (40.18% of paramedics versus 73.58% of doctors). However, the main obstacles to the practice of pharmacovigilance were it teaching hours considered insufficient (94.39% of paramedics versus 75.47% of physicians), the lack of knowledge on the location of the pharmacovigilance unit (80.37% of paramedics versus, 40% of physicians) and the reporting of the adverse drug reactions to a hierarchical supervisor (60.60% of paramedics versus 37.25% of physicians). A regular visit of pharmacovigilance monitors in the hospital services (34.57% of paramedics versus 29.24% of physicians) and the availability of reporting forms (30.84% of paramedics versus 27.35% of physicians) could improve the perception of pharmacovigilance by the healthcare professionals. Conclusion: Our investigational survey has highlighted some factors that may influence the perception of pharmacovigilance by the healthcare professionals in Ivory Coast.
文摘Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.
文摘Background: Pharmacovigilance of biological medicines is crucial because it ensures that medicines meet the World Health Organization (WHO) standards. In Zambia, there is little information on healthcare professionals’ familiarity, knowledge and practices on the pharmacovigilance of biological and biosimilar medicines. Therefore, this study investigated the familiarity, knowledge, and practices related to the pharmacovigilance (PV) of biological and biosimilar medicines at selected hospitals in Lusaka, Zambia. Methods: The study was an analytical questionnaire-based cross-sectional study conducted among healthcare professionals (HCPs) at the Adult hospital, Cancer Diseases hospital, Paediatrics hospital and Women and New Born Hospital in Lusaka. Data were collected over four weeks in May and June 2021 and subsequently analysed using IBM SPSS version 21. The statistical significance was set at a 95% confidence interval. Results: Of 245 participants, only 115 (48.9%) of the HCPs were familiar with biological medicines to a basic understanding. Regarding the term biosimilars, most of the HCPs (40.9%) never heard of this word. The mean score for knowledge regarding the PV considerations of biological medicines was 4.1 out of 8 questions. Most HCPs used non-proprietary names (44.2%) when prescribing, dispensing, or administering biological medicines. Additionally, more than half (57.3%) of HCPs did not record batch numbers when dispensing or administering biological medicines. Conclusion: Healthcare professionals were more familiar with the term biological medicines than biosimilars. Healthcare professionals generally scored poorly when their knowledge regarding the PV considerations of biological medicines was assessed. Thus, there is a need to provide adequate training and continuous professional development among healthcare professionals on the pharmacovigilance of biological and biosimilar medicines.
文摘Objective: To assess the perception on pharmacovigilance by the nurses and midwives at the University Teaching Hospital (CHU) of Cocody in 2017. Methodology: Descriptive and analytic cross-sectional study conducted in 17 services of the University Teaching Hospital (CHU) of Cocody using an anonymized and standardized questionnaire. Results: The response rate was 39.33% for the 86 nurses and 21 midwives with at least 10 years of professional experience (50.6%). 57.94% of the respondents (n = 62) have already heard about pharmacovigilance during their basic training (40.18%, n = 43). However, only 19.63% (21/107) of the respondents knew about the existence of a pharmacovigilance unit which they wrongly located to the pharmacy (11/21) of the CHU of Cocody. 40.18% of respondents (n = 43) had previously experienced an adverse drug reaction that was reported (76.74%, n = 33) to a hierarchical supervisor (60.60%, n = 20). The causes of non-reporting were either the frequent occurence (4/10) or the benign nature (2/10) of the adverse drug reaction. Specific actions to be taken (37.38%, n = 40) and a feedback (28.97%, n = 31) were the respondents’ main expectations for the stimulation of the reporting system. They also wanted the pharmacovigilance monitors to regularly visit their services (34.57%, n = 37) and to provide them with the reporting forms (30.84%, n = 33). Conclusion: Our study has allowed us to highlight the lack of knowledge of the pharmacovigilance and to identify certain factors that could improve the perception of the pharmacovigilance by the nurses and the midwives in Ivory Coast.
基金funded by General Program of National Natural Science Foundation of China(NO.81473798):Study on allergic reaction mechanism of post-marketing Chinese medicine injections with active monitoring and network target monitoringNational Science and Technology Major Project of"Development Program of Significant New Drug"(2015ZX09501004-001-002/009)Entrusted Project of China Center for Food and Drug International Exchange,The State Food and Drug Administration:International promotion of Chinese medicine safety
文摘With the widespread concern about the safety of Chinese materia medica, China urgently needs to build a Chinese materia medica pharmacovigilance system that conforms to the national development policy and has the characteristics of traditional Chinese medicine(TCM). A good job of pharmacovigilance of Chinese materia medica not only helps Chinese pharmaceutical companies to control their risks, but also guides them to use drugs safely and rationally. And it is also of great significance to the national drug regulatory work. Based on the monitoring of herbal safety in WHO pharmacovigilance system, the establishment of a Chinese materia medica pharmacovigilance system was explored in order to provide a valuable reference for the risk control of Chinese pharmaceutical companies, the clinical use of Chinese materia medica, and the national drug regulatory work.
基金Supported by the National Natural Science Foundation of China(No.81630100)Beijing Nova Program(No.Z181100006218001)Project of China PLA General Hospital(No.2019MBD-023)。
文摘Objective To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus(BGZP)related with hepatobiliary adverse drug reactions(ADR),in order to reinforce pharmacovigilance.Methods A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December 2016.Serious and general ADRs were analyzed and assessed.Results There were 355 cases of hepatobiliary ADR related to BGZP.Both the amount of cases and the proportion of serious ADR showed an increasing growth by years(P<0.05).It was found that 10.43%of 355 cases may be involved with irrational drug use,including overdose,repeated medication,and combination of multiple drugs.There were 190 cases which used BGZP(non-combination),and they were mainly for common in diseases caused by abnormal immune activation(accounting for 40.53%of the total cases).Especially at the age group with the most cases with age of 41–50 years,the cases associated with immunological diseases of female were obviously more than that of male(P<0.05).The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days,and the median latency was 27.5 days,along with the range of cumulative dose(0.45–520.02 g)as well as the daily dose(0.09–2.64 g/d)after the conversion.Conclusions Cases of hepatobiliary ADR related to BGZP showed significant individual differences,and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary ADR.It may be similar with idiosyncratic drug-induced liver injury,and recommended that BGZP should be used with more caution under monitoring liver function,especially in female patients with immunological diseases.
基金This activity was supported by funds from PATH,USA.The funders had no role in the study’s design,data collection and analysis,decision to publish,or preparation of the paper.
文摘Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas(subdistricts)of 26 districts(these include VL,PKDL,treatment failure,and relapse VL and cutaneous leishmaniasis cases).This study aimed to investigate the feasibility of using focused pharmacovigilance for VL(VLPV)in Bangladesh’s National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions(ADRs).Methods:This activity has been going on since December 2014.Activity area includes secondary public hospital or Upazila health complex(UHC)in hundred sub districts and Surya Kanta Kala-azar Research Center(SKKRC)in Mymensingh District,a specialized center for management of complicated VL and PKDL cases.Communicable Disease Control(CDC)of the Directorate General of Health Services(DGHS)assigned twenty five of hundred UHCs and SKKRC(total 26)as treatment centers depending on their suitable geographical location.This was implemented for better management of VL cases with Liposomal Amphotericin B(AmBisome®)to ensure patient convenience and proper utilization of this expensive donated drug.A VLPV expert committee and a UHC VLPV team were established,an operational manual and pharmacovigilance report forms were developed,training and refresher training of health personnel took place at UHCs and at the central level,collected information such as patient data including demographics,treatment history and response,adverse events were analyzed.This report includes information for the period from December 2014 to December 2016.Results:From December 2014 to December 2016,1327 leishmaniasis patients were treated and 1066(80%)were available for VLPV.Out of these,57,33,9,and 1%were new VL,PKDL,VL relapse,and other cases,respectively.Liposomal amphotericin B was mostly used(82%)for case management,followed by miltefosine(20%)and paromomycin(3%).Out of the 1066 patients,26%experienced ADRs.The most frequent ADR was fever(17%,176/1066),followed by vomiting(5%,51/1066).Thirteen serious adverse events(SAEs)(eight deaths and five unexpected SAEs)were observed.The expert committee assessed that three of the deaths and all unexpected SAEs were possibly related to treatment.Out of the five unexpected SAEs,four were miltefosine-induced ophthalmic complications and the other was an AmBisome^(■)-induced avascular necrosis of the nasal alae.The Directorate General of the Drug Administration entered the ADRs into the World Health Organization Uppsala Monitoring Centre(WHO-UMC)VigiFlow database.Conclusions:This study found that VLPV through NKEP is feasible and should be continued as a routine activity into the public health system of Bangladesh to ensure patient safety against anti-leishmanial drugs.
文摘AIM: To inform clinicians on the level of hepatotoxicrisk among antimycotics in the post-marketing setting,following the marketing suspension of oral ketocon-azole for drug-induced liver injury(DILI).METHODS: The publicly available international FAERSdatabase(2004-2011) was used to extract DILI cases(including acute liver failure events), where antimycot-ics with systemic use or potential systemic absorptionwere reported as suspect or interacting agents. The re-porting pattern was analyzed by calculating the report-ing odds ratio and corresponding 95%CI, a measure ofdisproportionality, with time-trend analysis where ap-propriate.RESULTS: From 1687284 reports submitted over the8-year period, 68115 regarded liver injury. Of these,2.9% are related to antimycotics(1964 cases, of which 112 of acute liver failure). Eleven systemic antimycotics(including ketoconazole and the newer triazole deriva-tives voriconazole and posaconazole) and terbinafine(used systemically to treat onychomicosis) generated a significant disproportionality, indicating a post-market-ing signal of risk.CONCLUSION: Virtually all antimycotics with systemic action or absorption are commonly reported in clinically significant cases of DILI. Clinicians must be aware of this aspect and monitor patients in case switch is con-sidered, especially in critical poly-treated patients under chronic treatment.
文摘The aged population is constantly growing, thus fostering an increase in age-dependent diseases. Among these, diabetic retinopathy (DR) along with age-related macular degeneration entails progressive vision loss. Since such conditions are associated with the proliferation of novel vessels, their pharmacotherapeutic management consists of the intravitreal injection of anti-vascular endothelial growth factor drugs, able to hinder the driving of vascular proliferation prompted by vascular endothelial growth factor. The humanized anti-vascular endothelial growth factor monoclonal antibody ranibizumab provided evidence for efficacy in several trials, hence earning approval by the US Food and Drug Administration for therapeutic use in all the stages of DR. Due to the lack of epidemiologic and pharmacoeconomic evaluation in the local Calabria Region context, the present retrospective observational study focused on prevalence of DR and age-related macular degeneration, treatment and cost of therapy with ranibizumab in 870 patients arriving to clinical observation at the "Mater Domini” University Hospital in Calabria, Italy from January 2014 to June 2017. Data were extracted from the database of ophthalmology ward and subjected to statistical analysis. The results suggest that the most frequent retinal diseases are age-related macular degeneration and DR and that the use of ranibizumab has been decreasing over the 4-year study period together with the associated cost per patient which was similar for both disorders. Therefore, appropriateness of treatment with drugs other than ranibizumab needs to be assessed in this setting and deep monitoring of pharmacologic treatment for retinal diseases is necessary to prevent or delay visual acuity decrease and complete vision loss. Study procedures were performed in accordance with the "Mater Domini” University Hospital ethical standards of the responsible committee on human experimentation.
文摘In recent years,the popularity increased for nutritional supplements and herbal products.Prescription drugs,but not herbal therapies are paid by health insurances.They are sold over-the-counter(OTC)on the patients’own expense.However,there are potential risks of self-medication,e.g.incorrect self-diagnosis,severe adverse reactions,dangerous drug interactions,risk of addiction etc.They are often used by patients at their own discretion without knowledge of and control by their physicians.Certain users are at risk of intoxication.Multiple medications taken by older patients increase the risk for adverse drug reactions,drug-drug interactions,and compliance problems for this age group(polypharmacy).Herbals should be discontinued prior to operations to avoid interactions with anesthetics or anticoagulants.Herbal preparations may also be carcinogenic or interfere with cancer treatments.Pregnant women use various OTC preparations.However,in many cases,it is unclear whether their use is safe for mother or baby.Self-medication with herbals is also largely distributed among anxious and depressive patients,and patients with other conditions and symptoms.The popularity of herbal products has also brought concerns on quality,efficacy and safety.Cases of botanical misidentification,contaminations with heavy metals,pesticides,radioactivity,organic solvents,microbials as well as adulteration with chemical drugs necessitate the establishment of international quality control standards.Hepatotoxic effects have been reported for more than 300 plant species,and some commonly used herbs have been demonstrated to interact with Western medication.Health care professionals have a critical responsibility assessing the self-care ability of their patients.Databases are available for pharmacists with information on action,side effects and toxicities as well as herbdrug interactions.There is a need for established guidelines regarding the correct use of nutritional supplements and herbal OTC preparations(phytovigilance).Physicians,pharmacists,and other health care professionals have to counsel patients and the general public on the benefits and risks associated with herbal drugs.Information centers for consumers and general practitioners are needed,and convincing evidence on safety and efficacy of herbal products has to be demonstrated in placebo-controlled,double blind and randomized clinical trials.
文摘Even though randomized controlled clinical trials(RCTs)have been accepted as the gold standard for official assessment of novel interventions,there is a substantial gap between the efficacy observed in RCTs and the impact on clinical practice and in terms of patient benefit.While real-world studies(RWS)are emerging to confer valuable complementing evidence in this regard and beyond,the evolving role of RWS is yet to be agreed.This article delineates an updated profile of RWS covering effectiveness verification,rare adverse effects discovery,indication repurposing,to name a few.RWS tends not only to improve the efficiency of clinical investigations for regulatory approval,but also optimizes the whole-life cycle evaluation of biomedical/pharmaceutical products.
文摘Coronavirus disease 2019(COVID-19)consists of a systemic disease that can present many complications.The infection presents broad clinical symptoms and a high rate of transmissibility.In addition to severe acute respiratory syndrome,the patients manifest complications beyond the respiratory system.The frequency of liver damage in COVID-19 patients ranges from 14.8% to 53% of patients.One should pay attention to drug-induced liver injury(DILI)in patients with COVID-19,especially considering the off-label use of drugs in prophylactic and therapeutic regimens applied on large scales.This review aims to present relevant information on the medication used so far in COVID-19 patients and its possible hepatotoxicity.We reviewed liver damage in patients with COVID-19 on PubMed and Virtual Health Library to investigate DILI cases.Four studies were selected,involving the medicines remdesivir,tocilizumab and a pharmacovigilance analysis study.The hepatotoxicity profile of drugs presented in the literature considers use in accordance to usual posology standards for treatment.However,drugs currently used in the management of COVID-19 follow different dosages and posology than those tested by the pharmaceutical industry.The deficiency of uniformity and standardization in the assessment of hepatotoxicity cases hinders the publication of information and the possibility of comparing information among healthcare professionals.It is suggested that severe liver injury in COVID-19 patients should be reported in pharmacovigilance institutions,and physicians should pay attention to any considerable abnormal liver test elevation as it can demonstrate unknown drug hepatotoxicity.Liver disorders in COVID-19 patients and the use of several concomitant off-label medications—with a potential risk of further damaging the liver-should at least be a warning sign for rapid identification and early intervention,thus preventing liver damage from contributing to severe impairment in patients.
文摘BACKGROUND The antidepressant escitalopram is widely prescribed for the treatment of depression.It is generally well-tolerated,and cholestasis is not mentioned in its summary of product characteristics(Sm PC).We present a case of cholestatic and cytolysis liver injury due to escitalopram and a Vigi Base?study.CASE SUMMARY A 68-year-old man was admitted to our emergency unit due to clinical jaundice associated with hepatitis,pruritus and dark urine.We tested the patient for the most common etiologies of jaundice,including hemolysis,viral hepatitis,cirrhosis,carcinoma,cholangitis,cholelithiasis and intrahepatic or extrahepatic obstruction.The etiological study was negative,and an adverse drug reaction was the sole possible explanation.The patient was receiving treatment with escitalopram.Two days after its withdrawal,pruritus was resolved.Ten days after withdrawal,clinical jaundice disappeared.It took a month and three weeks after withdrawal for the patient to have normalized liver function tests.To our knowledge,this is the first reported case of cholestasis where treatment with escitalopram was the only possible cause,with a highly probable causality.In addition,we determined whether escitalopram is associated with hepatotoxicity and cholestasis by performing a disproportionality analysis.All cases of hepatobiliary disorders induced by escitalopram and reported in the World Health Organization pharmacovigilance database(Vigi Base?)were analyzed to characterize this toxicity.We found that patients treated with escitalopram had an increased risk of hepatitis[odds ratio(OR)=1.938(1.186-3.166)]and cholestasis[OR=1.866(1.279-2.724)][OR(95%confidence interval)].The median duration between the introduction of escitalopram and the occurrence of acute hepatitis and/or cholestasis was ten days+/-seven days.CONCLUSION Although extremely rare,this case report,the review of the literature and the pharmacovigilance update confirm that escitalopram can cause drug-induced hepatotoxicity and cholestasis,generally within a week after initiation.Thus,escitalopram should be withdrawn immediately if an iatrogenic cause cannot be excluded.If its responsibility is ascertained,escitalopram should be consequently contraindicated.In addition,serotoninergic antidepressants in patients with nonsevere depression are ineffective and harmful.Finally,the Sm PC of escitalopram should be updated to alert for this risk and give clear clinical guidelines.
文摘Objective:To examine the frequency and profile of spontaneous reports of adverse drug reactions(ADRs)sent to Ethiopia's pharmacovigilance(PV)database system.Methods:The descriptive and retrospective study analysed spontaneous ADR complaints reported to the PV database by healthcare professionals between 2013 and 2018.Spontaneous ADR reports that reached the PV center and met the minimum reporting criteria were identified and assessed in terms of reporting rate,patient characteristics,type of ADRs,suspected drugs,report sources,and reporters’profession.Results:A total of 657 spontaneous ADR reports were filed to the PV center between 2013 and 2018.During the study period,the reporting pattern of ADRs changed dramatically.The number of reports increased from 2013(n=12)and peaked in 2015(n=205),and then declined from 2016 to 2018(n=144,142 and 65 in 2016,2017 and 2018,respectively).Females had a higher percentage of reported cases(56.3%)than males(43.7%).The highest number of ADRs was reported in the age categories of 15-64 years(475,72.3%),followed by 0-14 years(154,23.4%),and 65 years and above(21,3.2%).Pharmacists reported the majority of ADRs(81.7%),followed by health officers(7.2%),nurses(5.8%),and physicians(5.2%).Skin and subcutaneous tissue abnormalities were the most commonly reported ADRs.The anatomical therapeutic chemicals code class"anti-infective for systemic use"was the most usually suspected medication.Trimethoprim with sulfamethoxazole as a combination ADRs was the most commonly reported drug that cause ADRs(14.2%).Conclusions:The number of ADRs reported in Ethiopia was small and unpredictable compared to developed countries,indicating the performance of PV system and level of awareness of health care professionals towards ADR reporting was not satisfactory.In order to increase the frequency of spontaneous reports,more efficient PV methods and public policies must be implemented.
基金support given by the research project HR-QoD - Quality of data (outliers, inconsistencies and errors) in hospital inpatient databases: methods and implications for data modeling, cleansing and analysis (project PTDC/SAUESA/75660/2006)
文摘AIM: To detect ophthalmic adverse drug reactions(ADRs), that occurred in Portugal from 2000 to 2009, through the utilization of administrative hospital databases. We also intended to compare the results of this methodology with spontaneous reporting.METHODS: We conducted a retrospective nationwide study using hospital administrative databases, which included all inpatients and outpatients in all public hospitals in Portugal, from 2000 to 2009. We used International Classification of Diseases- 9th Revision- Clinical Modification(ICD-9-CM) coding data that allowed the detection of ADRs. We used WHO's definition for ADR. We searched all of ICD-9-CM terms in Ophthalmology for codes that included "drug-induced", "iatrogenic", "toxic" and all other that could signal an ADR, such as "362.55- toxic maculopathy" or "365.03- steroid responders", and also "E" codes(codes from E930 to E949.9, that exclude intoxications and errors).RESULTS: From 11944725 hospitalizations or ambulatory episodes within that period of time, we identified 1524 probable ophthalmic ADRs(corresponding to a frequency of 1.28 per 10000 episodes) and an additional 100 possible ophthalmic ADRs. We used only 4 person-hours in the application of this methodology. A total of 113 spontaneous reports arose from ophthalmic ADRs from 2000 to 2009 in Portugal(frequency of 0.095 per 10000 episodes).To our knowledge, this was the first estimate of the frequency of ophthalmic ADRs through the use of databases, and the first nationwide estimate of ophthalmic ADRs, in Portugal. We identified 1524 probable ADRs and 100 possible ADRs. CONCLUSION: This database methodology adapted for Ophthalmology may represent a new approach for the detection of ophthalmic ADRs, since these codes exist in the ICD-9-CM classification. Its performance was clearly superior to spontaneous reporting.
文摘Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Objective: To assess the safety of TransferonTM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with TransferonTM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with TransferonTM (MD 1.9, IQR 1.7 - 2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with TransferonTM, and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: TransferonTM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.
