Patterns of adverse drug reactions (ADRs) in Saudi Arabia

BackgroundPharmacovigilance enhances post-market drug safety. However, analytical reports of a pattern of adverse drug reactions (ADRs) experienced by patients in Saudi Arabia are demanded.ObjectiveTo describe patterns of ADRs submitted to the Saudi Central National Pharmacovigilance and Drug Safety Center (NPC), Saudi Food and Drug Administration (SFDA), from its inception in 2015 until the end of 2017 to understand the pattern of ADR reporting in Saudi Arabia.MethodsIn this retrospective study, data from cases reported to the NPC were used to determine ADRs and identify the most common associated drug classes based on anatomical therapeutic chemical (ATC) classification system.ResultA total of 17,730 ADR cases were reported during study period. An annual increase in ADRs was clearly evident. Approximately 54% of the total ADRs reported were serious. Most commonly reported ATC drug classes were anti-infective agents for systemic use (22.27%), antineoplastic and immunomodulating agents (21.49%), alimentary tract and metabolism (15.48 %), cardiovascular system (11.11%) and nervous system (10.23%). Vancomycin (2.7%), ceftiraxone (1.8%), fingolimod (1.4%) and paracetamol (1.4%) were the most common drugs associated with serious ADRs.ConclusionThis study provide valuable insights in hypothesis generation for future studies on drug-event interactions and amplification studies. The NPC educational programs and awareness campaigns to promote systematic reporting of ADRs among healthcare professionals and general public should be continued.     

Adverse drug reactions in elderly patients

Many studies from around the world show a correlation between increasing age and adverse drug reaction (ADR) rate, at least for some medical conditions. More than 80% of ADRs causing admission or occurring in hospital are type A (dose-related) in nature, and thus predictable from the known pharmacology of the drug and therefore potentially avoidable. Frail elderly patients appear to be particularly at risk of ADRs and this group is also likely to be receiving several medicines. The toxicity of some drug combinations may sometimes be synergistic and be greater than the sum of the risks of toxicity of either agent used alone. In order to recognize and to prevent ADRs (including drug interactions), good communication is crucial, and prescribers should develop an effective therapeutic partnership with the patient and with fellow health professionals. Undergraduate and postgraduate education in evidence-based therapeutics is also vitally important. The use of computer-based decision support systems (CDSS) and electronic prescribing should be encouraged, and when problems do occur, health professionals need to be aware of their professional responsibility to report suspected adverse drug events (ADEs) and ADRs. "Rational" or "obligatory" polypharmacy is becoming a legitimate practice as increasing numbers of individuals live longer and the range of available therapeutic options for many medical conditions increases. The clear risk of ADRs in this situation should be considered in the context that dose-related failure of existing therapy to manage the condition adequately may be one of the most important reasons for admission of the elderly to hospital. Thus, age itself should not be used as a reason for withholding adequate doses of effective therapies.     

94例老年患者药物不良反应分析

目的分析94例老年患者ADR的分布及相关因素.方法从我院历年的患者ADR报告表中,选出60岁以上的老年患者ADR报告表,逐项统计整理.结果①老年患者ADR占39.5%,男＞女;原患疾病以心脑血管疾病及感染性疾病居多.②94例老年患者ADR的临床表现以皮肤反应和神经系统反应为主,列居第一、二位.③诱发ADR的药物主要是抗菌药物和治疗心脑血管病的药物.结论老年人药物治疗中,合并用药及原患疾病状况等情况与ADR的发生关系密切.     

A prospective study of adverse drug reactions in hospitalized children

AIMS: There are few publications of adverse drug reactions (ADRs) among paediatric patients, though ADR incidence is usually stated to be higher during the first year of life and in male patients. We have carried out a prospective study to assess the extent, pattern and profile risk for ADRs in hospitalized patients between 1 and 24 months of age. METHODS: An intensive events monitoring scheme was used. A total of 512 successive admissions to two medical paediatric wards (47 beds) were analysed. The hospital records were screened daily during two periods (summer, 105 days and winter, 99 days), and adverse clinical events observed were recorded. RESULTS: A total of 282 events were detected; of these, 112 were considered to be manifestations of ADRs. The cumulative incidence was 16.6%, no differences being observed between periods. Although there were no differences between patients under and over 12 months of age, risk was found to be significantly higher among girls compared with boys (RR=1.66, 95% CI 1.03-2.52). The gastro-intestinal system was most frequently affected. The therapeutic group most commonly implicated was anti-infective drugs and vaccines (41.5%). The ADRs were mild or moderate in over 90% of cases. A consistent relationship was noted between the number of drugs administered and the incidence of ADRs. CONCLUSIONS: Hospitalized patients exhibited an ADR risk profile that included female sex and the number of drugs administered. No particular age predisposition was observed. The most commonly prescribed drugs are those most often implicated in ADRs in paediatric patients.     

Adverse drug reactions in patients with phaeochromocytoma: incidence, prevention and management.

The dangers of phaeochromocytomas are mainly due to the capability of these neuroendocrine tumours to secrete large quantities of vasoactive catecholamines, thereby increasing blood pressure and causing other related adverse events or complications. Phaeochromocytomas are often missed, sometimes only becoming apparent during therapeutic interventions that provoke release or interfere with the disposition of catecholamines produced by the tumours. Because phaeochromocytomas are rare, evidence contraindicating use of specific drugs is largely anecdotal or based on case reports. The heterogeneous nature of the tumours also makes adverse reactions highly variable among patients. Some drugs, such as dopamine D(2) receptor antagonists (e.g. metoclopramide, veralipride) and beta-adrenergic receptor antagonists (beta-blockers) clearly carry high potential for adverse reactions, while others such as tricyclic antidepressants seem more inconsistent in producing complications. Other drugs capable of causing adverse reactions include monoamine oxidase inhibitors, sympathomimetics (e.g. ephedrine) and certain peptide and corticosteroid hormones (e.g. corticotropin, glucagon and glucocorticoids). Risks associated with contraindicated medications are easily minimised by adoption of appropriate safeguards (e.g. adrenoceptor blockade). Without such precautions, the state of cardiovascular vulnerability makes some drugs and manipulations employed during surgical anaesthesia particularly dangerous. Problems arise most often when drugs or therapeutic procedures are employed in patients in whom the tumour is not suspected. In such cases, it is extremely important for the clinician to recognise the possibility of an underlying catecholamine-producing tumour and to take the most appropriate steps to manage and treat adverse events and clinical complications.     

Adverse drug reactions in adult medical inpatients in a South African hospital serving a community with a high HIV/AIDS prevalence: prospective observational study

Aims

To describe the frequency, nature and preventability of community-acquired and hospital-acquired adverse drug reactions (ADRs) in a South African hospital serving a community with a high prevalence of human immunodeficiency virus (HIV)/ acquired immunodeficiency syndrome.

Methods

A 3-month prospective observational study of 665 adults admitted to two medical wards.

Results

Forty-one (6.3%) patients were admitted as a result of an ADR and 41 (6.3%) developed an ADR in hospital. Many of the ADRs (46.2%) were considered preventable, although less likely to be preventable in HIV-infected patients than in those with negative or unknown HIV status (community-acquired ADRs 2/24 vs. 35/42; P < 0.0001; hospital-acquired ADRs 3/25 vs. 14/26; P = 0.003). Patients admitted with ADRs were older than patients not admitted with an ADR (median 53 vs. 42 years, P = 0.003), but 60% of community-acquired ADRs at hospital admission were in patients <60 years old. Among patients <60 years old, those HIV infected were more likely to be admitted with an ADR [odds ratio (OR) 2.32, 95% confidence interval (CI) 1.17, 4.61; P = 0.017]. Among HIV-infected patients, those receiving antiretroviral therapy (ART) were more likely to be admitted with an ADR than those not receiving ART (OR 10.34, 95% CI 4.50, 23.77; P < 0.0001). No ART-related ADRs were fatal. Antibiotics and drugs used for opportunistic infections were implicated in two-thirds of hospital-acquired ADRs.

Conclusions

ADRs are an important, often preventable cause of hospitalizations and inpatient morbidity in South Africa, particularly among the elderly and HIV-infected. Although ART-related injury contributed to hospital admissions, many HIV-related admissions were among patients not receiving ART, and many ADRs were associated with medicines used for managing opportunistic infections.

What is already known about this subject

• Studies conducted primarily in developed countries have shown that adverse drug reactions (ADRs) are a significant cause of hospital admission, prolong hospital stay and consequently increase the cost of disease management in patients.
• Cardiovascular medicines, hypoglycaemic agents, nonsteroidal anti-inflammatory drugs and antibiotics are the most frequently implicated medicines in these studies.
• A large proportion of these ADRs have been shown to be preventable through improved drug prescribing, administration and monitoring for adverse effects.

What this paper adds

• This is the first Sub-Saharan African study in the HIV/AIDS era that describes the contribution of ADRs to patient morbidity, hospitalisation and mortality.
• Cardiovascular medicines and antiretroviral therapy contributed the most to community-acquired ADRs at the time of hospital admission while medicines used for opportunistic infections (such as antifungals, antibiotics and antituberculosis medicines were most frequently implicated in hospital acquired ADRs.
• ADRs in HIV-infected patients were less likely to be preventable.

     

儿童中常见的药物不良反应

病人特别是儿童常发生药物不良反应,在新生儿监护室中发生的不良反应高达30％。甲氧氟普胺引起的肌张力障碍,抗惊厥药引起嗜睡,氯霉素引起灰婴综合征以及皮质类固醉造成的发育障碍都可在儿童中出现。药物有关不良反应在儿童中发生率比成人高的主要原因可能是儿童代谢功能不成熟之故。     

鱼腥草注射液不良反应及成因分析

简述鱼腥草注射液的不良反应及原因并对鱼腥草注射液的不良反应及成因进行分析归纳。对鱼腥草注射液的不良反应应进行多方面的基础研究,确保安全、可靠、有效;同时应完善、提高、统一其质量标准。     

A prospective study of adverse drug reactions in a dermatology department

The objective of this study was to evaluate the clinical pattern and risk factors for adverse drug reactions (ADRs) in patients hospitalized in a specialized dermatology department. A prospective study was conducted in the Clinic of Dermatology and Venereology in Stara Zagora for a 5-year period. ADRs were classified by type, severity and causality. Case-causality was scored according to Naranjo et al. (1981). A total of 1041 admissions were analyzed. ADRs occurred in 147 patients. Cutaneous reactions represented the most common ADRs followed by endocrine/metabolic, cardiovascular and gastrointestinal disorders. The prevalent clinical patterns of cutaneous ADRs were exanthematous and urticarial. ADRs were almost evenly distributed as type A and type B reactions. Drug classes most frequently responsible for ADRs were glucocorticosteroids (GLCs) and antiinfective agents. The factors significantly associated with ADRs were the use of GLCs (OR 11.11; 95% CI 6.69-18.43), antiinfective agents (OR 1.48; 95% CI 1.04-2.11) and older age. Patients hospitalized in a dermatology department may develop ADRs with multiorgan clinical presentation. The most important risk factors for ADRs in this sample of patients were the use of GLCs, antiinfective agents and older age. The study establishes a specific ADR risk profile of patients with dermatological disorders in a hospital setting.     

新生儿药物不良反应监察

对６５７名新生儿进行药物不良反应的医院内集中监察。监察期间共有６８名新生儿发生药物不良反应７３次，发生率约为１０％。严重的不良反应包括上消化道出血、肾功能衰竭、心律失常、钙盐沉积和肺损害。抗生素、脂肪乳剂、地高辛和镇静药为最常涉及的药物。本课题首次提供前瞻性药物流行病学报告，以促进新生儿安全用药。     

Adverse drug reactions in an elderly outpatient population.

The prevalence of adverse drug reactions (ADRs) in elderly outpatients was investigated, along with factors that might be associated with their occurrence. The medical records of elderly patients attending an interdisciplinary geriatric clinic and a general medical clinic during 1988 were audited to collect a variety of demographic and treatment data and to detect documentation of first-time ADRs. Subjects were classified as having had an ADR if a physician documented this or if a relevant symptom was noted in the record and a score of 1 or above was obtained on the Adverse Drug Reaction Probability Scale. The presence of potential drug interactions was also assessed. The sample size was 463 patients, of whom 332 attended the medical clinic and 131 attended the geriatric clinic. Potential drug interactions were identified in the records of 143 subjects (31%). There were 107 documented ADRs in 97 patients (21%). Of these patients, 86 were noted by the physicians as having had an ADR. Twelve patients were hospitalized as a direct result of an ADR. Significant risk factors for ADRs were attendance in the geriatric clinic, the use of potentially harmful drug combinations, and the use of drugs that require therapeutic monitoring. Patient age and the number of drugs had no association with ADRs. In the elderly population studied, patients with frailty arising from multiple pathologies were more likely to have ADRs than the more robust elderly, even when their therapeutic regimens were simplified.     

Adverse drug reactions in liver cirrhosis

Summary Impaired liver function may increase susceptibility to drug toxicity. In a prospective drug surveillance study of 1280 patients the frequency of adverse drug reactions (ADR) was higher in 333 patients with clinical and/or histopathological evidence of liver cirrhosis than in 188 with other liver diseases (p<0.01) and than in 759 without liver disease (p<0.0001). The 128 cirrhotics had 339 events considered definitely or probably related to drug therapy by consensus of the monitoring team and the attending physicians. ADR were 93.8% dose-related, 11.2% were severe but only one was fatal. ADR were most commonly associated with diuretics (32.6% of patients administered the drugs), potassium salts (6.5%), antimicrobials (3.9%) and sedatives (3.5%). Most common manifestations were metabolic (62.6%), gastrointestinal (13.2%) and neurologic (11.9%). The frequency of ADR was higher in females (p<0.05), patients receiving more drugs (p<0.001), those with longer hospital stay (p<0.001) and those with ascites (p<0.0001), portal hypertension (p<0.0001), prior hepatic encephalopathy (p<0.02) or prolonged prothrombin time (p<0.0001). Adverse reactions were more common for drugs biotransformed greater than 50% by the liver (p<0.005). These findings show that ADR are more frequent in severe hepatic dysfunction.