Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy

Petrova, Guenka; Stoimenova, А.; Dimitrova, Maria; Kamusheva, Maria; Петрова, Даниела; Georgiev, Ognian

doi:10.1177/2050312117690404

Cited by 35 publications

(41 citation statements)

References 19 publications

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“…15,16 A study by Petrova et al states that incidence rate of poisoning, toxicity, overdosing and accidents is also quite high approximately 3.6% of the reported ADRs. 17 About 13% of ADRs identified were directly linked to high costs and required hospital admission. 17 In our study only 4 cases (2%) was reported with the overdose this was due to the short study period and is considered as the limitation.…”

Section: Discussionmentioning

confidence: 99%

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Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India

Bhuvaneshwari

Chakradhar

Sravani³

2019

Int J Basic Clin Pharmacol

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Background: Drugs are double edged weapons, they are used in treatment of the patients but in return can harm as well. The safety of drug prescribing has become a need of the hour topic in medicine. Safety monitoring of patients via Pharmacovigilance tool has become an integral part of pharmacotherapy. This study has been undertaken to analyze the various individual case safety reports including the Special situation cases of medicational error and over dose and to promote the reporting of adverse drug reactions (ADRs) among the healthcare professionals (HCPs).Methods: A retrospective non-interventional observational study was done for indexed period of six months at AMC-PvPI under Osmania Medical College and General Hospital. The reported individual case safety reports (ICSRs) are evaluated on basis of demographics of age and gender, seriousness criteria, outcome parameters and causality assessment of suspected drug (s) and suspected ADR/AE (s) as per the ICH guidelines and WHO causality assessment scale.Results: A total of 177 ICSRs are reported out of that 137 were ADRs, 36-medication error cases and 4-cases of over dose. The incidence of ADRs in females are high compared with males was identical. The occurrence of ADRs in adult patients (61%) was significantly higher than other age groups. Of total ADRs, most of them were with analgesics (26%) and highly reported system organ classification was CNS. Overall, 79% patients were recovered from ADRs.Conclusions: The results depicted an insight to the HCPs on the importance of monitoring and reporting of ICSRs. Our study results emphasized need to roll out a pharmacovigilance practice tool to ensure the safe use of drugs for better Pharmacotherapy and development of pharmacogenomic studies.

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Section: Discussionmentioning

confidence: 99%

“…17 About 13% of ADRs identified were directly linked to high costs and required hospital admission. 17 In our study only 4 cases (2%) was reported with the overdose this was due to the short study period and is considered as the limitation.…”

Section: Discussionmentioning

confidence: 99%

Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India

Bhuvaneshwari

Chakradhar

Sravani³

2019

Int J Basic Clin Pharmacol

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“…Severity was evaluated in accordance with the Modified Hartwig and Siegel Severity Assessment Scale (Mild, Moderate, Severe). [13,14] Subsequently, the causal relationship was assessed in accordance with the Naranjo algorithm as: indefinite, probable, possible, doubtful or un-assessable. [15] All ADR were listed in System Organ Class (SOC) and Preferred Term (PT) according to MedDRA v 22.0 (Medical Dictionary for Regulatory Activities).…”

Section: Methodsmentioning

confidence: 99%

A drug safety surveillance study of a ciprofloxacin / dexamethasone ophthalmic fixed combination in Peruvian population

Contreras-Salinas¹,

Baiza-Durán²,

Barajas-Hernández³

et al. 2020

Preprint

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(1) Background: drugs provide a significant benefit; however, their use implies an intrinsic potential danger, with the possibility to cause unwanted effects. These effects are known as adverse drug reactions (ADRs). Post-marketing drug safety surveillance detects unknown risks that have not been identified in clinical trials and it is necessary to monitor marketed medications under real-life practice. Due to the scarce information about fixed combination of ciprofloxacin 0.3% / dexamethasone 0.1% (SDO), we performed a drug safety surveillance study. (2) Methods: A prospective non-controlled drug safety surveillance study was conducted in Peruvian population. A total of 236 patients prescribed SDO were included derivates from 12 sites. Patients' standardized information was collected through two phone calls, including demographics, medical history, prescribing patterns of SDO, concomitant medication, and ADRs in detail. The ADRs were classified by causality and severity, followed by outcome measures to identify new risk. (3) Results: 236 patients prescribed with SDO participated in the study and 220 were included. A total of 82 ADRs/220 patients were reported after the use of SDO, presenting a ratio 0.37 ADR/patient. The most frequent ADR with SDO administration was eye irritation (30%). The totality of the ADR was classified as non-serious, and the 97.5% (n=80) was classified as mild and 2.5% as moderate (n=2). No cases under the severe category were identified. (4) Conclusion: No new risks were found in the population where this study was conducted.

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“…al, and Guenka Petrova et al, life threatening and hospitalisation were included in serious category 12. …”

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confidence: 99%

A study on pattern of adverse drug reaction in an adverse drug reaction monitoring centre of a tertiary care hospital in South Kerala, India

Rajan¹,

Ramani²,

Raj³

2019

Int J Basic Clin Pharmacol

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Background: Adverse drug reactions (ADR) are rated as fifth leading cause of death and accounts for approximately 5% of all hospital admissions. Under reporting of ADR from healthcare professional is considered as the contributing factor for increased morbidity and mortality. India has taken well appreciated step to launch Pharmacovigilance Programme of India (PvPI) to safeguard heath care of Indian population. This study looks into the detailed analysis of ADR reported to adverse drug reaction monitoring centre (AMC), Government Medical College, Trivandrum to assess its pattern, causality, severity and seriousness of ADR. Primary objectives of this study are the pattern of adverse drug reactions reported to ADR monitoring centre (AMC) and secondary objective is to assess causality, severity.Methods: A record based descriptive study was conducted in the ADR monitoring centre of government medical college, Trivandrum, Kerala from September 1st 2016 to February 2017(6 months). The data were collected from the all reported case records/ ADR report form of CDSCO. The details of the various adverse drug reactions were identified and analysed to find the pattern of adverse drug reactions including distribution of age, gender, causal drug group, system organ class. Also, an attempt is made to do causality assessment using WHO UMC scale and severity by using Heart wig Seigel Scale.Results: Out of 320 ADR cases, majority of reports were due to cutaneous manifestations. Most common ADRs were erythema, induration, and rash, itching. Females were 56% and males were 44%. Majority cases were of adult age group. Causality 91.88% were probably related, 75.6% were mild reaction. 25% of cases were serious. 77.5% were recovered. Antibacterial implicated 25(7.8%) followed by anti-epileptics 24 (7.5%) ADR.Conclusions: The pattern of adverse drug reactions reported to this AMC is comparable to the studies done in other parts of country. A strong need for streamlining of ADR monitoring system and reporting reemphasized by this study, which will promote the ADR reporting in healthcare professionals.

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Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy

Cited by 35 publications

References 19 publications

Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India

Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India

A drug safety surveillance study of a ciprofloxacin / dexamethasone ophthalmic fixed combination in Peruvian population

A study on pattern of adverse drug reaction in an adverse drug reaction monitoring centre of a tertiary care hospital in South Kerala, India

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