scholarly journals Pharmacovigilance or patient safety: analysis from a patient safety program

2018 ◽  
Author(s):  
Yira Constanza Cortázar C ◽  
José Gilberto Orozco D ◽  
José Julián López G

AbstractPurposedrugs are the common point of pharmacovigilance and patient safety programs. Despite using a common language, the same epidemiological method and legislation that requires the operation of the two programs, there does not seem to be a clear relationship between them.Methodologyobservational descriptive cross sectional study of the reports database from an institutional patient safety program. Medication errors were classified according to the document The Conceptual Framework for the International Classification for Patient Safety (ICPS) WHO 2009. Adverse Reactions (ADR) were classified according to Uppsala Monitoring Center.Resultsthe omission of drugs or doses was the most frequent error with 42.8% followed by ADRs (20.9%). No harm incidents corresponded to 61.2% and the remaining 38.8% was represented in near missincidents and no harm incidents. There were included 41 ADR and 15 therapeutic failures corresponding to a point-prevalence of 57 ADR/10,000 patients-year and 28.6% (56/196) of reports related to drugs. Phlebitis is the most frequently reported with 23, 7% followed by hypersensitivity reactions with 18.4% and excessive neuromuscular blockade with 13.1%.Conclusionsconsidering time, level of care and number of bed, ADR prevalence seem low. A very important proportion of reports corresponding to near miss incidents or no harm incidents is not taken into account by the security managers, losing a valuable risk management opportunity in the patient safety programs.

2019 ◽  
Vol 48 (2) ◽  
pp. 396-410
Author(s):  
Yira Constanza Cortázar ◽  
José Gilberto Orozco ◽  
José Julián López

Introduction: pharmacovigilance and patient safety programs have in common the monitoring of drugs, but despite sharing epidemiological method, language and legislation, there does not seem to be a clear relationship between them. Objectives: characterize and analyze the reports sent to the institutional patient safety program. Materials and methods: observational descriptive cross-sectional study of the reports database from an institutional patient safety program during 2016. Medication errors were classified according to the document WHO 2009. Adverse Drugs Reactions (ADR) were classified according to Uppsala Monitoring Center. Results: from the patient safety program it was detected that the omission of drugs or doses was the most frequent error (42.8%) followed by ADRs (20.9%). Harmful incidents were the most frequent (61.2%) followed by no harm incidents (38.8%). From the pharmacovigilance program 41 ADR and 15 therapeutic failures were identified, in which Phlebitis was the most frequently reported (23, 7%) followed by hypersensitivity reactions (18.4%) and excessive neuromuscular blockade (13.1%). Conclusions: a very important amount of incidents is not considered by any of the two programs, losing a valuable risk management opportunity. The program did not identify a clear distinction between harmful incident and ADR.


2021 ◽  
Vol 6 (2) ◽  
pp. 244-250
Author(s):  
Era Zana Nisa ◽  
Destanul Aulia ◽  
Siti Saidah Nasution

The goal of patient safety is one of the requirements that must be applied to the patient safety program in all hospitals. The implementation of patient safety programs is influenced by behavioral factors, namely the actions of nurses. The implementation of patient safety goals at PTPN IV Kebun Laras Hospital, Simalungun Regency is still not maximally implemented, seen from the actions of nurses, namely there are still incidents that endanger patients (KTD and KNC), and not all nurses behave in accordance with SOPs in implementing patient safety goals. The research used observational analytic method with cross sectional design. The samples were 62 nurses. The results showed that supervision variable had an effect on the actions of implementing nurses in the implementation of patient safety at PTPN IV Kebun Laras Hospital, Simalungun Regency. Keywords: Supervision, Nurses, Patient Safety.


2019 ◽  
Author(s):  
Jeehee Pyo ◽  
Eun Young Choi ◽  
Won Lee ◽  
Seung Gyeong Jang ◽  
Young-Kwon Park ◽  
...  

Abstract Background: Physicians are in the most critical position vis-à-vis disclosure of patient safety incidents (DPSI), and improper perceptions of DPSI among them could be a major barrier to proper execution of DPSI in clinical practice. The present study investigated physicians’ perceptions regarding the need for, effects of, and barriers to DPSI. Methods: An anonymous online questionnaire survey was conducted to investigate physicians’ perception regarding DPSI, in particular of when DPSI was needed in various situations and of methods for facilitating DPSI. Physicians’ perceptions were then compared to the general public’s perceptions regarding DPSI identified in a previous study, and a chi-squared test was performed to check for statistically significant differences. Results: A total of 910 physicians participated. Most participants (94.9%) agreed that any serious medical error should be disclosed to patients and their caregivers, whereas only 39.8% agreed that even near-miss errors, which did not cause harm to patients, should be disclosed. Among the six known effects of DPSI presented, participating physicians showed the highest level of agreement (89.6%) that “DPSI will lead physicians to pay more attention to patient safety in the future.” Among six barriers to DPSI, participants showed the most agreement (75.9%) that “It is unreasonable to demand DPSI in only the medical field, and disclosure is not actively conducted in other fields.” With respect to methods for facilitating DPSI, participants agreed that “A guideline for DPSI is needed” (91.2%) and “Manpower to support DPSI in hospitals is required” (89.1%). Meanwhile, 79.3% agreed that “If an apology law is enacted, physicians will perform more DPSI” and 72.4% that “I support the introduction of an apology law.” Conclusions: Korean physicians generally have a positive perception of DPSI, but less than the general public. The items used here allow comprehensive examination of physicians’ perceptions regarding DPSI across countries.


2021 ◽  
Vol 10 (9) ◽  
pp. e27210918024
Author(s):  
Gisele da Silveira Lemos ◽  
Ionara Vieira Rocha da Mota ◽  
Lucas Brasileiro Lemos ◽  
Edson Perini ◽  
Mário Borges Rosa ◽  
...  

To evaluate the knowledge of health professionals in a public teaching hospital about the National Patient Safety Program. Cross-sectional study, applying knowledge questionnaires from the National Patient Safety Program and Hospital Survey on Patient Safety Culture (HSOPSC). Descriptive, univariate and multivariate analyzes were performed. The study included 331 professionals, 44.0% nursing technicians / assistants, 29.7% nurses, 17.1% doctors and 10.5% other professionals. Of the 287 professionals who answered the question about the Program's knowledge, 78% said they did not know it, almost all (94.5%) were unaware of its six protocols and 90.1% did not receive training on this public policy. Nurses (OR = 15.46; 95% CI = 2.88-82.96) and professionals who held administrative positions with direct contact with the patient (OR = 55.46; 95% CI = 10.23-300.54) if highlighted the knowledge of the existence of the protocols. The degree of knowledge reported by the professionals proved to be insufficient, demonstrating a possible negligence regarding the theme by managers and educators.


2016 ◽  
Vol 2 (1) ◽  
pp. 62-78
Author(s):  
. Hemraj ◽  
Raj Kumar ◽  
Sourabh Kosey ◽  
Amit Sharma ◽  
Nalini Negi

To determine the most common physical side effects experienced by local chemotherapy patients. Their perceptions of these side effects and informational needs from clinical pharmacists were also evaluated. This was a single center, observational cross-sectional study conducted at department of General Surgery, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab. A face to face interview was conducted. Information collected included chemotherapy related side effects after last chemotherapy experience, the most worrisome side effects, overlooked by healthcare professionals and the preferred method, amount and source of receiving related information. In this study, hundred patients were enrolled out of them 48 were male and 52 were female. When differential calculations was done, common side effects or adverse effects of chemotherapy in the patients of breast, lung cancer, Ovarian Cancer, Colon cancer, Prostate cancer, Lymphoma Cancer, Cervix cancer where there is much irregular medicine intake 57.4% may be due to common problem of joint pain reported by all the patients under study, with the consecutive problem of nausea and vomiting. The high prevalence of chemotherapy related side effects among local patients is a major concern and findings of their perceptions and informational needs may serve as a valuable guide for clinical pharmacists and physicians to help in side effect management. This study shows the common problems reported by the patients when they are suffering from cancer condition, according to their incidence perceptions as experienced by the patient, this will allow the physician and clinical pharmacist to effectively counsel and manage the common symptoms as reported prior to its occurrence in the patient, so that withdrawal can be checked.


2020 ◽  
Vol 22 (3) ◽  
pp. 141-145
Author(s):  
Krishna Chandra Devkota ◽  
S Hamal ◽  
PP Panta

Pleural effusion is present when there is >15ml of fluid is accumulated in the pleural space. It can be divided into two types; exudative and transudative pleural effusion. Tuberculosis and parapneumonic effusion are the common cause of exudative pleural effusion whereas heart failure accounts for most of the cases of transudative pleural effusion. This study was a hospital based cross sectional study performed at Nepal Medical College during the period of January 2016-December 2016. A total of 50 patients who fulfilled the inclusion criteria were enrolled. Pleural effusion was confirmed by clinical examination and radiology. After confirmation of pleural effusion, pleural fluid was aspirated and was analysed for protein, LDH, cholesterol. The Heffner criteria was compared with Light criteria to classify exudative or transudative pleural effusion. Among 50 patients, 30 were male and 20 were female. The mean age of patient was 45.4±21.85 years. The sensitivity and specificity of using Light criteria to detect the two type of pleural effusion was 100% and 90.9%, whereas using Heffner criteria was 94.87%, 100% respectively(P<0.01). There are variety of causes for development of pleural effusion and no one criteria is definite to differentiate between exudative or transudative effusion. In this study Light criteria was more sensitive whereas Heffner criteria was more specific to classify exudative pleural effusion. Hence a combination of criteria might be useful in case where there is difficulty to identify the cause of pleural effusion.


2017 ◽  
pp. 46-52
Author(s):  
Thanh Thai Le ◽  
Phuong Nam Tran ◽  
Thi Ngan An Nguyen

Aims: To study outcomes of septoplasty and partial inferior turbinectomy (PIT) method, expecting leastsurgical equipment, good result, price rationalization. Methods: Prospective, cross-sectional study. Including 40 patients treated by septoplasty and PIT method. Assessment had been made after 3 months post-op. Results: The common symptoms were nasal obstruction (100%), headache (40%). The deformities of nasal septalwere deviation (42.5%), crest (30%). There were 67.5% of patients with severe bilateral hypertrophic inferior turbinate, mostly over grade II, enlargement both soft and bone parts (60%). After 3 months, the nasal obstruction and headache presented good or great results in 90% of patients, 93.7% of patients had straight nasal septaland 90% hadsmall inferior turbinate.VAS: patients’s contentment was 100%. Conclusions: The study showed that septoplasty and partial inferior turbinectomy presented good results with 87.5% after surgery and 90% after 3 months. Key words: septal deformity, hypertrophy inferior turbinate, septoplasty, partial inferior turbinectomy


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e039459
Author(s):  
Abdallah Y Naser ◽  
Zahra Khalil Alsairafi ◽  
Ahmed Awaisu ◽  
Hassan Alwafi ◽  
Oriana Awwad ◽  
...  

ObjectiveTo evaluate the attitudes of undergraduate pharmacy students towards patient safety in six developing countries.DesignA cross-sectional study.SettingParticipants were enrolled from the participating universities in six countries.ParticipantsUndergraduate pharmacy students from the participating universities in six developing countries (Jordan, Saudi Arabia, Kuwait, Qatar, India and Indonesia) were invited to participate in the study between October 2018 and September 2019.Primary outcomeAttitudes towards patient safety was measured using 14-item questionnaire that contained five subscales: being quality-improvement focused, internalising errors regardless of harm, value of contextual learning, acceptability of questioning more senior healthcare professionals’ behaviour and attitude towards open disclosure. Multiple-linear regression analysis was used to identify predictors of positive attitudes towards patient safety.ResultsA total of 2595 students participated in this study (1044 from Jordan, 514 from Saudi Arabia, 134 from Kuwait, 61 from Qatar, 416 from India and 429 from Indonesia). Overall, the pharmacy students reported a positive attitude towards patient safety with a mean score of 37.4 (SD=7.0) out of 56 (66.8%). The ‘being quality-improvement focused’ subscale had the highest score, 75.6%. The subscale with the lowest score was ‘internalising errors regardless of harm’, 49.2%. Female students had significantly better attitudes towards patient safety scores compared with male students (p=0.001). Being at a higher level of study and involvement in or witnessing harm to patients while practising were important predictors of negative attitudes towards patient safety (p<0.001).ConclusionPatient safety content should be covered comprehensively in pharmacy curricula and reinforced in each year of study. This should be more focused on students in their final year of study and who have started their training. This will ensure that the next generation of pharmacists are equipped with the requisite knowledge, core competencies and attitudes to ensure optimal patient safety when they practice.


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