Intensive safety monitoring program of antineoplastic medicines: A pilot study in a Portuguese oncology hospital

2019 ◽  
Vol 26 (1) ◽  
pp. 133-140
Author(s):  
Diogo Mendes ◽  
Graça Rigueiro ◽  
Rui S Silva ◽  
Ana Penedones ◽  
Carlos Alves ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Drug Reactions ◽  
Improve Patient Safety ◽  
Monitoring Program ◽  
Safety Monitoring ◽  
Prescription Data ◽  
Trastuzumab Emtansine ◽  
Drug Reactions ◽  
Number Of Patients ◽  
Improve Patient

Purpose The aim of this study was to test the feasibility and the usefulness of an intensive safety monitoring program to identify adverse drug reactions for medicines under additional monitoring that are used to treat cancer patients within a Portuguese oncology hospital. Methods This pilot intensive safety monitoring program was a three-month prospective, observational study. Patients undergoing treatment with one of the following medicines were included: nivolumab, olaparib, palbociclib, pembrolizumab, pertuzumab, ramucirumab, ribociclib, trastuzumab emtansine, or trifluridine/tipiracil. Potential eligible patients were identified by pharmacists based on prescription data. Clinicians used proper paper-based reporting forms to record adverse drug reactions. Clinical secretariats sent those reports through an electronic platform to the pharmacovigilance department for analysis. Results Seventy-five patients were on treatment with selected medicines. Of those, 33 (44%) experienced adverse drug reactions: 23 (69.7%) cases were serious and 5 (15.2%) unexpected. Considering the number of patients exposed to each medicine and the number of patients experiencing adverse drug reactions, trifluridine/tipiracil (72.7%; 8/11) was associated with the highest rate of toxicity, followed by olaparib (66.7%; 2/3), trastuzumab emtansine (50.0%; 3/6), pertuzumab (47.8%; 11/23), pembrolizumab (45.5%; 5/11), palbociclib (25.0%; 1/4), and nivolumab (18.8%; 3/16). A total of 59 adverse drug reactions were identified (i.e. 1.8 adverse drug reactions/patient), mainly gastrointestinal disorders ( n = 15; 25.4%), and blood and lymphatic system disorders ( n = 14; 23.7%). Conclusion This intensive safety monitoring program was feasible and allowed identifying serious and unexpected adverse drug reactions, adding value to pharmacovigilance and therefore contributing to improve patient safety. Further research is needed to confirm the findings of this pilot study.

Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study

2018 ◽  
Vol 19 (4) ◽  
pp. 333-339 ◽  
Author(s):  
Deborah Dillon McDonald ◽  
Sarah Coughlin ◽  
Candy Jin
Keyword(s):  
Older Adults ◽  
Pilot Study ◽  
Adverse Drug Reactions ◽  
Drug Reactions

scholarly journals Knowledge and attitude of Iraqi pharmacists in Baghdad community toward ‎adverse drug reactions monitoring

2017 ◽  
Vol 10 (4) ◽  
pp. 219
Author(s):  
Samer Imad Mohammed ◽  
Amna Fouad Abdul Al-razaq
Keyword(s):  
Adverse Drug Reactions ◽  
Demographic Data ◽  
Monitoring Program ◽  
Drug Reactions ◽  
Pv System ◽  
Cross Sectional ◽  
Convenience Sample ◽  
Herbal Products ◽  
High Tendency ◽  
Wide Range

Objectives:Adverse drug reactions (ADR‎s) can lead to many complications associated with the use of medications .In Iraq where a wide range of medications misused widely due to different reasons, the Iraqi pharmacovigilance program started out few years ago to collect information about adverse drugs reactions and since the success of this program depends on the effective participation of all medical staffs including pharmacists in this program. This study aimed to assess the knowledge, attitude, and degree of awareness of Iraqi pharmacists in Baghdad community toward adverse drugs reactions monitoring and pharmacovigilance program.Methods: This study was a cross-sectional descriptive survey based on individual questionnairethat administered in the English language to a convenience sample of 150 pharmacists working in 3 colleges of pharmacy, 20 community pharmacies and 3 hospitals situated in different areas of Baghdad which are the capital of Iraq. The questionnaire consists of three parts that collect demographic data on the ‎participants and their knowledge, attitudes toward Pharmacovigilance‎. Results: Although about (62%) of pharmacists have observed ADRs in their practice‎ only half of the respondents have heard about the term pharmacovigilance, 48% were aware of the national PV program ‎‎.Moreover , (‎47.33%‎) of the respondents mentioned that ADRs associated with herbal ‎products should not be reported. Although ‎79% of the respondents thought that reporting ADRs is a pharmacist’s duty nevertheless 82% of them  ‎thought that ADRs reporting in Iraq is not widely promoted by the relevant authority .The study showed a high tendency for participation in an adverse drug reaction  monitoring program. Interestingly,‎ 60% of respondents report that their workplace ‎doesn’t encourage them for reporting ADRs, while 48% of respondents indicated that they don’t ‎have enough time for reporting ADRs and 38% of them declared their fearing of facing ‎legal problem from that .  ‎Conclusion: Iraqi pharmacists although have a high tendency in participation in ADR monitoring  program but have  a poor knowledge about pharmacovigilance practices; they lack ‎understanding of the details about the national PV system and ADRs ‎reporting process and may need more information on how ADRs ‎reporting are performed. Keywords: Knowledge, Attitudes, Adverse drug reactions, Pharmacovigilance.

scholarly journals Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India

2013 ◽  
Vol 6 (1) ◽  
pp. 41-46 ◽  
Author(s):  
Dindayal Patidar ◽  
Mithun S. Rajput ◽  
Nilesh P. Nirmal ◽  
Wenny Savitri
Keyword(s):  
Drug Therapy ◽  
Adverse Drug Reactions ◽  
Drug Exposure ◽  
Improve Patient Safety ◽  
Tertiary Care ◽  
Good Method ◽  
Morbidity And Mortality ◽  
Multiple Drug ◽  
Drug Reactions ◽  
Multiple Drug Therapy

Abstract Adverse drug reactions (ADR) are a significant cause of morbidity and mortality, often identified only post-marketingly. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health. Hospital-based monitoring is one of the methods used to collect data about drug prescriptions and adverse events. The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature, and to target these ADRs in order to take future preventive measures. A prospective study was conducted over a 7-month period in an internal medicine department using stimulated spontaneous reporting for identifying ADRs. Out of the 254 admissions, 32 ADRs in 37 patients (14.56%) were validated from the total of 36 suspected ADRs in 41 patients. Female predominance was noted over males in case of ADRs. Fifty percent of total ADRs occurred due to multiple drug therapy. Dermatological ADRs were found to be the most frequent (68.75%), followed by respiratory, central nervous system and gastrointestinal ADRs. The drugs most frequently involved were antibiotics, antitubercular agents, antigout agents, and NSAIDs. The most commonly reported reactions were itching and rashes. Out of the 32 reported ADRs, 50% of the reactions were probable, 46.87% of the reactions were possible and 3.12% of the reactions were definite. The severity assessment done by using the Hartwig and Seigel scale indicated that the majority of ADRs were ‘Mild’ followed by ‘Moderate’ and ‘Severe’ reactions, respectively. Out of all, 75% of ADRs were recovered. The most potent management of ADRs was found to be drug withdrawal. Our study indicated that hospital based monitoring was a good method to detect links between drug exposure and adverse drug reactions. Adequate training regarding pharmacology and optimization of drug therapy might be helpful to reduce ADR morbidity and mortality.

scholarly journals Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan

2015 ◽  
pp. 173 ◽  
Author(s):  
Michiko Yamamoto ◽  
Kiyoshi Kubota ◽  
Mitsuhiro Okazaki ◽  
Akira Dobashi ◽  
Masayuki Hashiguchi ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Drug Reactions ◽  
Drug Reactions

The final report of post-marketing surveillance for cetuximab in colorectal cancer in Japan.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 590-590 ◽  
Author(s):  
K. Yamaguchi ◽  
T. Satoh ◽  
T. Watanabe ◽  
M. Ishiguro ◽  
K. Maruyama ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Drug Reactions ◽  
Infusion Reaction ◽  
Gastrointestinal Disorders ◽  
Final Report ◽  
Skin Disorders ◽  
Drug Reactions ◽  
Post Marketing Surveillance ◽  
Number Of Patients ◽  
Post Marketing

590 Background: Cetuximab (ERBITUX) was approved in Jul 2008 in Japan with indication for EGFR-positive and unresectable metastatic or refractory colorectal cancer. Post-marketing surveillance is required by Japanese Health Authority to collect, obtain, verify or validate information on the safety, efficacy and quality of medicines. We conducted this surveillance in all patients treated with cetuximab to access in practical use since clinical data on Japanese patients are limited. Methods: The target number of patients was 1,800. Following adverse drug reactions were investigated: infusion reaction, skin disorders, interstitial lung diseases, electrolyte abnormalities (including hypomagnesemia), heart toxicities, gastrointestinal disorders, thrombosis/embolism, delayed wound healing, and eye disorders. Results: Between Sep 2008 until Jan 2010, 2,126 pts registered, 2,006 pts were evaluable for safety (safety population), 1,687 pts for efficacy (efficacy population). Of the 2,006 pts, 1,975 pts (98.5%) were EGFR-positive. Patients characteristics: male/female; 1,234/772 (61.5%/38.5%), median age; 64 (range 18-87), site of primary tumor; colon/rectal/others (multiple selection); 1,235/775/3 (61.6%/38.6%/0.2%), PS0/PS1; 1,370/630 (68.3%/31.4%), combination chemotherapy; cetuximab monotherapy/CPT-11/FOLFIRI: 460/1,255/256 (22.9%/62.56%/12.8%). Of the 2,006 pts, 133 pts (6.6%) and 1,869 pts (93.2%) were treated in second-line and in third-line or later treatment, respectively. The adverse drug reactions incidence was 89.9%. Incidence of skin disorders, gastrointestinal disorders, electrolyte abnormality including hypomagnesaemia, and infusion reaction were 83.7%, 23.1%, 11.5%, and 5.7%, respectively. Efficacy result: Of the 1,687 pts, 658 pts (39.0%) were evaluated to be effective. Of the 658 pts, 614 pts (93.3%) experienced skin adverse reactions. Conclusions: This post-marketing surveillance confirms the safety and efficacy of cetuximab in the Japanese population treated in clinical practice. The outcome of this surveillance with Japanese 2,006 pts would be useful for clinical use of cetuximab. [Table: see text]

The role of electronic records in reporting adverse drug reactions.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 309-309
Author(s):  
Alanna M. Poirier ◽  
Paul Nachowicz ◽  
Subhasis Misra
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Electronic Health Record ◽  
Adverse Drug Reactions ◽  
Improve Patient Safety ◽  
Cancer Center ◽  
Health Record ◽  
Drug Reactions ◽  
History Of ◽  
Electronic Health

309 Background: The Pharmacy and Therapeutics committee at a regional cancer center is responsible to report and trend existing adverse drug reactions. The electronic health record did not have an option to document the history of an event or have an alert function if a medication was re-ordered. The frequency of documented adverse drug reactions did not correlate to what was being observed on the units with the use of a paper document. Methods: InAugust 2010 a Lean Six Sigma project was initiated to improve adverse drug reaction reporting. An adverse drug reaction document along with standard work instructions was completed by March 2011. A report was built in the electronic health record and a computer based learning module was created and rolled out to clinical staff by October 2011. Results: The turn-around time in days to document an adverse drug reaction in the patients chart decreased from 6.8 days to 0.7 days. The documented adverse drug reactions increased by 37%; verified by the use of supportive medications. Conclusions: The root cause for under-reporting was attributed to lack of knowledge, process, and automation. The history of an adverse drug reaction can now be viewed and an automatic alert is produced requiring physician acknowledgement decreasing the chance of repeated discomfort or harm to the patient. Adverse drug reaction documentation can be retrieved within 24 hours, analyzed, trended, and used for educational purposes to improve patient safety. [Table: see text]

Community pharmacists’ views on adverse drug reactions reporting in Malaysia: a pilot study

2010 ◽  
Vol 32 (3) ◽  
pp. 339-342 ◽  
Author(s):  
Kang-Nee Ting ◽  
Dane Michael Stratton-Powell ◽  
Claire Anderson
Keyword(s):  
Pilot Study ◽  
Adverse Drug Reactions ◽  
Community Pharmacists ◽  
Drug Reactions

Antidepressant-Induced Adverse Reactions in a Patient with Hemorrhagic Stroke

2005 ◽  
Vol 39 (10) ◽  
pp. 1755-1757 ◽  
Author(s):  
Zoran Bogdanovic ◽  
Jhansi R Nalamati ◽  
John K Kilcullen ◽  
Sunil Dhuper
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Hemorrhagic Stroke ◽  
Hormone Secretion ◽  
Drug Reactions ◽  
Inappropriate Antidiuretic Hormone Secretion ◽  
Number Of Patients ◽  
Close Supervision ◽  
Post Stroke Depression ◽  
History Of

Objective: To report a case of antidepressant-induced adverse drug reactions in a patient with hemorrhagic stroke. Case Summary: A 56-year-old man developed life-threatening adverse reactions after fluoxetine was added to his previously prescribed regimen of buspirone and olanzapine. One week after starting fluoxetine 60 mg/day, the patient developed syndrome of inappropriate antidiuretic hormone secretion and serotonin syndrome concurrently. The patient had experienced a hemorrhagic stroke before the adverse drug reactions occurred. DISCUSSION: A patient with a history of hemorrhagic stroke developed serious adverse drug reactions when fluoxetine was added to his drug therapy. When the combination therapy was stopped, all adverse effects gradually disappeared and laboratory abnormalities were corrected. The likelihood that the adverse reactions were caused by fluoxetine is probable according to the Naranjo probability scale. In addition, a history of stroke may be a risk factor for the development of such reactions. CONCLUSIONS: Today, patients with depression after experiencing a stroke are treated more effectively, but antidepressant-induced adverse drug reactions may be serious. A growing number of patients are treated for post-stroke depression; they require close supervision and careful dosing of antidepressants to prevent full-blown adverse reactions from occurring.

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