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Pharmacy
Special Issues
Patient Safety and Adverse Drug Events in Medication Practice
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Patient Safety and Adverse Drug Events in Medication Practice

A special issue of Pharmacy (ISSN 2226-4787).

Deadline for manuscript submissions: closed (31 July 2018) | Viewed by 37763

Special Issue Editor

Prof. Dr. Mojtaba Vaismoradi

E-Mail Website
Guest Editor
Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway
Interests: medicines management; patient safety; nursing care
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Adverse drug events (ADEs) and medication-related hospitalisations are of main concern across the world. It has been reported that medication errors and healthcare-related ADEs are responsible for a considerable percent of treatment follow ups and hospitalisations in healthcare settings. Therefore, there is a need to reduce ADEs and also the provision of safe healthcare services, by healthcare providers, using preventive and pro-active interventions, including optimal prescribing, dispensing, administration and monitoring of medicines, and reporting ADEs.

The development of strategies to identify preventable ADEs and incorporate appropriate strategies, by physicians, nurses, and pharmacists in routine care, require knowledge development and evident-based practice. Therefore, this Special Issue, “Patient Safety and Adverse Drug Events in Medication Practice”, aims to open the discussion on medicine management, with a focus on ADEs as important components of patient safety. In this Special Issue, research articles, theoretical and methodological reviews on ADEs are welcomed. Additionally, practical experiences and reflections on the application of advanced technologies and new methods of medicine management for ADEs are encouraged.

Dr. Mojtaba Vaismoradi
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmacy is an international peer-reviewed open access semimonthly journal published by MDPI.

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Keywords

  • Adverse Drug Events
  • Drug-Related Side Effects and Adverse Reactions
  • Medication error
  • Medicines’ management
  • Patient safety
  • Pro re nata (PRN)

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Published Papers (6 papers)

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Editorial

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3 pages, 150 KiB  
Editorial
Call for Role Development and Application of the Monitoring Profile in ADEs and ADRs
by Mojtaba Vaismoradi
Pharmacy 2018, 6(4), 118; https://doi.org/10.3390/pharmacy6040118 - 25 Oct 2018
Cited by 2 | Viewed by 3599
Abstract
Adverse Drug Events (ADEs) are injuries resulting from medicine-related interventions. [...] Full article
(This article belongs to the Special Issue Patient Safety and Adverse Drug Events in Medication Practice)

Research

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9 pages, 233 KiB  
Article
Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients
by Siraj Sundaran, Anjali Udayan, Keerthi Hareendranath, Basil Eliyas, Babu Ganesan, Ashik Hassan, Rajesh Subash, Vishnu Palakkal and Mohammed Saji Salahudeen
Pharmacy 2018, 6(4), 108; https://doi.org/10.3390/pharmacy6040108 - 29 Sep 2018
Cited by 20 | Viewed by 7733
Abstract
Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of medicines. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting [...] Read more.
Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of medicines. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type, severity and preventability were assessed using necessary assessment scales. The study included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions (n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderate to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability was observed in 28 (54.9%) reported ADRs. The prescribed medicines most frequently associated with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the way it could be done to promote safer medication use. Similar ADR reporting programs are necessary to educate and to improve awareness among healthcare professionals in some countries. Full article
(This article belongs to the Special Issue Patient Safety and Adverse Drug Events in Medication Practice)
10 pages, 258 KiB  
Article
Assessment of Knowledge, Attitude and Barriers towards Pharmacovigilance among Physicians and Pharmacists of Abbottabad, Pakistan
by Akash Syed, Saira Azhar, Muhammad Mohsin Raza, Humaira Saeed and Shazia Qasim Jamshed
Pharmacy 2018, 6(2), 29; https://doi.org/10.3390/pharmacy6020029 - 31 Mar 2018
Cited by 18 | Viewed by 4970
Abstract
Objectives: Pharmacovigilance in Pakistan needs robust preference in terms of implementation and consistent movement of structured approaches. The objective of this study is to explore the knowledge, attitude and barriers towards adverse drug reaction (ADR) reporting among physicians and pharmacists and to explore [...] Read more.
Objectives: Pharmacovigilance in Pakistan needs robust preference in terms of implementation and consistent movement of structured approaches. The objective of this study is to explore the knowledge, attitude and barriers towards adverse drug reaction (ADR) reporting among physicians and pharmacists and to explore the encouraging factors of ADR reporting. Methods: The current research was a cross-sectional study design in which a pre-validated questionnaire was administered to physicians and pharmacists in Abbottabad, Pakistan. The study was conducted for two months from January 2016 to February 2016. Results: A total of 194 physicians and pharmacists responded with a response rate of 35.3%. All the respondents either strongly agreed or agreed that ADRs reporting is a part of their duty. Half of the respondents agreed that monitoring of drug safety is important. Around three quarters of respondents (74.2%) stated that they did not report ADRs due to unavailability of reporting forms while 70% cited lack of a proper pharmacovigilance center as one of the key barriers. Half of the respondents (52.2%) did not report due to their insufficient knowledge. A large majority (81.8%) said that they would report ADRs if there is pharmacovigilance center. On the point of incentives, opinion seems to be divided. Slightly less than half (47.8%) cited their wish to have few incentives while the remaining 52.2% either preferred to be neutral or disagreed. Conclusion: Based on the study findings, barriers were mostly related to general unfamiliarity with ADRs reporting guidelines and the non-existence of a pharmacovigilance center. It is highlighted that the regulatory body should carve a niche for a properly functional pharmacovigilance center and initiate educational programs for strengthening knowledge and attitudes towards ADR reporting. Full article
(This article belongs to the Special Issue Patient Safety and Adverse Drug Events in Medication Practice)
14 pages, 391 KiB  
Article
Clozapine Patients at the Interface between Primary and Secondary Care
by Marita Barrett, Anna Keating, Deirdre Lynch, Geraldine Scanlon, Mary Kigathi, Fidelma Corcoran and Laura J. Sahm
Pharmacy 2018, 6(1), 19; https://doi.org/10.3390/pharmacy6010019 - 26 Feb 2018
Cited by 8 | Viewed by 5278
Abstract
Patients receiving clozapine must undergo routine blood monitoring to screen for neutropenia, and to monitor for potential agranulocytosis. In Cork University Hospital, Cork, Ireland, clozapine is dispensed in the hospital pharmacy and the pharmacists are not aware of co-prescribed medicines, potentially impacting upon [...] Read more.
Patients receiving clozapine must undergo routine blood monitoring to screen for neutropenia, and to monitor for potential agranulocytosis. In Cork University Hospital, Cork, Ireland, clozapine is dispensed in the hospital pharmacy and the pharmacists are not aware of co-prescribed medicines, potentially impacting upon patient safety. The aim of this study was to examine the continuity of care of patients prescribed clozapine. A retrospective audit was conducted on patients attending the clozapine clinic at Cork University Hospital and assessed patients’ (i) independent living, (ii) co-prescribed medicines and (iii) knowledge of their community pharmacists regarding co-prescribed clozapine. A list of prescribed medicines for each patient was obtained, and potential drug-drug interactions between these medicines and clozapine were examined using Lexicomp® and Stockley’s Interaction checker. Secondary outcomes included patients’ physical health characteristics, and a review of co-morbidities. Data were collected between the 29 May 2017 and 20 June 2017. Local ethics committee approval was granted. Patients were eligible for inclusion if they were receiving clozapine treatment as part of a registered programme, were aged 18 years or more, and had the capacity to provide written informed consent. Microsoft Excel was used for data analysis. Of 112 patients, (33% female; mean age (SD) 43.9 (11.3) years; 87.5% living independently/in the family home) 86.6% patients reported that they were taking other prescribed medicines from community pharmacies. The mean (SD) number of co-prescribed medicines in addition to clozapine was 4.8 (4) per patient. Two thirds of community pharmacists were unaware of co-prescribed clozapine. Interactions with clozapine were present in all but 3 patients on co-prescribed medicines (n = 97). Lexicomp® reported 2.9 drug-drug interactions/patient and Stockley’s Interaction Checker reported 2.5 drug-drug interactions/patient. Secondary outcomes for patients included BMI, total cholesterol, and HbA1c levels, which were elevated in 75%, 54% and 17% respectively. Patients prescribed clozapine did not receive a seamless service, between primary and secondary care settings. Community pharmacists were not informed of clozapine, prescribed for their patients, in two thirds of cases. Patients in this study were exposed to clozapine-related drug-drug interactions and hence potential adverse effects. This study supports reports in the literature of substandard management of the physical health of this patient group. This study shows that there is an opportunity for pharmacists to develop active roles in the management of all clozapine-related effects, in addition to their traditional obligatory role in haematological monitoring. This study supports the need for a clinical pharmacist to review inpatients commencing on clozapine, monitor for drug-drug interactions and provide counselling. Full article
(This article belongs to the Special Issue Patient Safety and Adverse Drug Events in Medication Practice)
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Review

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18 pages, 832 KiB  
Review
Patient Safety and Pro Re Nata Prescription and Administration: A Systematic Review
by Mojtaba Vaismoradi, Sara Amaniyan and Sue Jordan
Pharmacy 2018, 6(3), 95; https://doi.org/10.3390/pharmacy6030095 - 29 Aug 2018
Cited by 22 | Viewed by 7465
Abstract
PRN is the acronym for ‘pro re nata,’ written against prescriptions whose administration should be based on patients’ needs, rather than at set times. The aim of this systematic review was to explore safety issues and adverse events arising from PRN [...] Read more.
PRN is the acronym for ‘pro re nata,’ written against prescriptions whose administration should be based on patients’ needs, rather than at set times. The aim of this systematic review was to explore safety issues and adverse events arising from PRN prescription and administration. Electronic databases including Scopus, PubMed [including Medline], Embase, Cinahl, Web of Science and ProQuest were systematically searched to retrieve articles published from 2005 to 2017. Selection criteria: we included all randomized controlled trials (RCTs) and studies with comparison groups, comparing PRN prescription and administration with scheduled administration, where safety issues and adverse events were reported. The authors independently assessed titles, abstracts and full-texts of retrieved studies based on inclusion criteria and risk of bias. Results were summarised narratively. The search identified 7699 articles. Title, abstract and full-text appraisals yielded 5 articles. The included studies were RCTs with one exception, a pre-test post-test experimental design. Patient populations, interventions and outcomes varied. Studies compared patient-controlled or routine administration with PRN and one trial assessed the effect of a practice guideline on implementation of PRN administration. More analgesia was administered in the patient-controlled than the PRN arms but pain reduction was similar. However, there was little difference in administration of psychotropic medicines. No differences between patient-controlled and PRN groups were reported for adverse events. The PRN practice guideline improved PRN patient education but non-documentation of PRN administration increased. This systematic review suggests that PRN safety issues and adverse events are an under-researched area of healthcare practice. Variations in the interventions, outcomes and clinical areas make it difficult to judge the overall quality of the evidence. Well-designed RCTs are needed to identify any safety issues and adverse events associated with PRN administration. Full article
(This article belongs to the Special Issue Patient Safety and Adverse Drug Events in Medication Practice)
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Other

19 pages, 2575 KiB  
Discussion
Adverse Drug Reactions, Power, Harm Reduction, Regulation and the ADRe Profiles
by Sue Jordan, Patricia A. Logan, Gerwyn Panes, Mojtaba Vaismoradi and David Hughes
Pharmacy 2018, 6(3), 102; https://doi.org/10.3390/pharmacy6030102 - 18 Sep 2018
Cited by 19 | Viewed by 7777
Abstract
The power and influence of healthcare systems comes largely from the ability to prescribe efficacious medicine. However, medicine can sometimes cause harm rather than bring benefits. Systematically checking patients for the adverse effects of medicines, as listed in manufacturers’ literature, would protect patients [...] Read more.
The power and influence of healthcare systems comes largely from the ability to prescribe efficacious medicine. However, medicine can sometimes cause harm rather than bring benefits. Systematically checking patients for the adverse effects of medicines, as listed in manufacturers’ literature, would protect patients from iatrogenic harm, but this is rarely undertaken. We argue for the benefits of this approach using the example of the prescription of antipsychotics to older adults. Prescribing antipsychotics to control challenging behaviours associated with dementia is a controversial matter, and regulatory intervention is under discussion. Improved regulatory systems could protect against iatrogenic harm, such as over-sedation, falls, tremor, or drug-induced Parkinsonism. However, measuring the impact and outcomes of regulatory interventions has proved difficult, not least because there are rarely systematic records of all adverse effects of medicines. We indicate how regulatory initiatives to reduce antipsychotic prescribing can be supported by systematic monitoring and documentation of patients’ signs and symptoms of putative adverse drug reactions. Monitoring documentation then provides the rationale and support for professionals’ responses to identified problems. Longitudinal monitoring records would improve understanding of the impact and outcomes of adverse drug reactions (ADRs) on health and wellbeing, and the many costs of ADRs. Full article
(This article belongs to the Special Issue Patient Safety and Adverse Drug Events in Medication Practice)
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