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

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

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 HbA_1c 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

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

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