Pharmacovigilance: an evaluation on the practice of pharmacists acting in pharmacies and drugstores

Abstract

Pharmacists acting in pharmacies and drugstores stores are some of the most accessible healthcare providers and the last to intervene before the patient takes their medicine. This puts the pharmacist in a position of authority that should be harnessed for the benefit of health. Thus, this professional is strategic for performing pharmacovigilance. Our objective of this study was to interrogate the practice of pharmacists in relation to pharmacovigilance activities, and to identify difficulties and possible stimuli for the improvement these activities in pharmacies and drugstores. The information was collected through an online questionnaire via Survey Monkey®. The data were analyzed statistically using SPSS software. Responses were received from 5174 pharmacists: mostly young women within five years of graduation and experience in pharmaceutical retail. 81% of them reported having identified suspected substandard medicines, but only 16% used the Brazilian notification system Notivisa. More than 85% of pharmacists agreed with the importance of pharmacovigilance and the recognition of reporting services as part of pharmacist duties and pharmaceutical care. The main barriers to making notifications were the lack of access and knowledge about Notivisa. Pharmacists agreed that simplifying the system would be a stimulus for notifications, and requested more feedback from notifications, as well as material and courses to understand the notification process. Pharmacists have important data to feed into pharmacovigilance systems, recognize their responsibilities and are willing to contribute, but still demonstrate low compliance. Simplification of the system and training on it are likely to increase notifications.

The impact of global falsified medicines regulation on healthcare stakeholders in the legitimate pharmaceutical supply chain: a systematic review

“…In Supplementary Table 2 , the prominent stakeholders addressed within included studies is hospital pharmacy [ n = 8] ( 29–34 , 36 , 37 ) and the patient [ n = 6] ( 16 , 29 , 30 , 35 , 38 , 39 ). Research articles greatly focused upon studies conducted within hospital pharmacy and the impact of FMD on secondary care environments.…”

Expanding Community Pharmacists’ Roles in Pharmacovigilance in Romania

“…This Master program has formed, every year, between 15 and 35 specialists in pharmacovigilance, including community pharmacists, with the aim to improve public health and patient safety in relation to the use of human medicines [18]. Other authors have also demonstrated, by their studies, that further and continuous training in pharmacovigilance is necessary so that community pharmacists may expand their activities of risk management related to the patients' use of medicines and that the reporting of adverse reactions to the competent authorities may become current practice [14,15,20,28,57]. Some authors have shown the benefits of a good collaboration between physicians and pharmacists for managing issues related to the use of medicines, especially in elderly patients, which would require shared learning initiatives for widening physicians' knowledge [36].…”

“…As in other countries [52,57], neither in Romania do we have a culture of pharmacovigilance and reporting adverse reactions to the competent authorities. We realise that feedback, support and reminders from the authorities would help increase confidence and sustain continuity in pharmacovigilance activities [14][15][16]57], but we also believe, like other authors, that specific and experiential training in assessing and classifying adverse reactions, establishing the causality relations between medication and suspected adverse reactions, communicating with patients and physicians, other health professionals and competent authorities are essential in developing this activities of community pharmacists [17,28,36,52,57]. In fact, the implementation of the pilot program of anti-flu vaccination in pharmacies required mandatory theoretical and practical training of community pharmacists, according to a well-established curriculum that included adverse events management, in order to obtain authorisation for this activity [27].…”

“…The role of community pharmacists in the health care services for the general population has developed in the recent years, from the mere dispensing of medicines to quality pharmaceutical services aiming at the rational, efficient and safe use of medicines [3,14,17,38,52,53]. The increased safety of the medicines for human use was the aim of the European Union (EU) in developing the legislation on pharmacovigilance, during 2010 -2012, which established obligations in this field, but only for the competent authorities and the marketing authorisation holders [4,8,10,11,[41][42][43].…”

“…In 2013 however, the Directive 2005/36/EC on the recognition of the professional qualifications was also modified, by adding the following activities that EU pharmacists could pursue: personalised support for patients who administer their medication, contribution to local or national public health campaigns and reporting of adverse reactions of pharmaceutical products to the competent authorities [9,12]. Though community pharmacists are acknowledged as the most accessible professionals in the health system, being the best positioned to help patients manage their medication safety issues [2,14,19,20,28,35,38,52,53], reporting adverse reactions of medicines to the competent authorities is not a current activity of these professionals [14-17, 20, 52, 57]. Among the reasons put forward are the insufficient training in pharmacovigilance, intricate reporting procedures, limited collaboration with the prescribing physicians, work overload, therefore lack of time for pharmacovigilance, unpaid activity, lack of interconnectivity between the pharmacy management software and the one used for reporting adverse reactions to the competent authority [14-20, 28, 36, 52, 53, 57].…”