Assessing Legal Responsibility in Romanian Pharmaceutical Practice

Abstract

By law, doctors and pharmacists may be held liable for professional misconduct. The pharmacist's roles and responsibilities have been expanding in patient care, particularly in times of COVID-19 pandemic and now they may perform a diverse range of professional activities as attested by the newly adopted legislation, Minister of Health's Order no. 2382/2021. However, pharmacist malpractice is different than medical malpractice because pharmacists' responsibility is based on pharmacist professional standards and legal duties. Despite the existence of overlaps, there are differences between the doctors' and the pharmacists' professional duties. Our study identified ten main legal professional duties of pharmacists and provided examples of negligence. The results could be used as a tool for malpractice risk assessment and management. We also argue that the Romanian legal framework allows malpractice claims to be filed by both the patient and/or the doctors when shared accountability is involved and this increases the pharmacists' risk of being sued. Moreover, the chief pharmacist is responsible for the pharmacy's overall activity, including liability for tasks entrusted to subordinated personnel. RezumatÎn conformitate cu legea, medicii si farmaciștii pot fi răspunzători pentru comportament profesional necorespunzător. Rolurile și responsabilitățile farmaciștilor s-au extins, în special în perioada pandemiei COVID-19, aceștia putând să desfășoare, în prezent, activități profesionale diversificate, așa cum rezultă din legislația adoptată recent, Ordinul Ministerului Sănătății nr. 2382/2021. Cu toate acestea, malpraxisul farmaceutic este diferit de cel medical, pentru că răspunderea farmaciștilor este evaluată în funcție de standarde profesionale și responsabilități legale specifice farmaciștilor. Deși există suprapuneri, responsabilitățile profesionale ale medicilor și farmaciștilor sunt, în general, diferite. Studiul nostru a identificat zece responsabilități profesionale principale ale farmaciștilor și exemple de neîndeplinire a acestora. Am arătat, de asemenea, că acuzațiile de malpraxis pot fi inițiate atât de pacient, cât și de doctor atunci când responsabilitatea este divizată între acesta și farmacist, iar acest lucru crește riscul formulării acuzațiilor de malpraxis împotriva farmaciștilor. Nu în ultimul rând, farmacistul șef răspunde pentru întreaga activitate la nivelul farmaciei, incluzând și responsabilitatea pentru sarcinile delegate personalului subordonat.

Ethics and Business in Community Pharmacies – A Framework for an Ethical Dialogue

“…A project of the pharmacists' professional association to promote public health and the development of environmental ethics within community pharmacies would also contribute to the education of the population in this respect, as we have maintained in previous studies [22]. We strongly believe in a probable positive response from pharmacists' employers to the proposal of the professional association to build a common project of environmental and public health protection, not only because of economic reasons but also because of the moral legitimation of this purpose [7,25]. In fact, the extent to which pharmaceutical companies will assume their social and environmental responsibilities will also reflect the success of the ethical dialogue between the stakeholders [20].…”

“…Dealing with such conflict situations frequently may have a major negative impact on the pharmacists' professional satisfaction and commitment to providing quality services to their patients [10,18,26]. Furthermore, the broadening of community pharmacy activities (e.g., medication review and management, screening, testing, and vaccination) and the development of online pharmacies (e.g., internet sales, online communication with patients, providing software for health monitoring) require pharmacists to develop their ability to manage conflicts between ethics and business, including clinical versus commercial communication, in order to preserve the status of health professionals and protect the patients' interests [7,10,19,27]. Although pharmacists perceive commercial practices as unethical [6,11,[16][17][18]24], patients do not share the same opinion when it comes to incentives or loyalty programs: "pharmacists are perceived to be ethical decision makers" [15].…”

Qualitative Study on the Factors Influencing the Utilisation of Products Labelled “Food for Special Medicinal Use” (FSMP)

“…Without the limits typically imposed on communication to the general public, HCPs must receive complete information regarding the product composition, clinical justification, appropriate usage, preparation, and intended target group [5,20]. Pharmacies and pharmacists must investigate the legal responsibilities for dispensing FSMPs, as there are no formal prescription requirements to trace the recommendation process [28].…”

Current use of medicinal plants for children’s diseases among mothers in Southern Romania

“…60.9%) originating from Romanian ethnomedicine ( Mărculescu et al, 2004 ; Benedec et al, 2017 ). The first edition of the RPh, consisting of 790 pages and written at the initiative of Dr. Carol Davila, was recognized as one of the most appreciated pharmacopeia in Eastern Europe, with its value corresponding to the scientific standards of that historical period ( Besciu et al, 2011 ; Benedec et al, 2017 ). Out of the 301 drugs included in RPh I, 207 were of herbal origin ( Stancu et al, 2014 ).…”