**1. Introduction**

The medical practice has been regulated throughout its entire historical evolution by specific legal and ethical norms, which are aimed at carrying out the medical act in optimal conditions, protecting the patients, and sanctioning the doctors who violate the norms of good practice [1]. Medicine and science, in general, enjoy quasi-constant advancements, which bring multiple benefits through their wide applicability [2]. Nonetheless, by increasing public expectations, emphasizing the publicity of patient rights [1,3] and the marketing of medicine [3], the progress in technology places a greater burden on the shoulders of the doctors, which often leads patients to have unrealistic expectations and causes them to sanction any mistake or any result that does not coincide with their expectations [4]. This, in turn, leads to tensions in the doctor–patient relationship [2]. Thus, the current medical practice risks being dominated by fear of potential malpractice complaints and their consequences on the medical staff.

The increasing number of medical malpractice complaints represents an alarming reality worldwide, with reports from various health services in Europe, the United States of America, and Australia confirming it [5,6]. Thus, Jena et al. (2011) showed that in the United States of America, 7.4% of medical professionals are accused of malpractice each year [7]. Likewise, a 2009 study showed that about 4% of the 108,000 physicians insured by a German insurance company faced a medical malpractice accusation each year [8]. In the United Kingdom, the number of complaints against general practitioners (GP) increased more than two-fold during a period of 5 years, between 2007 and 2012 [6]. In Romania, the malpractice complaints submitted to the court annually increased from 8 in 2008 to 65 in 2017, with a total of 331 in the period 2007–2018, 62 (18.73%) of these being registered in the eight counties included in our study [9].

The increase in the number of malpractice complaints is a burden for both the doctors and the medical system through their impact on the medical practice, as it can lead to the approach to the medical act in a defensive manner, as well as through the judicial procedure which usually lasts for a long time and involves significant costs for physicians and medical institutions [2,6].

Defensive medicine involves requesting more medical tests, more medical opinions, prescribing more drugs, more referrals to specialized examinations, refusing to perform certain high-risk procedures, or even refusing to assist patients with severe illnesses. These practices are not always for the benefit of the patients; on the contrary, they subject them to unnecessary and sometimes risky interventions, increase the costs of medical care, and decrease the level of satisfaction among physicians [2].

To reduce the negative impact of the judicial process for the resolution of malpractice complaints on doctors and patients, an extrajudicial procedure (e.g., no-fault system, mediation) has been introduced in many countries alongside the judiciary system. This extrajudicial procedure has a number of advantages for both the patient and the doctor and the medical system in general. In out-of-court settlements, complaints are resolved more quickly and efficiently, with lower costs compared to judicial resolution. An out-of-court settlement promotes the disclosure of medical practice incidents, which can increase patients' trust in physicians and can improve the physician–patient relationship, thus being preventive, and increases patient safety by improving the quality of medical care [10–12]. Likewise, resolving the complaints out-of-court decreases the level of psychological stress to which the doctor and the patient are subjected, and the doctor can continue or resume his/her professional activity without fear or pressure resulting from the complaint being made in court or released in the press. These latter aspects are particularly important as after the disclosure of the complaints in the press and the presentation in court, even if the doctor is exonerated, the associated psychological stress could irreversibly damage his/her professional life [12].

In Romania, the out-of-court procedure for resolving medical malpractice complaints was legislated in 2006, when the Commissions on monitoring and professional competence for malpractice cases were created. These Commissions carry out their activity at the level of the Public Health Directorates (PHD) in each county and in Bucharest, and their composition is mixed, covering the activity of physicians, dentists, nurses, midwives, and pharmacists. The working procedure of these commissions provides that patients who consider themselves harmed as a result of the medical act, or their family members (in the case of deceased or incompetent patients), may submit complaints accompanied by documents certifying the harm. The complaints are analyzed with the support of medical experts in the targeted medical specialty to determine whether or not the patients have suffered as a result of malpractice. The medical experts who analyze the complaints belong to various medical specialties and are included in a list available nationwide. They are designated randomly, by drawing lots, and their fee is paid by the plaintiff. To prove an act of malpractice, four criteria must be met cumulatively: (a) the existence

of a deed produced during a prevention, diagnosis, or treatment activity; (b) the deed is causing patrimonial or non-patrimonial (moral) damage to the patient; (c) the guilt of the medical professional; (d) the causal relationship between the deed and the prejudice [13].

This study aimed to analyze the reasons for the complaints of medical malpractice submitted to the commissions at the PHDs in the region of Moldova, as well as the factors that facilitate the complaints, to identify ways to prevent the complaints and, implicitly, to improve the medical practice. Moldova is a large territory located in the northeast and partially the southeast of Romania, between the Carpathians Mountains and the Prut River, and includes 8 counties out of the total of 41, plus the capital city, Bucharest (Bacau, Botosani, Galati, Iasi, Neamt, Suceava, Vaslui, and Vrancea), with a total surface of about 46,000 km<sup>2</sup> and around 4 million people.

To our knowledge, this research is the first of its kind in Romania.

This study is part of a broader doctoral research, which aims to identify methods to prevent the complaints of medical malpractice submitted by patients and to reduce their impact on the medical staff.
