Introduction
Nurses constitute the largest professional group in the healthcare system. Over the years, with the political, social, and cultural changes occurring in societies, the professional role of nurses has evolved. Changes in nursing, including numerous scientific research conducted by nurses, lead to their acquisition of knowledge in the field of medicine and health sciences, resulting in the expansion of their authority. Currently, the scope of the nursing profession is analyzed in terms of the skills, knowledge, and social competencies possessed by nurses [1].
According to the document titled “New Competencies of Nurses and Midwives” produced by the Ministry of Health in 2020 as part of the project “Development of Nursing Competences” co-financed by The European Union under the European Social Fund, it is estimated that out of approximately 300,000 registered nurses in Poland, 11,205 nurses obtained authority to prescribe medications and issue prescriptions or to continue on a doctor’s order based on completing Part 1 of the course on prescribing medications and issuing prescriptions, and 5,079 nurses obtained authority based on Part 2 of the course (as of December 31, 2019) [2].
Study aim. To analyze the number of e-prescriptions issued by nurses in the initial period following the introduction of the obligation to issue prescriptions in electronic form.
Nursing prescription – legal analysis
Similar to initiatives introduced earlier in the Netherlands, the United Kingdom, Sweden, New Zealand, Canada, and the USA [3], in Poland, as of January 1, 2016, nurses obtained the authority to issue prescriptions for medications and special dietary products, issue referrals for specific diagnostic tests, and prescribe and issue orders for reimbursed medical devices, under the Act of July 22, 2014, amending the Act on the professions of nurse and midwife and certain other acts (Journal of Laws of 2014, item 1136) [4].
The rights granted to nurses under the law can be categorized into two aspects: independent prescribing and prescription continuation, also known as collaborative prescribing. The division of these rights is based on the level of education of the nurses.
Independent prescribing and prescription issuance are reserved for individuals with a master’s degree in nursing or specialization in nursing, with an additional requirement for nurses to independently perform preventive, diagnostic, therapeutic, and rehabilitative services. The prerequisite for independent prescribing and prescription issuance is completion of a specialized course on prescribing medications and issuing prescriptions for nurses and midwives. Collaborative prescribing applies to individuals with a bachelor’s degree in nursing and involves executing medical orders. In this case, the completion of a specialized course on prescribing medications and issuing prescriptions for nurses and midwives is also a significant requirement [5]. Based on the Act of July 15, 2011, on the professions of nurse and midwife (Journal of Laws of 2011, No. 174, item 1039) [6], since 2019, the obligation to complete a specialized course on prescribing medications and issuing prescriptions for nurses and midwives does not apply to nurses who, as part of their education in nursing schools and within the framework of specialization training, acquired knowledge covered by such a course (Article 15a, paragraph 7).
The principles regarding the issuing of prescriptions by nurses are contained in the Regulation of the Minister of Health of October 28, 2015, regarding prescriptions issued by nurses and midwives (Journal of Laws of 2015, item 1971) [7]. The regulation specifies the method and procedure of issuing prescriptions, the template of a prescription entitling the acquisition of a medical product, special dietary food, or medical device, the method of providing prescription forms, their storage, the procedure for fulfilling prescriptions, and monitoring their issuance and fulfillment. The regulation of October 28, 2015, was amended by the announcement of the Minister of Health of July 26, 2017, regarding prescriptions issued by nurses and midwives, which incorporated changes introduced by the Regulation of the Minister of Health of August 24, 2016, amending the regulation on prescriptions issued by nurses and midwives (Journal of Laws, item 1360) [8]. It primarily concerned changes in patient entitlement codes.
The competencies acquired do not entitle nurses to issue prescriptions for all available medications. The Regulation of the Minister of Health dated January 18, 2018, regarding the list of active substances contained in medications as well as special dietary foods and medical devices prescribed by nurses and midwives, as well as the list of diagnostic tests for which nurses and midwives are entitled to issue referrals (Journal of Laws of 2018, item 299) [9], strictly defines which active substances a nurse can prescribe. The cited regulation includes a detailed list of 31 active substances contained in medications, one special dietary food intended for the treatment of food allergy with a milk substitute diet (milk protein hydrolysates), and 27 medical devices for which nurses and midwives, in accordance with the Act of July 15, 2011, on the professions of nurse and midwife, are entitled to issue prescriptions and referrals (Article 15a, paragraph 1, of the aforementioned Act) [6].
The right to issue prescriptions by nurses is also regulated by Article 43-46 of the Act of August 27, 2004, on healthcare services financed from public funds (Journal of Laws of 2015, item 581, as amended) [10], the Act of May 12, 2011, on reimbursement of medicines, special dietary foods, and medical devices (Journal of Laws of 2019, item 784, as amended) [11], as well as Articles 95b, 96a, and 96b of the Act of September 6, 2001, Pharmaceutical Law (Journal of Laws of 2001, No. 126, item 1381) [12], the Act of April 7, 2017, amending the Pharmaceutical Law (Journal of Laws of 2017, item 1015) [13], and the Act of May 25, 2017, amending the Act on healthcare services financed from public funds and certain other acts (Journal of Laws of 2017, item 1200) [14].
The history of the development of the information society
The dynamic development of the information society occurred at the turn of the 20th and 21st centuries. The term “information society” was first used in 1963 in an article titled “Information Industry” by Tadao Umesamo, a Japanese sociologist, in which he described the evolution of theories about a society based on information technologies. Since then, the concept of the information society has rapidly evolved and become the subject of research conducted worldwide. In Europe, the term first appeared in 1978 in a report by French sociologists Simon Nora and Alain Minc titled “L’Informatisation de la Société” [15]. However, it was not until the publication of the report by EU Commissioner M. Bangemann in 1994, which addressed the changes brought about by modern ICT technologies, known as the Bangemann Report (Europe and the Global Information Society, Recommendations of the Bangemann Group to the European Council), that the term “information society” became more widespread [16]. In Poland, the first official document introducing the concept of the information society was the resolution of the Sejm of the Republic of Poland of July 14, 2000, regarding the construction of the foundations of the information society (Journal of Laws of 2000, No. 22, item 448) [17]. Another milestone, at the end of 2008, was the adoption by the government of the Republic of Poland of the “Strategy for the Development of the Information Society in Poland until 2013,” which referred to European policy in the field of the information society [18]. According to this strategy, the government’s priority actions in the field of digitization included removing legal barriers and supporting the construction and use of telecommunications infrastructure and internet access, improving the activities of government and local government institutions using information and telecommunications technologies, and combating negative phenomena related to internet use. In her analysis of the aforementioned document, Czerwińska emphasizes that the information society represents significant economic, social, and cultural value due to the possibilities of information processing using information and communication technologies [19]. At the turn of 2019-2020, a particular test of the functioning of digital solutions was the events related to the spread of the SARS-CoV-2 coronavirus pandemic and the disease it caused, COVID-19. These circumstances demonstrated the importance of electronic communication, especially in contacts with public administration. Supporting the creation and implementation of intelligent management systems (e-Administration, e-Health, e-Logistics, e-Finance, e-Commerce, e-Work, e-Education) included in the long-term development strategy of the country presented on January 11, 2013, by the Ministry of Administration and Digitization is currently a priority goal until 2030 [20].
The history of e-prescriptions in Poland
In Poland, since April 28, 2011, two teleinformatics systems supporting the healthcare information system have been implemented under the act on the healthcare information system (Journal of Laws of 2011, No. 113, item 657): the Platform for Online Sharing of Services and Digital Resources of Medical Registers, and the Electronic Platform for Collecting, Analyzing, and Sharing Digital Resources on Medical Events. These systems enable, among other things, the streamlining of processes related to planning and delivering healthcare services, monitoring and reporting their implementation, as well as the transmission and exchange of information in the healthcare sector. The act also puts into effect the Medical Information System (SIM), which is a teleinformatics system used for processing data concerning provided, ongoing, and planned healthcare services. The module of orders within the SIM system contains data on issued and fulfilled referrals, prescriptions, and orders in the form of electronic documents, allowing patients to obtain specific types of healthcare services [21]. The module of orders within the SIM system is designed to facilitate, among other things, the electronic handling of e-prescriptions.
A prescription is a document upon which a pharmacist dispenses medication. According to the Act of April 28, 2011, on the healthcare information system (Journal of Laws of 2011, No. 113, item 657) [21], and based on Article 9, point 18, paragraph 2 of the Act of July 19, 2019, amending certain acts in connection with the implementation of solutions in the e-health sector (Journal of Laws of 2019, item 1590) [22], paper prescriptions could be issued until January 7, 2020. From January 8, 2020, according to Article 95b, paragraph 1 of the Act of September 6, 2001, on pharmaceutical law [12], prescriptions can be issued both electronically and in paper form. Based on Article 95b, paragraph 2 of the cited law, issuing paper prescriptions is possible only in several cases, including, among others, lack of access to the teleinformatics system.
The implementation of e-prescriptions into the Polish healthcare system took several years. One of the first mentions of the possibility of introducing such solutions can be found in the “Strategy for the Informatization of the Republic of Poland – ePoland for the years 2004-2006” prepared in December 2003 by the Ministry of Science and Informatization. The project outlined in the strategy, referred to as “Gates of Poland,” aimed to transfer 26 basic public services to an electronic platform, including providing advice by a doctor and patient registration via electronic communication [23]. On the other hand, the Regulation of the Council of Ministers of March 28, 2007, regarding the State Informatization Plan for the years 2007-2010, envisaged the introduction of an electronic platform for gathering, analyzing, and sharing digital resources on medical events, of which e-prescription was to be a component (Journal of Laws of 2007, No. 61, item 415) [24]. The breakthrough in implementing e-prescriptions in Poland occurred in 2018. From May 25, 2018, the Ministry of Health and the Center for Health Information Systems began a pilot program to implement digital services in healthcare. The first phase of the pilot program was the implementation of e-prescriptions, initially carried out in Siedlce and Skierniewice, followed by Chełm, Polanica, and Krynica-Zdrój. From January 1, 2019, all pharmacies in Poland were required to connect to the Electronic Platform for Gathering, Analyzing, and Sharing Digital Resources on Medical Events (P1). The platform enables the implementation of e-prescriptions and the generation of the electronic Prescription Realization Document (DRR), both in paper and electronic form. This means that every realized prescription, whether electronic or paper, will be registered in the system and made available to the patient, upon their login, on their Personal Patient Internet Account on the pacjent.gov.pl portal [25]. Since January 1, 2019, e-prescriptions could be realized in any pharmacy in Poland, and from January 8, 2020, the obligation to issue prescriptions in electronic form came into force, with the exception of situations where there is no access to the e-health system, which may be due, for example, to a system malfunction or lack of internet access [25].
The introduction of e-prescriptions brought tangible benefits for patients. It solved, among other things, the problem of illegible paper prescriptions, increased safety by reducing the likelihood of dispensing the wrong medication different from what was prescribed, and enabled the collection of each medication at a separate pharmacy without the need for a copy of the prescription. The implementation of e-prescriptions improved the coordination of the treatment process, especially by providing doctors with access to all prescriptions issued to the patient and, with the patient’s consent, access to documents of their fulfillment [26].
E-prescriptions issued by Polish nurses
Issuing prescriptions, both in paper form and electronically (e-prescriptions), is possible for individuals holding the right to practice a medical profession, who, based on the provisions concerning the practice of a given medical profession, as referred to in Article 2(14) of the Act of 12 May 2011 on reimbursement of medicines, special dietary products, and medical devices (Journal of Laws of 2019, item 784, as amended), are de facto entitled to issue prescriptions [11]. The issuance of prescriptions by entitled nurses is regulated by Article 15a and Article 15b of the Act of 22 July 2014 amending the Act on the professions of nurse and midwife and certain other acts (Journal of Laws of 2014, item 1136) [4]. Under independent prescribing (Article 15a(1)), a nurse may, after conducting a physical examination, issue a prescription for medicinal products (excluding those containing highly active substances, narcotic drugs, and psychotropic substances), special dietary foods, and orders for medical devices specified in the Regulation of the Minister of Health of 18 January 2018 on the list of active substances contained in medications, special dietary products, and medical devices prescribed by nurses and midwives, as well as the list of diagnostic tests for which nurses and midwives are authorized to issue referrals [9]. In the case of issuing prescriptions as part of continuation of treatment (Article 15a(2)), a nurse may issue a prescription for medicinal products (excluding those containing highly active substances, narcotic drugs, and psychotropic substances), as well as a prescription or order for the supply of medical devices, if justified by the patient’s health condition reflected in the medical documentation.
Graduates of bachelor’s and master’s studies, who, in the course of their education, acquired the right to prescribe medications through independent prescription or continuation under a doctor’s order, left universities for the first time in June 2019. Nurses who do not have such authority are obliged to complete Part 1 and/or Part 2 of the specialized course “Prescribing medications and issuing prescriptions.” According to data from the Center for Postgraduate Education of Nurses and Midwives, in the years 2016-2019, 11,205 nurses and midwives participated in Part 1 of the course on prescribing medications and issuing prescriptions, while in Part 2 of the course, as of December 31, 2019, only 5,079 people participated [2].
According to pharmaceutical law, in the case of an electronic prescription, a nurse can prescribe for one patient a maximum quantity of medicinal product, special dietary food, or medical device necessary for the patient for a period of up to 180 days, calculated based on the specified dosage regimen on the prescription. This includes a contraceptive medicinal product only as part of the continuation of a medical prescription. A nurse can issue up to 4 prescriptions for consecutive periods of use, not exceeding a total of 120 days [12].
Since the introduction of digital services, with electronic prescription being the first, the number of e-prescriptions issued by nurses has been growing dynamically. Data from the National Centre for Healthcare Information, established by the Minister of Health, indicates that nurses were already issuing e-prescriptions in 2019, before the obligation to issue electronic prescriptions came into force [27]. However, the number was relatively small. The lowest number of e-prescriptions was issued by nurses in Dolnośląskie region (110), Zachodniopomorskie region (242), Podkarpackie region (316), Pomorskie region (498), and Śląskie region (697). The regions with the highest number of e-prescriptions issued by nurses in 2019 were Mazowieckie (145,287), Podlaskie (18,774), Kujawsko-pomorskie (14,340), and Wielkopolskie (11,210). In total, in 2019, nurses issued 223,051 e-prescriptions. In 2020, when the obligation to issue electronic prescriptions was introduced, nurses from all regions issued a total of 2,790,310 e-prescriptions, and in 2021, twice as many, i.e., 4,575,053 (Table 1). During the same period, as reported by e-zdrowie.gov.pl, over 1.2 billion e-prescriptions were issued in the system. By 2022, e-prescriptions had been issued to patients by 10,099 nurses [28] out of 307,832 nurses and midwives registered in the central registry of nurses and midwives (as of 2021), accounting for only 3.3% of all registered nurses [29].
Table 1
The number of e-prescriptions issued by nurses in Poland in the years 2018-2022
Summary
There is a lack of statistics in Poland allowing for the assessment of the effects of improving care for chronically ill patients due to nurses issuing electronic prescriptions. Data obtained from the 4-year period of nurses issuing e-prescriptions indicate progress in the quantities of prescriptions issued. However, in the scale of all e-prescriptions issued in this period, the number of prescriptions issued by nurses is negligible. Similarly, only a small number, just 3.3% of registered nurses in Poland, have the authority to prescribe medications and issue prescriptions, including electronic prescriptions.