ORIGINAL RESEARCH

Characterization of medication prescription by nurses in Primary Health Care protocols

Cláudia Santos Martiniano^I; Ardigleusa Alves Coêlho ^II; Marize Barros de Souza^III; Isabel Cristina Araújo Brandão^IV; Anny Karine Freire da Silva^V; Severina Alice da Costa Uchôa^VI

^I PhD in Health Sciences. Professor, Nursing Department at the State University of Paraiba. Campina Grande, Paraiba, Brazil. E-mail: cmartiniano@ibest.com.br
^II PhD in Health Sciences. Professor, Nursing Department at the State University of Paraiba. Campina Grande, Paraiba, Brazil. E-mail: ardimanu@ig.com.br
^III PhD in Health Sciences. Professor of the School of Health of the Federal University of Rio Grande do Norte. Natal, Rio Grande do Norte, Brazil. E-mail: marizebs@gmail.com
^IV Master in Nursing. FACEX University Center. Natal, Rio Grande do Norte, Brazil. E-mail: isabrandao_ab@hotmail.com
^V Degree in Nursing. Natal, Rio Grande do Norte, Brazil. E-mail: aninha529@hotmail.com
^VI PhD in Public Health. Graduate Program in Health Sciences. Natal, Rio Grande do Norte, Brazil. E-mail: alicedacostauchoa@gmail.com

DOI: http://dx.doi.org/10.12957/reuerj.2016.13923

ABSTRACT

Objective: to characterize the model for medication prescription by nurses in Primary Health Care Protocols in Brazil. Method: 10 clinical protocols published between 2002 and 2011 by the Health Ministry were subjected to ethno-methodological document analysis. Data were collected from August to December 2011. The project was approved by the research ethics committee (CAAE No. 2813.0.000.133-10). Results: there are no prerequisites in most protocols; nursing diagnosis is possible in pregnancy, child nutrition and sexually transmitted diseases; varying degrees of autonomy were observed; and a broad group of drugs were prescribed by nurses. Conclusion : In Brazil, this confirms a practice of prescribing without requirements and with a diversity of guidelines, inducing a multiplicity of actions, which may impair the quality of prescribing.

Keywords: Nurse; drugs prescription; primary health care; clinical protocols.

INTRODUCTION

In the global context, in recent decades, the role of nurses in prescribing drugs has been increasing in Primary Health Care (PHC) by the need to implement patient care; extension of services to rural communities; more rational cost-benefit in management of health systems; professional legitimation and development; improved working relationships among health professionals; and the need to reduce the workload of medical staff ¹.

Countries like Sweden, Canada, Australia, New Zealand, South Africa, Ireland and the United Kingdom have consolidated drug prescription by nurses². In the latter, there has been highlight for the effectiveness and acceptability of professionals and users³.

Among the drug prescription models performed by nurses, there are: the independent prescriber, the supplementary prescriber and the group protocol prescriber, or patient group directions (PGD), as it is known internationally^4,5.

In Brazil, the prescription is the group protocol type and is regulated by the professional nursing practice law (Law 7.498 / 86)⁶ and it is restricted to primary care standardized by the Ministry of Health (MOH). The inclusion of drug prescription by nurses in PHC has been object of deep debate within the category and reason for polemic discussions around the medical act⁷. It also coincides with external factors to the category, which are structural, arising from the reformulation of the Brazilian health system with the creation of the Unified Health System (SUS) in the 80s. There has been a large expansion of population coverage promoted by the Family Health Program (FHP) created in 1994 and that in 2000s became a national strategy for organizing this level of care. The MOH provides a set of focused actions and procedures aimed at PHC and arranged in care protocols or Primary Care Booklets (PCB) to be adopted by the different professionals involved in the intervention process, such as nurses, doctors and dentists. The booklets deal with situations and health problems within a particular service or institution, highlighting the technical actions and the use of drugs⁸.

Starting from the assumption of restriction to PHC and dispersion in PCB aimed at the role of different professionals, this study aims to characterize the drug prescription model for nurses in Primary Health Care protocols in Brazil. As this subject still generates controversy, its analysis in the light of international experiences, many of which are innovative when compared to the Brazilian situation, will contribute to promote progress and overcome challenges with a view to the quality of care provided in PHC. It can also give a starting point for further development of research in this field of nursing.

LITERATURE REVIEW

Although drug prescription by nurses is permitted by law⁶, physicians exert strong resistance to prescription and diagnosis by other professionals in Brazil. The law which regulates the medical profession (Law 12,482/2013)⁹ caused dissatisfaction among physicians for failing to ensure exclusivity regarding formulation of diagnosis and establishment of therapy⁷.

In other countries, physicians have also been resistant to prescription by nurses. In the UK this resistance has been overcame for more than a decade. One of the factors contributing to this was the union of nurses with their class entity at the national level in favor of the introduction of drug prescription in that country to improve patient care and legitimize their skills and knowledge. Another important measure was a government-funded research that provided feedback on the acceptability, efficacy and safety of this procedure^10,11.

In Brazil, this practice has not been standardized in services. Study on prenatal care performed by nurses in Sao Paulo revealed that only 31% (40/131) used protocols to treat infections in pregnant women and their partners¹². Other studies have revealed that nurses show fear and lack of confidence in prescriptive actions¹³ or that they fear complaints¹⁴.

There are some possible reasons for this situation. The first hypothesis is that, as opposed to the recommended by the International Council of Nurses (ICN), in Brazil there is no requirement of specialized knowledge, clinical experience and prescriber's registry as prerequisites to prescription by nurses. The second hypothesis is that a large number of protocols were developed by the MOH in a centralized manner with little involvement of local health teams and there is complaint about the lack of local protocols and the misperception that there are restrictions by the Brazilian Nursing Council¹⁵.

In Brazil, there is no research characterizing the drug prescription model performed by nurses in PHC. There is lack of requirements and debate to support the discussions on the need to strengthen the training and the autonomy of nurses towards an advanced practice with quality, as seen in developed countries.

METHODOLOGY

This is an ethnomethodological documentary analysis that understands documents as a specific version of the contextual reality constructed with specific goals¹⁶. Documents are not analyzed as information containers but as communicative devices^17,18.

Authors selected initially 33 Primary Care Booklets based on a preliminary analysis about the authenticity (primary and provided by the author), representativity (contains information necessary for the object of the study) and significance (comphehensive to the actors involved in the context)¹⁷.

Inclusion criteria were: year of publication, from 2002 and programmatic vulnerability (children, women, communicable and chronic diseases). Researchers excluded protocols addressing promotion, service organization, integrative practices, oral health, medical and surgical procedures and home visits, by not including actions of drug prescription by nurses. The sample size was ten (10) protocols for achieving the degree of saturation of the possible information obtained to answer the research question¹⁸.

The analyzed documents were accessed between August to October 2011 in the Primary Care Department website of the Ministry of Health (MOH) - http://dab.saude.gov.br/caderno_ab.php/ . The collection script used the theoretical model categories¹⁹ applied to the body of the documents analyzed based on ICN²⁰. The variables analyzed were: object/area of care, protocol name/identification, professional(s) to whom the protocol is targeted, prescription context with justification, existence of prerequisites to the prescription by the nurse (clinical experience/training), evidence of prescriber's registry, nurse's assignments in the prescription, sharing or not of prescription's assignments, group of drugs that may be prescribed by nurses, date of publication and localization.

The collection script was sent by e-mail between October and November 2011 to five judges or experts - researchers with intellectual production on the subject over the past 5 years. All items had inter-rater agreement (IRA) of 100% on the representation and clarity of the items regarding the studied content.

The use of public documents dismissed the need for approval by the Ethics Committee in Research with Human Beings.

Authors proceeded to the qualitative analysis based on the six steps guided by Mayring²¹. In the first stage, the relevant excerpts in the documents were selected, those that matched the research theme. In the second, researchers analyzed the data collection and found that the documents were from MOH. In the third, authors performed a formal characterization of the document and found out that it was from the Primary Care Booklets Series. In the fourth stage, it defined the direction of analysis tracking, the protocols, content related to prescription assignments. In the fifth stage, the analysis through the content analysis technique was carried out in two stages: first reduction, in which little relevant excerpts and paraphrases are omitted, and second reduction, in which similar paraphrases are grouped and summarized. In the last stage, authors chose as analytical unit both the coding units represented by the word prescription and the context units, or explanatory excerpts of how drug prescription occurred.

RESULTS

Primary Care Booklets analyzed

The analyzed protocols are described in Figure 1. For each PCB a reference code was used for its identification in this research.

FIGURE 1: Sample of 10 Primary Care Booklets (PCB) according to object of care, name/year of publication, localization and reference code in the research. Brazil, 2011.

Prerequisites of drug prescription by nurses

Most protocols analyzed showed no prerequisites for the prescription by nurses, and this practice is allowed to those who had completed a degree in nursing.

Only the Comprehensive Care Protocol to Prevalent Childhood Illness (CCPPCI) and the Tuberculosis Nursing Protocol refer some kind of training as requirement. The first recommends eight days of theoretical and practical classes. The other indicates that the nurse should receive training but does not specify the duration of training.

The CCPPCI course aimed to train the professional [with higher education degree] is carried out in eight days, with a major component in practical activities. (CAB/CR/1, p. 23).

Nurses trained in TB control actions should identify clinical, epidemiological and social information of the disease suspects and take steps to clarify the diagnosis. (CAB/TB/1, p. 36).

In none of the protocols the clinical experience was required as a condition for prescribing drugs.

Possibilities of achieving clinical diagnostic

There are different situations for the achievement of clinical diagnosis. There is the possibility of diagnosis by nurses in Child Nutrition Protocols to identify and treat problems related to breastfeeding; in the Prenatal Care Protocol, in which the nurse makes the diagnosis of pregnancy and of the most frequent clinical events; and in the Protocol for Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), Hepatitis and other Sexually Transmitted Diseases (STD) the diagnosis is the presumption of the main syndromes.

Upon confirmation of pregnancy in medical or nursing consultation, the monitoring of pregnant women is initiated [p. 21]. ... Diagnosis can be clinical and the most common findings are [...]. (CAB/UM/1, p. 77).

The health professional, knowing the main anatomical and functional aspects of both the male and the female body may associate the anamnesis data and make a presumption diagnosis of the main syndromes (syndromic approach). (CAB/DST/1, p. 45).

In Protocols for Hypertension, Diabetes, Leprosy, Tuberculosis and Cervical and Breast Cancer the clinical diagnosis is made solely by the physician because it is not included in the nurse's assignments.

Regarding Tuberculosis Protocol there is a particularity since a protocol does not allow nurses to make a diagnosis; however, in the Nursing Protocol for TB the diagnosis is implicit in the duties of this professional.

The nurse enrolled in the tuberculosis control program must organize and meet the recommendations of the Ministry of Health and, according to the Primary Care Decree No. 648, of March 28, 2006, the diagnosis of tuberculosis in health services is implicit in this professional's duties [...]. (CAB/TB/1, p. 36).

Distinctively, the CCPPCI Protocol does not include the stage of diagnosis, since its goal is to identify clinical signs and do a quick screening for the necessary care and prescription to the following symptoms: malnutrition, diarrhea, acute respiratory infections, malaria, among others.

The objective of the CCPPCI strategy is not to establish a specific diagnosis of a disease but to identify clinical signs to enable the adequate evaluation and classification of the picture and do a quick screening on the nature of care required by the child [...]. (CAB/CR/1, p. 05).

Nurses' autonomy levels for drug prescription

There are different levels of autonomy of nurses on drug prescription, of which three subtypes are described as follows. The first subtype involves dependence on initial medical diagnosis and prescription. In this case, the physician is responsible for therapeutic decision and sets the start of treatment, as seen in Protocols for Hypertension, Diabetes, Cervical and Breast Cancer. The nurse monitors users and in subsequent consultations should maintain the same medical prescription.

Nurses' duties: [...] 2. Perform nursing consultation, addressing risk factors, non-drug treatment, adherence and possible complications of treatment, referring the individual to the physician when necessary. (CAB/HAS/1, p. 40-41).

In the second subtype of autonomy, dependence is only on the medical diagnosis, which can be found on Tuberculosis Protocol. In this case, in the absence of the physician, the nurse can set the treatment and schedule appointment with a doctor.

If the service has a physician, the nurse should refer the patient immediately to the consultation; otherwise, the nurse starts treatment and schedules the appointment to the physician. (CAD/TB/1, p. 81).

The third subtype of autonomy is no dependence on medical diagnosis and prescription. In the Protocols for Child Nutrition, CCPPCI, Prenatal Care and HIV/AIDS, Hepatitis and other STDs nurses work similarly to the physician by integrating the PHC team.

Health professionals have an important role in the prevention and management of these difficulties. [...] 1.9.6.1 Management: The treatment initially is local, with topical Nystatin, Clotrimazole, Miconazole or Ketoconazole for two weeks. (CAB/CR/2, p. 43).

In situations of persistent emesis, the healthcare provider should prescribe antiemetic drugs orally or intravenously and hydration. (CAB/UM/1, p. 89).

Sharing and distinction between health professionals in situations of drug prescription

In some protocols, the assignments are common among the health team and in others there is distinction of responsibilities between physicians and nurses. It was observed that in the Protocols for Child Nutrition, CCPPCI, Prenatal Care, HIV/AIDS, Hepatitis and other STDs prescription assignments are common to nurses and physicians.

The aim of this service is to provide in the first appointment the diagnosis, treatment and appropriate counseling [...]. Following the flowcharts steps, the professional will be able to: 1. Make syndromic diagnosis. 2. Start treatment immediately. (CAB/DST/1, p. 44).

In Protocols for Tuberculosis, Leprosy, Diabetes, Hypertension and Cervical and Breast Cancer assignments are specific to each professional, with exclusive prescription by the physician. In Protocols for Hypertension and Diabetes, the participation of nurses in drug treatment is collaborative, restricted to the maintenance of the drug after initial medical prescription.

Nurses' duties: [...] 9. Repeat medication of controlled and uneventful individuals. (CAB/DIA/1, p. 47).

Groups of drugs prescribed by nurses

Nos protocolos nos quais há dependência de prescrição médica inicial o enfermeiro pode realizar a prescrição subsequente dos seguintes grupos de medicamentos: antituberculosos, anti-hansenianos, anti-hipertensivos, antiglicemiantes.

Para os protocolos em que a prescrição não depende do diagnóstico médico, os grupos de medicamentos que podem ser prescritos pelos enfermeiros são: antibióticos, analgésicos, antipiréticos, antiparasitários, broncodilatadores, vitaminas e sais minerais para o grupo infantil, antibióticos, antifúngicos, anti-inflamatórios não esteróides, anti-helmínticos, antiparasitários, antimicóticos e sulfas.

DISCUSSION

With regard to the prerequisites of nursing prescription, most protocols are in accordance with the rules of nursing practice in Brazil, which does not require specialized knowledge or prior clinical experience. However, in order to perform drug prescription, the nurse must acquire specific, though of short duration, training as seen in many countries⁴, as in the UK³.

The CCPPCI and the Nursing Protocol for Tuberculosis are in line with the international proposal by requiring prior training, but it does not meet the recommended by the ICN, which is the master's degree, or equivalent²⁰. A study conducted in Bahia and Ceara on childhood diseases protocols showed that after receiving training, nurses' performance was as good or better than the physicians' performance²².

There is no specific registry in the Nursing Council for those who are prescribers. On the other hand, there are more than 48,000 nurses of teams enrolled in the MOH linked to the FHS²³ that are potential prescribers. There is no record of the existence of monitoring of these professionals, their adherence or not to this assignment and possible difficulties.

As for the possibility of conducting clinical diagnosis, there are different situations. In the Protocols for Child Nutrition, CCPPCI, Prenatal Care, STD/AIDS, Hepatitis and other STDs nurses can provide diagnosis.

It is noteworthy that, in countries where the nurse in an independent prescriber there is greater flexibility for diagnosis and prescription in the scope of their competence¹⁰.

Even when following the protocol, nursing prescription may represent greater independence from physicians, historically considered the solely responsible for diagnosis and prescription^7,5. A study conducted in Natal-RN on the monitoring of pregnant women with syphilis revealed that only six of the 30 nurses investigated prescribed medication for diagnosed clients. Other professionals claimed to be a medical procedure, referred to the absence of municipal protocols, restrictions by Nursing Councils and insecurity¹⁵. However, there are no such restrictions by these Councils. Another study on prenatal care revealed that nurses indicated as one of the difficulties in the operationalization of care the institutional prohibition on drug prescription¹².

In the Protocols for Hypertension, Diabetes, Leprosy and Tuberculosis, in which the prescription depends on the diagnosis of diseases, the diagnosis remains restricted to the physician. The exception that allows nurses to establish the treatment of tuberculosis in the absence of the physician may be justified by social exclusion involving carriers of the disease and the long period of treatment and high dropout rate.

The autonomy subtypes found in the protocols reveal the greater or lesser degree of dependence on physicians and, consequently, autonomy of nurses. However, it is noteworthy that a professional should not be in a situation of submission to the other under penalty of having their autonomy limited¹³.

Study in the United Kingdom, in applying the form of Medicines Adequacy Ratio to prescribers nurses and pharmacists, revealed that these professionals make appropriate clinical decisions when prescribing¹.

This different way of autonomy can bring questions to the professional and entail limited or discretionary prescribing practices, making it unsafe to nurses and clients. This situation shows that there is no standardization of work processes of PHC teams, which can affect the quality of services offered⁸.

As for the sharing or distinction of prescription situations in the protocols, it was observed that, when there is distinction of the duties, the diagnosis is reserved to the physician. When assignments are common between health professionals, the nurse receives greater autonomy. This differentiation in assignments appears to be related to different health situations. In the case of CCPPCI, the strategy can promote rapid and significant reduction in infant mortality, setting itself as the best cost/benefit²⁴.

It should be clarified that this study does not intend to exalt the medicalization of care, since when performed in a fragmented manner, this function can contribute to the reproduction of the biomedical model²⁵. In this sense, there is need to establish de-medicalization strategies with a view to a more humanistic approach to health care²⁶.

On the international scene, the supplementary prescriber nurse is willing partner of the independent prescriber, usually a physician²⁰. According to the Scottish public, it is very important communication and cooperation among physicians and non-physicians prescribers as it can affect care and patient safety¹⁰.

There has been a significant number of drug classes that may be requested by nurses, indicating that the MOH has an interest in mantaining this assignment. However, a study on the dynamics of family planning exercised by nurses showed that only 48.3% of them prescribed contraceptives¹⁴.

In the UK, independent prescribers nurses prescribe any medication, including controlled drugs². In England the average of drug prescription by nurses is one every 2.82 consultations¹¹. When compared to the international scenario, it can be said that in Brazil prescription is still incipient, possibly because it has not been universalized in health services⁷.

The reaffirmation of nursing prescription in the current National Primary Care Ordinance and the guaranty that this assignment is not private of physicians make the Brazilian government an important ally in the maintenance of nurses as prescribers.

On one hand, the Brazilian government has promoted drug prescription by nurses through protocols, but on the other it has not introduced governance measures and support for its implementation in local health systems. In this sense, it is not enough only to regulate prescriptions, the government needs to build strategies for broader dissemination, qualification and monitoring of prescribing nurses.

CONCLUSION

In Brazil, there has been a prescriptive practice almost without requirements. The diagnosis by nurses is possible in some situations, but in others, the protocols recommend limiting the diagnosis and institution of therapy to the physician.

The different levels of nurses' autonomy relate to the degree of dependence on the physician. Thus, the prescription assignments are sometimes shared, sometimes distinct, yet the protocols ensure some space for prescription by entering the nurse as a legitimate prescriber. This can be seen by the variety of groups of drugs that nurses can prescribe.

There are a variety of guidelines on the prescriptive practice of nurses, with variations for the same situation, such as in case of tuberculosis. The lack of standardization can have a negative effect on the quality of nurses' prescription.

It is recommended that the occupation of this space by the nurse is accompanied by directing training for qualification of therapeutic prescriptive practice under the responsibility of higher education institutions, the Nursing Councils and the nurse themselves, responsible for their decisions in the professional practice.

The study presents as limitation the solely institutional view of the problem in question. As this is an exploratory study and facing the shortage of knowledge on the subject, researchers suggest the conduction of an evaluative study on the quality of drug prescription that have been performed by nurses.

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