Elaboration and Validation of the Medication Prescription Safety Checklist 1

ABSTRACT Objective: to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. Method: methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. Results: the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). Conclusion: the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use.


Introduction
In recent years, concerns with patient safety have emphasized the aspect of risk management associated with medication use (1) . Medicines are products capable of preventing, diagnosing, curing illnesses or relieving symptoms, but countless errors occur in the medication treatment process the patients receive (2) .
One of the main adverse events hospitalized patients are victims of are medication errors, representing a severe problem in health services, besides being frequent (3)(4) and common in all health institutions due to the complexity of the process. It can happen in the prescription, dispensing or administration of medicines and is established as one of the causes of iatrogenic effects (5) .
The Conselho Nacional de Coordenação de Relatórios e Prevenção de Erros de Medicamentos (National

Coordinating Council for Medication Error Reporting
and Prevention -NCCMERP) defines medication error as an avoidable event, which can lead to the bad use of medication or to patient damage while the patient is under the professional's control (6) .
Based on an analysis of the contribution of medical errors to deaths in the United States of America, it was estimated through research that medical errors can represent approximately 251 thousand deaths per year in the country, ranking third. Error is considered as an unintentional act, which did not produce the desired outcome, as well as execution or planning errors or failures in the care process (7) .
The most sensitive method to identify medication dispensing and administration errors is observation, while the review of records is considered more appropriate to identify errors in medication prescriptions (8) . Among the different medication errors, prescription errors stand out due to their potential to cause harmful consequences to the patients (9) and because they represent a considerable proportion of avoidable drug-related problems (10) .
The prescription process is complex and permeated by errors (11) . Prescription errors happened in 14.7% of the medication prescriptions in the United Kingdom, the most common being omission, wrong dose and incomplete prescription (12) .
The medical prescription is the reference document that guides and influences the other phases of the medication process. It is an essential communication tool among health professionals (11) and plays an important role in the prevention and occurrence of errors (13) .
An analysis of systematic reviews to determine the effects of hospital technologies on the quality, safety and efficacy of care demonstrated that, for the electronic prescriptions, substantially lesser evidence of medication errors was found, as well as greater compliance with the guidelines and better control of illnesses and better response time to the dispensing (14) .
The prescriptions should be comprehensive, in terms of the existence of information needed for all professionals who use them, as omitting information from the prescription can contribute to the occurrence of errors (13) . It should be kept in mind that error reporting by all health professionals, in combination with organizational changes, can favor patient safety and minimize medical errors (7) .
The engagement of different professionals in the various phases of the medication prescription process is essential, as reports on the occurrence of possible errors represent a possibility for learning, for the implementation of preventive measures, for high-quality care provision and for patient safety promotion through medication governance (15) .
To reduce the incidence of adverse events in public and private health services and promote safe medication usage practices, in the Brazilian literature, the Medication Prescription, Usage and Administration Safety Protocol stands out, which addresses safe practices for medication prescription, distribution and administration (16) .
In view of the need for studies that identify the absence of information from the prescriptions and the lack of instruments in the literature, in this study, we intended to answer the following question: does a checklist permit verifying compliance with the safety recommendations concerning the structure of medication prescriptions?
Hence, considering that medication errors compromise the quality of care and patient safety, in this study, we aimed to elaborate a checklist to identify the compliance with recommendations for the structure of medication prescriptions, as well as to carry out the face and content validation and the reliability analysis.  (16) . The tool constructed was called Lista de Verificação de Segurança na Prescrição Pires AOM, Ferreira MBG, Nascimento KG, Felix MMS, Pires PS, Barbosa MH.

de Medicamentos (Medication Prescription Safety
Checklist -LVSPM) and covers identification data of the prescription and its medicines.
For the face and content validation, five multiprofesional judges were selected, being: one physician, one pharmacist and three nurses, all of whom held a Ph.D. and were experienced in the theme area of the research, four of them being faculty members at federal universities.
Initially, the judges were contacted by e-mail, inviting them to participate in the content validation phase of the LVSPM. After they had agreed, a document was forwarded with the description, purpose and objectives of the research, as well as the instrument, in order to assess whether it is measuring what it is intended to measure (face validation) and the relevance of each item in the construct studied (content validation) (17) , that is, if both properly represent the hypothetic universe of the object, i.e. patient safety in medication prescription. Protocol. It is highlighted that, before the start of the data collection process, the judges were submitted to training for the sake of conformity of the data collection.
In the data analysis, the categorical variables were subject to univariate analyses through absolute and relative frequency tables. The interrater reliability was substantial (0.61-0.80) and almost perfect (≥0.81) (18) , and the intraclass correlation coefficient as adequate when >0.70 (19) in the second part, in view of the quantitative nature of the variable. Significance was set at 0.05.   To determine the compliance score, the answers with score 1 (one) are added up, according to the The agreement proportion corresponded to 100% for all items in the first part of the instrument, that is, the judges agreed on all items of the 27 prescriptions analyzed.

Discussion
Other research results evidence the importance of using tools that permit the identification of possible prescription errors, contributing to improve the medication administration process, which involves different health professionals of relevant importance for the nursing team.
In one study, it was affirmed that prescribing correctly represents one of the essential skills to guarantee patient safety and, therefore, 74 medicine students were assessed in a study of the number of prescription errors committed in a prescription test.
These tests were assessed by means of a checklist to identify the prescription errors, evidencing that the students committed 69% of errors (10) .
In another study, the impact of introducing a omissions. After the implementation of the verification and correction checklist, the error rates corresponded to 7.3 and 5.5%, respectively. As for the clinical error, no significant impact of the intervention was detected.
The researchers concluded that the implementation of a verification and correction checklist led to improvements in the quality of written prescriptions (20) .
A Chilean research also aimed to adapt and validate two checklists, one to measure the errors in handwritten prescriptions and the other to detect errors in the medication preparation process. The instruments were submitted to three phases: adaptation, as the instruments were based on the error classification of the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP); review by experts and reliability analysis. The checklists for medication prescription and dispensing consisted of 12 items to measure the prescription errors and seven to measure the preparation errors. The instruments showed to be valid and reliable (21) .
To reduce the prescription errors, a French study is also highlighted, a pioneer in the development of a preliminary screening tool to identify omissions and inappropriate prescriptions in pediatrics, based on international and French guidelines (5) .
In a different study, aiming to explore factors that provoke prevalent errors in hospitals tending to prevent the recurrence of medication errors (22) .
In another study, the importance of reporting the medication errors was highlighted, as this represents a possibility to learn and implement preventive measures. In addition, the need for the safety culture in institutions was emphasized, where medication governance promotes patient safety and high-quality care provision (15) .
The use of the LVSPM is recommended as a management tool in the nurses' clinical practice, offering support for the implementation of evidencebased care. The recommendations of a literature review corroborate this assertion, identifying evidence-based health care as a subculture of the patient safety culture.
The best evidence-based practices include standardized processes, protocols, checklists and orientations, aspects that favor the safety culture (23) .
The application of a checklist like the LVSPM in daily work and the careful analysis of the results obtained can significantly improve the quality and safety of the medication therapy provided to the patients, besides guiding the professionals, especially the nurses to eliminate the errors deriving from the medication process (24) .
We consider that the predictive validity represents a limitation in this study. It should be highlighted though that this tool can be used in a subsequent study with a longitudinal and prospective design to estimate the predictive validity of complying with the recommendations, using the occurrence or not of medication-related adverse events as a criterion.
We also consider that the LVSPM items refer to the practice at any healthcare level. Hence, future studies are needed to assess the use of the checklist in other contexts beyond the hospital.

Conclusion
In view of the above, the validity and reliability of the LVSPM were demonstrated. The checklist can be