Hospital pharmacy practice and medication errors in Brazil

Abstract

Purpose

To analyse conformity with the Basel statements focused on patient safety by Brazilian hospital pharmacies.

Methods

A web-based cross-sectional study was performed, with data collected from an electronic survey based on the Basel statements, answered by pharmacists from hospitals in all areas of the country.

Results

Pharmacists from 111 hospitals from all areas of Brazil participated. It was found that the Brazilian hospital pharmacist performs several services without meeting the minimum requirements to guarantee patient safety in this environment.

Conclusion

Much still needs to be done to meet international standards, from training to supervision of services.

Introduction

Medication errors and unsafe medication practices are a leading cause of avoidable harm in healthcare systems worldwide. Annually, the cost associated with medication errors has been estimated at US$ 42 billion.¹ In Brazil, a study analysed 242 entries in nursing records and identified 230 medication errors, with the majority classified as preparation and administration errors (n=148; 64.3%), followed by dispensing errors (n=59; 25.6%) and prescription errors (n=23; 10.1%).² In total, 37.4% of the errors were potentially dangerous. Patient safety is considered a fundamental principle and an indispensable element of healthcare delivery. Seeking to improve and humanise healthcare at all levels of care and complexity is considered a critical component of quality management. The occurrence of an adverse event may cause adverse outcomes to the patient which may manifest as increased length of hospitalisation, increased hospital expenditure, short-lived disability and even death.³

In 2017, the WHO launched the 3rd Global Patient Safety Challenge, a global initiative to reduce 50% of serious and preventable drug-related harms around the world over the next 5 years.¹ In line with this, the pharmacies of the Brazilian Society of Hospital Pharmacy and Health Services (SBRAFH) promoted the safe and correct use of medicines by publishing their standards.⁴ This was also supported by the International Pharmaceutical Federation (FIP) which promoted similar messages in the Basel declarations, updated in 2014 by thousands of pharmacists gathered in Switzerland, and reflect the preferred view of the profession for hospital pharmacy. Inspiring the existing health system stakeholders’ activities, capabilities and resources are aligned to ensure that patients receive the right medications at the right time, use them appropriately and benefit from them.⁵ Several studies use the statements for analysis, monitoring and development of hospital pharmacy activities in several countries.^{6 7}

Methods

Our group investigated the extent to which the practice of hospital pharmacy in Brazil was aligned with the revised Basel statements, through a questionnaire constructed from the transformation of the Basel Declarations in the Portuguese version into questions. The questionnaire had been previously tested by students and teachers of the pharmacy course. From February to September 2016, Brazilian hospitals of high and medium complexity registered in the National Register of Health Establishments (CNES) were contacted via their electronic address and were selected for the study (http://cnes2.datasus.gov.br/). A letter was sent via email to the responsible pharmacists of all the registered hospitals, inviting them to participate in the research. Based on a population size of 4790 hospitals found by Santos et al,⁷ a sample size of at least 95 responses was considered adequate, with an anticipated 50% variation of practices ±10% confidence limits, 95% confidence level and a design effect of 1.0 (Openepi v.3; www.openepi.com). From September 2016 to July 2017, hospital pharmacists in Brazil participated in the research, particularly on five issues focused on drug safety, based on the revised Basel Declarations 19, 38, 39, 46 and 51 (table 1). Statistical analysis was performed using SPSS 19.0 (IBM SPSS Statistics v.19).

Table 1.

Questions focused on drug safety, based on the revised Basel Declarations.

Number	Question
19	Are the ‘seven rights’ (right patient, medicine, dose, route, information, documentation and time) fulfilled in all medicine-related activities in the hospital?
38	In your hospital, are concentrated electrolyte products (such as potassium chloride and sodium chloride) and other institutionally identified high-risk medicines dispensed in ready-to-administer dilutions and stored in secure, separate areas with distinct labels?
39	In your hospital, do hospital pharmacists develop simple rules-based approaches to advancing patient safety; for example, when a large number of dosage units is needed to give a dose (more than two tablets, vials, etc), is the prescription verified prior to preparation or dispensing?
46	In your hospital, do hospital pharmacists develop and implement policies and practices that prevent errors of administration routes?
51	In your hospital, has an easy-access, non-punitive medication error notification system, including near-miss events, been deployed and maintained? Are medication error reports reviewed internally and forwarded to the regional or national pharmacovigilance regulatory programme? Is this data regularly reviewed to improve the quality and safety of drug practices?

Results

Pharmacists from 111 hospitals in Brazil completed the electronic survey. From those that responded to the survey, 88.3% (n=98/111) of pharmacists answered that their hospital was fulfilling the ‘seven rights’ (right patient, medicine, dose, route, information, documentation and time) in all medicine-related activities. Also, the majority stated that they verify prescriptions prior to preparation or dispensing (58.6%, n=65/111) and that they do not dispense concentrated electrolyte products (such as potassium chloride and sodium chloride) and other institutionally identified high-risk medicines in ready-to-administer dilutions, nor store them in secure separate areas with distinct labels (66.6%, n=74/111). However, if there was a near-miss or adverse event, only 39.6% (n=44/111) had an easily accessible, non-punitive reporting system for medication errors and only 34.2% (n=38/111) had developed and implemented policies and practices to prevent administration route errors.

Discussion

In Brazil, the National Patient Safety Program, created in 2013, established the ‘Safety Protocol on Medications Prescription, Use and Administration’ with the purpose of promoting safe practices in the use of medicines in health facilities. The five Basel statements researched by this team are also described in the protocol as issues that need to be addressed in hospital pharmacies all over the country.⁶ According to the results presented in this report, even after 5 years of programme implementation, adherence to meeting these objectives is still low. If this reality does not change, it will be nearly impossible to fulfil the WHO goal for all medication errors to cease by 2022.¹ In order to promote medication safety it is essential that all health units have a complete multiprofessional team. Unfortunately, Santos et al ⁷found that more than half (50.9%) of Brazilian hospitals do not have a hospital pharmacist in their health team.

The development and implementation of policies and practices that avoid administration route errors should be also a pharmacist’s role.⁸ But why is this role not being effectively fulfilled? Protocols need to be elaborated on the roles of each team member including pharmacists. Hospitals that do not have a pharmacist or have a pharmacist who is unqualified or lacking updated training for their duties may pose a greater risk to their patients.⁹ In order for these professionals to be trained according to the most advanced scope of Pharmacy Services, the Brazilian Curricular Guidelines for Undergraduate Pharmacy courses underwent changes in 2017 to include, besides the pharmaceutical services implemented in 2002, the development of competencies that are the autonomy of the human being, his singularity and the real context in which he lives, enabling a better quality of life.¹⁰

Additionally, applied inspection and application of error reporting systems are essential for patient safety. The supervision should verify the presence of the pharmacist and also require the fulfilment of these tasks. Along with error feedback, the adverse events report should reduce or eliminate similar occurrences in the future, promote learning and, through research and analysis of the incidents, generate useful information to correct failures.¹⁰ Even though the notification of adverse events by the health services has been mandatory in Brazil since the creation of the National Patient Safety Program, cases of underreporting are still very common, hindering the improvement of the service. A safety culture must be established in every institution and, in turn, punitive behaviour needs to be abolished as professionals begin to hide their problems for fear of punishment.²

Conclusion

This study provides an important evaluation of the activities of hospital pharmacies in the search for greater safety for patients through the Basel statements. It points out that the the need for a drug safety culture should be included during undergraduate study and become part of every workplace culture. Pharmacists need to be recognised as essential members of the multidisciplinary team who can oversee the medication safety procedures in each setting. Pharmacists must continually seek to update their knowledge so they can lead medication management services and medication errors that harm patients can be reduced. The new pharmacist must take responsibility for the hospital pharmacy, assuming their role as health professionals and key players in ensuring patient safety.

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

Ethics statements

Patient consent for publication

Not required.

Ethics approval

CAAE: 56738416.3.0000.5545.