Trends in pharmacy staff's perception of patient safety in Swedish community pharmacies after re-regulation of conditions.

BACKGROUND: All changes in the regulation of pharmacies have an impact on the work carried out in pharmacies and also on patient safety, regardless of whether this is the intention or not.
OBJECTIVE: To compare staff apprehension regarding some aspects of patient safety and quality in community pharmacies prior to and after the 2009 changes in regulation of the Swedish community pharmacy market.
METHODS: Questionnaires targeted at pharmacy staff before and after the changes in regulation (in 2008, 2011/12, and 2012/13 respectively) used four identical items, making comparisons of some aspects possible.
RESULTS: All four items demonstrated a significant decrease in the first survey after the changes as compared to before. In the second survey significant differences were found on the two items representing safety climate whereas the items representing team climate and management showed no significant differences.
CONCLUSIONS: The comparison carried out in this study indicates a negative effect in Swedish community pharmacies on safety and quality issues, as experienced by pharmacy staff. It is recommended that the possible effects of healthcare reforms are assessed before implementation, in order to counteract conceivable decline in factors including patient safety and working conditions.

INTRODUCTION

All changes in the regulation of pharmacies have an impact on the organization and work carried out in pharmacies and also on patient safety, regardless of whether this was the intention or not. It has also been suggested that regulatory changes for pharmacies often lead to increased workload for staff, with less time for counseling and advice to patients. Increased demands on financial profitability are also said to affect working conditions.1

In July 2009 there were major changes in the regulation of the pharmacy market in Sweden, which went from a state-owned pharmacy monopoly to an open market. The purpose of this study was to examine staff apprehension regarding some aspects of patient safety and quality in community pharmacies prior to and after this reregulation.

The political rationales for the re-regulation were focused on availability to pharmacies, and ownership issues.2,3 It has resulted in e.g. an increase in the number of pharmacies (from 925 pharmacies in July 2009 to approximately 1,350 in January 2014)4 , mostly in densely populated areas.5 There are now few restrictions on ownership of pharmacies. Pharmacies are today operated by a wide range of owners; including international chains, newly-established domestic chains, and individuals, including a few pharmacists, but mostly other professions.6

Patient care in pharmacies includes optimization of patients’ drug therapy, achieving better patient outcomes and improving the quality of patient’s lives.7 Quality and patient safety was however not in focus during the political process preceding the regulatory change. The one substantial outcome in this area was the regulation of a specialist function–a pharmacist responsible for pharmacy operations meeting quality requirements.8 The function existed prior to the reregulation but has now become regulated.9,10

Several factors impact patient safety in pharmacies, among them the working conditions for staff11 which can influence the detection of drug-drug interactions12, pharmacists’ interventions13,14 and number of dispensing errors.15,1617,18 There are reports of increased pressure on pharmacy staff after the reregulation. In one survey 58% of respondents reported experiencing more stress, and 4% less stress, than before the reregulation.19 In another survey, the conditions regarding safe dispensing of medicines had deteriorated in comparison to the situation before the re-regulation, according to 55% of the respondents, while 28% considered the conditions unaltered and 11% as improved. The work load was considered to have increased by 72% of the respondents.6

However, in both surveys mentioned above the respondents were asked to compare the present situation with their former experience, thus recall bias is an obvious problem. Baseline data are scarce, but before the re-regulation a study was carried out on patient safety in Swedish pharmacies in which safety culture and the handling of equality markers such as errors were highlighted.20,21 The reuse of some items originating from this study provides an opportunity to make comparisons between the situation prior to and after the reform.

METHODS

In the study carried out prior to the reregulation, the Safety Attitude Questionnaire Swedish Community Pharmacy Version; SAQ was used.20 SAQ was developed to assess the quality of safety- and teamwork-related norms and behaviors of individual workers, in a particular setting.22 This survey was adapted to and used in Swedish community pharmacies.20 This survey includes 40 questions, aggregated into six dimensions. It is hereafter referred to as the SAQ study.

After the reregulation, two surveys were carried out by The Swedish Agency for Public Management, hereafter named the Agency studies. These surveys were mainly studying competencies and safety in drug handling after the reregulation. Four questions were derived from the SAQ study mentioned above (Personal communication, Anna Eriksson, Swedish Agency for Public Management, August 7, 2012), see Table 1.

Table 1

Questions and dimensions derived from the SAQ Swedish Community Pharmacy version, used also in the studies carried out by the Swedish Agency for Public Management.6,20,23

Questiona	Dimension
I would feel safe as a customer hereb	Safety Climate
Dispensing errors are handled in a correct way at this pharmacy	Safety Climate
The staff level at this pharmacy is sufficient to handle the number of customers	Teamwork Climate
The management of this pharmacy supports me in my daily workc	Perceptions of Management

The response alternatives applied in all three studies were: Disagree strongly / Disagree slightly / Neutral / Agree slightly / Agree strongly / Not applicable.

Here implies at this pharmacy

This item is not included in the compilation carried out by the Agency, even though it was included in the survey.

In the SAQ study all staff members working in Swedish pharmacies, which at the time of the study in the spring of 2008 encompassed approximately 870 pharmacies, were included. All staff members listed as employed on December 1st 2007 in these pharmacies were invited to participate. A total of 7,244 questionnaires were distributed via e-mail.20

The Agency surveys were conducted in December 2011 – January 2012 and December 2012-January 2013, respectively. They were distributed to a total of 1,500 (2012) and 2,500 (2013) randomly selected pharmacy employees. The respondents were all members of one of the two unions – The Swedish Pharmaceutical Association or Farmaciförbundet. The unions organize >95% of the working staff in Swedish pharmacies and comprise approximately 7,500 members each.6,23 The questionnaire was distributed to 750 (2012) and 1250 (2013) members of each union, by e-mail.6,23

Differences between the results of the SAQ and Agency studies were calculated using a two-sided t- test. Significance was tested at the 5% significance level.

RESULTS

In the SAQ study the response rate was approximately 61% (4,090 respondents); 70% of the respondents were pharmacists and 26% pharmacy technicians. In the Agency studies the response rates were 63% and 60% respectively (1401 and 1519 respondents). Of these 71 and 70 % were pharmacists and 27% of the respondents in both studies were pharmacy technicians. Out of the respondents in the two Agency studies 84% (both studies) had been employed in a pharmacy before July 1st 2009, i.e. before the re-regulation.

The distribution of answers is displayed in Table 2.

Table 2

Comparison - proportion of respondents distributed on response alternatives in the studies conducted prior to and post reregulation.6,20,23

	I would feel safe as a customer here (%)			Dispensing errors are handled in a correct way at this pharmacy (%)			The staff level at this pharmacy is sufficient to handle the number of customers (%)			The management of this pharmacy supports me in my daily work (%)1
	Prior reform 2008	Post reform 2012	Post reform 2013	Prior reform 2008	Post reform 2012	Post reform 2013	Prior reform 2008	Post reform 2012	Post reform 2013	Prior reform 2008	Post reform 2012	Post reform 2013
Disagree strongly/ slightly	1.8	11.6	6.3	1.5	8.3	6.1	46.4	55.1	44.8	11.8	19,3	15.4
Neutral	2.1	6.4	3.0	4.5	7.4	2.2	6.5	5.0	4.5	10.3	9.9	7.3
Agree slightly/ strongly	95.6	81.6	90.2	91.1	80.8	87.1	46.7	39.6	50.4	76.3	68.0	76.6
Not applicable/ no opinion	0.5	0.4	0.5	2.9	3.5	4.6	0.4	0,3	0.3	1.6	2.8	0.7

For two items there was a significant decrease in both studies carried out after, as compared to before the reform (see Table 3). These items are “I would feel safe as a customer here” and “Dispensing errors are handled in a correct way at this pharmacy”. For the two other items “The staff level at this pharmacy is sufficient to handle the number of customers” and “The management of this pharmacy supports me in my daily work”, a significant change was present in the study carried out in 2012, but not in the latter study carried out in 2013.

Table 3

Comparative items, t-values and significance levels. Comparisons made with the SAQ study from 2008.6,20,23

Item	t-value		Significance level
	2012	2013	2012	2013
I would feel safe as a customer here	16.4	8.06	P<0.01	P<0.01
Dispensing errors are handled in a correct way at this pharmacy	11.4	6,68	P<0.01	P<0.01
The staff level at this pharmacy is sufficient to handle the number of customers	5.4	0,90	P<0.01	ns
The management of this pharmacy supports me in my daily work	5.2	1,51	P<0.01	ns

DISCUSSION

The extent of the comparison of the studies is limited, although carry strength, since all three studies are large. The SAQ study includes a total population; i.e. all pharmacy staff, while the Agency studies are carried out on large samples.

The comparison of the two items representing the dimension Safety Climate in SAQ, demonstrate significant differences in both studies performed after, as compared to before, the reregulation, which could be attributed to less favourable conditions in pharmacies. In the SAQ study the Swedish community pharmacies demonstrated high scores for this dimension, as compared to health care settings in other countries.20 One possible explanation then was that the state-owned monopoly for a considerable time had put great effort into quality management. Thus good quality awareness, with a focus on safety issues in these pharmacies, was established.24 Obviously a change has occurred in the transition from monopoly to diversity within the Swedish pharmacy market. This might be a consequence of the main focus of the transformation of the Swedish pharmacy system being on availability to pharmacies and de- monopolization of ownership– and not on safety issues.

A more pronounced interest in patient safety and quality issues in the regulatory change process might have brought about another result. Also, the pharmacy owners’ focus on profitability rather than patient care probably has an impact on the transition outcome. According to one of the Agency reports, many staff members believe that attention has moved from pharmacy to profit concerns e.g. sale campaigns; and 45% report having too little time for dispensing, one reason being the management’s demand for selling of additional products.6 This might contribute to less time and interest spent on quality management.

The other two items are about working conditions and these results do not demonstrate any significant changes in the latest survey even though both items demonstrated significantly lower values in the first

Agency survey. The reregulation brought about a major change since many pharmacy staff had to work in new organizations with new goals and managements. Changes on both the political, i.e. changes in the system, and the organizational level can have constituted stressors for staff25 – which could explain this variation. Working conditions are settling over time and also, the staff is getting used to their change in circumstances.

The results imply that there is a change in the attitude of staff towards patient safety issues in pharmacies. One could ask if this possibly could have been anticipated and prevented. In the impact assessment that was carried out by the investigation preceding the reregulation there are few comments on safety issues. No risk analysis was performed and no reflections regarding the impact of the reregulation on these matters are to be found. With such an extensive and rapid change in the healthcare sector, there should be concerns about patient safety. If a comprehensive impact assessment had been carried out, it might have predicted the problems and difficulties that the change could entail. Re-organizing, as in this case, an entire sector within health care, obviously has effects on staff and, consequently, on patients in community pharmacies.

Limitations

The studies were carried out by different parties and had different frames for sample selections, where one study comprised all staff in Swedish community pharmacies and the other a sample of union members. However, the method, an electronically submitted questionnaire, was the same.

CONCLUSIONS

Political reforms in healthcare can have an impact on patient safety. The comparison carried out in this study indicates a negative effect in Swedish community pharmacies on safety and quality, after a reregulation of the pharmacy market. The possible effects of healthcare reforms should be assessed before implementation, in order to counteract a conceivable decline in factors including patient safety and working conditions.