Fifty-five participants took part (16 participants each in Jordan and Oman, and 23 in Kuwait). All but two interviews were audio-recorded with detailed notes taken for the remaining two. In Jordan two interviews were conducted with individuals from regional pharmacovigilance centres. Most participants were pharmacists (n = 48) and mainly employed by the pharmaceutical industry (n = 38).
The findings of the study are presented in the form of a comparison between the three countries divided into two parts. The first part covers the two dimensions of Matland's (28) model, namely the levels of ambiguity and conflict associated with the pharmacovigilance policy present in Jordan, Oman, and Kuwait. The second part covers the factors that impacted both policy ambiguity and conflict.
Factors impacting policy ambiguity and conflict
The themes extracted from the interviews are presented whilst identifying, where applicable, which group and which country they came from to allow for the comparison of the similarities and differences between them. Emerging themes were mapped onto Matland's (28) model to identify the factors and process associated with successful pharmacovigilance policy implementation in the Arab countries with better-performing systems than Kuwait.
The main themes extracted from the interviews were: political support, stakeholder involvement, training, policy characteristics, implementation planning, and pharmaceutical company-related factors. In what follows, the impact of the underlying factors pertaining to each of these themes will be first discussed as related to policy ambiguity followed by their impact on policy conflict. Table 2 outlines the effects of each factor on policy ambiguity and conflict in the three study countries.
Political support
Decision-maker (political) support was cited as a contributing factor to reducing policy ambiguity by some participants from the national and regional centres in Jordan. This view was also held by members of the pharmaceutical industry in Jordan and Oman. Participants outlined how decision-makers engaged and communicated with policy implementors throughout the entire implementation process to minimise policy ambiguity by ensuring that there was an understanding of how it was to be carried out. Participants also identified decision-makers' role in providing implementors with continuous support and encouragement which made them feel valued.
“I feel that the administration was constantly supporting us. …I never got the impression that what we [members of the National Pharmacovigilance Centre] were doing was underestimated, and they [the administration] would discuss things with us such as why certain things were done. There was an understanding.” (Participant 1, JFDA)
The situation in Kuwait contrasted with that in the other two countries as participants from both sectors pointed to decision-makers' (from the Ministry of Health (MOH) and the national drug authority) lack of encouragement or support as a barrier contributing to increased ambiguity. Moreover, it was revealed that pharmacovigilance policy implementation was the result of the personal endeavours of some of the staff at KDFCA. This lack of support resulted from what a few participants believed to be a lack of awareness of the subject of pharmacovigilance and thus the minimisation of its importance.
“People think it’s not a serious thing. I’m not supposed to mention names or something, [but] there are people in charge who think what we do is very simple.” (Participant 1, KDFCA)
Concerning the issue of conflict, political (managerial) support (from the national drug authority or the MOH) was cited by some participants (Jordan's national and regional centres as well as the Jordanian and Omani pharmaceutical industry) as a facilitator as it reduced the conflict in policy implementation means. This was evident in providing the national centre with official recognition, independence within the national drug authority's organisational structure, and binding the policy to the law (in Jordan), thus providing both the national centre with the necessary legitimacy, importance and authority to be able to carry out the implementation process. This also expedited obtaining approvals for conducting activities including training workshops, awareness campaigns, and conferences.
"In terms of [facilitators] within the Directorate, there is the support of the administration… The support of the administration is exemplified in the way they provide us with resources, or how they refine our skills, the planning, how they send us to courses or workshops related to pharmacovigilance. Another example is the director, who tries to teach us new things, keeping us updated with the latest information… So, there is communication." (Participant 10, Oman DGPA&DC)
Some participants from both sectors in Kuwait identified the lack of political will by decision-makers in the MOH towards issues related to pharmacovigilance as a clear barrier to pharmacovigilance policy implementation. Participants believed that this stemmed from decision-makers’ resistance to (or fear of) change. Examples of this included the lack of official recognition of the national pharmacovigilance centre or the lack of a statutory provision for pharmacovigilance. This pointed to the presence of some conflict between implementors and decision-makers surrounding the policy means. The belief among these participants was this was in part due to these decision-makers’ lack of understanding of pharmacovigilance's importance.
"The barriers of the implementation…the key personnel, the key personnel don’t know anything about pharmacovigilance. So that’s why I’m assuming that they will not implement such or they will not recognise such a guideline or such a mandate because of the knowledge, their knowledge. They don’t know what pharmacovigilance is." (Participant 18, pharmaceutical industry, Kuwait)
Stakeholder involvement
Many industry participants from Jordan and Oman described their collaboration with the national centre in the development of pharmacovigilance policy, and how their opinions were taken into consideration. Members of Oman's national centre indicated that members of other departments within the national drug authority were also involved during the policy's drafting and provided feedback before its finalisation. This participation had an important role in facilitating implementation through defining clear policy goals which reduced policy ambiguity. This was exhibited in pharmaceutical companies being allowed to read and comment on the policy during the drafting process. Furthermore, it was highlighted in Jordan that all key stakeholders (the JFDA, the pharmaceutical industry, and the University of Jordan) had a role to play in the implementation of the policy. Participants from Oman's national centre indicated that discussions were held with members of the pharmaceutical industry with regards to the policy before it was issued.
"In the beginning, the JFDA prepared a draft guideline, and several companies received a copy of the draft guideline and they asked us to give our opinion and if we had any comments, which we did, and they took some comments into consideration until the final guideline was published." (Participant 14, pharmaceutical industry, Jordan)
Participants from both sectors in Kuwait revealed that the pharmaceutical industry did not play a role in the policy development process. This acted as a barrier because it led to some implementors from the pharmaceutical industry viewing the policy as ambiguous due to their lack of understanding of how the policy was to be implemented (i.e., policy means).
"[A barrier to policy implementation was] The companies not understanding the guidelines clearly." (Participant 21, pharmaceutical industry, Kuwait)
Participants from Jordan also outlined the importance of collaboration between both the national centre and the pharmaceutical industry in competency building among healthcare professionals in the country (therefore reducing ambiguity concerning the policy). Jordan's industry representatives described this collaboration as important in developing a robust pharmacovigilance system.
"So, it was not only the Health Authority wanting to implement the guideline. It was done hand in hand with the marketing authorisation holders, applicants, experts, and expert working groups. There were effective communication channels, effective competency building, and all groups working hand in hand. This was the major contributor to successful implementation." (Participant 5, pharmaceutical industry, Jordan)
Many participants from both sectors shared their belief that a major obstacle to implementation was linked to healthcare professionals' (mainly in Jordan and Kuwait), the public's (all three countries), and pharmaceutical company managers' (all three countries) lack of knowledge, awareness, or understanding of the pharmacovigilance policy. They believed that these issues stemmed from these stakeholders’ perceived ambiguity regarding the goals and/or the means of implementing the policy.
"... they [healthcare professionals] don't know how to report or they don't know the importance of reporting. They're saying they don't know where to report, how to report, what they have to do if this is the case…" (Participant 7, pharmaceutical industry, Kuwait)
Like policy ambiguity, the involvement of stakeholder groups such as the pharmaceutical industry in the policy development process through providing feedback on the pharmacovigilance policy acted as a facilitator for its implementation in Jordan and Oman by reducing policy conflict. The involvement of stakeholders in this process also meant that there was an agreement between all parties involved in the policy implementation process concerning its goals and means, which contributed to a reduction in resistance and subsequent delays.
"…we [members of the national pharmacovigilance centre] discussed the subject [the pharmacovigilance policy] with the marketing authorisation [holders] and the pharmaceutical companies it was well accepted. And because whatever we mentioned in our guideline, it was discussed with them and agreed with them." (Participant 7, Oman DGPA&DC)
Most participants from both sectors in all three countries shared the belief that a major obstacle to implementation was connected to some healthcare professionals and pharmaceutical company managers' negative attitudes (or resistance) towards implementing the policy. In these cases, the policy was not viewed as a priority, but instead as an added burden that these stakeholder groups were forced to take upon themselves (i.e., conflict on policy goals and means).
"Maybe [one of] the barriers, [is] the company. Maybe in the beginning they were not very aware of the importance of pharmacovigilance in the companies. Because it's not stopping registration or marketing of any product. So, for the companies, it was not a priority to have a pharmacovigilance team in their companies." (Participant 8, pharmaceutical industry, Jordan)
Training
Many industry participants in Jordan and Oman cited the training provided by members of the national centre in these countries to implementors as a facilitating factor, which made clear what was expected of them and thus reduced policy ambiguity. It was also mentioned that this training helped increase awareness regarding pharmacovigilance in the country, which in turn helped policy implementors develop a better understanding of the policy's goals and its means of implementation.
"…the authority had several workshops teaching the companies how to prepare a PSMF [pharmacovigilance system master file], a PSUR [periodic safety update report]. I think that also they had several workshops for healthcare professionals about pharmacovigilance, its importance, how to implement it, they tried to help people to some extent." (Participant 14, pharmaceutical industry, Jordan)
Unlike in Jordan and Oman, participants in Kuwait indicated that implementors from the pharmaceutical industry did not receive training regarding the policy, which acted as a barrier to implementation. This contributed to policy ambiguity as some of the companies operating in the country did not have enough knowledge concerning the policy, which resulted in them delaying their implementation of the policy.
"We need to know from where to start, for example, where does the reporting cycle start? We see all this on paper, but we haven’t yet actually implemented this into practice, nor do we know how to implement it. When they [the authority] issue guidelines they should be cooperative with us so that we can understand and implement." (Participant 5, pharmaceutical industry, Kuwait)
A perceived barrier to implementation cited by a few national centre participants in both Jordan and Oman was the lack of experience in pharmacovigilance of many of the centres' employees. This resulted in a perceived policy ambiguity among some implementors given their expectation that it was the duty of members of the national centre to explain and provide them with training on implementing the policy.
"… as a department it’s only been working since 2014 so we’re not talking about a long time. So, most of us [national pharmacovigilance centre staff] do not have that much experience. So, the low experience may be a reason [for difficulties in implementation]" (Participant 2, JFDA)
Interestingly, none of the participants cited training as a factor impacting policy conflict.
Policy characteristics
Participants in all three countries pointed to the nature of the policy itself as a facilitating factor for policy implementation. Members of the national centre and pharmaceutical industry in Jordan and Oman pointed out that the policy was written in a manner that made it easier for implementors to understand its purpose and its means of implementation. It was also emphasised that the level of detail present within the policy helped reduce ambiguity. In the case of Jordan, this was aided by the JFDA's creation of checklists to accompany the policy, which covered and simplified implementation. In Oman, this was enacted by the creation of a national abridged version of the original Arab GVP guideline. These factors made the policy practical and thus easy to implement.
"…when we [members of the national pharmacovigilance centre] developed our own summarised guidelines this process [implementation] became easier; we were able to communicate properly with the companies. We were able to understand the companies and they were able to understand us." (Participant 1, Oman DGPA&DC)
"It [the policy] is a simplified version of the Arab GVP guidelines. The companies have informed [us] that it is quite to the point and simple." (Participant 14, pharmaceutical industry, Oman)
Some industry participants from Kuwait noted a lack of clarity in the policy (i.e., policy ambiguity) which meant that companies were uncertain on how to proceed with implementing the policy. Participants from Kuwait noted that the country's policy lacked enough detail regarding its means of implementation (e.g., if medication errors were to be reported) and that there was inconsistency in the information being provided to them (e.g., submission of Periodic Safety Update Reports (PSUR)/ Periodic Benefit-Risk Evaluation Reports (PBRER) for generic products). The result of this was that companies were individually implementing the policy based on their own beliefs on what was required of them, hence leading to variations between them.
”…. the guidelines are not very clear for Kuwait, it’s like all over.” (Participant 10, pharmaceutical industry, Kuwait)
“Sometimes I get a question about the PSURs for generics. In the EU [European Union], we don’t have to submit PSURs for generics, but in the Arab guideline it is mandatory. So, who should we follow?” (Participant 21, pharmaceutical industry, Kuwait)
As was the case with policy ambiguity, participants noted that the nature of the policy also impacted policy conflict. Participants in the three countries stressed the importance of the policy's compliance with both the Arab GVP guideline and the European GVP guidelines, which it derived from, as an important facilitator.
This meant that the goals of the policy were aligned with those of regional and international guidance, which were centred on drug safety and hence decreased the likelihood of conflict occurring due to stakeholders' differing views.
"I agree with them [the policy goals], yes, because actually, these are international guidelines. We are not drafting something new. It is all adopted from international guidelines. There are of course certain things that might be customised according to the country, and I agree with them." (Participant 10, pharmaceutical industry, Jordan)
A few participants in Jordan and Oman described how the tailoring of the national policy according to the country's capabilities also acted as a facilitator for policy implementation by reducing policy conflict around its means of implementation. Participants elaborated by indicating that this was done through incorporating only those aspects of the Arab GVP guideline whose implementation was deemed achievable (when considering the local conditions) into the national policy. Participants from Kuwait also cited this factor as acting as a facilitator in reducing conflict associated with policy implementation despite its limited scope.
"I have seen countries who have implemented very vast guidelines, but they don't know what is in it. So, some countries are... I mean their structure is not capable of implementing those guidelines which already stated to be in place. Whereas in Oman it is not the case, their team have studied [the Arab GVP guidelines] and they have taken only the things that they can implement in this stage." (Participant 9, pharmaceutical industry, Oman)
Implementation planning
Only participants from Jordan indicated that decision-makers in the country set up a formal working committee that was tasked with developing the operational aspects of the pharmacovigilance system. Therefore, an implementation plan was laid out whereby it was made clear to implementors how, when, and what aspects of the policy were to be implemented at a particular point in time, and that this facilitated implementation by reducing ambiguity. Although participants in Oman did not indicate the establishment of a formal working committee, it was pointed out that there was a constant line of dialogue between the industry and the national centre during the different stages of the implementation process.
“They [the national pharmacovigilance centre] first of all they started by insisting that you had to have as a company a pharmacovigilance department, not a department as such, but activities, and then you had to have a master file, and then, later on, they said that you should have a resident Omani pharmacist as a local safety person in Oman…" (Participant 3, pharmaceutical industry, Oman)
Another facilitator described by participants from both sectors in Jordan was the national centre carrying out pharmacovigilance inspections both during the initial stages of the policy implementation and once the policy was fully implemented. This helped reduce policy ambiguity among implementors from the pharmaceutical industry since it allowed members of the national centre to not only monitor but also assist pharmaceutical companies to ensure proper implementation of the policy.
"In Jordan, they were able to accompany most of the companies and to provide them with guidance. For a while, maybe a year or two, even when they would say they were coming for an inspection; it was not so much an inspection as it was an assessment of the situation while providing guidance or recommendations…" (Participant 14, pharmaceutical industry, Jordan)
In contrast, there was a consensus among participants from Kuwait that an implementation plan was lacking for the KDFCA in implementing its policy, which acted as a barrier to implementation by causing ambiguity to companies in terms of how the policy was to be implemented.
"No [there were no steps taken from the authority with regards to the implementation of the policy], they just issue the policy, and they say, effective so and so date and we have to adhere to that." (Participant 10, pharmaceutical industry, Kuwait)
According to participants from both sectors in Jordan, a gradual implementation of the policy which involved not mandating policy implementation on all companies (particularly those with little experience in pharmacovigilance) from the outset facilitated implementation by reducing conflict. It was explained that a stepwise approach, whereby aspects of the policy which were more achievable (e.g., developing a PSMF and ADR reporting forms) were focused on in the beginning, gradually moving onto more complex aspects (e.g., preparing PSUR/PBRER), thus resulting in a smoother implementation process due to reduced conflict between stakeholders around the policy means.
"…they [the national pharmacovigilance centre] were not tough from the beginning in that they published the guideline today and then required that they be implemented within the next month; they gave the companies sufficient time to have a PSMF, to know how to fill out the form, to adapt the timelines, all of these things." (Participant 14, pharmaceutical industry, Jordan)
A few participants from Kuwait's pharmaceutical industry viewed the national drug authority's failure to provide them with an adaptation period before implementation of new policies as a barrier. These participants revealed that they were not provided with an adequate timeframe to allow for adjustment to ensure proper implementation which points to conflict among implementors around the means of implementation. This contrasted with the situation in Jordan and Oman where participants from both sectors indicated that companies were afforded an adjustment period for policy implementation and the absence of policy conflict.
"In general, in Kuwait, the barriers would be that they impose things without giving a grace period. In other countries, when a new guideline is issued, they inform you that implementation will start from a certain date. They give you a grace period to prepare yourself." (Participant 5, pharmaceutical industry, Kuwait)
Despite indicating the presence of an implementation plan, most participants from Jordan's national centre, as well as a few from the industry, identified the absence of funding as a barrier and a source of incompatibility of stakeholder views surrounding policy means resulting in policy conflict. This hampered efforts in building awareness and conducting training workshops for stakeholders. In contrast, most participants from Oman and Kuwait did not highlight the issue of funding as being a factor indicating the absence of policy conflict.
"At the end of the day you are in the governmental sector, and in this country, we don’t have resources allocated for pharmacovigilance to promote awareness or other things that we need. We found solutions by forming collaborations with stakeholders, drug manufacturers and drug agents to do such events in Jordan." (Participant 7, JFDA)
Company-related factors
Participants from both sectors in all three countries, particularly those from the pharmaceutical industry, believed that being a multinational company with experience operating in developed countries where pharmacovigilance policies and regulations were more stringent acted as a facilitator. Similarly, it was viewed that for local companies to have a licensing agreement with multinational companies made policy implementation easier due to them benefiting from having clauses in their agreements that required them to have standards in place on par with those of the multinational. This meant that there was less ambiguity due to the presence of a degree of familiarity with the guidance and hence policy implementation proceeded more smoothly.
"…most of the points that are in the [Arab GVP] guidelines it is already implemented by the multinational companies because it is part of the European guideline, so it was easy to implement by these pharmaceutical companies." (Participant 7, Oman DGPA&DC)
Some of Jordan's pharmaceutical industry participants and a few of Oman's pointed to the lack of harmonisation among Arab countries in implementing the guideline on GVP for Arab countries as part of their national policies. This lack of harmonisation meant that each country in the region had its own set of rules and guidelines extracted from the same source, which confused companies operating in multiple countries in the region. This represented a source of conflict between the companies and the national pharmacovigilance centres.
“Sometimes external regulatory authorities having different requests acts as a barrier. There is a unified guideline, but no unified actions. So, we have the same guideline, but different requests, regulations in each country." (Participant 15, pharmaceutical industry, Jordan)
Table 2
Factors impacting policy ambiguity and conflict
| Ambiguity | Conflict |
| Jordan | Oman | Kuwait | Jordan | Oman | Kuwait |
Political support | Decrease | Decrease | Increase | Decrease | Decrease | Increase |
Stakeholder involvement | Decrease | Decrease | Increase | Decrease | Decrease | Increase |
Training | Decrease | Decrease | Increase | N/A | N/A | N/A |
Policy characteristics | Decrease | Decrease | Increase | Decrease | Decrease | Decrease |
Implementation planning | Decrease | Decrease | Decrease | Decrease | Mix | Mix |
Company-related factors | Decrease | Decrease | Decrease | Increase | Increase | Increase |