Saturation of the data collection was achieved after 20 interviews and further three interviews were conducted for assurance. The semi-structured interviews (n = 23) were carried out as per the study plan. The characteristics of participants are presented in Table 1.
The data analysis identified three significant themes: (1) Enablers and barriers faced by pharmacists in promoting safe utilisation of DOACs; (2) Factors related to other healthcare professionals (HCPs) and to the patients; (3) Strategies to promote DOACs safety. Figure 1 represents an overview of the themes and subthemes.
1. Pharmacists as a facilitator for DOACs safety
Participants described pharmacists acting as a source of information, assist other HCPs in decision making and offering assessment of bleeding risk assessment, managing anticoagulation clinics amongst many other diverse ranges of roles described.
Study participants revealed that as drug information pharmacists, they provided information about DOACs by answering related questions in addition to their role in providing formulary decisions that have an impact on the use of DOACs and their safety.
“Mainly drug information pharmacist so, I deal with mostly questioned related to DOACs …… and also was involved in formulary decisions related to DOACs. Those are my main two encounters so, questions received in the drug information centre and, during discussion for formulary addition.” Participant 8, pharmacist (Riyadh)
Participants further illustrated conducting appropriate risk assessments to help improve safe DOACs prescribing.
"Again, you have to conduct a reasonable risk assessment, bleeding versus thrombosis risk assessment, based on the given scenario and, there is nothing to say this is non-essential, you have to include all related information. Once the assessment is done, risk assessment has been complete and appears in front of you, I think you can then prescribe DOACs safely. Without this assessment, which is absent in many cases I've seen, they never do it, you cannot really give a reasonable choice among them." Participant 2, pharmacist (Dammam)
Many participants described undertaking dosing adjustment based on patient’s renal function tests to recommend continuation, adjustment, or discontinuation of DOACs.
“….one of our roles as clinical pharmacists is to usually get questions like renal dose adjustments, when can we minimise, dose based on creatinine clearance (CrCl)and when to hold and when to resume and how to dose based on indication” Participant 8, pharmacist (Riyadh)
As members of the drugs and therapeutics or formulary (DTC) committee, many participants had taken important roles in developing hospital formulary which included recommendations to HCPs on evidence-based use of DOACs. Participants also suggested that many played a vital role in patient counselling process especially during discharge. Pharmacists provided information on proper use of DOACs drugs and how to deal with missing doses.
",,,,I'm working in the team named discharge medication counselling team since 2012. So, I'm just dealing with the patient at discharge from the ward, going home, with their DOACs medication, home medication also from the clinic, from the anticoagulation clinic, and counseling patient for each drug dispensed and give full instruction to patient on how to use the drug, when, and what to do if any dose was forgotten, not taken or when buying any drug from OTC that can lead to increase bleeding ,,," Participant 4, pharmacist (Riyadh)
Participants discussed that clinical pharmacists managed pharmacist-led anticoagulation clinics where they provided recommendations on switching patients from warfarin to DOACs, follow up of patients, assess their risk for bleeding or coagulation, and counsel them on the appropriate use of such drugs during discharge.
2. Barriers faced by pharmacists in promoting safe utilisation of DOACs
Pharmacists identified that lack of knowledge of dosing guidelines and information related to DOACs as key barriers that might lead to errors while using these drugs.
",,,Honestly, I'm unfamiliar with all DOACs dosing unfortunately but, in some cases I need to be more careful and DOACs dosing in some cases are not mentioned in the guidelines in addition, the guidelines are not clear enough for me..."Participant 9, pharmacist (Riyadh)
Many reported that effective reporting and follow up systems were lacking. They described that underreporting of DOACs related errors were common. Factors such as lack of time, workload, bored, or just careless attitude were often the reasons for underreporting of DOACs related safety issues.
"Regarding reporting any incident in safety reporting system in our hospital, to be honest, I don’t do it. Why I didn't do that because I don't have time, or sometimes I feel lazy to do this, to be honest." Participant 4, pharmacist (Riyadh)
Pharmacists revealed that unlike warfarin, DOACs lack monitoring tools or criteria for dosing. Moreover, availability of antidotes to counteract the overdoses of these drugs was another problem that hindered the safe use of DOACs.
"I am feeling high responsibilities but, it is not like warfarin. Why? because there is no monitoring criteria for test unlike warfarin “INR”” Participant 1, pharmacist (Jazan)
Participants discussed the impact of patient education and adherence to DOACs on medication errors.
"I' definitely haven't done patient counselling since very, very long time but, if I were to, to put an ideal, way in counselling, I am worried if the patient is adhering to medications or not, but I always like to describe what the drug does. I think that, that really sinks in with the patient. So, just let them know what this drug is for to help them in continuing and adhering to the medication, and then also describing very carefully what are the side effects to look out for and be careful about and, finally, definitely, are things that can increase the risk of bleeding. So, drug interaction and, any surgeries or, any encounters with other healthcare providers, that they should know, he's on this." Participant 8, pharmacist (Riyadh)
Theme two: Factors related to other healthcare professionals (HCPs) and related to the patients
1. Factors associated with HCPs
While many described experiences of positive multidisciplinary working, some participants described that physicians do not accept their recommendations offered to them after medication review.
“….other thing, even the, the resistance from the physician side, when we contact him, he refuses to keep this medication as discontinued so, I feel under pressure if I will review that order, maybe the nurse will give it to the patient, or if I will not review it, maybe also the patient get harm if this medication not administered to him after the OR” Participant 3, pharmacist (Riyadh)
The participants further identified that knowledge regarding the clinical protocols and guidelines was sometimes lacking, particularly amongst physicians.
“Yeah, some of the physicians do not collaborate with pharmacists especially when catch dosing error we show them and sometimes if, I show them in the intranet how to get to the protocols and guidelines, some of them, they don't know that there is a guideline protocols for each medication, so I show them because, if, if there's any mistake happen, then they will be, they will go back to this protocol and these guidelines, regardless of the reference he has.” Participant 7, pharmacist (Riyadh)
Participants further illustrated that the nurses’ role should be further emphasized. Education and training about identifying side effects of these drugs was important as they closely monitor the patients.
“Now, if I'm teaching the nurses … on the importance of my checking, check, double check … monitor the patient for any signs of bleeding, because we need to teach the nurses on the side effects, more than the indication, because they are assessing the patient monitoring the patient vital signs and lab.” Participant 1, pharmacist (Riyadh)
2. Factors associated with the patients:
Pharmacists discussed that medication related errors could be serious or even fatal if patients do not understand dosing information. These were deemed important especially when the patients were switched from one anticoagulant to the other.
“...so, sometimes the patient, and when we shift him from one anticoagulant to another and he continue to use both.” Participant 2, pharmacist (Riyadh)
Pharmacists identified that medical history should be clear to avoid prescribing DOACs to those who have comorbidities or contraindications to these drugs.
“Wrong patient criteria, for example, patient has advanced liver disease and was prescribed DOAC.” Participant 2, pharmacist (Riyadh)
Many noted that patients often develop knowledge on DOACs through their own experiences of use.
“Yeah, of course, patient more experienced with the medication, it will minimize the error. if the patient has used DOACs drugs for long time and he/she knew what is that medication used for and what side effects may happen.” Participant 2, pharmacist (Riyadh)
Pharmacists discussed the importance of effective communication with patients in minimising errors. They reported that it was difficult in some situations where patients were not able to communicate with pharmacists because of mental health disorders, cognition impairing diseases, being stressed by pain or depression, in addition, to illiteracy and clinical situations. Some also noted that there was often reluctance in some patients to discuss medication related issues with a pharmacist.
"I think the most important thing where we have to give them counselling with full information regarding this medication. But some patients refuse and want to get the medications without counseling especially elderly patients, in our culture, the elder patient is not willing to listen or to learn anything about his/her medications….” Participant 4, pharmacist (Jazan)
Theme 3: Strategies to promote DOACs safety
When asked about their recommendations to minimize these medications-related errors, participants reported that reviewing medications by a clinical pharmacist, dose adjustment according to indication and renal function, careful assessment after taking patient history, risk assessment for bleeding tendencies, providing patient education and continuous monitoring for patients after receiving the drugs were effective strategies to minimize errors associated with DOACs use.
",,,the clinical pharmacist should review the dosing after physician prescribed because some of the physicians they are not aware of the dose adjustment in case of renal impairment, also, some of the patient, the doctor, they don't know that the, the dose is different of the same, same medication, the dose is different according to the indication. For example, pulmonary embolism or, venous embolism dose for rivaroxaban is different than the, an AF patient. Its very important to do carful assessment of right indication for patient before prescribe drug " Participant 4, pharmacist (Jazan)
Pharmacists also revealed that nurses can play a major role in prevention of errors by double checking DOACs orders. They described that five patient’s rights (the right patient, the right drug, the right dose, the right route, and the right time) should also be evaluated for DOACs users.
"the nurse should perform independent double checking, it is very important, especially for this high alert medication for indication and dose and strength and time (5 rights) once she want to administer DOACs to the patient" Participant 2, pharmacist (Riyadh)
Multidisciplinary teams in which different HCPs work together to carefully assess the patients’ cases and decide whether a patient would be a candidate to receive DOACs safely would also minimize errors.
"I think, forcing implementing the multidisciplinary approach is the number one goal to, to minimise the prescribing errors." Participant 2, pharmacist (Riyadh)
Pharmacists demonstrated that research is important to generate evidence regarding DOACs prescribing for new patient populations such as COVID-19 patients. Having strong evidence to prescribe such drugs is essential before using them.
"Sometimes physicians don’t have any strong evidence, e.g: the doctor prescribe DOACs for post-COVID patient but, they don't have any strong evidence regarding to those thing, like they, they said we have to give the patient the, the rivaroxaban or apixaban for maybe three or four weeks, post-COVID and they don't, they don't have strong evidence regarding to those medication and we had a lot of discussion regarding to those thing. I mean, like, I, I told them, you have to have strong evidence and if you give the patient new oral anticoagulant, okay, and they sometimes dispense those things for the, the COVID patient and they were wondering about the risk of pulmonary embolism, and they usually give DOACs." Participant 2, pharmacist (Jazan)
Participants discussed that identification of patients on DOACs by having specific cards to show to healthcare providers can help in receiving proper anticoagulation care and minimize medication errors. Participants also described that medication reconciliation is another high priority strategy that should be in place by pharmacists to combat this problem. This can help identify patients at risk and DOACs associated medication errors and prevent them.
" ,,,,,I believe the reconciliation is a very high priority when it comes to catching these kinds of errors. So, if we have proper reconciliation so, upon admission, upon discharge, you make sure that the patient has been taking, er, what he's admitted with and what's he taking from other institutions, as long as you have that very good screening, er, you can pick up that kind of medication errors and, I think of our most risky ones that can happen." Participant 8, pharmacist (Riyadh)
Interviewees identified that improving clinical decision support systems to alert, not only physicians during prescribing, but also pharmacists and nurses would be beneficial when dispensing and administering DOACs for patients at high risk.
"If we goanna solve the medication error first must look to the root of this incident, we need to do modification in the electronic system itself. So, if the physician wants to order medication that, it's restricted and, he wanted to be on hold, they, they need to add a function in the system as a hold order. So, once he prescribes it, it will show to the pharmacist like an icon or alert, this medication on hold. So, for me, I will know that the patient will not receive it. Even the nurse, she will not administer to the patient. So, once I review it, it will, no label will be printed for me so I will not dispense and even for the nurse side, it will alert her that this medication should be on hold, after two days you can resume it to the patient." Participant 8, pharmacist (Riyadh)
Pharmacist raised the importance of improving the working environment and decreasing the workload to provide enough time for more attention and care for patients. Heavy duty shifts and busy areas in the pharmacy can affect safety of those patients negatively.
Participants discussed that encouraging HCPs to report errors associated with DOACs is needed. Safety culture of reporting should be augmented, and the reporting system should be simplified to save time and facilitate reporting.
"And let me tell you things about minimizing the error. Now, when it comes to reporting the error. Everybody is reluctant to report. The incidence, everybody is reluctant to report the error. So, at the end of the road, we cannot learn from our mistakes. So again, institution needs really needs to implement safety culture for reporting need to have better system for reporting. I'm talking about our institution; the reporting system and our institution is very good system. Yes, it's very sophisticated and it took from me almost 45 minutes to report the incidence and this will take from my time." Participant 1, pharmacist (Riyadh)
Interviewees identified that improving awareness and enforcing strict follow up for institutional guidelines would help HCPs during prescribing and distributing DOACs especially if they are integrated in the electronic order entry system in Saudi Arabia Hospitals called computerized physician order entry (CPOE).
"Well, I believe that, first, there should be a strict protocols and guidelines, and this should be disseminated to all care providers, so they would know what the policy and educational activities is should be also done to them so they will know what's the policy."Participant 7, pharmacist (Riyadh)
Participants indicated that empowering clinical pharmacists to perform their daily tasks in dealing with these high alert medications is very critical. Pharmacists run the anticoagulation clinics, contribute to identifying major adverse effects of these drugs, communicating them to other healthcare providers in the team, follow up of patients and readjust doses based on the patients’ kidney function could also help in minimizing potential DOACs-related errors. Therefore, contacting clinical pharmacists by physicians before prescribing such drugs was deemed very important.
" I will ask the clinical pharmacists to stay in morning round and in the anticoagulant, since I told you it's role of clinical pharmacist who going to follow case, like a checklist during the counselling the patient regarding his medication and sometimes readjusted the dose of DOACs and monitoring the Crcl daily and discussed with physicians regarding and case” Participant 6, pharmacist (Dammam)