SPEAKER_01 0:08

Welcome to Drug Safety Matters, a podcast by Uppsala Monitoring Center, where we explore current issues in pharmacovigilance and patient safety. The loss of vital health records is a universal problem for refugees. When their medical information goes missing, patients are less likely to receive the care they need and more likely to be prescribed the wrong treatments. Thankfully, the International Society of Pharmacovigilance Egypt chapter and the Palestine Red Crescent Society are taking on this problem to reduce medication errors and improve reporting practices. I'm your host, Federica Santoro, and this episode is part of the Uppsala Reports Long Reads series, where we select the most topical stories from our magazine, Uppsala Reports, and bring them to you in audio format. Our pick for today is Egypt Addresses Safety Issues Faced by Refugee Community. Written by Mohammed El Awari, Islam Ali and Hadir Rostom. The article appeared online in October 2021. After the read, I sit down with two of the authors, Mohammed and Hadir, to find out more about medicine safety in the refugee community. So make sure you stay tuned till the end. But first, let's hear the article. When it comes to providing complete patient medical information at the point of care, we continue to find a significant number of referrals associated with preventable medication errors. In particular, we see this among Palestinian refugees who fled or were driven from their homes in the Gaza Strip to Egypt, seeking medical assistance or primary health care facilities. Much of the support for the registered Palestine refugee population in Egypt is provided through the Palestine Red Crescent Society, whose Egypt branch operates Palestine Hospital in Cairo. But for these patients, the paper-based referral system makes it quite difficult for primary care providers to follow up on referral letters to specialists, to ensure better care coordination between providers, and to improve the overall effectiveness of the referral tracking process. One of the hindrances to instant communication of patient information is the confusion provoked by perpetual and severe shortages in medications. These shortages jeopardize the life of patients in the Gaza Strip and may give rise to medication errors, adverse drug reactions, or other complications. Though there is plenty to list, the potential risks that medication shortages pose to patient safety include non-optimal or analog substitute of the same medicine entity being dispensed. Furthermore, Palestine hospital healthcare workers who are unable to access an easy-to-find, clear, and comprehensive patient medical information can face confusion about or misunderstand the distinct difference between adverse patient outcomes of analog alternatives and adverse reactions related to comorbid conditions. The current conditions also mean that medication errors are more likely to occur at all stages, from injecting the medication into the wrong route or administering excessive doses of an agent, through to prescribing an incorrect drug that is less effective, has a worse adverse effect profile, or involves a complex dosing schedule. Movement restrictions on medical supplies to the Gaza Strip have also exacerbated pre-existing conditions, such as inaccurate substitutions of home medication regimens and administration of out-of-date or expired medicine that jeopardizes patient safety. Power outages in Gaza also continue to disrupt essential health services for at least two million Palestinians, including the stability of vaccines and other pharmaceuticals. With medication errors and adherence challenges faced by patients from refugee backgrounds gaining greater recognition as an integral component of patient safety culture, the Egypt chapter of the International Society of Pharmacovigilance, or ISOP, organized a medication errors training course targeting hospital pharmacists. The designated workshop, held in January 2021, aimed to raise attention to the problem of medication errors and highlight the potential contributing factors. In addition, it focused on equipping healthcare providers with the knowledge and skills to conduct an operational assessment, evaluate potential impact on patient care, and ultimately use their investigation to develop a risk reduction strategy. After attending the training course, the pharmacy department in the Palestine Hospital decided to put the lessons they had learned into practice. This led to an effective initiative to tackle potential medication-related errors by creating an executable framework and a well-defined therapeutic management strategy. The action plan adopted by the Palestine Red Crescent Society to improve patient safety aims to facilitate improvements in ordering, receiving, dispensing, and supplying medicines. It also addresses the challenges of providing humanitarian aid to thousands of patients living with disabilities. In the context of accurate medication use and decreased errors, the ISOP Egypt chapter engaged in developing a streamlined electronic health record software that renders patient medical information, including medical history, previous surgeries, treatment plans, and other data, available instantly to Palestine hospital health care workers and Palestine Red Crescent Society branches in Jordan, Lebanon, and Syria. As such, the management of patient clinical data, derived largely from internal event reporting and conceived to substantially improve a hospital's medication safety, would result in better care coordination of strategies in both the inpatient and outpatient settings. Project activities include identifying and addressing gaps in the development of an information technology infrastructure to support and leverage utilization of electronic health records, determining effective data collection and processing techniques, deciding on different types of coding schemes to represent data, evaluating a cluster of individual case safety reports in a particular database, and integrating the drug safety information obtained, promoting systems-based drug safety, involving patients in treatment-related decision making to improve health outcomes through the development and implementation of educational programs geared towards stakeholder engagement. All in all, administrative staff in charge of entering patient data into the medical records were trained on how to manage databases to store and retrieve data, whereas selected members of clinical staff were instructed on how to interpret information about an aspect of patient care and to look at the prevalence and effectiveness of their designated treatment. The application of a robust computerized medication errors reporting system has been deemed successful as a means of capturing and disseminating information on safety events rapidly and in real time. Palestine hospital healthcare providers, along with administrative staff, should continue to preserve their capacity for effective adaptation in terms of coping with changing technology trends and investigating new approaches to drug safety. Mohammed is a pharmacist at the Egyptian Ministry of Health and a research assistant at the Faculty of Pharmacy of Ayn Shams University. He also does volunteer work at the ISOP Egypt chapter. Hadir co-founded the pharmacovigilance system in Egypt and is now a pharmacovigilance consultant for the World Health Organization. She is also a pharmacovigilance lecturer at MSA University and president of the ISOP Egypt chapter. I hope you'll enjoy our chat. Hi Hadir and hi Mohammed. Welcome to Drug Safety Matters. It's a pleasure to have you on the show with me today. Mohammed, why don't we start with you? Tell me more about the Palestine Red Crescent Society and how you came to collaborate with them.

SPEAKER_02 9:57

Actually, Palestine Red Christian Society is a humanitarian organization that is part of the International Committee of the Red Cross in Geneva. They provide hospitals, emergency medicines, ambulance services, and primary healthcare centers in the West Bank and Gaza Strip. They also have branches where there are gatherings of Palestinian refugees in Lebanon, Jordan, Syria, and Egypt. Here in Egypt, they are operating one hospital in Cairo called Balestine Hospital. I worked actually for two years in this hospital as a clinical pharmacist after my graduation, before moving to work in the Egyptian Ministry of Health. The hospital is completely managed by Balestine Christian Society, but the medical staff are Egyptian, as in Egypt you must have a license to legally practice any medical profession. And when Dr. Hadir told me about the medication error training, which will be organized by Eyes of Egypt chapter, I directly told my colleagues in the pharmacy department and we were very excited to attend that training. Especially the trainers are international experts, and after the training, we decided to put the lessons we had learned into practice to manage the safety issues in our hospital.

SPEAKER_01 11:07

What are the most frequent causes of medication errors in this particular refugee community you've been working with? Maybe you identified some systemic problems.

SPEAKER_02 11:20

Actually, all the refugees who come to Egypt seeking medical assistance are from Gaza Streb. And the problem can be summarized in two main reasons. The first one, the frequent power outages that affect the availability of thermosensitive drugs like insulin and vaccines. And I think everyone knows that the vaccine storage must adhere to specific conditions, and if not done correctly, it can result in an adverse event. And the second reason, in my point of view, is the medicine shortage, which caused several risks, including have to use expired medicines or alternative analog. Because we found many risks occur if the alternative medication is not well documented in the patient records or in the referral forms. In another word, I want to say if the physician doesn't have full details about the patient medications, the doctor may not be able to make the right decision for that treatment. And I think the electronic health records software which we established in Palestine hospitals helps the health care professional to detect the optimum diagnosis by giving the doctor full details about the patient medication and their previous clinical history.

SPEAKER_01 12:34

So there's a bunch of different challenges that need to be addressed. But the first thing you did was to organize a training on medication errors for hospital pharmacists. Hadir, why was that important?

SPEAKER_00 12:48

So, as you know, Federica, that pharmacovigilance in its expanded scope is concerned with what might affect patient safety while they are using medicinal products. And of course, these include medication errors among its scope. So, unlike adverse drug reaction, hospital pharmacists can play an important role in analyzing and mitigating the medication errors because the root cause for having such errors markedly differs from one setting to another. And also the suitable measures to mitigate these medication errors will again differ depending on the root cause. So that's why training for hospital pharmacists was very important to make them able to identify the medication errors that might happen in their organizations or their settings and adopting suitable mitigating strategy. And another important point was intended from this training is to raise their attention to the role of pharmaceutical companies that they can play in this era. Because as a part of the risk management plan, when the product has a potential for medication errors, this should be considered by the pharmaceutical companies and they should adopt measures to minimize such risk from this medication error. And this might, for example, include some educational materials directed to the healthcare professionals. So again, this raises the importance to bridge the role of the institution itself and the role of regulatory action taken by the authority as well as the role that can be played by the pharmaceutical company to make this bridge all it was an intended outcome from this training.

SPEAKER_01 14:39

Where do patients fit into the equation? Because you write that involving patients in treatment-related decision making is a key factor. But realistically, how do you make sure that patients remember the important information about their drugs when they leave the hospital? And I'm guessing this will be especially important for refugees who might have experienced bad use of medicines before. So are you planning any similar training initiatives for patients?

SPEAKER_00 15:12

Yes, I agree with you that consideration for the patient is very important. However, regarding the training for patients, not for the current stage, because it's very important to get healthcare professionals well trained first and consequently they will play a role in training patients during their clinical practice. So, yes, there is a consideration to conduct training for the patient, but not at the current stage. And for the patient, how can they memorize the instructions for their medicine, especially for patient the discharge of inpatients? They got written instructions on how to use their medicines. So this I think will help. And again, back to the idea of the risk management plan, some of the materials developed by the pharmaceutical companies are intended to be delivered or handed out to the patient for their guidance while they are at home using their medicine.

SPEAKER_01 16:17

And all this new knowledge you're generating on medication errors in the hospital setting, how do you make sure this is continuously made available to healthcare professionals? So basically, how do you keep them up to date?

SPEAKER_00 16:32

Here, the communication of such information to healthcare professionals can take two different levels. The first level is within the hospital itself, because as I told you, the hospital itself, depending on what medication errors they capture and what is their root cause and how they should mitigate such medication errors, so there will be internal dissemination of the communication within the hospital. So this will be the first level. And another level is when these uh medication errors and the consequent adverse outcome resulting from such errors reported to the pharmacovigilance center or reported to the pharmaceutical companies and then to the pharmacovigilance center, and when it necessitates having a regulatory action and to generalize this action to other hospitals, so here there is a second level of communication delivered from the pharmaceutical company in coordination with the regulatory authority in the form of direct healthcare professional communication or again in the form of additional risk minimization measures like prescriber guide or prescriber checklist or something like that. So the safety communication of the information here comes in these two levels.

SPEAKER_01 17:53

Thank you, Hadir. Mohammed, back to you. You write in the article that the computerized system for reporting medication errors has helped to disseminate drug safety information in real time. Can you give me some examples of that and how the system has helped prevent harm to patients?

SPEAKER_02 18:14

In Palestine Hospital, the majority of medication errors are revolved around prescribing and dispensing. For example, sometimes there is not enough time to make counseling between the patient and the health care professional, and this may lead to the confusion about the administration route, like swallow chewable tablets. And I think the system solved such problems by making sure the order is legal and complete, including all the necessary information such as the optimum dose, the right administration route, and patient instruction sheet. In addition, the system can make a checkup for the drug-drug interaction and drug laboratory interaction and alert the prescriber if needed.

SPEAKER_01 18:57

Hadir, what is the role of pharmacovigilance centers in all this? Have they been involved in analyzing the electronic health records you helped implement?

SPEAKER_00 19:07

So for the role of the pharmacovigilance, uh the analysis of the data captured at the hospital level, it will be the main responsibility of the hospital. However, they report the adverse outcome resulted from these medication errors to the pharmacovigilance center to be handled on the national level.

SPEAKER_01 19:25

What would your suggestion be then for health systems that cannot afford similar high-tech solutions? So, in your opinion, how do you go about preventing medication errors in a low-tech setting?

SPEAKER_00 19:41

I think it will be a little bit challenging because such technologies facilitate the capturing of the information and facilitate the tracking. And also in the first place, it facilitates preventing such medication error from uh from happening in the first place. So technologies are very important in the whole era. However, the list is better than nothing. So if such technologies is not available or if it is not affordable, I think that hospitals can depend on some simple tools like Microsoft Access tool or qualified spreadsheets, this can help. And one important criteria here in preventing medication error is a good recording of the patient information and good recording of all of his medication and the full history of all the investigation done to the patient. So having this data recorded in a patient-centric way, even though if there is no electronic system, but it will be important to have this pool of information for a specific patient.

SPEAKER_01 20:50

I'd like to go back now to a point you raised in the article and that you also raised earlier in this interview of monitoring the safety of medicines in challenging conditions like the ones refugees live in. When medicines aren't easy to access, medicine safety often becomes an afterthought. And many would argue there's no point in even watching out for side effects if people don't have the medicines they need in the first place. But you would actually argue the opposite, that medicine shortages can and often will harm patients. Mohammed, can you tell me a little more about this?

SPEAKER_02 21:31

Well, safety monitoring is a priority in all conditions because even if there are shortages of medicines, this may lead to adverse events by miscommunication between the patient and the healthcare professional, as we see in the example in Uppsala Rebort article, how when the doctor became unable to differentiate between adverse patient outcome of the analog alternatives and adverse reactions related to comorbid conditions.

SPEAKER_00 21:57

In addition to the points raised by Muhammad, in my opinion, even when there is a shortage of medicine, safety monitoring is crucial. It's not a luxury because when there is a shortage, then we should focus on reserving our resources. And having adverse reactions due to a shortage of medicine, this will make the problem deeper because patients may use some products they shouldn't use, and on the other hand, other patients who need these medicines will not have it. In addition, the resulting adverse drug reactions here will need more medicinal product to treat such adverse drug reactions. So even with medicine shortage, we should watch out the safety of patients, not to leak our resources, which is very scarce in the first place.

SPEAKER_01 22:54

And finally, to wrap up, where are you planning to take the project next?

SPEAKER_02 23:00

The hospital is now ready to implement the final phase of the barcode project. All the medication and the intravenous solution will have a barcode on the outside of the package and must be scanned with the handle device for administration. Also, the nursing staff will start to use an electronic medication administration record and a handle device for scanning patient ID to positively identify patients before administrating medication.

SPEAKER_01 23:26

That was all I had for you both today. Thank you very much for taking the time to talk to me and joining me on drug safety matters.

SPEAKER_00 23:36

Thank you, Federica, so much for giving us this opportunity to share this experience.

SPEAKER_01 23:42

Thank you. That's all for now, but we'll be back soon with more long reads as well as our usual in-depth conversations with medicine safety experts. If you'd like to know more about medicine safety in the refugee community, visit upsalareports.org or check out the episode show notes for useful links. For more stories like this one delivered straight to your inbox every month, sign up for our free newsletter at upsalareports.org slash subscribe. And of course, if you don't want to miss future episodes of Drug Safety Matters, subscribe to the podcast in your favorite player. Uppsala Monitoring Center is on Facebook, LinkedIn, and Twitter. And we'd love to hear from you. Send us comments or suggestions for the show, or simply spread the word about it so other listeners can find us. For Drug Safety Matters, I'm Federica Santoro. I'd like to thank Mohammed El Awari and Hadir Rostom for taking the time to talk to me, Magnus Ekelou for pre-production input, Matthew Barwick for post-production support, and of course you for tuning in. Till next time.