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Adverse drug events are unintended and harmful effects of medication use. Using existing information and communication technologies (ICTs) to increase information sharing about adverse drug events may improve patient care but can introduce concerns about data privacy.
This study aims to examine the views of patients and their caregivers about data protection when using ICTs to communicate adverse drug event information to improve patient safety.
We conducted an exploratory qualitative study. A total of 4 focus groups were held among patients who had experienced or were at risk of experiencing an adverse drug event, their family members, and their caregivers. We recruited participants through multiple avenues and iteratively analyzed the data using situational analysis.
Of the 47 participants recruited, 28 attended our focus groups. We identified 3 primary themes. First, participants felt that improved information sharing about adverse drug events within their circle of care would likely improve care. Second, participants were concerned about data handling and inappropriate access but believed that the benefits of information sharing outweighed the risks of privacy breaches. Finally, participants were more concerned about data privacy in the context of stigmatized health conditions.
Current conditions for maintaining health data privacy are consistent with participants’ preferences, despite the fact that health data are susceptible to breaches and mismanagement. Information sharing that increases patient safety may justify potential privacy risks. Greater attention to patient concerns and the effect of social and contextual concerns in the design and implementation of health information technologies may increase patient confidence in the privacy of their information.
Adverse drug events are unintended and harmful outcomes of medication use and a leading cause of emergency department visits and unplanned hospital admissions [
Poor communication about adverse drug events reflects broader fragmentation and siloed information in health. Recent initiatives at the provincial and federal levels of the government in Canada aim to address these communication gaps. In Ontario, the Digital First for Health Strategy intends to increase the availability of patient records for frontline clinicians and reduce barriers to integration [
Enhanced communication about adverse drug events may improve patient safety but can also reveal sensitive diagnoses to a broader range of clinicians than those currently aware of them. This could introduce privacy concerns for patients, particularly among those living with stigmatized illnesses. We examined patients’ perceptions about the need to share information about adverse drug events to optimize patient safety while maintaining data privacy.
We conducted a qualitative study to explore patients’ perceptions of information privacy and sharing in the context of developing software to facilitate adverse drug event documentation and communication. Research ethics boards of the University of British Columbia and Simon Fraser University reviewed and approved the protocol. All participants provided written informed consent.
Our target study population included adults (≥19 years) who had lived experience with or were at risk of an adverse drug event and family members and caregivers of patients who had experienced an adverse drug event. All participants lived in the Vancouver area or Whistler, British Columbia, between September 2016 and May 2017. We excluded patients who were living in long-term care facilities, did not manage their own medications, were receiving palliative care, were from out of province, or did not speak English. If we approached a patient who was excluded based on the above criteria, we attempted to recruit a family member or caregiver for participation, if they were present during recruitment.
We used multiple sampling strategies to recruit patients who had lived experience with an adverse drug event or who were at risk of an adverse drug event because of their age (≥65 years) or exposure to polypharmacy and the family members and caregivers of patients who had experienced an adverse drug event. We recruited in person, through posters, and through web-based advertisements.
From September to November 2016, we recruited those who were experiencing or who were at risk of experiencing an adverse drug event. Emergency department pharmacists recruited a convenience sample of patients presenting to the emergency department of Vancouver General Hospital, a tertiary care hospital in Vancouver, Canada, when completing medication reviews. We placed posters in high-traffic areas in the emergency department and at a hospital-based research center to encourage patients and their family members to contact the research team if they were interested in participating. We also sought to recruit members of the general population by posting web-based advertisements on Kijiji and Craigslist and by snowball sampling from personal connections. In recruitment advertisements, we stated that we were seeking patient opinions on having information about their medication-related problems shared among care providers. Our intent was to reach a broader range of individuals who met our target sample criteria, including those that may not have had direct contact with the acute care setting at the time of the focus groups.
From February to May 2017, we recruited individuals with stigmatized illnesses (HIV and/or substance use disorder) by placing posters at a clinic that provides care to HIV-positive women. We hypothesized that these patients may have specific privacy concerns and also because HIV medications are currently not documented in the provincial medication dispensing database, PharmaNet, in part because of privacy concerns at the time of PharmaNet’s implementation [
Among those recruited through snowball sampling from personal connections, there was an established relationship between the researchers and participants before the study. For all others, beyond contact for recruitment purposes, there was no prior established relationship.
The focus groups followed a semistructured discussion guide developed collaboratively by the research team to address themes relevant to adverse drug event information sharing (
Key themes addressed in the discussion guide were experiences with adverse drug events, knowledge of information-sharing practices, and attitudes about data privacy and privacy policy. We allowed participants to engage in open dialog and ask questions beyond the discussion guide and identify and discuss new concepts that we had not considered.
We held focus groups in a research office at the Vancouver General Hospital. The principal investigator (EB), a female social scientist with extensive experience in qualitative methods, led the focus groups, and a research assistant (SS) attended to take notes. At the beginning of each group, we introduced the researchers present and provided a brief definition of adverse drug events, including examples, providing rationale for the groups. Recruitment materials informed prospective participants that we sought to gather opinions to guide the development of a system to support sharing of information about adverse drug events among health care providers. We reiterated this at the time of the focus groups.
We gathered additional information about the participants, including demographic information, using a short debriefing survey at the conclusion of each focus group (
We coded and analyzed transcriptions using
Of the 47 participants we recruited, 28 attended a focus group. Each focus group had 5 to 8 participants (
Focus group composition (N=28).
Group ID | Participants, n (%) |
A | 8 (29) |
B | 7 (25) |
C | 5 (18) |
D | 8 (29) |
Each focus group lasted for 120 min. Most participants (25/28, 89%) completed the debriefing survey (
Participants’ characteristics (N=28).
Variable | Participants, n (%) | ||
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|||
|
Male | 6 (21) | |
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Female | 19 (68) | |
|
No response | 3 (11) | |
|
|||
|
<20 | 0 (0) | |
|
20-35 | 2 (7) | |
|
36-50 | 5 (18) | |
|
51-65 | 10 (36) | |
|
>66 | 8 (29) | |
|
No response | 3 (11) | |
|
|||
|
Yes, have lived experienced with an adverse drug event | 3 (11) | |
|
Know someone who has experience with an adverse drug event | 7 (25) | |
|
Both lived experience and know others who have experienced an adverse drug event | 6 (21) | |
|
No, have not experienced an adverse drug event | 6 (21) | |
|
Unsure | 3 (11) | |
|
No response | 3 (11) | |
|
|||
|
Some high school | 3 (11) | |
|
Completed high school | 3 (11) | |
|
Some postsecondary | 7 (25) | |
|
Completed college or university | 7 (25) | |
|
Some graduate school | 2 (7) | |
|
Master’s degree | 1 (4) | |
|
Doctoral degree | 1 (4) | |
|
No response | 4 (14) |
We identified 3 primary themes about information sharing and privacy in the context of adverse drug event communication. Participant quotes to support each theme are presented in the corresponding textboxes, which are representative of the findings for each theme.
Many participants described experiences with fragmented information sharing (
“I don’t think there’s a lot of communication between the doctors. Say you have a GP, you have a rheumatologist, you have an HIV specialist – you tell one doctor one thing and they say, ‘oh I didn’t know that, when did that start?’…So you gotta follow up yourself because he can’t… they get so busy, or they forget, or they don’t care or whatever.” [Participant 25, group D]
“I have been to [the] emergency department with an adverse reaction twice, and it’s very busy. The doctors who see you don’t have time to write your discharge report up in time for you to take a copy away with you…I would like to have further information and would like to be able to pass it on to my GP.” [Participant 11, group B]
“I think in my father-in-law’s case, [the lack of information sharing] cost our system more money…there were more doctors involved…there was more angst involved…my father-in-law’s condition plummeted. And there were more people involved, there was more testing done, ambulance was called ten times.” [Participant 1, group A]
“I don’t think it’s very well shared. If it is, it’s pretty piecemeal.” [Participant 3, group A]
“I’ve just always heard that adverse effects are supposed to be reported…but I never had any confidence that they were.” [Participant 8, group A]
“I have learned that in many cases, the people to whom I go for one medical event or another don’t always share the information.” [Participant 12, group B]
“My family doctor gets everything, but I particularly have to make a point of asking for copies to be sent to a couple of my specialist physicians.” [Participant 11, group B]
Participants felt that better communication between providers in their circle of care would have a positive effect on health outcomes and could improve their experience with the health system, including improved disease and medication management (
“And then…someone who is elderly, who may have dementia, who doesn’t have someone advocating for [them] – that information needs to be shared so that somebody can make sure that they’re making good decisions around their health care and prescription medications.” [Participant 1, group A]
“[My father-in-law’s] health would have been maintained at a higher level for a longer period of time, had the information been shared more regularly.” [Participant 1, group A]
“Yes, the more [my care providers] know [about my] medications…the better they’re taking care of me.” [Participant 27, group D]
“When my mother was admitted and all they need is her care card number…all the information [is] there already, so it’s a lot easier for us.” [Participant 19, group C]
“You’d think that the more information that your caregivers have…the better off you’re going to be if you have a problem or if you’re unconscious or whatever.” [Participant 20, group C]
“I think the more we share the information, it’s a huge financial benefit…both the emotional and financial side.” [Participant 7, group A]
“…We have the language barriers, we have culture barriers, we have all of those things to deal with and it makes things very, very difficult, so another reason for having this information [available] to so many people.” [Participant 3, group A]
“My view is that I am less concerned about privacy, and more concerned about people [caring] for me having the information that they need.” [Participant 8, group A]
Many participants supported the use of health information technologies to share adverse drug events and medication information (
“I personally would want it electronically, just because with the technology age nowadays it’s…the easiest method and the quickest method to transfer information…also it’s more eco-friendly than having all these pieces of paper that might get lost…” [Participant 18, group C]
“I think I’d want it electronic because it is simpler, and mounds of more paper aren’t necessary…or needed.” [Participant 16, group C]
“All I’ve gotta say is: is there an app for that?” [Participant 3, group A]
“I don’t think we should lose the ability to ever…pick up the phone, because there are quick emergency situations that can save a life…but generally I think that electronically is the most practical.” [Participant 7, group A]
“I’m in favour [of] electronically, but with ensured back up because you could lose everything.” [Participant 8, group A]
“Digital is my first choice.” [Participant 14, group B]
“There’s been breaches with confidential medical files when it comes to computers.” [Participant 21, group D]
“I would want it electronically and [on] paper because…we live in an earthquake zone.” [Participant 17, group C]
Participants focused on the different professional groups that would access their health information rather than the information systems that would mediate information sharing (
“I would say it would be ok for [my information to be shared] as long as it’s…the doctor... Say…someone on a team…like maybe a social worker of something, they might be valuable on the team, but the medication part would have absolutely nothing to do with them. So, they shouldn’t be having access to that information because they can’t do anything about it.” [Participant 21, group D]
“When it comes to doctors and nurses…they share. But if…the definition of ‘care team’ is broader than that, then I would need to know who they were and what they were doing [with my information.]” [Participant 17, group C]
“[Care aides are] usually wonderful people, but they don’t have the information…on how to deal with the ethics of private information. This is my experience with my mother. But yeah, it would depend who it was. I mean my physio doesn’t need to know, right?” [Participant 17, group C]
“It’s more of a question of what is their education, what is their guidelines…Like a pharmacist…keeps everything confidential. Does the assistant?” [Participant 7, group A]
“Maybe…the key is who gets the information [is] anybody that has to do with the prescription.” [Participant 3, group A]
“You run into a whole hornet’s nest when you’re talking about other people getting that information, like for example insurance companies.” [Participant 12, group B]
“[The doctors] always have [medical] students in their office, right? They come in with the doctors…So the [medical student has] your information, they’ve got everything in that conversation…And where does it go from there?” [Participant 25, group D]
“I was just going to say that all the medical and allied health, secondary health professions, have confidentiality and privacy as a really major, serious part of their curriculum…It’s as secure as it can be given people.” [Participant 8, group A]
Participants believed that data stored electronically in medical facilities were unlikely to be secure (
“I think if someone really wanted to get [my medical information] they could get it…People within the office [of] the hospital, if they wanted to get access to it, I think they could get it. Even if they don’t have…official approvals. And, data hacking is advancing.” [Participant 17, group C]
“I never thought of it as being that confidential…It’s on a computer and in your pharmacy, and there’s a zillion people [that] have access to it. I just accept the system the way it is.” [Participant 20, group C]
“[Information is] only as secure as the individuals handling it.” [Participant 3, group A]
“I don’t think pharmacies are very secure.” [Participant 15, group B]
“There’s a lot of hackers out there that can get access to [your information].” [Participant 25, group D]
“There’s faxes that have…gone to the wrong fax number, so there’s a breach of confidentiality there.” [Participant 21, group D]
“And where the breaches occur are chatting down the hallway, nurses chatting in the elevator, people in the cafeteria…” [Participant 8, group A]
“I’ve heard of…an operator throwing some CDs or…storage device in the garbage and then somebody went in the garbage and pulled it out, and there’s half a million records on there.” [Participant 3, group B]
“I mean, there have been serious privacy breaches on record with the provincial government specifically.” [Participant 15, group B]
“A whole stack of personal information and somebody just dumped it out in the back lane somewhere.” [Participant 14, group B]
Discussions about stigma and discrimination around health data emerged in most groups (
“When [a care provider] comes in and [is] talking about someone’s health, you just don’t outright say ‘hey how’d you get that?’ That’s really disrespectful to a person whether they have diabetes, cancer, HIV, or Hep C, or whatever their medical situation is.” [Participant 21, group D]
“So, depending on who’s accessing that information…that’s where stigma, discrimination comes in, because [the patient] could…end up being judged from the medication they’re on because [the care provider] knows what those medications are used for.” [Participant 21, group D]
“I remember all the stigma around cancer when I was a child. It was like the ‘c-word’. You didn’t even call it cancer. And it’s great to see the shift now…It would be lovely if we could get that way with stuff like mental health, Hep C, HIV. You know, there’s definitely more awareness out there but unfortunately there’s…the ignorance.” [Participant 21, group D]
“I’ll tell you right now, the honest truth about the Downtown Eastside is [care providers] don’t care about you. You’re just a number, you’re just an addict, you’re just a prostitute, you’re just a drunk…You’re not a human being…You’re just shuffled through, seen by whoever’s there [at the clinic] …They don’t [have] your files.” [Participant 28, group D]
“There was the case of the woman refused entry into the US because she was on anti-depressants.” [Participant 17, group C]
“I have a mental illness…if I’m a danger to myself or to others, and I’m not taking my meds…then yes, my diagnosis along with my meds need to be passed on to somebody…if I’m stable, then just my medication [information should be shared].” [Participant 4, group A]
“You know, [doctors] want you to tell them everything…but I don’t want to tell you [doctors] this part, because I don’t trust you guys.” [Participant 25, group D]
“I just feel…the students…or the…residents, they need to be better educated on…bedside manners.” [Participant 21, group D]
“I do see more often that…the confidentiality blurbs are out there more often when you’re signing things, [saying] this is how we protect information. That never used to be out there, so I think there is more awareness out there, but I think it needs to continue, like even…ramp it up. And not [allow] people [to] get…complacent about it.” [Participant 21, group D]
We explored patients’ perceptions about information privacy and sharing in the context of developing a health information technology that will enable electronic documentation and automated communication of adverse drug event information between providers and across care settings. Most participants supported improved information sharing about adverse drug events, expected technologies, and clinicians to protect their privacy and understood that a lack of information sharing could pose a greater risk to their safety than potential threats to privacy. In the following sections, we explore how existing organizational and institutional measures to protect data privacy are consistent with participant expectations.
Privacy legislation provides a framework for data management. In British Columbia, the Freedom of Information and Protection of Privacy Act (FIPPA) governs the collection, use, and dissemination of personal information by public entities, including health authorities and hospitals. Under FIPPA, public entities must enact and enforce security measures to prevent unauthorized collection, use, access, disclosure, and disposal of personal information. Public entities such as hospitals and clinics must notify individuals that their information is being collected and used but do not require patient consent to share patient information with other members of the care team [
Improvement in communication about adverse drug events may be achieved by leveraging existing health information technologies, such as PharmaNet. PharmaNet employs numerous data management safeguards, including physical security (eg, limited access to equipment), operating system security (eg, user access keys), network security (eg, firewall), and screen security (eg, only certain items viewable based on each user’s security profile) [
Despite the privacy measures implemented in health information technologies, security under real-world conditions is more volatile. Breaches of health data have been a recurrent focus of media attention and critique, including incidents involving PharmaNet. In 2014, for example, approximately 1600 profiles were compromised by an unknown, unauthorized individual using a doctor’s account [
In addition to legislative frameworks, concerns about handling sensitive health information can be addressed in the design of systems by implementing role-based access functionality, building complex password requirements, and regularly auditing use and users. Participants’ concerns regarding threats to data security among staff in medical facilities can be addressed through other nontechnical approaches. Implementation should incorporate education that addresses safe information handling, including proper methods of sharing data and disposing of paper records, and strategies for maintaining the security of log-in credentials. These measures may increase clinicians’ ability to maintain the security of information in their custody while increasing patients’ confidence in the privacy of their information and in the efficacy of information sharing in health.
Sample composition is the primary limitation of this study. Participant self-selection and recruitment from an urban area may have introduced selection bias. More women participated than men. Participants in rural regions, men, and those with other health trajectories or access points within the health system may have different experiences in the health sector that are not reflected. As such, our findings may not translate to other regions, populations, and health conditions. In addition, we did not screen participants who volunteered via classified websites (n=5) to determine whether they met the defined sample criteria (ie, at risk of or experienced an adverse drug event or a family member or caregiver). Therefore, we cannot verify whether all responses are representative of these sample criteria.
Participants were generally supportive of enhanced informational continuity of care about adverse drug events to facilitate care delivery. The belief that enhanced information sharing would improve care and that a lack of information sharing poses safety risks indicates patient support for broader use of information and communication technologies (ICTs) in health. Privacy considerations were important to participants but largely in the context of the human actors handling the data rather than the electronic systems that mediate information transfer. Fears about stigma and discrimination were prominent drivers, particularly among patients who had experienced stigmatization. Our findings suggest the need to consider the ways that social and contextual factors (eg, living with a stigmatized illness) that affect patient privacy can be addressed at both the human and technical levels in the design and implementation of ICTs in health.
Discussion guide.
Follow-up survey.
Freedom of Information and Protection of Privacy Act
information and communication technology
This research was sponsored by the Canadian Institutes of Health Research eHealth Innovations Partnership Program (no. 348320) and the Michael Smith Foundation for Health Research (no. 16724).
None declared.