Participants varied in age and demographic background (see Table : Participant Demographics) and had experienced a range of different NHP-related suspected ADRs such as rash, nausea, digestive disturbance and anxiety/irritability. The final sample was predominantly female and highly educated, although efforts were made to recruit more males and participants from different socioeconomic backgrounds. All the suspected ADRs experienced by the participants in this study were non-serious (i.e., did not require hospitalization or lead to permanent disability or death), but differed in perceived degree of severity from mild to moderate to severe (see Table : Participant Reactions and Behaviours).
Participant Reactions and Behaviours
Although Health Canada accepts direct reporting of suspected NHP-related ADRs by consumers, the participants did not seem to know that was an option. The only ones who were aware of their ability to independently report their suspected ADRs were told this by their health providers, or personally had some kind of health care training and, therefore, had been exposed to the reporting scheme through their professions.
The main themes that emerged from this research were: 1) how participants first identified their suspected ADRs; 2) how they associated the reaction with their NHP treatments; 3) what influenced their likelihood of reporting the suspected ADR to health care providers, the Canadian Vigilance Program, or anyone else; 4) barriers and enablers to reporting.
Identifying the suspected ADR as NHP-related
Once they had experienced ADRs, the consumers first had to identify that they were in fact ADRs and not just new illnesses or worsening of pre-existing conditions. Consumers tended to use a process of elimination, re-challenge and investigative reasoning to evaluate their symptoms.
I was trying to think back to all the things I'd eaten the day before. I took, like maybe two, two additional ones and like within an hour the rash had spread ... and that's when I was like, oh, it must be this new product! (Consumer 1)
I had never experienced anything like that before. (Consumer 6)
There had to be a change within my diet or my lifestyle or something to trigger this headache... I kind of know when something might be different or changing so I knew, I just felt that this migraine was triggered by the medication. I can't see it being anything else. (Consumer 9)
Most participants chose to consume the NHPs that they associated with suspected ADRs without advice or monitoring from a healthcare provider. Thus, when they experienced the suspected ADR, they felt obliged to take responsibility to interpret the reaction on their own. Participants reported methodically evaluating their reactions in order to determine the purported cause. They generally came to the conclusion that the symptoms they were experiencing were related to the NHP after considering the possibility of alternative explanations for the symptoms. For example, they ruled out changes in lifestyle, behaviour or other medication, and also based their decision on criteria such as the temporal proximity of ingestion of the product to the reaction, by trying a different brand of the product and, in some cases, stopping (de-challenge) and then re-starting (re-challenge) the product suspected of causing the reaction:
Question: How did you decide that it was the product that caused these things?
I guess because I'd never taken it before.... that was the only thing I could attribute it to. (Consumer 12)
From using one brand and then switching to another, the fact that they were different brands but they were the same ingredients I was using. They contained the same things. I was just trying another brand and I was still getting the same symptoms and then I also linked it because just at this time when I was taking it, I wasn't taking any other products at that time. (Consumer 4)
I noticed if I skipped it, like I forgot -- it's lunch or something - then I didn't have the symptoms ... so, yah, that was a clue. (Consumer 5)
I would take it and about within an hour, I would start to feel nauseous (Consumer 10)
I think because other people developed it and the only thing we had in common was we took this product. (Consumer 2)
I had some, you know a little bit later. The same thing happened and so I put two and two together. (Consumer 6)
When you're dealing with something that's given for dieting you sort of know that there's a chance that it might be something that it shouldn't be and so I just figured that that was probably something that it wasn't. (Consumer 6)
Likelihood of reporting
Participants' perceptions of the severity and seriousness of their ADRs appeared to influence their behaviour. Most participants confused the meaning of severe and serious, and used them interchangeably. If they perceived the reactions to be mild and/or non-serious, they would generally attempt to mitigate the symptoms independently. Participants claimed that if their reactions had been severe, they would be more likely to seek help or support with managing NHP-related ADRs:
Question: What would make you more likely to talk to someone about your reaction?
I suppose a cardiac event, like, for sure you would want to tell somebody about that. I think that would be significant. If you broke out into a rash, you should probably tell somebody about that. If a product, you know, made you nauseous or dizzy or something like that, you might want to mention that to somebody as well. (Consumer 7)
If the adverse event is mild then it just won't come up, but if it is severe and it's an emergency situation or if it has ongoing repercussions in health [i.e., serious] then it's vital that they be disclosed. (Consumer 5)
I guess if it was a more severe reaction or if it hadn't cleared up ... [then I'd] go the hospital or something like that. (Consumer 1)
Interestingly, some participants who experienced what they defined as severe ADRs still did not report the reaction to anyone or seek advice. This suggests that there may be a difference between how consumers say they would act, and what they actually did. Hypothetically, more severe or serious reactions would result in an increased likelihood of reports.
Barriers and enablers to reporting
Participants outlined a range of reasons for not reporting. Barriers to reporting included: taking responsibility for self prescribing, lack of awareness of who to tell and the specific reporting process, perceived complexity of the reporting process and fear of losing access to NHPs. Similarly, the main enablers to reporting were feeling comfortable with the person with whom they shared their ADR experience and knowing that one could or should report the ADR.
Many participants believed that since they had independently made the decision to take NHPs, they also had a responsibility to "deal with" the negative consequences of that decision on their own. Consumers' decisions regarding how to respond to NHP-related ADRs therefore depended largely on whether or not they believed themselves to be responsible for the decision to initiate NHP use without advice from a healthcare practitioner:
We often combine products in a way that it can be detrimental to our health and I believe that this adverse reaction had to do with that more than the product itself... so that just has to do with irresponsible consumption... So yeah, the adverse reaction is my problem. (Consumer 5)
I mean I told my doctor about the [pharmaceutical medication] because he was the person who prescribed it to me. I didn't tell anybody about the [NHP] because nobody prescribed it to me so I thought, well, I guess I didn't think that I should tell anyone. I think I just didn't think I should tell anybody! (Consumer 7)
I didn't [report] because there wasn't anyone really to tell about it because I wasn't seeing a doctor at the time and I was more sort of trying things on my own. (Consumer 10)
A key reason why consumers experiencing NHP-related suspected ADRs did not report was because they did not know who to talk to. In part, this was because they had self-purchased the NHP and didn't think there was anyone to turn to. In some cases, the decision not to discuss their experiences with others was because they didn't feel that they could confide in their health care providers (often physicians). These participants perceived that their health care providers would disapprove of their use of NHPs, or not give adequate attention to their concerns:
After I figured out what was going on I knew it was me doing it to me, by choosing to take it, I knew that that I was the cause of it but my doctor wouldn't do anything about it and she would just kind of blow it off so, there would be no point in taking it to her because I just didn't have a therapeutic relationship with her. (Consumer 10)
Well our family doctor is, sort of, you know, she likes to take things lightly, so in a sense sometimes I feel like I shouldn't even go so I should wait things out before I talk to her about them because I feel like she's just going to say the same thing to me, like, oh well, whatever, just go home and have some rest and it will be okay. It's a matter of, there hasn't been the time, the time has not been permitted to go into much detail about it. (Consumer 7)
These quotes illustrate the challenges that many participants had with their conventional medical practitioners, especially when discussing issues associated with NHPs. Most were of the opinion that their healthcare providers (most often physicians and pharmacists) would not support their decisions to try NHPs and this resulted in a lack of communication about suspected NHP-related ADRs:
Her [the pharmacists'] initial reaction when I told her [that I had had a reaction to an NHP], was like, there's no need for me to discuss this any further. (Consumer 1)
I've had a doctor tell me that I [the doctor] don't really believe in all that [NHP] stuff. So I personally wouldn't bother telling them about my adverse effects. I'd just tell the naturopath, or the health food store. (Consumer 4)
If participants thought their friends and family would understand their decisions to use NHPs, they might share their NHP-related ADR experiences with people in their social network. Other participants, who wanted reassurance or guidance about their experiences, discussed approaching other resources such as retailers at the location where they purchased NHPs such as pharmacists and health food store personnel. However, overall, they seemed not to have strong relationships with their pharmacists, which negatively affected their likelihood of reporting ADRs to pharmacists:
Let's say that I buy something from [drug store name]. If I'm not happy with it, generally if I can't return it. ... I probably wouldn't take it back or take any type of concern to that particular store because I feel like the people that work there would not necessarily not care, but that they just don't want to deal with that kind of thing. They have so many other things that they're selling in that store. It's just not an open and friendly environment to bring stuff to. With regards to smaller stores, smaller health food stores, it's an environment where the owner always tries to have a good customer relationship. (Consumer 10)
In some cases, participants described a general distrust of conventional medicine which appeared to be driving their use of NHPs in the first place and was likely a key factor in why they did not turn to conventional health care providers for help. This also seemed to be related to perceptions of conventional medicine having much higher risk than NHPs which were thought to be safe:
I come from a family with immensely little trust of any sort of medical doctors ... especially conventional medical practitioners so I try avoid medicines in general (Consumer 6)
I think in general natural health products are safer to take. You can take them for a longer period of time, you can take them for many different conditions as well. (Consumer 8)
Participants tended to feel comfortable with their health food store personnel and often described good relationships with the staff working in these retail settings. Consumers reported reliance on the health food store staff for information and feeling comfortable talking to them about side effects or problems with their products:
I would trust [staff] more from a health food store because they do - usually the owners of the store have good information and have some knowledge whereby the pharmacies would have nothing, and a pharmacist would probably bash it down anyway! (Consumer 3)
Besides health food stores, participants also felt comfortable contacting the NHP manufacturer in situations of suspected ADRs.
I contacted [the manufacturer via the health food store]... I just wanted to tell them, in case anyone else had the same thing. That way the more people who talk about it the more chances that they'll actually do something. (Consumer 1)
Because I was satisfied with the product and then something changed [from the last time I used it], and I was extremely unsatisfied with it, I felt the need to address that. (Consumer 5)
I feel like I did have resources and I certainly followed up on them [with the manufacturer]... I'm not happy with the answer that I was provided with. I have taken other products from this company and it's not that I don't feel like they manufacture unsafe products, I just don't particularly agree with how they handled this particular situation. (Consumer 8)
A related barrier to reporting directly to Health Canada's ADR reporting system was that participants did not always know that reporting their suspected ADR to Health Canada was an option. Typical of this was the response of one respondent who stated he was not familiar with the process for reporting. He went on to add, "... They should make people more aware of it". (Consumer 3)
For participants who knew that reporting to Health Canada was an option, another barrier was the perceived complexity of the reporting process online. For example, the following participant knew that online reporting to Health Canada was encouraged but still had trouble navigating through the system.
I was trying to follow the different links [to report online] but there were so many layers, maybe three or four layers, and you had to consent, you know, this is for information purposes and it wasn't very easy to do, I have to say. (Consumer 2)
Another barrier to reporting, described by several participants, was the fear that the implicated product would be withdrawn from the market, which would limit or prevent access to it in the future.
It is the only product that I've found effective for my health condition. It is something that I feel when used properly it doesn't cause an adverse reaction. I think that [reporting] jeopardizes the status of products that may be required for certain health conditions. (Consumer 7)
It's totally inconsistent as to how I can even access it, which is a problem... hence my concerns about it being pulled from the market. (Consumer 6)