Background
Methods
Ethics approval
Choice of key stakeholders
Data collection
Data analysis
Results
Barriers hindering pharmacists’ duty of care regarding CMs
Barriers | Practicing Pharmacist 1 | Practicing Pharmacist 2 | Pharmacy owner | Pharmacist profession al organization | Consumer advocacy group | Doctor professional organization | CM practitione r profession al organization | Leader within a pharmacy school | Regulatory authority senior staff 1 | Regulatory authority senior staff 2 | CM industry | |
---|---|---|---|---|---|---|---|---|---|---|---|---|
1. Insufficient knowledge about | YES | YES | YES | YES | YES | YES | YES | YES | YES | YES | YES | |
2. Pharmacists’attitude | Being skeptical | YES | YES | |||||||||
Lack of initiative | YES | YES | YES | YES | YES | |||||||
Lack of confidence and communication skills | YES | YES | YES | |||||||||
3. Lack of research skills | YES | YES | YES | YES | YES | YES | YES | |||||
4. Lack of evidence for efficacy and safety of CM s | YES | YES | YES | YES | YES | YES | ||||||
5. Lack of access to reliable and reputable information and support | YES | YES | YES | YES | YES | YES | YES | YES | YES | |||
6. Lack of time | YES | YES | ||||||||||
7. Consumers’attitude | Misperception about CMs | YES | YES | |||||||||
Pharmacists don’t know much | YES | YES | ||||||||||
8. Lack of defined role | YES | YES | ||||||||||
9. Miscommunication with doctors | YES | YES |
The lack of knowledge was attributed to a deficit in the undergraduate curriculum as the importance of CMs was not generally recognized at a university level. It was mentioned that:“Education and information resources are the biggest gap right now and vulnerably open, not quite equipped when it comes to these issues. It is very hard for pharmacists to have all the knowledge given it is such a large range of products. The sources of data is also a bit patchy. There is a lot of new products, market driven. To keep current is also a challenge.” (Key representative of a consumer advocacy group)
According to another interviewee, pharmacists had been ‘calling out’ for educational materials on CMs as part of the pharmacy training for nearly two decades. However, this request had not been responded to effectively. It was indicated that:“I think lack of knowledge very much come from the deficit in the undergraduate curriculum and I think the reason for that deficit is because you find that some people who head up the pharmacy faculties don’t see that is important or maybe have a bias against it.”(Key representative of the CM industry)
“We did an educational need analysis primarily for our own benefits. Pharmacists at that stage were crying out for graduate education in complementary medicines. That was in the early 2000. Everything that I have seen where they have done this sort of educational need analysis since, they are coming up with the same sort of findings. Basically, pharmacists are in the situation where they need to start to demand their professional and educational bodies provide appropriate education.” (Key representative from a doctor professional organization)
Three participants were concerned that pharmacy graduates lacked the confidence to have a conversation with patients/consumers about pharmaceutics and other OTC products let alone CMs. The qualities of self-motivation, confidence and communication skills were suggested to be lacking among young pharmacists. Pharmacists’ lack of motivation to learn about CMs and the evidence for efficacy was considered another contributing factor to a reactive rather than proactive approach in this area. It was indicated that:“I think there is a mismatch between the growing pharmacy business which has been growing at an exponential rate with complementary medicines but that has not been reflected in the knowledge base increase exponentially for pharmacist or the consent that I actually making so much money in complementary medicine so I should know more about and giving back more advice. There is no correlation or probably inverse correlation. It is quite discouraging. Pharmacists are aware of their duties but somehow they don’t think it relates to complementary medicines.”(Leader within a pharmacy school)“They probably do have different level of professional service and different attitude. Because probably many of them don’t have the knowledge. The other thing is that in their minds, they don’t think complementary medicines carry big risks to become a concern.” (Senior staff from the regulatory authority)
Pharmacists could be excessively skeptical about the safety and efficacy of these products as suggested considered by 2 participants. It was indicated that:“The other issue is confidence. I mean you would find a lot of pharmacy graduates, even if they know a lot about OTC, they lack of the confidence to have the conversation. I also think that the way pharmacy students gain entry to the course need to be looked at in general to make sure that you have people with good communication skills regardless if it is about complementary medicines or even prescription medicine and OTC, and that they do come out from behind the counter and talk to people. It is a lack of motivation and lack of confidence.”(Key representative of the CM industry)“There will be a small number that will talk to a pharmacist. The flip side of that very often pharmacist don’t come out and talk about these because they don’t have the training or the confidence. In an ideal world, pharmacist should be actively involved in that discussion. The reality at the moment is that they are not.” (Key representative of the CM industry)“My experience when I go to pharmacy to buy complementary medicines, I don’t go ask the pharmacist. I don’t even see one on the floor.” (Senior staff from the regulatory authority)
Some participants raised an important point that pharmacists who did not ‘believe’ in CMs, yet chose to sell them without providing any professional service or advice face a professional dilemma.“The major barrier would be the people like me who are skeptical. I am not an advocate of complementary medicines mainly because I am a scientist.” (Senior staff from the regulatory authority)“The biggest barrier in health care is that doctors and pharmacists won’t learn the evidence. I am questioning whether pharmacists know what evidence means quite honestly. They think they know and then they would turn it around like a shield of evidence-base, but what kind of evidence are you talking about? What is evidence? I think they don’t even have that understanding.” (Key representative of the CM industry)
“Anyone can go on the PubMed but I think pharmacists are not very well trained to read the scientific papers. Even when you give them the hard-core scientific evidence, a lot of them did not really understand it. It is fascinating.” (Key representative of the CM industry)“It would also be hard for some pharmacists to interpret a good study from a not so good study even if they log on a database. How well trained they are in that. It is going to take them time to pick a good quality study.” (Key representative of a consumer advocacy group)“I mean not only the knowledge base but also being able to filter and assess in an independent way. People choose what they believe or what not to believe but pharmacists should be able to filter through the information and sort the garbage through.” (Leader within a pharmacy school)“Very often pharmacists don’t interpret what is available to them is information the same way I would with the same scientific thinking and clinical capabilities.” (Key representative of a pharmacist professional organization)“Pharmacists need the skills and experiences like people who have done research to look through the literature to interpret the findings. This is a skill to learn from doing research. But general pharmacist may not have the time and skills.” (Senior staff from the regulatory authority)
It was proposed, that the CM industry are not adequately incentivized to conduct original research for 2 reasons: (1) The industry realized that the availability of quality evidence to support efficacy had, if any, minimal correlation with the volume of sales since neither the consumers nor the pharmacists, as a general rule, assessed the quality research to support a CM products use; (2) No intellectual protection measures were in place to prevent the use of results by competitors in the development of equivalent products. It was indicated that“The main drawback in Australia and the main drawback all over the world is that there is no proof of efficacy when you register complementary medicines to the best of my knowledge. That is the problem. What is happening is that the practitioner is standing on a ground that is moving. And this is unfair. Grossly unfair. So that makes it doubly difficult to people. It goes back to the proof of efficacy.” (Practicing pharmacist)“That is the safety of a product that I see as a major barrier. Again, because we don’t know what is in there. It is getting probably better in Australia. But then again, even if we know what is in there, the studies hasn’t been done to prove that they are safe and of course efficacy we don’t know yet. The science and evidence is the main barrier.” (Senior staff from the regulatory authority)
“If I were to fund half a million for a clinical trial on a particular ingredient, every other company can copy that. I think that is a failure from the regulator who is actually not promoting innovation and advance in sciences.” (Key representative of the CM industry)
“I think it will be better to have more details about quality control, about safety and about existing data available on efficacy. Ideally, even with some data about interactions. Those information should be available for public. The more data or quality, validated information available, the better for the public and for the industry. I will say at this stage, all this information is quite limited and we need more information.” (Key representative from a CM practitioner professional organization)“There are a number of resources available to them (pharmacists) but a lot of them are not aware of them. For example, they might rely on the Australian Medicine Handbook or Australian Therapeutic Guidelines. They will look at those and think there is not much complementary medicine information in there if any. And they would assume that there is all there is. They didn’t realize that there are many other dedicated databases and text books specifically focusing on these areas.”(Key representative of the CM industry)“The resource of reliable information is not readily to pharmacist. You have to make a special effort.” (Practicing pharmacist)“Right now pharmacists rely on to large degree information from product sponsors. So products come in, they get training and information. I think they rely on and read what sponsors provide. Hopefully, this information is reliable and reputable. But things are not certainly arm’s length. I am imaging that they could be just like consumers and google about things. But it is a key challenge to have a single source of credible information unbranded.” (Key representative of a consumer advocacy group)
“The biggest challenges would be ….. trying to manage consumer’s misperception about the implied endorsement of safety and efficacy of a product being sold in the pharmacy.” (Key representative of a pharmacist professional organization)“The reality is also that people don’t actually ask pharmacist because they know pharmacists don’t know the answer. Unfortunately, pharmacists have proven it that they don’t know the answer. So there is a lot of work to be done on both sides.” (Key representative of the CM industry)
“There is no absolute legal requirement at the moment. At the moment, pharmacists can recommend it freely without worrying about it. If you take it to a higher policy level, the National Medicine Policy that was put out in 2014 stated that all roles and responsibilities in the quality use of medicines and the definition of medicine included Prescription, complementary medicines and OTC so you can take it that even though we may not pin dart on a dart board on complementary medicine, it is part of overall provision of medicine.” (Leader within a pharmacy school)“There is certainly not an agreement on how this can be managed. Whether they constitute the same degree of care as pharmaceutical prescription medicine. It is generally more polarized rather than balanced from this viewpoint.” (Leader within a pharmacy school)“We have a law requiring us to have people supervised when we talk about medicines, but there is no supervision required with complementary medicines.” (Key representative of a pharmacist professional organization)
“The doctor said to me, ‘If you have been taking it seriously as a health care professionals, you could have got rid of all the shit out at the front. All the bloody vitamins and stuff.’ The fact that we are selling them, talking about them or even promoting them will be enough to make my GP upset about them.” (Key representative of a pharmacist professional organization)“You could argue that you want to make sure the doctors know they are taking these things (complementary medicines). There is a privacy issue though. So you don’t want to ring up the doctor and tell him your patient took this from your pharmacy.” (Leader within a pharmacy school)
Solutions to support pharmacists’ extended role in these products
Solutions | Practicing Pharmacist 1 | Practicing Pharmacist 2 | Pharmacy owner | Pharmacist professional organization | Consumer advocacy group | Doctor professional organization | CM practitioner professional organizatio | Leader within a pharmacy school | Regulatory authority senior staff 1 | Regulatory authority senior staff 2 | CM industry | |
---|---|---|---|---|---|---|---|---|---|---|---|---|
1. Integration of CMs into pharmacists’ education | University training | YES | YES | YES | YES | YES | YES | YES | YES | YES | YES | YES |
Internship training | YES | |||||||||||
CPE | YES | YES | YES | YES | YES | YES | YES | YES | ||||
Post graduate training | YES | YES | YES | YES | ||||||||
2. Clear definition of the pharmacists’role in CMs | YES | YES | YES | YES | YES | |||||||
3. Pharmacies employing a naturopath | YES | YES | YES | YES | YES | YES | YES | YES | ||||
4. Establishment of reliable, easilyaccessed information | Database | YES | YES | YES | YES | |||||||
Product information endorsed by authority | YES | YES | YES | |||||||||
Others validated information | YES | YES | YES | |||||||||
Guidelines/Red flag system | YES | YES | ||||||||||
5. Promoting quality CMs research | YES | YES | ||||||||||
6. Collaboration among health care professionals | YES | YES | ||||||||||
7. Provision of consumer education | YES | YES |
All participants emphasized the importance of integrating CMs into undergraduate pharmacy education in order to ‘sensitize’ pharmacy students to these products. This was believed to be critical to make sure pharmacists would communicate about these products the same way as they would any other medicine. A concern was raised that the current CPE requirements allow pharmacists to pick and choose CPE topics based on their personal interests. This could result in pharmacists limiting or receiving no training about CMs. It was indicated that:“They also need to receive some training in herbal medicine or complementary medicines in order to enable them to handle them because they are under different philosophy and different framework with different clinical applications.”(Key representative from a CM practitioner professional organization)“Unless pharmacists try to get the same level of education about complementary medicines themselves, they will be deficient and they will feel insecure and they will feel unhappy, unsettled, because the complementary medicine requests and complementary medicine information are probably requested several times every day. So that is the professional and economic reality of it.”(Practicing pharmacist)
Some participants suggested that at the very least, the undergraduate curriculum should cover the top-selling CMs equipping graduates with evidence-based knowledge regarding the efficacy and safety of common CMs. It was indicated that:“I think something we are trying to do here is to make sure they treat them the same way as pharmaceutical medicine in terms of to the approach to the conversation with the patients. So it is managed from a communication viewpoint in the same way.” (Leader within a pharmacy school)“The inclusion of more content into the undergraduate curriculum is very critical. Because you will find a lot of pharmacy graduate once they leave the university, when it comes to CPE and ongoing education, they can pick and choose. So if they don’t have any interests in this area, they can then keep choosing to attend those kind of lectures that are in different areas then they are going to completely miss the education.”(Key representative of the CM industry)“I think it is important for the current education to ensure university graduates of doctors and pharmacists to have more information and knowledge. Complementary medicines only took off in the last 10 to 20 years. So people should start to learn more.” (Senior staff from the regulatory authority)
Another important aspect of undergraduate training identified in this study was research and analytical skills. As one participant illustrated, knowledge always changed and what pharmacy students learnt in the university might change over time. Therefore, the ability to independently filter, interpret and select accurate information was critical when trying to provide advice to people. The volume of information and published literature is overwhelming and could sometimes be misleading. It was suggested that pharmacists needed the skills and experience to search the literature, to interpret the findings, to determine the quality of the clinical studies and to regularly revisit the literature to ensure currency.“I think I would appreciate it if at least they taught about the top 20 baseline stuff. Because a lot of that stuff I would have had to learn on my own. And that’s only because I have had an interest in it.” (Pharmacy owner)
For the pharmacists who had already registered, continuing professional education (CPE) was one of the major ways to keep up-to-date with new findings about the safety and efficacy of CMs. Most participants agreed that if pharmacists were working with patients who used CMs, they should include training related to CMs in their CPE plan. As suggested by 4 participants, taking into consideration the costs and time related to undertaking CPE, a structured CPE plan that included a compulsory CMs element could be useful. Other incentives should also be in place to help pharmacists maintain interests in seeking training in this area. It was indicated that:“If it (complementary medicine education) is not happening in university, then it should be in their internship year. Because what they do is in that 12 months, they are going to be in the pharmacy that has the issue happening then the aim of the exercise is they will be able to use university skills to interpret or read or know that they must find out. To my way of thinking, that is when pharmacists start to gain some knowledge and perspective about complementary medicines that are important to them.”(Practicing pharmacist)
If pharmacists were to provide information and clinical advice, they should have formal training comparable to a post-graduate level. Based on an interviewee’s experience, pharmacists with additional qualifications in naturopathy or CM are in a better position to guide consumers in making informed decisions.“Any professional requirements that requires additional training means you are taking people out of their day-today duties. This also means that they will lose income and they need to pay money to learn new skills. Unless things have become more mandatory or people will choose those things, it will be less likely to be able to achieve high level of compliance. The barriers will be like additional training, costs, taking them out of the job. The problem or the question is that will additional qualification allow tem a higher level of income. For example, if you are able to handle more than just western medicines, and also complementary medicines, will you get a higher level of pay rate or a higher level of income to reward additional learning?” (Key representative from a CM practitioner professional organization)
Three participants had doubts whether it was appropriate for pharmacists to take on a role related to CMs. It was indicated that“I think they need to identify the role of pharmacist in handling the complementary medicines. It needs to clearly define the role whether pharmacists are just selling the products or if they are providing health advice. And then from there, it is to design a very clear articulated capability requirements for these people to be adequately plays these roles and from there you can identify key knowledge, skills and attributes required. This will lead to the final design of the training course o enable the people to achieve the outcomes.”(Key representative from a CM practitioner professional organization)“If we don’t have a policy about these things, there is no trust in our professional generally. I think what will happen over time is that the statement (The Complementary Medicines Position Statement by the Pharmaceutical Society of Australia) will get tighter and the only way for it to get tighter is to provide more examples and clinical example into it.”(Key representative of a pharmacist professional organization)
“Should complementary medicines be highlighted as part of pharmacists’ role? It is a complex question. There is a general role for pharmacist. It is unfair at this point of time given registered pharmacists have not received undergraduate training in complementary medicines to be developing role for them that is largely being a role for naturopath and other TM practitioner where all of a sudden we are saying that you should be having responsibility in this area too because you are selling them.” (Key representative of a consumer advocacy group)“I agree that it is quite unfair to ask pharmacist to really provide certain level of service with Complementary medicines as they are not trained. I think they should be trained before handling the products because herbal medicine are not naturally all safe.”(Key representative from a CM practitioner professional organization)“If you read the actual code of ethics of pharmacists, it basically says that pharmacists are required to be aware of the underlying pharmacology of all the things that are actually dispensed in the pharmacy. I don’t think anybody would want it to be explicit. Because if it were made explicit at the moment, virtually every pharmacist in the country would be in breach of that ethical code.”(Key representative from a doctor professional organization)
However, there were two interrelated limitations to this proposed solution. In Australia, Naturopathic practitioners are not governed by statuary regulation and this is associated with significant variations in education. The implications for pharmacists who employ naturopaths is that they are ultimately responsible for the advice given by the naturopaths. Other ethical and legal implications need to be considered when a statutory regulated profession takes advice from a self-regulated profession such as naturopathy or herbalism. The implications for the consumer relates to a potential lack of standardized naturopathic advice across pharmacies that may lead to confusing or unreasonable expectations and misplaced trust. It was indicated that“With the research that I do, we have actually showed that two-thirds of people would be very happy for pharmacies to even have naturopaths in the store so they will have someone who is an expert to talk about these because they are recognizing that pharmacists don’t know enough.” (Key representative of the CM industry)“If you have a nutritionist or a naturopath, these people will be the expert on nutrition and complementary medicines and pharmacist can work in collaboration.” (Key representative of a consumer advocacy group)“Ideally, it should be the pharmacist who should deal with consumers’ complementary medicine use. But in the interim of what we have, I am happy to have a naturopath in my practice to deal with the situation. Having a naturopath in the pharmacy is an attraction to the customers.”(Key representative of a pharmacist professional organization)“I think pharmacists basically need to actually either know the medicine that they actually have in the pharmacy or they need to actually have a content expert on hand to be able to discuss the questions.”(Key representative from a doctor professional organization)
“The pharmacist is the captain of the ship. The naturopath, even though they are independent practitioner, they are like pharmacy assistant to pharmacist in a pharmacy. They are assisting pharmacist. As a pharmacy assistant, they need to make sure what they are doing is acceptable to pharmacist. So if the pharmacy assistant is recommending a product, then the pharmacist must know what is happening in the end.” (Practicing pharmacist)“One trend that has been occurring in Australia pharmacies is a lot of pharmacists are employing graduated naturopaths. A difficulty is that the naturopathic medicine is not yet a registered health profession in this country and so the interested still places the liability on the actual pharmacists and that creates some dilemma. There are some risks associated with that is that they are using a non-regulated professional at the moment.” (Key representative from a doctor professional organization)
“There should be a red-flag system to help pharmacist remember important things.” (Practicing pharmacist)
“Unfortunately, it is the companies which can go much further in terms of really ensuring quality or really ensuring evidence, there is no incentive for them to do that. So I think that is unfortunate. As long as there is no incentive to actually do an original research, you get no advantage. If I were to fund half a million clinical trial on a particular ingredient, every other company can copy that. I think that is a failure from the regulator who is actually not promoting innovation and advance in sciences.” (Key representative of the CM industry)“It goes back to the industry and research university that has the evidence for them where to from here and how do we get the government to do more research on products or how to we get the government to give some sort of IP and data protection to companies because right now I may publish a paper to support a claim and all my competitors will be using it for the next day. It is different than if you have a registered prescription product. This is some incentive we don’t see in CM.”(Key representative of a consumer advocacy group)
“GPs, pharmacists, nutritionists, naturopaths and all the other health care providers and the whole system should be ‘reimagined’ so there is a collaborative view with the consumer in there and their beliefs, their values and their empowerment at the center of it.”(Key representative of a consumer advocacy group)
“Consumer education is also a great issue. Australian public need better understanding of what complementary medicine is and how it is managed in Australia by regulatory processes.” (Leader within a pharmacy school)
“There might also be a policy to make sure people should know about the safety and efficacy of CM.” (Key representative of the CM industry)