You may have taken law and ethics courses in the past and probably heard lots about our obligations under the Health Information Privacy Code 1994 (HIPC). If you are like me, you will have wondered just how we are meant to even remember, let alone apply all these rules in our day-to-day practice. In the second part of the series I’m going give you a practical, straight-forward overview with respect to collecting, using and disclosing information about sales of codeine containing pharmacist-only products. As I have mentioned it in Part I of the series, many of us are worried about selling codeine-containing products and all the issues around their misuse. The case of codeine containing products is a great example of the difficulty we often see when having to apply the same set of rules to a diverse class of medicines. It also highlights a more general problem that medicines are not amenable to being put into classes, because they are so diverse, they almost need product-specific rules in our practice.
As I’m focusing on the issue of collection, use and disclosure of the information about the sale, I’m not going into the wider protocol for selling pharmacist-only medicines. There are a whole bunch of protocols, rules and ethical obligations around these sales, but most of them are intuitive and in line with our training. What I’d like to go into is the part that’s not so intuitive, the one that doesn’t come naturally. An important lesson I learned from my legal studies is that when you deal with law, an intuitive approach is almost always misleading anyway. You really need to understand a rule to be able to apply it to your practice, and it is very risky to go by intuition.
I’m now going to walk you through, step by step, the relevant parts of the HIPC to show you how they apply to sales of codeine containing pharmacist-only products, and how the application of the rules differ from sales of other pharmacist-only medicines. The difference is due to the abuse potential of codeine and the fact that pharmacists may wish to use or disclose information relating to the sale in an endeavour to prevent misuse, for example by contacting the Police or other pharmacies to let them know about suspicious activity.
Definitions
“…a driver’s licence number is health information…”
Even though some of it is quite obvious, it’s still worth laying down the basics. In fact, any legal analysis should always start with the definitions, because we always want to establish whether and why a particular rule applies to the issue. So here, the HIPC applies to these pharmacist-only sales because the pharmacist (a service provider) collects information about the consumer in the course of providing a health service. The definition section of the HIPC leaves no room for doubt, as Clause 4(1) is formulated very widely. Here, for example, although many would find it surprising, in this context, a driver’s licence number is health information, to which the HIPC applies, because it is collected as part of a pharmacist-only medicine sale.
Purpose of collecting health information
The purpose pre-determines what the information may be used for
Rule 1 of the HIPC gets sometimes overlooked, because it seems an inconspicuous, formal rule, but don’t be fooled. It’s crucial, and it’s restrictive. In practice, the most important bit that tends to be forgotten is that, according to Rule 1, we are only allowed to collect information that is connected with the function or activity of the pharmacy and is necessary for that purpose. This means that for every bit of information collected, we must be able to provide a reasonable explanation how that particular bit of information is necessary for us to be able to carry out our functions.
In other words, we must be able to name the purpose for which the information is collected, because we need to be able to explain to the person why the information is collected. But, more importantly for our practice, the purpose pre-determines what the information may be used for and under what circumstances can it be disclosed. I’m sure you see where this is going. You have to be clear about why you want to record a person’s date of birth or driver’s licence number when you sell them a codeine containing product. Later, in Part III of this series I will discuss the drug abuse prevention initiative in Canterbury and how that addresses the issue of purpose.
For now, the take-home message is that you have to be upfront and clear about why you collect information. For most pharmacist-only medicines the purpose will be quite obvious, i. e. to have the compulsory record of sale, also for future reference, complementing the medication history of the patient, perhaps to have contact details in case of recall or other safety concerns, etc. In addition to this, if you are selling codeine containing medicines, one of the purposes of the collection may be drug abuse prevention. And if this is the case, then the customer should be aware of this before making the purchase. It is also important to note that all of the above still applies even if a pharmacy has a “No ID no sale” policy. In other words, if you ask for ID as a matter of policy, you still have to be able to articulate the underlying reason for doing so, and cannot simply say that this is the policy. It is also worth mentioning here that collecting the likes of driver’s licence number, date of birth or even a phone number is not a legal requirement under the Medicines Regulations, therefore having a clear reason for doing so is all the more important.
Use and disclosure of health information
You should rely on clearly communicating the purpose for which the information is collected
Rule 10 and 11 of the HIPC limit the use and disclosure of health information. There are many different restrictions and exceptions, rules, sub-rules and sub-sub-rules, but the most relevant of all is, as I mentioned above, the purpose for which the information was collected. This is what really determines what the information can be used for and under what circumstances can it be disclosed.
I often see the “serious and imminent threat” exception mentioned as being relevant in pharmacy practice. I have two problems with this. One is that most of the pharmacists I talked to are not aware that the word “imminent” has been removed from the HIPC so the first quote is no longer accurate. Second is that, in my opinion, it could hardly if ever be used as grounds for use or disclosure of information in a pharmacy setting, and certainly won’t be applicable in the context of pharmacist-only sales and drug abuse prevention. The threshold for something to be a “serious threat” is very high, for example, someone’s life has got to be in real danger. So, as far as pharmacist-only medicine sales are concerned, I think, it would be foolish to rely on anything else than clearly communicating the purpose for which the information is collected.
So the customer has to be informed that the driver’s licence number is recorded as part of the pharmacist-only medicine sales in order to be able to use or disclose that information to help in drug abuse prevention. This can be achieved with a poster displayed prominently in the pharmacy as it’s done in many pharmacies in Canterbury. However, because this may be unexpected by some customers, it’s also a good idea to draw their attention to it, to make sure they understand the consequences.
We must “take appropriate steps to prevent harm to the patient and the public.”
And on that note, I will now go right back to where we started, Rule 1, our almost forgotten, nevertheless very important rule. Rule 1 says that information can only be collected if it is for a purpose connected with a function or activity of the pharmacy. Although it is worded somewhat broadly, we still have to establish how exactly abuse prevention is connected with the pharmacy’s normal functions or activities. One may argue that it is entirely within our scope, because according to the Code of Ethics we must “take appropriate steps to prevent harm to the patient and the public.” On the other hand some pharmacists say that we are not the Police, it’s not our job, we shouldn’t be involved in this. Personally, I think, we need to distinguish between “ringing the neighbouring pharmacies to tell on naughty customers” and taking part in properly organised initiatives that aim to reduce the harm caused by drugs. Whereas the former can easily turn into an inappropriate, perhaps even illegal disclosure of health information, the latter is our duty. And, yes, I believe that this should be considered part of our normal activities. And this is why I decided to dedicate Part III of the series to the drug abuse prevention initiative in Canterbury.
Consequences of refusal to give information
It becomes very important to have reasonable grounds for refusing the sale, and it cannot be just the policy
As a final thought, I’d like to steer back to the “No ID, no sale” policy and the curly question of what happens if the customer refuses to provide the requested health information. There are two distinct cases and, again, this is partly due to the fact that codeine containing products are not ordinary pharmacist-only products.
The first case is simple. If the information being refused by the customer is listed under Regulation 54A and is compulsory for us to record, then there will be no sale, end of story. In the second case, suppose that the customer is refusing to give their date of birth or driver’s licence number, which is not listed as being required by law, but is required under the pharmacy’s policy. We then have to use our judgement and discretion, and have regard to all the circumstances, including the reason for the customer to not co-operate. At this point, it becomes very important to have reasonable grounds for refusing the sale, and it cannot be just the policy. We do have a duty to prevent harm to the public and the patient, but the patient’s well-being is paramount.
In Part III of the series I will discuss the Canterbury initiative to prevent drug abuse, which I consider a good model. I believe that we have a duty to participate in a properly coordinated initiative to curb the misuse of drugs and to help people who struggle with this problem.
If you haven’t read Part I – The Codeine Problem, you may wish to go ahead and read it now, or jump to Part III – The Canterbury Model, where I discuss a working example of a successful system.
If you would like to suggest a correction, please do so in the comment section or contact me directly via email: mate@pharlaw.nz
