This is the first in a series of articles focusing on the tension between drug abuse prevention and health information privacy. In our day-to-day practice we encounter this problem way too often and we are expected to get the balance right between protecting the patient (and the public) and respecting their rights under the Health Information Privacy Code. The series offers insight and guidance for pharmacists to better understand the legal issues, what’s expected of them and enabling them to make better calls in curly situations.
A number of codeine containing products are available in New Zealand as pharmacist-only medicines. As with all pharmacist-only products, the pharmacist is required to record information related to the sale under Regulation 54A of the Medicines Regulations. There is a range of reasons why these records must be kept. From the patient’s perspective perhaps the most significant reason is to have a complete medicine history for future reference. From the pharmacist’s perspective the record ensures accountability as well. In case of OTC codeine, however, the records are often used to track usage with a view to identify and prevent misuse. This sets OTC codeine products apart from other pharmacist only medicines as far as health information privacy is concerned.
According to a survey, the majority of pharmacist are concerned about the adverse effects of OTC codeine use, particularly the consequences of misuse. A Stuff article quoted a study published in The Lancet that concluded that over-the-counter and prescription opiate use quadrupled in New Zealand during the last decade. True, the study did not address the question whether and how much misuse and addiction contribute to the increase. In fact, the researchers were at a loss to explain the dramatic increase in opioid consumption. Nevertheless, the rate of increase combined with pharmacists day-to-day experience, the statistics are concerning.
The issue of misuse and addiction has always been a problem, and recently there has been a call from pain specialists for a ban on OTC codeine products. The gist of the argument is that codeine is not effective enough to warrant the risk of addiction. The harmful consequences of codeine addiction are numerous. Number one on the list, and this is largely why “the Therapeutic Goods Administration’s Advisory Committee on Medicines Scheduling in October last year made an interim decision to remove codeine-containing products from over-the-counter sales from June this year”, is the fact that OTC codeine is always in combination with Paracetamol or Ibuprofen. Because there is relatively small amount of codeine in these products, addicts tend to take large quantities, going well beyond the safe limit of the other ingredient, leading to liver failure or stomach bleeding, respectively. However, in response to the TGA’s interim decision further submissions were filed by pharmaceutical companies, so OTC codeine is not going away in Australia, for now anyway. As to New Zealand, “Medsafe said it had not been told of concerns about the medicines.“
Consequently, OTC codeine products are here to stay, and pharmacists continue to be required to make the sales in accordance with the law. The next article will break down the issue of recording the required health information as it applies to codeine containing pharmacist-only products, in light of their potential to be misused.
Drug Abuse Prevention vs Health Information Privacy – Part II – A Practical Analysis
Drug Abuse Prevention vs Health Information Privacy – Part III – The Canterbury Model
