This quarter a new project came in requiring us to revive our long-sleeping narcotic license as we were requested to take on the distribution of a newly developed narcotic drug for the treatment of pain in the Netherlands. Contrary to non-narcotic medicinal products, such opioids cannot be distributed from a single European warehouse to all member states. Global narcotic regulations here prevent the “free movement of goods, capital, services and people throughout the EU” and each cross-border transaction of narcotics in the EU requires the presence of a narcotic import-license on the receiving side as well as a narcotic export license on the sending side. In addition to this, regular quarterly and yearly reports are required by the Narcotics Authority in every country.
While apparently some patients require the administration of such narcotics for their pain relief, other patients require quite the opposite as they suffer from a disease called narcolepsy and which is characterized by the loss of the brain’s ability to regulate sleep-wake cycles normally, leading to excessive daytime sleepiness. This quarter we got involved in organizing the pre-approval distribution of a new medicinal product for this indication. Such a compassionate-use program requires specific statements from prescribing physicians and requires dedicated cooperation by pharmacists as no reimbursement applies to medicinal products without a marketing authorization. Luckily enough we have enough experienced pharmacists in our team who know community pharmacies from within and are able to communicate effectively with general practitioners and community pharmacists.
But more paperwork was on the table this quarter as we submitted another biocide application for one of our clients. Although certain elements of such applications are very similar to medicinal product applications, in particular the manufacturing and quality control aspects, other elements strongly differ. First of all, the ecological toxicity is more significant compared to medicinal products as usually larger quantities of the product will be used to disinfect surfaces or body areas and as a consequence the environmental impact is larger. But more important is the reflection of efficacy studies in the product information. If the efficacy studies demonstrate a necessary residence time of 15 minutes for the required biocidal effect, how do you get your cleaning and disinfection staff to really wait such a period of time in their late evening shift, and when sleepy times arrive……?