Drug manufacturers release varying amounts of API with the waste that leaves their facilities. The environmental significance of this dumping? No one knows. What is for sure, believes Dr. Irene Ruhoy of Touro University Nevada, is that we must take the issue seriously. Manufacturers need a heightened sense of Pharmecovigilance, she says. The term has myriad components, Ruhoy says, but at its essence it is balancing ecological and human health and safety. Manufacturers must be stewards in regards to the impact of their drugs upon the environment.
We spoke with Ruhoy to get feedback about the problem, and her proposed solutions:
PhM: Would you say that the issue of drugs in our water supply (from wastewater to treated drinking water) is being taken seriously in the U.S.?
I.R.: Yes. In the past five years, there has been an increase in interest from government, industry, NGOs, press, and public advocacy groups. There has also been an increase in published media.
PhM: The main focus of attention thus far has been how consumers dispose of their medications, but how significant is the issue of what manufacturers are releasing in their production wastewater? Are groups such as the PiE (Pharmaceuticals in the Environment) working group equally focused on both issues?
I.R.: Certainly the initial dialogue that began a decade ago focused on disposal. It was a low-hanging fruit since it was common behavior that directly resulted in pharmaceutical injection into the environment. Disposal behaviors allow for a conversation on intervention strategies and potential pollution prevention. Manufacturer release of pharmaceuticals, on the other hand, is a more complex issue. I would say there has been increasing focus on this particular source of pharmaceuticals in the environment by both PiE and other groups.
PhM: What does “Pharmecovigilance” entail from the drug manufacturer’s standpoint? What should manufacturers be doing that they’re not doing now?
I.R.: PharmEcovigilance encompasses all points of the life cycle of pharmaceuticals. This includes the manufacture of the compounds. Manufacturers can play a role in Pharmaecovigilance by monitoring their production waste release for pharmaceutical compounds and periodically assessing production techniques to ensure minimal waste in general and little pharmaceutical release in particular. I am not very familiar with the inner workings of pharmaceutical manufacturing but I would imagine the quality assurance evaluations would include such an assessment.
In addition, Pharmecovigilance further asks manufacturers to contribute to the continued monitoring of rates of non-compliance and hence, disposal, of the medications produced.
Finally, Pharmecovigilance also includes the continued research and development of drug compounds that may help to minimize the impact of pharmaceuticals in the environment – i.e., reduced ecological toxicity, improved environmental or treatment transformation, decreased side effect profile to improve compliance, or even improved metabolic profile for decreased human excretion of parent compound.
PhM: As part of its “green drugs” program, the EU requires pharmaceutical companies to assess the environmental impact of new drugs. Why isn’t this kind of program happening here in the U.S.?
I.R.: I do not know the reasons. There are some forms of toxicity testing done by pharmaceutical companies as required by the FDA. I think in time we will be able to include a comprehensive environmental risk assessment. Historically the emphasis has been on human and public safety and now the emphasis is broadening to include ecological safety.
PhM: Drug manufacturers releasing high levels of API is of course a global issue, with pollution having been documented in India and no doubt occurring in many places. What kind of global effort do you envision to combat this?
I.R.: Increased regulatory oversight for all manufacturing facilities across the globe. We first need more research to assess what would be the maximal allowable concentration of pharmaceutical residues in facility effluent. We have to better understand the fate, transport, and exposure risk of APIs in the environment. With that, we can impose rules and regulations as well as expect stewardship from the manufacturers of the products they manufacture.
PhM: Regarding consumers, one of your recommendations is to have more sophisticated take-back programs for unused medications. Would manufacturers participate in such programs, and if so, how?
I.R.: Manufacturers have recently expressed interest in take back events and some have even given funding for such events or research into the efficacy of such events. I do not think I have advocated take back programs as the ultimate resolution as many obstacles still remain and I am unsure of the long term viability. However, to have a locale that is willing to accept unwanted medications from consumers is a reasonable expectation. At the very least, it can prevent a certain percentage of drugs from simply being flushed down the toilet. It would give consumers option which is something they have asked for.
Manufacturers can contribute by lending their financial support since take back events or tack back options in, for example, pharmacies, can be labor intensive and therefore costly. Tack backs have the potential of providing data on non-compliance of particular medications.
PhM: A primary concern is the toxicological impact (to humans and the environment in general) of long-term exposure to low levels of APIs. Where are we in studying and understanding this impact?
I.R.: Early. There are many factors that make this type of research complicated. We are chronically exposed to multiple compounds and there may be individualized responses to such doses and frequencies of exposure. Nonetheless, it is an area of increasing interest for risk assessors, environmental scientists, toxicologists, and policy makers.