EVRA AND THE ENVIRONMENT

(A closer look at one product and its impact on the environment, to accompany the Women and Health Protection fact sheet, “Pharmaceuticals in the Water”)

Prepared by Suzanne Elston for Women and Health Protection
September 2004

Evra is the first contraceptive hormonal patch approved for use in Canada. This transdermal patch, which was approved for use in 2002, is promoted for its convenience. Once used, it still contains a large amount of a persistent, synthetic hormone that has been found to feminize male fish. Each patch contains 6.0 mg of norelgestromin and 0.60 mg of ethinyl estradiol, which are delivered at a daily rate of 150 mcg and 20 mcg, respectively. When the patch is discarded after seven days, it still contains 4.95 mg of norelgestromin and 0.46 of ethinyl estradiol (or 82.5% and 76.7%, respectively). According to Janssen-Ortho, the manufacturer of the patch, this high level of waste is necessary to ensure adequate transdermal delivery.

If the patch is folded in half and discarded with other household waste, as Janssen-Ortho recommends, the residual hormone may well find its way into the ecosystem and pollute our waterways. In Europe, the patch is distributed with its own disposal pouch. While this still doesn't guarantee that the hormones won't eventually leak out into the environment, it does illustrate an important point. Disposal instructions are not based on what's good for the global ecosystem, but rather on what's required in each regulatory environment.

The Evra patch is just one example of how our legislative framework has failed to examine the entire life cycle of a drug before it is licensed for use. A similar product, Organon's NuvaRing disposable contraceptive ring, will be available in Canada early in 2005. In Europe, where the ring is already in use, the recommended disposal options are compliant with strict European environmental standards. In the US, the product comes in a reclosable foil pouch with a safety warning. Organon Canada will determine how the disposal of their product is presented in this country based on current regulations.

Both products shed light on a glaring hole in the drug approval process in Canada. In both cases, use has been approved based on direct health applications; but our current regulatory framework doesn't even consider their lasting impact on our environment - which ultimately affects our health. The problem is that drug approval - a responsibility of Health Canada - does not take drug disposal into account. Health Canada's jurisdiction over drug disposal currently extends only to controlled substances, whether illegal or narcotic.

The impact that the disposal of drugs has on the environment is the responsibility of environment ministries, mostly at the provincial level. The actual disposal of hazardous drugs is the responsibility of municipal waste systems, for wastes disposed of by individual households, and of licensed medical/hazardous waste disposal companies in pharmacy take-back programs. This multi-level, multi-ministerial, public/private sector shared responsibility has created a jurisdictional gridlock. Unfortunately most prescription drugs, including those containing synthetic hormones that are known to be endocrine disruptors, are not classified as hazardous waste.

So in response to the question, "How can drugs like Evra be approved without an environmental assessment?" the answer is that Health Canada had no regulation that required it. While the Canadian Environmental Protection Act (CEPA), passed in 1999 and administered by Environment Canada, does have a set of regulations intended to protect Canada’s environment by preventing pollution, these regulations were not designed to deal with some of the special problems posed by pharmaceutical products. Neither Environment Canada nor Health Canada have applied CEPA regulations to Evra or other pharmaceutical products.

Every opportunity for a pharmaceutical chemical to leach into the water table, allows a discharge into the natural environment. Although we are only beginning to understand the bioaccumulative effect that these chemicals can have on the health of the ecosystem, the little we do know is enough to say that any discharge is unacceptable. What we ingest will ultimately be excreted into the sewer system. Currently, there is no way to avoid or control the amount of discharge once drugs have been consumed. Where we do have control is in preventing unused or expired medication, in this case the residual hormone contained in the Evra patch, from entering the ecosystem. The question is, how?

The first step is consumer education. Product packaging should be clearly and prominently labeled. Women need to understand that the bulk of the hormones remain in the patch after use, necessitating special disposal procedures to prevent environmental harm. This raises a question about the wisdom of using the patch rather than more environmentally friendly alternatives. If patches are used, they should never be flushed down the toilet. Used patches must be kept out of reach of small children and pets.

The second, and perhaps most important, step is regulation. All levels of government need to support an ecosystem approach to drug approval in Canada. The safety, use and efficacy of any drug only represent part of the picture. How that drug enters the environment and how it interacts with other drugs and known pollutants must be taken into consideration. The Environmental Impact Initiative, a federal program formerly known as the Environmental Assessment Regulations Project, is moving in this direction. This program includes regulatory changes, research and public education. But the development of regulations is proceeding at a snail’s pace and new regulatory requirements are unlikely to take effect for several years. To be truly effective, environmental considerations must become systemic and primary in all levels of government decision-making, with a status similar to that of financial considerations. In order to accomplish this, Health and Environment ministries at the federal and provincial levels must make concerted efforts to harmonize their regulations.

The third step is disposal. Dumping used pharmaceuticals in landfills is not an acceptable option. Many pharmacies offer take-back programs for their customers. Once drugs have been accepted by a pharmacy, there are provincial regulatory requirements that govern their safe disposal by a licensed company, either through medical waste incineration or autoclaving and landfilling. Unlike garbage incineration, medical waste incineration is subject to much tougher emissions and combustion guidelines and provides a safer environmental option for disposing of these wastes than landfilling or dumping into the sewage system. However, costs can be considerable, with incineration costing ten times as much as traditional landfilling and these costs are currently assumed by the pharmacies, not the pharmaceutical companies. Pharmacies generally pay a pick-up fee, plus a cost per pound for disposal. They can refuse to take back used and expired drugs, particularly if they haven't dispensed them.

Unfortunately even if these programs recovered all post-consumer pharmaceutical waste, one senior waste management executive estimates that this would only constitute about 10 percent of the total tonnage of prescription drugs that ultimately ends up in landfills. Pharmaceutical companies are directly dumping the rest - legally! There are no regulations that prevent the dumping of non-hazardous waste and the bulk of pharmaceuticals, including hormone products, are not classified as hazardous. What's needed is a national, regulatory initiative that considers the cradle-to-grave impact of pharmaceuticals.

For the consumer, take-back programs provide one option for responsible waste disposal. Environment Canada's mercury thermometer take-back program was extremely successful. Consumers returned mercury thermometers to their pharmacy in return for a $10 discount on a digital unit. Pharmacies and manufacturers - both of whom benefited from the sale of new digital thermometers - shared the cost of the program. An important aspect of the success of this program was that it made good business sense for both pharmacies and manufacturers.

The second option for consumers is to use the household hazardous waste programs that have been established by many municipalities across Canada. Even though they are technically not classified as hazardous, used and expired pharmaceuticals can be dropped off at hazardous waste centres along with household chemicals, paints and used batteries.

Ultimately we get what we demand. Speak up. Contact your federal member of parliament, member of provincial parliament and local municipal representative. Use the toll-free number included on most product packaging to demand that pharmaceutical companies adopt responsible waste management policies.

Let your voice be heard!

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Glossary of terms

Transdermal: Literally to transfer through the skin. Certain drugs/chemicals are absorbed more effectively through the skin and provide a constant, steady dose of medication.
Endocrine disruptor: Dr. Theo Colborn, author of "Our Stolen Future" defines an endocrine disruptor as "a compound that interferes with the production, release, transport, metabolism, binding action and /or elimination of hormones in the body."
Bioaccumulative: Toxic chemicals are isolated and stored in fatty tissue of living organisms. These toxins accumulate exponentially as they move up the food chain. Much like the greenhouse "effect" this is known as a bioaccumulative "effect" - i.e. the end product of many chemicals interacting.
Autoclaving: The process of sterilizing drugs, vaccines and bio-hazardous waste with pressurized steam. The process doesn't destroy or reduce the waste, which still requires landfilling.

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