Pharma, Pollution & Patchwork Laws: Vic Explains

By Ed Silverman

Three months ago, Alameda County in California pass an ordinance that requires drugmakers to pay for the disposal of unused and expired prescription medicines. The move, which had been closely watched by other local governments around the country, is the first of its kind in the US and comes after the pharmaceutical industry lobbied to defeat the effort. wants to reduce contaminants in drinking water and also lower the threat of drug abuse stemming from painkillers that linger in household medicine chests (back story). Although various municipalities sponsor ‘Take Back Prescription Medicine Days,’ the ordinance may prompt other local governments to attempt similar efforts, creating a potential patchwork set of laws around the country, a development the pharmaceutical industry does not fancy. Last week, for instance, a legislative commission in Rhode Island was formed to study ways to prevent pharmaceuticals from entering the state water supply. We spoke with Victor Vercammen, director of quality and regulatory affairs at Genco Pharmaceutical Services, which works with drugmakers to develop disposals plans, about the implications

Pharmalot: So now that Alameda County has passed this ordinance, do you expect others to do the same?
Vercammen: Speaking specifically about the initiative in Alameda County, it could be difficult (for the pharmaceutical industry) if we end up with different local initiatives that create a patchwork set of regulations. I don’t believe industry wishes for it to go that way. Whether there is a statewide effort or something that comes along that (addresses the issue) more broadly, that would appear to be easier to deal with.

Pharmalot: Is it catching on?
Vercammen: I don’t have hard data, but there does seem to be a sense that in California, some of the large cities, such as San Francisco and Oakland, have looked at what Alameda County was able to do and did so by gaining political support. And the state assembly in Sacramento is looking at it as well. I would not be surprised if you see some bills introduced for consideration.

Whether it expands to a larger area remains to be seen. There’s a province in British Columbia that is an example of where government has attempted to put a process in place for consumers to have a safe disposal pathway. But the strategies in the US have been disjointed. Some municipalities do it as part of a hazardous waste collection day, like paints, and have pharmaceuticals returned to the same event. Other communities have done it as part of a DEA effort such as narcotics. But there doesn’t seem to be a unified approach. Alameda is unique in providing a funding mechanism and seems to build a template.. That’s really just speculation, but that seems to be what Alameda did.

Pharmalot: You mentioned the DEA. How does the agency fit into this issue?
Vercammen: One of the biggest impediments to a true, comprehensive customer take-back around pharmaceuticals is the controlled substance or narcotic issue. Right now, the DEA permits, under limited circumstances, a citizen to return or turn in a controlled substance. It’s a peculiarity in the way the Controlled Substances Act requires record keeping is performed. The DEA assumes most patients will take all of the product (that is prescribed). But the DEA has struggled with getting that product back on the grid. Part of the problem has been a prohibition on pharmacies and wholesalers taking back controlled substances from citizens, with one exception – police departments.

The impediment to having entities offer a take-back mechanism is that a lay person is not able to separate what’s a controlled substance. You can have an antibiotic versus a sleep aid or a painkiller. You want a single stop to take back your drugs. And it’s fairly spotty around the country. Certain states or metropolitan areas have a strategy. Northern Illinois, through solid waste agencies that handle municipal waste collection, will offer medication take-back mechanisms at the same time they’re taking florescent tubes or paints. But not every community does it that way. On the flip side, there’s an increasing understanding among the public that pharmaceuticals may pose an environmental risk.

Pharmalot: So where does this leave the pharmaceutical industry?
Vercamman: Our advice is, and has been, that we take the Alameda strategy – whether it gets litigated remains to be seen, but I’m not aware of any formal problems – but let’s assume, as with other issues, there’s an attempt to litigate or delay. Just the same, this could provide a template so manufacturers could be ready to deploy a solution ahead of legislation or as a negotiation point against future legislation. It’s not a guarantee, but sometimes you can offer a voluntary solution to forestall a regulation forced upon you. Alameda provides a framework for building a true strategy, to collaborate with a permitted distributor and provide information that’s required.

Pharmalot: What will it be like to implement?
Vercammen: It will be difficult for implementation, as it written. One example – it assumes the citizen is able to return any and all product regardless of who manufactured it and where. It’s not terribly specific. It says there should be a kiosk or mail drop location somewhere in the county. Let’s say that if you sell in the county and your market share is relatively small. If your ability to sell product and inventory turn is also relatively small, you can still end up disposing of a larger share of unwanted pharmaceuticals than sales would otherwise dictate. So I would assume, at some point, pricing would have to take disposal into account. Who’s paying for the service? Even if there are volume discounts, compliance is still costly – incineration, for instance. It seems to be drafted in a way that it comes out of pharma’s margin.

Pharmalot: But many local governments are strained, so is it unreasonable to ask pharma to pay for some of the cost?
Vercammen: If products were prescribed in a manner to support the true need of the patient – and if the products are consumed in a compliant way, there wouldn’t be a lot left over. There is sa hared responsibility. The pharmaceutical industry is not entirely to blame and the patient is not entirely to blame for not finishing product that wasn’t finished. I simply believe that you have to acknowledge there’s more than one party who is responsible for left over product.

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