State of Washington Passes “Drug Take-back Program for “Covered Drugs”

On June 7, 2018, the Engrossed Substitute House Bill 1047 (ESHB 1047) officially went into effect in the State of Washington for all holders of Washington State issued pharmaceutical licenses.¹ In an attempt to ensure “a ‘secure medicine take-back system for Washington residents,’² ESHB 1047 establishes a ‘Drug Take-back Program.” This bill establishes new reporting requirements for wholesale distributors: “[t]his law requires that all drug wholesalers provide DOH with a list of manufacturers of covered drugs sold for residential use in or into Washington.”³

The impetus behind the creation and passage of this law is tied to legislative findings that many of the problems Washington faces in relation to medical drugs (abuse, suicide, accidental poisonings/overdoses, etc.) result from easy access to medical drugs use in the home.⁴ As such, the Washington legislature believes that by instituting a Drug Take-back Program, to ensure that any unused or expired product that is present in residents’ homes does not accumulate and become the source of the problems mentioned above.⁵

Additionally, the Washington Legislature wanted to ensure that there would be a uniform and accessible procedure in place to prevent possible harmful disposal methods such as “disposing of medicines by flushing them down the toilet or placing them in the garbage can contaminate groundwater and other bodies of water,” which can “contribut[e] to long-term harm to the environment and animal life.”⁶ ESHB 1047 goes on the specify the funding source for this program as well, stating explicitly that the program is to be “operated and funded by drug manufacturers.”⁷

1. In theory, Washington’s program sounds great. It establishes a program to help combat common problems caused by easy access to medical drugs. However, on a more detailed level, the program as it stands now has many logistical and legal difficulties that will surely affect its implementation and success.
   First among these difficulties is the sheer amount of data the Washington DOH will have to handle in establishing and maintaining this program. The program requires wholesale distributors licensed in Washington to provide lists of manufacturers of “covered drugs” for which the wholesale distributors sell drugs into Washington for “residential use.”⁸ The reason for concern lies in these two terms. Both terms are clearly very specialized terms when it comes to this program, but, as discussed below, this can cause problems for both wholesale distributors and the DOH when trying to comply with the requirements for this program.

“Covered drugs” include both prescription and non-prescription drugs, any drugs contained in medical devices, and any drugs used for veterinary use for household pets.⁹ This definition covers a massive number of drugs, meaning that wholesale distributors will likely have to send the DOH very long lists of manufacturers, which the DOH must then work through and validate to assess compliance with ESHB 1047. This not only creates much additional work for the DOH, but it also raises concerns for oversights or mistakes due to the sheer volume of data.

Related to the point above, the DOH will likely receive much more data than it actually needs or is relevant to the reporting requirements established by ESHB 1047, because many of the key terms of the law are vague or difficult to understand. For example, the law specifies that distributors must provide lists of manufacturers of drugs the distributor sells “for residential use.” Nowhere in the law itself is “for residential use” defined. Presumably, based on the enumerated purpose behind the law and also the types of “covered drugs” listed (and the types of exempts listed),¹⁰ “for residential use” would apply to any drug that is to be administered/used by a patient in their own home, without any medical professional’s assistance. But, this is only a hypothesis, as there exists no concrete definition of “for residential use.” This total lack of a definition would create difficulty for wholesale distributors and the DOH for the following reason.
 
“For residential use” is not defined anywhere in the text of the bill. Because of this, it will be difficult for wholesale distributors to determine exactly which drugs/manufacturers are subject to the reporting requirement. This could also result in either under-reporting or over-reporting. In the case of under-reporting, this could cause problems for the wholesale distributors in the form of possible disciplinary actions from the DOH and also would result in problems for the DOH, because certain manufacturers may slip through the cracks if there is under-reporting, thus undermining the purpose (and funding source) of ESHB 1047. In the case of over-reporting, this would cause a burden for both the wholesale distributor, in the form of having to spend more time in adding non-covered manufacturers to its reporting list, and the DOH, which would be dealing with a lot of non-relevant data and having to deal with the heavy operating burden discussed earlier. Either way, both the DOH and wholesale distributors would be hurt.

In sum, although the purpose and subsequent program behind ESHB 1047 are theoretically a good idea, as the law stands now in terms of implementation, language, etc. achieving that purpose most likely will prove difficult due to operational and legal concerns. In order for this program to actually achieve what it was created to do, ESHB 1047 needs to be refined more to address the problems enumerated above. If Washington State can manage to do that, and establish an efficient and detailed procedure and set of rules for its Drug Take-back Program, it could serve as a model for many of the other states in this country that are being ravaged by the same problems, addiction, abuse, suicide, etc. Washington State attempts to remedy with this program. But until such time that Washington State can refine this program and the rules surrounding it, it will only serve to hurt wholesale distributors and the DOH, which will prevent the program from truly achieving the purpose it was created to serve.

References

1. E.S.H.B. 1047, 65th Leg., 2018 Reg. Sess. (Wa. 2018).
2. Chris Baumgartner, Subject: Notification to drug wholesalers selling covered drugs in or into Washington, WA. DEPT. OF HEALTH DIV. OF HEALTH QUALITY ASSURANCE (June 7, 2018).
3. Id.
4. E.S.H.B. 1047, 65th Leg., 2018 Reg. Sess. (Wa. 2018).
5. Id.
6. Id.
7. Id.
8. Baumgartner, supra note 2.
9. Id.
10. Id. at 2.

About Us

Based just outside of Philadelphia, Pharma Solutions provides actionable guidance and excellent administrative services with a focus on client care across Compliance, Commercial, and Quality solutions. Our mission is to improve the health and welfare of the American public by providing solutions and implementing best practices for companies in the pharmaceutical supply chain.