ANALYZING SOLUTIONS FOR UNSAFE PHARMACEUTICAL DISPOSAL

Santa Clara University

Olivia Chambliss, Keely Graskamp, Allison McNamara, and Mallory Miller

Table of Contents Executive Summary………………………………………………………………………….. 2-3 Introduction…………………………………………………………………………………... 3-5 Review of Literature…………………………………………………………………………………..… 5-11 Research Methods……………………………………………………………………………………... 11-13 Findings……………………………………………………………………………………... 13-20 Policy Options……………………………………………………………………………..... 20-21 Evaluative Criteria ….………………………………………………………………………. 22-23 Future Scenarios…………………………………………………………………………….. 23-25 Comparative Analysis ………………...…………………………………………………….. 25-27 Critical Analysis……………………………………………………………………………. 27 Recommendations …………………………………………………………………………… 28 Conclusion………………………………………………………………………………….. 28-29 Appendices………………………………………………………………………………… 30 References …………………………………………………………………………………. 31-32

2

Executive Summary

Unused pharmaceuticals pose risks to the environment and to public health. Ecosystems,

and the organisms that inhabit them, are adversely affected by pollution from pharmaceuticals.

Unused medication in the home is also a poisoning risk to children and the elderly. Extended

producer responsibility (EPR) is one way to resolve the consequences created by this issue. To

better understand this problem, our group researched the perspectives of various stakeholders

that are affected by the improper disposal of pharmaceuticals. We reached out to consumers,

lobbyists for the Pharmaceutical Research and Manufacturers of America, Generic

Pharmaceutical Association, and Biotechnology Industry Organization (conclusively PhRMA),

small scale pharmacies, chain pharmacies, and city government officials through interviews. We

also researched cases of EPR in the pharmaceutical industry as well as in other industries to

better understand the logistics of these programs.

Our research suggests that PhRMA has not shown support of county level ordinances that

require the industry to fund pharmaceutical drop off locations. Consumers and small scale

pharmacies are supportive of increasing pharmaceutical drop off locations at pharmacies. Chain

pharmacies recommended disposing of unwanted pharmaceuticals at police stations, but would

be supportive or more options similar to city funded disposal programs.

We suggest three possible policy options to mitigate the issue of improperly disposed

medication. These options are city ordinances that require PhRMA to fund drop off locations,

city funded drop off locations, and privatized disposal that puts the burden directly on the

consumer. County ordinances that require PhRMA to fund drop off locations would be the best

course of action to resolve this issue because it holds the producer responsible for the life cycle

of its product. This would result in increased public awareness about the issue, cleaner water

3

sources, and improvement in public health. This would also put pressure on PhRMA to design

pharmaceuticals that do not persist in the environment.

Introduction

PhRMA is a multibillion dollar industry in the United States and produces all of the

prescription drugs bought and sold in the country. In the year 2012, the top 11 PhRMA

companies in the nation earned nearly $85 billion in net profits (drugwatch.com), but currently,

there are no federal laws put in place that enforce PhRMA to fund extended producer

responsibility programs.

Extended producer responsibility is “an environmental policy approach in which a

producer’s responsibility for a product is extended to the post-consumer stage of a product’s life

cycle” (OECD 2014). The purpose of potentially adopting laws that would enforce PhRMA to

fund EPR programs would be to provide consumers with a safe alternative to dispose of

unwanted drugs, and also to encourage the producers to consider environmental issues in the

design and production of goods.

Sometimes consumers do not finish taking prescribed medications, and as a result they

are either disposed of improperly, left in a cabinet to sit, are stolen, or are dangerously

consumed. Each of these options pose a health threat to the public and the environment. These

public and environmental health threats are defined in greater detail in the Review of Literature

of this report.

According to the Santa County Department of Agriculture and Environmental

Management, the adoption of county ordinances that would enforce PhRMA to fund EPR

programs is the ideal solution to mitigating the public and environmental health issue that come

with improper disposal or improper storage of unused pharmaceuticals. In fact, Santa Clara

4

County’s neighbor, Alameda County, is the first to pass an ordinance to do just so. PhRMA,

however, has been bitterly fighting the enforcement of the ordinance in state and Supreme Court

lawsuits. Shortly after the federal court ruled in favor of upholding the Alameda County

ordinance, the county and city of San Francisco introduced legislation modeled after Alameda’s

that would also require pharmaceuticals to fund EPR programs at pharmacies. The

pharmaceutical industry appealed the ruling, however, so the appeal case is still pending in the

Supreme Court, and these ordinances have yet to be implemented.

Our client, Rob D’Arcy, who is the division manager of Santa County Department of

Agriculture and Environmental Management, asked our group to interview various stakeholders

who partake in the pharmaceutical manufacture supply chain for our project. He wanted us to

find out what policies these stakeholders would like to be put in place to help solve the

environmental and public health threats that come with the improper disposal and neglect of

unused pharmaceuticals. We interviewed lobbyists, manufacturers, distributors and sellers of

pharmaceuticals and conducted a convenience sample survey of 50 residents of Santa Clara

County to answer the following, carefully crafted research questions:

• What is PhRMA’s opinion of EPR?

• What is PhRMA’s desired program to deal with unused pharmaceuticals?

• What do pharmacies (small-scale and chain) think of EPR?

• What is pharmacies’ desired program to deal with unused pharmaceuticals?

• What does the public know about safe drug disposal?

• What is the public’s desired program to deal with unused pharmaceuticals?

• How do unsafe disposal and consumption of pharmaceuticals affect the environment and

public health?

5

In addition to sharing the findings to these research questions, in this report we propose

and critically evaluate four policies various stakeholders discussed that could potentially

decrease the improper disposal of pharmaceuticals, and the public and environmental health

threats that inevitably come with it.

Review of Literature

Consequences of Improper Disposal of Pharmaceuticals

Public Health and Safety

The most important and disturbing effect of improperly storing and disposing of

pharmaceuticals is the adverse consequences for health and safety. Drug overdose is the top

cause of accidental death in the United States for working-age adults, and half of these deaths are

due to abuse or misuse of prescription drugs (Newsmax). In 2012, prescription drug overdoses

occurred most frequently in adults between ages 45 and 49 and the lowest rate was in children

under age 15 (CDC). Moreover, in 2013, 51.8% of drug overdoses were due to prescription drug

abuse (22,767 deaths total).

Teenagers and young adults have been found to take advantage of the lackluster way in

which drugs are disposed of. “Pharm parties” are social gatherings during which medications

from around the household are collected and then recreationally ingested in order to get

high. These parties have been compared to a game of Russian roulette by doctors in

rehabilitation centers because effects of mixing medications, especially when alcohol is

involved, is widely unknown (xcpi.com). Reportedly 19% of teenagers across America have

taken prescription medication as a recreational way to get high (McBride 2015). Drugs for these

parties are acquired as both over-the-counter purchases and from stealing out of medicine

cabinets in their homes.

6

The elderly (age 60 and older) fall victim to prescription drug abuse due to confusing

bottles and pills, not being able to read descriptions and side effects, and forgetting what drugs

they have taken. With 83% of the elderly population taking prescription drugs, one quarter of

prescription drugs sold in the United States are purchased by the elderly, and prevalence of abuse

is nearly 11% within this demographic (Baska 2008; Culberson and Ziska 2008). This issue is

magnified by the amount of medications that go unfinished and wait in the homes of the elderly

until taken at a later time or being disposed of. With drugs literally at their fingertips, abuse and

addiction is easy and convenient.

Accessibility of prescription drugs that have been stored around the household instead of

safely disposed of contributes to ease with which people access dangerous drugs. No longer is

the concern only for children who accidentally swallow pills they may find, but also for elderly

who mistake drug labels, or working-age adults who use medication as a way to unwind after

work. This is not a problem that is taking care of itself, as evident by the fact that the number of

drug overdoses on prescription drugs more than doubled between 1999 and 2013 (CDC).

Environmental Impacts

Water quality of the San Francisco Bay has gained attention due to pharmaceutical

residues that have been detected that may cause adverse effects in both aquatic species and

humans. According to the National Oceanic and Atmospheric Administration (NOAA) chemical

compounds from medications and hormones remain biologically active long after consumers

forget about them, especially hormones such as estrogen. Wastewater plants are unable to treat

for the chemical compounds found in medications, therefore the only place for pharmaceutical

residues to go is into our aquatic system. Ecological effects of these contaminants in sediments,

rivers, streams, estuaries, and groundwater are largely unknown but evidence is mounting that

7

they negatively affect aquatic species reproduction and stimulate development of antibiotic

resistant bacteria.

Threatening chemical compounds from pharmaceuticals enter the waste water in several

ways. A common, and incorrect, form of disposing of unused pharmaceuticals is flushing the

pills down the toilet or pouring them down the drain where they directly enter

wastewater. PhRMA’s website recommends that consumers dispose of unused pharmaceuticals

in their household waste by mixing it with cat litter or some other masking agent. From here the

drugs make their way to a sanitary landfill where chemical compounds eventually leak through

the protective layers and into the groundwater with leachate, eventually entering wastewater and

the bay. Moreover, roughly 80% of all pharmaceuticals consumed by patients are naturally

excreted through the body and into the wastewater.

Extended Producer Responsibility

Extended Producer Responsibility (EPR) is defined by the Organization for Economic

Co-operation and Development as “an environmental policy approach in which a producer’s

responsibility for a product is extended to the post-consumer stage of a product’s life cycle”

(OECD). The purpose of EPR is not only to shift responsibility, but also to encourage producers

to consider environmental issues in the design and production of goods. Pharmaceutical

companies and Pharmaceutical Research and Manufacturers of America (PhRMA) have been

fundamentally opposed to the idea of implementing EPR for pharmaceuticals although the costs

would ultimately pass along to the consumers in the form of increased product prices. EPR has

been successfully implemented for several other types of hazardous waste such as paint, as well

as with pharmaceuticals in other countries such as Canada and states in the European Union.

PaintCare Inc.

8

PaintCare Inc. is a non-profit organization that represents paint producers in the United

States to plan and operate paint stewardship programs (paintcare.org). Since PaintCare has been

established across eight states, including California, paint retailers can volunteer to be drop-off

locations thus relieving the burden put previously on government-run household hazardous waste

(HHW) facilities. According to PaintCare’s official website, the paint manufacturing industry

supports EPR laws because they enable the industry to implement collection by providing a level

playing field among manufacturers and retailers. PaintCare is funded through additional fees on

each container of architectural paint sold in states with a paint stewardship program which vary

from state to state. This small line item funds “paint collection, transportation, recycling, public

outreach, and public administration,” as well as the disposal of the “expired” product (Need

citation).

Single-Use Batteries

Battery companies like Duracell and Energizer execute Extended Producer Responsibility

by voluntarily paying for take-back programs. A contact of our client, Mark Boulish, has

calculated that for a successful take-back program for batteries, the cost to customers would

increase only about one cent per battery. The SB 1100 (Corbett) Household Battery Recycling

Bill of California would have mandated that household battery manufacturers cover the costs of

planning for and implementing end-of-life management of their products (CLCV). SB 1100

would have greatly reduced the waste from single-use batteries and made their disposal safe and

convenient. However, lobbying from battery manufacturers and high tech firms depleted

Assembly support and the bill died at the closing of the 2009-10 legislative session. California

Senator Ellen Corbett was the author and main advocate for SB 1100 (CAW). Despite red-tape

and trouble on the west coast, Vermont has managed to become the first state in the United

9

States to pass House Bill 695 which requires battery manufacturers to coordinate collection and

recycling of alkaline or single-use batteries (Elliot 2014). Consumers will most likely face a

slight increase in battery price to cover the costs. Producers are required to create at least two

collection locations for batteries in each of the state’s 14 counties (Elliot 2014). Connecticut is

planning to introduce a similar bill during its 2015 legislation (environmentalleader.com)

Pharmaceutical EPR in the EU

Several countries within the European Union have exemplary pharmaceutical EPR

programs. The most senior of these programs is Cyclamed in France which was found in 1993

as a voluntary program, but became a mandated law in 2007. This program is completely funded

by the pharmaceutical industry and all 22,400 pharmacies in the country are drop-off locations

(calpsc.org). Bonusage in Belgium was organized in 2002 through pharmaceutical wholesalers,

manufacturers, and pharmacies, and funding for the program is split between wholesalers and

manufacturers. Hungary passed legislation in 2005 to establish Recyclomed which is funded by

drug manufacturers and mandates all pharmacies to be drop-off locations. Portugal implemented

Sistema Integrado de Gestao de Residuous de Embalagens de Medicamentos (SIGREM) in 2001

which is a voluntary participation program for pharmacies that is funded by pharmaceutical

manufacturers, distributors, and the national pharmacy association. Despite the voluntary status

of this program, 99% of pharmacies participated in take-back in 2011. Since 2003, Spain has

had take-back directed by nonprofit organization SIGRE Medicines and the

Environment. Funding is provided by manufacturers and over 21,000 pharmacies operate as

collection sites (calpsc.org).

10

Case Studies

Alameda County Ordinance

Alameda County, California passed the Alameda County Safe Drug Disposal Ordinance

in July 2012; however, it has yet to be implemented due to opposition and lawsuits by

PhRMA. Although both city and state legislation has found the Ordinance constitutionally

sound, PhRMA has appealed to the Supreme Court and the case is pending approval.

If implemented, the Alameda Ordinance will mandate that pharmaceutical companies

fund EPR programs throughout the county. Pharmacies, clinics, and hospitals will act as drop-

off locations for both medications and controlled substances. Our client estimates that the

program will cost roughly $315,000 to serve close to 5 million citizens. This cost would

eventually fall back on the consumer as pharmaceutical companies slightly raise prices (by a few

cents) to compensate the cost of running the program. Medications that are dropped off at the

designated locations will be picked up and taken for safe disposal by incineration.

PhRMA argues that implementing the Ordinance violates the dormant Commerce

Clause. Lobbyists claim that it will interfere with interstate commerce while the county argues

that lack of a take-back program not only endangers public and environmental health, but

unfairly places the burden of cost on consumers (Keely’s citation). The California State

Association of Counties and the League of California Cities supports Alameda County on the

grounds that (1) local governments may, under the dormant Commerce Clause, enact non-

discriminatory laws that affect but do not burden interstate commerce, (2) local governments

have the power to place the responsibility of waste disposal on private entities as part of their

traditional authority to regulate waste disposal, and (3) “shifting” costs of waste disposal from

Alameda County to the private sector is within the county’s authority (Amicus Brief SCC).

11

Sunnyvale City-Funded Disposal

Sunnyvale, California decided to take the issue of improper disposal into its own hands

and has begun a city funded drop-off program at fire stations. Locals are able to bring extra

pharmaceuticals to the stations which will then store them safely until they are shipped off for

destruction.

Research Methods

Overview

This section summarizes methods used to determine the various perspectives of

stakeholders regarding EPR and pharmaceutical take back programs. Stakeholder interviews

were conducted in person and over the phone to generate opinions about the most feasible

solutions for reduction of improper medicinal disposal. These include interviews with PhRMA

lobbyists, chain pharmacies, small-scale pharmacies, and members of city government. Similar

information was collected from consumers by surveying 50 Santa Clara County residents in front

of the Martin Luther King Jr. Public Library in San Jose, CA. These surveys shed light on public

knowledge of safe disposal and preferences for unwanted pharmaceuticals. Geographic

Information Systems (GIS) mapping was used to overlay population density data with current

pharmaceutical drop off locations within the county. Google Maps was used to identify all

pharmacies in Santa Clara County, in turn reflecting the potential for increased drop-off locations

through promotion of EPR. The pros and cons of city-funded and producer-funded disposal

programs were assessed through a comparative case study. The subjects in this analysis are

Sunnyvale and Alameda County. Finally, risks generated from improper consumption and

disposal of medications were assessed for both public health and water quality.

12

This project is founded on information supplied by our client regarding PhRMA’s

opposition to take back programs, similar industries that exercise EPR, consequences of expired

and excess medication, and quantitative data regarding finances for programs. Documents

regarding policies, court cases, environmental and public health and safety, and pharmaceutical

industry-based responses have been analyzed, and help generate a footing for finding new and

more detailed information. Incorporating background and client information has proven to be the

foundation of this project. Specifics for each method outlined above are listed below, while

results and conclusions can be found in the Findings section.

Stakeholder Interviews

Two in-person interviews were conducted with pharmacies we categorized as “small”

because they were not chain stores, sold nothing but medications and medical supplies, and were

independently owned. Discussions with the pharmacists at each respective location regarded

opinions on the funding of medication drop offs as well as organizations that redistribute

unneeded medication and the proposed bills that allow this to occur.

Four Walgreens chain-store pharmacies were contacted by phone. These locations were:

one Sunnyvale, one San Jose, and two Santa Clara locations. Questions regarded the pharmacies’

suggestions for disposal of unwanted or expired medications and the potential for increased

pharmaceutical collection sites.

To learn more about city-funded collection programs and suggested locations for

disposal, various departments of different city government offices and businesses were

contacted. These phone conversations include insight from the Santa Clara Hazardous Household

Waste hotline, the Sunnyvale Environmental Services and Solid Waste Department, a Santa

Clara Pet Hospital, and Fire Departments in both Santa Clara and Sunnyvale. Additionally, in-

13

person interviews were conducted regarding current disposal practices of Santa Clara University

with Cowell Health Center and the Facilities Manager.

Public Survey

Fifty residents of the city of Santa Clara, encountered in front of the Martin Luther King

Jr. Library in San Jose, CA, were given a seven-questions survey asking the following

questions:

1. What do you think is the safest way to dispose of unused prescription drugs? 2. What is your age? 3. Do you have unused prescription drugs in your home? 4. If so, where are they located? 5. How do you dispose of unused prescription drugs? 6. Do you know where your nearest unused prescription take back medication station is located? 7. How would you prefer to safely dispose of unused prescription drugs? Contacting Lobbyists

Two phone interviews took place with one previous and one current PhRMA lobbyist.

Questions asked regarded opinions of county-adopted EPR ordinances, proposed bills such as

AB-45, and recommended policies.

Assessing EPR Programs

Current organizations that exercise EPR were analyzed to better understand the costs to

both producers and consumers, and any potential middlemen involved in the distribution process.

Specifically, PaintCare’s methods for successfully funding take-back programs were assessed.

Battery companies like Energizer and Duracell also exercise producer-funded voluntary take

back and were briefly incorporated into this study.

Findings

Our stakeholder interviews revealed a variation in opinion on how the issue of improper

pharmaceutical disposal should be handled. The lobbyists that represented distributors and

14

manufacturers of pharmaceuticals did not support EPR. Surprisingly, opinions among

pharmacies differed between small scale pharmacies and chain pharmacies. Small scale

pharmacies favored producer funded EPR while chain pharmacies favored police stations as drop

off locations. Representatives for Santa Clara University’s Health Center and Facilities

Department both supported EPR. The Santa Clara County Recycling and Waste Reduction

Division Manager supported EPR for pharmaceuticals as well. Our public survey revealed that

most people do not know that the improper disposal of pharmaceuticals is a public health risk as

well as an environmental one.

Stakeholder Opinion

PhRMA Lobbyist Against county adopted EPR ordinances due to danger of drug diversion, supports AB-45 as a citizen, not as a lobbyist

Past PhRMA Lobbyist PhRMA wants a consistent policy that is controlled by the federal government as to avoid discrepancies between counties

Small-scale pharmacies Supports producer funded EPR with drop-off locations at pharmacies and redistribution programs

Chain pharmacy Suggested police stations for drop-off locations

SCU Cowell and Facilities representatives

Support campus as a drop-off location, but need resources

SC County Recycling and Waste Reduction Division Manager

Supports PhRMA funded EPR and safe disposal of drugs with drop-off locations at pharmacies

Lobbyist Interviews

We conducted a phone interview with John Benton, who is currently a lobbyist consultant

for AmerisourceBergen Corporation, one of the three biggest pharmaceutical distributors in the

nation. Benton has represented the generic pharmaceutical association and has worked with

pharmaceutical companies in the past. Benton does not support county adopted ordinances that

15

require “producers” to fund take back programs at local pharmacies (J. Benton, personal

communication, February 6, 2015).

One potential problem Benton sees with the Alameda County EPR Ordinance is that the

drug diversion aspect of it could be dangerous. The two pronged approach that Alameda

County’s Safe Drug Disposal Ordinance uses says controlled substances, like pain killers, are

supposed to be dropped off at the police station and other drugs are supposed to go to retail

pharmacies. The problem is, however, that some consumers may not know the difference

between the two, and controlled substances could accidentally be brought to pharmacies, while

safe pharmaceuticals could accidentally be brought to police stations. Benton thinks that is very

likely that if this ordinance goes into full effect, drugs will get mixed up in the improper bins.

This is problematic because controlled substances will be sitting in bins that are not being

watched by a police officer. Benton has concerns that police stations will be inundated with the

drugs from consumers who don’t know the difference between controlled substances and those

that can be dropped off at the pharmacy.

Benton spoke about a bill that has been proposed in the 22nd District of California to help

mitigate this issue. The bill, AB-45, “would establish curbside household hazardous waste

collection programs, door-to-door household hazardous waste collection programs, and

household hazardous waste residential pickup services as the principal means of collecting

household hazardous waste” in order to divert it from California’s landfills and waterways

(Mullin, 2014, p.1).

Under this approach the existing waste system in every county would work with the local

waste management company to develop a process where the consumer could put old drugs in a

safe container. A safe container will be delivered to consumers upon request, and they will place

16

the drugs in it to be picked up with the rest of their trash, recycling, and green waste. The

company responsible for picking this up will organize a safe and reliable system for getting the

hazardous waste to a medical waste hauler who will dispose of it properly. Those using the

service would then get billed in the broader rates for waste, or get billed at a special cost for the

individuals. Benton thinks more people would use the service if it were to be spread across the

overall rate paid for waste. This bill would take care of drug diversion issues that are happening

with the ordinance laws.

Benton personally likes the AB-45 approach, not speaking for his client. He said it would

provide him, as a consumer, an opportunity to safely dispose of these drugs without having to

figure out what kind of drugs he has exactly and therefore the proper place to bring them to.

Emily Lam is the Vice President of Health Care and Federal Issues for the Silicon Valley

Leadership Group. The Silicon Valley Leadership Group (SVLG) is a business group that

conducts non-partisan analyses of public policies for their clients. SVLG has worked for PhRMA

in the past and a discussion with Ms. Lam offered some insight in to the reasoning behind the

industry’s decision to not support take back programs (E. Lam, personal communication,

February 2, 2015). When asked in the phone interview what PhRMA’s opinion on extended

producer responsibility for their products is, Ms. Lam emphatically responded that PhRMA did

not wish to shirk responsibility on the issue of old and unwanted prescription drugs. PhRMA’s

reluctance to participate in take back programs is due to the inconsistency of county level

ordinances for these programs. According to Lam, PhRMA prefers predictability when it comes

to using their funds to finance take back programs. A county by county implementation of take

back programs is not the best way to organize these programs. Lam said that PhRMA would be

open to working with a nationwide, federally implemented take back program. This would

17

ensure that policy would be consistent and enable PhRMA to work more efficiently to allocate

funds for take backs. When asked whether or not PhRMA was actively looking to work at a

federal level to help start a nationwide take back program, Lam said that SVLG hasn’t worked

with PhRMA recently and that she did not know the answer to this question.

Pharmacy Interviews

Interviewing pharmacies was divided into two categories: small scale pharmacies and

chain store pharmacies. For chain pharmacies, we concluded that suggested drop off locations

are police stations, however there was a general lack of understanding if all police stations acted

as collection sites, if there were additional collection sites near the pharmacies, and why the

pharmacies do not collect unwanted medications themselves. Small pharmacies, on the other

hand, preferred acting as a drop-off location but were generally unable to fund this program

themselves, therefore supporting EPR. Additionally, redistribution programs for the pharmacy

that was connected with a health center seemed to be the most desired option. These programs

allow excess medications within participating health centers or assisted living locations to be

redistributed when patients no longer require them.

18

Public Survey Results Figure 1

On February 17, 2015 we

collected 50 surveys outside of

Martin Luther King library in San

Jose, a city located in Santa Clara

Valley. San Jose is the county seat of

Santa Clara County and is the largest

city in the San Francisco Bay Area

(City of San Jose, 2015.) We

conducted the survey in this location

with the hopes of obtaining a

representative sample of the San Jose

population. The purpose of the survey

was to assess public knowledge about

the issue of improperly disposed

pharmaceutical. We found that fifty-

two percent of the people surveyed had unused medication at home (see figure 1). Many people

did not know how to properly dispose of the their pharmaceuticals and they did not know where

their nearest drop off station was located (Seventy-two percent and eighty-three percent

respectively.) When asked how they would prefer to dispose of their unused medication fifty

percent of the people surveyed said that they would prefer to return their medication to their local

pharmacy. Nine percent preferred to drop off their pharmaceuticals at a police station and

thirteen percent said that they would like to have their unused medication picked up in a safe

19

container with their recycling and garbage. Roughly a quarter of the people surveyed (twenty-six

percent) said that this was the first time they had heard about the problem of unsafe

pharmaceutical disposal. Two percent said that it did not matter how their medication was

disposed of.

Geographic Information Systems and Google Mapping Figure 2

Figure 2 uses GIS to show the fourteen

current pharmaceutical drop-off locations in

Santa Clara County overlaid with population data.

The layers of the map emphasize convenience, or

lack thereof, of pharmaceutical disposal for

differing concentrations of people. Figure 3

depicts store locations of existing pharmacies in

the county. When juxtaposing these maps we can

assess the ease at which residents can access

pharmaceuticals and the difficulty and

inconvenience to safely rid of them.

20

Figure 3 similarly represents the potential Figure 3

amount of drop off locations consumers could

expect to see through programs that incorporate

EPR at pharmacies.

Policy options

Alternate Situations

Throughout the data and information collecting process for this project, four potential

policy options remained relevant to each conversation. The options and their respective

descriptions are listed in Table 1. Opinions regarding the presumed benefit for each option are

described in the Findings and Results section, along with results from each method presented

above.

21

Table 1: Different options for improved pharmaceutical waste disposal.

Option Description

Alameda County Ordinance

PhRMA argues that passing this ordinance will interfere with interstate commerce while the city argues that the lack of a take back program not only endangers public and environmental health but unfairly places the burden of cost on consumers as opposed to producers3.

Sunnyvale’s City-Funded Disposal

The City of Sunnyvale funds secure collection at various fire departments so that residents have more accessible pharmaceutical drop-off locations.

Redistribution Programs

Companies redistribute unwanted and/or unneeded pharmaceuticals to people who are unable to afford them but still in need of them, decreasing the incineration process as well as the occurrence of improper disposal.

Privatization- AB 45

This proposed bill would establish curbside household hazardous waste collection programs, door-to-door household hazardous waste collection programs, and household hazardous waste residential pickup services as the principal means of collecting household hazardous waste (Alameda County Personnel, Administration, and Legislation Committee Request Form, 2015).

22

Evaluative criteria

Table 2: Environmental, social, and economic impacts for each policy option

Policy Option Environmental Impacts Social Impacts Economic Impacts

A) County Ordinance -EPR and pharmacies as drop off locations

- Reduction of pharmaceutical residues and waste in waste water and SF Bay - Increase amount of material incinerated and emissions from incineration and transportation

- Reduction in instances of accidental overdoses - Reduction in instances of “pharm parties” - Reduction of trace amounts of pharmaceuticals in tap water - Convenience of disposal for consumers

- Increase in consumer cost of prescription by cents - Increase in disposal costs for PhRMA

B) City Funded -Fire Stations as drop off locations

- Reduction of pharmaceutical residues and waste in waste water and SF Bay - Increase amount of material incinerated and emissions from incineration and transportation

- Extra responsibility and liability for firefighters - Reduction in instances of accidental overdoses - Reduction in instances of “pharm parties” - Reduction of trace amounts of pharmaceuticals in tap water - Convenience of disposal for consumers

- Financial burden on city to provide funds for safe storage and disposal of drugs

C) Privatization (AB 45), curb- side pick up

- Reduction of pharmaceutical residues and waste in waste water and SF Bay

- Increase employment - Increase of social awareness - Security issue of curbside HHW collection - Convenience factor is very high

- Increase employment - Burden of cost is put on consumer

23

D) Business as Usual

- Increase of contamination in the Bay - Pollution of tap water - Antibiotic resistant bacteria - Buildup of pollution in sediment - Fish and amphibian reproductive and hormone disruption

- Continuation of overdoses and poisonings - Unsafe storage of drugs in homes - Lack of public awareness and education continues

- Economic output continues unchanged

Future scenarios

The Alameda County Ordinance is implemented, PhRMA companies and distributors

will have to launch educational programs to spread awareness of their extended producer

responsibility programs. This would have a very positive effect on the county. More people

would understand why it is important to bring back their drugs to their local pharmacy, and

because every pharmacy would be required to have an EPR program, it would be much more

convenient for the public to dispose of their unused drugs properly. This ideally, would lower the

amount of pharmaceutical residues in waste water and in the San Francisco Bay, reduce the

amount of accidental overdoses due to improper consumption of unused pharmaceuticals, reduce

the amount of controlled substance abuse, and reduce the amounts pharmaceutical traces in tap

water. But there are also a variety of barriers that could happen if this ordinance were to be

implemented. This ordinance is not clear in determining who will fund the EPR programs.

Because the term “producer” in the ordinance is defined as “The Person who manufactures a

Covered Drug and who sells, offers for sale, or distributes that a Covered Drug in Alameda

County under that Person's own name or brand,” any of the top 11 PhRMA companies or the top

3 distributor companies will potentially have to fund the educational aspect and the take back

aspect of this ordinance. There will create discrepancies as to who “produced” (made or

24

distributed) which drugs, which could result in fights over who should fund the EPR programs of

the various pharmacies. This could result in pharmaceutical manufacturers and distributors suing

each other over who should pay for what. The ordinance is very vague in this sense. Pinpointing

the responsible party will be a difficult process, especially if consumers are returning drugs to

pharmacies they didn’t originally get them from. A city funded take back program would allocate funds to secure collection at various fire

departments so that residents have more accessible pharmaceutical drop-off locations. This

would place a heavy burden on the city though to find the money to do so, taxes would probably

be bumped up a bit. Also, the educational aspect of unsafe pharmaceutical disposal wouldn’t

really be covered, and the public would remain unaware of the situation. Therefore, the situation

wouldn’t really be solved. This solution still would not drastically increase the amount of

convenient places a consumer could to drop off drugs at.

Implementing the bill AB-45 would privatize the take back industry. Consumers would

have to pay private companies to pick up their pharmaceutical waste. This could play out in two

different ways-- consumers would happily adopt this practice similar to how consumers have

adopted to recycling waste, or they would not want to bear the burden of paying for an additional

curbside pickup program. However, if consumers were to adopt this method, PhRMA companies

will be much less likely to design, fund, and operate collection and end-of-life management

systems for their products (CPSC 2015), and they would be much less likely to use green

chemistry in the future to produce their products to break down more naturally in the

environment. But overall, because this proposed bill has not been fully developed, and only

contains intent language, future impacts to the County cannot yet be fully determined (acgov.org,

2015).

25

If business as usual continues to press forward, children and the elderly will continue to be

exposed to pharmaceuticals that are stored improperly in cabinets. Pharmaceuticals will continue

to be disposed of improperly, and the public will remain uneducated about this problem. This

option could potentially be the worst out of all of the options. Contamination in the Bay and in

drinking water will increase, antibiotic resistant bacteria will develop in our water, fish,

amphibian, and even human reproductive and hormonal balances will increasingly be disrupted.

We do not have enough information on how pharmaceutical build up in our water truly affects

humans, this is a fairly new problem. We cannot fully predict exactly how humans will be

affected by pharmaceutical build up in our water, but we can guess that it will not be good.

Comparative Analysis

Considerations regarding environmental impacts consist of either negative effects in

wastewater resulting in endocrine disruption for aquatic species, antibiotic resistant bacteria, and

trace amounts ending up in tap water, or increased transportation emissions from hauling

medications to proper disposal and the emissions generated from incineration once delivered to

the incineration plant. Effects on the public are categorized by reduced risk of accidental

overdose, reduced occurrence for pharm parties as described in Table 2, greater convenience for

unwanted medication disposal, and reduction of trace amount of pharmaceuticals in tap water.

Economic burdens alternate between consumer, producer, city government, and city residents.

Each of these components is addressed when comparing and evaluating each policy option after

implementation.

Overall, implementing a county ordinance like that of Alameda would generate improved

benefit for the aquatic environment and public health while placing economic burdens on

consumers and producers. The economic “burden” to consumers, however, would equate to cents

26

per prescription, and when evaluated with benefits to public health through decreased

opportunity for accidental overdose and cleaner available water, this financial cost does not

suggest opposition from consumers. Additionally, the increased cost of disposal for PhRMA

could pressure them to create “greener” products that either absorb more efficiently into the

patient –thus reducing waste from excretion- or do not pose as many risks to aquatic organisms

and wastewater. Impacts generated through the incineration of pharmaceutical and

transportation emissions to these sites continue to pose risks for the environment, concentrated

specifically in Utah where the burning takes place.

City funded collection programs similarly reduce social risk by decreasing likelihood for

overdose and environmental risk in wastewater. Environmental impacts regarding incineration

and transportation remain the same when comparing county ordinances and city funded

collection, however consumers are no longer placed with the small financial burden. Now, local

governments are burdened with the fees of establishing secure drop-off locations while PhRMA

is not required to pay for their lack of EPR.

Implementation of proposed bills like AB45 also generate less environmental risk in

wastewater, greater environmental impact through increased transportation emissions and

incineration practices, and increased convenience for disposal. Financial burdens are absorbed by

all residents whether or not they are consumers of pharmaceuticals, as well as the city to supply

proper means for disposal to residents. This proposal also increases the likelihood for

undocumented and illegal drug use and sales, which in turn generates greater risk for public

health and safety.

Refraining from implementation of any policy generates the greatest impact to public

health because of the opportunity for abuse and overdose to occur, inconvenience of ridding of

27

unwanted medications, and negative consequences that result from pharmaceuticals in

wastewater. Consumers who do not live, work, or travel near any of the 14 disposal locations in

the county are placed with a financial burden equal to that of increased cost for a county

ordinance. Emissions for transportation and incineration are still generated, but PhRMA does not

face any economic burdens,

Critical Analysis

Overall our project was very hands-on, consisting of three differents kinds of research.

We conducted multiple interviews with stakeholders, analyzed policy, and conducted a public

survey. Conducting interviews with a wide range of stakeholders was intimidating at first,

especially when lobbyists did not acknowledge our efforts. Fortunately, the more calls we made,

the more confident we felt discussing these important issues with professionals in the industry.

Stakeholders representing the pharmaceutical companies’ interests were not receptive to abiding

by county level ordinances regarding pharmaceutical disposal, using the argument that interstate

commerce should not be regulated at county level. The only way to get these companies to pay

for these programs seems to be through court action.

Analyzing policy took patience because reading through so many legal documents,

legislation, and court documents required concentration and dedication. The most intriguing

results of the survey was the fact that most people did not know that improper disposal of

pharmaceuticals is currently a pressing issue. The survey illustrated that the public needs to be

more educated on this problem. We think that the aspect of the Alameda County Ordinance,

which would require pharmaceutical companies to launch educational campaigns on the issue,

would be a vital aspect of mitigating the problem.

28

Recommendations

The improper disposal of pharmaceuticals directly threatens public and environmental

health, making immediate action necessary. Legal action has proven to be the most likely means

of encouraging pharmaceutical companies to fund take back programs. Proposed bills, such as

AB-45, mitigate the occurrence of improper disposal but they are dependent on public support

for implementation. Therefore, increased public education should be prioritized. Additionally,

financial support and government participation are all necessary to resolve this issue. The

solution to the improper disposal of pharmaceuticals must address the needs of all stakeholders

both fairly and equitably.

Conclusions

As we have demonstrated in this report, pharmaceutical waste is a complex issue with

extensive public health and environmental ramifications. The stakeholders involved in this issue

are consumers, pharmacies, the drug manufacturers and distributors (represented by lobbyists

and private interest groups.) In order to determine what would be the best and most feasible

solution to this issue, we used interviews, surveys, and a case studies. The solution would have to

best serve the interests of every stakeholder involved.

The most important information revealed by the survey highlighted the fact that most

people do not know where their local pharmaceutical drop off was located. This showed that this

is an issue that does not have a lot of visibility. Through interviews with pharmacies local to

Santa Clara County we found that most pharmacies were open to creating drop off programs

providing they had the funds to facilitate these programs. A few interviews with lobbyists and

other representatives revealed that pharmaceutical companies would be willing to provide

financial assistance with take back programs if the federal government were to get involved and

29

set a nationwide standard. These stakeholder issues came to a head in our case study of the

Alameda County ordinance that required pharmaceutical manufacturers to provide funding for

take back programs. The pharmaceutical companies protested with some arguments that it this

ordinance unfairly targeted drug manufacturers when many other parties and stakeholders were

responsible for the movement of pharmaceuticals.

The issue of improper pharmaceutical disposal is a complicated one with many different

stakeholder viewpoints on how to solve this problem. Any type of positive change would require

the government, the public, or the private sector to act. Though there has been some public

action in support of EPR, there needs to be much more public and government support if this

problem is ever to be resolved.

30

Appendices

Apendix 1:

Santa Clara University Research Survey Survey Location: MLK library Survey # _______ 1. What do you think is the safest way to dispose of unused prescription drugs? 2. What is your age?

a.18-29 years b. 30-49 years c. 50-64 years d. 65 years and older

3. Do you have unused prescription drugs in your home? a. Yes b. No

4. Where are they located? a.Kitchen cabinet b.Bathroom c.Bedroom d.Out in the open e.Other

5. How do you dispose of unused prescription drugs? a. I don’t b. Flush down toilet c. Throw away in garbage in plastic bag d. Throw away in garbage e. Other

6. Do you know where your nearest unused prescription take back medication station is located? a. Yes b. No

7. How would you prefer to safely dispose of unused prescription drugs?

a. Drop off at nearby pharmacy b. Drop off at police station c. Have it picked up in safe container with recycling and trash d. Doesn’t matter e. This is the first time I’ve ever heard of this

31

References Alameda County Safe Drug Disposal Ordinance. Title 6, Chapter 6.53, Sections 6.53.010 through 6.53.120. Baska, Belinda. (2008). The elderly and prescription drug misuse and abuse. Prevention Tactics 9:2. Big Pharma Manufacturers Drug & Device Companies; Lawsuits & Facts. (2015, January 9). Retrieved February 24, 2015, from http://www.drugwatch.com/manufacturer/ "California - PaintCare." PaintCare. N.p., n.d. Web. 11 Feb. 2015. <http://www.paintcare.org/paintcare-states/california/>. CAW. (2014). SB1100 Household battery recycling bill. CDC. (2015). Prescription Drug Overdose in the United States: Fact Sheet. Culberson, J. W., & Ziska, M. (2008). Prescription drug misuse/abuse in the elderly. Geriatrics, 63(9), 22-31. E. Lam, personal communication, February 2, 2015 Elliot, B. (2014). Vermont is first to usher in battery EPR. Resource Recycling. Environmental Leader. (2014). Connecticut prepares to launch battery EPR bill. "Fact Sheet: Community Profile." Sanjoseca.gov. City of San Jose, 2015. Web. J. Benton, personal communication, February 6, 2015 Levy, M. (2010). Drugs in water: a San Francisco Bay case study. The Sustainability Review. McBride, H. (2015, March 8). Pharm Parties: Fact or Fiction? Mullin. (2014, December 1). AB 45 Assembly Bill - INTRODUCED. Retrieved March 13, 2015, from http://www.leginfo.ca.gov/pub/15-16/bill/asm/ab_0001-0050/ab_45_bill_20141201_introduced.html Newsmax. (2014). Top Cause of Accidental Death in US: Drug Overdoses. http://www.ecovote.org/bill/battery-epr-bill-shorts-out "Our Service." SIRUM. N.p., n.d. Web. 12 Feb. 2015. <http://www.sirum.org/our-service/>.PAL LEGISLATIVE COMMITTEE REQUEST FORM. (2015, January 12). Retrieved March 13, 2015, from http://www.acgov.org/board/bos_calendar/documents/DocsAgendaReg_1_12_15/PAL/PAL_AB_45_Mullin_1_12_15.pdf

32

Pharmaceutical Research and Manufacturers of America; Generic Pharmaceutical Association; Biotechnology Industry Organization, v. Alameda County, California; Alameda County Department of Environmental Health. The United States Court of Appeals for the Ninth Circuit. 22 Jan. 2014. Print. Sanborn, H. (2015, February 9). Letter of Concern on AB 45 – Household Hazardous Waste Local Government Mandate. Retrieved March 13, 2015, from http://calpsc.org/mobius/cpsc-content/uploads/2015/02/CPSC-Letter-of-Concern-AB-45-Mullin-FINAL-2-9-15.pdf vv