SlideShare a Scribd company logo
1 of 32
Download to read offline
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

More Related Content

What's hot

Marijuana, Opioids and State Laws – What HR Teams Need to Know
Marijuana, Opioids and State Laws – What HR Teams Need to KnowMarijuana, Opioids and State Laws – What HR Teams Need to Know
Marijuana, Opioids and State Laws – What HR Teams Need to KnowCareerBuilder
 
The Opioid Crisis: The Important Role of CPAs
The Opioid Crisis: The Important Role of CPAsThe Opioid Crisis: The Important Role of CPAs
The Opioid Crisis: The Important Role of CPAsPYA, P.C.
 
Effective Strategies For Intervening With Drug Abusing Offenders
Effective Strategies For Intervening With Drug Abusing OffendersEffective Strategies For Intervening With Drug Abusing Offenders
Effective Strategies For Intervening With Drug Abusing Offenderslakatos
 
Miami dade-den-report-2009-2010
Miami dade-den-report-2009-2010Miami dade-den-report-2009-2010
Miami dade-den-report-2009-2010satoriwatersfl
 
MADD Hawaii: Staci Hoff, PhD - Drugged Driving, The Latest Data and Research
MADD Hawaii: Staci Hoff, PhD -  Drugged Driving, The Latest Data and ResearchMADD Hawaii: Staci Hoff, PhD -  Drugged Driving, The Latest Data and Research
MADD Hawaii: Staci Hoff, PhD - Drugged Driving, The Latest Data and ResearchMADD Hawaii
 
State profile -_new_york_0
State profile -_new_york_0State profile -_new_york_0
State profile -_new_york_0satoriwatersfl
 
PSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient Safety
PSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient SafetyPSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient Safety
PSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient SafetyThe Partnership For Safe Medicines
 
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...The Partnership For Safe Medicines
 
Ethics & pharmaceutical industry
Ethics & pharmaceutical industryEthics & pharmaceutical industry
Ethics & pharmaceutical industrySeth Romary
 
Piletz scholarly paper on HW Clinical Trials & Health Disparities presented a...
Piletz scholarly paper on HW Clinical Trials & Health Disparities presented a...Piletz scholarly paper on HW Clinical Trials & Health Disparities presented a...
Piletz scholarly paper on HW Clinical Trials & Health Disparities presented a...John Piletz, PhD
 
Hendricks, la velle a new synthetic drug ije v2 n1 2014
Hendricks, la velle a new synthetic drug ije v2 n1 2014Hendricks, la velle a new synthetic drug ije v2 n1 2014
Hendricks, la velle a new synthetic drug ije v2 n1 2014William Kritsonis
 
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 InterchangePSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 InterchangeThe Partnership For Safe Medicines
 
Verify Network Services Presentation
Verify Network Services PresentationVerify Network Services Presentation
Verify Network Services Presentationmslevy
 

What's hot (18)

TOC PROJECT PPT
TOC PROJECT PPTTOC PROJECT PPT
TOC PROJECT PPT
 
Marijuana, Opioids and State Laws – What HR Teams Need to Know
Marijuana, Opioids and State Laws – What HR Teams Need to KnowMarijuana, Opioids and State Laws – What HR Teams Need to Know
Marijuana, Opioids and State Laws – What HR Teams Need to Know
 
Miami2014
Miami2014Miami2014
Miami2014
 
The Opioid Crisis: The Important Role of CPAs
The Opioid Crisis: The Important Role of CPAsThe Opioid Crisis: The Important Role of CPAs
The Opioid Crisis: The Important Role of CPAs
 
Effective Strategies For Intervening With Drug Abusing Offenders
Effective Strategies For Intervening With Drug Abusing OffendersEffective Strategies For Intervening With Drug Abusing Offenders
Effective Strategies For Intervening With Drug Abusing Offenders
 
Miami dade-den-report-2009-2010
Miami dade-den-report-2009-2010Miami dade-den-report-2009-2010
Miami dade-den-report-2009-2010
 
MADD Hawaii: Staci Hoff, PhD - Drugged Driving, The Latest Data and Research
MADD Hawaii: Staci Hoff, PhD -  Drugged Driving, The Latest Data and ResearchMADD Hawaii: Staci Hoff, PhD -  Drugged Driving, The Latest Data and Research
MADD Hawaii: Staci Hoff, PhD - Drugged Driving, The Latest Data and Research
 
State profile -_new_york_0
State profile -_new_york_0State profile -_new_york_0
State profile -_new_york_0
 
Offlabel strategy
Offlabel strategyOfflabel strategy
Offlabel strategy
 
Prescription Drug Abuse in America
Prescription Drug Abuse in AmericaPrescription Drug Abuse in America
Prescription Drug Abuse in America
 
Drugs In The Water
Drugs In The WaterDrugs In The Water
Drugs In The Water
 
PSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient Safety
PSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient SafetyPSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient Safety
PSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient Safety
 
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
 
Ethics & pharmaceutical industry
Ethics & pharmaceutical industryEthics & pharmaceutical industry
Ethics & pharmaceutical industry
 
Piletz scholarly paper on HW Clinical Trials & Health Disparities presented a...
Piletz scholarly paper on HW Clinical Trials & Health Disparities presented a...Piletz scholarly paper on HW Clinical Trials & Health Disparities presented a...
Piletz scholarly paper on HW Clinical Trials & Health Disparities presented a...
 
Hendricks, la velle a new synthetic drug ije v2 n1 2014
Hendricks, la velle a new synthetic drug ije v2 n1 2014Hendricks, la velle a new synthetic drug ije v2 n1 2014
Hendricks, la velle a new synthetic drug ije v2 n1 2014
 
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 InterchangePSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
 
Verify Network Services Presentation
Verify Network Services PresentationVerify Network Services Presentation
Verify Network Services Presentation
 

Similar to ANALYZING SOLUTIONS FOR UNSAFE PHARMACEUTICAL DISPOSAL final

5.2. Reason for Concern (Batz)
5.2. Reason for Concern (Batz)5.2. Reason for Concern (Batz)
5.2. Reason for Concern (Batz)Teleosis Institute
 
Action research on drug safety assestment
Action research on drug safety assestmentAction research on drug safety assestment
Action research on drug safety assestmentReymart Bargamento
 
Green pt1 state-pmp
Green pt1 state-pmpGreen pt1 state-pmp
Green pt1 state-pmpWelcome40
 
Marijuana Truth or Propaganda?
Marijuana Truth or Propaganda?  Marijuana Truth or Propaganda?
Marijuana Truth or Propaganda? Teresa Miller
 
3.5. Facts About Disposal in the U.S. (Kreisberg)
3.5. Facts About Disposal in the U.S. (Kreisberg)3.5. Facts About Disposal in the U.S. (Kreisberg)
3.5. Facts About Disposal in the U.S. (Kreisberg)Teleosis Institute
 
Global Medical Cures™ | Responding to America's Prescription Drug Abuse Crisis
Global Medical Cures™ | Responding to America's Prescription Drug Abuse CrisisGlobal Medical Cures™ | Responding to America's Prescription Drug Abuse Crisis
Global Medical Cures™ | Responding to America's Prescription Drug Abuse CrisisGlobal Medical Cures™
 
Money and politics the opiate epidemic
Money and politics the opiate epidemicMoney and politics the opiate epidemic
Money and politics the opiate epidemicMrsunny4
 
Alcohol, tobacco and other drugs
Alcohol, tobacco and other drugsAlcohol, tobacco and other drugs
Alcohol, tobacco and other drugsemy1353
 
INTERPROFESSIONAL COLLABORATION IN PHARMACOEPIDEMIOLOGY STUDIES
INTERPROFESSIONAL COLLABORATION IN PHARMACOEPIDEMIOLOGY STUDIES  INTERPROFESSIONAL COLLABORATION IN PHARMACOEPIDEMIOLOGY STUDIES
INTERPROFESSIONAL COLLABORATION IN PHARMACOEPIDEMIOLOGY STUDIES Surya Amal
 
Pharmacoepidemiology (2)
Pharmacoepidemiology (2)Pharmacoepidemiology (2)
Pharmacoepidemiology (2)Ahmad Ali
 
2012 How did Rx abuse become a National Epidemic in the US
2012 How did Rx abuse become a National Epidemic in the US2012 How did Rx abuse become a National Epidemic in the US
2012 How did Rx abuse become a National Epidemic in the USTeresa Miller
 
The-Case-for-Practice-Integration[1]
The-Case-for-Practice-Integration[1]The-Case-for-Practice-Integration[1]
The-Case-for-Practice-Integration[1]Amy Williams
 

Similar to ANALYZING SOLUTIONS FOR UNSAFE PHARMACEUTICAL DISPOSAL final (17)

5.2. Reason for Concern (Batz)
5.2. Reason for Concern (Batz)5.2. Reason for Concern (Batz)
5.2. Reason for Concern (Batz)
 
Action research on drug safety assestment
Action research on drug safety assestmentAction research on drug safety assestment
Action research on drug safety assestment
 
ENVS capstone poster
ENVS capstone posterENVS capstone poster
ENVS capstone poster
 
Green pt1 state-pmp
Green pt1 state-pmpGreen pt1 state-pmp
Green pt1 state-pmp
 
Marijuana Truth or Propaganda?
Marijuana Truth or Propaganda?  Marijuana Truth or Propaganda?
Marijuana Truth or Propaganda?
 
Booklet version 7.7
Booklet version 7.7Booklet version 7.7
Booklet version 7.7
 
3.5. Facts About Disposal in the U.S. (Kreisberg)
3.5. Facts About Disposal in the U.S. (Kreisberg)3.5. Facts About Disposal in the U.S. (Kreisberg)
3.5. Facts About Disposal in the U.S. (Kreisberg)
 
14drugpr
14drugpr14drugpr
14drugpr
 
Pharmacogenetics Ppt
Pharmacogenetics PptPharmacogenetics Ppt
Pharmacogenetics Ppt
 
Global Medical Cures™ | Responding to America's Prescription Drug Abuse Crisis
Global Medical Cures™ | Responding to America's Prescription Drug Abuse CrisisGlobal Medical Cures™ | Responding to America's Prescription Drug Abuse Crisis
Global Medical Cures™ | Responding to America's Prescription Drug Abuse Crisis
 
Money and politics the opiate epidemic
Money and politics the opiate epidemicMoney and politics the opiate epidemic
Money and politics the opiate epidemic
 
Alcohol, tobacco and other drugs
Alcohol, tobacco and other drugsAlcohol, tobacco and other drugs
Alcohol, tobacco and other drugs
 
INTERPROFESSIONAL COLLABORATION IN PHARMACOEPIDEMIOLOGY STUDIES
INTERPROFESSIONAL COLLABORATION IN PHARMACOEPIDEMIOLOGY STUDIES  INTERPROFESSIONAL COLLABORATION IN PHARMACOEPIDEMIOLOGY STUDIES
INTERPROFESSIONAL COLLABORATION IN PHARMACOEPIDEMIOLOGY STUDIES
 
Pharmacoepidemiology (2)
Pharmacoepidemiology (2)Pharmacoepidemiology (2)
Pharmacoepidemiology (2)
 
2012 How did Rx abuse become a National Epidemic in the US
2012 How did Rx abuse become a National Epidemic in the US2012 How did Rx abuse become a National Epidemic in the US
2012 How did Rx abuse become a National Epidemic in the US
 
Addco
AddcoAddco
Addco
 
The-Case-for-Practice-Integration[1]
The-Case-for-Practice-Integration[1]The-Case-for-Practice-Integration[1]
The-Case-for-Practice-Integration[1]
 

ANALYZING SOLUTIONS FOR UNSAFE PHARMACEUTICAL DISPOSAL final

  • 1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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