The Ecology of Sampling: A Call to Action

Even taking into account the escalating costs of medications, pharmaceutical companies’ supply of samples to physicians appears to be increasing. Extrapolating from the last figures (published by the Kaiser Foundation in 2004), the pharmaceutical industry now distributes in excess of $22 billion in medication samples in the US. The industry’s spending on free samples, as a percentage of total promotion, has also continued to rise.

The significant waste in the packaging of sample drugs has been well documented. In one study, Eighty-eight percent of pharmaceutical samples’ weight was found to come from materials other than the pills themselves. Another study found that compared to the same medications obtained at a retail pharmacy, five times as much packaging is used to deliver samples.

At a time of growing “green” awareness, and in light of the inertia of the pharmaceutical industry to changing its marketing behavior in medication sampling, there is a need to revisit the issue of waste inherent in medication sampling. There’s a front-end environmental cost to the packing of samples, be it trees or the energy required in manufacturing packaging.

By the Numbers
We examined 13 expired medication samples given to an indigent-care pharmacy
by physicians’ offices. The samples represented five of the top ten drugs on the market-Lipitor, Nexium, Advair, Zyprexa, and Effexor. Likewise, 11 pharmaceutical companies, including six of the top 10 (Pfizer, GlaxoSmithKline, Novartis, AstraZeneca, Merck, and Abbott) by global drug sales in 2006 were represented in our survey.

Weight and composition of the shipping containers were not assessed. Most of the
samples had large outer boxes which contained smaller inner boxes or sleeves. Most of the inner boxes contained a plastic container in the form of either a bottle or housing with pill blisters. Materials used to package the pills included cellophane, metal foil, plastic, and paper making it difficult to compare types of waste between samples. We weighed component parts of the samples, separating pills and inhaler devices from plastic and paper packaging accompanying the samples. The weight of the total waste in a given sample was divided by the total weight of the pills delivered.

There was marked variability in packaging materials and accompanying paper products. Fosamax (one pill per sample) carried the most waste per pill, expressed as a ratio. Almost 99 percent of the total weight of the package was used to deliver the pill. Synthroid and Avandamet required the least packaging, 50 percent of the total package weight. The weight of package inserts (PI), when found, ranged from 2.56g to 10.93g, which for one drug represented 35 percent of the total package weight.

We are fortunate to live in an abundant society; but we are the unfortunate heirs of the by-products of the waste generated by that plethora. This perspective is not intended to indict society at large or any particular industry. The responsibility the healthcare system bears to our environment, society, and the future does not fall on the pharmaceutical industry alone. The United States Pharmacopeia (USP) sets standards that allow for interpretation but must be adhered to. Patients and medical society (hospitals and physicians) must also each play a significant role.  While society needs to acknowledge with greater certitude the pharmaceutical industry’s charitable efforts, PhRMA must emerge as a proactive steward of our environment. Nearly 10 years ago, PhRMA formed an internal task group to address the many issues of pharmaceuticals’ environmental impact. Today, PhRMA needs to promote and champion a new agenda of ecology.

Pharmaceutical companies fully recognize the marketing power of providing samples, as evidenced by the majority of marketing expenditures on sampling and detailing. Packaging contributes to product branding of the samples. The physical presence and appearance of a given drug often dictates prescriptive behavior of clinicians. The amount of medication samples has increased through time. Based on the medication samples distributed in the year 2000, pharmaceutical industry drug sampling practices have then accounted for over 5,700 metric tons of waste. Nine years later, the pharmaceutical industry distributes three times as much medication sample material to physicians; waste in drug sampling may now approximate 20,000 metric tons.

The Ecology of Packaging
This article does not attempt to dissuade pharmaceutical companies from the practice of giving samples. Rather, it challenges pharmaceutical companies to reduce the environmental impact of their packaging and the drugs delivered. Waste produced by drug sampling is the equivalent of the waste produced by over 26,000 individuals in the United States in one year. Advances in recycling are being overshadowed by ever-increasing waste production, demonstrating the need for conservation of materials.

Packaging is the single largest source of solid waste, as well as one that could easily be
reduced through better practices. There are three options for reducing the impact of sampling of medications on the environment: the ecology of sourcing, the ecology of destruction, and education.

Ecology of Sourcing
Sourcing refers to the origin of materials. The drug industry needs to dematerialize minimize the amount of packaging per pill used to deliver samples. This could start as an initiative to reduce packaging per unit pill by at least 20 percent. This goal might be achieved by using thinner and lighter materials. Less material, however, does not necessarily translate into environmentally friendly material. Consideration of what makes the least environmental impact should guide any change. Paper products in the outer packaging of samples we reviewed were made exclusively of virgin paper.

Recycled paper is not as sturdy or as shiny, and ultimately, as desirable as virgin paper. Recycling paper, however, reduces sourcing (forest destruction) and minimizes air and water pollution. And recycled materials, including corrugated paper, need not be more expensive; technology is moving the discussion from sourcing products that are
biodegradable to sourcing of products that are biorenewable. The pharmaceutical industry
should seek to use plastics manufactured from biopolymers that are made from renewable
plant starch not petrochemicals.

The weight of inner packaging can also be pared. GSK and Novartis have moved to eliminate a package insert (PI) with each sample. Instead, certain medications, (e.g. Advair), are accompanied with a medication leaflet which is a fraction of the weight of the PI. This positive step should be adopted industry-wide, as much of the package’s total weight is attributable to the PI. A PI is rarely given to a patient when medication is dispensed at a pharmacy. FDA only requires that one PI be included in each case of samples, and that such detailed information be offered to clinicians by pharmaceutical representatives. Two drugs in our survey, Avandamet and Lescol, carried no drug information packaging.

Ecology of Destruction
In addition to the problems of packaging waste, there is a toxicological toll to a heavily medicated society. More sample medications, and medications in general, ultimately add to the pollution of our food chain and water supply. An estimated 23 million pounds of pharmaceuticals unused by manufacturers and pharmacies are incinerated every year by reverse distributors.

How much medicine is also discarded in the form of solid waste in our ecology chain (landfills) and disposed of by both patients and doctors? Medicines bled and leached into our water supply have potential deleterious effects ranging from promotion of bacterial resistance to teratogenicity to carcinogenicity. A green strategy would also look to remove unused medications and minimize reentry of medications into landfills and our water supply. A green strategy would look to make packaging materials less toxic and biodegradable. The pharmaceutical industry could move to providing more samples per (less) package or more vouchers obviating the need for a subset of samples.

Each company has non-publicized take-back programs of expired samples from doctors’ offices that their own representatives did not know of when questioned. The industry needs to encourage and publicize return or take-back programs of non-used medication from patients and doctors. Such programs need to be a collaborative effort between hospitals, insurance industry, groceries, consumers, politicians, and manufacturers. However, these “take-back” programs address the issue of preventing active pharmaceutical ingredients from entering the environment, they do not address the issue of packaging waste.

The Tao of Education
The environmental philosophy that pharmaceutical companies choose to espouse will be central to inculcating universal change. On March 10, 2008, PhRMA issued a Policy Statement that said, “We are constantly working to ensure that the manufacture, distribution, use, and disposal of our products continue to be conducted in an environmentally safe manner.”

However, corporate jargon and philosophy are not sufficient to create real change. The pharmaceutical industry needs to change the inertia of their business model to become visibly more green. Their actions must challenge the medical complex as well government to follow suit. In turn, physicians and patients need to be educated to become more ecologically conscious. Lastly, the government needs to incentivize those members of PhRMA that cater to the needs of both the environment’s and their patients’ health.

The author would like to acknowledge Nick Saites, a BS candidate at MTSU, for his help in researching this article.