Tag Archive for: Pharmaceuticals

Section 2: Scientific Explanation of Pharmaceutical Contamination

Pharmaceuticals in Our Water Part 3: Section 2, Subpart B – Scientific Explanation of Pharmaceutical Contamination, Environmental Impact. Meanwhile, the link between the consumption of pharmaceutically contaminated water and ill health effects in humans has been insufficiently studied. However, there is no shortage of studies establishing deleterious effects to animals living in environments with pharmaceutically contaminated waters.  Such effects include the following: “abnormal thyroid function and development in fish and birds; decreased fertility in fish, shellfish, birds, and mammals; decreased hatching success in fish, birds, and reptiles. In addition, demasculinization and feminization of fish, birds, reptiles, and mammals; defeminization and masculinization of gastropods, fish, and birds; decreased offspring survival; and alteration of immune and behavioral function in birds and mammals.”[23]

              Firstly, of particular note is the effect that pharmaceutical estrogens and antidepressants have on aquatic life. For example, in a Canadian study, scientists polluted a lake with estrogens in concentrations similar to that found in a local municipal water supply.[24] Secondly, scientists observed the fathead minnow present in the lake water and after four years, “the fish had all but disappeared from the lake.”[25] Furthermore, the male fish had become sterile or transformed into female fish and the female fish essentially received a low dose administration of birth control (which is essentially estrogen).[26] In conclusion, three years after the scientists ceased the estrogen treatment, the fish population returned to normal.[27]  

Contaminants should never be present in our water supply.

However, a different study about pharmaceuticals in our water found that when male fathead minnows are exposed to birth control for a majority of their life, they become female and are unable to reproduce.[28]  For instance, such gender-swapping effects have been observed in fish at estrogen concentrations as low as three parts per billion.[29]  For reference, this concentration can be achieved by dissolving one birth control pill into 2,641 gallons of water.  “[A] Generally, a human female using the birth control pill will excrete this amount in her urine over the course of a single day.”[30]  In addition to estrogens, the presence of antidepressants has ill effects on aquatic life including the triggering of spawning in bivalves and crustaceans, decrease in prey capture ability, and reduced predator avoidance.[31]

[23] Thomas M. Crisp et al., Environmental Endocrine Disruption: An Effects Assessment and Analysis, 106 Envtl. Health Persp. 11, 11 (Supp. 1998).

[24] Halford, supra note 2.

[25] Id.

[26] Id.

[27] Id.


[28] Id.


[29] Id.

[30] Id.

[31] Melissa M. Schultz et al., Antidepressant Pharmaceuticals in Two U.S. Effluent- Impacted Streams: Occurrence and Fate in Water and Sediment, and Selective Uptake in Fish Neural Tissue, 44 Envtl. Sci. & Tech. 1918 (2010).

Section 2: Scientific Explanation of Pharmaceutical Contamination

A.   Human Impact

              Most pharmaceuticals in the water occur in concentrations far below prescribed dosages.  Nevertheless, micro-dose exposure to many drugs over a long period poses great human health risk.[8] Pharmaceuticals are designed to effect biological change, and thus these compounds pose a greater risk to human health than other anthropogenically- originating chemicals in the environment.[9] Additionally, human exposure to pharmaceuticals in water is not limited to the water humans consume.  Exposure also occurs through the consumption of fish and shellfish that have bioaccumulated pharmaceuticals or have been in contact with contaminated water.[10] The most studied side effect of consuming pharmaceutically contaminated water is endocrine system disruption.[11]

 Endocrine resistance occurs when drugs that mimic naturally occurring hormones or drugs that are exogenous forms of hormones produced in the body are consumed and cause the endocrine system to stop producing its own hormones.[12] Such endocrine disrupting affects can “include breast cancer and endometriosis in women, testicular and prostate cancers in men, abnormal sexual development, reduced male fertility, alteration in pituitary and thyroid gland functions, immune suppression and neurobehavioral effects.”[13]  There is a direct relationship between the generational decline in men’s testosterone and luteinizing hormone levels and the amount of birth control prescribed for and consumed by women.[14]

              Pharmaceuticals in the water also contribute to antimicrobial resistance, which occurs when microbes that adapt to antimicrobial agents reproduce and then pass on that resistance gene.[15] Such resistance poses serious public health risks, such as the need for\multiple rounds of antibiotics to kill bacteria or the inability to fight infections altogether.[16]

              While antimicrobial resistance of the endocrine system and to antibiotics is an indisputable effect of consuming pharmaceutically contaminated water, some scientists argue that there are few other side effects to human consumption of such water.[17] This camp believes that new sewage treatment mechanisms are not necessary. But there is a large group of scientists who disagree. They argue that there have not been enough studies conducted and that presently there are inefficient means to detect the threats that long term, low dose consumption of many pharmaceuticals pose.[18]


  Despite the lack of human studies, there have been many studies on how pharmaceutically contaminated water impacts individual human cells. In one study, scientists exposed healthy cells to a dosage of pharmaceuticals similar to that found in Italian rivers – the result was that cells grew a third as fast as they did prior to exposure.[19] Another study found that breast cancer cells exposed to estrogens taken fromfish that were caught near sewage plants grew twice as quickly as unexposed cells.[20]  Other studies have found that individual drugs can cause cell growth, but when drugs that cause growth are combined with other drugs, growth can actually be slowed.[21] Such effects prove that pharmaceuticals have synergistic effects. Yet in the lab and in testing for humans, such effects are not studied because most drugs are not designed to be stacked with other compounds.[22]

[8] Kolpin, supra note 1.

[9] Halford, supra note 2.


[11] Karyn Feiden, Pharmaceuticals Are in the Drinking Water: What Does It Mean?, Rapid Pub. Health Pol’y Response Project: Geo. Wash. Sch. of Pub. Health & Health Serv., 3 (April 2008)

[12] Thomas M. Crisp et al., Environmental Endocrine Disruption: An Effects Assessment and Analysis, 106 Envtl. Health Persp. 11, 11 (Supp. 1998).

[13] Tanya Tillett, Summit Focuses on Pharmaceuticals in Drinking Water, 117 Envtl. Health Persp. A16, A16 (2009).

[14] Id.

[15] Antimicrobial Resistance, World Health Org. (Mar. 2016), http:// www.who.int/ mediacentre/factsheets/fs194/en/.

[16] Christopher T. Nidel, Regulating the Fate of Pharmaceutical Drugs: A New Prescription for the Environment, 58 Food & Drug L.J. 81, 83-84 (2003).

[17] Halford, supra note ii.

[18] Id.

[19] How Meds in Water Could Impact Human Cells, MSNBC (Feb. 16, 2010), http:// www.msnbc.msn.com/id/23558785.

[20] Id.

[21] Id.

[22] Francisco Pomati et al., Effects and Interactions in an Environmentally Relevant Mixture of Pharmaceuticals, 102 Toxicology Sci. 129, 129 (2008).

Section 1: Introduction

              Pharmaceuticals in our water. Pharmaceuticals are in our rivers, streams, lakes, oceans, and ground and soil waters.  A U.S. Geological survey conducted from 1999-2000, found at least one of ninety-five organic wastewater contaminants, such as “antibiotics, other prescription drugs, non-prescription drugs, steroids [and] reproductive hormones” in eighty percent of the one-hundred and thirty-nine streams sampled.[1] A 2008 Associated Press investigation revealed “[a] vast array of pharmaceuticals including antibiotics, anti-convulsants, mood stabilizers and sex hormones […] in the drinking water supplies of at least 41 million Americans” in twenty-four major metropolitan areas.[2] In 2013[3], the U.S. Environmental Protection Agency found that there were at least twenty-five different active pharmaceutical ingredients in the water at fifty large wastewater treatment plants across the United States.[4]

              Despite the pervasiveness of pharmaceuticals in our nation’s waters, authorities have taken little action to prevent further contamination or to address existing contamination.  However, federal environmental statutes do not directly address the discharge of pharmaceuticals into water.  As a result, most wastewater processes do not target pharmaceutical contaminants[5];nor could they due to lack of capacity and technology.[6] Therefore, many believe that regulating pharmaceutical discharge is a futile exercise.  Christian Daughton of the EPA noted that “[g]iven the vast array of mechanisms of drug action and side effects. The total number of different toxicity tests possibly required to screen the effluent from a typical [sewage treatment plant] could be impractically large.”[7]

              Furthermore, the discussion that follows includes a scientific explanation of the human and environmental impacts of pharmaceutical discharges and the sources of such discharges. (as Section 2); The current legislation that regulates pharmaceutical discharges (as section 3); the scientific solution to preventing pharmaceuticals from entering waters (as part of section 4); and a feasible legal remedy to pharmaceutical discharges (as part of section 4). Additionally, the discussion as a whole makes the case that unregulated pharmaceutical discharges present serious environmental and human health risks that demand statutory directive.

[1] Dana W. Kolpin et al., Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999–2000: A National Reconnaissance, 35 ENVTL. SCI. & TECH. 1202, 1203 (2002).

[2] WORLD HEALTH ORG., PHARMACEUTICALS IN DRINKING WATER 15 (2012); Jeff Donn et al., Pharmawater I: Pharmaceuticals Found in Drinking Water, Affecting Wildlife and Maybe Humans, ASSOCIATED PRESS (Mar. 9, 2008), http://hosted.ap.org/ specials/interactives/pharmawater_site/day1_01.html; Matt Harvey, Your Tap Water Is Probably Laced with Antidepressants, SALON (Mar. 14, 2013), http://www.salon.com/ 2013/03/14/your_tap_water_is_probably_laced_with_anti_depressants_partner/; David Noble, Trouble at the Tap, WATER QUALITY PRODUCTS.

[3] That year Americans filled nearly four billion prescriptions.

[4] M.S. Kostich et al., Concentrations of Prioritized Pharmaceuticals in Effluents from 50 Large Wastewater Treatment Plants in the U.S. and Implications for Risk Estimation, 184 ENVTL. POLLUTION 354 (2014)

[5] See Staffan Castensson, Pharmaceutical Waste, in PHARMACEUTICALS IN THE ENVIRONMENT: SOURCES, FATE, EFFECTS AND RISK 489, 497 (Klaus Kümmerer ed., 2008) (“Pharmaceuticals are designed to be resistant to biological degredation”)

[6] Id.

[7] Christian G. Daughton & Thomas A. Ternes, Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change?, 107 ENVTL. HEALTH PERSP. 907, 908 (1999).

Pharmacy Negligence? Someone who does not feel well books an appointment with a doctor. During the exam, a doctor diagnoses the patient and prescribes him some medication. The patient takes a doctor’s prescription to the pharmacy, where the pharmacist verifies the patient’s condition and medical history and fills the correct prescription. The patient returns home and takes the medicine for the prescribed time period, and the medication helps the patient recover.

That is how it is supposed to go, but what if, instead, the pharmacy commits a serious mistake and injures the patient? When this happens, multiple parties may be liable for the injury.

Duties of the Pharmacy

Doctors are tasked with understanding medications and prescribing the proper type and dose. A pharmacy is tasked with dispensing medicine according to the prescription. Medicine in correct quantities can be healing, but that same medicine in larger quantities can be harmful. If the pharmacy provides the patient with an incorrect dosage that harms a patient, the pharmacy can be liable for negligence. Alabama tort law imposes a duty of care on the pharmacy that it must act under a reasonable standard of care.

Dispensing incorrect dosages to patients is a breach of that duty of care. Similarly, the pharmacy had a duty of care to only purchase and obtain drugs that are safe. If the pharmacy’s supplier is not following regulatory standards and the pharmacy knowingly or negligently disregards this issue, then the pharmacy breached its duty of care. In such a situation, the pharmacy can be liable for negligently dispensing deficient drugs.

Doctor’s Orders

Liability may be relevant even if the pharmacy follows doctor’s orders. A pharmacist’s duty is to analyze a patient’s reactions to medication even though the doctor prescribed the medication. The pharmacy has a duty not to dispense medication if it believes the patient will have a bad reaction. Regardless of the doctor’s prescription. A pharmacist is responsible for evaluating the prescription as well as all other medications the patient is prescribed and determining whether it is safe. If the medications interact negatively, the pharmacist is obligated not to dispense the prescribed medicine. Thus, if the pharmacist negligently disregards patient risk by dispensing medicine. As a result, the patient suffers injury, the patient is a victim of pharmacy malpractice.

The Law of Agency

If you suffered a pharmacy-related injury, the law of agency may allow you to collect from different parties. The pharmacy can be liable for the pharmacist’s negligence because the pharmacist acts as an agent for the pharmacy. The same is applicable for the pharmacy technician or anyone else involved in dispensing the medicine. The law of agency imputes liability from an individual to an entity, which can be from the pharmacist to the pharmacy. By the same token, if the pharmacy’s delivery man is negligent by leaving the medicine in the hot sun, for example, and that results in tainted medicine, then the pharmacy would be responsible for negligence, as well.

If you are the victim of pharmacy malpractice, contact the law firm of Boles Holmes White, Alabama plaintiff attorneys.

Zohydro, the new Oxy? Criminal defense attorneys historically accustomed to dealing with clients charged with illegal possession of oxycodone, Xanax, methadone, and dihydrocodeine will soon become familiar with the a recently approved pain medication called Zohydro.

For years, drug abusers raided medicine cabinets looking for OxyContin, with many hard core abusers freebasing it. However, drug manufacturers modified the oxycontin formula. However, causing it to gelatinize, making it difficult, if not impossible for drug addicts to inject it through a syringe.

Zohydro, which first hit the market in 2014, is a time released painkiller containing hydrocodone. It is not believed to be manufactured with the abuse deterrent factors now implemented by the makers of OxyContin. Unlike previous hydrocodone products on the market, such as Vicodin and Lortab, Zohydro reportedly does not contain any acetaminophen. Therefore, leaving promoters to claim it is safer due to liver damage attributed to acetaminophen overdose. However, due to the high levels of hydrocodone contained in Zohydro, opponents fear an addiction epidemic is on the way.

Law enforcement officials have fought to prevent Zohydro’s release into the market, but it appears it has been a losing fight. Now they will gear up to prosecute those in possession of Zohydro without a prescription. It is also likely both state and federal prosecutors will carefully monitor the amounts of Zohydro prescribed by pain management clinics. If inordinate amounts of the drug are being prescribed by any one doctor, the authorities are likely to initiate criminal “pill mill” proceedings against the doctor and his company. Furthermore, federal drug conspiracy, drug distribution and money laundering charges.

Only time will tell, but as long as pain killers are available, there will be those that abuse them. It is suspected that Zohydro will be no different.