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Define pharmacoepidemiology as it relates to pharmacy and public health. Identify two limitations of clinical trials and two limitations of spontaneous adverse event reporting in understanding drug use in a population. Describe the need for pharmacoepidemiology in the U. Explain how health care databases have facilitated the growth of the pharmacoepidemiology discipline. Provide three practice-related questions of interest to pharmacoepidemiologists. List three ways in which pharmacists or public health practitioners can contribute to pharmacoepidemiology.

Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. Pharmacology is the study of the effects of medications in humans. Epidemiology is the study of the factors that determine the occurrence and distribution of diseases in populations. Epidemiology can often be divided into infectious and chronic disease epidemiology. Chronic disease epidemiology is more dependent on complex sampling and statistical methods; which are often used in pharmacoepidemiology studies to evaluate drug exposure over time.

Pharmacoepidemiology studies quantify drug use patterns and adverse drug effects. Pharmacoepidemiologists also conduct safety studies of drug use in large populations. Arleen, however, did not receive any help from her family and her welfare benefits were decreased after she missed an appointment. Their landlord filed a five-day eviction notice after a building inspector, summoned following a neighborhood shooting and police investigation, issued repair orders.

She withheld the charges from her rent and was threatened with eviction. Poor families like the Hinkstons are often compelled to accept substandard housing in the aftermath of eviction. For many landlords, evictions are cheaper than the cost of maintaining rental properties. Scott assisted Teddy with the cooking, cleaning, and shopping, and helped Teddy manage his partial paralysis. This process of screening prospective tenants, and reviewing their past evictions, felonies, criminal charges, and court cases creates a geography of advantage and disadvantage.

This process affects what neighborhoods have good schools, where there is crime and gang activity, and which areas have a spirit of neighborliness. At eviction court, Arleen agreed to voluntarily move out of the apartment before Sherrena called the sheriff. Almost all tenants were summoned for missing rent payments. Of those, three in four are women. Eviction is shaping the lives of poor black women, just as incarceration defines the lives of men from impoverished black neighborhoods.

Rent Recovery Service, a debt collection service, claims to help tenants get back on their financial feet while charging high interest rates. The Homeless Prevention Program also requires loss of income, and a current income that could cover future rents.

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The two programs support families per year, the number of Milwaukee families evicted in six weeks. Homeowners were encouraged to refinance under risky terms. She had two daughters. Larraine did not have family she could ask for help, and her pastor believed her hardship was self-inflicted. For a landlord like Sherrena, the rent is virtually guaranteed. In disadvantaged neighborhoods, the FMR often exceeds market rent, bringing economic gains to landlords.

Crystal allowed Arleen and her boys to stay until they found another place to move. This kept families afloat but did little to lift them out of poverty. Social service agencies began to limit kin dependence by reducing funds available to people who lived with relatives. Disposable ties facilitate the flow of various resources, but the bonds are often brittle and fleeting. The strategy of forming, using, and burning disposable ties allows families caught in desperate situations to make it from one day to the next, but it also breeds instability and fosters misgivings among peers.

She forgot about a welfare meeting, and her food stamps were cut off. He received a cash bonus from the park owner based on the amount of rent he collected. He tried to follow the NA warning that addiction tightened its grip when a person was hungry, angry, lonely, or tired. Support systems that arise organically in poor neighborhoods promote social interaction that helps people make ends meet, but they also expose them to heavy doses of trauma and adversity, which dampens political efficacy.

A community that clearly sees its own pain has a difficult time sensing its potential. This subjected Sherrena to additional law enforcement costs because her property was designated a nuisance property. In black neighborhoods, 1 in 16 eligible properties receive a citation. The number of domestic violence incidents exceed the total number of all other kinds of assaults, disorderly conduct charges, and drug-related crimes combined.

This places domestic violence survivors in a difficult situation: Carol agreed to rent to Arleen after Arleen offered to arrange a vendor payment with her W-2, automatically deducting her rent each month. Arleen moved her possessions into storage and secured a room at a shelter. When she contacted Carol, she learned that the apartment had been rented to somebody else. She had an IQ of 70 and was recommended for long-term mental health treatment and supportive assistance.

Payments are cut until the money is spent, and SSI recipients see this as a disincentive to save. Individuals like Larraine live with so many compounded limitations that it is difficult to imagine the amount of good behavior or self-control that would allow them to lift themselves out of poverty. The distance between grinding poverty and even stable poverty can be so vast that those at the bottom have little hope of climbing out even if they pinch every penny. After contacting the landlords of 40 apartments, she did not have luck on the private market and her public housing application was still being processed.

Larraine moved in with her neighbor, Ms. Job loss can lead to eviction, but more often, dealing with the aftermath of an eviction leads to job loss. When Congress passed the Fair Housing Act in , it did not consider families with children a protected class, which led to discrimination and evictions.

Some units charged children-damage deposits and monthly surcharges. Eight years later, housing discrimination against children and families was outlawed but continued in practice. Families with children were turned away in as many as seven in ten housing searches. She and her boys had 29 days left at the shelter. Fearing her electricity would be shut off from unpaid utility bills and fearing Child Protective Services would take away her children, she participated in an armed robbery.

After her plea hearing, she was fired from her job and evicted. But race-based housing discrimination is the main cause of segregation. Some slums were cut off from basic municipal services and local wells. Landlords had nothing to gain by improving their run-down houses. Policies blocked black families from homeownership. Over three centuries, systematic dispossession from the land created a semi-permanent black rental class and an artificially high demand for inner-city apartment units.

The house failed the tenants and the tenants failed the house. The family became lethargic and depressed. The children missed homework, and their grades dropped. The next day she swaddled her new baby and took him back to where her family was living in the rat hole. Vanetta and Crystal were approved for a run-down apartment after trying to rent 73 places. Vanetta paid for the damages and kicked Crystal out. She later received a call from Child Protective Services and suspected Crystal had notified them.

The public defender did not argue that she was waking at 5 am every morning to look for housing, attend GED classes, and care for children. The judge imposed an month sentence—15 months in prison and 66 on probation. She began selling sex to make ends meet. He was required to attend biweekly AA meetings, pay to have his urine tested at least once per week, and had to stay sober for five years. Because he could not afford both methadone and rent, he checked into a shelter. Two years and three months after losing his license, Scott started saving for the necessary lab tests. Her son Jori attended five different schools between the 7th and 8th grades.

But shortly after moving into that apartment, Jori kicked his teacher, and a police officer followed him home. The landlord offered to refund the rent and security deposit if Arleen and her children moved out by the end of the week. Arleen lost all of her possessions in storage. She missed three appointments, and her welfare case was closed. Patrice earned her GED and enrolled in community college.

Housing Authorities count evictions and unpaid debt as strikes when reviewing applications—and so the rent-burdened and evicted are systematically denied assistance. Between , suicides attributed to evictions and foreclosures doubled. Rental assistance programs lift roughly 2. But those who receive housing assistance account for the lucky minority of qualified poor families.

The unlucky majority receive nothing. Establishing public-funded legal services for families in housing court would be a cost-effective measure that would prevent homelessness and decrease evictions. Wainwright, the Supreme Court established the right to counsel for indigent defendants in criminal cases on grounds that a fair trial was impossible without a lawyer.

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Most of the 12 million Americans who take out high-interest payday loans do so not to buy luxury items or cover unexpected expenses but to buy food, pay rent, or meet regular expenses. Many low-income working families dedicate some or all of their Earned Income Tax Credit to pay back rent in the month of February, contributing to the lowest monthly rates of eviction. This discovery showed that drugs from plants can be purified and administered in precise dosages regardless of the source or age of the material Rousseaux and Schachter ; Hartmann This approach was enhanced by the discovery of penicillin Li and Vederas With this continued trend, products from plants and natural sources such as fungi and marine microorganisms or analogs inspired by them have contributed greatly to the commercial drug preparations today.

Examples include antibiotics e. Between and , 13 drugs derived from natural products were approved in the United States. Average life expectancy at birth has increased from around 41 years in the early s to approaching 80 years in many developed countries. Consequently, the percentage of elderly people 65 years and above in our populations is increasing.

The graying of our populations brings an increasing burden of chronic age-related disease and dependency. Aging is associated with a progressive decline in physiological function and an increased risk of pathological changes leading to cancer, cardiovascular disease, dementia, diabetes, osteoporosis, and so on. Lifestyle factors such as nutrition or exercise play an important role in determining the quality and duration of healthy life and in the treatment of chronic diseases Bozzetti ; Benzie and Wachtel-Galor , It is most likely that there is no one cause of aging, and different theories of aging have been suggested over the years.

Genetic factors are undoubtedly important, but among all the metabolic theories of aging, the oxidative stress theory is the most generally supported theory Harman ; Beckman and Ames This theory postulates that aging is caused by accumulation of irreversible, oxidation-induced damage oxidative stress resulting from the interaction of reactive oxygen species with the DNA, lipid, and protein components of cells. However, even if the aging process itself is found to be unrelated to oxidative stress, highly prevalent chronic age-related diseases all have increased oxidative stress Holmes, Bernstein, and Bernstein ; Beckman and Ames ; Finkel and Holbrook ; Rajah et al.

Antioxidants in herbs may contribute at least part of their reputed therapeutic effects Balsano and Alisi ; Tang and Halliwell Given the market value, potential toxicity and increasing consumer demand, particularly in the sick and elderly members of our populations, regulation of production and marketing of herbal supplements and medicines require attention. WHO has recognized the important contribution of traditional medicine to provide essential care World Health Organization, http: In , the U.

Congress established the Office of Alternative Medicine within the National Institutes of Health to encourage scientific research in the field of traditional medicine http: November 5, , and the European Scientific Cooperative on Phytotherapy ESCOP was founded in with the aim of advancing the scientific status and harmonization of phytomedicines at the European level www. This led to an increase in investment in the evaluation of herbal medicines. While this scale of investment is low compared to the total research and development expenses of the pharmaceutical industry, it nevertheless reflects genuine public, industry, and governmental interest in this area Li and Vederas With tremendous expansion in the interest in and use of traditional medicines worldwide, two main areas of concern arise that bring major challenges.

These are international diversity and national policies regarding the regulation of the production and use of herbs and other complementary medicines and their quality, safety, and scientific evidence in relation to health claims WHO ; Sahoo et al. The diversity among countries with the long history and holistic approach of herbal medicines makes evaluating and regulating them very challenging.

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In addition, there are a great number of different herbs used. Legislative criteria to establish traditionally used herbal medicines as part of approved health care therapies faces several difficulties. In a survey conducted across countries, WHO reported the following issues regarding herbal medicines: The support needed from different countries includes information sharing on regulatory issues, workshops on herbal medicines safety monitoring, general guidelines on research and evaluation of herbal medicines, provision of databases, herbal medicine regulation workshops, and international meetings.

National policies are the basis for defining the role of traditional medicines in national health care programs, ensuring that the necessary regulatory and legal mechanisms are established for promoting and maintaining good practice, assuring the authenticity, safety, and efficacy of traditional medicines and therapies, and providing equitable access to health care resources and their resource information WHO Another fundamental requirement is harmonization of the market for herbal medicines for industry, health professionals, and consumers Mahady Herbal medicines are generally sold as food supplements, but a common regulatory framework does not exist in different countries.

As a result, information on clinical indications for their use, efficacy, and safety are influenced by the traditional experience available in each place. A brief outline of the legislation in United States, Canada, and Europe is given in this section, and could be used to guide the legal aspects of the herbal medicine industry in other countries.

Under DSHEA, herbal medicines, which are classified as dietary supplements, are presumed safe, and the FDA does not have the authority to require them to be approved for safety and efficacy before they enter the market, which is the case for drugs. This means that the manufacturer of the herbal medicine is responsible for determining that the dietary supplements manufactured or distributed are indeed safe and that any representations or claims made about them are sustained by adequate evidence to show that they are not false or misleading. Regarding contamination, the FDA has not issued any regulations addressing safe or unsafe levels of contaminants in dietary supplements but has set certain advisory levels in other foods FDA ; Gao A product being sold as an herbal supplement dietary supplement in the United States cannot suggest on its label or in any of its packaging that it can diagnose, treat, prevent, or cure a specific disease or condition without specific approval from the FDA.

A claim also cannot suggest an effect on an abnormal condition associated with a natural state or process, such as aging FDA ; Gao According to these regulations, all natural products require a product license before they can be sold in Canada. In order to be granted a license, detailed information on the medicinal ingredients, source, potency, nonmedicinal ingredients, and recommended use needs to be furnished. Once a product has been granted a license, it will bear the license number and follow standard labeling requirements to ensure that consumers can make informed choices.

A site license is also needed for those who manufacture, pack, label, and import herbal medicines. In addition, GMPs must be employed to ensure product safety and quality. This requires that appropriate standards and practices regarding the manufacture, storage, handling, and distribution of natural health products be met.

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The GMPs are designed to be outcome based, ensuring safe and high-quality products, while giving the flexibility to implement quality control systems appropriate to the product line and business. Product license holders are required to monitor all adverse reactions associated with their product and report serious adverse reactions to the Canadian Department of Health. The directive establishes that herbal medicines released on the market need authorization by the national regulatory authorities of each European country and that these products must have a recognized level of safety and efficacy Calapai The registration of herbal medicinal products needs sufficient evidence for the medicinal use of the product throughout a period of at least 30 years in the European Union EU , at least 15 years within the EU, and 15 years elsewhere for products from outside the EU.

With regard to the manufacturing of these products and their quality, products must fulfill the same requirements as applications for a marketing authorization. Information is based on the availability of modern science—based public monographs in the European Pharmacopeia and their equivalents developed by the pharmaceutical industry.

The standards put forward allow not only to define the quality of products but also to eliminate harmful compounds, adulteration, and contamination. Within the EU, a number of committees were set up to attempt and standardize the information and guidelines related to herbal medicines. A variety of materials has been produced, such as monographs on herbs and preparations, guidelines on good agricultural and collection practice for starting materials of herbal origin, and guidelines on the standardization of applications and setting up pragmatic approaches for identification and quantitative determination of herbal preparations and their complex compositions Routledge ; Vlietinck, Pieters, and Apers Herbal medicine has been commonly used over the years for treatment and prevention of diseases and health promotion as well as for enhancement of the span and quality of life.

However, there is a lack of a systematic approach to assess their safety and effectiveness. The holistic approach to health care makes herbal medicine very attractive to many people, but it also makes scientific evaluation very challenging because so many factors must be taken into account. Herbal medicines are in widespread use and although many believe herbal medicines are safe, they are often used in combination and are drawn from plant sources with their own variability in species, growing conditions, and biologically active constituents.

Herbal extracts may be contaminated, adulterated, and may contain toxic compounds. The quality control of herbal medicines has a direct impact on their safety and efficacy Ernst, Schmidt, and Wider ; Ribnicky et al. But, there is little data on the composition and quality of most herbal medicines not only due to lack of adequate policies or government requirements but also due to a lack of adequate or accepted research methodology for evaluating traditional medicines WHO ; Kantor In addition, there is very little research on whole herbal mixtures because the drug approval process does not accommodate undifferentiated mixtures of natural chemicals.

To isolate each active ingredient from each herb would be immensely time-consuming at a high cost, making it not cost-effective for manufacturers Richter Another problem is that despite the popularity of botanical dietary and herbal supplements, some herbal products on the market are likely to be of low quality and suspect efficacy, even if the herb has been shown to have an effect in controlled studies using high-quality product. There is a belief that herbs, as natural products, are inherently safe without side effects and that efficacy can be obtained over a wide range of doses.

A major hypothetical advantage of botanicals over conventional single-component drugs is the presence of multiple active compounds that together can provide a potentiating effect that may not be achievable by any single compound. This advantage presents a unique challenge for the separation and identification of active constituents. Compounds that are identified by activity-guided fractionation must be tested in appropriate animal models to confirm in vivo activity.

Ideally, the composition of the total botanical extract must be standardized and free of any potential hazards, and plants should be grown specifically for the production of botanical extracts under controlled conditions and originate from a characterized and uniform genetic source with a taxonomic record of the genus, species, and cultivar or other additional identifiers. Records should be maintained for the source of the seed, locations and conditions of cultivation, and exposure to possible chemical treatments such as pesticides.

Because the environment can significantly affect phytochemical profiles and the efficacy of the botanical end product, botanical extracts can vary from year to year and may be significantly affected by temperature, drought, or flood as well as by geographic location.

Therefore, biochemical profiling must be used to ensure that a consistent material is used to produce a botanical.



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The concentration step can also be challenging, and the process to concentrate active compounds to a sufficient level can negatively affect their solubility and bioavailability. Therefore, improving efficacy by increasing concentration can be counterproductive, and the use of solubilizers and bioenhancers needs to be considered just as for drugs Ribnicky et al. However, there are major challenges to achieving this. Although in theory botanicals should be well characterized and herbal supplements should be produced to the same quality standards as drugs, the situation in practice is very different from that of a pure drug.

Herbs contain multiple compounds, many of which may not be identified and often there is no identifier component, and chemical fingerprinting is in its early stages and is lacking for virtually all herbs see Chapter This makes standardization of botanicals difficult, although some can be produced to contain a standardized amount of a key component or class of components, such as ginsenosides for ginseng products or anthocyanins for bilberry products see Chapter 4 on bilberry and Chapter 8 on ginseng in this volume.

However, even when such key compounds have been identified and a standard content is agreed or suggested, there is no guarantee that individual commercial products will contain this. Another interesting point to consider is that herbal materials for commercial products are collected from wild plant populations and cultivated medicinal plants. The expanding herbal product market could drive overharvesting of plants and threaten biodiversity.

Poorly managed collection and cultivation practices could lead to the extinction of endangered plant species and the destruction of natural resources. It has been suggested that 15, of 50,—70, medicinal plant species are threatened with extinction Brower The efforts of the Botanic Gardens Conservation International are central to the preservation of both plant populations and knowledge on how to prepare and use herbs for medicinal purposes Brower ; Li and Vederas Research needs in the field of herbal medicines are huge, but are balanced by the potential health benefits and the enormous size of the market.