2
Overview of the Drug Development, Regulation, Distribution, and Use System

CHAPTER SUMMARY

The drug system encompasses four main stages—research and development; regulatory review; medication manufacturing, distribution, and marketing; and medication use—that each contain multiple critical control points at which quality, safety, and efficacy can be addressed, and at which breakdowns can occur. This chapter provides an overview of the major components of the drug system and the points that might lead directly or indirectly to errors as well as opportunities for learning, recovery, and improvement.

As noted in two previous Institute of Medicine (IOM) reports—To Err Is Human: Building a Safer Health System (IOM, 2000) and Crossing the Quality Chasm: A New Health System for the 21st Century (IOM, 2001), redesigning health care to improve quality and safety requires definitive action by all stakeholder groups interacting with the health system. Applied to this report, stakeholders of the drug system associated with research, innovation, regulation, clinical practice, payment, education, legislation, and reporting should be assessed according to how well quality and safety are (or can be) achieved, among other factors. Advancing this concept requires that the disciplines of human factors engineering, organizational psychology, sociology, and informatics must become the basic sciences of quality just as molecular biology, pharmacology, and genetics are the basic sciences of medicine (Brennan et al., 2005). Quality and safety in medication use depends directly on the extent to which the principles of these



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Preventing Medication Errors 2 Overview of the Drug Development, Regulation, Distribution, and Use System CHAPTER SUMMARY The drug system encompasses four main stages—research and development; regulatory review; medication manufacturing, distribution, and marketing; and medication use—that each contain multiple critical control points at which quality, safety, and efficacy can be addressed, and at which breakdowns can occur. This chapter provides an overview of the major components of the drug system and the points that might lead directly or indirectly to errors as well as opportunities for learning, recovery, and improvement. As noted in two previous Institute of Medicine (IOM) reports—To Err Is Human: Building a Safer Health System (IOM, 2000) and Crossing the Quality Chasm: A New Health System for the 21st Century (IOM, 2001), redesigning health care to improve quality and safety requires definitive action by all stakeholder groups interacting with the health system. Applied to this report, stakeholders of the drug system associated with research, innovation, regulation, clinical practice, payment, education, legislation, and reporting should be assessed according to how well quality and safety are (or can be) achieved, among other factors. Advancing this concept requires that the disciplines of human factors engineering, organizational psychology, sociology, and informatics must become the basic sciences of quality just as molecular biology, pharmacology, and genetics are the basic sciences of medicine (Brennan et al., 2005). Quality and safety in medication use depends directly on the extent to which the principles of these

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Preventing Medication Errors sciences are built into the overall drug system (Califf et al., 2002). Integrating the sciences of quality with the biomedical and health sciences will ultimately facilitate the translation of safety and quality in medication use from theory to clinical practice. As a first order of business, the points at which safety and quality can be compromised must be identified. Currently, the potential for harm is present throughout the system. Harm can be due to any number of factors, many of which are now in the national spotlight, including undisclosed harmful side effects of a drug for specific patient populations; lax follow-through on regulatory responsibility after product approval; human error in prescribing, dispensing, administering, and monitoring effects in patients; and inadequate patient activation and education. This chapter identifies the key issues of the overall drug system that affect safety and quality in medication use. Subsequent chapters in this report provide recommendations for improvement, many of which incorporate the “sciences of quality” mentioned above. STRUCTURE OF THE OVERALL DRUG SYSTEM Currently more than 10,000 prescription drugs and biologics (FDA, 1999) and more than 300,000 over-the-counter (OTC) products are on the market in the United States (RSW, 2001). In 2004, 215 prescription and 71 OTC drugs were recalled because of manufacturing and distribution problems or serious adverse reactions (FDA, 2004a). The regulatory element of the drug system evolved over the past century from being focused on regulating interstate transport and misbranded products to being built on an infrastructure with the goal of reliable standards, processes, and laws to ensure some degree of safety and efficacy in medicinal agents. The result is a sophisticated, comprehensive drug system encompassing four stages that interact with, support, and reinforce each other to varying degrees (see Figure 2-1): (1) research and development (R&D), where ideas for new drugs are conceived and candidates are clinically tested; (2) regulatory review by the Food and Drug Administration (FDA) to validate or counter the research findings and ensure proper labeling; (3) manufacture, distribution, and marketing of products that have received regulatory approval; and (4) use of medications available either through a prescription or OTC. Prescription drugs, biologics, and some OTCs follow this model. The product development and regulatory review stages are abbreviated for other OTCs and for generics. Each element of the drug system is governed by its own set of standards and methods for scientific analysis to advance the safety, quality, and efficacy of products and their use. As the chief protector of the public health, the FDA has responsibility for developing and enforcing the standards in all

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Preventing Medication Errors FIGURE 2-1 Four stages of the drug system. NOTE: AADA = Abbreviated Antibiotic Drug Application; ANDA = Abbreviated New Drug Application; BLA = Biologic Licensing Application; DTC = direct to consumer; FDA = U.S. Food and Drug Administration; IND = Investigational New Drug Application; NDA = New Drug Application; OTC = over-the-counter; PBM = Pharmacy Benefits Manager.

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Preventing Medication Errors areas except clinical practice, which is governed by state boards of medicine, nursing, and pharmacy; professional societies; and accreditation organizations.1 Compliance with FDA regulatory standards is the responsibility of the manufacturers who promote their products in the marketplace. Safe and effective use of medications is the responsibility of providers who prescribe the medications and patients who take them. Standards2 for each component of the drug system act as links in a chain of events that have an important bearing on the competence and effectiveness of drug therapies in medical care. The key points at which important interventions can be implemented are identified in Figure 2-1. Building safety and quality into the system starts with rational ideas for new drug products, followed by sound scientific research; reliable clinical testing; rigorous regulatory reviews; appropriate labeling; use of good manufacturing processes; proper distribution techniques; adequate supplies; ethical marketing practices; competent prescribing, dispensing, and administration of medications; and finally suitable monitoring of the patient, reporting of errors, and measurement of outcomes (Martin, 1978). If standards do not exist, are inadequate, have not been met, or are not enforced at any point along this chain, patient safety and quality of care can be compromised. For example, restriction on the publication of a drug’s side effects can affect a prescriber’s ability to choose the best drug for a patient or to identify and respond to an adverse reaction in a timely manner; lax enforcement of regulatory requirements for drug labeling can result in product confusion in a high-stress, fast-paced clinical setting; formulary restrictions can force a switch to a medication that may be less appropriate for a patient than the one initially prescribed; or the failure to document all of the medications a patient is taking (including OTCs and dietary supplements) can cause a drug–drug interaction that could have been prevented. In the first three of these examples, problems in the drug development, regulation, and distribution systems contribute to medication-use errors that should be corrected. Yet most links or components of the drug system operate in a quasi-silo state with less-than-ideal means of sharing important 1 The Center for Drug Evaluation and Research (CDER) regulates prescription (including therapeutic biologics), generic, and nonprescription drugs; the Center for Biologics Evaluation and Research (CBER) regulates the remaining biologics and blood products; and the Center for Devices and Radiological Health regulates medical devices, including those used to administer medications. The FDA’s authority, established by the Federal Food, Drug, and Cosmetic Act of 1938, has evolved steadily over the past 60 years through a series of legislative and regulatory actions to foster safety and efficacy through all stages of the drug system. 2 A set of characteristics or quantities that describes features of a product, process, service, interface, or material. The description can take many forms, such as the definition of terms; specification of design and construction; detailing of procedures; or performance criteria against which a product, process, and other factors can be measured (NRC, 1995).

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Preventing Medication Errors information or responding to safety-related problems. In the last example, the problem results from an error within the medication-use system itself (e.g., insufficient information). Most often this is the case: medication errors are the result of a problem incurred during the prescribing, dispensing, administration, or monitoring phases of the medication-use system. Nevertheless, both aspects of causation—how the drug is prepared (developed, regulated, distributed) and how it is used in clinical practice or self-care—must be addressed if errors in the medication-use system are to be reduced and prevented. The remainder of this section addresses the former (research and development; regulatory review; and manufacture, distribution, and marketing). The second section of the chapter addresses medication use. Research and Development The R&D process involves more than the development of new products; it encompasses the overall generation and disclosure of high-quality data that can be used with confidence by providers and patients in medical care, by providers and technology vendors to populate knowledge bases and clinical decision-support systems, by regulators in assessing benefit/risk balances for protection of the public health, and by researchers for continued innovation and advancement of science and medicine (Califf, 2004). Issues related to study design, data quality, and disclosure can have direct bearing on the development of the medication knowledge base needed to support clinicians and pharmacists in clinical decision making and prescribing; preparation and administration of appropriate dosages; and monitoring of patient response (positive and negative) to a medication, particularly the ability to discern symptoms of disease from effects of the drug. Public availability of information from trials also is necessary to support consumers in their self-care, disease management, and medication self-management. Data quality can be compromised by poor clinical study designs, less-than-optimal methods of data analysis, and/or conflicts of interest that affect the objectivity of investigators (Califf and DeMets, 2002a,b; Strom, 2004; March et al., 2005). The failure to disclose negative study results (e.g., serious adverse side effects) can have fatal effects on patients (Bodenheimer, 2000; Moore et al., 1998). Current State of R&D Pharmaceutical R&D for new drugs and biologics aims to meet a medical need in a specified patient population by creating medications with characteristics of high activity, low toxicity, and relatively few side effects. Fundamentally, approval for marketing a drug is based on an assessment of

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Preventing Medication Errors the balance of the benefit and risk of using the drug in the specified population. The ability to separate toxic and side effects from therapeutic effects on the basis of preclinical evaluation is an ongoing challenge. Sizable amounts of time and effort are spent on trying to increase this margin, but ultimately the balance of benefit and risk cannot be defined until clinical trials have been conducted in relevant populations (Martin, 1978; Califf, 2004). Trends in drug development over the past few decades have led to significant improvements in study designs, reducing the incidence of incorrect conclusions concerning dosage, efficacy, and safety while deepening understanding of how the molecular structures of potential new drugs interact with specific human cellular structures. More recent scientific discoveries in the areas of genomics, biotechnology, and informatics are expected to increase significantly the number of new molecular targets and the ability to develop medicines with greater specificity and fewer side effects (NRC, 2004), although this promise has not been realized, and the time frame for pragmatic advances remains unclear (Califf, 2004). Clinical Study Design Traditionally, the R&D process has been performed in sequential stages. After discovery of potential compounds for new medicines and preclinical testing in the laboratory and in animals for safety and biological activity against the targeted disease, the manufacturer (i.e., sponsor) submits an Investigational New Drug Application (IND) to the FDA or other international regulatory authority for review.3 The IND contains plans for clinical studies in humans (Phases I, II, and III), all data from preclinical testing, and complete structural and manufacturing information. At any time after the IND has been submitted, the sponsor may request an accelerated development and approval track (“fast track”) for drugs that promise substantial benefit over existing therapies for serious or life-threatening illnesses. Granting of fast track status is based on the case that the drug would fulfill a critical unmet health need, early evidence of the drug’s effects on a surrogate end point,4 commitments to undertake postmarket studies, and/or agreement to restrict distribution and use after approval (FDA, 1999). Most Phase I studies use healthy volunteers to test the drug’s actions, both metabolic (pharmacokinetics [PK]) and pharmacologic (pharmacody- 3 The FDA performs clinical, chemistry, toxicology, and safety reviews of the IND and, if it is accepted, makes adjustments to clinical trial parameters as needed. The IND sets the stage for the FDA’s interaction with the sponsor during clinical studies. 4 A surrogate end point is a laboratory finding or physical sign that may not, in itself, be a direct measurement of how a patient feels, functions, or survives, but nevertheless is considered likely to predict therapeutic benefit (FDA, 1999).

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Preventing Medication Errors namics [PD]);5 side effects associated with increasing doses; and if possible, early evidence of efficacy (FDA, 1998). Phase II studies use a small group of patients with the condition in well-controlled circumstances to evaluate the dose that optimally affects the chosen biological target, the method of delivery (e.g., oral, intravenous), the dosing interval, and short-term side effects, and to extend the preliminary evidence of safety from Phase I (Walters, 1992; Leonard, 1994; FDA, 1998). A substantial number of drug trials are discontinued after both Phases I and II because of ineffectiveness, safety problems, or intolerable side effects. If the Phase I and II trials are successful, the sponsor may apply for Treatment IND status to provide promising drugs to patients with a life-threatening disease (e.g., AIDS) if no comparable therapy exists or the patients cannot participate in clinical studies. Phase III trials are the most critical in the determination of a drug’s approval for labeling by the FDA and international regulatory authorities. Typically, Phase III trials are structured as randomized controlled trials involving enough patients carefully selected, often across multiple sites, to obtain data on the drug’s overall benefit/risk relationship so that regulators, often guided by expert panels, can be comfortable that the balance is favorable for the defined population (Nies, 2001). While such studies typically can last from 1 to 4 years and commonly include from 1,000 to 10,000 patients, generally only a few hundred patients are treated for more than 3 to 6 months with the drug, regardless of the duration of treatment required in clinical practice. As a result, only the most profound and overt risks and side effects that occur immediately after taking a drug can be detected if the occurrence rate is 1 in 100 administrations. Risks that are medically important but delayed, less frequent than 1 in 1,000 administrations, or not evenly distributed across the population may not be revealed prior to marketing (Nies, 2001). In particular, serious adverse effects for a specific patient population (e.g., pediatric, geriatric, those with renal dysfunction or multiple comorbidities) usually will not be known, as those groups are not well represented in the trials (Lee et al., 2001; Klein et al., 2002). Accordingly, postmarket surveillance and evaluation studies (Phase IV) are often requested for further evaluation of safety issues (e.g., adverse effects) after approval. During a January 2005 meeting on drug development science sponsored by the FDA and the Association of American Medical Colleges (AAMC), participants from academia, industry, and government identified 5 Pharmacodynamics denotes the biochemical and physiological effects of a drug and the relationship between drug concentration and effect. Pharmacokinetics is the activity or fate of drugs in the body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion.

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Preventing Medication Errors crucial problems with the current model and opportunities for improvement (AAMC, 2005). The participants found that study designs often are not tailored to the pharmacology of potential new drugs and the patient populations that will use them, and frequently are not structured to allow adequate evaluation of a broad range of doses. Each of the above factors can contribute to issues of patient safety and quality of care in the medication-use process. For example, drugs can produce very different effects in elderly patients and younger adults. The elderly are more likely to have impaired kidney and renal function, to be taking other medications, or to have other medical conditions. Few clinical studies include substantial numbers of elderly patients, however, even though the elderly are a growing proportion of the general population (FDA, 1999; Noah and Brushwood, 2000; Boyd et al., 2005). Data Quality While randomized controlled trials are considered the gold standard for assessing efficacy, they rarely provide all the information needed in clinical practice (Teutsch et al., 2005). Drugs are usually compared with a placebo, and studies frequently use surrogate or intermediate measures of efficacy, such as blood pressure, low-density lipoprotein cholesterol, or tumor shrinkage, rather than tangible patient outcomes, such as mortality, morbidity, and quality of life. Placebo-based comparisons serve regulatory requirements, leaving long-term studies comparing treatments to post-approval. Without data on health outcomes, extrapolation from the carefully selected patient populations used in clinical trials to patient populations seen in typical practice settings and from the patient population used in a trial to another patient population introduces uncertainty (Teutsch et al., 2005). A variety of leaders have voiced concern about the threat posed to scientific integrity by conflicts of interest among industry and academic researchers, private-sector investigators, and regulators (Bodenheimer, 2000; Chopra, 2003; Fontanarosa et al., 2004; Psaty et al., 2004). There is evidence that research has tended to overemphasize drug benefits while downplaying risks (Rochon et al., 1994; Rothman and Michels, 1994; Bero and Rennie, 1996; Bekelman et al., 2003). Disclosure of Results Currently, public disclosure of results through registration is required only for clinical gene-transfer trials registered with the National Institutes of Health (NIH) and studies conducted under INDs (FDA, 2004b). Nondisclosure (failure to register) of all clinical trials from start to completion and

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Preventing Medication Errors BOX 2-1 Summary of Key Problems with the Research and Development Process Affecting Safety and Quality in the Medication-Use System Study designs are insufficient to generate data for the full range of knowledge needs (for example, to evaluate metabolic and pharmacologic effects and clinical outcomes in specific populations). Studies are short-term, but medication use can be long-term; thus long-term effects are unknown. Public disclosure of clinical trial results may be selective. failure to report results (both positive and negative) in a public database have left sizable gaps in the knowledge base that can affect decision making by regulators and clinicians, as well as the work of researchers and editors of medical journals (Steinbrook, 2004; IOM, 2006). (See Box 2-1 for a summary of key problems with the research and development process.) Regulatory Review Prior to marketing in the United States, all new prescription drugs (including generics), OTC drugs, and biologics are subjected to formal regulatory review and approval by the FDA’s Center for Drug Evaluation and Research (CDER). The primary objectives of the regulatory review are to evaluate a drug’s safety and effectiveness and to determine whether its benefits outweigh its risks. Regulatory review also verifies that industry has taken the appropriate measures to prepare the products properly for the market. The balance of benefit and risk is influenced significantly by intended use, and varies from drug to drug and from one patient group to another (FDA, 1999; University of Utah, 2006). For example, greater risk may be tolerated for a drug designed to treat a life-threatening illness than for one designed to treat the common cold. Likewise, lower risk may be required for drugs intended for geriatric patients, who are more likely to have renal or hepatic impairment and multiple conditions (FDA, 1994). As genomics and proteomics enable drug development to become increasingly individualized, it will be possible to establish more specific benefit and risk assessments for particular patient populations with certain clinical or genetic characteristics. This capability will necessitate reexamination of the current benefit/risk model used for regulatory approval (Califf, 2004).

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Preventing Medication Errors Review of Clinical Data for New Drugs and Biologics Assessment of new drugs (i.e., new molecular entities [NMEs]) is based on the New Drug Application (NDA) or the Biologic Licensing Application (BLA)—dossiers submitted by the drug sponsor that include all data from preclinical and clinical studies on safety and efficacy, proposed labeling, and manufacturing details. A team from CDER’s Office of New Drugs reviews the dossiers; communication with the sponsor occurs throughout the process to address scientific, medical, and procedural issues. The FDA uses advisory committees of external scientific experts for advice and opinions to broaden its basis for decision making on an NDA/BLA or regulatory issue. For a drug to win approval, the FDA does not require that it be better than products already available, only that it be effective (better than nothing [i.e., placebo]) and fairly safe (Deyo, 2004). A drug is determined to be effective if it achieves a “surrogate outcome” (e.g., lowers cholesterol) without its effects on life expectancy being known. The FDA does not approve every use for which a drug may be prescribed by a clinician, only the use evaluated during its clinical trial. Postmarket Surveillance of New Drugs Some of the risks associated with a new drug are not known at the time of regulatory review because the data from clinical trials are limited in terms of patient population, study size, and/or duration. Consequently, drugs must continue to be evaluated as they are used in clinical settings to detect less frequent but significant adverse side effects, long-term effects, or effects in different patient populations. Two mechanisms are available for this purpose: (1) postmarket surveillance studies, and (2) the FDA’s adverse event reporting systems (see later in the chapter). Both approaches rely on manufacturers to collect, evaluate, and report data on their own products (Fontanarosa et al., 2004). Postmarket studies can be designed to observe a drug’s effects in a larger, more heterogeneous population over 3–4 years (Berndt et al., 2005). The FDA requires postmarket studies as a condition for approval in only two product categories—drugs granted fast track status and drugs for which the manufacturer desires a pediatric indication (Fontanarosa et al., 2004). Such studies are optional for other product categories, although strongly encouraged. Manufacturers complete fewer than half of the postmarket studies they commit to undertaking as a condition for approval (FR, 2004a; Fontanarosa et al., 2004). At the request of the FDA, the IOM Committee on Assessment of the U.S. Drug Safety System is evaluating the agency’s postmarketing surveillance. More detail on surveillance systems is given in

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Preventing Medication Errors the section on adverse event reporting and surveillance systems later in the chapter. Review of Clinical Data for Generics and OTCs The FDA uses a process similar to that for NMEs to review new generic drugs and OTCs. Sponsors of generics file an Abbreviated New Drug Application (ANDA) or Abbreviated Antibiotic Drug Application (AADA) that provides information supporting equivalence to an FDA-approved brand-name drug in terms of active ingredients, dosage, safety, strength, administration, quality, performance, and intended use. Generic manufacturers are not required to replicate the extensive clinical trials of the original drug, but must demonstrate bioequivalence; this can be done by measuring bioavailability (e.g., rate and extent of absorption) of the generic in 24 to 36 healthy subjects (FDA, 1999). For OTCs the FDA has established drug monographs for each OTC product class, covering acceptable ingredients, doses, and formulations (FDA, 1998). An FDA team assesses a product’s conformance to the monograph, as well as to OTC labeling guidelines. Product Labeling After deciding to approve a drug for a specific indication, the FDA evaluates the product labeling. Labeling is a broad term that encompasses a number of materials developed by pharmaceutical companies, including the professional product label (also known as the package insert); medication guides (for drugs posing a serious public health concern); patient package inserts (with content often used in media advertisements); product packaging (which pertains to the external package labeling of the drug); and any written, printed, or graphic material used for marketing (Kenny, 2001). Professional product labels (package inserts) are developed by companies on the basis of Phase III data. They are evaluated by the FDA for compliance with federal regulations, rather than for usefulness6 to health care professionals and consumers. Medication guides and patient package inserts are written for consumers in a more user-friendly language. However, problems with the design and content of all labeling materials affect their readability, comprehensibility, and usefulness (FR, 2006; Hubal and Day, 2006). The FDA’s recently published new rule on drug labeling is an 6 The Code of Federal Regulations requires that labels describe the drug’s ingredients, structural formula, and clinical pharmacology; its indications, contraindications, warnings, and precautions; its associated adverse reactions and potential for abuse; the signs and symptoms of overdose; guidelines for proper use; and how the drug is supplied.

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