The FDA has authority to regulate advertising of prescription medications to professionals and laymen, but only limited authority over the advertising of nonprescription drug products. Advertising of OTC drugs is actually under the authority of the Federal Trade Commission. Claims made for nonprescription drugs should have a scientific basis, and corrective advertising can be required by the FTC. For example, Warner-Lambert once claimed that Listerine mouthwash prevents colds and sore throats. The FTC found this claim to be unsubstantiated and required Warner-Lambert to include a corrective message in subsequent advertising. Penicillin is very safe (apart from occasional, possibly severe, allergies). It is almost without pharmacological effects in humans. But it is a prescription-only medicine almost worldwide. The conditions that are to be treated with penicillin almost always need medical attention. There would be no reliable means to limit the OTC sale of penicillin in the United...
To help explain this difference, let's consider a woman who has had a stroke and has lost her ability to walk. A doctor might prescribe anticoagulants, blood pressure medication, change in diet, and regular exercise to help reduce the probability of future strokes. These prescriptions would be considered treatment. The doctor might also prescribe physical therapy to help return the patient to the highest level of physical mobility after the deficits caused by the stroke. This therapy aimed at returning the patient to normal or near-normal functioning would be considered rehabilitation. Finally, a rehabilitation professional making a home visit might recommend that a ramp be built to the front door, that doorknobs be changed to levers, and that the bathroom be fitted with hand bars. These modifications to the patient's environment would also be considered part of the rehabilitation process.
Drug therapy would appear near the top of most people's lists of how a health professional might remove the harm of disease or promote good. More than half of all physician office visits result in one or more prescriptions. The ideal objective of drug therapy is to improve the quality of a patient's life.2 In part because of legal requirements for the licensing of new drugs, drug products have more rigorous scientific evidence regarding safety, basic efficacy, and often, physiological effects than any other mode of therapy. It seems that drug therapy would exemplify the idea of applying scientific knowledge to improve people's lives. This very often occurs. One need only cite antibiotics to establish this.
One of the challenges of the travel clinic encounter is to impart the large amount of travel health advice and information applicable to a given trip in a way that can be remembered by the patient within the time allocated for the travel clinic encounter (typically 45-60 minutes). Most travel clinics find that the preparation of patient information brochures, preprinted prescriptions, and printed instructions on what to do for vaccine-associated side-effects will save significant time during the travel clinic appointments. The printed materials enable multiple providers to communicate the advice on each relevant topic and provide prescriptions according to the practice standards determined for the given travel clinic. Health topics that have proven useful in the University of Washington travel clinics over the years include
Current data indicate that, in 50 or more of patients in industrialised countries, the source of infection cannot be identified although transmission by contact with blood and contaminated materials is likely to be important, 35 of patients have a history of intravenous drug misuse. Household contact and sexual exposure do not appear to be major factors in the epidemiology of this common infection, and occupational exposure in the health care setting accounts for about 2 of cases. Transmission of HCV from mother to infant occurs in about 10 of viraemic mothers and the risk appears to be related to the level of viraemia. It should be noted, however, that information on the natural history of hepatitis C is limited because the onset of the infection is often unrecognised and the early course of the disease is indolent and protracted in most patients. Coinfection with HBV is not uncommon.
In this first chapter of our tutorial, we begin with an outline of the physics needed to understand the impact of force on lifetime of a single bond. Then deriving prescriptions for rate of transition under force, we analyze the stochastic process of unbonding in a probe experiment and
Cocaine enhances dopamine-mediated neurotransmission by blocking dopamine re-uptake at axon terminals. The striatum is one such site of action. Chronic exposure to cocaine up-regulates several transcription factors that alter gene expression and which could mediate the long-term neural and behavioural changes induced by the drug. One such transcription factor is DeltaFosB, a protein that persists in striatum long after the end of cocaine exposure. Using DNA microarray analysis of striatal tissue from both indu-cible transgenic mice engineered to overexpress DeltaFosB and mice treated with cocaine, cyclin-dependent kinase 5 (Cdk5) was identified as a downstream target gene of DeltaFosB 79 . Overexpression of DeltaFosB, or chronic cocaine administration, raised levels of Cdk5 messenger RNA, protein and activity in the striatum. Interestingly, injection of Cdk5 inhibitors into the striatum potentiated behavioural effects of repeated cocaine administration. This elegant study implicates...
Several attempts have been made to test such models. Often this process is circular, involving just another panel of experts making qualitative assessments (O'Neil et al. 1988). In other cases, models have been tested using results of a study on habitat use (Lancia et al. 1982) or use relative to availability (Thomasma et al. 1991 Powell et al. 1997), with the inevitable associated shortcomings discussed in detail in this chapter. In some instances, habitat management prescriptions based on common knowledge or expert opinion have, through collection of better data, been proven faulty (Brown and Batzli 1984 Bart 1995 Beyer et al. 1996). I found one case in which model-derived habitat scores for individual home ranges were compared with reproduction, juvenile growth rates, and home range size, but no significant relationships were observed (Hirsch and Haufler 1993). Studies of habitat use would benefit greatly from replication. Significant insights might be gained from comparisons of...
Despite its name, DUE does not assess the quality of drug use, just prescribing. Furthermore, most ambulatory care DUE is done from prescriptions dispensed and submitted for payment. Occasions when the prescription was not needed, when a prescription should have been written but was not, or when the order was never carried out (e.g., where the patient should have filled the prescription but did not) would often be ignored. DUE ordinarily does not consider drug administration, consumption, or effects, and sometimes does not consider dose. DUE is a useful, but very limited assessment tool, even for prescribing. It should be supplemented by one or more methods useful for evaluating medications use, e.g., as listed in Table 5.4. DUE data may be useful for identifying potential problem areas in prescribing, but decisions based only on DUE data should be appropriately limited.
But in this case the danger is that, while responding to the particular context and moment to ask your question, you either betray too much of your own perspective in the formulation you use or, in the heat of the moment, are lost for words. This is why it is useful to pose topic headings in the form of questions so that you do not have to do so much thinking on your feet. In general you should ask open questions, not only in the sense of avoiding questions that can be answered with a simple yes or no (unless you follow this up with a 'Can you say a bit more about that *), but also avoiding formulations that could be interpreted as prescriptions for, or prohibitions on, what can be talked about - unless you consider that the situation or topic merits you positioning yourself more clearly.
The Drug Enforcement Administration administers the Controlled Substances Act (CSA). The objective of the CSA is to regulate the distribution of substances with a potential for addiction, including many with legitimate medical purposes recognized by the FDA. The federal law cannot regulate which drugs may be prescribed, the quantity prescribed, or the frequency of prescriptions. Nonetheless, the DEA's War on Drugs does sometimes inhibit medically necessary use of controlled substances, in particular control of severe chronic pain. A physician who treats many patients with narcotic analgesics in high doses and the pharmacist who fills those prescriptions may attract the attention of the DEA and may need to defend against criminal or professional charges.
As indicated above, it is not uncommon for the primary care team to provide the only medical input for some patients. In most instances these will have relatively well-controlled symptoms, either completely in abeyance or interfering little with function. They require repeat prescriptions over long periods, occasional reassessment, and an avenue for contact with secondary services. However, in other cases, management solely by the GP is inappropriate, the situation having arisen because of imperfect follow-up procedures or because patients have detached themselves from the community psychiatric services. Thus, the decision to manage patients with schizophrenia solely within the primary care setting should be active the situation should not arise by default.
There is a growing need to contain medical costs. OTC drugs are not only cheaper than prescription drugs, due to their simpler and more efficient distribution channels, but they also eliminate the need for an expensive visit with the doctor for each episode of illness. The professional intervention required to prescribe pharmaceuticals represents the dominant cost 5. There is a need to increase treatment effectiveness, which is not ordinarily considered an advantage of self-medication. The increase in effectiveness depends on the generally more rapid availability of OTC medications than prescription medications, so that treatment may begin sooner. This can significantly shorten the total length of suffering, especially when the natural course of a disease is brief or when severe discomfort makes prompt therapy especially helpful.
The philosophy for OTC study design is significantly different from that of prescription medication studies. With prescription medications, you are typically striving to answer the basic scientific questions of 'can this drug work effectively ' and 'is it safe to administer to people '. Therefore, it is appropriate to study these new chemical entities primarily in controlled settings with extensive inclusion and exclusion criteria. This provides increased safety for the study participants, who will be using a drug of relatively unknown toxicity, and allows a reduction in the inherent variability of the study population, so as to obtain a clearer scientific answer to the questions of basic safety and efficacy. Every effort is made in studies of this type to control for all possible variables and to reduce random real-world circumstances to a minimum.
Studies of drug utilization in the elderly showed that older people receive disproportionate amounts of medication (Rochon and Gurwitz 1995). A study in rural persons 65 years or older showed that, of 967 interviewed, 71 took at least one prescription drug and 10 took five or more prescription medications. Again, women took more medications than men, and in both groups the To compound this worrying situation, there is the concomitant use of over-the-counter (OTC) non-prescription drugs. Only 50 of physicians or health workers ask about OTC drug use, yet 40 of all drugs used by the elderly are non-prescription drugs. In all, 69 of the elderly use OTC drugs and 70 take at least one prescription, as described earlier. In addition, 31 take alcohol frequently (Conn 1992).
Prescribing restrictions (PrRs) may be the most frequently used form of prescribing influence. In managed care networks, prescribing restrictions are administrative policies that restrict payment for unapproved drug products. In hospitals, physical access may be restricted directly if the hospital pharmacy does not provide non-formulary (i.e., locally unapproved) drug products or requires prior authorization. Common examples of PrRs are (a) formularies that list acceptable choices and exclude or limit access to other agents, (b) prior approval requirements for access, (c) specific limits on number of prescriptions or total prescription expenditure per person per month, and (d) specific limits on prescriber drug expenditures.
Susan Horn et al. studied the relationship between formulary restrictive-ness and utilization of other health care services in six managed care organizations (MCOs) located in six states.28,29 The study included 13,000 patients over 1 year and used prospective data collection and multiple regression analysis. Formulary restrictiveness was associated with higher rates of emergency department visits and hospital admissions for all included diagnoses except otitis media, and was associated with higher drug cost, more prescriptions, and more office visits for some diagnoses. The range of effect was approximately twofold i.e., the most restrictive formulary tended to be associated with twice the utilization of the least restrictive formulary. Some managed care programs may limit the number of prescriptions that they will pay for per month, or their monthly expenditure per capita. Soumerai et al. studied the effects of a limit of three prescriptions per patient per month, established for an...
The potential usefulness of the new drug in a pediatric population. If it is likely to generate over 100 000 prescriptions year, this would indicate the need to develop a pediatric formulation and suitable pediatric studies. If it is likely to generate less than 50 000 prescriptions year, the sponsor may be granted a waiver by the FDA for pediatric data, and a disclaimer statement allowed. Either way, in a children's disease, if less than 200000 patients year may benefit, then orphan-drug status with seven year exclusivity may be applicable. This would then apply only to that pediatric indication.
Aparasu and Fliginger estimated the prevalence of inappropriately prescribed medicines by analyzing 1992 data for patients aged 65 years and older from the National Ambulatory Medical Care Survey (NAMCS). The NAMCS is a nationwide cross-sectional survey of office visits by ambulatory patients. Prescribing appropriateness was measured as the prevalence of prescriptions for any of 20 medicines considered inappropriate for use in the elderly. Office-based physicians prescribed at least one inappropriate medication in about 8 of the elderly who received prescriptions.45
Beers et al. studied prescribing appropriateness in a prospective cohort study of 1106 residents of 12 nursing homes in the greater Los Angeles area. Prescribing appropriateness was evaluated using explicit criteria developed by 13 experts from the United States and Canada. The experts reached consensus about 19 drugs that should generally be avoided in the elderly and 11 doses, frequencies, or durations of use of specific drugs that generally should not be exceeded. Based on these criteria, 7 of all prescriptions were inappropriate 40 of residents received at least one inappropriate medication order, while 10 received two or more concurrent inappropriate medication orders.46
Gregor et al. carried out a naturalistic study of selective serotonin reuptake inhibitors (SSRIs) using data from the Regenstrief Medical Record System. They analyzed the dosing of SSRIs in a cohort of 3350 outpatients of an urban teaching hospital. Of these, 2859 had received fluoxetine (Fx), 460 had received sertraline (St), and 31 had received paroxetine (Px). Mean daily doses were calculated for patients receiving Fx and St. A mean of 5.0 of all patients continuing Fx therapy had their daily dose increased with each prescription refill during the first nine prescriptions. A mean of 14.9 of all patients continuing St therapy had their daily dose increased with each prescription refill during the first nine prescriptions. The frequency of St dose increases was two to three times the rate for Fx. The authors used this information to compare the effectiveness of Fx and St for control of symptoms of depression during the initial stages of therapy.49
Lindley et al. studied 416 successive admissions of elderly patients to a teaching hospital. Of the 416, 26 (6.3 ) were attributed to adverse drug reactions (ADRs). Thirteen of these 26 (50 ) were due to inappropriate prescribing. Forty-eight patients (11.5 ) had a total of 51 drugs with absolute contraindications (CIs) (3.8 of prescriptions). At admission, 175 unnecessary drugs were discontinued in 113 (27 ) patients. A total of 103 patients (27.0 of those on medication) experienced 151 ADRs. Seventy-five of the 151 ADRs (49.7 ) were due to unnecessary drugs or drugs with absolute CIs. This ADR rate was significantly higher than that observed for all prescriptions. The authors concluded, much drug-related morbidity in the elderly population may be avoidable, as it is due to inappropriate prescribing. 52
Documentation and reporting of adverse events are critical steps in the effort to prevent ADRs. Adverse reactions should be clearly described and documented in the medical record. This is mandated by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) as a method for preventing serious adverse reactions from re-exposure to a medication to which a patient may be allergic or intolerant. Most adverse reactions, however, are not properly documented or reported. Despite the importance of spontaneous adverse drug reaction reporting, it is estimated that only 1 in 10 serious adverse drug reactions is reported to the FDA. Given the large number of drug prescriptions written each year in the United States, this figure most likely overestimates the number of reports.
An indicator is a quantitative measure that can be used to monitor and evaluate the quality of important clinical and support functions that affect patient outcomes 1 A performance indicator is a quantitative criterion measurement that is related to a guideline, for example the percentage of prescriptions for a certain therapeutic objective that were written and used in accordance with guidelines. An indicator is not a direct measure of quality. Rather it is a tool that can be used to assess performance and that can direct attention to . issues that may require more intense review within an orga-nization. 1 That is, in order to be useful, an indicator need not correctly identify every case, say as acceptable or unacceptable. It must, however, correctly classify enough cases to allow tracking of overall performance levels. This is the issue of indicator validity, explained further below.
In an effort to relieve the working memory and retrospective memory burden associated with prescription labels, Morrell, Park, and Poon (1990) hypothesized that pictorial labels may improve older adults' knowledge about prescriptions when compared to labels that only include text because older adults maintain stable memory for pictures (Park, Puglisi, & Smith, 1986 Park, Royal, Dudley, & Morrell, 1988). Surprisingly, the presence of the pictures on some of the labels increased younger adults' performance on tasks related to the information these labels contained, but this pictorial label type did not help older adults, and in fact for this group the picture labels were associated with lower levels of performance than were the text-based labels.
With the advent of the Prescription Drug User Fee Act (PDUFA), which legislated new timelines for NDA reviews, the FDA introduced the project team concept for both IND and NDA reviews. For INDs, an FDA project team is established upon IND submission. When an NDA is received, an important responsibility of the NDA review team is to determine whether the submission is adequate for review by the FDA. Within 45 days of the NDA submission, the NDA review team will either accept the NDA for review or return the submission to the sponsor along with the reasons why it was not acceptable for review (Refuse to File). The role of project manager has been created in both CDER and CBER. An FDA medical officer generally leads the technical review and a project manager, sometimes called a regulatory manager, oversees the process.
Service utilization, labor market participation rates, and cost estimates were made from national databases. The primary sources for disability-specific service utilization were the 1994 and 1995 National Health Interview Survey-Disability Supplement (NHIS-D) (inpatient, prescription medications, therapy and rehabilitation, long-term care and the 1994 and 1995 National Health Interview Survey (NHIS) (physician visits). Pricing of outpatient medical care services relied primarily on the 1987 National Medical Expenditure Survey (NMES), whereas inpatient service cost was based on charge data from the 1995 Healthcare Cost and Utilization Project adjusted to costs using Medicare cost-to charge ratios. The receipt of special education services by developmental disability was based on the MADDSP, whereas special education placement category for those receiving services by disability was taken from the NHIS-D. Average special education costs were then estimated based on the incremental price...
The past few years have witnessed a dramatic increase in the use of herbal products as well as other methods associated with alternative and complementary medicine. What has fueled this shift toward herbal and nutritional supplements Many patients view herbal products as offering a gentler, more natural form of therapy with fewer side effects. While this may be true for some supplements, the side effects of many herbal products have simply not been publicized adequately. In addition, the use of herbal products also puts the patient in control of his treatment, since most do not require prescriptions.
This is essentially an extension of traditional, hands-on epidemiology, which assembles all patients that are prescribed a drug into a cohort which is then followed. In the UK, for example, through the Drug Safety Research Trust, all or a sample of this cohort is assembled from the records of the prescription pricing authority, generally within the first year or two of initial marketing of the product. Each patient can be followed-up with a confidential enquiry for serious adverse events using a form that, in the UK, is popularly called by its appearance the 'Green card' (this term has an entirely different meaning in the USA, and, curiously, describes a pink document ). It is a classic example of an observational as opposed to an experimental method, in which all uses and all outcomes (events) are observed, generally without a simultaneously collected comparison population. Thus, data stemming from these sorts of activities are fraught with analytical and methodological traps....
Drug therapy may be the most common modality of therapy in the industrialized world. In the United States, just under two thirds of all physician office visits include one or more prescriptions. The frequency of prescription use increases slightly with age (Figure 1.1).1 Number of prescriptions (mentions) per 100 physician office visits in the United States in the year 2000 (National Ambulatory Medical Care Survey). Number of prescriptions (mentions) per 100 physician office visits in the United States in the year 2000 (National Ambulatory Medical Care Survey). Some health care policies may worsen the problem. For example, efforts to control expenditures include pressure on professional fees. To maintain their incomes, physicians and pharmacists may feel pressure to see more patients and fill more prescriptions. Pharmacists are not held to standards requiring them to participate in managing drug therapy outcomes. High prescription volumes and low professional service expectations may...
Ashwell and New Hampshire Medicaid may not show a callous disregard for the needs of people in order to reduce costs. In the New Hampshire example, the overall program paid much more than the cost of the denied prescriptions. More likely, the cause of problems like Mr. Ash-well's death is a misguided effort to control one part of the health care mix at the expense of others. (Such decisions are called suboptimization.) By now
The role of the pharmaceutical physician in the OTC division of a major pharmaceutical company is substantially different from that played in the research or medical affairs departments dealing with prescription drugs. One might assume that OTC work is simpler and less involved than that related to prescription medications. In many ways, the opposite is true. One of the most surprising aspects of the pharmaceutical physician's role in OTC medication is the very high degree of creativity required of the physician. With prescription medication, one must work with whatever compounds have been previously developed by chemistry and toxicology. These are brought to the physician for clinical testing. There is seldom any input by the physician into drugs he she will select to work on. Sometimes the project on which the physician will be spending years of his her life is of considerable medical interest, in other cases it is not. No matter what the case,
It is sometimes possible to accelerate the accumulation of data for a promising OTC candidate by specialized Phase IV studies. These studies accelerate the process of data collection by conducting what amounts to a survey amongst physicians using the drug on a prescription basis. Since the sole interest is the gathering of adverse reaction data, with special emphasis on rare and serious events, record forms are kept very minimal, often to a single page. The study design consists simply of a survey, done without control groups. Hundreds of physicians, or even thousands, must be contacted to participate in the survey by submitting brief record forms on patients they treat in their usual manner with the prescription drug. Such a survey can rapidly provide a much more reliable database than spontaneous reporting. With a survey, you get both a frequency of the various side effects and a reasonable estimate of the number of patients treated, which permits the calculation of accurate rates...
On release, geriatric ex-prisoners may face unique challenges reentering the community. These challenges are social as well as medical, and include frailty in an unsafe neighborhood concerns about employability as an older person multiple chronic illnesses with functional limitations and or lack of medical insurance or prescription drug benefits. In addition, serious mental illness and the psychological syndrome of institutionalization cannot be underestimated as challenges to long-term inmates when they are released to the community. With long-term incarcerations, older adults who are to be released may not have made up for opportunities missed in their life such as education, job advancement, and strengthening family relationships (Aday, 2003). Despite this, the Bureau of Justice reports that geriatric parolees have lower recidivism rates (54 ) during their parole terms, and increasing age is one of the most reliable predictors of low recidivism as older ex-prisoners are the least...
Another factor consistently associated with decreased medication compliance is substance abuse (Heyscue, Levin, & Merrick, 1998). Some individuals discontinue medication when drinking alcohol or abusing substances. Some of these individuals also take to self-medicating with both legal prescription drugs and illicit drugs on a dosage and schedule they choose. This is discussed in more detail in Chapter 8, which addresses dual diagnoses.
In 1999, prescription drug expenditures totaled 99.6 billion, 8.2 of the total health expenditure of 1211 billion. In the same year, prescription drug expenditures increased 17 higher than the average annual rate of increase of 12 between 1995 and 1998. From 1990 to 2000, the CPI for prescription drugs increased by 3 to 6 . Prescription drugs posted one of the highest rates of CPI increase in 1999, 5.7 , while it dropped to 4.4 in 2000. In 1999, 43 of prescription drug expenditures were paid by private health insurance (up from 25 in 1990), 35 by out-of-pocket payments (down from 59 in 1990), and 17 by Medicaid.3 So, the debate goes on. On the one hand, we get a lot of value for 8 of health care expenditures. On the other hand, much of that 99.6 billion is spent out-of-pocket, so people feel the pain of expensive prescriptions. Medicare does not cover outpatient prescriptions, and many insurance programs force people to pay a significant share of prescription costs. Prescription drug...
The Pediatric Use Working Group, chaired by Miriam Pina (1995) (FDA Division of Pulmonary Drugs), examined data that the FDA had acquired on 1994 pediatric prescriptions from IMS. From these they identified the top ten drugs used 'off label' in children Albuterol, Phenergan, Ampicillin i.m. or i.v., Auralgan otic solution, Lotison, Prozac, Intal, Zoloft, Ritalin (under 6 years old) and alu-pent syrup (under 6). A combined total of over 5 million of these 10 products were prescribed in 1994.
When using a known human teratogen, particular attention should be given to prevention of pregnancy. This includes counseling the patient on the fetal effects of the drug being used and on the use of one or more effective forms of contraception. Therapy should be begun with a normal menstrual period or no more than 2 weeks from a negative pregnancy test. When renewing prescriptions for these drugs, it is necessary to verify again that the patient is not pregnant.
Substance use disorders include the formal medical diagnoses of substance abuse and substance dependence for many types of drugs of abuse, including alcohol and prescription drugs. These disorders are characterized by recurrent problems in everyday life or physical or emotional distress and impairment that are caused or exacerbated by the use of the substances of abuse.
Severe P. falciparum malaria requires urgent treatment with parenteral antimalarial agents. Quinine is the drug of choice unless the malaria was definitely acquired in a chloroquine-sensitive area. Quinidine may be used as an alternative to quinine if the latter is not available. Drugs with short half-lives (quinine, quinidine, artemesinin) should be given for at least 7 days if given alone. Shorter treatments are required for drugs with longer half-lives (chloroquine, mefloquine, pyr-imethamine sulphadoxine). It is important to distinguish between base and salt when calculating the drug dose. Chloroquine, mefloquine and primaquine prescriptions are usually written as the amount of base, whereas quinine and halofantrine are written as the amount of salt. Always check the doses carefully.
Biological membranes fulfil vital functions as interfaces to the outside world, as interfaces between cells, and as boundaries of intracellular compartments. Membrane proteins share a common property part of their structure is embedded in a lipid bilayer. Therefore, being located at an interface, it is almost inevitable that they mediate communication between both sides of the membrane receptors, pores and channels are all signal transducers. Membrane proteins are abundant they are estimated to constitute a third of the complement of proteomes. An analysis of the genomes of eubacterial, Archaean and eukaryotic organisms predicted that 20-30 of the open reading frames encode integral membrane proteins (Wallin and von Heijne 1998). The number of lipid-interacting proteins should be increased if we consider the proteins presenting two conformational states, one of them stable in solution and the other one attached to a membrane or a lipid interface. This is the case for the great family...
Drug dependence requires the same thorough evaluation by both a psychiatrist and an addictions specialist. Data are emerging to support the hypotheses that patients with polysubstance abuse are at higher risk to return to substance use than those who abuse only alcohol. Although current drug dependence is usually considered a contraindication to transplantation, methadone-dependent patients in a standing methadone maintenance program have been successfully transplanted several times in our program. The transplant program should be in close contact with the methadone program and look for patient compliance with the program's treatment plan and a stable relationship with the counselor. Dependence on prescription drugs poses a difficult challenge. The prognosis is improved if the patient maintains a good relationship with one physician, does not develop tolerance, and is on a minimum of medications.
Physical access to prescription medications, however, requires an unbroken chain of decisions and actions that are often more important than geographic location. In order for a patient to have physical access to drug therapy for a particular indication, a drug product would have to exist for that indication. This is not quite as obvious or as simple as it may first appear. Drug products (whether natural or synthetic) have to be discovered and developed. An approved manufacturer must have produced and tested a drug product. Before a drug product can be marketed within legitimate channels in the United States, its sponsor (manufacturer) must have received Food and Drug Administration (FDA) approval. Approval is for specific indications, and the manufacturer cannot promote the product for other (off-label) uses. According to the pharmaceutical industry, developing a new drug product requires an average of 15 years and costs an average of 880 million.
And the 37-year-old man became a frequent and popular volunteer at area health clinics. One day, Mr. Ashwell went to the emergency room at the local hospital. The emergency room doctor diagnosed early stage pneumonia and prescribed an antibiotic. But Mississippi limited how many prescriptions it would purchase each month for Medicaid patients, and someone at the drugstore said that Mr. Ashwell had reached his limit. According to the hospital, Mr. Ashwell could not buy a sixth drug, the antibiotic, because of financial problems. Unable to pay for the 45 antibiotic, he went home. Three days later, his infection had worsened severely and he was hospitalized. Hospital records describe painful and expensive attempts to save Mr. Ashwell after his untreated pneumonia worsened, but it was too late. He died, and Medicaid had a 4900 hospital bill.* The clearest examples of this phenomenon were reported by Steven Soume-rai and his group at Harvard. During an 11-month period, New Hampshire...
From providing sufficient amounts of medication for discharge, inmates should be given a prescription to cover the time period from release to the first TB appointment in the community (Hammett et al.). Case managers should also inform inmates about public hospitals and clinics affiliated with state or local health departments that may provide free or low-cost TB care and medications. Regardless of whether medications or prescriptions are given, case managers should ensure that the inmates understand the proper dosing and administration of the TB medications and provide written instructions in the inmates' preferred languages.
When evaluating the safety and tolerability of a drug for possible OTC use, one must first consider the quality of available information. Many drugs, particularly those used for a long time as prescription medications, have extensive safety databases. However, some do not, particularly older drugs that predate modern research standards and newer drugs with insufficient usage. Also, with some drugs, the tolerability of one formulation may differ greatly from that of another. One example is benzyl peroxide, in which formulations may very greatly, even at the same strength but with different excipients. Where such problems mean that there is an inadequate database for an intended OTC formulation, clinical testing will be needed before launch. The therapeutic index (the ratio of therapeutic dose to toxic dose), which varies widely for both prescription and OTC drugs and is often less of a safety determinant than might be supposed. For example, the prescription drug sucralfate for the...
As a result of this, and the fact that 30 of prescription drugs by then were consumed by just 12 of the population (those over 65 years), a new guideline was issued. Thus, the FDA Guideline on Drug Development in the Elderly (1990) recommended that, if a drug was likely to have significant use in the elderly, then studies should be done in an elderly population. These studies should look at effectiveness and adverse events by age. In addition, other studies should determine whether older people handle the new drug differently (a 30 decrease in renal excretion and liver metabolism is normal in a healthy elderly person). This guideline also required studies of the pharmacokinetics and, where possible, pharmacodynamic studies of the new drug in the elderly. The Guideline also urged the study of possible drug interactions with drugs commonly used concurrently in this age group. Digoxin was given as an example. Looking even further forward to the future, the...
The study of a pharmacological agent, such as a prescription medicine, an over-the-counter drug, an alternative medicine such as St. John's wort, or even a nutritional supplement, requires an interdisciplinary approach. Knowledge of pharmacokinetics, pharma-codynamics, pharmacogenetics, chronopharmacology, modulators, and biologic molecular markers must all be incorporated to ensure the development of safe
It has also been claimed (because gender data are rarely mentioned in clinical studies, papers or reports) that gender differences are not sought. This presupposes that data are neither collected nor examined. In fact, the opposite is much more likely 94 of surveyed pharmaceutical firms were found to collect gender data in their studies (Edwards, 1991). The reality is that findings of no differences are rarely reported, but sometimes this finding may just be a function of small sample size for each individual study or the small degree of difference to be found. It must also be recognized that many drugs were introduced into medicine prior to the current modern-day comprehensive testing programs. Nonetheless, after many years and millions of prescriptions, it is of reassurance that few have shown significant clinically important gender-related differences.
Pharmacopoeias contain much information regarding drug and veterinary substances. Those commonly use or include the United States, British, and European Pharmacopoeias. The U.S. Pharmacopoeia (www.usp.org) has more than 4000 monographs featuring the standards for prescription and non-prescription drug ingredients and dosage forms, dietary supplements, medical devices, and other healthcare products. The monographs include descriptions, requirements, tests, analytical procedures, and acceptance criteria. Information on the British Pharmacopoaeia can be obtained from www.pharmacopoeia.org.uk and on the European Pharmaco-poaeia from www.pheur.org.
Major categories include alcohol sedatives hypnotics nicotine marijuana opioids, such as heroin stimulants, including amphetamines, cocaine, crack, and caffeine inhalants, such as glue, paint, nitrous oxide (laughing gas), and shoe polish hallucinogens, including phencyclidine (PCP or angel dust ), LSD ( acid ), MDMA (an amphetamine-like drug with hallucinogenic effects, also known as X or ecstasy) anabolic steroids and even some types of prescription drugs, such as Valium.
PC-SPES is a combination of seven Chinese medicinal herbs Reishi (Ganoderma lucidum) spores, Balkal skullcap (Scutellaria baicalenesis) root, Rabdosia (Rabdosia rubescens) root, Dyer's wood (Isatis indigotica) root, mum (Dendranthema morifolium) flower, san-qi ginseng (Panax notoginseng) bark and licorice (Glycyrrhiza glabra) root with the addition of one North American herb, saw palmetto. This herbal product appeared a few years ago and is widely used by patients as a treatment for their prostate cancer. The story of this herbal product illustrates the positive and negative aspects of the current regulatory environment with regard to supplements. This product did not proceed through the standard process by which prescription drugs are approved by the FDA. Shortly after this product was introduced, many of us became aware that in some patients this product induced a significant decrease in tumor size. Physicians initially had no information about appropriate dosing, side effects and...
One objective of the food and drug act is to prevent the marketing of worthless and unsafe drugs. Examples of drugs without proven therapeutic value are purported cancer cures like krebiozen and laetrile. However, drugs being promoted for nonscientific uses include more than these well-recognized examples. Prior to the 1962 Kefauver-Harris amendments to the FDCA, reputable pharmaceutical manufacturers promoted many drugs based on evidence of effectiveness that could not withstand scientific review. After the 1962 amendment, the FDA contracted with the National Academy of Sciences National Research Council (NAS NRC) to review the scientific evidence supporting the efficacy of drugs marketed between 1938 and 1962. Approximately 360 prescription drugs (about 7 of the drugs reviewed) were rated as lacking substantial evidence of effectiveness by the NAS NRC review and were
This psychotherapeutic drug revolution has had some negative consequences, however. Drug side effects range from the annoying to the life threatening. Community mental health treatment centers have not grown in number or received funding sufficient to meet the needs of all the patients released from long-term care facilities. Many mentally ill patients have fallen through the cracks of community-based care and live on the streets or in shelters for the homeless. In addition, some physicians and patients have come to expect a pill for every ill and fail to use other, equally or more effective treatment methodologies. Researchers estimate that 15 percent of the population of the United States receives a prescription for a psychotropic drug each year, greatly adding to the nation's health care costs. The majority of these prescriptions are written by generalist physicians rather than by psychiatrists, raising concerns about excessive or inappropriate prescribing. Some people abuse these...
Until the twentieth century, deductive logic and the psychology of human thought were considered to be the same topic. The mathematician George Boole titled his 1854 book on logical calculus An Investigation of the Laws of Human Thought. This book was designed to investigate the fundamental laws of those operations of the mind by which reasoning is performed. Humans did not always seem to operate according to the prescriptions of logic, but such lapses were seen as the malfunctioning of the mental machinery. When the mental machinery functioned properly, humans were logical. Indeed, it is human rationality, the ability to think logically, that for many thinkers throughout time has separated humans from other animals (for example, Aristotle's man as rational animal) and defined the human essence (for example, Ren Descartes's I think, therefore I am ).
Logic and reasoning are essential elements of the human mind and underlie many daily activities. Although humans may not follow the prescriptions of formal logic precisely, human reasoning is nevertheless often systematic. Study of the structures and processes involved in the use of logic and reasoning provides insight into both the human mind and the possible creation of intelligent machines.