Prescription Medications Ebook

Prescription Freedom: Natural Remedies To Live Drug Free

Prescription freedom is a product that helps individuals free up themselves from drug prescriptions. It is based on ancient natural solutions and applicable to all people irrespective of age and gender. It is a product of Kevin Christianson, once a victim of drug prescriptions but now free from such chains. The ancient remedies recommended can quickly give you power and reverse any kind of illness that plagues your heart. More importantly, the program has been found to be effective even to those with difficulties in weight management, blood pressure, depression, and diabetes among other conditions. It is about natural solutions that attack your problem from the core. By means of simple booster tricks unleashed in the guide, your body will be rejuvenated to prevent the disease along with harmful bacteria from getting into your body. In case the product does not serve you as expected, feel free to claim for a refund. There is a 60-day money back guarantee and unlike other products, you will still maintain ownership of the course along with all the bonuses.

Prescription Freedom Natural Remedies To Live Drug Free Summary


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Prescription Drug Data

After a patient receives a prescription from his her doctor, the patient takes it to the community pharmacy where it is dispensed. Dispensed prescriptions are then sent to the Pharmacy Practice Division (PPD) of the Information and Statistics Division of the Common Services Agency to obtain reimbursement and dispensing fees. After paying the pharmacists and dealing with any appeals, PPD sends the cashed prescription forms to MEMO. GP prescribing information is captured by MEMO by a unique menu driven computer system, which links the prescribing information with the CHI number database (Figure 28.1). Using this system, it is possible to allocate the CHI number from the patient details on the prescription. Both generic and proprietary names are used so the ability to differentiate between product types is available. The total amount of drug dispensed is also entered together with the dosing instructions, thus allowing the duration of any prescription to be calculated. Community...

Drug Control And Development

Before the twentieth century, most government controls were concerned not with drugs but with impure and adulterated foods. Medicines were thought to pose problems similar to those presented by foods. Efficacy was questioned in two respects adulteration of active medicines by addition of inert fillers and false claims made for the so-called patent (secret) medicines or nostrums. Indeed, much of the development of the science of pharmacy in the nineteenth century was standardizing and improving prescription drugs. Prescription drugs also were subject to control under the 1906 law. In fact, until 1953 there was no fixed legal boundary between prescription and nonprescrip-tion medications. Prescription medications received a lower priority, since food and patent medicine abuses were judged to be the more urgent problems.

Modern Drug Legislation

Obscure provision of the 1938 act was destined to be the starting point for some of the most potent controls the Food and Drug Administration (FDA) now exercises in the drug field. This provision allowed the prescription drug to come under special control by requiring that it carry the legend Caution to be used only by or on the prescription of a physician. Drug regulation in the United States is continuing to evolve rapidly, both in promulgation of specific regulations and in the way regulations are implemented (Table 1.1). The abolition of patent medicines is an outstanding example, as is control over the accuracy of claims made for drugs. Since the 1962 amendments, the advertising of prescription drugs in the United States has been increasingly controlled to a greater extent than in most other countries. All new drugs introduced since 1962 have some proof of efficacy. This is not to say that misleading drug advertisements no longer exist manufacturers still occasionally make...

Francis s Collins md PhD

Five years ago pharmacogenomics was unfamiliar to most scientists and health care providers. Today we are witnessing an exponential increase in research on the topic, new journals are springing up, and observers in both the academic and private sector are predicting a substantial impact on clinical medicine in only a few years. In such a rapidly-changing environment, it is critical to stand back from the avalanche of scientific information and consider the broader view, with special attention towards the impact on society. In that regard, the birth of this new textbook, which considers social and ethical issues as well as scientific and clinical underpinnings, comes at an auspicious moment. In this remarkably broad and far-reaching work, editor Mark Rothstein and his distinguished list of contributors have laid out an impressive framework for the field. Beginning with a survey of public attitudes, and progressing through scientific, clinical, governmental, legal, economic, and...

Food and Drug Administration Rockville Maryland USA

Optimize drug doses and dosing schedules. Approximately 70 of drug-related adverse events are due to extended pharmacological actions. Thus, there is growing evidence to suggest that drug doses approved for marketing may be higher than is necessary and may be contributing to the high frequency of serious drug side effects. A recent study that examined the doses of 354 prescription drugs recommended in the label and released between 1980 and 1999 found that approximately 17 of these drugs had a reduction in dose or a new restriction for use in special populations such as patients with renal or hepatic disease 8 . Furthermore, it has been reported that prescribers in their practice frequently use doses which are lower than the FDA-approved label dose 9 . In an informal survey, it was also found that doses approved in other countries, e.g., Japan, are

Hypothesisgenerating Methods

Doctors (in some countries other health care professionals or patients as well) are provided with forms upon which they can notify a central authority of any suspected ADRs that they detect. In the United Kingdom the yellow card has been used for this purpose since 1964. Similar forms are provided in the FP10 prescriptions pads, the British National Formulary, and other sources. In the United States, the MedWatch form is used, and is made broadly available to health professionals to encourage reporting. PEM, as conducted in the United Kingdom and New Zealand, represents a hybrid method, combining aspects of public health surveillance and spontaneous reporting with aspects of formal epidemiologic studies. This important technique in the United Kingdom takes advantage of a number of features of the British National Health Service (NHS). Within the NHS, prescriptions written by general practitioners are sent, once they have been dispensed, to a central Prescription Pricing Authority (the...

Table 21 Drug Information Sources

Multiple drops at one time is not advisable. The conjunctival sac can hold no more than a single drop. Multiple drops will only increase unwanted side effects. The extra drops spill down the cheek, wasting drops and burdening the patient with the expense of additional prescriptions.

Physician as Catalyst

That allegedly controls the body's Cortisol levels, thereby suppressing appetite, which the promoters claim results in weight reduction. Another product, marketed in San Antonio, Texas, was a liquid solution taken at 8 pm, with nothing to eat after that time. It reportedly burned away the fat while the consumer slept. An individual told me she had tried this product four times without success and asked me what she was doing wrong. I told her that her lack of success was due to the fact that the product did not work. Even the medical community has contributed to the magic pill myth. For years physicians have written prescriptions for various obesity medications, typically with poor results. If any one medication was the magic pill for obesity, there would be no overweight physicians. Pharmacotherapy can be a useful adjunct to dietary control and behavior change, but it can never be the primary treatment. Chapter 6 will discuss phar-macotherapy in more depth.

Contributions Of Many Cultures

Ancient Egyptian medical papyri contain numerous prescriptions. The largest and perhaps the most important of these, the Ebers papyrus (1550 b.c.), contains about 800 prescriptions quite similar to those written today in that they have one or more active substances as well as vehicles (animal fat for ointments and water, milk, wine, beer, or honey for liquids) for suspending or dissolving the active drug. These prescriptions also commonly offer a brief statement of how the preparation is to be prepared (mixed, pounded, boiled, strained, left overnight in the dew) and how it is to be used (swallowed, inhaled, gargled, applied externally, given as an enema). Cathartics and purgatives were particularly in vogue, since both patient and physician could tell almost immediately whether a result had been achieved. It was reasoned that in causing the contents of the gastrointestinal tract to be forcibly ejected, one simultaneously drove out the disease-producing evil spirits that had taken...

Of FDCAFees Relating to Drugs Sections 735736

This chapter and its sections are the result of the Prescription Drug User Fee Act of 1992. Under this part of the FDCA, fees are authorized and specified as to what is to be charged to a drug manufacturer or sponsor who submits a human drug application via 505(b)(1) or 505(b)(2), or as a supplement to such an approved application. The fees are to cover the expenses that are incurred for the review of an application. As a result of a reauthorization in 1997, fees are now not to extend past October 1, 2002 unless there is another reauthorization.

CFR 30050Combination Drugs

Under this CFR part it addresses fixed-combination prescription drugs for humans. It states that Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug. It further explains that special cases of this general rule are where a component is added (i) to enhance the safety or effectiveness of the principal active component and (ii) to minimize the potential for abuse of the principal active ingredient.

Drugs Acting On The Central Nervous System

In general, elderly people are more sensitive to medications that affect central nervous system function. Drugs of particular relevance in this regard are benzodiazepines, major tranquillisers and antidepressants, which are all frequently used by elderly patients. In a study of medicine use in general practice, psychotropic drugs were prescribed more commonly than any other group and accounted for up to one-fifth of all prescriptions (Skegg et al., 1977). The proportion of patients receiving such medicines increased steadily with age 21.4 of men and 29.9 of women over 75 years of age were receiving a sedative or hypnotic. Adverse reactions due to psychotropic drugs are known to be a frequent cause of hospital admission in the elderly (Williamson and Chopin, 1980 Hallas et al., 1992).

Clinical Trials And Observational Data

For all of the advantages offered by longitudinal data, there are some issues to be aware of especially when using clinical data. The issues are well described elsewhere (Stang, 1998 Strom, 2000) however, they bear brief mention here. Paramount among the concerns of the scientist using longitudinal or any data for that matter, is to understand why and how these data were collected. Data that derive from clinical practice or billing will only represent detected clinical illness and may not contain other factors that are useful in assessing risk (e.g. non-prescription drug use (OTC, street drugs, alcohol, smoking) or other medical disorders that may not be clearly or consistently captured in the data). The lack of capture may be due to how data are captured for a segment of care (hospitalizations for example) which may lack the necessary detail (as in the

Pharmacological and psychological aspects of drugs of abuse

Drug abuse, misuse, and addiction are major issues in society because of their enormous personal, social, and economic costs. They also have important psychiatric components. Many drug treatment programmes are run by psychiatrists, and the evidence strongly supports the notion that a significant proportion of severe drug abusers are psychiatrically ill. Moreover, drug misuse is becoming more frequent in patients with other psychiatric disorders, where it can lead to problems in treatment and a poor outcome. It is therefore essential for all psychiatrists and related health professionals to have a good understanding of the basis of drug misuse.

Personality variables and the genetics of addiction

The role of personality in addiction is a major issue, with some believing in an 'addictive personality' and others suggesting different personality types might predispose to different aspects or forms of drug misuse. (26,27 In this highly controversial field a few facts are generally agreed. Predisposition to experiment with both licit and illicit drugs is more likely in those with sensation-seeking or impulsive behaviour traits, and in extroverts rather than introverts. However, once drug dependence is established, those with obsessional, dependent, or anxious characteristics find it hardest to stop. (2B)

The routes and risks of addiction

In addition to the impact of drug misuse on the social aspects of life, it can lead to significant medical problems. The dangers of drug abuse relate to two main factors the route of use of the drug and the effects it has in the brain outside of the reinforcement circuit.

Epidemiological Studies Of Drug Safety

The basic elements necessary for an epidemiologi-cal study of drug safety are (1) a record of drug exposure (2) a record of outcomes and (3) access to detailed medical information about individual cases. The first two elements may be held in the same database (as in the UK General Practice Research Database) or in separate databases which are record-linked . The key element of record linkage is the cross-identification of individuals in both databases so that exposures and outcomes are linked for individual patients (Figure 9.6). This is exemplified in the Medicines Monitoring Unit (MEMO) system based in Tay-side, UK, where completely separate databases of encashed prescriptions and hospital discharge records are linked through a unique identifier known as the Community Health Index number (Evans and MacDonald, 2000).

Discretionary powers left with the member states

For the regulation of the use of plant protection products-other than for marketing-more discretion seems to have been left to the member state. Although article 1 of the Directive states that it also concerns the use of the products, use does not fall completely within its scope. The Directive does contain some important provisions prescribing use and requiring 'proper use' of plant protection products, but it does not regulate all aspects of use, such as the training of users, requirements for application equipment and financial measures such as levies on pesticide use. Commission Regulation 451 2000 explicitly mentions the rights of member states to introduce charges, levies or fees in accordance with the Treaty (article 14). A member state does have the discretion to introduce national measures on these aspects. This discretion seems limited, though, because prescriptions on use are not to interfere with the harmonisation of pesticide marketing.

Section Vi Common Systems Of Measure 139 Introduction

In the pharmacy, both systems have been replaced, for the most part, by the metric system. Prescriptions and drug orders could, however, have the weights or volumes expressed in units of one of the common systems. To facilitate the interpretation of these prescriptions, the relationships and conversion factors contained in this lesson must be committed to memory.

Services for individuals with comorbidity

There is an increasing recognition of the problems associated with alcohol and other drug misuse and mental illness (see Chapter. Often alcohol misuse is complicated by multiple substance misuse. For example, in the Epidemiologic Catchment Area Study half of all patients with schizophrenia also had a substance misuse disorder,(76 and a recent British survey of psychotic patients found that 36 per cent misused drugs or alcohol. (77) However, there is currently no consensus on the most appropriate treatment services for patients with comorbidity.(78) Substance misuse can be particularly problematic in the context of mental illness, and is associated with higher rates of violence and poor treatment outcome (see Chipie.L11 4.4). Such patients are often non-compliant and disruptive in mental health services, and typically do not engage in alcohol or drug services. Assertive community outreach and integrated service models, covering both mental illness and substance misuse, have...

What is meant by the harmreduction approach

In the early 1980s, a radical departure from the conventional abstinence-oriented approach took place when it was appreciated that 'the spread of HIV is a greater danger to individual and public health than drug misuse'. (23 A harm-reduction philosophy is centred on the belief that it is possible to exert a powerful impact upon morbidity and mortality without necessarily insisting upon abstinence. A hierarchy of aims begins with attempts to make contact with as many problem drug users as possible in order to provide access to clean needles and syringes, advice about safer sex and injecting, basic health care, and help with housing, child care, or legal issues. Then, for some people but not all, a move away from street drugs on to a prescribed oral substitute may be feasible, possibly followed by detoxification and rehabilitation.

Prescribing drugs to opiate addicts

In the United Kingdom all doctors may prescribe methadone for the treatment of dependence and other opiates for analgesia or other clinical indications except dependence. Only doctors in possession of a Home Office license are able to prescribe heroin for the treatment of dependence. In recent years there has been growing concern over the diversion of licitly prescribed methadone to the illicit 'grey' market, with such diversion contributing to many of the deaths related to methadone (i.e. in non-tolerant users). Prescriptions for abusable drugs like methadone may contain directives that determine how and when the prescription is dispensed by the pharmacist, and such considerations may limit the diversion of such drugs. For example, the prescription may dictate that the drug is dispensed daily from a named pharmacist or, as is increasingly the case in some areas, methadone is prescribed so that it is taken on site in the pharmacy (supervised administration) or is administered daily...

Formulas for Calculating the Desired Dose

In the real world, the dose specified in the medical prescription may not be available. The hospital might have 10-mg tablets of Inderal and not the 15-mg tablets prescribed. Instead of asking the prescriber to change the medication order, the nurse calculates the proper medication to give the patient based on the medication order and the dose that is on hand.

Needs assessment methodologies

A needs assessment approach is equally valuable for the development of new services as it is for the audit and review of an existing treatment system. There is, however, no single best needs assessment methodology in the drug misuse field.(60) With the identification of priority segments of the drug misusing population, organizations involved with the planning of treatment services should identify the following

Proper use and integrated control

In the Dutch Pesticides Act the provision on proper use has not been implemented. For integrated control a vague provision has been established. Prescriptions have to be given 'where possible concerning the application of the principles of integrated control' (article 5(2)). In this vague provision the aim of stimulating integrated control, which can be seen in Directive 91 414, seems distant.

Trajectories heuristics and a technological paradigm

The strobilurin account also contains many elements of what could be considered the technological paradigm of the agrochemical industry. A 'technological paradigm' can be understood as the industry-wide and shared understanding of what is a 'normal' pattern of solving particular problems it embodies strong prescriptions on which directions of technical change to pursue and which to neglect. A technological paradigm thus has a strong exclusion effect in making R&D managers, scientists and engineers 'blind' to other solutions to the particular problem at hand (Dosi 1982). In this respect, it is close to what Spender calls 'industry recipes', i.e. 'the shared knowledge-base that those socialised into an industry take as familiar professional common sense' (Spender 1980). Industry recipes emerge as managers develop ways of dealing with uncertainty, often by imitating the earlier, creative solutions or heuristics of other companies in their business, in this case relating to agricultural...

Exclude the impact of drugs

Many prescription drugs and several illicit drugs cause delirium ( Tabje.3 and Tab e.4). Of particular interest are those used commonly in intensive care settings (Tabje. . .4). A thorough review of the medications given, i.e. study of the nurse's records rather than the doctor's order book, is essential. The clinician must also be aware of drug-drug interactions that can lead to significant elevations of one or more drug levels even when used at deceivingly low dosages.

Pharmaceutical Classification

When an NDA is approved, the FDA determines if the drug should be available via a physician's prescription or made available to the public over the counter (OTC i.e., without a prescription) 6 . If a drug is habit forming, is not safe for self-medication, is potentially hazardous, is new and has not completed its safety testing, or presents uncertainties in its administration, it will be classified as a prescription drug. Medications that do not fall under these restrictions are made available to the public as OTC medications. Many OTC drugs were introduced as prescription medications, then reclassified after confirming results of safety testing and consumer use information had been reviewed. Note that the introduction of new OTC medications into the marketplace requires the manufacturer to complete the IND NDA approval process.

Glucoseinsulin infusions

Insulin promotes potassium entry into cells by mechanisms separate from glucose entry glucose is also required to prevent hypoglycemia. There is no general agreement on the dose to be used. Commonly used prescriptions include 15 units of soluble insulin in 50 ml of 50 per cent glucose given centrally over 20 to 30 min, and 15 to 20 units of insulin in 500 ml of 10 or 20 per cent glucose over 30 to 60 min. All methods will reduce plasma potassium by approximately 1 mmol l over a period of 30 to 60 min and will usually maintain potassium at the lower level for 3 to 6 h, after which the treatment may be repeated. This may be sufficient to maintain plasma potassium levels at acceptable levels, but is usually inadequate in hypercatabolic patients and those with established renal failure in such cases it will buy time for definitive treatment.

Adr Reporting In The United States

The FDA has maintained a computerized repository of these voluntarily reported ADRs since 1969 (Kennedy et al., 2000). This repository and the system to manage it have grown and changed since then. In recent years, the FDA has received over 250 000 reports annually and the total number in the database exceeds 2.5 million, covering all marketed prescription drug products in the United States. For most over-the-counter (non-prescription) products, manufacturers are not required to submit ADR case reports to the FDA.

Observedtoexpected Analysis

The other piece of information that must be obtained is an estimate of the total exposure-time to the drug of interest within the population. This estimate is usually derived from data estimating the total number of prescriptions dispensed for a specific drug, along with an estimate of the average prescription length in days. At the FDA, such data are usually available through a contract with a commercial drug-utilization data vendor. This information is sometimes supplemented by drug-utilization data obtained through the FDA's Cooperative Agreement Program. This program provides access to large, automated claims data from population-based healthcare plans (Graham et al., 2000).

The Value And Future Of Pharmacovigilance In The United States

It is not an exaggeration to state that pharmaco-vigilance is the cornerstone of postmarketing drug safety activities in the United States, and will likely remain so for the foreseeable future. Nearly all postmarketing labeling changes related to drug toxicity are based on spontaneous case reports. The same holds true for drug withdrawals. Since 1980, there have been 18 major prescription drug withdrawals in the United States. Of these, spontaneous case reports and their analysis were a critical informational component contributing to the withdrawal decision in 16. The two exceptions were encainide and flosequinan, where randomized clinical trials identified the increased mortality risk conferred by these approved drugs (Echt et al., 1991 Massie et al., 1993). This should not be a surprise because patients with cardiac arrhythmias under treatment for those arrhythmias will sometimes experience sudden death due to arrhythmias,

Preparing to Administer Antimicrobial Medication

Intramuscular injections of antibiotics should be given deep into the muscle and sites should be rotated if more than one injection is prescribed. Stop orders and the need for renewal orders will depend on the healthcare agency policy. However, it is common that antibiotic orders are for 72 hours only until the results of a culture and sensitivity test can be obtained. Antibiotic prescriptions are usually not renewed. This is an effort to limit the opportunity for the microbial to become resistant to the medication.

Management of aggressive behaviour

Every effort should be made to calm patients by sympathetic understanding and reassurance. Violence is often a response to paranoid experiences and patients can be pacified if they believe that the doctor appreciates the reasons for their behaviour. If this can be achieved medication may be accepted voluntarily otherwise compulsory treatment becomes unavoidable if patients are endangering themselves or others. Physical restraint should be applied with the assistance of security staff the safety of all involved is best ensured by having more than a sufficient number of staff available. At least one person should restrain each limb while another administers medication.60,61 Haloperidol 10-20 mg intramuscularly is the preferred drug, except for cases of alcohol or drug misuse or patients with serious physical illness. Benzodiazepines should then be given instead for example diazepam 10 mg by slow intravenous injection or lorazepam 2 mg intramuscularly. Once the risk of aggression

Physical Treatments Electroconvulsive treatment ECT

Nevertheless, the frequency of the use of ECT appears to be declining in countries where its use had continued unabated since the end of the last world war (Glen & Scott, 1999). In particular, there seems to be considerable variation in its use, even between clinicians working in the same setting (Glen & Scott, 1999). This is, however, not an argument against the efficacy or rationality of prescribing ECT, as it merely confirms the influence other, non-evidence-related factors have on medical decisions. In fact, there has been a renaissance of ECT research in the USA, which appears to be associated with an upward trend in ECT prescriptions. (Sackeim et al., 2000). One of the drawbacks of ECT is its time-limited action, which tends to dissipate after a couple of weeks and requires follow-up medication. (Sackeim et al., 2001). Another is the occasionally occurring retrograde amnesia, which tends to resolve completely or, more rarely, with some residual impairment (Lisanby et al., 2000...

Supplemental Reading

Mary Smith is a 46-year-old secretary who complains to her primary care physician mainly of fatigue. She reports having low energy over the past 2 months and finding it more and more difficult to maintain her home and work responsibilities. Although tired, she is unable to sleep through the night and awakens several times each night. Her appetite has been low and she has lost 10 pounds over this time. Her husband has noticed that she has lost interest in her hobbies and has withdrawn from their friends. He is concerned that she now has to bring office work home because her impaired attention and concentration make it impossible for her to complete her assignments during the workday. On this visit, Ms. Smith is neatly dressed, appropriate in conversation, but worried about why she has become unable to execute her tasks at work and enjoy her family and friends. She becomes tearful when describing this, feels guilty, and describes her mood as down. She expresses concern that she may not...

Polymorphisms and Drug Development

Less of a chance of detecting the full range of ADRs associated with the drug. The enzymes responsible for drug metabolism will be different from those responsible for drug efficacy except when a slow metabolizer variant increases toxicity as well as efficacy. Roses suggests that, once efficacy is demonstrated in phase III trials for those with a certain pharmacogenetic profile, provisional marketing approval be given for those in whom pharmacogenetic tests reveal the favorable profile. The first few hundred thousand who receive prescriptions could have blood spots stored on filter paper in an approved location. As ADRs are documented, DNA could be extracted for patients with a particular drug-related adverse event and compared with well-matched patients who took the drug but did not experience the ADR. The abbreviated SNP profile for these ADRs could then be added to the abbreviated SNP profile for efficacy (Roses, 2000b).

Quantifying Risk And Risk Factors For Serious Events Associated With The Indicated Condition

Following the observation of a small number of cases of SUD co-occurring with lamotrigine therapy during the clinical development (Leestma et al., 1997), GW sponsored several cohort studies of the incidence of SUD in epilepsy. At the time, a literature search showed that there was little quantification of the frequency of these events in epilepsy. However, there were a number of case series from autopsies describing SUD in epilepsy. The new observational studies initiated by GW consisted of cohort studies of people with epilepsy and were performed in the large multipurpose administrative health care databases of Saskatchewan Health (Tennis et al., 1995), Group Health Cooperative (Jick et al., 1992), and General Practitioners Research Database (GPRD) (Derby et al., 1996). In all these studies, people with epilepsy were identified through their anticonvul-sant prescriptions, and diagnoses or patterns of medication use were used to exclude people without epilepsy. The incidence of SUD...

Quantifying The Risk Of And Risk Factors For Serious Adverse Events Associated With A Medication

The PEM study of lamotrigine users was conducted by the Drug Safety Research Unit (DSRU) at the University of Southampton, UK (Mackay et al., 1997). All first-time users of lamotrigine between December 1991 and February 1995 were identified through General Practitioner (GP) prescriptions from the national British Prescription Pricing Authority. Six months after the first lamotrigine prescription, a follow-up form was sent to each prescribing GP. On this form the GP listed any adverse event, regardless of cause, occurring since the first lamotrigine prescription. For any significant medical event, such as hospi-talization for rash or reported Stevens-Johnson Syndrome (SJS), the DSRU followed up for more information. Lamotrigine was not licensed for use in pediatric patients in the United Kingdom before May 1994, and neither pediatric dosing guidelines nor the formulation (5 mg tablets) of lamotrigine needed to dose many children accurately were available prior to licensing for use in...

Organization Of Pharmacovigilance In The Netherlands

Following the thalidomide affair of the late 1950s and early 1960s, the Netherlands decided to adopt a more systematic approach to the safety of prescription medicines. The Dutch Medicines Evaluation Board was founded in 1963. Based on the American model of the Food and Drug Administration, this would assess new pharmaceutical preparations for both effectiveness and safety prior to marketing authorization. Also in 1963, the Royal Dutch Medical Association (KNMG) joined the government in setting up a reporting system for adverse drug reactions. In 1965, the task of processing reports was taken over by the National Drug Monitoring Centre, which was part of the Public Health Supervisory Service and came to acquire an extremely good reputation. With a relatively small staff, the Centre produced a significant number of publications calling attention to the potential adverse effects of prescription drugs (de Koning, 1984). Each year, the National Drug Monitoring Centre received...

Direct Responsibility Of Doctors And Pharmacists

Doctors and pharmacists are themselves responsible for the safe and responsible use of prescription drugs. The barriers to reporting suspected adverse reactions would be significantly lowered if those reports were made to a peer group organization. After all, the occurrence of an adverse reaction may cause the doctor or pharmacist to ask himself (or herself) whether he should assume partial responsibility for this reaction. It is possible that some would be less eager to report an adverse drug reaction to a ''higher authority'' such as the government.

Drugs and Genetic Harms

The California Supreme Court ruled that the daughters of women who had taken DES to prevent miscarriages could not hold the manufacturers liable under product liability doctrine because DES injured them in utero (Brown v. Superior Court, 1988). The plaintiff-daughters' increased risk of cancer and other reproductive abnormalities meant that more medical monitoring and procedures to prevent malignancies as well as some actual cancers were not the legal responsibility of the manufacturers of DES. In formulating a rule for prescription drugs that set them apart from general product liability doctrines, the court noted that the manufacturer had a duty to properly prepare the drug and warn of its dangerous propensities that were either known or reasonably scientifically knowable at the time of manufacture (Brown v. Superior Court, 1988). This latter duty has been characterized as one arising out of negligence, whereas the plaintiff's proposed product liability theory has been called a...

Manufacturer Liability for Harms to Patients

If the physician remains the primary mode of distributing prescription drugs, a protective stance toward drug manufacturers might make sense. But we know that the traditional notion that drug manufacturers market their products to physicians is rapidly giving way to direct to consumer advertisement of prescription drugs. Although this practice has not led to an abandonment of the restrictive application of product liability doctrines to prescription drugs or narrow views of manufacturers' duty under negligence doctrine, it has led at least one court to remove one of the drug manufacturers' defenses the learned intermediary doctrine in some limited circumstances. The New Jersey Supreme Court held in 1999 that the drug manufacturer's duty to warn the consumer patient was not satisfied by warnings to physicians when the drug manufacturer advertised directly to consumers (Perez v. Wyeth Laboratories, 1999). In those cases, the manufacturer must also warn the consumer. This crack in the...

Methods For Solving Percentage Problems

(7) Which of the following prescriptions calls for a different amount of boric acid from the other two (8) Which of the following prescriptions calls for a different amount of silver nitrate from the other two (9) Which of the following prescriptions calls for a different amount of atropine sulfate from the other two

Historical Perspectives On Carbohydrate

Before the discovery of insulin in 1922, diets prescribed for diabetes were very low in carbohydrate, around 5 of energy, and very high in fat, around 75 reviewed by Truswell (11) . Even after the advent of insulin, doctors were cautious and very low carbohydrate diets continued. By 1930, diet prescriptions of carbohydrate had risen to 15 of energy. In the 1940s and 1950s, carbohydrate allowances had come up to 25-30 of energy and carbohydrate exchange lists came into use. There was little questioning of the principle that carbohydrates were bad for people with diabetes and focus was on the insulin treatment.

What Are Economic Consequences

The analysis of PVA members with MS estimated that the average annual cost was 51,318 in healthcare items and services and lost earnings. Forty-seven percent of that total, or approximately 24,352, was direct costs for hospitalization, medical practitioner services, personal assistance and custodial care, durable medical equipment, and prescription medications. The aggregate cost for all 1,904 PVA members with MS in 1992 was 97.7 million. For anyone living with a chronic condition, it is important to understand that these studies show unequivocally that economic aspects can be quantified and that, over a lifetime, we are talking about serious amounts of money. You need to count your costs in order to understand your personal financial needs.

Dispensing Dates And Quantity

It is well recognised that a proportion of prescriptions given to patients is not submitted for dispensing. Records of dispensing are therefore a more reliable indicator of drug use than prescriptions, although uncertainty remains as to the compliance of patients in using the medicines dispensed. With the continuous records of dispensings in the IMMP, patients who have ceased therapy can be identified when prescription records stop being received. The prescriber is then sent a questionnaire asking the reason for cessation. This provides important information, which is discussed below. The monitoring of omeprazole demonstrated another use of continuous recording of prescriptions. Some patients had relatively short courses and others remained on treatment long term. In understanding the use of the drug it was useful to be able to identify how many courses of treatment patients were having and how long these were. Patients who had been on continuous therapy for a year or longer were...

Administration pharmacokinetics and dosage Administration

As implied above, there are major advantages for many patients to be treated with the atypical antipsychotic drugs and it is generally recommended that, where possible, these agents be considered as the first-line treatment.(43) The atypical antipsychotic drugs have already become the dominant antipsychotic treatment for schizophrenia, mania, and psychotic depression in clinical practice in the United States by 1999, they already accounted for 50 to 60 per cent of all new antipsychotic drug prescriptions in that country. Risperidone and olanzapine account for about 20 to 25 per cent each while clozapine and quetiapine account for about 4 to 5 per cent of all antipsychotic drug prescriptions. There is considerable international variation in their usage. Clozapine is much more widely used than any other atypical antipsychotic in Shanghai and Beijing. By contrast, the atypical antipsychotics that are 5-HT 2A antagonists are used in only about 15 per cent of patients in the United Kingdom...

Quantifying The Problem The Cost Of Drugrelated Problems

The most comprehensive study to date, conducted by Bootman and Johnson (11,12), suggests that DRPs in the ambulatory setting cost society approximately US 76 billion annually. Using an expert panel, they developed a model of therapeutic outcomes resulting from drug therapy and estimated the magnitude of drug-related mortality and morbidity in the US (excluding hospital DRPs). The largest component of the total cost comprised drug-related hospitalizations (62 of total cost), followed by admissions to long-term care facilities. Based on model estimates, more than 28 of hospitalization admissions result from drug-related morbidity and mortality. Additionally, the panel members estimated that approximately 60 of patients taking prescription medication would have an optimal therapeutic outcome. Recently, the analysis was updated and the estimated cost in 2000 was US 177.4 billion(13). All of these estimates lead to the same conclusion drug-related morbidity and mortality is a common and...

Attentiondeficit hyperactivity disorder

The use of amphetamines, particularly methylphenidate, has increased rapidly during the past 25 years, particularly in the United States where 3.5 million children were reported to be receiving the drug in 1997. The largest increases in use in recent years have been among girls and teenagers. It is becoming clear that the beneficial effects of these drugs in prepubertal children continue into adolescence. ( .5 Indeed, one of the still unanswered questions is when should such treatment stop The use of amphetamines in Europe has been at a much lower level so far, although their use in ADHD has also been increasingly rapidly. In the United Kingdom, for example, only 2000 prescriptions for methylphenidate were written in 1990, but this number had risen to 92 000 by 1997. In turn, such widespread use provokes other problems. The relatively free availability of psychostimulant drugs in the classroom has led to some 'trafficking' and a small, but worrying, increase in intravenous abuse. 9

Effects of Pharmacogenomics on Health Care System

In an economic sense, the value of health care interventions resides in their ability to improve physical and psychosocial well-being. Such improvements may translate into lower overall health care expenditure or improved productivity. For 2001, national expenditures for prescription drugs is estimated to be 124.4 billion, and the annual growth in expenditure is expected to continue in the range of 11 to 12 (HCFA, 2001). A recent study evaluated primary drivers for drug expenditure increases over the period 1999-2000. The authors reported that about 42 of the increase in drug expenditure was related to an increase in prescription volume, whereas approximately 36 was attributed to a shift in utilization to newer, higher-priced medicines and the remainder (22 ) was explained by drug price increases (NIHCMR, 2001). On the basis of these figures, it is reasonable to expect that the introduction of pharmacogenomics-based drugs will contribute to a continued trend of rising total national...

Variation In Prescribing And Medication Compliance

Prescribing may vary by patient factors that are independent of need or disease severity. For example, the variation of use of hormone replacement therapy by socio-economic status independent of need (Evans et al., 1997a). Compliance to labelled medication direction or therapy is a related issue. By assessing how patients collect dispensed medication, in terms of numbers of prescriptions dispensed and intervals between them, and linking to outcome data sets, patient compliance or non-compliance to medication can be studied. For example, a study in diabetes showed that adolescents in Tayside who have brittle diabetes are often non-compliant with insulin (Morris et al., 1997b).

Business Fundamentals

On the other hand, variable costs are those directly related to each patient, and they can be either direct or indirect. Direct costs here would include professional fees for transplant surgeons and other physicians acquisition costs for the patient ancillary services such as lab, radiology and esoteric and supplies and prescription medications. Indirect costs in this model are business-unit related costs that are indirect to the patient. These include malpractice costs, teaching research labs, marketing and business development, and business unit administration.

Narcotic Agonistantagonists

A narcotic agonist-antagonist (agonist) is an opioid narcotic mixed with nal-oxione (antagonist) to try to curb a form of drug misuse. Although the exact mechanism of action is unknown, these agents have both agonist and antagonist effects on the opioid receptors. Generally, these drugs are less potent and have a

Final Thoughts Science

Cardiovascular disease, that may be heavily treated by prescription medication. The monthly cost is great. Many pharmaceutical companies have compassionate use programs, but the paperwork for qualification is a burden for patients, and overworked clinic staff often bear the load. A company representative speaking to a group of pulmonary physicians was pleased that his company could bring an MDI to their institution for 60 instead of the 70 charged by the competition. Any price improvement is of course helpful, but patients who could not afford 70 also could not afford 60, and many cannot afford 15, especially when there are so many other prescriptions to be bought.

Group Health Cooperative Of Puget Sound

GHC offers comprehensive health care coverage for outpatient care, inpatient services, emergency care, mental health services, and prescribed drugs, although the latter are not provided to Medicare enrollees new to GHC since 1994. Nearly all benefit plans require small co-payments for services, such as prescriptions, outpatient visits unrelated to preventive care, and emergency treatment. Coverage for outpatient drugs is controlled by GHC's drug formulary. Multiple database files exist, and date from varying time-points. The current enrollment file consists of some 460 000 individuals historical files contain records for some 2 million persons ever enrolled in GHC 1.5 million persons have been enrolled since 1980 (Saunders et al., 2000). The Pharmacy file, dating from 1977, includes records generated when prescriptions are filled. The drug data include drug number, therapeutic class, drug form and strength, date dispensed, quantity dispensed, cost to GHC, and refill indicator. The...

Estimated Therapeutic and Loael Doses of Enzymes

Orally administered enzymes are very safe. In Germany in 1992, over 1.4 million prescriptions were made for enzyme preparations with no reports of any grave adverse effects.217 No lethal dose for orally administered polyenzyme preparations could be determined in animal models, even at a daily dose of 15 g kg. This was also true for individual enzymes (trypsin, chy-motrypsin, papain, and bromelain). At high doses mild effects may be seen, such as stool modifications, sedation, appetite reduction, and weight loss.185

Kaiser Permanente Northern California

The Pharmacy Information Management System has been operational in all 108 Kaiser pharmacies since 1994, recording information on approximately 15 million prescriptions per year. Information on each prescription is entered into the database prior to its being dispensed, and includes patient and prescribing physician identification numbers, drug name, strength, and route, date dispensed, treatment regimen, and days supply. Most of the enrollees have a pharmacy copayment of up to 10 per prescription per month. Importantly, recent surveys suggest that 15 -20 of enrollees fill at least some of their prescriptions at non-Kaiser pharmacies (Friedman et al, 2000).

Kaiser Permanente Southern California

A vast array of computer-stored information is maintained on membership, hospital admissions and discharges, pharmacy prescriptions, outpatient appointments, and laboratory and radiologic tests. In addition, several special databases have been created specifically for use in research and epidemiologic analyses MORTLINK-SC was created by linkage of membership data from 1988 to 1999 with information from the California Death Index for the same period of time. The database, which is updated annually, has information on deaths among members who died in California, regardless of health plan membership at time of death The Diabetes Research Registry database was created by linking information from the Pharmacy Information Management System, the Laboratory Management System, and the hospital database to identify all members with diabetes mellitus. The database has been evaluated against independent sources of information on diabetes and found to have a sensitivity of 0.93 for the...

Harvard Pilgrim Health Careharvard Vanguard Medical Associates

Approximately 90 of HPHC members have prescription drug benefits, which offer a copay-ment of up to 10 a prescription for a 30-day supply at member pharmacies. For each prescription dispensed, the following data are recorded unique patient identifying number, gender, date of birth, dispensing date, prescriber identifier, generic drug name, dosage strength, amount dispensed, route, American Hospital Formulary Service (AHFS) code, NDC code, member's contract number, and dependency code (noting the relationship between family members and contract holders).

Health Databases In Saskatchewan

Drugs covered by the drug plan are listed in the Saskatchewan formulary non-formulary drugs are generally not covered. The drugs listed are intended for outpatient use, although the database includes prescriptions to residents of long-term care facilities. The formulary is updated semi-annually as of July 1998, 2875 drug products were listed (Downey et al., 2000). The drug database contains information from September 1975, with an 18-month hiatus in 1987-88 when data were incomplete. The database includes patient, pre-scriber, pharmacy, and cost information. Drug information includes pharmacologic-therapeutic classification, using the AHFS classification system, active ingredient, generic and brand names, strength and dosage form, drug manufacturer, date, and quantity dispensed. Unavailable is information on non-formulary drug use, over-the-counter drugs, use of professional samples, and in-hospital drugs. The database also does not provide information about the dosage regimen...

Weighing The Relative Merits And Limitations

None of these databases can assess the use of over-the-counter drugs, use of complementary alternative therapies, or the use of physician or other professional samples. Patient compliance is not directly measurable, although the benefit of a claims database compared with use of physician records is knowing that, not only was a prescription written by the physician, it was also dispensed by the pharmacist. Prescriptions that are renewed suggest that the patient was indeed taking the drug. The extent of use of drugs taken intermittently for symptom relief is difficult to assess.

Computerisation Of The Dutch Community Pharmacy System

Computerisation of outpatient pharmacy records in The Netherlands is almost universal, and so is (due to the patient's habit of frequenting only one pharmacy) the compilation of longitudinal prescription drug histories. Although computerisation has started for administrative (reimbursement) purposes, medication surveillance and computerised stock holding and ordering have become important incentives for the optimal registration of drug dispensing. Computerised medication surveillance tracks changes in dosages of chronic medications, correct dosing (especially for the elderly and children), contraindications (deduced from previously prescribed medications) and interactions between concomitant medications. In the case of abnormal situations a signal will be generated that needs to be verified by the pharmacist (Herings, 1993 Leufkens and Urqu-hart, 1994). The longitudinal data collection in pharmacies, the completeness of the data, and the fact that all prescription drugs are recorded...

Computerisation Of Danish Pharmacies

Similar to The Netherlands, GPs in Denmark act as gatekeepers to second-line healthcare and provide most of the medical care. The majority (97 ) of citizens are assigned a GP and these GPs generate 90 of the prescriptions. Although initiatives have been taken to create GP databases, the most important source for pharmacoepide-miological studies in Denmark to date constitutes data from the Danish pharmacies that have become increasingly computerised over the last decade and have allowed for the establishment of regional and national prescription registries (Gaist et al., 1997). As part of its tax-funded healthcare for all inhabitants, the Danish National Health Service (NHS) provides medical attendance free of charge and reimburses 50 of all expenditure on a wide range of prescribed medicines independently of the presenter's income and employment status. Measured in defined daily doses, 73 of all medication sold in Denmark in 1996 was on prescription (Gaist et al., 1997). The NHS is...

Access to Health Care

Lack of access to drugs often leads to declines in health status (Lurie et al., 1984). This decline is explained by increased ambulatory care visits to obtain medications and the shifting of care to provider settings, such as hospitals and nursing homes, where prescription drug reimbursement is available (McCombs et al., 1994). The cost of prescription drugs and drug utilization vary considerably among individuals (Doonan, 2001). The poor, uninsured, and elderly have reduced access to drugs and rely on safety net providers for pharmaceuticals (Committee on the Changing Market Managed Care and the Future Viability of Safety Net Providers, 1999). With few exceptions, Medicare does not cover outpatient prescription costs. Consequently, older Americans spend three times as much of their income on drugs as the general population. Thirty-five percent of seniors do not have prescription drug coverage, and many with coverage have high deductibles and caps on total...

Disparities in Treatment

Numerous studies demonstrate that even for those able to gain access to the health care system, disparities in treatment based on race and ethnicity are profound, even controlling for insurance coverage, education, and income. For example, Moore found that race was the strongest predictor for the receipt of drug therapy, with African Americans 41-73 less likely to receive drug agents (Moore et al., 1994). In a study of over 4000 elderly nursing home residents with cancer who experienced daily pain, African Americans were 63 more likely than whites to receive no pain medication (Bernabei et al., 1998). In diabetes care, African Americans were more likely to be treated with insulin but less likely to receive daily injections or to self-monitor their glucose levels (Cowie and Harris, 1997) A study of African American and white Medicaid-insured children in Detroit found that African American children were much more likely than their white counterparts to receive inadequate therapy, which...

Course and prognosis

Evidence regarding the efficacy of treatments for delirium is sparse ( Chapter 4.1i.2). Guidance on clinical management can be divided into pharmacological and non-pharmacological strategies. The drug treatment of the symptoms and behaviours of delirium in the elderly is similar to that of younger patients, although it is necessary to start with lower doses, such as haloperidol 0.5 to 2 mg orally, or intramuscularly if necessary, repeated until the disturbance is controlled. Prescriptions should be for short periods only (24-48 h) to encourage review of the effects and the necessary dosage. Once the delirium has resolved, the medication should be reduced discontinued over a period of 3 to 5 days. If the patient cannot tolerate neuroleptic drugs, then a benzodiazepine (for instance diazepam, lorazepam, or alprazolam) should be used instead. The cholinergic hypothesis of delirium raises the intriguing possibility, as yet untested, that cholinergic agonists such as the cholinesterase...

Selective Serotonin Reuptake Inhibitors

It has recently been suggested that the ingestion of selective serotonin re-uptake inhibitors is associated with upper gastrointestinal bleeding (de Abajo et al., 1999). From a general practice research database, 1651 cases of gastrointestinal bleeding were identified along with 10 000 controls matched for age, gender and year of identification. Current use of selective serotonin re-uptake inhibitors or other antidepressants within 30 days before gastrointestinal bleeding was assessed. Use of selective serotonin re-uptake inhibitors was identified in 3.1 of patients with upper gastrointestinal bleeding compared with 1 of controls. The relative risk was unaffected by gender, age, dose or duration of treatment. The absolute risk of upper gastrointestinal bleeding was estimated as one case per 8000 prescriptions or one case per 1300 users. The authors also reported that the risk of upper gastrointestinal bleeding was greatly potentiated by the concomitant use of NSAIDs and, to a lesser...

What Shall We Aim for

Therefore, it seems obvious to attack the three major pathophysiological defects in T2D, peripheral insulin resistance, increased HGP in the liver and the loss of first-phase insulin response related to a meal, using lifestyle changes and at least three pharmaceutical drugs. This suggestion is based on a few short-time studies, but longer studies are on their way.

Prevalence of medication use

The number of prescriptions of medication for children with AD-HKD has more than doubled over the last two decades to 5 million in 1994 in the United States about 3 per cent of persons aged 5 to 18 years (1.5 million children) are taking medication for AD-HKD. (H4) The prevalence of the use of medication is lower in Canada, Europe, and Australasia than in the United States, but is beginning to rise. Community physicians rely heavily on medication for the treatment of AD-HKD as many as 88 per cent of diagnosed children receive drug treatment. (H8)

Frequency Of Hepatic Adverse Reactions

Despite increasing awareness of hepatotoxicity and the availability of less toxic alternatives, the absolute frequency of hepatic drug reactions has not decreased in the last decade, in keeping with the increasing number of prescriptions and pharmacological agents available (Larrey, 2000). Hepatic injury accounts for 3.5 -9.5 of all ADR reports and up to 14.7 of fatal adverse reactions (Friis and Andreasen, 1992). Using data from the computerised Danish National Hospital Registry, the incidence of drug-induced liver disease was calculated as 19 and 22 per million person-years for men and women, respectively (Almdal and Sorensen, 1991). Another study from the United States estimated the overall incidence of drug-induced liver disease requiring hospitalisation to be 1 per 100 000 person-years (Beard et al., 1986). Drug-induced liver disease accounts for between 1 in 666 and 1 in 3000 hospital admissions in Denmark and United States (Jick et al., 1981 Hallas et al., 1992).

Background To The Daubert Decision

The litigation in Daubert arose out of allegations of birth defects allegedly sustained as a result of the mothers' ingestion of the anti-nausea prescription drug Bendectin. The challenged expert testimony involved animal studies, chemical structure analyses, and re-analysis of previously published epidemiological (human statistical) studies that supported the plaintiffs' contention that Bendectin was the cause of their children's birth defects. The District (trial) Court ruled that the proffered testimony was inadmissible under Frye because the methods used were not generally accepted. Most emphatically, the Court rejected the epidemiological re-analyses because they had not been subjected to peer review publication. Because this left the plaintiff without proof of the cause of the birth defects, summary judgment was granted, thereby ending the lawsuit. This decision was appealed and ultimately decided by the U.S. Supreme Court. The case was remanded back to the trial court to...

The Poison Prevention Packaging Act Of 1970

The purpose of the Poison Prevention Packaging Act of 1970 is to reduce poisonings among small children. The Act provides that certain household products (such as aspirin and certain other drugs, including oral prescription drugs furniture polish oil of wintergreen, antifreeze some cleaners for drains and ovens turpentine and cigarette lighter fluid), which are found to be hazardous or potentially hazardous must be sold in safety packaging. This safety packaging must be designed so that most children under five years of age cannot open the packages.

Summary of Research and Conclusions

The active metabolite of vitamin A, all-trans retinoic acid, or ATRA, has received a fair amount of research as an anticancer compound. In fact, ATRA is now a prescription drug approved by the Food and Drug Administration for the treatment of some types of cancers. Because this book concentrates on compounds not yet approved as drugs (see Chapter 1), our discussions focus on vitamin A (retinol), covering ATRA only in its role as a metabolite. More specifically, we focus on the form of retinol commonly found in foods and supplements, the retinyl ester form (i.e., retinyl palmitate). ATRA remains a viable treatment compound, however, and it may be preferable in some situations. For information on the use of ATRA, the reader is referred to drug reference books and manufacturer's literature.

Considerations For The Outpatient Pharmacy

Child--resistant packaging has been in use for quite some time. It has, without a doubt, decreased the number of cases of accidental poisonings. If you have purchased items or received prescriptions packaged in child-resistant containers, you are aware of the advantages and disadvantages of this means of preventing accidental poisonings. In your position in the pharmacy, you may hear comments about the packaging. Some patients are quick to complain about the packaging. Here are some considerations about the act that are pertinent to you

Roles of Health Professionals

By increasing the amount of medical information necessary for prescribing and dispensing, pharmacogenomics will demand that physicians and pharmacists work together more closely than has often been the case. For example, if pharmacists are to serve as a safety net for physician prescribing (Brushwood, this volume), then the pharmacist must have the genetic information on which the prescription is based. Are physicians prepared to take the additional time to share this information and to include nonphysicians in the prescribing function Are pharmacists willing to accept this additional duty, especially in some retail settings where productivity is measured by the number of prescriptions filled How are patient education and warnings to be coordinated

The International Organization for Standardization

As it turned out, in general, pharmaceutical drug manufacturers already operating under GMP did not expect a marked benefit from being officially ISO 9000 certified. As a commonsense approach to take and combine the best of ISO and GMP, however, the use of a quality management system along the structure proposed by ISO 9000 became accepted practice in the industry. Manufacturers of API, on the other hand, and producers and suppliers of bulk chemicals, found the idea of getting the ISO 9000 certification quite attractive.

Adverse Reactions Contraindications and Interactions

Heavy kava users have also been observed to lose weight and have low plasma protein levels and low platelet and lymphocyte counts. Pulmonary hypertension and shortness of breath have rarely occurred. Kava should be avoided in pregnant women and children, since the consequences of use are unknown. A recent cause for concern is an uncommon idiosyncratic liver toxicity associated with kava use in some cases, this has been severe enough to warrant liver transplantation. It is unclear whether kava alone is to blame, but the safety of this herb is under review. Several European countries, where this problem was first reported, have either suspended sales or are acting to make kava a prescription drug.

Postmarketing Experience 19831986

The increasing incidence of haemolytic anaemia from 1983 might appear to have been related to the launch of the 100 mg single daily dose formulation on 31 January 1983 (see Figure 12.1). However, no evidence emerged to support this. It appears that new additional sales were generated by this launch and that the associated promotion may have made doctors more aware of nomifen-sine. Prescriptions, sales and market share increased in 1983 by 21 , 32 and 18 , respectively. This, together with the data sheet changes and literature reports, may have served to alert doctors to the association of unusual symptoms with the use of nomifensine. Table 12.2 shows the UK manufacturer's total database of 296 events this is to be compared with the CSM's Yellow Card database of 543 suspected adverse reactions. The company had 45 reports of haemolytic anaemia of which 43 were thought to be associated with the drug. This is to be compared with the CSM's 59 reports of which 49 contained sufficient...

Clinical characteristics

The socioeconomic impact of hMPV infection on children and their households is not well known. It is reported that household contacts of hMPV-infected children, like influenza-infected children, fell ill significantly more frequently, required more medical visits, received more anti-pyretic prescriptions, and were also absent more frequently from work or school, than those of RSV-infected children 76 . These findings suggest that hMPV infection in children considerably affects their families.

Acetylonium ion acetyl radical ketene Toxic

Co-amoxiclav is a commonly used antibiotic, that causes cholestatic jaundice. The frequency of this ADR is about one case per 5000-80,000 prescriptions, and the risk increases with advancing age (124-126). Clavulanic acid rather than amoxicillin has been considered to be responsible for immu-noallergic hepatitis. Two case-control studies involving Caucasians have demonstrated that co-amoxiclav-induced jaundice is strongly associated with the HLA DRB1 *1501-DRB5*0101-DQB1*0602 haplotype (126,127). Subjects carrying the extended haplotype had a ninefold higher risk of cholestasis (126). These findings suggest that HLA class II molecules are important in presenting the drug-metabolite to the T-cell receptor of CD4+ helper T-cells with the subsequent stimulation of B-cells and cytotoxic T-cells and development of the immune reaction.

Central Nervous System Stimulants

Analeptics are benzphetamine (Didrex), deithylpropion (Tenuate), Mfluramine (Pondimin), and phentermine (Phentride). Caffeine is also a stimulant found in many beverages, foods, OTC drugs, and prescription drugs. Caffeine is found in many drugs including Anacin, Excedrin, Cafergot, Fiorinal, and Midol.

Commercial Arrangements and Development

Pharmacogenomics may be thought of as a cutting edge discovery and development tool used to optimize pharmaceutical drug innovation by personalizing medicine through genetic profiling and identification of appropriate disease subpopulations. The measured success of pharmacogenomics depends on the success of commercial relationships between various pharmacogenomics entities and pharmaceutical companies with whom they collaborate in improving the quality of therapeutic products. Licensing of pharmacogenomic platforms and technologies and collaborative partnerships built around such pharmacogenomic resources pair pharmacoge-nomics entities with pharmaceutical development entities that have the development and marketing resources to effectively bring drugs to consumers. Thus, cooperative arrangements between pharmacogenomic innovators and the traditional pharmaceutical industry ( Big Pharma ) promise to enhance the quality of diagnosis and drug treatment for patients.

Postmarketing Sources Of Data Regarding Reproductive Safety

The General Practice Research Database in the United Kingdom is another potentially fruitful resource (Jick and Terris, 1997 Jick, 1999). The primary advantages are the availability of large numbers of subjects and ease of access to data. This approach also avoids some of the biases involved in studies that rely entirely on maternal report to classify exposure. These strengths must be weighed against the limitations inherent in a study design that does not involve subject contact. For example, these studies usually cannot ensure that the medication prescribed was actually taken by the mother, or taken during the period of time critical for development of any specific birth defect. There are also issues related to misclassification of outcome depending on the quality of records used to determine or exclude the diagnosis of a congenital anomaly. However, as a relatively efficient method for surfacing and testing hypotheses related to prescription...

Possible defences related to substance misuse

Alcohol or drug misuse may give rise to a psychotic illness, such as delirium tremens, which may meet the requirements of the McNaghten Rules, but the insanity defence is rarely used. In theory, consumption of drugs or alcohol could lead to a state of insane automatism, but the defence of insanity is not available if the consumption has been voluntary.

Slowing the Emergence and Spread of Antimicrobial Resistance

Patients need to carefully follow the instructions that accompany their prescriptions, even if those instructions seem inconvenient. It is essential to maintain the concentration of the antimicrobial in the blood at the required level for a specific time period. When a patient skips a scheduled dose of a drug, the blood level of the drug may not remain high enough to inhibit the growth of the least sensitive members of the population. If these less sensitive organisms then have a chance to grow, they will give rise to a population that is not as sensitive as the original. Likewise, failure to complete the prescribed course of treatment may not kill the least sensitive organisms, allowing their subsequent multiplication. Misusing antimicrobials by skipping doses or failing to complete the prescribed duration of treatment promotes the gradual emergence of resistant organisms. In essence, the patient is selecting for the step-wise development of resistant mutants. A greater effort must...

Introduction A Outsourcing

Within the last 10 years the pharmaceutical industry has faced a tremendous amount of pressure on dual fronts. The inventory of the new drug molecule is running low, and the health care marketplace is exerting pressure on the industry to contain the costs of medicine. The industry is struggling to replenish the dwindling drug molecule pipeline. The impact of these pressures on the pharmaceutical industry is evident in the mergers and acquisitions that have taken place in the last 10 years. Governments and managed care organizations in major pharmaceutical markets have imposed price restrictions on prescription drugs. In the United States, the use of managed health care not only has affected the way pharmaceutical companies approach the sales of products and pricing factors, but also has forced many of them to adopt a very different long-term strategy. As of the year 2000, 18 blockbuster drugs were scheduled to lose their patent protection within 5 years. This will affect 37 billion...

Clinical Education and Product Marketing

The second area for ethical concern is clinical education and product marketing. The line between education and marketing is frequently a blurry one, and it is often difficult to separate a company's desire to educate physicians about products that may genuinely enhance patient care from the company's desire to increase profits. As the gatekeepers for all prescription drugs, physicians have the power to determine which drugs will compete successfully in the marketplace, making doctors the logical targets for marketing efforts by pharmaceutical firms. In fact, pharmaceutical companies spend more than 11 billion each year on promotion and marketing. Between 8,000 and 13,000 is spent annually on each physician. However, many company-sponsored arrangements may conflict with the physician's responsibility to act in the best interest of the patient. A voluntary code has recently been adopted by the Pharmaceutical Research and Manufacturers of America which establishes guidelines for...

Dynamical systems approaches Determinism and indeterminism

There are four important features about a control parameter. Firstly, when it is linearly scaled beyond some critical value, it may induce stochastic behaviour in the order parameter followed by a discontinuous change to another qualitatively different state. Secondly, it is completely aspecific with regard to the change it induces. Thus, a control parameter does not contain prescriptions as to how a system should change unlike its symbolic counterparts such as genetic programmes or schemata. Thirdly, different mechanisms can serve as control parameters at different ages (e.g., hormonal at one age, neural at another and cognitive at yet another). Fourthly, some form of experimental manipulation is required to identify such age-specific control parameters with any confidence. The last two points are brought into relief by a study of testosterone effects in seagulls (Groothuis & Meeuwissen 1992). When administered to young chicks, it induced precociously complete agonistic displays....

Trends in the Use of Antidiabetic Drugs

Interesting comparison between Finland and Denmark (with the expected prevalence of diabetes being 7.2 and 6.9 in 2003, respectively) it was found that in 2000, 3.15 of the population in Finland (insulin 1.76 , oral agents 2.40 ) was treated with antidiabetic drugs, the corresponding numbers for Denmark was 1.96 for any antidiabetic treatment (insulin 0.78 , oral agents 1.31 ) 11 . It is unlikely that differences in detection levels of diabetes or different diabetic phenotypes, let alone drug availability, can explain such a difference. Local therapeutic convention is a plausible explanation. As described in a comparison of two neighbouring communities in Sweden 12 tradition (specialized diabetes clinician compared with non-specialist clinicians) may have major influences on both drug type and dose. Along with progressively more aggressive treatment of glycaemia, the use of cardiovascular and lipid-lowering drugs also increases with time in patients with diabetes 13 . Although the...

Beef pork lamb and vealTotal fat grams

Studies which showed chromium improved muscle mass during strength training. Many well-controlled studies have been done in this area and have shown less promising results. In addition, there is no data to support the claim that chromium picolinate improves weight loss. More research is needed. While prescription medications undergo rigorous testing before approval, nutritional supplements do not. If the nutritional claim sounds too good to be true, it probably is

Cholesterol And Heart Disease

Furthermore, this net lack of survival benefit from cholesterol-lowering drugs does not even take into account any of the side effects of taking such medication. Lazarou et al. published a study that showed that in the United States in 1994, adverse drug reactions were the sixth-leading cause of death.2 The data did not even include another 2.2 million patients who were seriously injured by their prescription medications. Also not included was the fact that roughly equal numbers of patients died or were seriously injured due to errors of their health care providers. But don't avoid seeing your doctor. Just know that no treatment program comes without cutting both ways. Be an active partner with your health care practitioner in whatever therapies that you take or undergo. As with nearly all prescription drugs, the commonly prescribed anticholesterol preparations have a large number of potentially significant negative effects on an individual's blood chemistries and overall health. This...

Kaiser Permanente Northwest

Kaiser Permanente Northwest (KPNW) serves over 430 000 members, approximately 25 of the population of the area (Friedman et al., 2000), mostly in the outpatient setting, with one hospital in Portland and beds contracted in other community hospitals. The distribution of the membership by age, race, and gender proportionately reflects that of the population of the Portland-Vancouver area. Services provided by KPNW include hospital and surgical care, maternity care, X-rays, mam-mography, laboratory testing, allergy testing, home healthcare, doctor office visits, well-baby care, mental health, and dental care. Most of the members are covered by a prepaid drug benefit for the less than 10 without the drug benefit, prescriptions are provided at or below prevailing community charges. 1986 and records all prescriptions dispensed by its outpatient pharmacies, totaling more than two million annually (Friedman et al., 2000). Data include National Drug Code (NDC) number, quantity dispersed, days...

Chronic Diseases Epidemiology And Audit

The MEMO DARTS collaboration has used electronic record-linkage of information to create a robust clinical information system of all patients with type 1 and type 2 diabetes in Tayside whether they attend primary or secondary care. The DARTS database has information from many different sources including patients attending hospital diabetes clinics, dispensed prescriptions for diabetes-related medication and monitoring equipment, patients discharged from hospital, patients attending a community-based mobile diabetic eye screening facility, glycosylated haemoglobin and plasma glucose results from the regional biochemistry database, and information collected from case records of patients in every general practice in Tayside. The register has been used for pharmaco-epidemiologic research (Morris et al., 1997b, 1997c).

Why do people take drugs

A very common misconception is that drug misuse is simply a search for fun. In fact, people take drugs for many reasons other than to get the buzz or high. Indeed, studies have shown that straightforward pleasure seeking is the primary reason for initiation of drug use in fewer than 20 per cent of individuals. While the high or buzz is the most obvious pleasurable effect, many people also describe using drugs to feel comfortably numb, pleasantly drowsy, or full of energy and confidence. Many others will be chasing the high or buzz that they first experienced, always trying to attain the intensity of their initial experiences. Still others will be self-medicating for anxiety, strong emotions such as anger, for pain, boredom, lack of motivation, lack of self-confidence, and many other aversive states including withdrawal. alcoholics will point to anxiety as their reason for drinking (1) indeed, social anxiety is one of the most common causes of alcoholism in young men.(2) If this can be...

Cognitive Strengths Of Older Adults

Given the declining cognitive capabilities associated with normal aging, it has been widely believed that older adults are at substantially greater risk of non-adherence to medical regimens than younger adults. There is no question that older adults compared with younger adults are the larger consumers of medical care and take more medications, with an estimate of 2.9 prescriptions per older adult (Kiernan & Isaacs, 1981). Self-reported rates of nonadherence to medication regimens for older adults are quite high (Bergman & Wilhom, 1981 Botelho & Dudrak, 1992) however, information on medication adherence obtained without relying on self-reports presents a very different picture than the conventional wisdom. Despite their problems, George and Nancy form a dyad and collaborate to support health-related self-care and avoid medical errors. George often assists Nancy in reading the prescriptions and being certain that she takes the right medications, as her failing eyesight makes this a...

Legal control of recreational drugs

Maintenance prescriptions of morphine or cocaine to addicts did not constitute acceptable medical practice, and a punitive response to addiction was established which lasted until the HIV epidemic in the 1980s forced a change in philosophy. This coercive approach to recreational drugs gathered momentum. A national prohibition of alcohol was enacted in 1919 and was only repealed in 1933 because of a desperate need by the Roosevelt administration for taxation income. Many states banned cannabis, and its use was effectively outlawed nationwide by the Marijuana Tax Act 1937. By the same year, the majority of states had adopted the Uniform Drug Act to standardize their approach to recreational drugs. In a further effort to overcome what was regarded as a fragmented approach to enforcement, the Comprehensive Drug Abuse Prevention and Control Act came into force in 1970.

Treatment Management And Cost

Prescription Drugs 4.4 It is also important to deal with the issues related to cost of the disease for the patient, family and society. Unfortunately, available information is limited, and almost restricted to Europe and North America, which makes it difficult to extrapolate it to other regions of the world. It is perhaps better to analyse it in relative terms compared with a control population than to make absolute currency estimates. In a recently published study from the United States, the annual utilization of health services and cost for the PD cohort was significantly higher than for a control population. On an annual basis, PD patients spend approximately two more days in hospital, 43 more days in long-term care institutions, and fill more than 20 more prescriptions than do the controls. The total annual cost is more than double that of the control population, even before adding indirect costs (uncompensated care, productivity loss, etc.). Prescription drugs account for roughly...

Angiotensinconverting Enzyme Inhibitors

A 40-year-old man goes to the emergency department because of an intractable cough for the past few days. No one else in his household has any cough, fever, upper respiratory infection, and so on. He was released from the hospital a week ago with the diagnosis of idiopathic dilated cardiomyopathy following an extensive evaluation that revealed normal coronary anatomy and a left ventricular EF of 38 . He was discharged with prescriptions for digitalis, furosemide, captopril, and carvedilol. He has

Eula Bingham PhD John Zapp PhD deceased

Today, the National Toxicology Program (44) provides a significant portion of all new data on industrial chemicals used in the United State and in other countries. At present, 80,000 chemicals are used in the United States and an estimated 2,000 new ones are introduced annually to be used in products such as foods, personal care products, prescription drugs, household cleaners, and lawn care products. The effects of many of these chemicals on human health are unknown, yet people may be exposed to them during their manufacture, distribution, use, and disposal or as pollutants in our air, water, or soil.