Patient-consumers

Generally, nephrotoxicity is not a problem. Some cephalosporins, especially those with the 3-methylthiotetrazole side chain, such as moxalactam (48), show a tendency to promote bleeding. This appears to be due to a reduction in the synthesis of prothrombin and can be a problem especially in elderly patients, patients with renal insufficiency, or patients suffering from malnutrition (219). The same side chain seems to promote a disulfiramlike reaction in patients consuming alcohol following a cephalosporin dose (80,219). 

Bliss, D.Z. Stein, T.P. Schleifer, C.R. Settle, R.G. (1996). Supplementation with G A fiber increases fecal nitrogen excretion and lowers serum urea nitrogen concentration in chronic renal failure patients consuming a low-protein diet. The American Journal of Clinical Nutrition, Vol. 63, No.3, (March 1996), pp. 392-398, ISSN 0002-9165. 

Chen, L. et al.. Oxidative DNA damage in prostate cancer patients consuming tomato sauce-based entrees as a whole-food intervention, J. Natl. Cancer Inst., 93, 1872, 2001. 

Suprax suspension contains 100 mg/5 mL of the drug cefixime. If the patient takes one teaspoonful of the suspension twice daily for ten days, how many grams of the drug does the patient consume ... 

Zovirax tablets, containing the antiviral drug acyclovir, are usually given in a dose of 80 mg/kg/day for five days for treating chickenpox. If the patient weighs 165 lb, how many ounce(s) of acyclovir would the patient consume if he has to take the full dose prescribed ... 

Gene expression inhibition. Chloroform/ methanol extract (1 1) of the dried leaf, in cell culture, was active on hepatoma-Cos-7, IC50 600.0 pg/mL vs TAT-dependent activation of HIV promoter hioassay - . Hepatotoxic activity. The leaf, taken orally by a female adult, was active - . A patient consumed 15 tablets of the leaf per day for 4 months. Approximately 1 year after stopping consumption, liver enzymes returned to normal and fatigue was no longer a complaint - ". Infusion of the dried leaf, taken orally by a female adult at variable doses, was active. The 60-year-old woman who took Lama tridentata for 10 months developed severe hepatitis for which no other cause could be found. Despite aggressive supportive therapy, the patient s condition deteriorated and required orthotropic liver transplantation - " . Dried leaves, administered orally to adults at variable doses, were active. A public warning has been issued by the US Centers for Disease Control based on reports of liver toxicity after use of Lama tridentata tea - " k Dried leaves, administered orally to adults of both sexes at variable doses, were active - ". The plant, administered orally to adults at variable doses, was active - ". Dried leaves, administered orally to adults at variable doses, were active. One case of hepatotoxicity induced by Larrea tridentata taken as a nutritional supplement was reported - ". Thirteen patients were identified for whom Larrea tridentata tincture for internal use was prescribed. Additionally, 20 female and three male patients were identified from whom an extract of Larrea tridentata in castor oil for... 

In Chapter 2 we also explore the role of drug therapy from the patient-consumer s perspective. Thus, such issues as informed consent, the cost of treatment, and labelled versus nonlabelled uses for FDA-approved medications are carefully considered. 

The medical dosage of the contaminated product—The typical (some companies use maximum) daily dosage of a potentially contaminated product should be considered in the determination of limits. The idea here is simply that whatever the level of cross-contamination, the more of the contaminated product the patient consumes the greater the amount of contamination taken by the patient. Consider a tableted product. If the daily dose of the tablet is 24 tablets per day, the patient will receive 24 times as much contaminant than if the daily dose of the product was one tablet per day. 

A. Nicolay, P. Bertocchio, E. Bargas, F. Coudore, G.L. Chahin, J.P. Reynier, Hyperkalemia risks in hemodialysed patients consuming fluoride-rich water, Clin. Chim. Acta 281 (1999) 29-36. 

Q14 MAOIs, such as phenelzine and isocarboxazid, affect the sympathetic nervous system by inhibiting one or both forms of brain monoamine oxidase. Their sympathomimetic effects can produce a feeling of well-being and increased energy, which is helpful for depressed patients. However, psychosis may occur in a susceptible individual or may follow over-administration of these agents. An increase in sympathomimetic action (such as occurs with use of amphetamines, which increase the release of noradrenaline) can result in a lethal hypertensive crisis. In addition, a hypertensive crisis can also be initiated if the patient consumes a diet rich in amines foods with a high amine content include cheese, pickles, broad beans and wine. 

Burn patients consume many resources and have long lengths of stay. After the response to the disaster is over, these patients can remain hospitalized for months. The average length of stay for a patient with 50% TBSA burns is 50 days. Burn center staff may become exhausted, operating at or above capacity for this period of time. It is recommended that staff work regular 8-hour shifts if possible to prevent emotional and physical fatigue. 

The risk assessment process can be conducted by examining record types to see if they are GxP or non-GxP, and then applying severity checks, likelihood, and probability of detection criteria, as illustrated in Figure 15.2. The most severe scenarios shonld be linked to direct patient/consnmer impact. GxP noncompliance and broken license conditions are severe in their own right bnt not as critical as patient/consumer health in this analysis." Its likelihood will be influenced by the degree of human error in how the record is input and used. The probability of detection needs to take into account the probability of the impacted record being used. Once failure modes are understood, then the appropriate design controls can be introduced. These should be documented and validated as part of the computer system life cycle discussed earher in this book. 

The FDA has recently highlighted the importance of risk management as part of 21st century compliance. Other regulatory authorities such as MHRA share this perspective. Without risk management, computer validation costs can quickly become prohibitive. Taking the highest level of compliance for all aspects of a computer system will not necessarily lead to discernible, increased patient/consumer safety. 

Doctors prescribe, patients consume and, increasingly throughout the world, third (purchasing) parties (government, insurance companies) pay the bill with money they have obtained from increasingly reluctant healthy members of the public. 

No anticoagulant effect has been reported with either of the major components of cucurbicin. However, vitamin E antagonizes the effect of vitamin K and can cause an increased risk of bleeding, especially in patients taking oral anticoagulants. The amount of vitamin E in cucurbicin that these two patients consumed was 30-50 mg/day, corresponding to the recommended dose of 40-50 mg daily for vitamin E deficiency. The two cases suggest that caution should be exercised when cucurbicin is used concurrently with warfarin. 

In patients consuming diets based on medium-chain triglycerides, adverse effects reported include abdominal pain and diarrhea. 

Advertisements of nonprescription medicines directed to the general public must contain a text inviting patient-consumers to read the PIL and/or consult their doctor or pharmacist. Moreover, as a special Hungarian requirement, the side-effects must be listed in the advertisement. 

---