Prescribing information initiatives

Lack of information in paediatric prescribing has long been a problem for clinicians and pharmacists. In order to tackle this problem, in 1999, 

BNF for Children (2006). http //bnfc.org/bnfc/ (accessed January 2006). Commission of the European Communities (2004). Proposal for a regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004. Brussels. 

Department of Health and Human Services (2001). The pediatric exclusivity provision - January 2001 status report to congress. Food and Drug Administration, 2001. http //www.fda.gov/cder/pediatric/reportcong01.pdf (accessed January 2006). 

European Agency for the Evaluation of Medicinal Products (EMEA) (1997). Note for Guidance on Clinical Investigation of Medicinal Products in Children. London EMEA. 

---

A black box warning for life-threatening liver failure was added to the prescribing information for nefazodone. Treatment with nefazodone should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. 

The FDA s stability requirements for INDs are provided in FDA IND Phase 1 Guidance and FDA IND Phase 2/3 guidance. These guidances recognize the progressive nature of manufacturing and controls information and prescribe a limited amount of stability information initially, augmented by additional data as the clinical trials proceed. 

According to the manufacturer s prescribing information, the initial recommended dosage of tramadol ER is 100 mg once daily, with titration in 100 mg increments every 5 days (if required) up to a maximum dosage of 300 mg once daily. The drug is to be used in adults only, and may be administered without regard to food. 

In fact, as soon as the equivalent packing diameters are known, the porosity of a packing system can always be estimated by the simplified approach to the real packing problem encountered in practice as, for example, suggested in the literature In this simplified approach, the initial porosities of the components involved are used as prescribed information in a model calculation. Therefore, the porosity of the system considered can be given as ... 

CONSTIPATION The nurse checks the bowel elimination pattern daily because constipation can occur with repeated doses of a narcotic. The nurse keeps a daily record of bowel movements and informs the primary health care provider if constipation appears to be a problem. Most patients should begin taking a stool softener or laxative with the initial dose of a narcotic analgesic. Many patients need to continue taking a laxative as long as the narcotic analgesic is taken. If the patient is constipated despite the use of a stool softener, the primary health care provider may prescribe an enema or another means of relieving constipation. 

Judy Cowan, age 28 years, has been prescribed clomiphene to induce ovulation and pregnancy. Judy is very anxious and wants desperately to become pregnant. Her husband, Jim, has come to the clinic with her. Discuss assessments the nurse would consider important before initiating treatment with clomiphene. Discuss information the nurse would include in a teaching plan for Jim and Judy. 

The Swiss Agency of Environment and Landscape decided to re-evaluate mechanical metal separation techniques to reduce the landfill volume and to improve the BA quality for deposition by exploiting metal resources. A sampling campaign in all 28 incineration plants was initiated to verify BA quality and to establish a solid data base. A common sampling procedure, sample treatment, and analytical method were prescribed in order to obtain consistent information of chemical and structural composition and the leaching behaviour of current BA. This paper is focused on the chemical and mineralogi-cal results from the study. 

It is not possible to prescribe a set of rules which is applicable on all occasions. The amount of additional information available will most probably determine the amount of information it is necessary to obtain from the p.m.r. spectrum. However, the following general procedure will form a useful initial approach to the interpretation of most spectra. 

Another application relates to the auditing frmction (described earlier in the section Evaluating the pharmacy benefit ) as well as initiatives designed to improve compliance with prescribed therapies, warnings, or reminders to clinicians (pharmacists and physicians), and patient information that might improve their clinical outcomes of pharmaceutical care. 

He was hospitalized for revision of his arteriovenous shunt and postoperatively complained of symptoms of gastroesophageal reflux. This complaint prompted institution of cimetidine therapy. In view of the patient s impaired renal function, the usually prescribed dose was reduced by half. Three days later, the patient was noted to be confused. An initial diagnosis of dialysis dementia was made and the family was informed that dialysis would be discontinued. On teaching rounds, the suggestion was made that cimetidine be discontinued. Two days later the patient was alert and was discharged from the hospital to resume outpatient hemodialysis therapy. 

You are encouraged by Cheryl s motivation for treatment. However, you internally question whether she may fit the profile for bipolar II. In the process of the diagnostic interview, you elicit enough information indicative of hypomanic periods that predated the initiation of fluoxetine to warrant further consultation with her original prescriber or a psychiatrist. 

A multicomponent calibrator is employed for calibrating the Seralyzer. Two calibrators enable a 2-point calibration. Human serum is used as initial material to which substances have been added by a special preparatory procedure. Thus one of each calibrator is available with concentrations (activities) in the low and in the high range. The concentrations (activities) were determined by means of routine wet chemical methods no details have been stated. Few studies are available on the frequency of calibration, i.e. on its constancy. The U.S. Food and Drug Administration prescribes a seven-day calibration rhythm that has been increased to 14 and 30 days, respectively, for some components. The manufacturer, Bayer Diagnostic, informs us that in future the calibration cycle will be 30 days. 

---