Evaluation of the Macy Catheter®: a rectal catheter for rapid medication and fluid administration.

INTRODUCTION: Health care providers are increasingly challenged to balance cost considerations for devices, drugs, and staffing all while continuing to provide excellent care. Patients in both the post-acute and acute care settings often require fluid and/or medication when their oral route is compromised and vascular access may not be warranted or immediately accessible. The rectum is an underutilized administration point that can be accessed with speed and relative ease. Areas Covered: Literature reviews of pharmaceutical, medical, and nursing references reveal current and historical science that validates the rectal route as a means of alternative administration for fluids and medications. Expert Commentary: Historically the rectum has been used for medication and fluid delivery but in more recent times, use has waned due to many factors. The physiology of the rectum allows for rapid and reliable administration of a variety of medications as well as hydration. This serves as an introduction to a novel, simple, cost effective device that allows for discreet and painless rectal administration of fluids and medications when the oral route is compromised and/or intravenous access is difficult or unnecessary. This device is used in a variety of patients in many care settings.

Guideline for postmarketing Chinese medicine pharmacoeconomic evaluation.

Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation.

[Technical specifications for post-marketing pharmacoeconomic evaluation of Chinese medicine (draft version for comments)].

Pharmacoeconomics is an important part of the post-marketing evaluation of Chinese medicine, post-marketing pharmacoeconomic evaluation can better reflect the clinical and market value of Chinese medicine, the purpose of establishing the technical specifications for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines more scientific and fair. Every country's technical specifications for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the technical specifications which take into account the special characteristics of Chinese medicine; these are in preparation for post-marketing pharmacoeconomic evaluation Chinese medicine.

[Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

National surveillance of herbal dietary supplement exposures: the poison control center experience.

PURPOSE: The purpose of this report is to characterize reports to poison control centers (PCCs) involving two widely used herbal dietary supplements (HDSs), Echinacea, and St. John's wort (SJW). METHODS: We purchased data from the American Association of Poison Control Center's (AAPCC) toxic exposure surveillance system (TESS(R)) on reports made to PCCs in 2001 involving Echinacea or SJW. Analyses were limited to those cases in which Echinacea or SJW were the only associated products, and in which these HDSs were deemed primary to observed adverse effects. Descriptive statistics were generated for selected demographic and exposure-related variables. RESULTS: During 2001, PCCs were contacted regarding 406 exposures involving Echinacea and 356 exposures involving SJW. Most of the reported exposures for both HDSs occurred among children 5 years and younger, and the majority of exposures were coded as unintentional. For both HDSs, exposures among patients >/=20 years old were more likely to be associated with adverse effects. Intentional exposures accounted for 21% of SJW cases and 3% of Echinacea cases, with 13% of SJW exposures reported as 'suspected suicidal'. CONCLUSIONS: TESS represents a potentially important means of assessing and characterizing HDS-related adverse effects. Detailed studies validating the clinical events and outcomes of a sample of exposures reported to TESS(R) might offer substantial insights into adverse events (AEs) that could be systematically studied with other, established pharmacoepidemiological study designs.

Changes in prescribed drug doses after market introduction.

PURPOSE: The establishment of recommended dosing regimens has always been a difficult aspect of drug development. This paper examines the extent to which postmarketing prescribing deviates from initially recommended dosing regimens. We used the World Health Organization's (WHO) periodically updated compilation of the 'Defined Daily Dose' (DDD) to reflect prevailing patterns of prescribing in national markets. The aim of this study was to evaluate DDD changes over time (1982-2000) and to identify possible determinants of these changes. METHODS: Data on DDD changes were obtained from the WHO's Oslo Collaborating Centre. We performed a case-control analysis in which we compared drugs with (cases) and without (controls) postmarketing changes in DDD on possible determinants associated with DDD change. RESULTS: We found 115 instances of a change of DDD in the period 1982-2000 (45 (39.1%) increases and 70 (60.9%) decreases). Antibiotics showed the greatest number of changes in DDD: predominantly increases in the 1980s, while the 1990s were dominated by decreases in DDD of mostly cardiovascular drugs. CONCLUSION: Changes in DDD reflect the outcome of a melange of forces, including misconceptions of dose requirements during pre-market development of drug and postmarketing changes in pharmacotherapeutic knowledge, clinical concepts, economic forces, and, in the case of anti-infective agents, changing patterns of resistance/sensitivity of target microorganisms to the anti-infective agent(s) in question.