Information contents of drug advertisements: an Indian experience

OBJECTIVE: To critically analyze the drug information contained in Indian pharmaceutical advertisements. DESIGN: Analysis of pharmaceutical advertisements supplied by drug representatives (DRs) to prescribers from July 1, 1995, to June 30, 1996. SETTING: A university-affiliated urban teaching hospital in India. PARTICIPANTS: 585 pharmaceutical ad pamphlets. MAIN OUTCOME MEASURES: The ads supplied by DRs to physicians in different clinical departments of the hospital were collected. These were distributed to different systems/categories and a special reference to fixed-dose drug combinations was given. The drug information contained in these ads was evaluated by using a checklist, framed by incorporating the World Health Organization ethical guidelines for medicinal drug promotion and some relevant items from other studies. RESULTS: The most frequently occurring ads were for antimicrobial agents. The ads on fixed-dose drug combinations constituted 37.9% of the total. More than 85% of the ads mentioned the generic name, brand name, contents, and pharmaceutical dosage forms, as well as the name and address of the company. The information concerning adverse effects, precautions, contraindications, warnings, major interactions, ingredients known to cause problems, pharmacology, drug overdose, references, drug storage, and cost was present in less than 40% of these ads. CONCLUSIONS: There has been inadequate information in pharmaceutical ads supplied by DRs to the physicians in India. The current scenario could be improved by formulating some definite legislative guidelines for the minimum level of information to be included in pharmaceutical ads and adhering to that legislation.     

Critical evaluation of references in drug advertisements: an Indian experience

Drug advertisements have important effect in prescribing habits of physicians. WHO states that all the claims in drug advertisements should be supported by suitable documentary evidences (references). The present study evaluated citations (mentioned/not mentioned), sources (journals, books, conferences/symposia, personal testimonial, unpublished data in file) and adequacy (complete/incomplete) of the references in 585 drug advertisements supplied by medical detail persons to different clinical departments of our hospital. The references were cited only in 37.9% of the drug advertisements. In total, 1032 references (76% of journals, 15% of books, 2% of conferences/symposia, 4% of personal testimonials, 1% of unpublished data and 2% of data in file) were cited. Only 10% references of journals, 7% of books and 12% of conferences/symposia were found complete (according to standard bibliographic norms). The current situation can be improved if the government, industry and the prescribers formulate some guidelines for the mentioning of adequate references in drug advertisements.     

Pooling of clodronate urinary excretion data: a new pharmacokinetic method to study drugs with highly variable gastrointestinal absorption

OBJECTIVE: Our purpose was to study effects of vibroacoustic stimuli on electrocortical activity and heart rate changes in fetal sheep in utero. STUDY DESIGN: Seven chronically instrumented near-term fetal sheep were repeatedly stimulated by an electronic artificial larynx for 32 seconds during periods of rapid-eye-movement and non-rapid-eye-movement sleep. Responses to vibroacoustic stimulation were obtained by spectral analysis of the electrocorticogram (fast Fourier transform) and by assessment of changes in fetal heart rate and fetal heart rate variability. RESULTS: During non-rapid-eye-movement sleep vibroacoustic stimulation led to electrocorticogram desynchronization that consisted of a marked reduction of delta and theta band power (p < 0.05). A concomitant fetal heart rate decrease and fetal heart rate variability increase were also noted (p < 0.05). During rapid-eye-movement sleep vibroacoustic stimulation induced a significant increase in alpha and beta band power (p < 0.05) and a slight deviation in basal fetal heart rate and fetal heart rate variability (p < 0.05). CONCLUSION: Vibroacoustic stimulation of fetal sheep provokes reproducible changes in fetal electrocortical activity and heart rate patterns. These changes, which are not easily identifiable in gross polygraphic assessments of the fetal behavioral state, are indicative of fetal arousal.     

Development of a limited sampling approach in pharmacokinetic studies: experience with the antiepilepsy drug tiagabine

To examine the mechanisms involved in the progression of mercury chloride (HgCl2)-induced acute tubular necrosis (ATN), we investigated the histopathological changes and the expression of inducible nitric oxide synthase (iNOS) mRNA and protein in renal cortices of rats at 20 hours after exposure to HgCl2. The expression of iNOS mRNA was significantly augmented in renal cortices of rats with HgCl2-induced acute renal failure (ARF). Likewise, the induction of iNOS protein was observed in damaged proximal tubule epithelial cells of rats with HgCl2-induced ARF. Pretreatment of rats with iNOS inhibitor aminoguanidine, however, suppressed the development of proximal tubule epithelial cell injury and prevented an increase in blood urea nitrogen and serum creatinine as well as resulting in a marked fall in iNOS mRNA and protein in rats with HgCl2-induced ARF. These observations indicate that the induction of iNOS may play a role in the progression of HgCl2-induced ATN through the exacerbation of proximal tubule epithelial cell damage.     

Prescribing drug of choice to illicit heroin users: the experience of a U.K. community drug team

Functioning across several life domains, in the first cohort of illicit heroin users to be prescribed injectable diamorphine (pharmaceutical heroin) as an adjunct to treatment within a community drugs service, was assessed in a cross-sectional study with a 6-month follow-up. Case-control matching procedures were employed to compare outcomes in this group with an oral methadone-prescribed sample, attending different clinics within the same community service and geographical locale. The Heroin Prescribed (HP) group manifested lower levels of psychopathology and showed greater retention in treatment. Although reduced, illicit heroin misuse was not eliminated; the use of other illicit substances was comparable between groups but significantly more of the HP group were using illicit cocaine. Although no differences in current physical health were apparent, the sharing of used injecting equipment was reported only in the MP group. Criminal activity appeared significantly reduced, but not eliminated, in the HP group. Implications for prescribing practice are discussed.     

Cyclosporine A: clinical experience and therapeutic drug monitoring

This article updates current studies on the concentration-effect relationship for cyclosporine A using specific analytical methodology in whole blood. Most of the existing documentation concerns renal transplantation. Trough level monitoring is recommended as the standard monitoring technique. However, there is a need to compare trough level monitoring with monitoring of the area-under-the-concentration-versus-time curve in prospective controlled trials. Further, there is a continuous need to update the concentration-effect relationship when introducing new immunosuppressive drug regimens.     

Self-medication hypothesis: Connecting affective experience and drug choice.

According to E. J. Khantzian's (2003) self-medication hypothesis (SMH), a psychoanalytically informed theory of substance addiction that considers emotional and psychological dimensions, substance addiction functions as a compensatory means to modulate affects and self-soothe from the distressful psychological states. To manage emotional pain, dysphoria, and anxiety, substance abusers use the drug actions, both physiological and psychological effects, to achieve emotional stability. The SMH was retrospectively tested using 6 Minnesota Multiphasic Personality Inventory-2 special scales with 402 non-drug users and drug users to capture the psychological elements relevant to the SMH. Three logistic regression models were formed to predict alcohol, cocaine, and heroin "drug-of-choice" groups. Predicting variables were the Repression, Overcontrolled Hostility, Psychomotor Acceleration, Depression, Posttraumatic Stress Disorder, and Cynicism scales. Repression and, inversely, Depression scales significantly predicted the alcohol group. Psychomotor Acceleration was the only significant predictor of the cocaine group. Cynicism significantly predicted heroin preference. The results are partially consistent with the SMH. Implications of these results for understanding the relationship between affect regulation and addiction and treatment interventions are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Competing perspectives on drug use: The Dutch experience.

Review of book: Competing Perspectives on Drug Use: The Dutch Experience by Govert Frank van de Wijngaart, Amsterdam/Lisse: Swets & Zetlinger B.V., 1991, 142 pp. Reviewed by Jon C. Laberg. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Long-term experience with an ultrapure individual dialysis fluid with a batch type machine

BACKGROUND: This paper discusses long-term experience with a specific type of dialysis equipment which has been used more than 15 years without variation. The system was designed to allow easy individualization of dialysis fluid composition and to deliver dialysate of the highest hygienic quality. METHODS: Data from 399 patients covering the period from 1971 onwards were analysed retrospectively. Survival probabilities were estimated by the Kaplan-Meier method and the median number of days in hospital was calculated. Additional data collected from patient subgroups included serum albumin level, erythropoietin requirement and antihypertensive treatments. Kt/V and PCR from one subgroup were computed using the formulae of Daugirdas and Depner. RESULTS: The estimated survival probability after 5 years for all patients was 59.1% (95% CI: 52.6-65.6%). The main risk factors from the available covariables were age and IDDM. The cumulative incidence of carpal tunnel syndrome after 10 years of dialysis was estimated as 7% (95% CI: 0-14%). Data from the subgroups revealed that 82% of the patients had serum albumin levels >4.0 g/dl, 65% of the patients received no antihypertensive drugs and 39% received erythropoietin (37 +/- 28 units/kg bw/week) to correct dialysis anaemia (haemoglobin level = 98 +/- 8 g/l). Average Kt/V was 1.21 +/- 0.17, PCR was 1.10 +/- 0.22 g/kg/day. CONCLUSIONS: The setup described permits individualized therapy of high quality. The high serum albumin values and our very low incidence of carpal tunnel syndrome underline the importance of water and dialysate quality.     

Smokeless tobacco: an addicting drug

OBJECTIVE: To describe the sexual behaviour of postnatal women, including time of restarting intercourse, problems encountered, use of contraception and related use of available services. DESIGN: Longitudinal survey using postal questionnaires following discharge from hospital, and at eight weeks and twelve to eighteen months postnatally. SETTING: The questionnaires referred to postnatal care received in a teaching hospital and general practitioner delivery units, and in the community. POPULATION: Randomly selected one in five sample of women who were delivered in the Grampian Region of Scotland over a 12-month period. MAIN OUTCOME MEASURES: Times to restarting intercourse and contraception; problems related to intercourse and their relation to perineal pain, tiredness and method of infant feeding; and perceived need for and adequacy of help. RESULTS: The median times to restarting intercourse and contraception were each six weeks. Problems with intercourse were reported by 569/1075 (53%, 95% CI 50-56) of women in the first eight weeks after delivery, and by 215/435 (49%, 95% CI 45-54) in the subsequent year. Women who reported perineal pain, depression or tiredness experienced problems related to intercourse more often than those who did not. Women who breastfed their infants were significantly less interested in intercourse than those who bottlefed, irrespective of tiredness or depression, but this effect did not persist in the long term. The need for help with problems was expressed by 7% to 13% of women, but a quarter of these had not sought it. CONCLUSIONS: Postnatal sexual problems are common. Health professionals ought to educate and prepare patients antenatally; be trained to identify problems; and be competent to deal with them openly and sympathetically.     

Placement of a coated stent in esophagotracheal fistula: initial experience with an "aortic stent"

Clinical and biological pitfalls that lead to incorrect or delayed diagnoses of airport malaria are described based on 7 cases reported from the Paris region in the summer of 1994. We also report the outcome and the epidemiological features of these patients.