Past, present and future perspectives of therapeutic drug monitoring in India.

Therapeutic drug monitoring (TDM) is the clinical practice of performing drug assays and interpreting results to maintain constant therapeutic concentrations in patients' bloodstream. Conventional TDM was started way back in the 1960s and served to optimise pharmacotherapy by maximising therapeutic efficacy by evaluating efficacy failure and monitoring drug compliance, while minimising adverse events, in drugs with a narrow therapeutic range. Currently, the scope of TDM has been extended to additional indications which are of importance to India. Apart from the conventional indications, TDM can also help combat drug resistance amongst patients treated with antimicrobials, including anti-tubercular drugs and critically ill patients with compromised pharmacokinetics. TDM is also indicated for patients on antiretroviral drugs under specific clinical scenarios and is of high importance to India. Target concentration intervention (TCI) and apriori TDM (by merging TDM with pharmacogenomics) are emerging fields explored in developed nations. The authors sought to assess the evolution of TDM in India and evaluate the potential impact of newer indications in rationalising pharmacotherapy. In the mid-1980s, TDM was presented to India. Despite showing some initial progress, its use is limited to conventional indications. Its utility is also challenged by cost and higher reliance on conventional prescribing practices. However, the newer indications such as antimicrobial resistance, tuberculosis and HIV, with their high prevalence in developing nations, present an opportunity for the growth of TDM in these countries. Indian clinician's awareness and buoyant demands alongside expert contributions from clinical pharmacologists could widen its scope.

A randomised double-blind study comparing sodium feredetate with ferrous fumarate in anaemia in pregnancy.

Iron deficiency anaemia is a major health problem in India especially in women of reproductive age group. The World Health Organisation recommends that the haemoglobin concentration should not fall below 11.0 g/dl at any time during pregnancy. The aim of study was to compare the efficacy and safety of two doses of sodium feredetate with ferrous fumarate in improving haemoglobin profile in pregnant anaemic women. Pregnant women with gestation period between 12 and 26 weeks having serum haemoglobin < 10 g/dl, serum ferritin levels less than 12 microg/l were included in the study. Patients were divided into 3 groups and drugs administered accordingly. A total of 48 patients were available for analysis which included 37 patients who had completed all the visits up to 75 days follow-up and 11 patients who were treatment failures. In group A combination of sodium feredetate (containing 33 mg of elemental iron) along with vitamin B12 (15 microg) and folic acid (1.5 mg) was administered twice a day. In group B combination of sodium feredetate (containing 66 mg of elemental iron) along with vitamin B12 (15 microg) and folic acid (1.5 mg) was administered twice a day. In group C combination of ferrous fumarate (containing 100 mg of elemental iron) along with vitamin B12 (15 microg) and folic acid (1.5 mg) was administered twice a day. Patients were evaluated for Hb, RBC count, MCV, MCH and MCHC at day 0, 30, 45, 60 and 75. Serum ferritin, serum iron, TIBC and transferrin saturation were assessed at recruitment and end study. Mean rise of haemoglobin at the completion of study, over that of basal values was 1.79 g/dl (0.71 to 2.87, 95% CI, p < 0.05) in group A, 1.84 g/dl (0.82 to 2.86, 95% CI, p < 0.05) in group B and 1.63 g/dl (0.38 to 2.88, 95% CI, p < 0.05) in group C. Safety assessment was done by doing liver and kidney function test at the time of recruitment and end study. Low doses of sodium feredetate (33 mg and 66 mg of elemental iron given twice daily) produce comparable results as higher dose of ferrous fumarate (100 mg elemental iron given twice daily). As there were no adverse effects reported with sodium feredetate, it can be concluded from this study that this new formulation appears to be effective in improving haemoglobin profile in pregnant anaemic women and is tolerated well.

Effects of antacid therapy in asymptomatic patients with presence of amoeba in stool report.

Amoebic infection caused by the protozoan parasite Entamoeba histolytica is a prevalent infection in the developing countries. Milder form of this infection is associated with loose stool, flatulence and borborygmi, may or may not be associated with pain in abdomen and treated symptomatically by some physicians by antacid. To find out the effects of antacid (sorbacid) therapy in patients with amoeba in stools by examining the changes in the stool report, a study was conducted among 25 patients enrolled in the study with complaints of "gas" in the abdomen with stool reports positive for amoeba. Antacid (sorbacid) in a dose of one teaspoonful (5 ml) was given three times a day for 3 days and stool examination was repeated. The report showed a significant reduction in the amoeba and mucus in stool (p<0.05) and a trend towards reduction in the presence of occult blood. Other parameters in stool reports did not change. Moreover, all the patients gave the history of passing formed stools and no complaints of "gas" in abdomen thus providing the symptomatic benefit. Antacids may have some beneficial effects in amoebiasis. More studies are required to confirm the above finding and to find out the place of antacid as an adjuvant therapy along with the standard anti-amoebic drugs.