Drug promotional literatures (DPLs) evaluation as per World Health Organization (WHO) criteria.

This study was aimed to evaluate the drug promotional literatures (DPLs) as per World Health Organization (WHO) criteria and also to evaluate claims, references and pictures presented in DPLs. It was an observational, cross-sectional study conducted at the outpatient department of Civil Hospital, Ahmedabad, a tertiary care teaching hospital for period of 2 months. Printed drug promotional literatures for modern drugs were collected as per selection criteria and analyzed. WHO guidelines were not fulfilled in any of the 200 DPLs. Out of 299 claims, most commonly presented claim in 192 DPLs was efficacy (45.15%) followed by pharmaceutical properties (26.75%). 130 (65%) DPLs did not provide any references to support claims while only 70 (35%) DPLs provided references. Most commonly used reference was journal articles 66 (88%) followed by websites 5 (6.66%). Most common source of journal article reference was research article 53 (85.48%) followed by review article 7 (11.29%). 125 (78.61%) DPLs presented with irrelevant pictures while only 25 (15.72%) DPLs presented appropriate pictures. Information on adverse drug reactions, contraindications and drug interactions was missing in most of DPLs. None of the promotional literatures contained all of the information as per WHO guidelines for medicinal drug promotion. They were lacking with scientific and critical information.

A comparison of the efficacy and safety of timolol in combination with dorzolamide, brimonidine or latanoprost in patients of primary open angle glaucoma.

The present study was undertaken to compare the efficacy and safety of timolol with dorzolamide, brimonidine or latanoprost in patients of primary open angle glaucoma. This prospective, observational study was conducted over one and a half year at the Regional Eye Institute, in patients of primary open angle glaucoma who were prescribed dorzolamide (2%) and timolol (0.5%) (DT), brimonidine (0.1%) and timolol (0.5%) (BT) or latanoprost (0.005%) and timolol (0.5%) (LT). Measurement of intraocular pressure (IOP) and indirect ophthalmoscopy was done at baseline and after 1, 3 and 6 months of treatment. Efficacy was assessed by the degree of reduction in intraocular pressure and change in cup-disc ratio. Adverse drug reactions (ADRs), if any, were recorded. The data was analysed using Student’s ‘t’ test and one-way ANOVA test. P value < 0.05 was considered to be statistically significant. Total number of 35 patients in DT group, 34 in BT group and 32 in LT group completed the study. At the end of 6 months, average reduction in IOP levels was 7.83, 9.39 and 9.73mmHg in DT, BT and LT groups respectively. Thus, a percent reduction of 29.4, 35.6 and 36.2 from baseline was observed in these groups respectively. While the reduction was maximum in LT group, there was no statistically significant difference between any of the groups at 1, 3 or 6 months. A total of 47 ADRs were reported, none of which required discontinuation. All three combinations are effective in reducing the IOP level in patients of primary open angle glaucoma and none appear to be superior to the others.

A Study of Potential Drug-Drug Interactions in Indoor Patients of Medicine Department at a Tertiary Care Hospital.

Drug interactions are an important cause of medication errors. The present study was conducted to evaluate the nature and clinical significance of potential drug-drug interactions (DDIs) in inpatients of Medicine Department at a tertiary care hospital in India. The second day prescription of every alternate indoor patient from five randomly selected medical units of a tertiary care hospital were collected. Prescriptions were analyzed for potential DDIs using the web based interaction checkers of Medscape and Current Index of Medical Specialties. The average numbers of drugs per prescription and potential DDIs per prescription and the types, age wise distribution and clinical significance of the potential DDIs were evaluated. A total of 3405 potential DDIs were detected in 257 prescriptions. An average 8.28 drugs were prescribed per prescription. The most common drug groups involved in potential DDIs were diuretics (n=255), NSAIDs (n=225), β blockers (n=143), cardiac glycosides (n=129) and statins (n=122). Potential DDIs were most frequent in patients between 61-75 years of age. The clinical significance was graded as serious (n=123), significant (n=949), minor (n=2328) and contraindicated (n=5). An increased risk of rhabdomyolysis (n=41) and an increase in QTc interval (n=38) were the most common potentially serious DDIs detected. Of the 1077 DDIs (excluding minor DDIs), 615 were pharmacodynamic and 462 were pharmacokinetic interactions. Potential DDIs increased with an increase in the number of prescribed drugs. Improved awareness among prescribers is required to reduce the risks associated with DDIs. Use of drug groups, commonly involved in potential DDIs, should be minimized and optimized while prescribing.

Availability of pediatric medicines and their perception among prescribers at a Tertiary Care Teaching Hospital.

The pediatric population is heterogeneous group with markedly different pharmacokinetics from that in adults. However, conventionally adult dosage forms are fragmented to treat pediatric patients due to the poor availability of child friendly formulations in public health facilities. An observational, cross-sectional study was undertaken at pharmacy store and pediatric department at a tertiary care hospital. Each medicine with dosage form and strength was listed separately and compared with WHO Model List of Essential Medicines for Children (EMLc), Key tracer and Priority medicines for children. Prescribers were also interviewed using a validated structured questionnaire. Out of 27 drug groups listed in WHO EMLc, a large deficiency was observed in chemotherapeutics (47%), gastrointestinal (50%) and ophthalmic preparations (100%). Out of total 258 paediatric medicines, 55.8% were available. A gross deficiency of child specific dosage formulations was also observed. Majority (91%) of the prescriber confessed of using fragmented adult formulations and experienced drug administration problem. The availability of paediatric medicines in appropriate dosage formulations and strength is not satisfactory at public health facilities. Pharmacologically, children are separate group and their need should be addressed by including child friendly formulations in EML or having separate EMLc.

Over prescribing and resistance to chloroquine.

Malaria is a major health concern in the developing world including India. Overdiagnosis and overprescribing of malaria may lead to increase morbidity, mortality and increases risk of resistance to antimalarial drugs and hence increase the economical burden to health care system. The present study was carried out to determine the actual cases of malaria and extent of chloroquine resistance at Civil Hospital Ahmedabad, a tertiary care teaching hospital in Gujarat, India. After Institutional Ethics Committee approval, adult patients of either gender, presenting with a history of fever at the Out Patient Department (OPD), diagnosed to be suffering from malaria and prescribed chloroquine were included in the study. Peripheral thick blood smear test and OptiMAL-rapid diagnostic test (RDT) were carried out. RDT was performed in these patients on day 0 before the start of chloroquine treatment and after completion of the 3 day chloroquine treatment. They were again subjected to RDT on day 4. The positive cases on RDTon day 4 were considered as resistant to chloroquine. During the study period of 12 months, out of the 250 clinically suspected cases of malaria who were prescribed chloroquine, 80 (31%) cases (35 cases of P. vivax and the 45 of P. falciparum ) were positive for malaria (by the peripheral smear and the Rapid Diagnostic Test (RDT) OptiMAL test). Thirty out of the 35 cases of P. vivax malaria, responded to the three- day chloroquine treatment. Out of the 45 cases of P. falciparum malaria, 30 responded to chloroquine while 15 patients (35%) continued to be OptiMAL positive on 4th day and required change of treatment. It suggests that an early diagnosis, definitive treatment and avoiding overprescribing could delay drug resistance and reduce the morbidity and mortality due the disease.

Comparative evaluation of anticonvulsant activity of calcium channel blockers in experimental animals.

Pentylenetetrazole (PTZ)-induced convulsions and the maximal electroshock (MES) seizure test were employed to study the anticonvulsant effects of nifedipine (2, 3.5 and 5 mg kg-1), flunarizine (10, 20 and 40 mg kg-1) and diltiazem (10, 15 and 30 mg kg-1). Nifedipine and flunarizine prolonged the latent period and reduced the mean duration of PTZ induced seizures. They also reduced the severity of convulsions and the number of deaths due to PTZ significantly. Nifedipine was more potent in this regard (P < 0.01). All these drugs prolonged the latent period and reduced the duration of tonic extensor phase of MES seizures in a significant manner. Flunarizine was most potent in this test. Complete protection from tonic extensor phase was observed in 10-50% animals pretreated with nifedipine and flunarizine in a dose dependent manner. The response of diltiazem was weak in both these tests. It is concluded that all three calcium channel blockers possess an important but different anticonvulsant effect and their significant clinical use can be made while keeping in view the characteristics of their pharmacological action.

Effect of nifedipine, a calcium channel inhibitor, on sedation produced by reserpine, clonidine and propranolol in mice.

Spontaneous motor activity, rotarod test and observational rating of sedation were employed to study effect of nifedipine on sedation produced by reserpine, clonidine and propranolol. Reserpine (2 mg kg-1), clonidine (4 mg kg-1), and propranolol (40 mg kg-1) significantly reduced spontaneous motor activity and staying capacity of animals on accelerating rotarod (P < 0.01). Observational sedation was also caused significantly as indicated by a higher score in test. Nifedipine (2 mg kg-1) produced no sedation or excitation on its own. Reduction in spontaneous motor activity produced by reserpine and clonidine was partially reversed in animals treated with nifedipine (P < 0.01). A similar effect of nifedipine was also evident on the observational sedation induced by reserpine and clonidine. Effect of these drugs on rotarod times was nearly totally antagonised by nifedipine. Nifedipine did not oppose the sedation produced by propranolol which actually became significantly greater in the animals pretreated with nifedipine in all three tests. It is concluded that nifedipine antagonizes the sedation produced by reserpine and clonidine, probably by blocking central alpha 2-adrenoceptors. The sedative effect of propranolol can be potentiated by nifedipine possibly because of a pharmacokinetic interaction.

Effect of calcium salts & related substances on the motility & viability of ejaculated human spermatozoa in vitro.

Effect of four calcium salts, three calcium antagonists, calcium ionophore (A 23187) and calmodulin was studied in vitro on the motility and viability of ejaculated normal human spermatozoa at different time intervals. Effect of calcium salts was also studied on the oligoasthenospermic samples with an original motility of 10 to 30 per cent. Calcium salts were found to improve the sperm motility by 6 to 16 per cent and this may be due to a direct excitatory influence and a protective action of calcium on the spermatozoa since the viability was also improved by 4 to 11 per cent in these cases. A similar improvement in motility (8 to 11%) and viability (5 to 9%) was observed in hypokinetic samples also, Calcium antagonists inhibited the sperm motility and viability significantly. Diltiazem was the most potent drug in this respect, the reduction in motility being by 11 to 22 per cent and in viability by 6 to 14 per cent, after 30 sec of incubation. Calcium ionophore and calmodulin were found to be more potent than calcium antagonists to produce a dose-dependent decrease in sperm motility and viability. The results confirm that ionized calcium plays an important role in the regulation of sperm motility. Although intracellular concentration of calcium may be a better determinant physiologically, the manipulation of extracellular levels in a critical range may promote the sperm motility, viability and other vital functions. This has a potential use in situations like artificial insemination, in vitro fertilization and semen banking. Calcium ionophores and calmodulin need further investigation for a possible use as vaginal spermicides.