Acute muscle dystonia resulting from medication error: a case report.

Acute Muscle Dystonia (AMD) due to medication error is rarely reported in the literature. We are reporting a case of adverse drug reaction due to a single dose of haloperidol. Patient was free from any psychiatric illness and still he developed AMD with use of haloperidol because of medication error. The patient recovered completely from AMD symptoms in one hour after receiving the treatment. This case report intends to improve the awareness among clinicians to be cautious while writing the prescriptions.

Adverse drug reaction profile at psychiatry out-patient department of a tertiary referral centre in Central India.

Modern lifestyle and unfulfilled desires leads to very common diseases of today like anxiety, depression and schizophrenia. Therefore, last one and half decade there has been an exponential rise in the use of psychotropic medication. Antipsychotic polypharmacy is being practiced with increasing frequency. Polypharmacy is one of the leading cause of adverse drug reactions (ADRs) in psychiatric patients. In India, pharmacovigilance activity is still in initial stages and there are only few reports available on incidence of ADRs due to psychopharmacological agents (PPAs). Also, India rates below 1% in terms of ADR reporting against the world’s rate of 5%. Very few studies have described patient characteristics and treatment patterns associated with long-term use of the drugs. This prompted us to do evaluation of adverse drug reactions of PPAs in tertiary referral centre for a longer duration. This study was designed to prospectively monitor and analyze the pattern of occurrence of ADRs to PPAs in OPD of our tertiary care hospital. Our further aim was to make causality and severity analysis of psychopharmacological drug reactions.

Comparison of Indian package inserts in public and private sector: an urgent need for self regulation.

Background: Package inserts are the authentic source of information for the new molecules in the market. Incomplete and incorrect product information may promote irrational prescribing and may have serious consequences. Hence, our aim was to analyse and compare the information supplied in the package insert according to the section 6.2 and section 6.3 of schedule D of Drugs and Cosmetic Act, 1940 in public (government) and private (non-government) sector. Methods: Package inserts of allopathic drugs which were supplied by government from drug store of tertiary care centre and hospital and from pharmacies on request were collected. A total of 270 package inserts in English were collected that is 38 from government hospital and 232 from the pharmacies nearby the hospital. The package inserts were analysed for the presentation of completeness of the information as per section 6.2 and 6.3. Results: The presentation of information on analysing 233 package inserts (28 government and 205 non government) was not uniform and it was difficult to locate and retrieve information easily due to lack of common layout and heading. Moreover, the package inserts were of variable shape and size with different font size which made it inconvenient for analysing as well as for reference. Posology and method of administration was incomplete in 3% package insert in non- government cases whereas in government supply it was 7%. Use of drug in pregnancy and lactation was deficient in 11% and 14% packages inserts of non-government sources and government sources respectively. Instructions for use were lacking in 25% and 29% package inserts of government and non-government sources respectively. Conclusions: The need of the hour is to further refine contents of the circulated package inserts to make them complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society.