Pharmacoeconomics of medicines used for geriatric individuals in a tertiary care hospital in Delhi.

BACKGROUND OBJECTIVES: Expenditure on healthcare is a major concern in the geriatric age group. The current study was carried out to assess the expenditure patterns on medicines utilized in geriatric inpatients. METHODS: An observational study was conducted on 1000 geriatric inpatients, aged ≥60 yr, admitted to the medicine unit. Data were collected regarding demographic characteristics, prescribed medicines, expenditure incurred on medicines, appropriateness of medicines prescribed and adverse drug reactions (ADRs). Appropriateness of the prescribed medicines was determined using the American Geriatrics Society 2015 Updated Beers Criteria. RESULTS: Geriatric inpatients comprised 41.3 per cent of the total individuals admitted in the ward during the study period. A total of 8366 medicines were prescribed in 127 formulations. The total expenditure on prescribed medicines was INR 1,087,175 with a per capita expenditure of INR 1087.17. Parenteral medicines accounted for 91 per cent of the expenditure on medicines. Maximum expenditure (70%) was incurred on 11.9 per cent of the medicines prescribed. The per capita expenditure was significantly higher in individuals with comorbidities (P=0.03) and those who had a longer duration of hospital stay (P<0.0001). About 28.1 per cent prescriptions were inappropriate. ADRs (140) were observed in 139 (13.9%) inpatients. Individuals with inappropriate medicines prescriptions and ADRs had a longer duration of hospital stay and more number of medicines prescribed. INTERPRETATION CONCLUSIONS: Comorbidities, prolonged hospitalization, polypharmacy, inappropriate medicines and parenteral medicines being prescribed contribute to increased expenditure on medicines in geriatric inpatients. In view of the rising number of geriatric inpatients, there is a need to frame a drug policy for them along with surveillance of expenditure on prescribed medicines. This needs to be treated as a priority.

Availability of Pediatric Formulations in Public Health Care System in India: A Case Study.

OBJECTIVES: To assess the availability of pediatric formulations in Essential Medicines Lists and public health care facility in India. METHODS: Availability of pediatric formulations in the public health sector was evaluated by assessing inclusion of pediatric formulations in the National List of Essential Medicines (NLEM), Delhi Essential Medicine List (DEML), Indian Academy of Pediatrics (IAP) Essential Medicines Lists (EML) and comparing it with the World Health Organization's list of essential medicines for children (WHO, EMLc). In addition, availability of 30 essential medicines in a public, tertiary care hospital was assessed over a period of 1 y. RESULTS: Many medicines present in WHO EMLc were not there in NLEM and DEML. The number of pediatric medicines formulations not available in pediatric doses as compared to WHO EMLc was 98,97 and 97 in NLEM, DEML and IAP respectively. Palliative care was the most neglected area in all the lists. In the public health care facility, only 53% of the tracer pediatric medicines were available. CONCLUSIONS: There is less availability of pediatric formulations in the Indian NEML and state DEML. Availability of key tracer pediatric medicine formulations in public health facility is poor. A separate pediatric EML is required in the country to improve focus on availability of child-specific formulations.

Drug utilization, rationality, and cost analysis of antimicrobial medicines in a tertiary care teaching hospital of Northern India: A prospective, observational study.

BACKGROUND: The burden of bacterial infections is huge and grossly under-represented in the current health-care system. Inappropriate use of antimicrobial medicines (AMMs) poses a potential hazard to patients by causing antibiotic resistance. This study was conducted to assess the: (i) AMM consumption and use patterns in patients attending the outpatients and inpatients of Medicine and Surgery departments of the hospital. (ii) Appropriateness of the AMM in the treatment prescribed, and (iii) cost incurred on their use in admitted patients. MATERIALS AND METHODS: An observational, prospective study was conducted among inpatients and outpatients of the Medicine and Surgery departments of a tertiary care hospital of northern India. Analysis of 2128 prescriptions and 200 inpatient records was performed using a predesigned format. The use of AMMs was reviewed using anatomical therapeutic chemical classification and defined daily doses (DDDs). To evaluate the expenditure incurred on AMMs, ABC analysis was performed. RESULTS: AMMs were prescribed to 37.9% outpatients and 73% of admitted patients. The percentage encounters with AMMs was 40.6% (medicine) and 25.6% (surgery) outpatients. The total DDDs/100 patient days of AMMs in medicine and surgery were 3369 and 2247. Bacteriological evidence of infection and AMM sensitivity was present in only 8.5% of cases. Over 90% of AMMs were prescribed from the hospital essential medicines list. Most of the AMMs were administered parenterally (64.9%). Multiple AMMs were prescribed more to inpatients (84.2% vs. 4.2% outpatients). Overall, expenditure on AMM was 33% of the total cost of treatment on medicine. ABC analysis showed that 74% of the expenditure was due to newer, expensive AMM, which constituted only 9% of the AMM used. The AMM therapy was found to be appropriate in 88% of cases as per Kunin's criteria for rationality. CONCLUSION: AMMs are being commonly prescribed without confirmation of AMM sensitivity in the hospital. A large proportion of expenditure is being incurred on expensive AMM used in a few number of patients. There is a need for developing a policy for rational use of AMM in the health facility.

Generic medicines: issues and relevance for global health.

Generic medicine is a pharmaceutical product which is bioequivalent to the innovator product in terms of dosage form, strength, route of administration, quality, safety, performance characteristics, and intended use. Generic medicines are a cornerstone for providing affordable medicines to patients. The major generic markets in the world include United States of America followed by European Union, Canada, Japan, and Australia. The major suppliers of generic medicines China and India are showing tremendous growth in the generic medicine sector. There are many legal and regulatory issues along with quality concerns associated with the use of the generic products. Lately, bilateral international agreements called free trade agreements, delaying tactics by originator companies like strategic patenting and litigations on generic manufacturers, have been a major setback for the generic medicine industry. These issues need to be addressed to optimize the use of generic medicines. The sustainability of generic medicine sector is crucial for improving access to essential medicines for the worldwide.

Biosimilars: current scientific and regulatory considerations.

The widespread use of biologics has paved way for newer options in therapeutics for once incurable illnesses. Their large and complex protein structure, post-translational modifications, elaborate manufacturing/production process and risk for immunogenicity adds to the uniqueness of a biologic product. Patent expiration of innovator biologics has led to the development of biosimilars; biologics similar /comparable to the reference product in terms of quality, safety and efficacy. We discuss the clinical safety and regulatory requirements for biosimilars in various countries across the world. Future holds promise for biosimilars to provide affordable, efficacious and safe treatment to a vast majority of patients with significant cost savings to the nation.

Cost of medicines & their affordability in private pharmacies in Delhi (India).

BACKGROUND & OBJECTIVES: Medicines can account for up to 90 per cent of health care spending by poor people. High costs of medicines contribute to decreased access to healthcare. This study was conducted to assess the cost of medicines and their affordability in the private pharmacies in Delhi, India. METHODS: A survey was conducted to assess the costs of prescribed medicines and treatment of community acquired pneumonia (CAP), with medicines purchased from 27 private pharmacies, in Delhi. Affordability of medicines was assessed by comparing the costs of treatment (medicines) to the monthly per capita expenditure (MPCE) on food, minimum monthly and daily wages for different classes of workers. RESULTS: A large variability in the costs of prescriptions was observed (129.37 ± 217.99) The cost of treatment of CAP varied from Rs. 34.50- 244.75 with azithromycin and Rs.72.20- 277.30 with levofloxacin. The percentage of MPCE on food spent for a prescription was 17.64 per cent for urban and 23.4 per cent for rural population. The percentage of MPCE on food spent for treatment of CAP ranged from 10.11 to 13.42 per cent with azithromycin and 13.28 to 17.61 per cent with levofloxacin. The number of days a worker on minimum daily wages would have to work to enable him to purchase his prescription medicines ranged from 1-17 days, depending on the problem. The cost of treatment of CAP required 1-3 days of work by a daily wage earner, depending on the brand of medicine prescribed. INTERPRETATION & CONCLUSIONS: The findings of our study show that the costs of medicines are highly variable and not affordable for the economically poor in India. Modifications in National Pharmaceutical Policy need to be done urgently.

Fixed-dose combinations for cough and common cold in India: an assessment of availability and rationality.

This study was conducted to determine the number and composition of the various cough and cold formulations available in the Indian market and to study their pharmacological rationale over a period of 7years. Data for the study was collected from an annual Drug Compendium entitled 'THE DRUG TODAY' of the years 2001, 2004, and 2007. Medications were assessed for total number, different formulations, and number of constituents present in each formulation, their pharmacological group and amount of each constituent per dose. Rationality of available preparations was assessed on a seven-point scoring criteria. There are over thirteen hundred drug products for cough and cold in the Indian market, which is an increase of 71.2% from the year 2001. More than 90% of the preparations were fixed-dose combinations (FDCs). Majority of the cough and cold preparations had 3-4 constituents. Many preparations contained more than one constituent of the same pharmacological group. Some preparations had constituents with opposing action. A wide variation in the amount of each constituent present per dose in different formulations was observed. The number of banned drug combinations for cough and cold showed an increase from 9 in 2001 to 27 in 2007. Rationality assessment of the FDC preparations revealed that most of the preparations were irrational and had no documented benefit in the treatment of common cold. Availability of such a large number of irrational FDCs for cough and cold requires serious review of the legal provisions in India for drug manufacturing and marketing.