Availability Of Pediatric Formulations Research Articles

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

To assess the availability of pediatric formulations in Essential Medicines Lists and public health care facility in India. 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. 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. 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.

Innovations in Pediatric Drug Formulations and Administration Technologies for Low Resource Settings.

Despite advances in regulations and initiatives to increase pediatric medicine development, there is still an unmet need for age-appropriate medicines for children. The availability of pediatric formulations is particularly lacking in resource poor areas, due to, for example, area-specific disease burden and financial constraints, as well as disconnected supply chains and fragmented healthcare systems. The paucity of authorized pediatric medicines often results in the manipulation and administration of products intended for adults, with an increased risk of mis-dosing and adverse reactions. This article provides an overview of the some of the key difficulties associated with the development of pediatric medicines in both high and low resource areas, and highlights shared and location specific challenges and opportunities. The utilization of dispersible oral dosage forms and suppositories for low and middle-income countries (LMICs) are described in addition to other platform technologies that may in the future offer opportunities for future pediatric medicine development for low resource settings.

AVAILABILITY OF PAEDIATRIC-EVALUATED FORMULATIONS IN SERBIA

Background/ObjectiveA lack of appropriately evaluated medicines for paediatric population is a major problem as it often leads to inadequate treatment of children. The aim of this study was to investigate the availability of paediatric formulations labelled for children up to the age of 12 years old in Serbia in 2013, as well as the availability of paediatric medicines reimbursed by the Republic Health Insurance Fund (RFZO). The availability of paediatric formulations in Serbia is also compared with the ‘Model List of Essential Medicines for Children’ by World Health Organization's (WHO).MethodsSources of information about medicines were: the Summary of Product Characteristics (SmPc), RFZO Drug Lists, WHO Model Lists of Essential Medicines for Children, and Serbia's official drug registry, editions 2013.ResultsIn Serbia only 49% (496) of INN drugs were suitable for children of which only 66% were licensed for paediatric use. Majority of licensed drugs were parenteral formulations, 57%, followed by drugs for local use, 28%, and formulations for oral use, 23%. The lowest availability of medicines was for children 0–27 days old. From the total number of licensed medicines for children up to 12 years old, the Republic Fund for Health Insurance covers 64% of drugs and from each therapeutic group at least one medicine is reimbursed by fund. The availability of WHO essential medicines for children in Serbia was 51%, from which 92% were licensed for paediatric use.ConclusionOur study showed that from already unsatisfactory number of available drugs for children only 66% is licensed. Limited availability of paediatric medicines for all ages of this population and for a broad range of therapeutic areas still represents a cause for concern in our country.

Treatment interruptions and inconsistent supply of anti-tuberculosis drugs in the United Kingdom

National Health Service (NHS) centres treating tuberculosis (TB) in the United Kingdom. To describe NHS TB treatment centres' experience of obtaining anti-tuberculosis drugs to treat drug-susceptible and drug-resistant TB between 2007 and 2009. In particular: 1) any difficulties experienced in obtaining different drugs; 2) resulting interruptions or alterations in the prescribed regimen; 3) availability of paediatric formulations; and 4) resources available to identify and manage drug shortages. Questionnaires were sent to pharmacists at 168 treatment centres. Of the 77 (46%) treatment centres that responded, 63% (48/77) reported difficulties in obtaining anti-tuberculosis drugs. Consequently, 27% had to interrupt the prescribed treatment regimen at least once, whilst 19% had to alter the regimen. Of 55 centres treating multidrug-resistant tuberculosis, 36% reported difficulties obtaining second-line drugs, 16% had to interrupt the prescribed treatment regimen at least once and 5% had to alter the regimen. A lack of licensed liquid formulations for children resulted in 26% of treatment centres using unlicensed, variable-strength liquids and locally prepared suspensions. Difficulties obtaining drugs to treat both drug-susceptible and drug-resistant disease are common in the UK. There are particular risks for children. Our data identify an urgent need for national strategic guidance to ensure a consistent and reliable supply of anti-tuberculosis drugs.

HIV infection in adolescents: A rising concern

Almost a third of all people with Human Immunodeficiency Virus (HIV)/(AIDS) Acquired Immunodeficiency Syndrome are between the ages of 15 and 24. Every minute, six young people under the age of 25 become infected with HIV. This study of HIV infection was carried out over a two-year period with 33 HIV-positive adolescents, at SSG hospital, Vadodara. The most common mode of transmission (MOT) was the vertical route in 21(64%) cases followed by the sexual route in four (12%) cases. The mean time for disease progression was 13 years in cases acquiring infection through vertical transmission (VT). Reasons for slow progression in these cases, in spite of the high prevalence of malnutrition and infectious diseases in a developing country like India, should be studied. Both parents were positive in 12 of 21 VT cases and eight were orphans. Multiple cases in the same family made treatment and care difficult. Only eight of the 21 VT cases were tested, due to positivity in their parents, while the rest were tested on being symptomatic, suggesting delayed testing. Late diagnosis led to a delay in the initiation of antiretroviral treatment (ART), influencing the growth and development of adolescents. Twenty-one cases sought treatment when they had already developed AIDS, thus preventing us from early intervention. Nine cases were on ART. These cases faced problems like dose adjustments, adherence, and availability of pediatric formulations.

Documentation of Pediatric Drug Safety in Manufacturers??? Product Monographs

To describe the provision of pediatric drug safety information in a national formulary of manufacturers' drug product monographs. We performed a cross-sectional evaluation of comprehensive product monographs contained in the 2005 Canadian Compendium of Pharmaceuticals and Specialities (CPS). We abstracted data describing indications for prescription, statements about pediatric safety, available preparations, and provision of dosing guidelines. For each monograph we classified pediatric safety data as either present, present but limited or absent. We then described the pediatric safety data in CPS monographs for drugs listed in the published formulary of the Hospital for Sick Children, Toronto, Ontario, Canada. A total of 2232 product monographs were screened; 684 were excluded and 1548 (66%) were further analyzed. 1462 (94%) had indications that did not exclude children. Pediatric safety information was present in 592 (38%), present but limited in 148 (10%), and absent in 808 (52%) drug monographs. Safety statements were absent in 224 (14%) drug monographs that provided both dosing guidelines and formulations suitable for administration to children, and in 214 (52%) of 411 drugs in the pediatric hospital formulary. We evaluated a widely available national source of pediatric prescribing information. Safety data for children was not mentioned in more than half of the product monographs. Moreover, the provision of safety data was discordant with indications for prescription, the availability of pediatric formulations, and dosing guidelines within the monographs, and with inclusion in a pediatric hospital formulary. Our study suggests that the presentation of pediatric safety data in drug product monographs can be improved to better inform prescribing and to optimize pharmacotherapy in children.