A STUDY AIMED TO INCREASE THE KNOWLEDGE ABOUT THE FIXED DOSE COMBINATIONS (FDC'S) AND IRRATIONAL FDC'S AVIALABLE IN INDIA.

2021 ◽  
pp. 45-46
Author(s):  
Tauseef Nazir Vaidha ◽  
Sabahat Farooq ◽  
Samina Farhat

Fixed dose combinations(FDC's) is a combination of 2 or more than 2 drugs in a single dosage formulations, it should not be confused with concomitant drug therapy which refers to taking 2 or more than 2 drugs separately. Fixed dose combinations may be rational or irrational. In India there are more FDC's than single drugs and majority of those FDC's are irrational. Many of these irrational FDC's are widely prescribed. The WHO essential medicine list incorporates only 23 FDC's while as the National list of essential medicines(NLEM) of 2011 has only 12 FDC's.

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045262
Author(s):  
Michael Sergio Taglione ◽  
Nav Persaud

ObjectiveEssential medicines lists have been created and used globally in countries that range from low-income to high-income status. The aim of this paper is to compare the essential medicines list of high-income countries with each other, the WHO’s Model List of Essential Medicines and the lists of countries of other income statuses.DesignHigh-income countries were defined by World Bank classification. High-income essential medicines lists were assessed for medicine inclusion and were compared with the subset of high-income countries, the WHO’s Model List and 137 national essential medicines lists. Medicine lists were obtained from the Global Essential Medicines database. Countries were subdivided by income status, and the groups’ most common medicines were compared. Select medicines and medicine classes were assessed for inclusion among high-income country lists.ResultsThe 21 high-income countries identified were most like each other when compared with other lists. They were more like upper middle-income countries and least like low-income countries. There was significant variability in the number of medicines on each list. Less than half (48%) of high-income countries included a newer diabetes medicines in their list. Most countries (71%) included naloxone while every country including at least one opioid medicine. More than half of the lists (52%) included a medicine that has been globally withdrawn or banned.ConclusionEssential medicines lists of high-income countries are similar to each other, but significant variations in essential medicine list composition and specifically the number of medications included were noted. Effective medicines were left off several countries’ lists, and globally recalled medicines were included on over half the lists. Comparing the essential medicines lists of countries within the same income status category can provide a useful subset of lists for policymakers and essential medicine list creators to use when creating or maintaining their lists.


Author(s):  
Rajeev Shrestha ◽  
Sushmita Gurung

<p class="abstract"><strong>Background:</strong> A large proportion of fixed dose combinations (FDCs) are manufactured and used widely in Nepal. This study aimed to evaluate the FDCs and its utilization in medicine department of tertiary care hospital.</p><p class="abstract"><strong>Methods:</strong> A cross-sectional study was conducted for 50 days among admitted patients in the medicine department of tertiary care hospital, Nepal. A predesigned form was used to collect the data at the time of patient discharge. Only the oral FDCs were selected for study.<strong> </strong>Microsoft Excel 2007 was used for statistical analysis and data were presented as number and percentage in tabulated and figure forms.  </p><p class="abstract"><strong>Results:</strong> Oral FDCs were used in 27.08% of admitted patients. A total of 295 FDCs were prescribed in 208 patients with 44 FDC items in 58 different brand names. Categorically, the most commonly used FDCs were of analgesics (34.24%) followed by antibiotics (25.76%) and vitamin supplements (22.71%). The 27.27% of FDCs prescribed contain more than two active pharmaceutical ingredients (APIs) up to nine and the highest number of APIs were found in vitamin supplements. All FDCs were prescribed in the brand names. The very few 2.27% and 4.55% of FDCs were prescribed from the essential medicine list of Nepal and world health organization, respectively.</p><p class="abstract"><strong>Conclusions:</strong> The use of FDCs listed in essential medicine list was very poor. Similarly, generic prescribing was also zero. The regulatory body must study the rationality of FDC before production, marketing, importing, and utilization in hospital.</p>


PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0241899
Author(s):  
Barbara Bortone ◽  
Charlotte Jackson ◽  
Yingfen Hsia ◽  
Julia Bielicki ◽  
Nicola Magrini ◽  
...  

Antibiotic fixed dose combinations (FDCs) can have clinical advantages such as improving effectiveness and adherence to therapy. However, high use of potentially inappropriate FDCs has been reported, with implications for antimicrobial resistance (AMR) and toxicity. We used a pharmaceutical database, IQVIA-Multinational Integrated Data Analysis System (IQVIA-MIDAS®), to estimate sales of antibiotic FDCs from 75 countries in 2015. Antibiotic consumption was estimated using standard units (SU), defined by IQVIA as a single tablet, capsule, ampoule, vial or 5ml oral suspension. For each FDC antibiotic, the approval status was assessed by either registration with the United States Food and Drug Administration (US FDA) or inclusion on the World Health Organization (WHO) Essential Medicines List (EML). A total of 119 antibiotic FDCs were identified, contributing 16.7 x 109 SU, equalling 22% of total antibiotic consumption in 2015. The most sold antibiotic FDCs were amoxicillin-clavulanic acid followed by trimethoprim/sulfamethoxazole and ampicillin/cloxacillin. The category with the highest consumption volume was aminopenicillin/β-lactamase inhibitor +/- other agents. The majority of antibiotic FDCs (92%; 110/119) were not approved by the US FDA. Of these, the most sold were ampicillin/cloxacillin, cefixime/ofloxacin and metronidazole/spiramycin. More than 80% (98/119) of FDC antibiotics were not compatible with the 2017 WHO EML. The countries with the highest numbers of FDC antibiotics were India (80/119), China (25/119) and Vietnam (19/119). There is high consumption of FDC antibiotics globally, particularly in middle-income countries. The majority of FDC antibiotic were not approved by either US FDA or WHO EML. International initiatives such as clear guidance from the WHO EML on which FDCs are not appropriate may help to regulate the manufacturing and sales of these antibiotics.


2011 ◽  
Vol 1 (4) ◽  
pp. 15-30
Author(s):  
Anita Kotwani

Pharmaceuticals are an integral component of a health care system; any weakness in governance of the pharmaceutical system negatively impacts health outcomes, especially in developing countries. It is believed that procurement on the concept of essential medicine list and transparency leads to improved efficiency and access to medicines, as has been described for the Delhi model. However, transparency is only the first step; accountability and sustainability are also needed. Information systems create opportunities for transparency and openness through the disclosure of information and improve decision-making and efficiency along the medicine supply chain. With the lessons learned from experiences of many developing countries, technical guidance and tools developed by international agencies, a transparent, accountable, sustainable public procurement system is possible but high-level political commitment is needed to mandate and enforce the system.


2019 ◽  
Vol 02 (02) ◽  
pp. 43-47
Author(s):  
Chuyu Li ◽  
Xinyao Pan ◽  
Wingting Leung ◽  
Zengshu Huang ◽  
Jing Zhou ◽  
...  

On 25 October 2018, National Essential Medicine List (NEML) of China was formally published by National Health Commission and it has been executed since 1 November. The new NEML, which includes 685 drugs with more than 1110 kinds of dosage forms and more than 1810 kinds of specifications, further standardizes dosage forms and specifications of drugs. The new catalog not only increases the number of categories, but also optimizes the structure of the drug list. It highlights the need for basic drugs in aspects of common diseases, chronic diseases, serious diseases and public health. Besides, the normalization of dosage forms and specifications, and the persistence of emphasizing the combination of Western and Chinese medicine are both the characteristics of it. This news report is composed of several parts including brief introduction of NEML, the difference between NEML and National Directory of Health Insurance (NDHI) which is likely to be confused with NEML, the dissection of the change of medicine varieties, relevant policies and potential issues of NEML. We intend to give a comprehensive interpretation of NEML from different perspectives.


Author(s):  
Sarang A Deshmukh ◽  
Yashasvi Agarwal ◽  
Harshita Hiran ◽  
Uma Bhosale

 Objective: The objective of the study was to evaluate antimicrobial prescription pattern in outpatient departments.Method: This was a prospective, cross-sectional and observational study over 12 weeks total 400 prescriptions of either gender and age; containing antimicrobial agents (AMAs) were analyzed for demographic data and the WHO prescribing indicators.Results: Most of prescription were given to men (n=262). The most common group of AMA used was Cephalosporins (n=141, 35.25%); of which Ceftriaxone was most commonly prescribed (n=73, 18.25%). 10 AMAs were from the WHO essential medicine list AMAs. Men outnumbered women in prescribing antibiotics (n=262 vs. 138). Most of AMAs receivers were between 26 and 35 years (n=128, 32%). Amoxicillin+Clavulanic acid fixed-dose combination was most common (n=84, 21%). Most of the prescriptions were containing four drugs per prescriptions (n=130, 32.5%). Only 10% of the prescription was given by generic name and rest 90% were given by brand name. Oral dosage form of AMAs was predominant (n=340, 85%). Vitamins and supplement were most common comedication received by patients.Conclusion: Antibiotic use was found to be reasonable and rational in most of the cases. However, still, prescribers should improve prescribing practices and make it more rational.


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