Fake antimalarials and public health
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Counterfeit medicines are drugs produced with the intention to deceive that contain incorrect or insufficient active ingredients which can lead to therapeutic failure or drug resistance and sometimes death. Substandard medicines are genuine drugs that do not meet quality specifications due to manufacturing problems and may contain less or more active ingredients than stated. The most frequently counterfeited drugs are expensive medicines like hormones, antibiotics, and anticancer drugs. Globally, 10% of drugs are counterfeit, rising to 25% in developing countries and 50% in some places. Counterfeiting is encouraged by the profitability, weak laws, and large price differences between identical drugs. Actions to address the problems include strong legislation, authentication markings on packages, surveillance, and education.
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2) A meta-analysis found an association between exposure to antineoplastic drugs in healthcare workers and adverse reproductive effects in women including increased fetal loss, congenital malformations, low birth weight, and infertility.
3) Body fluids from chemotherapy patients may contain drug residues for up to 7 days after treatment. Protective equipment should be worn when handling such fluids and contaminated materials to prevent exposure.
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has awakened due to large-scale patent expirations, competition from generics &
biosimilars, anemic pipelines, escalating clinical trial costs and a global health-care
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the revenue-generating potential of orphan drugs has shown to be huge with a greater
return on investment than non-orphan drugs. According to EvaluatePharma, the orphan
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prescription drugs by 2020, totalling 176 billion dollars.
The rare disease landscape is very complex due to the large amount of stakeholders
involved. Despite their different interests they have one goal in common: getting an
orphan drug approval that will help save or improve lives. But there are many challenges
on the road to orphan drug designation:
• Complex and changing national and regional regulations
• Clinical trial design and finding & keeping patients
• The lack of a central database designed specifically to list patient registries, which
asks for close stakeholder engagement
• Partnering and establishing financing for future development
• Establishing a foundation for price that is balanced and sustainable
• Achieving an efficient and timely access to market with equal access for patients
around the world
• Achieving timely and correct diagnosis to enable higher quality of life and more time
and information for developers
More information: http://www.orphandrugssummit.com/
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Times are changing. A renewed interest from big pharma in the rare disease landscape
has awakened due to large-scale patent expirations, competition from generics &
biosimilars, anemic pipelines, escalating clinical trial costs and a global health-care
reform. This means that the traditional blockbuster model has become less viable while
the revenue-generating potential of orphan drugs has shown to be huge with a greater
return on investment than non-orphan drugs. According to EvaluatePharma, the orphan
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prescription drugs by 2020, totalling 176 billion dollars.
The rare disease landscape is very complex due to the large amount of stakeholders
involved. Despite their different interests they have one goal in common: getting an
orphan drug approval that will help save or improve lives. But there are many challenges
on the road to orphan drug designation:
• Complex and changing national and regional regulations
• Clinical trial design and finding & keeping patients
• The lack of a central database designed specifically to list patient registries, which
asks for close stakeholder engagement
• Partnering and establishing financing for future development
• Establishing a foundation for price that is balanced and sustainable
• Achieving an efficient and timely access to market with equal access for patients
around the world
• Achieving timely and correct diagnosis to enable higher quality of life and more time
and information for developers
More information: http://www.orphandrugssummit.com/
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The topic touches upon the very thing that needs most attention in the Pharmaceutical Industry as of the current moment.
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Antimalarial activity gardenia lutea and sida rhombifolia ijrpp
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The document outlines the history and key pieces of legislation regulating drugs in the United States, beginning with the 1906 Pure Food and Drug Act which aimed to prohibit misbranded and adulterated drugs. Major laws included the 1938 Federal Food, Drug, and Cosmetic Act which gave the FDA power to ensure drug safety, the 1970 Controlled Substances Act which classified drugs into schedules based on abuse potential, and the 1996 Health Insurance Portability and Accountability Act (HIPAA) which provided privacy protections for patient health information. The legislation established the FDA and DEA and granted them authority to approve, schedule, and regulate drugs.
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View this presentation for information on:
*the different categories of medicines
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Fake antimalarial drugs pose a major threat to malaria control in Southeast Asia. A survey of antimalarial drugs purchased in pharmacies and shops across the region found that 53% of artesunate tablets labeled as such did not contain any artesunate. All counterfeit artesunate tablets were labeled as manufactured by Guilin Pharma and had packaging that was increasingly difficult to distinguish from genuine products. The prevalence of counterfeit artesunate increased 15% compared to a previous survey, with the exception of Myanmar which saw an 18% decrease. A small percentage (9%) of mefloquine samples also contained inadequate active ingredients, undermining treatment and confidence in antimalarials. The proliferation of
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Ayurveda, the knowledge of life, immortalized in the form of elegant Sanskrit stanzas in the samhitas describe diagnosis and therapy of disease as well as ways to maintain positive health. Although the technical term “Pharmacovigilance” does not feature in ayurvedic texts, the spirit of pharmacovigilance is vibrant and is emphasized repeatedly in all major texts. The major goals of pharmacovigilance, namely to improve patient care and safety in relation to drug use, and thus promote rational drug use are recurrent themes of ayurvedic pharmacology (dravyaguna vigyan) and therapeutics (chikitsa).
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This document discusses counterfeit drugs and medical devices, specifically in India. It begins by defining counterfeit products and noting that about 10-30% of medicines in low and middle income countries like India are estimated to be counterfeit. It then discusses challenges posed by counterfeit medicines in India, including lost business for manufacturers, undermining generics adoption, and increasing economic and social burdens. The document also outlines relevant Indian laws for addressing counterfeiting like the Drugs and Cosmetics Act of 1940. Finally, it states that combating counterfeit medicines requires collaboration between law enforcement, manufacturers, and health professionals.
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Fake antimalarials and public health
- 4. Fake Cinchona Bark 17 th C Europe Fake Quinine London 1829 Physicians chastising a drug seller 13 th C Arabia
- 9. Genuine Hologram Fake Artesunate ‘Type 8’
- 10. Genuine Hologram Fake Artesunate ‘Type 10’
- 13. An under appreciated Asian public health disaster * Malaria remains a problem in SE Asia, but we have the tools for control * Counterfeit artesunate MUST be a major risk for death and an impediment to malaria control * Despite 6 years of awareness - situation deteriorating and little action despite severe danger to public health * How many additional deaths - thousands ?
- 15. Debris, including Juglans pollen charcoal fragments
- 16. Dermatophagoides mite nymph
- 17. Valid batch numbers, stickers, multiple wrong AIs, calcite Invalid batch numbers, holograms, subtherapeutic artesunate
- 19. Genuine Hologram Fake Artesunate ‘Type 15’ Similar to Type 10 - found only in N Burma and N Laos (Westerly trade route)
- 21. Fake artemisinin derivatives in Africa
- 26. Acknowledgements The laboratories and their staff The Government of the People’s Republic of China Food and Drug Quality Control Centre & Food & Drug Department, Lao PDR Guilin Pharmaceutical Co. Ltd, China The Natural History Museum, London and Wolfson College, Oxford, UK David Pizzanelli, Mayfong Mayxay, Bryan Watt, Arjen Dondorp, Frank Smithuis, François Nosten, Lucy Paiphun, Aung Pyae Phyo, Khin Mg Lwin, Rose McGready, Shunmay Yeung, Chongkham Phonekeo, Christopher Curtis, Sue Lee, Nicholas Day, Nicholas White and anonymous collectors for their help and advice Funded by Wellcome Trust of Great Britain, the participating institutions and the United States Agency for International Development through US Pharmacopeia