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Generic drugs vs branded drugs/myths & beliefs demystified

<p><img src="/nairobi/PublishingImages/pharmacy%20body%20image.jpg" alt="" style="margin: 5px; font-family: helvetica;"/> </p><p><span style="font-family: helvetica;">When you are unwell and you seek medical attention from your doctor, very often you will receive a prescription. With this prescription, you will either get generic or brand drugs/medications to manage your condition. However, some patients may not be aware of the difference and those who do may harbor varied myths and misconceptions. Dr Jaimini Gohil, Chief Pharmacist and Dr Reuben Mogoi, Clinical Pharmacist at Aga Khan University Hospital, Nairobi shed light into these two versions of medications.</span></p><p><span style="font-family: helvetica;"><strong>What are generic drugs/medicines?</strong></span></p><p><span style="font-family: helvetica;">A generic drug is an off-patent pharmaceutical product which has the same strength, dosage form, route of administration as the branded drug; (this is known as pharmaceutical equivalence). It also must have the same effect in the body, safety, quality as the brand drug; (this is known as Bio-equivalence).</span></p><p><span style="font-family: helvetica;">According to WHO, “generic medicine&quot; is interchangeable with a brand drug manufactured without innovator company license, and marketed after the patent or other exclusive rights expiration.</span></p><p><span style="font-family: helvetica;">According to USFDA, It is also a drug product that is comparable to a brand/ RLD (reference listed drug) product in strength, dosage form, route of administration, performance characteristics, quality, and intended use</span></p><p><span style="font-family: helvetica;"><strong>What are original drugs/ Medicines?</strong></span></p><p><span style="font-family: helvetica;">An original drug (brand drug) is a pharmaceutical product that is developed and marketed under a patent or registered trademark by a pharmaceutical company. But it is approved after establishing the drug&#39;s safety and effectiveness through animal and clinical (human) studies. They are also, known as innovator drugs.</span></p><p><span style="font-family: helvetica;">The medicine regulators give patent and exclusivity protection to brand manufacturers to allow them to recover costs from their innovation and research for several years. Once the patent has expired, generics can enter the market through a shortened regulatory approval process after meeting the same quality, safety, and effectiveness standards as brands.</span></p><p><span style="font-family: helvetica;"><strong>What is the prevalence of use in Kenya for both generic and original drugs?</strong></span></p><p><span style="font-family: helvetica;">There is no clear preference in Kenya since the choice is determined by varying factors including, prescriber clinical judgement, affordability and availability of either the branded generics or the branded original medicines. Few months ago insurance data from the East African Standard showed that Kenya stands at 70 per cent in the use of branded drugs.</span></p><p><span style="font-family: helvetica;"><strong>How do generic drugs differ from original drugs?</strong></span></p><p><span style="font-family: helvetica;">Generic medications are a chemical copy of the original brand, with the same active ingredients, but their inactive ingredients (excipients) may vary. One or the other may have slightly more or fewer types of excipients (fillers, binders, flavors, etc.) depending on their manufacturing process.</span></p><p><span style="font-family: helvetica;">Data indicates the use of low-cost generics improves health outcomes for instance;  a significantly high number of patients started on generics had a 8% reduction in hospitalization for acute coronary syndrome (ACS) or stroke and the reason is people taking generics are likely to adhere and comply taking their prescribed medications without defaulting because generics are fairly affordable.</span></p><p><span style="font-family: helvetica;"><strong>In your opinion and experience, are patients aware of the difference between the two?</strong></span></p><p><span style="font-family: helvetica;">In most circumstances, cost is the major identifier by most patients.</span></p><p><span style="font-family: helvetica;">Owing to the harsh economic times that has resulted in high cost of living and inflation of basic commodities most of the time patients are looking for options of getting their prescriptions filled with affordable yet quality medicines.</span></p><p><strong style="font-family: helvetica;">Generic drugs are usually cheaper than branded drugs, why is this?</strong></p><p><span style="font-family: helvetica;">The cost of branded drugs is majorly determined by the number of years spent by the innovator companies in carrying out extensive research and development (R&amp;D) and brands have trademark protection. Lesser time and money is required in developing a generic drug since the innovator company has already discovered active ingredient and disclosed the excipients of that brand drug.</span></p><p><span style="font-family: helvetica;">After the expiration of a brand drug patent, market competition between multiple generic companies typically results in a low price.</span></p><p><strong style="font-family: helvetica;">In most cases, when we hear of generic drugs, we get the notion of reduced quality. What can you say about this?</strong></p><p><span style="font-family: helvetica;">The generic drugs are equally of comparable quality, efficacy and safety as the branded drugs. It is mandatory for the generic drug manufacturing companies to ensure that the drugs meet the Pharmacy and Poisons Board (PPB) quality standards like that of the branded drugs. The PPB through post marketing surveillance (PMS) reports for both the generic and the branded medicine ascertain the quality and safety of these medications.</span></p><p><strong style="font-family: helvetica;">What would determine if I should buy generic drugs or brand drugs?</strong></p><p><span style="font-family: helvetica;">Some medications are only available as a brand. But if a medication has a generic version, you and your pharmacist/doctor can discuss if a brand or generic is the best option for you based on your clinical condition and affordability.</span></p><p><span style="font-family: helvetica;">The pharmacy and poisons board has in its policy framework ensured access to affordable essential medicines in a sustainable manner which seeks to facilitate attainment of UHC and MDGs 4, 5 &amp; 6.</span></p><p><span style="font-family: helvetica;">PPB also ensures that all medicines both branded and generics; imports and locally manufactured, are safe, effective and of the highest quality standard before reaching the patients.</span></p><p><span style="font-family: helvetica;">Finally, always purchase your medicines from a registered pharmacy/chemist as you are more likely to get authentic medication.</span></p><p><span style="font-family: helvetica;"><strong><em>This article was first published in Business Daily on October 17, 2022</em></strong>

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