Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world
A lot of issues have been raised to argue that equivalent drugs may not work as well or at least the same as what the drug industry likes to call <em>innovator</em> products. Many doubts and biases are also reported in connection with the use of generic drugs. Doctors are mostly concerne...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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PAGEPress Publications
2014-05-01
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| Series: | Italian Journal of Medicine |
| Subjects: | |
| Online Access: | http://www.italjmed.org/index.php/ijm/article/view/399 |
| _version_ | 1827612415267700736 |
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| author | Roberto Nardi Marco Masina Giorgio Cioni Paolo Leandri Paola Zuccheri |
| author_facet | Roberto Nardi Marco Masina Giorgio Cioni Paolo Leandri Paola Zuccheri |
| author_sort | Roberto Nardi |
| collection | DOAJ |
| description | A lot of issues have been raised to argue that equivalent drugs may not work as well or at least the same as what the drug industry likes to call <em>innovator</em> products. Many doubts and biases are also reported in connection with the use of generic drugs. Doctors are mostly concerned about their efficacy, their tolerability, the quality and amount of active ingredients, their formulation or excipients, their packaging, their pharmaceutical form and their palatability. We describe the differences between <em>prescribability</em> (equivalence when prescribing a drug to a patient for the first time) and <em>switchability</em> (interchangeability of drugs for a patient already in treatment) considering the notions of average bioequivalence, population bioequivalence and individual bioequivalence as well as the usefulness of the U.S. Orange Book in the assessment of bioequivalence. Other key issues deserve attention, such as: <em>duplicate applications</em> for medicinal products, different salt forms, formulations used in the development of each medicinal product and excipients, product quality. Clinicians in collaboration with pharmacists and research pharmacologists have to find solutions for unanswered questions and unsolved doubts, by developing targeted studies, communication tools and shared guidelines. |
| first_indexed | 2024-03-09T08:23:02Z |
| format | Article |
| id | doaj.art-cc823f54f3df4b02becb5a8b55a03519 |
| institution | Directory Open Access Journal |
| issn | 1877-9344 1877-9352 |
| language | English |
| last_indexed | 2024-03-09T08:23:02Z |
| publishDate | 2014-05-01 |
| publisher | PAGEPress Publications |
| record_format | Article |
| series | Italian Journal of Medicine |
| spelling | doaj.art-cc823f54f3df4b02becb5a8b55a035192023-12-02T21:41:26ZengPAGEPress PublicationsItalian Journal of Medicine1877-93441877-93522014-05-0182889810.4081/itjm.2014.399418Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real worldRoberto Nardi0Marco Masina1Giorgio Cioni2Paolo Leandri3Paola Zuccheri4UOC Medicina Interna, AUSL Bologna, Ospedale Maggiore, BolognaUOC Geriatria, AUSL Bologna, Ospedale di Bentivoglio (BO)UOC Medicina Interna, AUSL di Modena, Pavullo nel Frignano (MO)UOC Medicina Interna, AUSL Bologna, Ospedale Maggiore, BolognaFarmacia Clinica H e Continuità H/T, AUSL Bologna, Ospedale Maggiore, BolognaA lot of issues have been raised to argue that equivalent drugs may not work as well or at least the same as what the drug industry likes to call <em>innovator</em> products. Many doubts and biases are also reported in connection with the use of generic drugs. Doctors are mostly concerned about their efficacy, their tolerability, the quality and amount of active ingredients, their formulation or excipients, their packaging, their pharmaceutical form and their palatability. We describe the differences between <em>prescribability</em> (equivalence when prescribing a drug to a patient for the first time) and <em>switchability</em> (interchangeability of drugs for a patient already in treatment) considering the notions of average bioequivalence, population bioequivalence and individual bioequivalence as well as the usefulness of the U.S. Orange Book in the assessment of bioequivalence. Other key issues deserve attention, such as: <em>duplicate applications</em> for medicinal products, different salt forms, formulations used in the development of each medicinal product and excipients, product quality. Clinicians in collaboration with pharmacists and research pharmacologists have to find solutions for unanswered questions and unsolved doubts, by developing targeted studies, communication tools and shared guidelines.http://www.italjmed.org/index.php/ijm/article/view/399generic/equivalent drugs, preconceptions, doubts and critical aspects in drug interchangeability, prescribability and switchability, average, population, individual bioequivalence. |
| spellingShingle | Roberto Nardi Marco Masina Giorgio Cioni Paolo Leandri Paola Zuccheri Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world Italian Journal of Medicine generic/equivalent drugs, preconceptions, doubts and critical aspects in drug interchangeability, prescribability and switchability, average, population, individual bioequivalence. |
| title | Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world |
| title_full | Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world |
| title_fullStr | Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world |
| title_full_unstemmed | Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world |
| title_short | Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world |
| title_sort | generic equivalent drugs use in internal and general medicine patients distrust confusion lack of certainties or of knowledge part 2 misconceptions doubts and critical aspects when using generic drugs in the real world |
| topic | generic/equivalent drugs, preconceptions, doubts and critical aspects in drug interchangeability, prescribability and switchability, average, population, individual bioequivalence. |
| url | http://www.italjmed.org/index.php/ijm/article/view/399 |
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