The National Academies Press

Currently Skimming:

Pages 169-189

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.

From page 169... ... 158 \| Drug Labeling in Developing Countries MIMS. For example, a painkiller marketed in the United Kingdom for "persistent pain, particularly muscle pain, headache, neuralgia," was indicated in Africa and the Caribbean also for "fibrosis, lumbago, back pain, sprains, strains, dysmenorrhoea, dental pain, bursitis, trauma, and chronic rheumatic pain." While this detail was not necessarily misleading, the researchers concluded that the emphasis in indications coupled with deficient wamings demonstrated that the companies were more interested in drug promotion than in providing objective prescribing information. Read the entire page →
From page 170... ... Major Studies of Pharmaceutical Labeling in Developing Countries \| 159 bido, nervousness, dizziness, loss of hair, and skin changes. Again, Silverman found prescribing guide entries with far more indications than in the PDR. Read the entire page →
From page 171... ... 160 \| Drug Labeling in Developing Countries During 1987 and 1988, at approximately the same time OTA gathered its labeling material, Silverman, Lydecker, and Lee revisited the issue of drug labeling in developing countries, this time with partial finan- cial support from 10 pharmaceutical companies. The researchers examined 40 single-drug entities or fixed combinations marketed as 1,500 products in the United States, the United Kingdom, and 74 develop- ing countries -- 28 countries in Africa (both English and French speaking) Read the entire page →
From page 172... ... Major Studies of Pharmaceutical Labeling in Developing Countries \| 161 age inserts (171) Read the entire page →
From page 173... ... 162 \| Drug Labeling in Developing Countries The primary explanation offered by companies for the differences between the information given in de- veloping and developed countries was that developing countries had different laws and regulations. As a for- mer President of the U.S. Read the entire page →
From page 174... ... Appendix B: Drug Registration and Labeling in Brazil, he following sections describe the legal re- quirements for drug registration and labeling in Brazil, Kenya, Panama, and Thailand, the four countries of the OTA survey. OTA did not evaluate how well these requirements are met in practice. Read the entire page →
From page 175... ... 164 \| Drug Labeling in Developing Countries to 3 years (192) Read the entire page →
From page 176... ... Drug Registration and Labellng in Brazil, Kenya, Panama, and Thailand \| 165 Initial applications for drug registration are assessed on grounds of safety, efficacy, and quality. Each reg- istration application must include the following infor- mation (106) Read the entire page →
From page 177... ... 166 \| Drug Labeling in Developing Countries chemical entities and that already are listed in locally approved pharmacopoeias are subject to lesser re- quirements, which include provision of a Free Sale Certificate, a Certificate of Analysis, the product for- mula, and samples of the product (106) Read the entire page →
From page 178... ... Drug Registration and Labeling in Brazil, Kenya, Panama, and Thaliand \| 167 gram were to provide an adequate supply of safe and good quality drugs, to reduce drug waste by using the essential drug strategy, to strengthen drug quality as- surance, to develop pharmaceutical raw material pro- duction capability, and to explore the potential of tra- ditional medicines (272) Read the entire page →
From page 180... ... OTA would like to express its appreciation to the following individuals. Maryanne Anderson U.S. Read the entire page →
From page 181... ... 170 \| Drug Labeling in Developing Countries Bernard J Clark American Cyanamid Co. Read the entire page →
From page 182... ... U.S. Inyang West African Pharmaceutical Federation Yaba, Lagos, Nigeria Pranee Jaiarj Mahidol University Bangkok, Thailand Sumlee Jaidee Chulalongkom University Bangkok, Thailand D.C. Read the entire page →
From page 183... ... 172 \| Drug Labeling in Developing Countries Steve Moore Food and Drug Administration Rockville, MD Lou Morris Food and Drug Administration Rockville, MD George Nakitare The University Glasgow, Scotland Goy E Navas Estafeta Univeritaria Panama, Rep. Read the entire page →
From page 184... ... Craig Smith Johns Hopkins University Baltimore, MD Gwen Solan Danbury, CT Payuree Sorasuchart Pfizer Intemational Corp. Bangkok, Thailand Walter Spath G.D. Read the entire page →
From page 186... ... . Abbott, K., "Defining the Extraterritorial Reach of American Export Controls: Congress as Catalyst," Cornell International Law Journal 17:81-145, 1984. Read the entire page →
From page 187... ... 176 \| Drug Labeling in Developing Countries 18. Read the entire page →
From page 189... ... 178 \| Drug Labeling in Developing Countries 65. Read the entire page →

From page 169...

... 158 | Drug Labeling in Developing Countries MIMS. For example, a painkiller marketed in the United Kingdom for "persistent pain, particularly muscle pain, headache, neuralgia," was indicated in Africa and the Caribbean also for "fibrosis, lumbago, back pain, sprains, strains, dysmenorrhoea, dental pain, bursitis, trauma, and chronic rheumatic pain." While this detail was not necessarily misleading, the researchers concluded that the emphasis in indications coupled with deficient wamings demonstrated that the companies were more interested in drug promotion than in providing objective prescribing information.