Nsimba SE. Problems Associated with Substandard and Counterfeit Drugs in Developing Countries: A Review Article on Global Implications of Counterfeit Drugs in the Era of Antiretroviral (ARVs) Drugs in a Free Market Economy. East Afr J Public Health. 2008;

OBJECTIVES: To review the global implications associated with the use of substandard and or counterfeit drugs in developing and may be developed countries. The focus of this review is particularly on antiretroviral (ARVs), antimalarials and other drugs. METHODS: Review of various literatures through Pub-Med, Medline, Google and Internet search to retrieve and download published materials…

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Liang BA.* Pigs, Drugs, and Terrorists. Patient Safe Qual Healthcare. 2008 Nov 1:10-12

Abstract. Making drugs is messy. Take heparin.You raise pigs and then slaughter them. You isolate the pig intestines and cook them. Then you scrape the intestinal insides, dry them, and get them to a factory to undergo more processing (Harris, 2008). Making drugs is also expensive. Outsourcing this messy activity to countries such as China…

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Panjabi SS, Panjabi RS, Shepherd MD*, Lawson KA, Johnsrud M, Barner J. Extended-release, once-daily morphine (Avinza) for the treatment of chronic nonmalignant pain: effect on pain, depressive symptoms, and cognition. Pain Medicine. 2008 Aug; 9(8):985-93.

Abstract. OBJECTIVE: To evaluate the impact of an extended-release, once-daily morphine sulfate formulation on depressive symptoms and neurocognition in patients with chronic nonmalignant pain.

DESIGN: Prospective, open-label, one-group trial with a pretest-posttest design.

SETTING: Outpatient pain management clinic.

PATIENTS AND INTERVENTION: Chronic nonmalignant pain patients inadequately controlled with short-acting opioid analgesics and eligible for treatment with once-daily morphine sulfate were initiated on a dose at or near the morphine-equivalent dose of the short-acting regimen.

OUTCOMES: The following assessments were made at baseline and 4 weeks after initiating intervention: pain intensity, pain unpleasantness, pain suffering, pain behaviors, Beck Depression Inventory, and cognitive function.

RESULTS: Eighty-four patients provided usable data. Pain intensity, unpleasantness, and suffering scores were significantly reduced at follow-up (P = 0.001). The mean Beck Depression Inventory scores were significantly lower at follow-up (P = 0.001). Significant improvements were seen in scores at follow-up on the three validated neurocognitive tests: the digit span test, the digit symbol substitution test, and the paced auditory serial addition test (P = 0.001).

CONCLUSIONS: Achieving adequate pain control with once-daily morphine was associated with a reduction in pain and improvements in depressive symptoms and cognitive functioning in the short term.

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Trefi S, Routaboul C, Hamieh S, Gilard V, Malet-Martino M, Martino R. Analysis of illegally manufactured formulations of tadalafil (Cialis®) by 1H NMR, 2D DOSY 1H NMR and Raman spectroscopy. J Pharm Biomed Anal. 2008 May 12;47(1):103-113

Abstract. Counterfeit and/or imitation medicines are becoming a major health problem not only in developing countries but also in wealthier countries. The need of new and easy analytical methods for quality control of drugs is essential. We describe the use of Raman spectroscopy, 1H nuclear magnetic resonance (NMR) and 2D diffusion-ordered spectroscopy (DOSY) NMR to analyse…

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Thevis M, Schrader Y, Thomas A, Sigmund G, Geyer H, Schanzer W. Analysis of confiscated black market drugs using chromatographic and mass spectrometric approaches. J Anal Toxicol. 2008;32(3):232-240.

In the context of house searches in Germany, numerous drugs were confiscated and subjected to chemical analysis, including anabolic agents such as various anabolic-androgenic steroids (stanozolol, testosterone derivatives, trenbolone esters, etc.) and clenbuterol, as well as agents with anti-estrogenic activity (tamoxifen, clomiphene), drugs stimulating virility (sildenafil, tadalafil), and unlabeled plastic bags. Liquid chromatography-tandem mass spectrometry,…

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Swaminath G. Faking it – I The Menace of Counterfeit Drugs. Indian J Psychiatry. 2008;50(4):238-40.

In a blow to the revenues of India's largest pharmaceiutical manufacturer and one of the world's leading generic companies, the United States Food and Drug Administration (FDA) has blacklisted about 30 generic drugs being manufactured by the company at two of their manufacturing sites, citing failure to adhere to current Good Manufacturing Practices requirements.  The…

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Liang BA.* Safety Issues in Regulating Follow-On Biologic Drugs. J BIolaw Bus. 2007;10(4):44-49.

Biologic drugs are expensive, and hence policymakers are considering accelerating copies, or "follow on" biologic products to market using abbreviated pathways. However, important concerns relating to biologic products may have implications for follow on product regulation. The information gaps regarding biologic science, clinical issues associated with product excipients and active ingredient, and supply chain issues…

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