Strengthening national pharmaceutical regulation through local production

AbstractAlsace, in particular Haut-Rhin, is one of the main clusters of COVID-19 in France. There has been a shortage of essential supplies in the area, especially alcohol-based hand sanitizer. In this context, and in accordance with the decree dated March 6, 2020, our hospital management team asked us to start local production of alcohol-based handrub. This was a real challenge: In one week, we had to implement the production of handrub to meet the needs of a 1,400-bed hospital. The production had to comply with the French preparation guidelines and take place on specific premises, with qualified and calibrated equipment, by qualified staff, under the supervision of a pharmacist. The other big challenge we faced was the supply of pharmaceutical raw and packaging materials. During this particular critical period, all suppliers were out of stock. Here, we describe the organizational set-up and the decisions made, e. g., to use technical-grade ethanol before the publication of the decrees dated March 13 and March 23, 2020.

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It Only Affects Me: Pharmaceutical Regulation and Harm to Others

HEC Forum ◽

10.1007/s10730-020-09409-5 ◽

2020 ◽

Author(s):

Connor K. Kianpour

Keyword(s):

Pharmaceutical Regulation ◽

Harm To Others

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Active and passive sensitization of the uterus of the cow in vivo against Trichomonas foetus antigen and the evidence for the local production of antibody in that site

Journal of Hygiene ◽

10.1017/s0022172400015825 ◽

1953 ◽

Vol 51 (3) ◽

pp. 405-415 ◽

Cited By ~ 28

Author(s):

W. R. Kerr ◽

Muriel Robertson

Keyword(s):

Anaphylactic Reaction ◽

Intramuscular Injection ◽

Local Production ◽

Passive Sensitization ◽

Free Antibody

1. Antibody occurs in the uterus and can be withdrawn by irrigation. Intrauterine antibody results from the introduction of antibody into the lumen of the uterus.2. Neither free antibody nor the sensitization of the uterus has been produced by intramuscular injection of antigen, even when antibody has circulated in the bloodstream for periods from a few weeks to many months.3. Active sensitization of the uterus follows upon the repeated introduction of antigen into the uterus.4. It is concluded that antibody can be produced locally by some of the cells in the uterus when T. foetus antigen is present.5. The uterus of the cow can be sensitized passively in vivo by the instillation of bovine anti-trichomonas serum so that the instillation 6–10 days later of Trichomonas antigen will produce the characteristic local anaphylactic reaction.

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Reform in the international food aid regime: the role of consensual knowledge

International Organization ◽

10.1017/s0020818300001491 ◽

1992 ◽

Vol 46 (1) ◽

pp. 225-264 ◽

Cited By ~ 18

Author(s):

Raymond F. Hopkins

Keyword(s):

Economic Development ◽

International Organizations ◽

Epistemic Community ◽

Food Aid ◽

Local Production ◽

Short Term ◽

The 1950S ◽

Food Imports

The principles and norms adopted by the regime governing food aid in the 1950s have changed substantially during the subsequent three decades. Explaining the changes necessarily includes analyzing the efforts of an international epistemic community consisting of economic development specialists, agricultural economists, and administrators of food aid. According to the initial regime principles, food aid should be provided from donors' own surplus stocks, should supplement the usual commercial food imports in recipient countries, should be given under short-term commitments sensitive to the political and economic goals of donors, and should directly feed hungry people. As a result of following these principles, the epistemic community and other critics argued, food aid often had the adverse effects of reducing local production of food in recipient countries and exacerbating rather than alleviating hunger. The epistemic community (1) developed and proposed ideas for more efficiently supplying food aid and avoiding “disincentive” effects and (2) pushed for reforms to make food aid serve as the basis for the recipients' economic development and to target it at addressing long-term food security problems. The ideas of the international epistemic community have increasingly received support from international organizations and the governments of donor and recipient nations. Most recently, they have led to revisions of the U.S. food aid program passed by Congress in October 1990 and signed into law two months later. As the analysis of food aid reform demonstrates, changes in the international regime have been incremental, rather than radical. Moreover, the locus for the change has shifted from an American-centered one in the 1950s to a more international one in recent decades.

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