First metered-dose non-CFC inhaler approved by FDA

First metered-dose non-CFC inhaler approved by FDA

THE LANCET POLICY AND PEOPLE Preliminary results of latest US child abuse survey released T he final report of the third US national incidence stu...

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Preliminary results of latest US child abuse survey released


he final report of the third US national incidence study of child abuse and neglect (NIS-3) will be released during the 11th National Conference on Child Abuse and Neglect to be held in Washington, DC, on Sept 16–21. This mammoth exercise was mandated by the US Congress, under a contract between the Department of Health and Human Services and Westat Inc, which is one of the largest social survey organisations in the USA. The director of NIS-3 (and its predecessor, published 8 years ago) is Andrea J Sedlak. She was in Dublin earlier this month for the congress of the International Society for the Prevention of Child Abuse and Neglect, and the DHHS permitted release of preliminary data. The major source for NIS-3 is the records of county child protection services (CPS). The data relate to the 3 months, Sept 5 to Dec 4, 1993, though the complete picture in these cases may not have emerged until the following year. De-duplication was carefully attended to and the counties sampled were analysed to

give a picture of national annual incidence. In NIS-3, as in NIS-2, “endangerment” was also recognised. In NIS-1

the test had been “demonstrable harm”. Recognition of a child in danger has to be on the forms supplied by sources; it is not a matter for indexers. The data released in Dublin are for the endangerment standard of which actual harm (fatal, serious, &c) is a subgroup (panel).

Emphasising that this was her personal view and not necessarily that of DHHS, Sedlak said that NIS-3 was revealing “a real increase” in the category “serious injury or impairment”. Why? This could only be speculation, she stressed, but the narrative accounts accompanying abuse cases frequently made reference to drug misuse; the increase might be reflecting the US “crack epidemic”. Cases of maltreatment doubled between 1986 and 1993, and the NIS-3 estimate of just over 2·8 million (endangerment only and harm) was made up of physical abuse 22%, sexual abuse 11%, and emotional abuse 19%; 70% of cases were neglect (physical, emotional, educational). These segments total more than 100% because children were included in every category that applied to them. Are these cases all confirmed

First metered-dose non-CFC inhaler approved by FDA


he world’s first metered-dose inhaler (MDI) that is free of chlorofluorocarbons (CFCs) has been approved by the US Food and Drug Administration. The albuterol sulphate inhaler is manufactured by 3M Pharmaceuticals. Although it has been approved in 23 other countries, the US approval is significant because as one of the signatories to the Montreal Protocol on Substances that Deplete the Ozone Layer, the USA has committed itself to not approving CFC–containing products

if alternatives are available. Also, drugs containing CFCs are banned under the US Clean Air Act. Despite these policies, the FDA had approved three generic albuterol MDIs since late 1995, each containing CFCs. At an FDA advisory committee meeting convened on Aug 16 to consider bioequivalence standards for generic albuterol, 3M spokeswoman Kerri-Ann Arnott claimed that the FDA initially began discussing a ban on CFC-containing products in 1978. She also said that

in June, 1996, the UN Technology and Economic Assessment Panel recommended that regulatory bodies should discourage development of CFC-containing products, and should stop approving them once alternatives were available. In its approval letter, the FDA acknowledged that “at some time in the future” it would be required to evaluate non-CFC containing products as medically acceptable alternatives. Alicia Ault Barnett

Prescription monopoly in Netherlands under attack


he Dutch government is trying to break the monopoly pharmacists have on dispensing prescrption drugs. Zilveren Kruis, the largest health insurance company, plans to deliver drugs to patients through an US mail-order firm, Caremark, based in Utrecht. Pharmacy wholesalers associations have refused to deliver drugs to Caremark. After an official complaint from Caremark, the minister of Economic Affairs,


Hans Wijers, is aiming to sue the pharmacists if rules of open competition are transgressed. The pharmacists have threatened to charge patients collecting their drugs, which they would then have to claim from their insurers' afterwards. Zilveren Kruis intends to apply for an immediate judgment since this signifies a refusal to honor the normal contract with the insurer. Both Wijers and Public Health minister Els Borst-

–Eilers have complained about prescription charges (DFl10; US$6). A system of bonuses and reductions ties everyone concerned “with golden strings to each other and I want to change that”, the minister said. The pharmacists are trying to avoid government intervention arguing that Caremark cannot possibly apply the drugs-control monitoring system that they provide. Marjanke Spanjer

Vol 348 • August 31, 1996