Healthcare given

In a recent seminar, a medical expert noted that the United States has given away economic and technical dominance in industry after industry to other countries. Healthcare research is one of the few areas in which the U.S. enjoys unparalleled leadership which has enormous impact on the quality of medical care. If the healthcare industry and the academic medical enterprise falters—and this is in danger right now—I think it will be an absolute disaster for this country [40]. Many in pharmacy, medicine, and other healthcare fields would concur with the above statement. The problem is that many others in the public sector do not fully appreciate what is at stake. Pharmacists have an opportunity to help tell the story, as difficult as it sometimes is to convey. 

LAIV should not be given to immunosuppressed patients or given by healthcare workers who are severely immunocompromised. 

Table 7.2 shows the regulatory authorities in selected countries. A summary of the health system, both public and private in selected countries, is given in Appendix 9. It shows the %GDP each country spends on healthcare, per capita health expenditure, number of hospital beds, and doctors/1000 population. 

The cost to bring a new drug to market has risen from 318 million to 802 million from 1991 to 2000, respectively. Clinical costs represent the majority of this spend ( 467 million vs 335 million in 2000). In addition, the increase in clinical costs over this same time period ( 104 million in 1991 vs 467 million in 2000) far exceeded that of the increase in preclinical costs ( 214 million in 1991 vs 335 million in 2000) (2). In order to maintain profitability and growth, given the current economic and regulatory and healthcare realities dis-... 

Text or reference books/information and other educational material may be given to healthcare providers if they serve a genuine educational function (IFPMA 2000, sec. IV). 

Interferon gamma is usually given by a trained, healthcare professional. However, the treatment may be given at home. The preparation should be stored in a refrigerator and checked for cloudiness prior to injection. If the solution is discoloured or cloudy, it should not be used. Do not shake the solution... 

Computer systems used by pharmaceutical and healthcare companies should appear on an inventory. The determination of whether individual systems impact GxP needs to be indicated on the inventory, together with the status of its validation. The assigned priorities given to the validation of different computer systems can also be shown here. In this way the inventory can be presented to a GxP regulator as evidence of the commitment of an organization to validate its computer systems and to present an overall report on progress to date. The amount of information to be disclosed to a regulator should be carefully considered. Inventory fields will normally include ... 

The supplier may require a briefing in the proposed audit process objectives and scope. The audit is then conducted and a report is prepared by the pharmaceutical or healthcare company concerned. The supplier should be given a chance to review and comment on the report so that any factual errors may be corrected, vendor comments added, or other necessary clarifications can be made at an early stage. Any corrective actions undertaken by the supplier should be followed up, and therefore the audit process may loop back by the arrangement of a follow-up visit. 

Instrumentation will include field instruments used in the manufacturing process and other instruments assoeiated with special tasks, such as that of monitoring laboratory or computer room environmental eonditions. The accessibility of instruments must be such as to permit their eleaning and maintenanee. Siting is also important, and instruments should be installed as close to the point of measurement as possible. The placement of flowmeters in piping dead-legs should be avoided. Careful consideration should also be given to the appropriate position of other instruments sueh as thermometers and thermocouples so that they, too, can fulfill their measurement and eontrol functions. Construction materials that come into direct contact with the pharmaceutical or healthcare production process stream must not contaminate or affect the manufactured product in any way. Instrument lubricants and coolants must not come into contact with in-process product or equipment. The reliability of instruments should also be considered for instance, a pressure transmitter that uses atmospheric pressure as its reference may suffer from poor reliability. A draft calibration schedule may also be prepared. 

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