Purchasing pharmaceutical sources

As nutraceuticals are not classified as medicinal products, their manufacture is often not legally regulated. Nutraceuticals are widely available for sale, and the many suppliers may formulate their products differently this leads to variations between products of different manufacturers. Products available for purchase are not necessarily of the same quality as those used in reported clinical trials. For effective and safe use, the products must contain the same active ingredient, at the same concentration, have known bioavailability per delivery system, and state detailed and correct information on packaging or patient leaflet. However, possibly due to purchase from non-pharmaceutical sources such as the Internet, there is often little information on efficacy, drug interactions, effect of long-term use, abrupt discontinuation, or potential adverse effects available to patients. 

Quality control tests or improvement of existing processes. Raw materials from various sources can be used in the manufacture of fine chemicals and pharmaceuticals. The raw materials can contain different impurities at various concentrations. Therefore, before the raw material is purchased and used in a full-scale batch its quality should be tested in a small-scale reactor. Existing full-scale procedures are subject to continuous modifications for troubleshooting and for improving process performance. Laboratory reactors used for tests of these two kinds are usually down-scaled reactors or reactors being a part of the full scale-reactor. 

Pharmaceutical substances form the backbone of modern medicinal therapy. Most traditional pharmaceuticals are low molecular mass organic chemicals (Table 1.1). Although some (e.g. aspirin) were originally isolated from biological sources, most are now manufactured by direct chemical synthesis. Two types of manufacturing companies thus comprise the traditional pharmaceutical sector the chemical synthesis plants, which manufacture the raw chemical ingredients in bulk quantities, and the finished product pharmaceutical facilities, which purchase these raw bulk ingredients, formulate them into final pharmaceutical products, and supply these products to the end-user. 

The Federal Supply Schedule (FSS) provides data on contract prices for pharmaceutical products (including vaccines) purchased by the U.S. government. This source contains data on 26 distinct active vaccine ingredients, 43 distinct vaccine brands, and 130 distinct vaccine products. ... 

Such policies face potential opposition from various camps. In the United States, a proposal for advanced purchase of vaccines coupled with a mandate that vaccines with high potential benefit be covered faced substantial opposition from three sources (1) from the U.S. pharmaceutical industry, which seems to have feared that the plan would lead to price controls in a country lacking price regulation of pharmaceuticals (2) from insurance... 

In the pharmaceutical industry, the level of user need varies tremendously. Some large global pharmaceutical manufacturers have very efficient research and development (R D), sourcing, and purchasing units, but this is by no means representative of the industry as a whole. The level of expertise and experience of customers... 

An observable advantage of purchasing excipients from a pharmaceutical excipient distributor is the ability of that distributor to consolidate the purchase of many excipients on behalf of the user. By this rationale, the distributor becomes an extension of the excipient user s sourcing and procurement departments. This presents obvious time-, resource-, and cost-saving opportunities to the user, because they can allocate their resources to other functions, while the distributor assembles all necessary documentation and executes all orders with the various excipient makers. 

Pharmacies often choose one pharmaceutical wholesaler and esfablish a prime vendor relationship. The prime vendor relationship is an agreement that stipulates that the pharmacy will purchase a set amount of drugs from the wholesaler. In return for guaranteed purchases, wholesalers provide a discormf to fhe pharmacy. As parf of the agreement, wholesalers may provide further discounts based on purchase volume. Some pharmacies might also retain a secondary wholesaler to use as an alternative source of pharmaceuticals. However, purchases from fhe secondary wholesaler are usually kept to a minimum so as not to jeopardize quantity discounts from the primary wholesaler. 

In a medical system where the reimbursement rate is set above the actual cost of drugs while reimbursement rates for physicians services, which are also set by the MHW, are set below cost (344), doctors and hospitals have depended on the sale of pharmaceuticals to make money. Profits from drug sales made up about 37 percent of the independent doctor s wages in 1987 (344). Since the Japanese health system offers few additional subsidies (outside the doctor s salaries or fees) to help clinics and private hospitals purchase equipment or maintain facilities, the sale of pharmaceuticals has become a primary source of revenue to ensure the normal functioning of nongovernmental medical facilities. With no formal method to keep track of physicians prescription habits,44 the incentive is strong for doctors to prescribe unnecessary and excessive medications (139, 163,344). 

In addition to contracting for research on the pharmaceutical R D process, OTA sought out other sources of data bearing on costs of R D and returns to the industry from these activities. Data availability was a major problem, particularly data on domestic and worldwide sales of new drugs introduced to the U.S. market during specific time intervals. OTA was able to purchase limited data on domestic sales from IMS America, Inc., a market research firm specializing in surveys of pharmaceutical purchases and prescriptions, but was required to rely mainly on a sales data analysis conducted for other purposes by the Food and D r u g A d ministration. OTA was also able to contract with Stephen Schondelmeyer of Purdue University to provide a report on pharmaceutical sales for drugs that have recently lost patent protection based on IMS America data. 

By frequently contacting pharmaceutical companies to find out the requirements from the purchasing/sourcing department and the trends in the types of chemistries and molecules that may be coming from R D departments and published in the literature, the agent can approach various... 

Electronic reference software applications provide source data used in technical operations. They are typically externally developed and accepted as authoritative by the purchasing firm. Where employed, they are important resources for specialized technical users. Software in this group included the 2000 International Building Code, Plumbing/Mechanical, Akton Psychrometric Chart for Windows, and AHFS First. The first two are self-explanatory the third is a pharmaceutical database. 

The handcrafted compounds from third parties are generally compounds that have been collected by vendors from academic sources which meet the selection criteria set by pharmaceutical companies for their compound acquisition programs. It is not our purpose to make a case for or against any particular source of compounds in the library it is to arrive at an approximate cost for a library of useful size. A nicely balanced library with 1 million compounds will cost between 25 million and 50 million to purchase. The costs of proper storage, retrieval, and maintenance are not included (see below). 

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