Contrasts with pharmacopeidemiology

The 1962 amendments to the Food, Drug and Cosmetic Act first contemplated establishment registration and the Drug Listing Act of 1972 provided FDA with a mechanism to require drug manufacturing establishment registration - the National Drug Code (NDC). Described in Title 21 Code of Federal Regulations ยง207.35, the regulation established a three-segment number that identified the drug's manufacturer (or last repackager or 'labeler'; this number is assigned by the FDA) in the first segment, the firm's active ingredient(s) and specific strength, dosage form, and formulation for a particular drug in the second segment, and package sizes and configuration in the third segment: labeler code - product code - package code [13]. While NDC listing provided FDA with a tool that facilitated various administrative and drug safety activities, it provided burgeoning health insurers offering a pharmaceutical benefit with an accurate method for pharmacy reimbursement [14], whether from pharmacy or health system records [15] or insurance claims data [16].

As displayed in Figure 12.1, two billing patterns dominate the healthcare industry. For pharmaceuticals dispensed through community pharmacies or mail order, the identity of

Patient ID Provider ID

Drug ID (NDC) that uniquely identities drug, i triamterene 37.5/25 mg #500 Quantity Charge, etc.

Patient ID Provider ID

Drug ID (NDC) that uniquely identities drug, i triamterene 37.5/25 mg #500 Quantity Charge, etc.

00591-0424-05 for Watson Lab's hydrochlorothiazide &

Data Switch

00591-0424-05 for Watson Lab's hydrochlorothiazide &

Patient ID Provider ID

Procedure Codes that may identity device type, i.e., C2619 for a pacemaker, dual chamber, non-rate responsive, implantable

LU O

Some electronic capture - i.e., IMS survey

Patient identity encrypted Linkage to medical records rare

Patient identity encrypted Linkage to medical records rare

Linkage to medical transactions possible, but access to clinical data rare

Data Swith - operates in the electronic insurance billing pathway and accepts or rejects claims, optionally performs edits, and directs the claim to the appropriate clams processor.

Figure 12.1 Typical billing stream for pharmaceuticals vs. medical devices the drug or biological is included in the billing stream through the embedded NDC, specified in the National Council for Prescription Drug Programs standard. The NDC uniquely identifies the drug or biological received by the pharmacy. What the patient receives may differ. In the example in Figure 12.1, the NDC specifies a container of 500 tablets, a quantity that would not typically be dispensed to a patient for a drug taken once daily. In this instance, the pharmacy would repackage and dispense a 30- or 90-day supply. Although unusual, some medical device manufacturers have obtained NDCs for devices sold through pharmacies to facilitate billing.

In contrast, medical products (drugs, biologicals, and medical devices) that are used or administered in a hospital or practitioner's office are typically bundled into a procedure code, and reimbursed at a preset rate. In consequence, the specific identities of medical products used in the procedure are not discernable from the billing stream. Some very expensive devices, for example, an external assembled lower limb prosthesis, may be billed separately. In some instances, there is only one marketed medical device associated with a procedure code, so exposure to that device might be imputed from billing records [17].

Thus, a side effect of billing procedures for medical products dispensed in pharmacies is exposure data that may be acquired at a relatively low cost for many drug products and some medical products. To the extent that high-cost medical products used or distributed through health devices care practitioners are billed separately, some product-specific exposure information may be available. Some insurers are seeking to unbundle billing for some costly medical products, for example, chemotherapy agents, to better reflect marketprices, and product-specific exposure information may become more available in the future.

A recent article by Samore etal. [18] and an associated editorial by Small [19] focused on surveillance systems in a hospital setting, including key word searches in electronic medical records, incident reports, medical engineering logs, review of prolonged telemetry data, and a posthospitalization survey. Even in this practically ideal setting, the authors found that they 'were not able to derive a definitive measure of the incidence of device-related problems, nor would such an estimate necessarily be generalizable to other institutions'.

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