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Weekly UpdatesNew regulations to increase health care worker accountability for compounding sterile preparations and safe handling of pharmaceuticals are affecting how hospitals and clinics select and administer parenteral medications. These regulations also are affecting the formulation, packaging, and marketing of these preparations by the pharmaceutical industry, presenting new opportunities to reach target audiences.
When the United States Pharmacopeia (USP), based in Rockville, Maryland, issued its chapter 797 regulation in January 2004, the agency set enforceable standards for compounding sterile preparations, and created a new set of compliance challenges for the pharmaceutical industry. Additional guidelines and recently proposed rules further complicate the framework under which compounded sterile preparations must be prepared. Pharmaceutical companies now have a significant opportunity to help customers meet the challenges of USP 797 and, in the process, stimulate customer loyalty and extend the marketing lifecycle of their products.
The USP 797 standards apply to practitioners rather than drug manufacturers, but they may affect an organization's accreditation status. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Oakbrook Terrace, Illinois, requires accredited health care organizations to consider USP 797 as they continue to improve the quality of the health care they provide.
Effect on Purchasing Decisions
The regulation sets standards for compounding sterile preparations but does not provide specific information about meeting those standards. This is an opportunity for innovative manufacturers to provide products with labeling and packaging that address medication safety and sterility requirements. Pharmacists may be looking for cost-effective products that help them to fulfill the new standards.
In the area of emergency or immediate patient care, compounded sterile preparations are exempt from the USP 797 standards if certain criteria are met. (Hazardous drugs do not qualify for this immediate-use exemption.) Commercial products and proprietary bag and vial systems help pharmacists provide medications for immediate use by clinicians.
A broad range of factors concerning the cost, safety, and convenience of compounding may influence the purchasing process for parenteral products and sterile drugs.
Ready-to-Use Compounds Preferred. In general, health care organizations want to avoid the risks and inconvenience of compounding. This is particularly true in instances where pharmacists delegate some compounding to nurses and other end users. Studies have shown that nurses and physicians are less accurate at calculating correct amounts of additives, and are more likely to contaminate an intravenous (IV) preparation, than trained staff in a centralized pharmacy admixture service. Consequently, it is critical that products compounded for immediate use by a nonpharmacist have a minimal margin for error.
Notwithstanding the risks of compounding by nonpharmacists, health care personnel do not want the added responsibility for this task. They prefer ready-to-use, ready-to-mix products, or closed additive systems. Popular ready-to-use products include prefilled syringes, premixed small volume parenterals for infusion (which also feature tallman lettering to distinguish them from any similar drug name), and frozen antibiotics for infusion. It is critical that the labeling and packaging of ready-to-use products consider product qualities and intended use. Some newer drugs are not suitable for packaging in glass, as glass can contain contaminants. Plastics should be considered for prefilled syringes, particularly for drugs with high protein content.
Ready-to-mix products include vial and minibag systems. Pharmaceutical product managers should attempt to make as many products as possible available in the same system, because pharmacists prefer to consolidate minibag systems in their hospital to avoid confusion for nurses and other end users.
Closed additive systems are available from manufacturers in efficient packages. When activated, mixed, and administered to the patient, they minimize waste and can help meet the USP requirements for compounding sterile preparations.
Hazardous Conditions
For health care providers, compliance with hazardous drug regulations or guidelines is often difficult and sometimes costly. Vial-washing processes are not perfect. Therefore, hazardous-drug containers are often already contaminated when shipped from manufacturers, in many cases with traces of the drug on the outside surface of the vials. This forces health care providers to use isolators or other sealed transfer devices, adding another step (and cost) to the compounding process. The frequency of this problem may cause the American Society of Health-System Pharmacists, based in Bethesda, Maryland, to petition manufacturers of hazardous drugs to formulate a plan that will minimize contamination on the outside of containers. If manufacturers can control such hazardous packaging issues, customers typically respond, as cost is always a consideration in product selection.
Proper Labeling and Packaging
Manufacturers that help minimize other safety issues through brand-name selection and packaging design are also addressing critical customer needs. Confusing drug names are a particular challenge for pharmacists and can result in medication errors (Table). Pharmacists are becoming increasingly aware of the importance of clear labeling and shelving of medications to minimize risk. Clear labeling and safe packaging have become such important considerations to many hospital Pharmacy and Therapeutics Committees that they review these factors, as well as safety, efficacy, and cost, when considering a product for formulary acceptance. Manufacturers, well aware of FDA regulations in labeling and packaging, will sometimes use the services of an outside source to assist in the issues of trademarks, labeling, and packaging of a new drug.
Some companies offer premarketing and postmarketing reviews of drug labeling and packaging to minimize medication errors. For example, they will advise whether a product should be packaged in a vial or prefilled syringe, glass or plastic container. These companies encourage manufacturers to use functional labels, such as peel-off labels for drugs whose lot numbers must be recorded in a patient's medical record. These are easy to use, promote accurate documentation, and assist with product recall. They also are useful if a medication is reconstituted and transferred into a different delivery container, or to document drugs prepared in pharmacies and sent without the original vial to a patient administration area.
A number of other factors also should be considered by manufacturers to minimize the risk of medication error. For example, color coding can cause mix-ups when similar cap colors are used for different drugs; also, some clinicians may be color-blind. Pharmacies often stock generic drugs alphabetically, but generic labels often are hard to read, resulting in errors. Appropriate font size and style on labels help avoid confusion. Tallman lettering is often used for generic products to emphasize the difference between drugs. Some manufacturers now use this font for brand-specific drugs. In addition, bar codes can help reduce error, even at the point of drug administration, where workers match a patient bar code with drug and product bar codes.
Safety, Convenience, and Service
For personnel safety, health care providers prefer needleless systems to avoid needle-stick injuries. Vials are preferred over ampules, as ampules pose a greater risk of microbial and particulate contamination, and, when opened, their sharp, glass edges are more dangerous to handle.
Personnel convenience also is an important consideration, including the number of steps and travel distance required to prepare parenteral medications, the space needed for storage and work, ergonomics (e.g., limited risk of carpel tunnel from use of large syringes), and the variety of products available. In addition, timeliness of service by manufacturers, as well as supply and environmental capital costs (e.g., leasing of biological safety cabinets, isolators, etc.), are common considerations before purchase.
The Effect of Regulations on Marketing
The effect of USP 797 has been significant, not only on the elemental aspects of pharmaceutical compounding of sterile preparations but also in their sale. In a highly competitive commercial environment, pharmaceutical and biotech companies are under extreme pressure to be first to patent and market products, establish stable cost-to-market pricing ratios, and grow marketshare. This challenge takes place against the backdrop of continual FDA surveillance; risk of product liability; and ultimately, the task of garnering customer awareness and satisfaction.
The USP 797 standard has forced pharmacists to look for products with labeling and packaging that will allow them to conform to these standards. Manufacturers, in turn, are responding with ready-to-use products to accommodate the immediate-use exemption, such as prefilled syringes, premixed infusions, frozen antibiotics, IV delivery systems, and proprietary minibags and vial systems.
Features that customers desire to maximize convenience and safety include stability after reconstitution, brand names that avoid confusion, tallman lettering; vials instead of ampules, proper color coding of caps and labeling, proper font size and legibility, needle-less transfer systems, bar-coded products, and manufacturing of the widest variety of products in the same system. Ultimately, customers will base a purchasing decision on the maximum combination of compliance, cost, safety, and convenience.
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