By Hank Rahe
The many facets of healthcare are going to be challenged this year, from basic drug discovery research work to delivery at the point of care.
Hospitals and physicians will continue to ask: “Who's going to pay for the cost of providing the things we have become accustomed to receiving?” All the while, pharmaceutical manufacturers will be under pressure to reduce the cost of prescription drugs with no thought to the fact that the income from these drugs is the fuel for research that creates our new pharmaceuticals.
On the delivery end, healthcare providers are seeing shrinking reimbursement for products and services rendered.
Several years ago, in response to similar cuts, many oncology practices moved outside the traditional hospital setting to maintain or increase cash flow by purchasing and preparing the cytotoxic drugs in an office environment. Using nurses in the office to prepare the drug, this allowed them to receive the reimbursement for the drug while eliminating the pharmacist from the preparation cost.
The oncology practices are now faced with more reduced reimbursement revenues and the fact that a loophole is closing, one that allows current practices used in the preparation of cytotoxic drugs.
Physician's offices are not required to comply with regulations established by state boards of pharmacy. This means that they can choose to mix hazardous drugs for patient use without providing adequate engineering controls in the office.
It has been widely publicized that state boards of pharmacy have established rules concerning the facilities and equipment used in preparation of hazardous drugs. Although the rules vary from state to state, the general engineering controls are either Class II biological safety cabinets or barrier isolators.
The barrier isolators have been shown to be more effective than the biological safety cabinets in dynamic comparisons. The level of potential exposures using the conventional biological safety cabinets has raised concerns in hospital pharmacies to the point that a number of states are changing regulations. While this is a pharmacy community concern, the physicians are left out of the loop either by choice or lack of communication.
The National Institute for Occupational Safety and Health (NIOSH), an organization that is concerned about the potential implications of excess exposures to workers, has gathered a group of stakeholders to create an alert, which will impact pharmacies, and physicians that handle hazardous drugs. This alert will create an economic impact and encourage proper engineering controls for all facilities preparing hazardous drugs.
This will suggest that all facilities preparing hazardous drugs take the preparation back to compliant hospital pharmacies or take the preparation to a third-party pharmacy with proper engineering controls.
However, no one involved in any of these equations is sure who is going to pay because all of the choices involve a loss of revenue or an additional capital expenditure in order to become compliant with expectations.
We are rapidly approaching a point where we will need to determine whether healthcare is a right or a privilege for those who can afford it through either supplemental insurance or direct payments. As we approach this point, each segment of healthcare will be asked to justify its role and the value it brings to the overall system. III
Hank Rahe is director of technology for Containment Technologies Group and is a member of the CleanRooms Editorial Advisory Board. He can be contacted at [email protected].