11.1 Hospital Organization and Functions

A hospital is a facility that provides many different kinds of medical care, including emergency, trauma, surgical, medical, and public health services, so the facility’s pharmacy services must also be varied to support these functions.

Organizational Framework

Not all hospitals provide the same depth and breadth of services. Since hospitals perform numerous major functions, as outlined in Table 11.1, they are generally categorized by a set of defining characteristics:

• bed capacity

• type of service (general or specialized) and targeted patient population (such as children’s hospital versus VA facility)

• affiliation (university or teaching hospital versus private or nonteaching hospital versus HMO facility)

• urban versus rural and the size of the population being served

• ownership (state-owned versus community-owned, government versus nongovernment)

• financial status (for-profit versus not-for-profit)

Quite often, hospitals establish an organizational structure that mimics a corporate framework. With the many recent changes in healthcare regulations and reimbursements, many hospitals in a specific area or servicing a particular type of patient have merged into one corporation to improve efficiencies in communications, inventory control, and billing to insurance. A president, or chief executive officer (CEO), runs the hospital and reports to the hospital’s board of directors or that of a larger healthcare system. The CEO guides the overall direction and long-range planning of the hospital and—depending on bed size and scope of services—may supervise several vice presidents and directors who preside over various departments in the hospital.

For example, a vice president of patient care typically oversees such departments as the laboratory, medical records, rehabilitation, respiratory care, social services, and pharmacy. Other vice presidents may oversee medicine, nursing, and finance departments. In larger hospitals, a chief operating officer (COO) usually supervises hospital operations and directs the departmental vice presidents. The pharmacy department interacts with all departments.

A hospital also requires committees of cross-department specialists to ensure the sharing of information and expertise for the best policies and solutions. The main committees relating to pharmacy include the Pharmacy and Therapeutics Committee, the Institutional Review Board, and the Infection Control Committee (to be discussed in Chapter 12).

Pharmacy and Therapeutics Committee

The Pharmacy and Therapeutics (P&T) Committee oversees the policies for all drug-related hospital issues. It handles numerous key tasks:

• reviewing, approving, and revising the hospital’s drug formulary

• maintaining the drug use policies of the hospital

• reviewing studies on the appropriate use of drugs within the hospital

• monitoring medication error reports (including computerized adverse drug event monitoring reports)

• reviewing investigational drugs after the Institutional Review Board has approved them for onsite clinical studies

The Pharmacy and Therapeutics Committee meets monthly to discuss drug formulary recommendations and review medication error reports and safety recommendations.

The P&T Committee is composed of several members of the medical staff as well as representatives from the hospital, nursing, and pharmacy administration. The director of pharmacy and a drug-information pharmacist often represent the pharmacy department. The director of pharmacy often acts as the committee secretary, recording and disseminating each meeting’s minutes. The drug-information pharmacist researches and makes objective, data-based drug formulary recommendations. In some hospitals, a pharmacy technician, called the procurement technician, is also part of the committee, representing the technicians and assisting the drug-information pharmacist in drug data collection.

Drug Formulary

Most P&Ts adopt a drug formulary, or a list of approved drugs for the institution, based on the committee’s recommendations about the best drugs to provide the most effective medications that can fit insurance reimbursements and hospital budgets. (Drug formularies do not exist in the community pharmacy setting with the exception of some HMO pharmacies, such as Kaiser Permanente.) It is important for technicians to get to know their specific hospital formulary well.

If medical staff members want the P&T Committee to consider adding a new drug to the hospital’s drug formulary, they must submit an extensive medication application form to the committee. The drug-information pharmacist then reviews the application’s information and completes an independent search of the medical literature. The cost, advantages, and disadvantages of the new drug are then compared with an existing formulary drug, and these findings are presented to the entire committee for its consideration.

At times, formulary approval of a particular high-cost or unusual drug may be restricted to an approved use for a specific department. For example, a new, high-cost antibiotic with limited indications and high resistance patterns may be restricted to use by members of the infectious disease service department. A prescriber outside of this department could not write a prescription for this new antibiotic, and the pharmacy could not fill this medication order without the approval and signature of an appropriate infectious disease prescriber.

If a hospital prescriber writes a medication order for a nonformulary drug—one not on the approved hospital list—they will probably need to justify the patient necessity for it to a member of the P&T Committee. In a teaching hospital, a medical resident usually needs to get approval from the supervising physician first to order a nonformulary drug.

Medication Error Reports

The P&T Committee also reviews all medication error reports that have been forwarded to the pharmacy department from medical, nursing, or even pharmacy teams and units. The pharmacy’s drug-information center researches, collates (a technician may assist in this information gathering), and analyzes these medication error reports. The adverse drug events are easily tabulated through the pharmacy software and electronic health records if the events have been reported and input properly in the system. When the committee reviews a medication error report, the focus is not to assign blame but to identify and correct any systematic problem to prevent similar errors from occurring. To receive hospital accreditation—approval of service quality—by the Joint Commission, each hospital needs to demonstrate stringent, accurate medication error reporting, resolution processes, and improvement achievements. (The Joint Commission and its standards will be described in detail at the end of the chapter.)

The Institutional Review Board

Some hospital physicians engage in pharmaceutical research studies with university or government researchers or manufacturers to test new medications and treatments. However, any clinical investigational drug research must first be approved by both the P&T Committee and the hospital’s Institutional Review Board (IRB). The IRB—also known as the Human Use Committee—typically meets monthly to review the proposed use of investigational drugs (not yet approved by the FDA or approved for a new indication) for hospital clinical studies or innovative surgical or therapeutic procedures. The IRB seeks to provide appropriate safeguards for the patients. It consists of representatives from the departments of medicine, pharmacy, nursing, and hospital administration as well as a consumer member.

The key investigator submits an application outlining the goals of the study and the participating patient population, including the number of subjects, their ages, and their healthcare status (such as patient or healthy volunteer). Both the IRB and the investigator must meet federal and state regulations that apply to clinical research investigational studies.

The IRB protects the patient by ensuring both adequate knowledge of the risks of the study and confidentiality of the personal medical information. The investigator must submit to each patient participant an informed consent form, or a document describing clearly (in layperson terms) the study, risks, potential benefits, reimbursement (if any), and follow-up responsibilities and procedures in the case of an adverse event. To participate in the study, the patients must read and sign the consent form to indicate their knowledge and approval. Special protective procedures exist for potentially vulnerable populations such as newborns, children, women of childbearing age, older adults, and those with mental health problems. A drug-information (or clinical) pharmacist is commonly responsible for educating nurses and monitoring investigational drug use within the hospital.

The investigational data collected may be collated and sent outside the hospital to a government agency or private sponsor; or it may be analyzed to be published in a medical or scientific journal. However, the individual patient’s identity and medical data must remain protected. Most commonly, patients are assigned an ID number as a study subject (separate from their hospital number) to maintain anonymity.

If an adverse reaction occurs during the study, it must be reported immediately by the nurse or the pharmacist to the primary physician investigator. Depending on the severity of the reaction, the Adverse Drug Reactions (ADR) may need to be reported to the IRB so that it can evaluate whether or not the study should continue.