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    Objectives: Upon completion of the chapter and exercises, the student pharmacist will be able to
  1. Define drug according to the FDA.

  2. Identify and discuss information that is required to be included on a prescription.

  3. Examine a prescription label to determine the appropriate information.

  4. Identify the factors that make a prescription legal.

  5. Define and distinguish the difference between controlled substances.

  6. List and explain the pharmacist's responsibilities for implementing Omnibus Budget Reconciliation Act of 1990 (OBRA 1990).

  7. List and explain the pharmacist's responsibilities for implementing the Poison Prevention Packaging Act.

  8. Define and differentiate between risk assessment and risk management.

  9. Describe the impact of the 2007 FDA Amendment Act on pharmacy.

  10. Describe the pharmacists' legal responsibility when providing medication therapy management to patients.

  11. Define political advocacy and its importance for the profession of pharmacy.

  12. Plan a course of action for successful political advocacy.

Patient Encounter

The responsibility for attending pharmacist has fallen to you this month in the ICU. The pharmacy director has always been supportive of the decisions made by the attending pharmacists in conjunction with the ethics team in the ICU. The legal issues of this situation may be different depending on where you practice. For the purposes of this case, let's say that the laws in the Country or State do not address this issue specifically.

The patient's family has not asked for the pain medications to be withheld. They have not asked for the ventilator to be stopped. How did the wife come to the decision to stop the antibiotics? How will you approach the family in order to gain the following outcome?


In this patient's case, he is temporarily in need of proxy decision makers, but will ultimately be able to state his own patient preferences. It is appropriate to continue antibiotics until the patient is able to communicate his own preferences. Because the patient had not communicated his wishes beforehand (and because you know that people, once disabled, often accept their disability), you are able to convince the family to wait until his speech therapy is successful and he is able to communicate his wishes.

What are the laws concerning practice of the pharmacist that take precedence in this scenario?

Do legal and ethical questions coincide here, is there a point where legal and ethical diverge?


To fill a prescription a pharmacist must be aware of all the legal requirements. The pharmacist must also keep in mind that his or her actions may be open to civil liability if he or she makes an error in filling a prescription and causes harm to a patient. This chapter discusses the Federal law and briefly touches on some state requirements for filling a prescription. The learning objectives outline the areas to be covered.

This chapter is designed to describe the legal aspects of filling a prescription systematically. One of the first steps is to ...

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