Pharmacy Law & Ethics. Frequently asked questions from The Iowa Board Of Pharmacy Examiners

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1 Pharmacy Law & Ethics Course 46:104 Spring 2005 Kenneth R. Baker, R.Ph., J.D. Self-Instruction Learning Project Frequently asked questions from The Iowa Board Of Pharmacy Examiners These answers are from the 2004 edition of the Iowa Pharmacists Association publication Iowa Pharmacy Law and Information Manual. For the purposes of the test, these answers will be considered as correct, even if the law has subsequently changed.

2 1. Can a physician write a prescription for a controlled substance for his/her personal use? No. Effective 1/5/00, self-prescribing or self-dispensing is considered grounds for disciplinary action by the Board of Medical Examiners. See 653 lac 12.4(19)a. In addition, 653 lac 12.4(19)b regulates the "prescribing or dispensing controlled substances to members of the licensee's immediate family for an extended period of time." 2. When a physician moves away from Iowa, ceases practice, or dies, how long can a pharmacy continue to fill his/her prescriptions? Iowa Board of Pharmacy administrative rule states that "Prescriptions issued in accordance with Iowa Code Section 155A.27 shall be valid as long as a prescriber/patient relationship exists. Once the prescriber/patient relationship is broken, and the prescriber is no longer available to treat the patient or oversee the patient's use of a prescription drug, the prescription loses its validity and the pharmacist, on becoming aware of the situation, shall cancel the prescription and any remaining refills. Provided, however, that the pharmacist shall exercise prudent judgment based upon individual circumstances to insure that the patient is able to obtain a sufficient amount of the prescribed drug to continue treatment until the patient can reasonably obtain the service of another prescriber and a new prescription can be issued." Thirty days is the rule of thumb. 3. What are Iowa's laws concerning the types of work that a pharmacy technician can perform in a pharmacy? Iowa code section (2) states that, "A pharmacist... may delegate nonjudgmental functions to staff assistants only when the verification of the accuracy and completeness of the prescription is determined by the pharmacist in the pharmacists physical presence." In keeping with that statute, Iowa Board of Pharmacy administrative rule addresses the issue of Technical Functions which a supervising pharmacist may delegate to a pharmacy technician. Those functions are as follows: 1. Performing packaging, manipulative, or repetitive tasks relating to the processing of a prescription or medication order in a licensed pharmacy. 2. Accepting prescription refill authorization communicated to a pharmacy by a prescriber or by the prescriber's office. 3. Contacting prescribers to obtain prescription refill authorizations. 4. Collecting pertinent patient information. 5. Inspecting drug supplies provided and controlled by an Iowa licensed pharmacy, including but not limited to, drug supplies maintained in an ambulance or other emergency medical service vehicle, a long term care facility, a hospital nursing unit, or a hospice facility. Board rule 3.21 also authorizes a pharmacist to delegate technical dispensing functions to a pharmacy technician but only if the pharmacist is on site when the delegated functions are performed, except as provided in (2). This subrule says "in the temporary absence of the pharmacist, only the pharmacist in charge may designate persons who may be present in the prescription department to perform technical and nontechnical functions designated by the pharmacist in charge. Activities identified in subrule 6.7(3) may not be performed during such temporary absence of the pharmacist. A temporary absence is an absence of short duration not to exceed two hours."

3 4. What are the laws concerning the partial filling of schedule II prescriptions? If the prescription is for a patient in a nursing home or for an ambulatory patient with a diagnosed terminal illness, a schedule 1/ prescription may be filled in partial quantities, including unit individual dosage units, for periods not to exceed 60 days. [See board administrative rule (2)] Prescriptions for individuals who are not in a nursing home or not suffering from a terminal illness may be partially filled as long as the balance is dispensed within 72 hours of the prescriptions issue date. [(See board administrative rule (1)] 5. How long, after issuance, can prescriptions for schedule II drugs be considered as valid prescriptions? 6 months. After that period of time, pharmacists should consider the prescription invalid and advise the patient that a new prescription order must be obtained. 6. Can more than one schedule II drug be included on a prescription blank? Yes. There is nothing in Iowa law or federal law which prohibits a practitioner from issuing such a prescription. 7. Can a generic drug that is not listed in the FDA (Orange Book) be substituted for a brand name product when the prescriber has not prohibited substitutions? The Iowa drug product selection statute 155A.32 authorizes the pharmacist to "exercise professional judgment in the economic interest of the patient by selecting a drug product with the same generic name and demonstrated bioavailability as the one prescribed. If the product prescribed is generically equivalent and bioequivalent, the pharmacist may select and dispense the generic drug. One reference which the pharmacist may utilize to determine drug equivalency is the FDA Orange Book. The FDA Orange Book, however, does not include all drugs marketed in this country, particularly those approved for marketing prior to For these drugs, the pharmacist must use professional judgment. 8. May a prescription issued by an out-of-state practitioner be lawfully filled by an Iowa pharmacist? Yes, Iowa code section 155A.30 authorizes Iowa pharmacists operating in licensed Iowa pharmacies to dispense "prescription drug orders issued by out-ofstate practitioners who would be authorized to prescribe if they were practicing in Iowa."

4 9. What may a physician assistant prescribe in Iowa and what must that prescription order contain? Physician Assistants may prescribe any drugs deemed necessary for their particular practice. They may not prescribe schedule II stimulants and depressants, e.g., amphetamine and secobarbital, respectively. See Iowa Code (4) and (5) for specific lists. However, such controlled substances may be authorized by the PA's supervising physician, who must then sign the prescription. The information contained in a prescription drug order issued by a physician assistant is mandated by Iowa Code section 155A.27 which requires the following: 1. Date of issue. 2. Name and address of the patient. 3. Name, strength and quantity of drug prescribed. 4. Directions for use of the drug prescribed. 5. Name, address and written or electronic signature of the practitioner issuing the prescription. Also, the order should include the name of the supervising physician and the DEA number of the PA, if appropriate. 10. Are all Advanced Registered Nurse Practitioners (ARNP's) authorized to prescribe? What may they prescribe and what must be included on their prescription drug orders? ARNP's are authorized to prescribe any drugs, including controlled substances, which are within their specialty practice. For example, a Certified Registered Nurse Anesthetist would be limited to prescribing and ordering the administration of drug to patients in a hospital or outpatient surgery setting. Prescription drug orders issued by ARNP's must include the information required by Iowa Code section 155A.27 (see question 9). Also, Iowa pharmacists should understand that ARNPs in Iowa are independent practitioners and their prescription orders do not have to include the name of a physician. Prescription orders for controlled substances must include the DEA number assigned to the ARNP. 11. Mayan Iowa pharmacy prepackage and pre-label a supply of medications for a physician who will later dispense them from his/her office? No, unless that pharmacy wishes to register with the federal Food and Drug Administration as a drug repackager and could qualify to adhere to FDA current good manufacturing practices. 12. What packaging and labeling rules must a physician in Iowa follow when he or she dispenses medication to a patient? Iowa code section (3) "b" requires the label of drugs dispensed by a physician to include the following: 1. Name and address of the dispenser. 2. Date of the prescription or its filling. 3. The name of the patient. 4. Directions for use and cautionary statements, if any. In addition, the administrative rules of the Iowa Board of Medical Examiners requires the label to contain the following additional information: 1. Name and strength of dispensed drug. Dispensing physicians in Iowa must also comply with the packaging requirements of the federal Poison Prevention Packaging Act and directions of manufacturers regarding the use of light resistant containers.

5 13. Does Iowa have a limit or restriction on the total number of dosage units of a controlled substance which may be prescribed/dispensed at anyone time? No. There are no federal or state laws which limit the number of controlled substance doses which can be prescribed or dispensed. 14. Can a pharmacist accept a prescription from a prescriber or prescriber's agent left on voice mail? Yes, if verified in some manner. It is the responsibility of the pharmacist to determine the validity of a prescription drug order before dispensing. 15. Can an agent (employee) of an authorized prescriber sign a prescription? No, a written prescription must be signed by an authorized prescriber. A prescriber's authorized agent may communicate a prescription orally. It is then the pharmacist's responsibility to determine the validity.