BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date:April 23, 2012 |Bill No:SB | | |1301 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Curren D. Price, Jr., Chair Bill No: SB 1301Author:Hernandez As Amended:April 16, 2012 Fiscal:Yes SUBJECT: Prescription drugs: 90-day supply. SUMMARY: Authorizes a pharmacist to dispense not more than a 90-day supply of medication pursuant to a valid prescription that specifies the initial dispensing of a lesser amount followed by periodic refills of that amount if the patient has completed an initial 30-day supply of the medication, as specified. Existing law: 1)Establishes the practice of pharmacy and provides for the licensing and regulation of pharmacies and pharmacists by the Board of Pharmacy (Board) within the Department of Consumer Affairs. 2)Specifies certain requirements regarding the dispensing and furnishing of dangerous drugs and devices, and prohibits a person from furnishing any dangerous drug or device except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian or naturopathic doctor, as specified. (BPC § 4059) 3)Prohibits a prescription for any dangerous drug or dangerous device from being refilled except upon authorization of the prescriber, as specified. (BPC § 4063) 4)Permits a prescription for a dangerous drug or dangerous device to be refilled without the prescriber's authorization if the prescriber is unavailable to authorize the refill and if, in the pharmacist's professional judgment, failure to refill the prescription might interrupt the patient's ongoing care and have a significant adverse effect on the patient's well-being. Specifies that the prescription SB 1301 Page 2 may be filled only after making every reasonable effort to contact the prescriber. Requires the pharmacist to inform the patient and the prescriber that the prescription was refilled under this circumstance. (BPC § 4064) 5)Provides that psychotropic medication or psychotropic drugs are those medications administered for the purpose of affecting the central nervous system to treat psychiatric disorders or illnesses. These medications include, but are not limited to, anxiolytic agents, antidepressants, mood stabilizers, antipsychotic medications, anti-Parkinson agents, hypnotics, medications for dementia, and psychostimulants. (Welfare and Institutions Code § 369.5 (d)) This bill: 1)Authorizes a pharmacist to dispense not more than a 90-day supply of medication pursuant to a valid prescription that specifies the initial dispensing of a lesser amount followed by periodic refills of that amount if the patient has completed an initial 30-day supply of the medication and all of the following requirements are satisfied: a) The total quantity of dosage units dispensed does not exceed the total quantity of dosage units authorized by the prescriber on the prescription, including refills. b) The prescriber has not specified on the prescription that dispensing the prescription in an initial amount followed by periodic refills is medically necessary. c) The pharmacist is exercising his or her professional judgment. 1)Requires a pharmacist dispensing pursuant to these provisions to notify the prescriber of the change in the quantity dispensed. 2)Specifies that the above provisions do not apply to psychotropic medication or psychotropic drugs as defined in Welfare and Institutions Code Section 369.5 (d). 3)Specifies that the above provisions shall not be construed to require a health care service plan, health insurer, workers' compensation insurance plan, pharmacy benefits manager, or any other person or entity, including, but not limited to, a state program or state employer, to provide coverage for a dangerous drug in a manner inconsistent with a beneficiary's plan benefit. SB 1301 Page 3 FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by Legislative Counsel. COMMENTS: 1.Purpose. This bill is sponsored by California Retailers Association (Sponsor) in order to permit a pharmacist to dispense up to a 90-day supply of a drug, other than a controlled substance and psychotropic medication, as defined in Welfare and Institutions Code Section 369.5 (d), pursuant to a prescription that specifies the initial dispensing of a lesser amount followed by periodic refills of that amount if certain requirements are met. According to the Sponsor and the National Association of Chain Drug Stores (NACDS), a single chain drug store makes approximately 4.5 million calls a month to get authorization to dispense a prescription refill in excess of a 30-day supply. Because physicians are typically busy and unable to take these calls, consumers end up either having to wait for authorization or they end up settling for the 30-day supply and leaving before the physician calls back. The Sponsor states that not only are these calls burdensome to the physicians and pharmacists, the patient is ultimately inconvenienced and will need to return to the pharmacy two additional times and pay two additional co-payments that he or she would have saved under this bill. The 90-day retail prescription option proposed in this measure offers value to the health care system but, more importantly, to the consumer, according to the Sponsor, and allows physicians to focus on more essential patient needs. 2.Background. According to a 2005 Federal Trade Commission study, private-sector entities that offer prescription drug insurance coverage, such as employers, labor unions, and managed care companies, often hire pharmacy benefit managers (PBMs) to manage these insurance benefits. Many PBMs use mail-order pharmacies to manage prescription drug costs. Many plan sponsors have encouraged patients with chronic conditions who require repeated refills to seek the discounts that 90-day prescriptions and high-volume mail-order pharmacies can offer. One way of managing growing medication costs is by using larger SB 1301 Page 4 prescription volumes. An article titled "Ninety-day versus thirty-day drug dispensing systems" published in American Journal of Health-System Pharmacy (July 2001) reported a study involving the U.S. Veterans Affairs San Diego Healthcare System which showed that dispensing less expensive drugs for 90-days rather than 30-days to patients with chronic diseases would result in significant cost savings without compromising safety, despite the possibility of increased wastage when drugs are discontinued. 3.Practices in Other States. According to the Sponsor, 20 states have varying statutes that in some way permit 90-day dispensing (Alaska, Arizona, Colorado, Florida, Hawaii, Idaho, Illinois, Kentucky, Main, Michigan, Montana, Nebraska, New York, North Carolina, Rhode Island, South Carolina, South Dakota, Texas, Vermont, and Wyoming). For example, New York mandates that if a health plan or insurer offers a 90-day supply through a mail-order pharmacy, the enrollee can obtain the same supply at a retail pharmacy, provided the pharmacy accepts the same contractual terms and conditions as the mail-order pharmacy. Indiana has legislation pending on the Governor's desk that permits 90-days' worth of medication upon the request of the patient if the patient has completed an initial 30-day supply of the drug. However, a pharmacist is required to notify the prescriber of the change in the quantity filled and comply with state and federal laws and regulations concerning the dispensing limitations concerning a prescription drug. 4.Arguments in Support. The California Retailers Association , in sponsoring the bill, writes: "With our aging population, health care costs will rise dramatically and prescription drug expenditures will also increase as more people are diagnosed with conditions that require maintenance drugs. Consumers want and deserve the option of obtaining a 90-day prescription for their convenience and to allow them to better adhere to their medical regimen." Walgreens writes that in California, when a patient presents a pharmacist a prescription for a medication with refills, the pharmacist is limited to a 30-day supply. If the patient requests a combined refill, the pharmacy must contact the prescriber to get their approval before dispensing the refill. In California, Walgreens makes 4.5 million of these contacts a month. Walgreens lists a number of benefits to this bill: Increases convenience for patients as they would not need to return to the pharmacy multiple times to refill a prescription; increases access to prescription medications and pharmacy services for those patients in rural and inner city areas where travel to a pharmacy is less convenient; reduces administrative burdens on the physician by negating the need SB 1301 Page 5 for office phone contacts to verify approval for appropriate refill prescriptions; saves the patient co-payments, where coverage permits; improves medication adherence, by ensuring fewer trips to the pharmacy for refill prescriptions; enhances patient choice to receive their prescription refills at their community pharmacy (which results in face to face interaction, advice and counseling from their trusted and chosen pharmacist); emergency planning personnel recommend having more than a 30-day supply of needed medications in case of disaster. California Pharmacists Association (CPhA) believes the bill takes a relatively small yet meaningful step to safely increase efficiency in the health care delivery system. CPhA states the bill allows pharmacists to utilize their professional judgment to provide medications in amounts that are most convenient to their patients. This is a safe way to make getting prescriptions filled a more consumer-friendly process, according to CPhA. California Healthcare Institute states that the health care system bears significant costs through patients suffering from chronic diseases that are not adhering to their prescribed treatment regimen. By allowing patients to receive up to 90-days worth of a refill prescription, SB 1301 will make it easier for patients to adhere to their treatment regimen, live healthier lives and lower costs throughout the health care system. 5. Recent Amendments. This bill was amended and passed by the Senate Health Committee on April 11, 2010. According to the Sponsor, these amendments were intended to address concerns with the bill, including those raised by the California Psychiatric Association (CPA) who expressed concern that from a psychiatric physician standpoint, many psychiatric medications are toxic or lethal, and that potential is increased significantly when a patient presents with suicidal ideation. The phrase "psychotropic drug" is a term referring to psychiatric medicines that alter chemical levels in the brain which impact mood and behavior. Thus the bill has been amended to not allow a pharmacist to dispense a 90-day supply of a psychotropic drug under the provisions of the bill. In discussing this measure with Committee staff, the Sponsor has indicated that the amendment requiring a patient to complete an initial 30-day supply of the medication before a pharmacist could dispense a 90-day supply was made out of drug waste and disposal concerns. Allergic or adverse reactions to medication would typically be apparent within the first month. However, if a three month supply were initially dispensed, consumers may very well find SB 1301 Page 6 themselves having to dispose of the balance of a prescription that they cannot use. NOTE: Double-referral to Health Committee, first. This bill was heard in Senate Health Committee on April 11 and approved by a 8 to 1 vote. SUPPORT AND OPPOSITION: Support : California Retailers Association (Sponsor) Aging Services of California BIOCOM California Healthcare Institute California Pharmacists Association Los Angeles County Board of Supervisors Mental Health America of California Walgreens 7 pharmacies Opposition : None received as of April 17, 2012 Consultant:G. V. Ayers