Collaborative practice, PBM oversight, biosimilar substitutions and modern prescription practices signed into law

Bills aimed at lowering drug costs for Alabama consumers, improving the relationship and communication between doctors and pharmacists and other pharmacy issues became law in the 2019 regular session.

COLLABORATIVE PRACTICE AGREEMENTS
Licensed Alabama pharmacists and physicians can enter into collaborative practice agreements, under an act signed into law June 4. Collaborative agreements are used to integrate pharmacists into team-based patient care. The sponsor was Rep. Ron Johnson, R-Sylacauga.

By Oct. 1, the Alabama Board of Pharmacy and the Alabama Board of Medical Examiners are each to draw up rules to govern the agreements, under Act No. 2019-368. The examiners will be responsible for the rules related to doctors, and the Pharmacy Board for those related to pharmacists. Each of the licensing boards also are to administer and collect any fees related to the agreements. The fees can be up to $300.

PHARMACY BENEFIT MANAGER OVERSIGHT
Alabama law now provides oversight and transparency for pharmacy benefit managers.

Among other provisions, Act No. 2019-457 by Sen. Arthur Orr, R-Decatur, requires pharmacy benefit managers to register, be licensed and maintain up-to-date contact information with the Alabama Insurance Department. It also bans the use of “gag clause” and “claw-back” provisions in PBM contracts with pharmacies. Pharmacy benefit managers provide claims processing services or other prescription drug or device services for private and public health benefit plans. The law became effective immediately after Gov. Kay Ivey signed it June 7.

SUBSTITUTING INTERCHANGEABLE BIOSIMILARS
New standards for making interchangeable biosimilar substitutions for biologic medicines takes effect Sept. 1 in Alabama.

Act No. 2019-406 by Sen. Tom Butler, R-Madison, requires pharmacists to provide the prescribing doctor with the name and manufacturer of any interchangeable biosimilar product dispensed. The U.S. Food and Drug Administration released its guidance May 10 for interchangeable biologics. The FDA has yet to approve any interchangeable biosimilars, but most states have established standards for when that approval occurs and the more cost-effective medicines reach the market. Without this law, using these new drugs as substitutions would not have been possible in Alabama.

A pharmacist, or a designee, can use electronic messages, telephone or faxes to notify doctors of a substitution, unless the doctor specifies a specific communication method. The law also allows voice mails left on a doctor’s phone number to constitute notice. Pharmacists are required to give doctors 24-hour-notice, excluding Sundays and recognized federal holidays, of substituting an interchangeable biosimilar for a biologic medicine. Pharmacists must inform patients of such a substitution prior to dispensing the medicine.

MODERN PRESCRIPTIONS AND DRUG SUBSTITUTION NOTATION
Starting Sept. 1
, how a doctor notes if substitutions are allowed for a prescription will be updated to accommodate modern methods of communication, under legislation signed into law June 7.

Doctors will no longer have to use the same exact wording in their instructions to pharmacists on written prescriptions, under Act No. 2019-441 by Rep. Arnold Mooney, R-Birmingham. Written prescriptions will still have two signature lines, each with its own option. Those options would be 1) indicate a brand name drug is to be dispensed or 2) indicate product selection is allowed.

The law clarifies that the two-signature lines requirement doesn’t apply to phone or modern prescription methods. The process for electronic prescriptions and e-faxes will be the same as prescriptions called into a pharmacist. On an electronic prescription or e-fax, doctors will include dispensing instructions for the pharmacist just as a doctor would do if calling in a prescription into a pharmacy.

Pharmacists must still seek documentation from doctors of a medical necessity for dispensing a brand drug when a generic is available.

STATE PROSECUTION FOR PRESCRIBING OR DISPENSING DRUGS FOR NON-MEDICAL PURPOSES
Doctors and pharmacists can now be prosecuted under state law for knowingly or intentionally prescribing or dispensing a controlled substance without a legitimate medical purpose.

Act No. 2019-537 by Rep. Chris England, D-Tuscaloosa, took effect immediately after Gov. Kay Ivey signed it June 10.

Previously, a licensed physician in Alabama writing a prescription for something other than medical purposes could only be  prosecuted under federal law. England said Drug Enforcement Administration agents told him the federal government needed more resources to combat the overprescribing of opioids in Alabama.

PHARMACY APPEALS
Appeals of Alabama State Board of Pharmacy orders can now be filed in the county where the board’s headquarters are located, currently Shelby County, or the county where the appellant lives, under Act No. 2019-357 by Rep. Jim Hill, R-Moody.  The law went into effect immediately after it was signed June 4.

PHARMACY TECH REINSTATEMENT
In Alabama, a pharmacy technician can be reinstated by paying a maximum of five years’ worth of unpaid penalties and fees without having to be reexamined by the Alabama Board of Pharmacy. Under Act No. 2019 -128, the maximum applies no matter how long a technician has not paid their fees.

The law by Rep. Ron Johnson, R-Sylacauga, and Sen. Tom Butler, R-Madison, went into effect immediately after it was signed May 8.

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