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Minnesota News: 2009 Legislation Affecting the Practice of Pharmacy
Reprinted from the October 2009 Minnesota Board of Pharmacy Newsletter.
A large number of bills related to the profession of pharmacy or to pharmaceutical manufacturers were introduced this past session. Descriptions of some of the provisions that were enacted into law follow.
Changes in Definition of Practice of Pharmacy
As originally introduced, this bill would have clarified that pharmacists can administer influenza vaccines to children 10 years of age and older. It would have also allowed pharma¬cists working under protocol with certain practitioners to sign legally valid prescriptions. The provision concerning vaccines was removed from the bill due to concerns expressed by the Minnesota Departments of Health (MDH) and Human Services (DHS). Those departments were unaware that legislation was passed last year to allow pharmacists to administer influenza vaccines to individuals under the age of 18. They indicated that allowing pharmacists to give any vaccines to children would put the state in violation of laws and rules concerning a free vaccine program. The Minnesota Pharmacists Association worked with DHS and MDH on that issue and a compromise was reached that allows pharmacists to continue administering influenza vaccines to children who are 10 years of age or older through December 31, 2009. After that date, pharmacists must enroll in the Minnesota Vaccines for Children Program that is administered by MDH if they want to continue administering influenza vaccines to children.
The provision allowing pharmacists to sign legally valid prescriptions proved to be non-controversial and was enacted into law. The relevant new language is as follows: “A licensed practitioner may prescribe a legend drug, without reference to a specific patient, by directing a nurse, pursuant to section 148.235, subdivisions 8 and 9, physician assistant, or medical student or resident, or pharmacist according to section 151.01, subdivision 27, to adhere to a particular practice guideline or protocol when treating patients whose condition falls within such guideline or protocol, and when such guideline or proto¬col specifies the circumstances under which the legend drug is to be prescribed and administered.”
The Board adopted the following guideline at its June 10, 2009 meeting:
If a pharmacist working per a protocol (as authorized in Minnesota Statutes 151.01, Subd. 27) uses a prescription form, a faxed prescription, or an electronic prescription, the phar¬macist should indicate the name of the authorized prescriber who developed the protocol, the name of the pharmacist who is implementing the protocol, and indicate that the prescrip¬tion is generated per protocol. As an example, the pharmacist might sign a prescription generated per a warfarin monitoring protocol as follows:
“Sven Svenson, RPh, per warfarin protocol with Ingrid Ingridsdottir, MD.”
Pharmacists should not fill a prescription signed by a pharmacist unless there is an indication on the prescription that the pharmacist signing the prescription is authorized to do so per protocol. As with all prescriptions, pharmacists should verify any prescription if there is a question as to its validity.
Changes Concerning Pseudoephedrine Sales
One change clarifies that the permitted amounts of pseudo¬ephedrine and other methamphetamine precursor drugs that can be contained in a single package, or that can be sold on a daily or monthly basis, refer to the base form of the drug – as opposed to the salt. Packages must contain no more than 3 g of ephedrine or pseudoephedrine, calculated as the base drug, not the salt. For example, Claritin-D® 24-Hour contains 240 mg of pseudoephedrine sulfate, but only 181.8 mg of the base per tablet.
Consequently, 15 tablets contain 181.8 mg * 15 = 2727 mg or 2.727 g of pseudoephedrine base. Two of the 15-count packages of this product would contain about 5.5 g of pseudoephedrine – which is under the 6 g monthly sales limit.
Another change requires pharmacies to retain pseudoephed¬rine sales logs for at least three years and clarifies that the logs “must at all reasonable times be open to the inspection of any law enforcement agency.”
Changes to State Controlled Substances Schedules
Legislation was passed that requires the Board to annually submit a report to the legislature that specifies the changes that the Board made to the state’s controlled substance schedules during the preceding 12 months. The Board is in the process of amending rules to add a number of federally scheduled drugs to the state schedules. This will have little impact on pharmacists since most of the drugs will be added to Schedule I and since those drugs that will be added to the other schedules must already be handled as controlled substances by pharmacists in order to comply with federal law. However, these changes will make it easier for county attorneys to bring charges under state law for controlled substances violations. The proposed rule changes can be found on the Statutes, Rules, and Guidelines page of the Board’s Web site at www.phcybrd.state.mn.us/Main-sta.htm.
Medication Therapy Management Provision
Legislation was passed that requires a pharmacy benefit manager to “make available medication therapy management services for enrollees taking four or more prescriptions to treat or prevent two or more chronic medical conditions.” The leg¬islation further defines “medication therapy management” to mean the provision of certain pharmaceutical care services by, or under the supervision of, a licensed pharmacist. At its June 10, 2009 meeting, the Board went on record as interpreting the “or under the supervision of” clause to refer only to registered pharmacy interns and that other individuals working under the supervision of a pharmacist may not provide medication therapy management services.
