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Wellington, Florida pharmacist Glenn Boyles has been elected as President-Elect of the Florida Pharmacy Association. Glenn, an active member of the Florida Pharmacy Association since 1985 has also been active in the Palm Beach County Pharmacy Association and Palm Beach Regional Society of Health System Pharmacists. Glenn has also held membership in the American Pharmaceutical Association now renamed the American Pharmacists Association and American Society of Consultant Pharmacists. The University of Rhode Island graduate has served on numerous committees and councils within the FPA. He will be installed as President-Elect during the 113^th Annual Convention at the Saddlebrook Resort, Tampa, Florida on Sunday, June 15, 2003.

FPA Treasurer, Leo Fallon Re-elected to FPA Office

Marion County Pharmacist, Leo Fallon was selected to serve another 2-year term as Treasurer of the Florida Pharmacy Association. Lee has been active in the Association since 1989 serving on various committees and councils. He received the Academy of Pharmacy Practice Practitioner of merit Award in 1995. Lee has been active in the Indian River Pharmacy Association, the Brevard County Pharmacy Association as well as the Marion County Pharmacy Association. Lee will be installed as Treasurer during the 113^th Annual Florida Pharmacy Association Convention.

Senate bill 74 creating a requirement for the reporting of adverse incidents in pharmacies has been referenced to the Senate Judiciary Committee. While the bill has been referenced it has not been scheduled for a hearing. Text of the bill is as follows:

Section 2: As used in this section, the term "pharmaceutical adverse incident" means the dispensing of a different medication, a different dose, or the correct medication in a container with different instructions than those specified in the prescription, which dispensation results in actual harm to a patient, but does not include the dispensing of a generic equivalent medication with the patient's consent. A pharmacist licensed under chapter 465, Florida 29 Statutes, or other health care practitioner as defined in section 456.001, Florida Statutes, who becomes aware of a patient's allegation that a pharmaceutical adverse incident has occurred which was caused by a health care practitioner must report such allegation to the Department of Health on forms provided by the department. This section does not apply pharmacists employed by pharmacies that participate in the program provided by Rule 64B16-27.300, Florida Administrative Code; or pharmacists employed by pharmacies that have notified the Board of Pharmacy that they will establish a continuous quality-improvement program consistent with the requirements of Rule 64B16-27.300, Florida Administrative Code. The required notification to the department must be submitted in writing by certified mail and postmarked within 15 days after the pharmacist or health care practitioner became aware of the patient's allegation that a pharmaceutical adverse incident has occurred.

Effective July 1, 2005, subject to subsequent act of the Legislature and a specific appropriation sufficient to cover the actual costs, the department shall review each incident and determine whether it potentially involved conduct by a pharmacist or health care practitioner who is subject to disciplinary action, in which case section 465.073, Florida Statutes, applies. Disciplinary action, if any, shall be taken by the board under which the pharmacist or health care practitioner is licensed. The Department of Health shall adopt forms and rules for administering this section.

Section 3: Section 2 of this act shall take effect 30 only upon the effective date of legislation that makes any 31 such information provided to the Department of Health

This bill is not supported by the Florida Pharmacy Association. You may want to contact members of the Senate Judiciary Committee. They are as follows:

Bill Sponsor

It was announced this week at a meeting of Florida’s Board of Pharmacy that Executive Director John Taylor will be assuming new responsibilities within the Department of Health. Surprised Board members praised Mr. Taylor for his years of service to the board and his knowledge of pharmacy law. John has served as the Board’s executive director for 13 years. During his tenure Florida’s Board of Pharmacy developed and implemented rules addressing medication errors in pharmacies. He has presented at a number of FPA law conferences discussing recent Board activities of interest to participants. The Board has received a national commendation for its innovative approach to error prevention. John Taylor will be transitioning into the Bureau of Pharmacy services, which is the regulatory agency for Chapter 499 F.S.

From the Department of Health - Small Pox Vaccine Shipments Arrive in Florida

TALLAHASSEE- The Florida Department of Health (DOH) has received a shipment of smallpox vaccine from the Centers for Disease Control and Prevention (CDC). The vaccine will be stored in strategic locations throughout the state for use during Stage 1 of Operation Vaccinate Florida, scheduled to begin on February 10.

"This shipment is designated for members of hospital and county health department smallpox response teams," said DOH Secretary John O. Agwunobi, M.D., M.B.A. "This first stage of smallpox vaccinations is expected to last approximately 30 to 60 days."

Agwunobi said DOH officials at the state and local level have continued to work closely with federal, state and local agencies, public and private representatives, legislators and other elected officials in their planning for the vaccination campaign. The planning was based upon the framework for collaboration provided by Governor Jeb Bush through his Domestic Security Task Forces at the state and regional levels.

Operation Vaccinate Florida involves the voluntary immunization of Florida residents in three stages, with varying degrees of time between each stage:

The first stage, which is scheduled to begin on February 10, will include the vaccination of hospital response teams and county health department personnel. DOH estimates that approximately 33,000 doses will be provided to protect these health care professionals;

The second stage, which at this point has no scheduled start state, is expected to include the vaccination of first responders such as law enforcement officers, fire fighters, emergency medical crews, etc., as well as other health care professionals. DOH estimates that during the second stage, approximately 300,000 to 400,000 doses will be provided to protect and prepare these individuals; and

The third and final stage, should the federal government determine the need to proceed, would include the voluntary vaccination of the general public. DOH estimates that up to 10 million individuals might be eligible in Florida for Stage 3 vaccinations against smallpox. An as yet undetermined number of the population will be ineligible to receive the vaccine due to pregnancy, eczema and various other contraindications.

Agwunobi once again emphasized that he has received no information that would lead him to believe that the threat of a smallpox attack has changed or that attacks are imminent; however, given the current status of the war against terrorism and other potential global events, he continues to believe it is prudent to aggressively prepare.

Department of Health to Begin Rule Development of Wholesale Distribution of Prescription Drugs

If you have a full wholesalers permit you may want to review proposed rules being considered by the Department of Health Bureau of Pharmacy Services. The FPA office received the following notice:

Because of the public health threat that exists from the recurrence of counterfeit and diverted prescription drugs in the marketplace in Florida, the department intends to enforce the provisions set forth in this notice beginning March 1, 2003. If you sell prescription drugs you did not manufacture to other wholesalers, you may want to take appropriate steps immediately to sell any prescription drugs in stock for which you do not have the documentation to trace each previous sale of the drug back to the manufacturer of the drug. Also, you may want to monitor any future prescription drug purchases or acquisitions to assure you will be able to comply with these provisions by March 1, 2003, if applicable to your activities.

(2) In addition to definitions contained in sections 499.003, 499.012(1), 499.0122(1), 499.028(1), and 499.61, F.S., the following definitions apply to rule chapter 64F-12:

b. “Affiliated group” – means the definition set forth in sec. 1504 of the Internal Revenue Code, which is incorporated by reference.

(j)~~(i)~~ "Ongoing relationship" means an association that exists between a manufacturer and prescription drug wholesaler that is currently occurring such that a specific unit of a prescription drug is purchased directly from the manufacturer by the prescription drug wholesaler. when a manufacturer and a distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's product(s) for a period of time or for a number of shipments, at least one sale is made under that agreement, and the name of the authorized distributor of record is entered on the manufacturer's list of authorized distributors of record or equivalent list. An ongoing relationship may also be documented by at least three purchases of a manufacturer’s product(s) directly from that manufacturer within a six month period from the date for which the authorized distributor of record relationship is claimed and the distributor’s name is entered on the manufacturer’s list of authorized distributors of record or equivalent list.

Specific Authority 499.05, 499.61, 499.701 F.S. Law Implemented 499.003, 499.004, 499.005, 499.0054, 499.0057, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121499.0122, 499.013, 499.014, 499.015, 499.023, 499.024, 499.025, 499.028, 499.03, 499.033, 499.035, 499.039, 499.041, 499.05, 499.051, 499.052, 499.06, 499.066, 499.067, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, and 499.75, F.S. History - New 1-1-77. Amended 12-12-82, 1-30-85, Formerly 10D-45.31, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.031, Amended 1-26-99, 4-18-01,

(3) Any person who distributes a prescription drug that it did not manufacture must provide to each purchaser and recipient that is a wholesale distributor either:

(a) upon the wholesale distribution, a statement on the invoice or transfer document as follows:

1. If the establishment is not a member of an affiliated group: “This establishment purchased the specific unit(s) of the prescription drug(s) represented on this document directly from the manufacturer as an authorized distributor of record.”

2. If the establishment is a member of an affiliated group: “This establishment or a member of our affiliated group that is licensed or permitted as a drug wholesaler purchased the specific unit(s) of the prescription drug(s) represented on this document directly from the manufacturer as an authorized distributor of record.”

(b) before the wholesale distribution, a written statement (“pedigree paper”) identifying each previous wholesale distribution of that unit of the drug back to the manufacturer.

(c) The pedigree paper~~s required by s. 499.0121(6)(d)~~ must include either the proprietary name or the generic name with the name of the manufacturer (manufacturer, distributor or relabeler) ~~or distributor reflected on the label of the product~~;, dosage form;, strength;, container size;, quantity by lot number;, the name and address of each prior owner of the prescription drug, consistent with (a) or (b) above; the name and address of each location from which it was shipped if different from the owner's;, and the transaction dates for all distributions subsequent to the distribution by the wholesaler, or its affiliated group member that purchased that unit of the prescription drug from the manufacturer. The pedigree paper must clearly identify the invoice to which it relates. A copy of the pedigree paper must be maintained by each recipient.

(d) For purposes of subsection (3), a repackager that purchased a specific unit of prescription drug that it repackages directly from the manufacturer must comply with paragraph (3)(a). For purposes of subsection (3), a repackager that does not obtain a specific unit of a prescription drug that it repackages directly from the manufacturer must comply with paragraph (3)(b).

Specific Authority 499.05, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.052 FS. Law Implemented 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.05, 499.051, 499.052 FS. History - New 1-1-77, Amended 12-12-82, 7-8-84, 1-30-85, Formerly 10D-45.53, Amended 11-26-86, 2-7-93, 7-1-96, Formerly 10D-45.053, Amended 1-26-99, 4-18-01, _________.

(a) Every person receiving prescription drugs other than the consumer receiving dispensed prescription drugs pursuant to Chapter 465, F.S., has a duty to examine the product to prevent acceptance of prescription drugs that are unfit for distribution or use. The extent of the examination should be predicated on the conditions surrounding the transaction, including but not limited to any previous sales of the product, i.e., purchase and delivery is not direct from the manufacturer; the conditions of transport; and environmental conditions to which the product may have been subjected. Upon receipt a prescription drug wholesaler must review the records required to be provided by Rule 64F-12.012(3) related to the purchase of prescription drugs for accuracy and completeness.

Specific Authority 499.0121(1), 499.05, FS. Law Implemented 499.004, 499.006, 499.007, 499.0121, 499.052, FS. History-New 7-8-84, Amended 1-30-85, Formerly 10D-45.535, Amended 11-26-86, 7-1-96, Formerly 10D-45.0535, Amended 1-26-99, 4-18-01, .

(4) The following codes outline department policy under s. 499.066(3)(a), F.S., and are used to designate the general severity in terms of the threat to the public health for violation and the range of action which the department will initiate.

3 = Warning Letter, Letter of Violation with no fine or Notice of Violation or Administrative Complaint with a fine ranging from $250* to $1,000 per violation per day.

(*) If medical oxygen is the prescription drug involved, the range of the fine is $50 to $1,000.

Administrative Complaint with a fine ranging from $1,000 - $5,000 per violation per day; suspension of the permit with a fine; or Revocation of the permit with a fine.

12.013(5) Failing to examine the transaction documentation and failing to determine their accuracy1

Specific Authority 499.05, F.S. Law Implemented 499.066, F.S. History - New 7-1-96, Formerly 10D-45.0595, Amended 1-26-99, 4-18-01, _____.

NAME OF PERSON ORIGINATING PROPOSED RULE: Jerry Hill, Chief of Statewide Pharmaceutical Services.

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Annie R. Neasman, R.N., M.S., Deputy Secretary for Health.

Message from APhA

The Department of Veterans Affairs (VA) has established guidelines for the prescribing of non-controlled substances by clinical pharmacy specialists, clinical nurse specialists, nurse practitioners, and physician assistants. This new guidance, released on January 28^th, clarifies that the VA will "exercise its authority in defining" prescribing authority for non-controlled substances for the specifically identified non-physician providers.

Prescribing controlled substances involves a different procedure. Pharmacists (and the other non-physician providers) must have specific authority to prescribe controlled substances in the scope of practice for the state in which they are licensed. VA facility directors are responsible for ensuring that the scope of practice includes the authority to prescribe controlled substances.

2. A PharmD or MS degree or equivalent (examples of "equivalent" include completion of an ASHP accredited residency program, board certification, or two years clinical experience)

Pulmonary Diseases in Older Adults	February 22-23, 2003 Hilton Sandestin Beach and Golf Resort Sandestin, Florida
FPA Law and Regulatory Conference	March 15-16, 2003 Wyndham Westshore Tampa, Florida
113th Annual Meeting and Convention	June 11-15, 2003 Saddlebrook Resort Wesley Chapel, Florida
20th Annual Southeastern Education Gatherin	August 3-6, 2003 Village of Baytowne Resort Destin, Florida
Florida Pharmacy Association CE at SEA	September 25-28, 2003 Port of Canaveral, Florida
FPA Law and Regulatory Conference	October 11-12, 2003 Ft. Lauderdale Marriott Ft. Lauderdale, Florida

For more information Contact the FPA Office of Continuing Education
(850) 222-2400 or email zandrews@pharmview.com