Judges: WILLIAM J. KENDRICK
Agency: Department of Health
Latest Update: Sep. 09, 1987
Summary: At issue in this proceeding is whether Respondent, a licensed pharmacist in the State of Florida, acted in good faith and in the course of professional practice, when he filled prescriptions for methaqualone during the period of August 1981 to January 1982. Cohn v. Department of Professional Regulation, 477 So.2d 1039 (Fla. 3d DCA 1985). At hearing, the parties agreed to the admissibility of the transcript of the previous hearing held June 21, 1983, together with the exhibits introduced at that
Summary: At issue in this proceeding is whether Respondent, a licensed pharmacist in the State of Florida, acted in good faith and in the course of professional practice, when he filled prescriptions for methaqualone during the period of August 1981 to January 1982. Cohn v. Department of Professional Regulation, 477 So.2d 1039 (Fla. 3d DCA 1985). At hearing, the parties agreed to the admissibility of the transcript of the previous hearing held June 21, 1983, together with the exhibits introduced at that hearing. Such documents were marked as Petitioner's exhibits 1-3, and received into evidence. In addition, Petitioner called as witnesses: Vernon K. Bell; Louis Fisher; John B. Handwerker, M.D.; Jacob N. Hodus; and Constantine Lopilato. The transcript of hearing was filed April 29, 1987, and the parties were granted leave until May 19, 1987, to file proposed findings of fact.Proof failed to demonstrate that pharmacist who filled 202,404 Methaqualone prescriptions within six-month period acted in bad faith or outside practice.
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82-2161STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )
)
Petitioner, )
)
vs. ) CASE NO. 82-2161
)
BEN COHN, )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, William J. Kendrick, held a public hearing in the above-styled case on April 6, 1987, in Miami, Florida.
APPEARANCES
For Petitioner: Henry N. Adorno, Esquire
T. Michael Kennedy, Esquire
ADORNO ALLEN SCHIFF & GOODKIND, P.A.
1501 Venera Avenue
Park Place II, Suite 240 Coral Gables, Florida 33146
For Respondent: Mark Krasnow, Esquire
9000 Southwest 87th Court, Suite 103
Miami, Florida 33176 PRELIMINARY STATEMENT
At issue in this proceeding is whether Respondent, a licensed pharmacist in the State of Florida, acted in good faith and in the course of professional practice, when he filled prescriptions for methaqualone during the period of August 1981 to January 1982. Cohn v. Department of Professional Regulation, 477 So.2d 1039 (Fla. 3d DCA 1985).
At hearing, the parties agreed to the admissibility of the transcript of the previous hearing held June 21, 1983, together with the exhibits introduced at that hearing. Such documents were marked as Petitioner's exhibits 1-3, and received into evidence. In addition, Petitioner called as witnesses: Vernon K. Bell; Louis Fisher; John B. Handwerker, M.D.; Jacob N. Hodus; and Constantine Lopilato.
The transcript of hearing was filed April 29, 1987, and the parties were granted leave until May 19, 1987, to file proposed findings of fact.
Consequently, the parties waived the requirement that a recommended order be filed within thirty, (30) days of the date the transcript is filed. Rule 22I- 6.31, Florida Administrative Code. Petitioner filed proposed finding of fact in
a timely manner, and they have been addressed in the appendix to this recommended order.
FINDINGS OF FACT
Respondent, Ben Cohn (Cohn), was at all times material hereto a licensed pharmacist in the State or Florida, having been issued license number 0009536. At all relevant times, Cohn was employed as a pharmacist at Don's Discount Drugs in South Miami, Florida. 1/
In or about October, 1981, Don's Discount Drugs was targeted by the Department of Professional Regulation and the Drug Enforcement Administration for a drug diversion audit of all Schedule II prescription drugs. The impetus for the audit was the quantity of methaqualone tablets, a Schedule II prescription drug, that were being dispensed at the store.
The audit revealed no improprieties in the control or accountability of Schedule II prescription drugs at Don's Discount Drugs, but did reveal that during the period from August 4, 1981, through January 6, 1982, Don's Discount Drugs had dispensed 202,404 methaqualone 300 mg. tablets on 4,695 prescriptions. 2/ Of theses Cohn dispensed 118,130 methaqualone tablets on 2,724 prescriptions. The vast majority of these prescriptions were written for 45 tablets.
The physicians who wrote the prescriptions which Cohn filled were largely employed by "stress clinics". These clinics actively advertised and solicited patients suffering from stress, and frequently prescribed methaqualone. There is, however, no competent proof that these clinics operated illegally, or that the physicians who wrote the prescriptions at issue in this case failed to do so in the good faith practice of their profession.
During the time in question, it was legal in the State of Florida to prescribe and to dispense methaqualone. However, of the approximately 400 community pharmacies in Dade County only 10 would fill methaqualone prescriptions.
Cohn knew he was dispensing a controversial drug with a high potential for abuse. Consequently, in filling each of the methaqualone prescriptions in question, as with all Schedule II drug prescriptions, Cohn followed a rigid procedure. As to each prescription, he verified that the person presenting the prescription was the person to whom the prescription was written by requiring a driver's license or others photo identification. Cohn then contacted the United States Department of Justice Drug Enforcement Administration to verify that the prescriber had a current DEA number. Cohn then verified with the prescriber that the prescription had been written for that patient and verified the number of tablets reflected on the prescription. Lastly, Cohn placed that patient's name and address on an index card together with the name of the doctor and the date of the prescription. These cards were maintained in a special file for reference in filling prescriptions to prevent dispensing any Schedule II drugs to the same person as a result of multiple prescriptions issued in too short a time period.
All of the prescriptions in question were written by prescribers who were duly licensed by the Florida Board of Medical Examiners. None of the prescriptions in question was written or filled for an excessive number of methaqualone written tablets. 3/ Further, the parties have stipulated that
Cohn complied with each of the conditions prescribed by Subsections (a)-(g), Section 893.04(1), Florida Statutes.
Notwithstanding the fact that Petitioner offered no proof that any prescription filled by Cohn was not issued by a physician in the good faith practice of his profession, or was otherwise counterindicated, it suggests that Cohn did not act in good faith and in the course of professional practice when he filled the prescriptions. Factors which Petitioner deems important to such conclusion are: (1) the large number of prescriptions issued for the same quantity of drug, (2) the limited number of prescribers, (3) that most prescribers worked at "stress clinics", (4) the sudden influx of patients 18-30 years of age to fill prescriptions, (5) the precounting and prepackaging of methaqualone at the store, (6) the "general tone" of the community in regard to the abuse factor of methaqualone, (7) Cohn's failure to ascertain whether the drug was "for the benefit and welfare" of the patient, and (8) that many of the prescribing physicians maintained their offices outside the general neighborhood of the store. Petitioner's proof was not, however compelling.
While the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, appears facially to be a large quantity, Petitioner offered no proof to demonstrate its significance. No evidence was presented comparing the total number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of methaqualone prescriptions filled in Dade County at the time. No evidence was presented comparing the number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of prescriptions filled at that pharmacy. No evidence was presented concerning the statistical significance, if any, of the quantities of methaqualone tablets dispensed at Don's Discount Drugs. In sum, the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, which represents an average of 35 prescriptions filled each day, was not demonstrated to be disproportionate to the legitimate needs of the population of Dade County.
While many of the prescribers did maintain their offices outside the pharmacy's neighborhood, and a large number of methaqualone tablets dispensed at Don's Discount Drugs, it is significant that only 10 of 400 community pharmacies in Dade County would fill such prescriptions. Under such circumstances, it would not be unusual for such physicians' patients to travel to fill their prescriptions. Neither would it be unusual to find a large number of prescriptions being filled at the limited number of pharmacies willing to fill them.
While Cohn did not ascertain whether the prescriptions were written "for the benefit and welfare" of the patient, or otherwise seek to second guess the attending physician by inquiring about the circumstances or diagnosis that prompted the prescription, he did confirm that the physician was properly licensed and that the physician had issued the prescription to the patient who presented it. The Department offered no credible proof that any physician misappropriately prescribed any drugs in this case. Accordingly, the presumption is that the physicians who wrote the subject prescriptions acted lawfully, and in the good faith practice of their profession. See: Atlantic Coast Line R. Co. v. Mack, 57 So.2d 447 (Fla. 1952). Under such circumstances, it cannot be concluded that Cohn failed to act in good faith and in the course of professional practice when he filled such prescriptions.
The remaining factors cited by Petitioner are equally unpersuasive. The fact that the prescriptions were written by a limited number of physicians,
most of whom were employed by "stress clinics", was not compelling because there was no showing that such physicians operated improperly. The fact that the store experienced a sudden influx of patients 18-30 years of age was not shown to be pertinent since there was no proof that the prescribing of methaqualone to such age group was counterindicated 4/ The fact that Don's Discount Drugs precounted and prepackaged methaqualone tablets demonstrated only that they anticipated a demand for the product; not any impropriety. Cohn's knowledge of the abuse potential for methaqualone and the procedures he employed to avert such abuse, was addressed in paragraph 6, supra.
In rejecting petitioner's contention that Cohn failed to act in good faith and in the course of professional practice, I do not suggest that the factors advanced by Petitioner are not necessarily pertinent to the inquiry. Rather, I conclude that in this case such proof was not persuasive because there was no competent proof that any physician misprescribed or acted other than in the good faith practice of his profession. Such being the proof, it cannot be concluded that Cohn violated a community standard by filling a lawful and proper prescription.
Cohn was first licensed as a practicing pharmacist in the State of New York in 1945, and has been practicing in the State of Florida since 1961. He has never been disciplined and has never had an administrative complaint, other than the instant complaint, filed against him regarding his practice of pharmacy.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties to, and the subject matter of, these proceedings.
Pursuant to the mandate issued in Cohn v. Department of Professional Regulation, 477 So.2d 1039 (Fla. 3d DCA 1985), this case was remanded to the Division of Administrative Hearings for the purpose of (a) conducting an additional administrative hearing on the issue of whether Cohn acted in good faith and in the course of professional practice, and (b) entering findings of fact, conclusions of law and a recommended order thereon. Pursuant to such mandate a hearing was held on April 6, 1987, and this recommended order entered.
Pertinent to this case is Section 465.016(1), Florida Statutes, which provides:
The following acts shall be
grounds for disciplinary action set forth, in this section:
* * *
Compounding, dispensing, or distributing a legend drug,
including any controlled substance, other than in the course of the professional practice of pharmacy. For purposes of this paragraph, it shall be legally presumed that the compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best interests
of the patient and is not in the course of the professional practice of pharmacy.
Also pertinent to this case is Section 893.04(1), Florida Statutes, which provides:
A pharmacist, in good faith
and in the course of professional practice only, may dispense controlled substances upon a written ... prescription of a practitioner...
No statute or Department rule defines "in good faith and in the course of professional practice" for a pharmacist in filling prescriptions. See: Cohn
v. Department of Professional Regulation, supra. Consequently, the Department sought to demonstrate the standard in the community. To establish this point, the Department relied on witnesses was opined that for various dubious reasons Cohn had breached the community standard. The Department's evidence was not, as discussed in the findings of fact, substantial or even persuasive.
In dealing with license disciplinary proceedings predicated on a retrospective characterization of conduct, the courts have, until recently, applied the standard established by Bowling v. Department of Insurance, 394 So.2d 165 (Fla. 1st DCA 1981). In Bowling the court stated:
In a proceeding under a penal statute for suspension or
revocation of a valuable business or professional license, the term substantial competent evidence
takes on vigorous implications that are not so clearly present on other occasions for agency action under Chapter 120. Although all questions of fact as distinguished from policy are determinable under the Administrative Procedure Act by substantial competent evidence,
Section 120.68(10), we differentiate between evidence which "substantially" supports conventional forms of regulatory action and evidence which is required to support "substantially a retrospective characterization of conduct requiring suspension or revocation of the act license.
Evidence which is "substantial" for one purpose may be less so on another, graver occasion ....
Id. at 171.
...[W]e glean a requirement for more substantial evidence from the very nature of licensee discipline
proceedings: when the standards of conduct to be enforced are not explicitly fixed by statute or by rule, but depend on such debatable expressions as "in the applicable regular course of business"; when the conduct to be assessed is past, beyond the actor's power to conform it to agency standards announced prospectively; and when the proceeding may result in the loss of a valuable business or professional license, the critical matters in issue must be shown by evidence which is indubitably as "substantial" as the consequences.
* * *
... the violation of a penal statute is not to be found on loose interpretations and problematic evidence, but the violation must in all its implications be shown by evidence which weighs as "substantially" on a scale suitable for evidence as the penalty does on the scale of penalties. In other words, in a world ensnarled by false assumptions and hasty judgments, let the prosecutor's proof be as serious-minded as the intended penalty is serious.
Id. at 172.
Recently, the Supreme Court of Florida, while concurring with the court in Bowling that the revocation of a professional license was of sufficient gravity and magnitude to warrant a standard of proof greater than a mere preponderance of the evidence, rejected the "nebulous sliding scale standard" of evidence as "substantial as the consequences" to be suffered established by Bowling and adopted the clear and convincing standard of proof. Ferris v. Turlington, 12 FLW 393 (Supreme Court of Florida, Case No. 69, 561, July 16, 1987). In so doing, the court stated at page 394.
The correct standard for the revocation of a professional license . . . is that the evidence must be clear and convincing. We agree with the district court in Reid v. Florida Real Estate Commission, 188 So.2d 846, 851 (Fla. 2nd DCA 1966), that:
"The power to revoke a license should be exercised with no less careful circumspection than the original granting of it. And the penal sanctions
should be directed only toward those who by their conduct have forfeited their right to the privilege, and then only upon clear and convincing proof of substantial causes justifying the forfeiture."
The proof in this case failed to demonstrate that Cohn acted other than in good faith and in the course of professional practice when he filled the methaqualone prescriptions at issue in this proceeding. The proof further failed to establish that Cohn compounded, dispensed or distributed any legend drug in an excessive or inappropriate quantity.
RECOMMENDATION
Based on the foregoing Finding of Fact and Conclusions of Law, it is RECOMMENDED:
That a Final Order be entered DISMISSING the Administrative Complaint. DONE AND ORDERED this 9th day of September, 1987, in Tallahassee, Florida.
WILLIAM J. KENDRICK
Hearing Officer
Division of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32399-1550
(904) 488-9675
Filed with the Clerk of the Division of Administrative Hearings this 9th day of September, 1987.
ENDNOTES
1/ Don's Discount Drugs opened for business August 1, 1981. Cohn was in employed in September 1981 as the store's full-time pharmacist. Cohn, together with four part-time pharmacists, was responsible for filling prescriptions at the store.
2/ The number of methaqualone prescriptions filled during this period constituted 97 percent of all Schedule II prescriptions dispensed at Don's Discount Drugs. There was, however, no competent proof offered to establish the number of other prescriptions filled at the store, or how the number of methaqualone prescriptions filled compared to the store's total prescription business.
3/ Petitioner presented the testimony of Dr. John Handwerker who opined that the recommended dosage for methaqualone was one or two 300 mg. tablets per night, for a period of two to three weeks. Therefore, according to Dr.
Handwerker, it was permissible to prescribe up to 42 methaqualone tablets for a
patient. The significance of prescribing 45 methaqualone tablets, as opposed to 42, was not shown to be significant. Further, Dr. Handwerker conceded that Lemmon was the only company lawfully producing methaqualone during the relevant time periods, that a prudent physician would examine that company's prescribing information in forming a judgment of whether to prescribe and how much to prescribe, and that he had not read such literature. Additionally, Dr.
Handwerker was not shown to have any knowledge concerning the need or condition of the patient for whom any of the prescriptions were written, and conceded that the prescribing physician was the person responsible for establishing the therapeutic drug needs of the patient. Under the circumstance, Dr. Handwerker's testimony is not persuasive and does not detract from the competent proof that none of the prescriptions in question was written or filled for an excessive number of methaqualone tablets.
4/ There was also no proof that the physical appearance or demeanor of any patient who sought to fill a prescription was such as to suggest they were drug abusers or that, for any other reason; the prescription should not have been filled.
APPENDIX TO RECOMMENDED ORDER IN CASE NO. 82-2161
Petitioner's proposed findings of fact are addressed as follows:
Addressed in paragraph 1.
Addressed in paragraph 2.
Addressed in footnote 1.
4-5. Addressed in Paragraphs 2 and 3.
6(a) Addressed in paragraph 3 and footnote 2. The portion of paragraph 6(a) that reads ". . . 4,693 prescriptions were issued for all other drugs at the pharmacy, a ratio of one-to-one" is rejected as not supported by competent proof.
6(b). Addressed in paragraph 3. 6(c). Addressed in Paragraph 3. 6(d). Addressed in paragraph 4.
6(e). Addressed in Paragraphs 8 and 12 6(f). Addressed in paragraphs 8 and 12
6(g). Addressed in paragraph 8 and 10. The portion of paragraph 6(g) that reads "Many of the prescribing physicians not only resided outside the general neighborhood is rejected as not supported by competent proof.
7-8. Addressed in Paragraph 6.
Addressed in Paragraphs 8 and 12.
Addressed in paragraph 4. That part of Paragraph 10 that reads "... and was aware that stress clinics were being investigated by the State Attorney" is rejected as not relevant. There was no proof that any physician or clinic operated improperly or illegally.
11a-e. Addressed in Paragraphs 6-13.
COPIES FURNISHED:
Henry N. Adorno, Esquire
T. Michael Kennedy, Esquire ADORNO ALLEN SCRIFF
& GOODKIND, P.A.
1501 Venera Avenue
Park Place II, Suite 240 Coral Gables, Florida 33146
Mark Krasnow, Esquire 9000 S.W. 87th Court Suite 103
Miami, Florida 33176
Rod Presnell, Executive D rector Board of Pharmacy
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32399-0750
Tom Gallagher, Secretary
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32399-0750
Joseph A. Sole, General Counsel Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32399-0750
=================================================================
AGENCY FINAL ORDER
=================================================================
STATE OF FLORIDA DEPARTMENT OF PROFESSIONAL REGULATION
DEPARTMENT OF PROFESSIONAL REGULATION, BOARD OF PHARMACY,
Petitioner,
DOAH NO. 82-2161
vs. DPR NO. 0019955
BEN COHN
Respondent.
/
FINAL ORDER
THIS CAUSE came on to be heard by the Florida Board of Pharmacy of the Department of Professional Regulation at a regularly scheduled meeting held on April 9, 1984, in Pensacola Florida.
Appearance for Petitioner: Bruce D. Lamb
Staff Attorney
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
Appearance for Respondent: No appearance
FINDINGS OF FACT
After reviewing the complete record the Florida Board of Pharmacy hereby adopts the Findings of Fact as set forth by the Hearing Officer in her order of November 1, 1983.
As a preliminary matter, the Board determined to deny the request for a continuance filed by Respondent in this cause insofar as this matter has previously been scheduled for two board meetings and continued at Respondent's request. Petitioner has filed exceptions to the Conclusions of Law of the Hearing Officer and Respondent has filed a written response to said exceptions.
The Hearing Officer in her Conclusions of Law and her recommendation of dismissal construed the provisions of F.S. 465.016(1)(e) which incorporates by reference the provisions of F.S. 893.04(1) in a manner which the board's opinion is erroneous as a matter of law.
As is pointed out in the exceptions to the Hearing Officer's Recommended Order filed by Petitioner in this cause the provisions of F.S. 465.016(1)(e) incorporated as grounds for discipline any violation of the provisions of Chapter 893, Florida Statutes. The relevant provisions of Chapter 893.04(1) state "a pharmacist, in good faith and in the course of professional practice only, (e.s.) may dispense controlled substances, upon a written or oral prescription of a practitioner under the following conditions . . ." The Hearing Officer went on to conclude that the listed conditions set forth in Chapter 893.04(1) are exclusive and strictly define what is "professional practice" in the practice of pharmacy. It is a position of the Florida Board of Pharmacy that such a construction of Chapter 893 is inappropriate since it is clear that there are two different sets of conditions which must be met in determining whether a pharmacist has properly followed the provisions of Ch.
893.04(1) and by reference s. 465.016(1)(e). Not only must a pharmacist be assured that the controlled substance in question meets the standards of Ch. 893 as regards to the form of prescription, the manner in which the prescription is to be filled, the labeling requirements for the container in which the medication is dispensed and record keeping requirements for the pharmacist in filling the prescription but also such dispensing should be in the course of the professional practice whether or not the actual format of the prescription is met. In other words, a pharmacist must not be permitted under the guise of having received a prescription or many prescriptions from a licensed prescriber to fill such prescription(s) when based upon his training and experience and all the facts surrounding the prescription(s) it is clear that such prescription or prescriptions taken as a whole have been written outside the course of
professional practice of pharmacy and would do harm to the patient or public. Thus, to the extent that the Hearing Officer determined that the analysis of a determination of a violation of s. 465.016(1)(e) and therefore Ch. 893.04(1), is limited to the determination of whether the formal requirements for an acceptable prescription had been met such a conclusion is erroneous. A further inquiry must be made as to whether or not in the common practice of the profession of pharmacy the prescription or prescriptions should have been filled in the course of acceptable professional practice and keeping in mind the preservation of the public health, safety and welfare. Based upon the expertise of the members of the Board of Pharmacy and the facts of this case it is determined that the practice of Respondent was in the course of professional practice. See Department of Professional Regulation v. Herman Ginsberg, DOAH Case No. 81-1951, Department of Professional Regulation v. BGJM and Robert E. Levy, DOAH Case No. 82-2096, U.S. v. Kershman, 555 F.2d 191 (5th Cir. 1977).
In light of the fact that the Hearing Officer's conclusion that the provisions of F.S. 465.016(1)(e), are found to be erroneous such conclusions are rejected and Respondent be and the same is found to be in violation of F.S.
465.016(1)(e) and his license to practice pharmacy in the State of Florida is hereby REVOKED. This Order shall take effect upon filing with the Clerk of the Department of Professional Regulation.
DONE AND ORDERED this 7th day of May, 1984, by the Florida Board of Pharmacy.
Wanda Willis, Executive Director Florida Board of Pharmacy
Copies furnished to:
Bruce D. Lamb, Esquire Mark Krasnow, Esquire
=================================================================
CORRECTED AGENCY FINAL ORDER
=================================================================
STATE OF FLORIDA
DEPARTMENT OF PROFESSIONAL REGULATION
DEPARTMENT OF PROFESSIONAL REGULATION, BOARD OF PHARMACY,
Petitioner,
DOAH NO. 82-2161
vs. DPR NO. 0019955
BEN COHN,
Respondent.
/
CORRECTED FINAL ORDER
THIS CAUSE came on to be heard by the Florida Board of Pharmacy of the Department of Professional Regulation at a regularly scheduled meeting held on April 9, 1984, in Pensacola Florida.
Appearance for Petitioner: Bruce D. Lamb
Staff Attorney
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
Appearance for Respondent: No appearance
FINDINGS OF FACT
After reviewing the complete record the Florida Board of Pharmacy hereby adopts the Findings of Fact as set forth by the Hearing Officer in her order of November 1, 1983.
As a preliminary matter, the Board determined to deny the request for a continuance filed by Respondent in this cause insofar as this matter has previously been scheduled for two board meetings and continued at Respondent's request. Petitioner has filed exceptions to the Conclusions of Law of the Hearing Officer and Respondent has filed a written response to said exceptions.
The Hearing Officer in her Conclusions of Law and her recommendation of dismissal construed the provisions of F.S. 465.016(1)(e) which incorporates by reference the provisions of F.S. 893.04(1) in a manner which the Board's opinion is erroneous as a matter of law.
As is pointed out in the exceptions to the Hearing Officer's Recommended Order filed by Petitioner in this cause the provisions of F.S. 465.016(1)(e)
incorporated as grounds for discipline any violation of the provisions of Chapter 893, Florida Statutes. The relevant provisions of Chapter 893.04(1) state "a pharmacist, in good faith and in the course of professional practice only, (e.s.) may dispense controlled substances upon a written or oral prescription of a practitioner under the following conditions . . . " The Hearing Officer went on to conclude that the listed conditions set forth in Chapter 893.04(1) are exclusive and strictly define what is "professional practice" in the practice of pharmacy. It is a position of the Florida Board of Pharmacy that such a construction of Chapter 893 is inappropriate since it is clear that there are two different sets of conditions which must be met in determining whether a pharmacist has properly followed the provisions of Ch.
893.04(1) and by reference s. 465.016(1)(e). Not only must a pharmacist be assured that the controlled substance in question meets the standards of Ch. 893 as regards to the form of prescription, the manner in which the prescription is to be filled, the labeling requirements for the container in which the medication is dispensed and record keeping requirements for the pharmacist in filling the prescription but also such dispensing should be in the course of the professional practice whether or not the actual format of the prescription is met. In other words, a pharmacist must not be permitted under the guise of having received a prescription or many prescriptions from a licensed prescriber to fill such prescription(s) when based upon his training and experience and all the facts surrounding the prescription(s) it is clear that such prescription or prescriptions taken as a whole have been written outside the course of professional practice of pharmacy and would do harm to the patient or public.
Thus, to the extent that the Hearing Officer determined that the analysis of a determination of a violation of s. 465.016(1)(e) and therefore Ch. 893.04(1), is limited to the determination of whether the formal requirements for an acceptable prescription had been met such a conclusion is erroneous. A further inquiry must be made as to whether or not in the common practice of the profession of pharmacy the prescription or prescriptions should have been filled in the course of acceptable professional practice and keeping in mind the preservation of the public health, safety and welfare. Based upon the expertise of the members of the Board of Pharmacy and the facts of this case it is determined that the practice of Respondent was not in the course of professional practice. See Department of professional Regulation v. Herman Ginsberg, DOAH Case No. 81-1951, Department of Professional Regulation v. BGJM and Robert E. Levy, DOAH Case No. 82-2096, U.S. v. Kershman, 555 F.2d 191 (5th Cir. 1977).
In light of the fact that the Hearing Officer's conclusion that the provisions of F.S. 465.016(1)(e), are found to be erroneous such conclusions are rejected and Respondent be and the same is found to be in violation of F.S.
465.016(1)(e) and his license to practice pharmacy in the State of Florida is hereby REVOKED. This Order shall take effect upon filing with the Clerk of the Department of professional Regulation.
DONE AND ORDERED this 30th day of May, 1984, by the Florida Board of Pharmacy.
C. Rod Presnell, Director FLORIDA BOARD OF PHARMACY
Copies furnished to: Bruce D. Lamb, Esquire
Mark Krasnow, Esquire
Docket for Case No: 82-002161
Orders for Case No: 82-002161
| Issue Date |
Document |
Summary |
|
Sep. 09, 1987 |
Recommended Order
|
Proof failed to demonstrate that pharmacist who filled 202,404 Methaqualone prescriptions within six-month period acted in bad faith or outside practice.
|
|
May 30, 1984 |
Agency Final Order
|
|
|
May 07, 1984 |
Agency Final Order
|
|
