Louisiana: Manufacturer of medicine (Main Street Family Pharmacy) and group of doctors sued by patient who received allegedly contaminated injection

GRETNA – A woman who claims her arm was severely infected and needed surgery after she received a contaminated injection is suing a healthcare provider and the producer of the medication.
Michelle Ellzey filed suit against Dr. James Patterson, Dr. Jorge Contreras, an unknown doctor, Pelican State Outpatient Center and Main Street Family Pharmacy in the 24th Judicial District Court on Dec. 26.
Ellzey asserts that on Dec. 26, 2012 she went to the Pelican State Outpatient Center located in Harahan with complaints of body aches, tiredness, cough and nasal congestion and was seen by Patterson who diagnosed her with an upper respiratory infection. The plaintiff alleges that an unknown employee of Pelican State Outpatient Center injected her with what was thought to be DepoMedrol a drug that was manufactured by Main Street Pharmacy. Ellzey claims that on July 19, 2013 she received a letter informing her that the drug that she injected was recalled due to contamination.
The plaintiff asserts that after receiving the injection the puncture hole from the needle became swollen and she began to experience pain in the area. Ellzey alleges that upon examination of the area Contreras advised her that the pain was normal and that he did not believe she was in any danger because the skin was not discolored and she did not have a fever. On Oct. 1, 2013, the plaintiff claims what she thought was a tumor was found in the area of the injection and that when a surgeon removed the growth it was found to be an infectious mass that was a result of the contaminated injection.
The defendant is accused of product liability and medical malpractice.
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Louisiana Board of Pharmacy Agenda for Meeting on august 27, 2013

AGENDA

1. Call to Order
   
2. Appearances
   
3. Notice of Intent re Regulatory Project 2013-4 ~ Preferential Licensing for Military Personnel
   
4. Notice of Intent re Regulatory Project 2013-5 ~ Collaborative Drug Therapy Management
   
5. Notice of Intent re Regulatory Project 2013-6 ~ Penal Pharmacy Permit Revision
   
6. Opportunity for Public Comment
   
7. Adjourn 
   

Louisiana Board of Pharmacy Agenda for Meeting on August 15, 2013

AGENDA
NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.
Revised 08-12-2013

1. Call to Order
   
2. Invocation & Pledge of Allegiance
   
3. Quorum Call
   
4. Call for Additional Agenda Items
   
5. Opportunity for Public Comment
   
6. Formal Hearings
   

01. PST.014998 - Nick Christopher Tran Case No. 10-0057

G. Report

2. CPT.008886 – LaShanda Toural Miles
   
3. PHY.006113 – Custom Pharmacy Solutions
   
4. PHY.006168 – Wellcare Pharmacy & Medical Supply
   
5. PHY.006235 – Pharmacy Alternatives of Texas
   
6. PHY.006650 – Post Haste Pharmacy
   
7. PST.011492 – Jeffery Paul Bolotte
   

H. Report

of General Counsel
Consideration of Voluntary Consent Agreements

Case Nos. 13-0129 & 13-013
Case No. 13-0137
Case No. 13-0183 Case No. 13-0241 Case No. 13-0240
Case No. 13-0238

of Violations Committee – Consideration of Voluntary Consent Agreements Case No. 12-0354 Case No. 13-0122 Case No. 13-0125 Case No. 13-0059

8. PHY.006694 – Belmar Pharmacy
   
9. CPT.008541 – Ilyssa Monique Johnson
   
10. PHY.006390 – Greer Pharmacy
    Consideration of Voluntary Surrenders
    
11. PST.014543 – Christian Allen Reuter, Jr. 
    
    
    12. PTC.018464 – Cynthia Perkins Little Case No. 13-0248
        
    13. PST.011145 – Louis Charles Gambina Case No. 13-0285
        Consideration of CDS Licenses for Disciplined Practitioners
        

    14. CDS.035358-MD – Andre’ Stephen Viator
        
    15. CDS.017125-MD – Ronald Dane Sylvest
        
    16. CDS.021107-DDS – David L. Ruegsegger
        
    17. CDS.006972-MD – Jerry Dwayne Helms
        
    18. CDS.025779-MD – Brian Allen Heise
        
    19. CDS.027772-MD – Howard Eugene Gidden
        

    I. Adjourn
    

    Case No. 13-0168 Case No. 13-0169 Case No. 13-0186 Case No. 13-0244 Case No. 13-0245 Case No. 13-0255 
    
    
    

Louisiana Board of Pharmacy Special Meeting Tuesday, January 29, 2013 at 8:30 a.m.--Compounding for Prescriber Use Consideration of Replacement Emergency Rule

4. Consideration of Replacement Emergency Rule re Compounding for Prescriber Use
Mr. Aron reminded the members of the disposition of their December 13, 2012 emergency rule and the January 18, 2013 legislative directive to issue a replacement emergency rule within two weeks. He reported the Regulation Revision Committee had met the previous week and prepared a regulatory proposal for a replacement emergency rule. Mr. Aron asked Mr. McKay, the committee chairman, to report on the committee’s meeting and proposal.
Mr. McKay reported the committee met on January 23 and that approximately twenty five guests were in attendance. He indicated the committee invited and received substantial input from the guests, which included a number of pharmacists practicing at several compounding pharmacies across the state. He directed the members to two documents in their meeting packet: the regulatory proposal developed by the committee, and a proposed declaration of emergency developed by staff. Following a brief discussion, Mr. McKay moved,
Resolved, that the Board approve the
Prior to the vote, Ms. Hall offered a clarifying amendment, which was approved without objection by the members. The motion for approval of the amended document was adopted after a unanimous roll call vote in the affirmative. Mr. McKay then directed the members to the regulatory proposal.
Declaration of Emergency – Compounding for Prescriber Use – LAC 46:LIII.2535.
In order to facilitate the discussion, Mr. McKay moved,
Resolved, that the Board approve Regulatory Proposal 2013-E-C ~ Compounding for Prescriber Use (Draft #1)
To authorize the Executive Director to submit the proposed amendment for promulgation upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process; and further, , to become effective as an Emergency Rule on January 31, 2013: and further,
To authorize the Executive Director to re-publish the Emergency Rule as may become necessary during the promulgation process.
During the discussion of that proposal, staff offered a suggested clarifying amendment within the paragraph relative to compounding commercial products not available. Mr. McKay moved to approve that clarifying amendment. The motion for approval of the clarifying amendment was adopted after a unanimous vote in the affirmative. Following additional discussion and comments from guests present, Mr. Aron called the question to a vote. The motion for approval of the amended regulatory proposal was adopted after a majority roll call vote in the affirmative. Mr. Adams, Mr. Bond, Mr. Burch, Mr. Dartez, and Mr. Valentine objected.
Following the vote, staff suggested a potential conflict in the interpretation of the regulatory proposal and the declaration of emergency. In particular, the regulatory proposal identified a limitation of ten percent of a pharmacy’s total dispensing and distribution activity, whereas the declaration of emergency identified a limitation of ten percent of a pharmacy’s compounding activity. The members reiterated their intent the

limitation should be applicable to a pharmacy’s entire dispensing and distribution activity and not just the compounding activity. Mr. Adams moved to direct the staff to prepare the appropriate amendment(s) for the declaration of emergency to reflect the language and intent of the regulatory proposal. That motion was adopted after a unanimous vote in the affirmative.
Source found here

Louisiana has proposed a law in its Pharmacy Practice Act that Uses the Term "Pharrmacy-Generated Product"

2013-A ~ Defines a new term 'Pharmacy-generated product' in the Pharmacy Practice Act.
               03-06-2013 - Amended, and then Draft #2 approved for filing by the Board.


Legislative Proposal 2013-A ~ PGP Draft #2
1 Louisiana Revised Statutes of 1950
2 Title 37 – Professions and Occupations
3 Chapter 14 – Pharmacy Practice Act
4 Part A. General Provisions
5 …
6 §1164. Definitions
7 As used in this Chapter, the following terms have the meaning ascribed to them by this Section:
8 …
9 (4.9) “Compounded pharmacy-generated product” means a drug product prepared by a pharmacy for
10 distribution as defined by rule.

Source found here




 

Louisiana Board of Pharmacy Meeting Today, March 6, 2013

Revised 03-01-2013
1. Call to Order
2. Invocation & Pledge of Allegiance
3. Quorum Call
4. Call for Additional Agenda Items
5. Consideration of Minutes from Previous Meetings – December 12-13, 2012 & January 29, 2013
6. Report on Action Items
7. Confirmation of Acts
8. Opportunity for Public Comment
9. Committee Reports
A. Finance – Mr. Pitre
• Consideration of Interim Report for Fiscal Year 2012-2013
B. Application Review – Ms. Melancon
• Consideration of Committee Recommendations re Applications
C. Reciprocity – Ms. Hall
• Consideration of Committee Recommendations re Applications
D. Violations – Mr. Bond
E. Impairment – Mr. Rabb
• Consideration of Committee Recommendations re Applications
F. Reinstatement – Mr. Adams
• Consideration of Committee Recommendations re Applications
G. Tripartite – Mr. Burch
H. Regulation Revision – Mr. McKay
• Consideration of Comments & Testimony at February 27, 2013 Public Hearing
• Consideration of Regulatory Proposal 2013-A ~ Pharmacy Recordkeeping (Draft #4)
• Consideration of Regulatory Proposal 2013-C ~ Pharmacy Technician Training
Programs (Draft #2)
• Consideration of Legislative Proposal 2013-A ~ Pharmacy-generated Product
• Consideration of Legislative Proposal 2013-B ~ Non-resident Pharmacies
• Consideration of Legislative Proposal 2013-C ~ Pharmacy Schools
• Consideration of Legislative Proposal 2013-D ~ PMP Delegates
I. Executive – Mr. Aron
• Consideration of Committee Recommendations re Contracts & Agreements
10. Staff Reports
J. Prescription Monitoring Program – Mr. Fontenot
• Consideration of Requests from Pharmacies for Waivers from Reporting to PMP
• Consideration of Memorandum of Understanding with Indian Health Service
K. General Counsel – Mr. Finalet
L. Executive Director – Mr. Broussard
11. Request for Opinion: Disposition of Dispensed (but not retrieved by patient) Prescription
Medications from Central Fill Pharmacy [LAC 46:LIII.1141] – Timothy Koch, Wal-Mart Pharmacies
12. Request for Review of Penal Pharmacy Rule [LAC 46:LIII.Chapter 18] – Joseph Wiley
13. Announcements
14. Recess

Source found here

Louisiana Board of Pharmacy Agenda for Meeting tomorrow, 2/20/13

A G E N D A
NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.
Revised 02-01-2013
1. Call to Order
2. Quorum Call
3. Call for Additional Agenda Items
4. Opportunity for Public Comment
5. Consideration of Minutes from Previous Meetings – January 10 & January 23, 2013
6. Old Business
a. Hospital pharmacy dispensing/distribution processes and recordkeeping rules
b. Act 142 of 2010 Legislature, re Chapter 29 – Prescription Monitoring Program
(addition of veterinarians)
c. Signatures on electronic prescriptions
d. Standards for pharmacies hosting immunization activities
e. Expansion of pharmacy permits to include:
(1) Call centers with cognitive services
(2) Pharmacists exercising cognitive services outside a pharmacy
f. Act 276 of 2012 Legislature – preferential licensing procedures for military trained applicants and their spouses
g. Collaborative drug therapy management (CDTM) update
h. Pharmacist verification of medications in automated dispensing systems [La. R.S. 37:1212]
7. New Business
a. Pharmacy generated products (non-patient-specific products)
b. Delegate accounts for PMP access
NOTE: Pursuant to the Open Meetings Law at La. R.S. 42:16, the committee may, upon 2/3 affirmative vote of those members
present and voting, enter into executive session for the limited purpose of (1) discussion of the character, professional competence,
or physical or mental health of a licensee, (2) investigative proceedings regarding allegations of misconduct, (3) strategy sessions or
negotiations with respect to litigation, (4) discussions regarding personnel matters, or other purposes itemized at La. R.S. 42:17.
c. Reimbursement for travel expenses for inspection of out-of-state pharmacies
8. Adjourn

Reminder: Louisiana Board of Pharmacy Public Hearing Regarding Office or Prescriber's Use of Compound on Feb. 27, 2013

9:00 a.m. on Wednesday, February 27, 2013 at the Board office, for the purpose to wit:
A G E N D A
1. Call to Order
2. Appearances
3. Notice of Intent re Regulatory Project 2013-1 ~ Compounding for Prescriber’s Use
4. Notice of Intent re Regulatory Project 2013-2 ~ Satellite Pharmacies
5. Opportunity for Public Comment
6. Adjourn

Louisiana Board of Pharmacy Regulation Revision Committee Agenda for Feb. 20, 2013 meeting

NOTICE IS HEREBY GIVEN that a meeting of the Regulation Revision Committee has been ordered and called for 8:30 a.m. on Wednesday, February 20, 2013 at the Board office, for the purpose to wit:
A G E N D A
NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.
Revised 02-01-2013
1. Call to Order
2. Quorum Call
3. Call for Additional Agenda Items
4. Opportunity for Public Comment
5. Consideration of Minutes from Previous Meetings – January 10 & January 23, 2013
6. Old Business
a. Hospital pharmacy dispensing/distribution processes and recordkeeping rules
b. Act 142 of 2010 Legislature, re Chapter 29 – Prescription Monitoring Program
(addition of veterinarians)
c. Signatures on electronic prescriptions
d. Standards for pharmacies hosting immunization activities
e. Expansion of pharmacy permits to include:
(1) Call centers with cognitive services
(2) Pharmacists exercising cognitive services outside a pharmacy
f. Act 276 of 2012 Legislature – preferential licensing procedures for military trained applicants and their spouses
g. Collaborative drug therapy management (CDTM) update
h. Pharmacist verification of medications in automated dispensing systems [La. R.S. 37:1212]
7. New Business
a. Pharmacy generated products (non-patient-specific products)
b. Delegate accounts for PMP access

c. Reimbursement for travel expenses for inspection of out-of-state pharmacies
8. Adjourn