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October 3, 2006 Heidi Klein, age 47 years, consulted her primary care physician at Methodist Foundation, Dr. John Reed, with complaints of leg cramps. Dr. Reed prescribed Quinine Sulfate.
October 3, 2006 Ms. Klein signed the CVS Pharmacy Prescription Pick- Up Log under the column that stated,
October 3, 2006 Ms. Klein signed the CVS Pharmacy Prescription Pick- Up Log under the column that stated, "No, I do not wish to speak with the Pharmacist regarding my prescription."
Heidi Klein Red Flag Warnings Ms Klein ignored the possible side effects of the use of Quinine. October 3, 2006 Ms. Klein signed the CVS Pharmacy Prescription Pick- Up Log under the column that stated, "No, I do not wish to speak with the Pharmacist regarding my prescription."
October 6, 2006 Ms. Klein returned for scheduled follow-up. Regarding the recent prescription of Quinine Sulfate for nocturnal leg cramps, Ms. Klein told Dr. Reed that it had worked wonders." Dr. Reed told her she could continue the medication for now since it did not appear to be causing her any problem.
October 16, 2006 Ms. Klein phoned Dr. Reed's office from Boston, Mass. requesting that he phone in a prescription for complaints of fever, chills and headache.
October 17, 2006 Ms. Klein was hospitalized and treated at the Tufts University Medical Center emergency room in Boston for a serious fever, rash, and headache. Upon admission, the Tufts doctors immediately ordered Ms. Klein to "stop" taking quinine.
Doctors at Tufts warned Ms. Kein to stop taking Quinine. October 17, 2006 Ms. Klein was hospitalized and treated at the Tufts University Medical Center emergency room in Boston for a serious fever, rash, and headache. Upon admission, the Tufts doctors immediately ordered Ms. Klein to "stop" taking quinine.
October 17, 2006 The doctors at Tufts expressly linked quinine sensitivity to the medical conditions requiring her hospitalization. Upon discharge from the Tufts University Hospital, her discharge orders stated, "Patient instructed to discontinue quinine use."
Third warning for Ms Klein to stop taking quinine. October 17, 2006 The doctors at Tufts expressly linked quinine sensitivity to the medical conditions requiring her hospitalization. Upon discharge from the Tufts University Hospital, her discharge orders stated, "Patient instructed to discontinue quinine use."
October 24, 2006 Dr. Reed next saw Ms. Klein on October 24, 2006, due to continued complaints of fever and headache. Ms. Klein reported that she had been advised to discontinue use of Quinine.
Ms Klein recognizes that she has been advised to stop taking quinine. October 24, 2006 Dr. Reed next saw Ms. Klein on October 24, 2006, due to continued complaints of fever and headache. Ms. Klein reported that she had been advised to discontinue use of Quinine.
October 24, 2006 Dr. Reed reviewed the medical record from Tufts New England Medical Center and told Ms. Klein that her condition was not related to Quinine Sulfate.
Dr. Reed should not have prescribe Quinine for leg cramps. He was wrong in his review of the medical records. October 24, 2006 Dr. Reed reviewed the medical record from Tufts New England Medical Center and told Ms. Klein that her condition was not related to Quinine Sulfate.
November 12, 2006 On November 12, 2006, Ms. Klein refilled the Quinine Sulfate prescription at CVS Pharmacy and signed the CVS Pharmacy Prescription Pick-Up Log under the column that stated, "No, I do not wish to speak with the Pharmacist regarding my prescription."
Ms Klein refused to speak with the Pharmacist for the second time. November 12, 2006 On November 12, 2006, Ms. Klein refilled the Quinine Sulfate prescription at CVS Pharmacy and signed the CVS Pharmacy Prescription Pick-Up Log under the column that stated, "No, I do not wish to speak with the Pharmacist regarding my prescription."
Excerpts from the December 2006 notice include: 1) Drug products containing quinine, quinine sulfate, or any salt of quinine currently being marketed may not be manufactured after the effective date of this notice (i.e. "currently marked products"), which is February 13, 2007. 2) Any firm distributing such an unapproved product may not ship the product in interstate commerce after June 13, 2007. 3) Unapproved drug products containing quinine, quinine sulfate, or any salt of quinine that are not currently marketed products on the effective date of this notice must not be distributed after December 15,2006.
FDA sent out excerpts about the manufacturing, distributing and marketing of Quinine Excerpts from the December 2006 notice include: 1) Drug products containing quinine, quinine sulfate, or any salt of quinine currently being marketed may not be manufactured after the effective date of this notice (i.e. "currently marked products"), which is February 13, 2007. 2) Any firm distributing such an unapproved product may not ship the product in interstate commerce after June 13, 2007. 3) Unapproved drug products containing quinine, quinine sulfate, or any salt of quinine that are not currently marketed products on the effective date of this notice must not be distributed after December 15,2006.
January 20, 2007 Ms. Klein refilled a Quinine Sulfate prescription at CVS Pharmacy and signed the CVS Pharmacy Pick-Up Log under the column that stated, "No, I do not wish to speak with the Pharmacist regarding my prescription."
Ms Klein refused to speak with the Pharmacist for the third time. January 20, 2007 Ms. Klein refilled a Quinine Sulfate prescription at CVS Pharmacy and signed the CVS Pharmacy Pick-Up Log under the column that stated, "No, I do not wish to speak with the Pharmacist regarding my prescription."
January 20, 2007 Ms. Klein did not retain the written information she was provided by the pharmacist and/or pharmacy on this date.
Ms Klein did not retain the written information that was provided by the pharmacist. January 20, 2007 Ms. Klein did not retain the written information she was provided by the pharmacist and/or pharmacy on this date.
January 20, 2007 The written information is entitled "Patient Prescription Information" and specifically stated under the "Uses" section, "... The U.S. Food and Drug Administration (FDA) warns that quinine or quinine sulfate should not be used to treat leg cramps."
FDA warns that Quinine Sulfate should not be used to treat leg cramps. January 20, 2007 The written information is entitled "Patient Prescription Information" and specifically stated under the "Uses" section, "... The U.S. Food and Drug Administration (FDA) warns that quinine or quinine sulfate should not be used to treat leg cramps."
February 19, 2007 February 19, 2007, Methodist Foundation Hospital issued a "Pharmacist's Letter," which stated in pertinent part:
February 19, 2007 Dear Pharmacists: 1) All quinine products EXCEPT Qualaquin will soon disappear. Qualaquin is the only quinine approved by the FDA. The others came on the market before FDA approval was required. Now the FDA will force the unapproved quinine products off the market. Shipments will cease by next June or earlier.
FDA warns all doctors about Quinine Sulfate that it will soon be disappearing of the shelves. February 19, 2007 Dear Pharmacists: 1) All quinine products EXCEPT Qualaquin will soon disappear. Qualaquin is the only quinine approved by the FDA. The others came on the market before FDA approval was required. Now the FDA will force the unapproved quinine products off the market. Shipments will cease by next June or earlier.
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