My Opera
Drug Shortages Persist in U.S. and it is Real and Alarming
Wednesday, November 21, 2012 1:22:35 AM
... the chief of a rural ambulance squad in southern Ohio, was down to his last vial of morphine...
Paul Davis, the chief of a rural ambulance squad in southern Ohio, was down to his last vial of morphine earlier this fall when a woman with a broken leg needed a ride to the hospital. The trip was 30 minutes, and the patient was in pain. But because of a nationwide shortage, his morphine supply had dwindled from four doses to just one, presenting Mr. Davis with a stark quandary. Should he treat the woman, who was clearly suffering? Or should he save it for a patient who might need it more?
In the end, he opted not to give her the morphine, a decision that haunts him still. “I just feel like I’m not doing my job,” said Mr. Davis, who is chief of the rescue squad in Vernon, Ohio. He has since refilled his supply. “I shouldn’t have to make those kinds of decisions.”
From rural ambulance squads to prestigious hospitals, health care workers are struggling to keep vital medicines in stock because of a drug shortage crisis that is proving to be stubbornly difficult to fix. Rationing is just one example of the extraordinary lengths being taken to address the shortage, which health care workers say has ceased to be a temporary emergency and is now a fact of life. In desperation, they are resorting to treating patients with less effective alternative medicines and using expired drugs. The Cleveland Clinic has hired a pharmacist whose only job is to track down hard-to-find drugs.
Caused largely by an array of manufacturing problems, the shortage has prompted Congressional hearings, a presidential order and pledges by generic drug makers to communicate better with federal regulators.
The problem peaked in 2011, when a record 251 drugs were declared in short supply. This year, slightly more than 100 were placed on the list, and workers say the battle to keep pharmacy shelves stocked continues unabated. The list of hard-to-find medicines ranges from basic drugs like the heart medicine nitroglycerin to a lidocaine injection, which is used to numb tissue before surgery.
A deadly meningitis outbreak caused by contamination at a large drug producer could worsen the situation, federal officials have warned. The Food and Drug Administration said that shortages of six drugs — medicines used during surgery and to treat conditions like congestive heart failure — could get worse after a big compounding pharmacy closed over concerns about drug safety. The pharmacy, Ameridose, shares some management with the New Eng-land Compounding Center, which is at the center of a meningitis outbreak that has claimed 33 lives.
“When you can’t treat basic things — cardiac arrest, pain management, seizures — you’re in trouble,” said Dr. Carol Cunningham, the state medical director for the Ohio Department of Public Safety’s emergency services division. “When you only have five tools in your toolbox and three of them are gone, what do you do?”
Dr. Margaret A. Hamburg, the F.D.A. commissioner, said in an interview this week that she was “guardedly optimistic” that the shortage crisis was abating. “I think there’s been an enormous amount of progress,” she said. “We’re seeing real change in the number of shortages that we’re able to recognize early.” More than 150 new shortages have been prevented this year, according to the agency.
But Erin Fox, who tracks supply levels for a broader range of drugs at the University of Utah, said once a drug became scarce, it tended to stay scarce. The university’s Drug Information Service was actively tracking 282 hard-to-find products by the end of the third quarter of this year, a record.
“The shortages we have aren’t going away — they’re not resolving,” she said. “But the good news is we’re not piling more shortages on top.”
In 2011, prompted by emotional pleas by cancer patients and others who said the drug shortage was threatening lives, President Obama issued an executive order requiring drug makers to notify the F.D.A. when a shortage appeared imminent. The agency also loosened some restrictions on importing drugs, and sped up approvals by other manufacturers to make certain medicines.
A law passed this summer contains several provisions aimed at improving the situation, including expediting approval of new generic medicines and requiring the agency’s enforcement unit to better coordinate with its drug-shortage officials before it takes action against a manufacturer.
Ralph G. Neas, the chief executive of the Generic Pharmaceutical Association, said fixing the drug shortage was complex and would take time, but was a top priority. “One shortage is one shortage too many,” he said. “One patient not getting a critical drug is one patient too many.”
Federal drug officials trace much of the drug shortage crisis to delays at plants that make sterile injectable drugs, which account for about 80 percent of the scarce medicines. Nearly a third of the industry’s manufacturing capacity is not running because of plant closings or shutdowns to fix serious quality issues. Other shortages have been caused by supply disruptions of the raw ingredients used to make the drugs, or by manufacturers exiting the market.
Some people have accused the F.D.A. of causing the shortages, saying overzealous enforcement and poor communication have led plants to close needlessly or to slow production. Others have cited economic factors, like market pressures and reimbursement policies that have set prices so low that some companies have stopped making certain drugs. Earlier this week, several Democratic members of Congress asked the Government Accountability Office to investigate whether the practices of so-called group purchasing organizations, which buy drugs on behalf of hospitals, was contributing to the shortage.
Regardless of the cause, the drug shortage has forced the F.D.A. to make some tough choices, including allowing manufacturers to sell drugs that, if it were not for the crisis, most likely would have been recalled. Last year, for ex-ample, the agency allowed the manufacturer American Regent to sell a drug used during chemotherapy that was found to contain glass particles. Doctors and nurses were instructed to filter the drug, sodium thiosulfate, before ad-ministering it to patients.
“If there wasn’t a shortage, we would never allow a company to continue marketing” in such cases, Dr. Sandra Kweder, deputy director of the F.D.A.’s office of new drugs, said. But “patients need it.”
Dr. Hamburg said drug manufacturers had invested significantly in improving their facilities, upgrades that will ultimately help ease the crisis but that in the near term are making some shortages difficult to resolve. “It’s not going to happen overnight, but we’re in the midst of a period of really, very significant change that offers great promise for the future,” she said.
Patients like Jennifer Lacognata, a mother of two in sub-urban Florida, say they cannot afford to wait. She has debilitating night blindness, skin lesions and other health problems because she cannot absorb vitamin A through her diet, a rare side effect of weight-loss surgery she had years ago. In 2011, her doctor prescribed Aquasol A, a liquid form of the vitamin, to be injected into her shoulder.
But Hospira has temporarily stopped selling Aquasol A after it decided to move manufacturing of the product from an outside company to one of its plants. The company recently decided to abort the plan, citing complex technical challenges, and now has a deal with another company to begin making the vitamin.
Ms. Lacognata sued Hospira unsuccessfully to try to compel the company to make it again.
A company spokeswoman said Hospira recognized the critical need for Aquasol A and was “working diligently” to return it to the market, but declined to provide an estimate of when.
Given that the delays have stretched for more than a year, Ms. Lacognata said she was not holding her breath. “If they don’t get their act together and do this, they’re not going to suffer,” she said.
“They’re still going to be making millions of dollars. It’s the little guy in the end who ends up with nothing.”
By KATIE THOMAS
Here is a listing of some of the more popular drugs becoming vacant from our pharmaceutical shelves...
A
Acetylcysteine Inhalation Solution1
Acyclovir Sodium Injection2 (initial posting 11/13/2012)
Alfentanil (Alfenta) Injection3 (initial posting 1/23/2012)
Amikacin Injection4 11/14/2012
Amino Acid Products5 (initial posting 2/14/2012)
Ammonium Chloride Injection6
Amphetamine Mixed Salts, ER (Adderall XR) Capsules7 (initial posting 10/31/2011) 11/14/2012
Amphetamine Mixed Salts Immediate-Release (Adderall) Tablets8 (initial posting 1/12/2012)
Atracurium besylate9 (initial posting 2/27/2012)
Atropine Sulfate Injection10
B
Bacteriostatic 0.9% Sodium Chloride11 (initial posting 9/10/2012) 11/14/2012
Barium Sulfate for Suspension12 (initial posting 10/12/2012)
Bismuth subsalicylate/tetracycline hydrochloride/metronidazole (Helidac) Therapy13 (initial posting 3/8/2012)
Bumetanide Injection14 (initial posting 6/21/2012)
Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection15
Buprenorphine hydrochloride (Buprenex) Injection16
Butorphanol (Stadol) Injection17
C
Caffeine, anhydrous (125 mg/mL) and Sodium benzoate (125 mg/mL)
18Caffeine and Ergotamine Tartrate Tablet19 (initial posting 3/8/2012)
Cardiolite, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection20 (initial posting 2/14/2012)
Cetrorelix Acetate for Injection (Cetrotide)21 (initial posting 9/20/2012)
Chloroprocaine (Nesacaine) Injection22 (initial posting 3/28/2012) 11/14/2012
Chromic Chloride Injection23
Citric Acid; Gluconolactone; Magnesium Carbonate Solution (Renacidin); Irrigation24 (initial posting 6/30/2012)
Corticorelin Ovine Triflutate25
D
Daunorubicin Hydrochloride Solution for Injection26
Denileukin diftitox (Ontak) injection27 (initial posting 9/22/2012)
Desmopressin Injection (DDAVP)28
Dexrazoxane (Zinecard) Injection29
Dextroamphetamine (Dexedrine) Tablets30 (initial posting 1/12/2012)
Dextrose Injection31 (initial posting 5/23/2012)
Diazepam Injection32
Dipyridamole Injection33 (initial posting 7/24/2012)
Doxorubicin (adriamycin) lyophilized powder34 (initial posting 12/2/2011)
Doxorubicin Liposomal (Doxil) Injection35
E
Edetate Calcium Disodium (Calcium Disodium Versenate) Injection36 (initial posting 10/12/2012)
Epinephrine Injection37 (initial posting 4/27/2012)
Epinephrine 1mg/mL (Preservative Free)38 (initial posting 6/21/2012) 11/14/2012
Erythromycin Lactobionate Injection39 (initial posting 6/12/2012)
Ethiodol (ETHIODIZED OIL) ampules40
Etomidate (Amidate) Injection41 (initial posting 2/9/2012) 11/14/2012
F
Fentanyl Citrate (Sublimaze) Injection42
Fluticasone Propionate and Salmeterol (Advair HFA) Inhalation Powder43 (initial posting date) - 10/17/2012)
Foscarnet Sodium (Foscavir) Injection44
Fosphenytoin Sodium (Cerebyx) Injection 45(initial posting 3/30/2012) 11/14/2012
Fospropofol disodium (Lusedra) Injection46 (initial posting 6/18/2012)
Furosemide Injection47 (initial posting 6/20/2012) 11/14/2012
G
Gallium Nitrate Injection (Ganite)48 (initial posting 4/4/2012)
H
Heparin Sodium Premixes49 (initial posting 7/5/2012)
Hydromorphone Hydrochloride (Dilaudid) Injection50 (initial posting 3/7/2012)
I
Ibandronate sodium (Boniva) injection51 (initial posting 6/6/2012)
Intravenous Fat Emulsion52
Isoniazid Tablets 53 11/14/2012
K
Ketorolac Tromethamine Injection54
L
Leucovorin Calcium Lyophilized Powder for Injection55 11/9/2012
Leuprolide Acetate Injection56
Lidocaine (Xylocaine) Hydrochloride Injection57 (initial posting date - 2/22/2012)
Lidocaine HCL, 4% Topical Solution (Laryng-O-Jet, LTA kit)58 (initial posting 5/31/2012)
Liotrix (Thyrolar) Tablets 59
Lorazepam (Ativan) Injection60
M
Magnesium Sulfate Injection61
Mannitol Injection (Osmitrol, Resectisol) Injection62 (initial posting date - 12/21/2011) 11/14/2012
Methadone Injection63 (initial posting - 11/13/2012)
Methazolamide (Glauctabs, Neptazane) Tablets64 11/14/2012
Methotrexate Injection65
Methoxsalen (Oxsoralen) 1% topical lotion66
Methyldopate HCL Injection67
Metoclopramide (Reglan) Injection68
Midazolam HCL (Versed) Injection69 11/14/2012
Mitomycin Powder for Injection70
Morphine Sulfate Injection71
Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free)72 11/14/2012
Multi-Vitamin Infusion (Adult and pediatric)73 9/18/2012
N
Nalbuphine HCl (Nubain) Injection74 (initial posting 5/15/2012)
Naloxone (Narcan) Injection75 (initial posting 2/22/2012)
Naltrexone Oral (Revia) Tablets76 (initial posting 2/22/2012)
Nefazodone (Serzone) Tablets77 (initial posting 4/16/2012)
Nitroglycerin Ointment USP, 2% (Nitro-Bid)78 (Initial posting 10/23/2012)
Norethindrone and Ethinyl Estradiol Tablets, USP (Ovcon 50 Tablets)79 (initial posting 4/16/2012)
O
Ondansetron (Zofran) Injection 2 mg/mL80 11/14/2012
Ondansetron Injection 32 mg/50 mL premixed bags81
Oxymorphone Hydrochloride (Opana) Oral Tablet82 (initial posting 3/19/2012)
P
Pancuronium Bromide Injection83
Peginterferon Alfa-2a (Pegasys) Injection-Prefilled Syringes84 (initial posting 3/26/2012)
Pentamidine isethionate inhalant (NebuPent)85 (initial posting 8/27/2012) 11/14/2012
Pentamidine isethionate for injection (Pentam 300)86 (initial posting 8/27/2012) 11/14/2012
Pentostatin for Injection (Nipent)87 (initial posting 3/21/2012)
Perflutren Lipid Microsphere (DEFINITY) Injection88 (initial posting 3/23/2012)
Phentolamine Mesylate (Regitine) Injection89
Pilocarpine HCL Opthalmic Gel 4% (Pilopine HS)90 (initial posting 6/1/2012)
Potassium Chloride Injection 2 mEq/mL91 (initial posting 5/15/2012) 11/14/2012
Potassium Phosphate Injection92
Procainamide HCL Injection93
Prochlorperazine Injection94 (initial posting 1/30/2012)
Promethazine Injection95 (initial posting 2/10/2012)
Propofol (Diprivan) Injection96 (initial posting 4/5/2012)
S
Secretin Synthetic Human (ChiRhoStim) Injection (ChiRhoStim)97 (initial posting 6/15/2012)
Selenium Injection98
Sodium Acetate Injection99 (initial posting 3/20/2012) 11/14/2012
Sodium benzoate and Sodium phenylacetate (Ammonul) Injection100
Sodium Bicarbonate Injection101 (initial posting 4/4/2012) 11/14/2012
Sodium Chloride 0.9% (5.8mL and 20mL)102 (initial posting 5/4/2012)
Sodium Chloride 23.4%103 11/14/2012
Succinylcholine (Anectine, Quelicin) Injection104 (initial posting 8/17/2012)
Sufentanil Citrate (Sufenta) Injection105
Sulfamethoxazole 80mg/trimethoprim 160mg/ml injection (SMX/TMP) Bactrim)106
T
Technetium Tc99m Bicisate for Injection (Neurolite)107 (initial posting 5/4/2012)
Telavancin (Vibativ) Injection
108Tetracycline Capsules109
Thiotepa (Thioplex) for Injection110
Thyrotropin alfa (Thyrogen) injection 1.1mg/vial111
Ticarcillin disodium/Clavulanic Potassium Injection (Timentin)112 (initial posting 8/16/12)
Ticlopidine (Ticlid) Tablets113
Tobramycin Solution for Injection114 11/14/2012
Tromethamine (Tham) Injection115 (initial posting 5/2/2012)
V
Viaspan Cold Storage Solution 1000 mL Bag116 (initial posting 4/16/2012)
Vinblastine Sulfate Injection117 (initial posting 1/31/2012)
Vitamin A Palmitate (Aquasol A) Injection118
Vitamin K1 (Phytonadione) Injectable Emulsion119
Z
Zinc Chloride Injection120 (initial posting 2/15/2012)
(0%)
Unregistered user # Thursday, November 22, 2012 4:36:08 AM