Posted on 06/20/2002 1:37:20 PM PDT by goody2shooz
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
Bio-Terrorism.Info
March 11, 2002 - March 18, 2002
Pg. 4
FACILITIES: Three towns competing to be site of vaccine production facility
Jefferson County, Arkansas, government and civic leaders hope what's already here will persuade federal officials to put a planned vaccine production lab in the Pine Bluff area, bringing 300 to 500 new jobs.
But Pine Bluff is competing against two other potential sites - San Antonio, Texas, and Aberdeen, Maryland - for the facility to make vaccines that would guard against a variety of bioterrorist threats.
The first government-owned vaccine production facility would be key in the U.S. military's effort to immunize soldiers who could be exposed to bioterrorist attacks, congressional sources said.
It also would be a major element of homeland security efforts, producing improved vaccines for anthrax and smallpox, and addressing what the Pentagon considers to be leading disease threats - plague, tularemia, botulinum and next-generation anthrax. The Pine Bluff area is already home to the Pine Bluff Arsenal and a $660 million Chemical Weapons Disposal Facility under construction at the arsenal, as well as the Clara Barton Emergency Preparedness Center and the National Center for Toxicological Research near the Jefferson community in northern Jefferson County.
That combination of weapons, defense and research facilities puts the community in a strong position to win the laboratory, Pine Bluff's proponents said.
"We have planned for this for years since the Desert Storm years," said Col. Mark R. Henscheid, commander of the Pine Bluff Arsenal. "We are poised to provide the infrastructure and security for the facility."
According to Henscheid, a 1994 Army report concluded that the arsenal was "the best site for the facility."
A request for proposals is expected this spring from the Defense Department or the Health and Human Services Department. The deadline for proposals will be in October or November, and an announcement is expected in 2003.
Dr. Kenton Lohman of the Air Force's Institute of Environment, Safety and Occupational Health Risk Analysis at Brooks Air Force Base in San Antonio said a team there is working to get the vaccine facility in the central Texas city.
"An influx of dollars into a city for something like this breeds very good things for everyone, including national and international recognition," Lohman said.
Advocates of a Maryland site argue on behalf of the Aberdeen Proving Ground, a major research facility for the Army.
Members of the Arkansas congressional delegation are pushing to make sure Pine Bluff gets strong consideration.
"We are going to make sure they are aware that the Pine Bluff Arsenal is the best site for the facility," said Rep. Mike Ross, D-Ark., whose 4th District includes Pine Bluff. "I want it at the Pine Bluff Arsenal because it will create jobs and opportunities for southeast Arkansas, and we will be doing a great service."
Sen. Tim Hutchinson, R-Ark., sponsored an amendment last year to spend $3 million for research and development for the laboratory.
In his State of the Union address on January 29, 2002 President Bush said more spending is necessary for programs and vaccines to fight biological warfare and bioterrorism threats.
The United States has only one manufacturer of anthrax vaccine - BioPort, a private company in East Lansing, Michigan. But BioPort's factory has repeately failed FDA inspections, forcing the military to suspend vaccination programs.
Hutchinson and other lawmakers cite BioPort's struggles in calling for the federal government to get into the vaccine-production business.
But Hutchinson concedes that, after spending $126 million with BioPort, there is no alternate supplier of anthrax vaccine in the short term. BioPort was cleared in early February to resume production of the vaccine.
The status of the anthrax vaccine underscores the need to develop a greater variety of options to combat deadline biological agents, according to Rep. Marion Berry, D-Ark. Building the vaccine laboratory in Pine Bluff would be a good start, he said.
"There's no question we have underfunded a number of programs in our effort to balance the budget, and bioterrorism is one of them," he said. "It's time to correct that problem."
Berry said the Arkansas delegation in Congress will make a strong pitch on Pine Bluff's behalf.
"They're not going to spend $1 billion and not have the Congress involved," he said. "It will be interesting to see how the Department of Defense handles this. Pine Bluff would seem to be a natural place."
It's nice having our own resident physician on board to help us with all this info. ;-)
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
Drug Topics
September 17, 2001No. 18, Vol. 145; Pg. 36
RUNNING ON EMPTY : What's behind the current rampant drug shortages? Pharmacists want to know.
Magill-Lewis, Jillene
Fentanyl, phenobarb, flu vaccine--the mere mention of these drugs, and a host of others, sends chills down pharmacists' spines. Pharmacists everywhere have come to dread the sight of a delivery printout and the words product unavailable. One shortage after another in recent years has made a nightmare of the once innocuous task of ordering drugs.
Pharmacists, physicians, and patients across the country have been asking, "Why?" Why have there been so many shortages lately? Why can some pharmacies get products, while others can't? Why are some prices skyrocketing? The Food & Drug Administration, state pharmacy boards, and groups such as ASHP have been hard at work looking for answers.
According to the FDA and ASHP, shortages can be caused by several situations. The issue "is multifactorial ... and it doesn't look like it's going away," said Joe Deffenbaugh, M.P.H., professional practice associate for ASHP. Manufacturers can spark shortages by abruptly discontinuing medications, either temporarily or permanently. Often, this is purely a financial decision. If a product isn't profitable, there isn't much incentive for a company to continue making it. When only two or three companies make a certain drug, discontinuation by one firm leaves the others holding the bag. Unlike other commodities, drug products can take months to manufacture. Even if the remaining companies scramble to step up production, it can be some time before they are able to fill the void.
This situation has been aggravated by company mergers. After combining forces, companies look at their product lines and eliminate poor performers. Also, if both firms have been manufacturing a particular drug, they may consolidate production of that drug. According to ASHP, this makes the product more vulnerable to shortage problems by reducing the number of manufacturers that make it.
Still another problem is aging facilities. Deffenbaugh pointed out that most of the drugs in short supply have been injectables. Manufacturing these drugs is complex and expensive. "What we've heard is that several manufacturers' sterile product facilities are getting old," he said.
As equipment ages, breakdowns are apt to occur more often. This stalls production as repairs are made. Some manufacturers are busy correcting the situation by building new plants. Others, when confronted with expensive major renovation requirements, have decided it's not worth manufacturing the product in question.
Unfortunately, no one has studied the phenomenon, so there is no way of knowing just how many plants need updating, said Deffenbaugh. Even worse, it's uncertain how many products may be affected in the future. Manufacturers are not exactly forthcoming with their plans. However, corporations do inform their stockholders of changes that may affect earnings, and Deffenbaugh said these reports have been a good source of information.
Other causes of shortages are even more problematic because of their unpredictability. Sudden, increased demand for a product can catch manufacturers by surprise. Raw material supplies are also vulnerable to a number of problems, as many suppliers are located in foreign countries. Natural disasters, wars, and disease in these countries can all inhibit or halt production of raw materials. These products may also undergo degradation or contamination before they reach the manufacturers, according to ASHP.
Can't the FDA do something?
In some cases, the FDA can help. In fact, the FDA has a department devoted to drug shortages. Mark Goldberg, M.D., is clinical coordinator of the department. Lisa Hubbard, R.Ph., and Valerie Jensen, R.Ph., are its project managers. Among other things, Hubbard, the senior project manager, and Jensen are responsible for communicating with R.Ph.s and the public about drug shortages. They maintain a Web site that highlights the shortages at www. fda.gov/cder/drug/shortages.
One of the main goals of Hubbard's department is to get shortage information to pharmacists as quickly as possible, so they can then explain it to their patients and physicians. At the Web site, R.Ph.s can sign up to receive notices and updates on drug shortages. You can also e-mail Hubbard and Jensen to let them know about a drug that's in short supply.
In addition to the Web site, Hubbard tries to have at least one contact person at all or most of the pharmacy organizations to better facilitate the dissemination of information. Her counterpart at ASHP is Deffenbaugh.
The FDA focuses on resolving shortages of medically necessary drugs, said Hubbard. She said that, believe it or not, most shortages are resolved before we even know about them. Only a small percentage ever becomes a problem. The agency continues to focus on the problem drugs until production is sufficient. While the FDA can't force companies to manufacture a drug, there are some things it can do.
For example, sometimes the FDA finds defects in facilities before manufacturers have had time to update them. The agency may have to halt production of a drug until the problem is corrected. If this seems likely to result in a shortage, and if the drug is medically necessary, the FDA will do what it can to alleviate the shortage.
In the case of updating facilities or correcting defects, the FDA can expedite inspections and application reviews. The agency can also look for alternative suppliers to help in the interim. In one case, a Canadian manufacturer was allowed to supply a drug while the original manufacturer got its plant up to par. When a sole supplier of a drug discontinues the product altogether, the FDA looks for manufacturers who may be willing to start making the drug.
One thing the FDA does not do is allow manufacturers to bypass steps that would affect drug quality. "The important thing to get out to the public is that we do not decrease our standards in any way," said Hubbard. Although the FDA is concerned about shortages, the agency is not willing to sacrifice drug safety and quality.
The problem is manufacturers are not in the habit of informing anyone in advance that they'll be discontinuing products. This means that no matter how quickly the FDA gets involved, there is likely to be a shortage until other manufacturers can meet the demand. For now, there's nothing more the FDA can do about this cause of shortages.
By law, only sole manufacturers of life-sustaining products that prevent a debilitating disorder are required to inform the FDA of intended discontinuation. In this case, manufacturers must give the FDA six months' notice before ceasing production. The public has the Food & Drug Administration Modernization Act (FDAMA) of 1997 to thank for this requirement.
After several drug companies discontinued products, which, in turn, created shortages, many people have been saying the FDAMA requirement should be extended to include other manufacturers and medications. ASHP agreed. "We've asked Congress to consider changing the FDA's definition to be much broader and to require all manufacturers of medically necessary drugs [to have to give six months' notice]," said Deffenbaugh. While several Congressmen support such legislation, it's unlikely anything will be done about it this year. Drug shortages are not at the top of their priority list at the moment.
What manufacturers have to say
Not much, unfortunately. There's usually a lot of finger pointing, generally in the direction of the FDA or raw material suppliers.
Deffenbaugh said he understands why manufacturers are reluctant to inform the public of changes that may affect supplies. If a company is going to discontinue a product, he said, it is going to want to sell everything it has. Informing buyers in advance may jeopardize this.
Shortages are one of the consequences of running a business, Deffenbaugh continued. In this country drugs are a commodity. Pharmaceutical manufacturers that have gone public (and most have) need to satisfy their stockholders. If a product isn't profitable, it's going to be dropped. This country wanted a free market system, and it got it. "So be careful what you ask for," he said.
Anatomy of a shortage
To better illustrate just how a shortage occurs, here are a few examples from the past year:
* Factor VIII--In November 2000 an FDA inspection of a Bayer manufacturing facility revealed bacterial contamination in some stages of recombinant Factor VIII (Kogenate FS) production. In January of this year, Bayer stopped distribution of the drug until the facility met FDA standards. More contamination problems in the spring led to another halt in production.
As Bayer's product became limited, demand for other Factor VIII products increased. Aventis distributes a Factor VIII, Helixate FS, but because it buys the drug from Bayer, the supply of this product also diminished. When Baxter stopped production of its version, Recombinate, the situation was aggravated even further. Baxter took a month this past spring to do some maintenance on its facilities. As if that weren't enough, Wyeth's albumin-free Factor VIII has also been limited because the company is updating its plant as well.
* Dexamethasone injectable--We can blame mad cow disease for this one. Dexamethasone used to be derived from beef protein sources. Because raw supplies were produced in other countries, and because mad cow disease was present in these countries, the importation of the product was halted. Switching to a plant source solved that problem, but it required FDA approval. The delays caused shortages until the plant-derived form of the drug could be produced.
[see table in next reply]
Facts and Comparisons
* Influenza vaccine--With this one, things are even more complicated. There are "inherent difficulties in producing essentially a new vaccine every year," said Deffenbaugh. About "75 or 80 million doses are the maximum that could ever be produced [with the current system]. That is substantially less than would be needed to meet the FDA's 2010 goals."
Here's why: The manufacturers can't start making vaccine until the World Health Organization figures out what the strains will be. The strains differ by region, so vaccines must be made regionally. Also, the vaccine is polyvalent, so multiple strains are needed for each vaccine. The seed cultures are started in the spring, and the FDA supplies quality control reagents to the manufacturers. Then the vaccine is made during summer in preparation for fall deliveries.
A breakdown at any stage of this process means a delay in availability. Last summer, a slow-growing strain was the first culprit. Then, two manufacturers had problems making the vaccine. With this drug, Deffenbaugh said we would continue to have problems. In order to immunize all the at-risk people, both production and provider communication to patients will have to be increased. The Centers for Disease Control & Prevention and the FDA are working on it, but "we still have too many preventable deaths from influenza," he said.
Life in the trenches
"I just spent days making phone calls," said Jane Younts, R.Ph., M.B.A., M.H.A., director of pharmacy at Morehead Memorial Hospital in Eden, N.C. "The drug companies just won't tell you [anything]." She believes most customer service reps honestly don't know why a drug is not available, and they certainly can't give her a release date. She has found that most often she has to go through several people at a given company in order to get this information.
"We used to just order drugs and give them to the patients, and that was it," said Younts. Now, much of her time is spent trying to locate medications. "We're talking the basics," she said, citing dexamethasone and naloxone as examples. In addition, one of her technicians has also had to devote all of her time to purchasing.
"We essentially have been rationing drugs," Younts explained. "We're not using the word rationing, but that's what we're doing." For example, "We have a list of reasons you can give tetanus vaccine." After months of scrounging for information, Younts has become a very savvy customer. She knows Wyeth stopped making tetanus vaccine, and she knows the FDA asked Wyeth's competitor to increase production of the product. The frustrating part is that she also knows it takes 18 months to make new vaccine, and therefore relief is not imminent. "I have spent hours and hours just on tetanus vaccine."
Explaining all of this to the physicians in her hospital has been no easy task. "In the beginning, a lot of them didn't believe me," Younts said. The anesthesiologists, in particular, were quite difficult when fentanyl and succinylcholine were running short last fall. Referring to one anesthesiologist, she said, "I truly think he thought I could just go back into the pharmacy and whip something up." The physician did not believe that she could not get any fentanyl. While the pharmacy community was well informed about the shortage, she noted the American Society of Anesthesiologists didn't inform its members until the shortage was nearly resolved.
Charles Cancro, R.Ph., procurement specialist for the Ralph H. Johnson VA Medical Center in Charleston, S.C., had a similar problem with fentanyl. The physicians in his hospital were upset when he told them he was out of the drug. He had to explain that he couldn't just get it overnight because fentanyl is a [Schedule] CII, and there was a shortage of it at the time. Doctors think if you're out of a drug, you can just order it," he said. "They don't understand."
At least the oncologists at Morehead were easier to work with. Younts said they worked around the dexamethasone shortage by switching to the oral (and readily available) form for routine, pre-chemotherapy use, and reserved the injectable for patients who still experienced nausea and vomiting after chemo.
Younts related a recent incident to illustrate her day-to-day battle with drug shortages: Because Wyeth has decided to no longer produce Antivenin (crotalide), an antidote for snakebites, her P&T committee selected CroFab (Savage Laboratories' new version of crotalide) as a replacement for the formulary. However, since the pharmacy still had some Antivenin in stock, the P&T committee agreed to use it up before switching to CroFab. Younts was satisfied another shortage problem had been avoided, until a patient came to the ER with a copperhead bite.
For some reason, the ER physician insisted on CroFab and would not use the Antivenin the pharmacy had in stock. Younts did not have any CroFab because the product was on back-order. Still unwilling to use anything but CroFab, the doctor ordered Younts to get a vial from a hospital 30 miles away. That hospital's pharmacist didn't want to loan her a vial because his supply was dangerously low. However his hospital also didn't want the patient, so in the end the vial was taxied over. But the patient recovered without needing the CroFab, and Younts had to send it back in another cab. She spent hours on this incident alone, not to mention a couple hundred dollars on cab fare, and couldn't charge the patient a dime because no drug was given.
On the retail side, shortages have also caused aggravation. Inhalers, especially, have been hard to come by. So have some oral drugs, such as generic butalbital and Rocaltrol (calcitriol, Roche).
Trish, a retail pharmacist in the San Francisco area who doesn't want her name revealed, said she's been having trouble with Vancenase AQ (beclomethasone, Schering-Plough). "It is still not available," she said. "Even if it is the formulary drug, we have had to call doctors to change to something else, and then call the insurance company for overrides. You know how much pharmacists like to spend time calling insurance companies."
The domino effect
When pharmacists find ways to deal with unavailable drugs, the shortages often worsen. "There is sort of a domino effect," said Deffenbaugh. "If you can't get your drug of choice, then you go to alternatives." Since these alternatives are usually limited, pharmacists and physicians often choose the same ones. It isn't long before the alternative drugs are also hard to come by.
A tragic example of this occurred in San Francisco this year. The dexamethasone shortage led to a shortage of other injectable steroids, including betamethasone. The shortage of betamethasone (Celestone, Schering-Plough) prompted an outpatient surgery center to obtain compounded betamethasone from a local pharmacy. The product was contaminated, and three patients died of meningitis after receiving epidural injections of it.
Cancro pointed out another problem: stockpiling. During a shortage, some pharmacies acquire as much of the drug as possible. This makes his job as procurement specialist very difficult. As some pharmacies order all the drugs they can find, this leaves the remaining pharmacies in the area with little supply.
Cancro commended his primary supplier, AmeriSource. The company didn't allow stockpiling and divvied up its supply of scarce drugs among all the orderers, said Cancro. "They wanted to make sure the patients got the drug."
A drug at any price
Many pharmacists, with irate patients and doctors breathing down their necks, will pay anything to get needed drugs. And that's just what some distributors are counting on.
Trish has paid higher prices for certain brands of albuterol inhalers. "We couldn't even get any from McKesson, our main wholesaler, so we had to get another brand from Majors, a secondary wholesaler." The inhalers from the second supplier were more expensive. She's had the same problem with phentermine. Her customers have suffered as well. "Fast Take test strips [for blood glucose meters] have been back-ordered for quite some time," she said. "And it has caused patients to have to go out and buy an entirely different meter because they couldn't get the strips."
Last year, ASHP received numerous complaints from hospital pharmacists about outrageous prices for flu vaccine. While hospitals waited for their supplies of flu vaccine, chain pharmacies in their areas held flu shot clinics. Then, the hospitals received faxes from small distributors offering the vaccine for $ 120 to $ 150 a vial.
Younts has had the same problem with dexamethasone. She used to pay $ 1.67 for one vial of the injectable. Now, a comparable dose sells for $ 167 a vial. That's 100 times the original price.
David Work, R.Ph., executive director of the board of pharmacy in North Carolina, has been investigating reports of price gouging in his state. Although the board does not have jurisdiction over pricing, Work has been working with the law enforcement agencies that do.
Also condemning price gouging is the AMA, which issued a statement denouncing the practice. The statement urged distributors to cease and desist.
The best-laid plans
Recognizing that the drug shortage is not going away, ASHP has published ASHP Guidelines on Managing Drug Product Shortages. The document, available from the organization and on its Web site gives practical, step-by-step advice on handling shortages.
The FDA continues to battle shortages and facilitate resolutions. The agency also encourages manufacturers and distributors to alleviate the domino effect by instituting allocation programs for drugs in short supply.
Meanwhile, Younts and Cancro are finding their own solutions. Younts has worked out an arrangement with the local health department regarding tetanus vaccine. Since physicians can't order the vaccine for their offices, they've had to send their patients to the emergency room for the vaccine. Now, Younts said, the health department has agreed to accept these patients so they can avoid the ER charges, at least during the week.
Younts is also giving physicians advance notice if it looks like a drug may be hard to get. Currently, she's having trouble with metoclopramide (Reglan, Whitehall-Robins Healthcare) injectable. Because this drug is used in the OR and recovery room, it's important that physicians know whether it's available before they order it.
When faced with a shortage, Cancro orders directly from the source. "We've called the manufacturer," he said. "Some of them do have emergency supplies [set aside]." And, when he orders, he tells the company, "I would like 10, but if you would ship me five, I'd be very happy."
Jillene Magill-Lewis, R.Ph.
Based in Washington, the author writes frequently on pharmacy-related subjects.
============================
RELATED ARTICLE: Quick tips for drug shortage management
* Be very careful of dosing errors when using alternate drugs.
* Prioritize patients so that scarce drugs get to those who need them most.
* Order only what your pharmacy truly needs. Stockpiling makes shortages worse and ruins budgets.
* Communicate with other pharmacies in your area. You may be able to share resources and information.
* Report shortages to ASHP and the Food & Drug Administration.
* Maintaining relationships with pharmaceutical representatives may be helpful. They may be able to provide information about shortages.
* Be alert to any situation that may potentially cause a shortage. For example, warning letters to manufacturers are published on the FDA's Web site. Plant deficiencies sometimes lead to manufacturing delays. Stockholder reports can also provide information about manufacturing issues or production decisions. Poor profits may prompt discontinuation of slow-movers. Also, drugs about to lose patent or switch to over-the-counter status sometimes become scarce. However, use caution when reacting to these situations--problems are often resolved before shortages occur.
Source: Adapted from ASHP Guidelines on Managing Drug Product Shortages and other sources
=============================
RELATED ARTICLE: On-line resources on drug shortages
Below are some Web sites that may offer useful information on drug shortages:
www.cdc.gov/nip/flu--Centers for Disease Control & Prevention's flu vaccine site
www.fda.gov/cder/drug/shortages--Food & Drug Administration's shortage site
www.ashp.org/shortage--ASHP's shortage site
Here's the table from the previous article. Sorry for the formatting. I'm not an expert at this.
Products in short supply this past year[*]
DRUG MANUFACTURER
albuterol inhalers Schering-Plough
anthrax vaccine BioPort
bacitracin inj. Pharmacia, Paddock (distributor), Pharma-Tek
beclomethasone inhalers Schering-Plough
(Vancenase AQ, Vanceril)
betamethasone inj. Schering-Plough
(Celestone Soluspan)
butalbital combination Novartis
product (Fioricet)
carboprost (Hemabate) Pharmacia
crotalide (Antivenin) Wyeth-Ayerst
cytarabine (Depocyt) SkyePharma
dexamethasone inj. Merck, Wyeth-Ayerst, Akorn, American Pharmaceutical Partners,
American Regent, Clint Pharmaceuticals, C.O. Truxton, and Moore
APP and American Regent now
diphenhydramine inj. Amphastar Pharmaceuticals/ International Medication Systems
etanercept (Enbrel) Immunex and Wyeth-Ayerst
fentanyl Abbott, ESI Lederle, Watson,
Mallinckrodt, and Taylor (Akorn)
flumazenil (Romazicon) Hoffmann-La Roche
ganciclovir (Cytovene) Hoffmann-La Roche
hyaluronidase (Wydase) Wyeth-Ayerst
influenza vaccine Aventis, Wyeth, Powderject
isoniazid inj. Bristol-Myers Squibb
isoproterenol inj. (Isuprel) Abbott, Wyeth-Ayerst
lorazepam p.o. soln. Roxane
(Lorazepam Intensol)
meningococcal vaccine Aventis
(Menomune-A/C/Y/W-135)
mesantoin Novartis
pyridostigmine (Mestinon Timespan) INC
methylprednisolone inj. Abbott, Pharmacia
(Solu-Medrol, A-Methapred)
nalbuphine inj. Abbott, Endo, Moore Medical
naloxone inj. (Narcan) Abbott, Baxter, Endo
norepinephrine inj. (Levophed) Abbott
phenobarbital inj. (Luminal) Abbott
phentermine various generic and brand
phenytoin (Dilantin Infatabs) Parke-Davis
prochlorperazine inj., caps, Abbott, GlaxoSmithKline,
and syrup (Compazine) Wyeth-Ayerst
protamine inj. Lilly, Wyeth-Ayerst
quinidine gluconate Lilly
recombinant Factor VIII Bayer, Aventis (distributes Bayer's)
succinylcholine inj. Abbott, GlaxoSmithKline, Organon
(Quelicin, Anectine)
tetanus vaccine (all products: Wyeth-Ayerst, Aventis
Td, TD, DTaP,
tetanus toxoid)
thiamine inj. American Pharmaceutical Partners, Wyeth-Ayerst (others distribute)
------------------------------
DRUG PROBLEM
albuterol inhalers manufacturing problems
anthrax vaccine plant renovation awaiting approval
bacitracin inj. manufacturing problems
beclomethasone inhalers
(Vancenase AQ, Vanceril) manufacturing problems
betamethasone inj.
(Celestone Soluspan) manufacturing problems
butalbital combination
product (Fioricet) manufacturing problems
carboprost (Hemabate) not clear
crotalide (Antivenin) increased demand, manuf. limitations; will stop production after 2001
cytarabine (Depocyt) not clear
dexamethasone inj. raw material shortage (switched from
beef to plant sources, req. FDA
approval) manufacturing problems;
approved and supplying
diphenhydramine inj. not clear
etanercept (Enbrel) increased demand
fentanyl increased demand
flumazenil (Romazicon) manufacturing problems; used for BZD overdose; reported by U of Utah
ganciclovir (Cytovene) manufacturing problems
hyaluronidase (Wydase) stopped production (compliance issues); AAO suggests compounded
influenza vaccine raw material problems
isoniazid inj. manufacturing problems
isoproterenol inj. (Isuprel) raw material shortage
lorazepam p.o. soln.
(Lorazepam Intensol) not clear
meningococcal vaccine
(Menomune-A/C/Y/W-135) increased demand for single-dose vials
mesantoin D/Cd; supplying some for transitioning
pyridostigmine (Mestinon Timespan) manufacturing problems
methylprednisolone inj. increased demand
(Solu-Medrol, A-Methapred)
nalbuphine inj. not clear (no reason given by any company)
naloxone inj. (Narcan) Wyeth-Ayerst D/Cd and others could
not meet demand (FDA temp. allowed
Sabex Inc., a Canadian company, to
supply to U.S.)
norepinephrine inj. (Levophed) "regulatory issues with FDA" (ASHP),
phenobarbital inj. (Luminal) bulk drug not available
phentermine not clear
phenytoin (Dilantin Infatabs) not clear
prochlorperazine inj., caps, increased demand, raw material
and syrup (Compazine) delays
protamine inj. not clear
quinidine gluconate not clear -- could be Lilly isn't
making enough because of
lack of demand
recombinant Factor VIII contamination in manufacturing; may
lead to shortages of other F
VIIIs (Baxter's, Aventis');
Wyeth's already limited
refurbishing plant)
succinylcholine inj.
(Quelicin, Anectine) increased demand, raw material delays
tetanus vaccine (all products: Wyeth stopped manuf.; Aventis raised
Td, TD, DTaP, prices 500%; U of Mass Biologic Labo-
tetanus toxoid) ratories increased production to help
thiamine inj. not clear
[*] Past 12 months or so
Source: FDA, ASHP, multiple articles, company Web sites,
--------------------------------
This has not occurred in vaccine manufacturing. The decision by the ACIP regarding small pox vaccine is another example of leftist physicians who don't understand a whit of economics!
If Aventis Pastuer donates the serum for 70 million doses of vaccine, is there any reason that ACIP or CDC can cite for NOT permitting physicians to VOLUNTARILY administer the vaccine to staff and family? If I'm on the front-line, where's my flak jacket????
I'm sure that the strategy proposed by CDC (which seeks to immunizes THEMSELVES only) is a great one for the hypocrites sitting on the ACIP committee. But, for the rest of America, who is the victim of this sham, we're left DEFENSELESS to smallpox. Worse yet, our children are defenseless to the virus!
All this shameless "cover your back" policy making occurs in the face of overwhelming evidence of stockpiles of biological weapons loaded with small pox virus. How many articles must Ken Alibek, Daniel Pipes, and the Washington Times staff write before the Administration tells the self-dealing physicians on the national committees to sit down?????????
Great point. It CAN'T be a good feeling knowing that every patient you see with acute onset of fatigue, headache, backache and high fever could potentially be carrying smallpox. And I'm not sure how much faith I have in the speed of those 12 pre-packaged push packs reaching a hot zone.
Knowing our government, the trucks carrying them will have a big "CDC Emergency Supplies" written on the side of the truck. Written in the middle of a big bullseye.
Frankly, the "push packs" will arrive too late to help the initial victims of a bioterrorist attack. Unfortunately, all physicians and medical offices are the likely victims in the first set of secondary infections following the attack. The current strategy appears to be to write off the initial victims in any terrorist hit. Frankly, this sucks! If you want me to be a physician defending our community's health, the Federal gov't needs to start to ante up!
This is totally unacceptable public health policy and it does not properly defend our citizenry. While I am a strong supporter for the GOP, I am growing dissatisfied with the lackluster performance of the response to bioterrorist threats. These threats are real and the foreign policy implications can be effectively neutralized through better preparation!
Knowing our government, the trucks carrying them will have a big "CDC Emergency Supplies" written on the side of the truck. Written in the middle of a big bullseye.
Since we're working publicly to evaluate the system, let us evaluate WHERE the push packs are located. Exactly where is the stockpile of vaccine located?
Are Feinstein and Boxer too busy to locate the vaccine stockpiles in California? Or are they more interested in discussing Chinese foreign investment and Oracle IT deals in Sacramento?
Since government hasn't been able to fully clarify how the response to smallpox will work, let me project a scenario. If a terrorist hits a local arena with a fly-by mist of viral particles, the city won't know that the flying advertisement was a bioweapon deployment. For the first two weeks everything will be fine, until the first cases avalanche into a local ER. Upon entering the ER, the entire facility will become contaminated with the viral particles and it will still take an additional 36-48 hours prior to full identification.
Since labs are not routinely running smallpox diagnostics on nasal swabs, you can bet that the first victims will get full-blown disease and a sizable percentage will perish.
Since initial waves of emergency response include paramedics, fire, police, hospital staff, physicians, nurses, and even candy-strippers; all will need to be quarantined and isolated for weeks. Since most of these people have families, their families will also be quarantined and their children are susceptible to disease in the second wave of contagion following the initial attack. Since most kids go to daycare or school, the schools will be contaminated within a few weeks of the initial hit. Mandatory immunization of the nation would likely be reinstituted at this juncture anyway.
Instead of permitting this type of disruption and civil unrest (with mammoth economic consequences that threaten US security), the ACIP should be permitting physicians to purchase the vaccines for Smallpox and Anthrax. The American citizenry deserves protection.
Just because a bunch of lunk-headed, CYA attorneys are unwilling to permit their company to be sued for product liability, 290 million Americans are at risk of bioweapons.
I suggest that freepers continue this discussion and begin to carefully evaluate their congressional delegation's logic. If your congress-critter doesn't stand up for "FREE MARKET" economics in healthcare, let's force them OUT!
In this case, the free market should permit us to purchase the vaccines. It is ONLY CLINTON ERA LIES that are preventing our own families from gaining the protection we deserve!
In June 2001, the Advisory Committee on Immunization Practices (ACIP) made recommendations for use of smallpox (vaccinia) vaccine to protect persons working with Orthopoxviruses, to prepare for a possible bioterrorism attack and respond to an attack involving smallpox. Because of the terrorist attacks in the fall of 2001, the Centers for Disease Control and Prevention (CDC) asked the ACIP to review their previous recommendations for smallpox (vaccinia) vaccination. As a result of this review, these supplemental recommendations update those for vaccination of 1) the general population and 2) persons designated to respond or care for a suspected or confirmed case of smallpox. In addition, they clarify and expand the primary strategy for control and containment of smallpox in the event of an outbreak.
Recommendations for vaccination of laboratory workers who directly handle recombinant vaccinia viruses derived from non-highly attenuated vaccinia strains, or other orthopoxviruses that infect humans (e.g., Monkeypox, cowpox, vaccinia, and variola) remain unchanged. Other aspects of the previous recommendations (e.g., screening for contraindications, care of the vaccination site) are being reviewed, and until new recommendations are published, the June 2001 recommendations should be consulted.
The following recommendations were developed after formation of a joint Working Group of the ACIP and the National Vaccine Advisory Committee (NVAC) and a series of public meetings and forums to review available data on smallpox, smallpox (vaccinia) vaccine, smallpox control strategies, and other issues related to smallpox (vaccinia) vaccination. A website was established to solicit public opinion and input on options for smallpox (vaccinia) vaccine use.
The ACIP will review these recommendations periodically, or more urgently if necessary. These reviews will include new information or developments related to smallpox disease, smallpox (vaccinia) vaccines (including vaccine licensure), risk of smallpox attack, smallpox (vaccinia) vaccine adverse events, and the experience gained in the implementation of the current recommendations. Revised recommendations will be developed as needed.
| Smallpox Transmission and Control |
Smallpox is transmitted from an infected person once a rash appears. Transmission does not occur during the prodromal period that precedes the rash. Infection is transmitted by large droplet nuclei and only rarely has airborne transmission been documented. Epidemiologic studies have shown that smallpox has a lower rate of transmission than diseases such as measles, pertussis, and influenza. The greatest risk of infection occurs among household members and close contacts of persons with smallpox, especially those with prolonged face-to-face exposure. Vaccination and isolation of contacts of cases at greatest risk of infection has been shown to interrupt transmission of smallpox. However, poor infection control practices resulted in high rates of transmission in hospitals.
The primary strategy to control an outbreak of smallpox and interrupt disease transmission is surveillance and containment, which includes ring vaccination and isolation of persons at risk of contracting smallpox. This strategy involves identification of infected persons through intensive surveillance, isolation of infected persons, vaccination of household contacts and other close contacts of infected persons (i.e., primary contacts), and vaccination of household contacts of the primary contacts (i.e. secondary contacts). This strategy was instrumental in the ultimate eradication of smallpox as a naturally occurring disease even in areas that had low vaccination coverage.
Depending upon the size of the smallpox outbreak and the resources that were available for rapid and thorough contact tracing, surveillance and containment activities in areas with identified smallpox cases was sometimes supplemented with voluntary vaccination of other individuals. This was done in order to expand the ring of immune individuals within an outbreak area and to further reduce the chance of secondary transmission from smallpox patients before they could be identified and isolated. Regardless of the geographic distribution, number of cases, or number of concurrent outbreaks, surveillance and containment activities remained the primary disease control strategy.
| Critical Considerations |
A number of factors and assumptions were used in developing these supplemental recommendations.
Level of disease risk and threat
Information provided to the ACIP indicated that the risk for smallpox occurring as a result of a deliberate release by terrorists is considered low, and the population at risk for such an exposure cannot be determined. It was further assumed that regardless of the mode of a bioterrorism release, the epidemiology of subsequent person-to-person transmission would be consistent with prior experience. These recommendations also assumed that in addition to vaccination, health care workers and others would be afforded protection from infection through appropriate infection control measures, including the use of appropriate personal protective equipment.
Expected severe adverse reactions to vaccination
These supplemental recommendations assume that appropriate screening for contraindications to vaccination would be implemented and would include both the vaccinated persons, as well as their contacts. It is further assumed that recommended precautions would be taken to minimize the risk of adverse events among vaccinees as well as their close contacts (e.g., patients, household members).
Vaccine and vaccinia immune globulin (VIG) supply
The supplemental recommendations assume that both would be available for use, in sufficient supply, and handled and administered correctly. Smallpox (vaccinia) vaccine and VIG are currently available only under Investigational New Drug (IND) protocols (i.e., protocols for products that are not yet licensed). As such, it was assumed that appropriate informed consent, patient follow-up, and administrative oversight by federal, state, and local public health officials would be required. Further, any administration of smallpox (vaccinia) vaccine would be voluntary.
State and local vaccination capacity and capability
Surveillance and containment, including ring vaccination, is the primary strategy for the control and containment of smallpox. In addition, state and local health departments would be able, if necessary, to expand immunization to additional groups, up to and including their entire population, in a timely manner.
| Smallpox Vaccines and VIG Availability |
Currently, there are no commercially available (e.g., licensed) smallpox vaccines. Smallpox vaccines previously produced by Wyeth (Dryvax) and Aventis-Pasteur are available under Investigational New Drug (IND) protocols held by CDC. Both vaccines were prepared from calf lymph with a seed virus derived from the New York City Board of Health strain of vaccinia virus. Studies conducted among young adults with no previous smallpox vaccination history showed that a 1:5 dilution of Dryvax (Wyeth Laboratories, Inc) produced take rates among vaccinees equivalent to those of the undiluted vaccine.
In October 2001, the federal government contracted with Acambis and Acambis-Baxter Pharmaceuticals for at least 209 million doses of smallpox vaccine produced in cell-culture. These vaccines use a clone of the same strain of vaccinia virus (New York City Board of Health), which was utilized in the smallpox vaccines produced from calf lymph. These doses are expected to be available at the end of 2002 or soon thereafter.
Smallpox vaccines are formulated and packaged for administration with a bifurcated needle, which provides a fast, easy, and effective means for administration. All vaccines are packaged in 100 dose vials, except when Dryvax is diluted 1:5 resulting in vials that contain 500 doses.
The CDC National Pharmaceutical Stockpile (NPS) has developed protocols to allow for the rapid, simultaneous delivery of smallpox vaccine to every state and US territory within 12-24 hours. State and local bioterrorism response plans should provide for the rapid distribution of vaccine within their jurisdiction.
Currently, there is enough VIG available under an IND protocol to treat about 600 serious adverse events. This is enough VIG doses to treat the adverse reactions that would be expected to result from the vaccination of 4 million to 6 million people. Contracts for additional supplies of VIG are in progress.
| Surveillance |
Currently, cases of febrile rash illnesses, for which smallpox is considered in the differential diagnosis, should be immediately reported to local and/or state health departments. Following evaluation by local/state health departments, if smallpox laboratory diagnostics are considered necessary, the CDC Rash Illness Evaluation Team should be consulted at 770-488-7100 or 404-639-2888. As smallpox was eradicated in 1980 and no longer occurs naturally, an initial case of smallpox must be laboratory confirmed. At this time, laboratory confirmation for smallpox is available only at CDC. Clinical consultation and a preliminary laboratory diagnosis can be completed within 8-24 hours.
To assist medical and public health personnel in evaluating the likelihood of smallpox in patients with febrile rash illnesses, CDC has developed a rash illness assessment algorithm. Poster copies of this algorithm are available from state health departments and on the CDC website Orders for copies of the poster can be made over the Internet at: https://www2.cdc.gov/nchstp_od/PIWeb/niporderform.asp
Surveillance activities, including notification procedures and laboratory confirmation of cases, would change if smallpox is confirmed. Additional information regarding surveillance activities following laboratory confirmation of a smallpox outbreak can be found in the CDC Interim Smallpox Response Plan and Guidelines.
| Recommendations |
|
Under current circumstances, with no confirmed smallpox, and the risk of an attack assessed as low, vaccination of the general population is not recommended, as the potential benefits of vaccination do not outweigh the risks of vaccine complications. Recommendations regarding pre-outbreak smallpox vaccination are being made on the basis of an assessment that considers the risks of disease and the benefits and risks of vaccination. The live smallpox (vaccinia) vaccine virus can be transmitted from person to person. In addition to sometimes causing adverse reactions in vaccinated persons, the vaccine virus can cause adverse reactions in the contacts of vaccinated persons. It is assumed that the risk of serious adverse events with currently available vaccines would be similar to those previously observed and could be higher today due to the increased prevalence of persons with altered immune systems. |
Pre-Release Vaccination of Selected Groups to Enhance Smallpox Response Readiness
Smallpox Response Teams
|
Smallpox vaccination is recommended for persons pre-designated by the appropriate bioterrorism and public health authorities to conduct investigation and follow-up of initial smallpox cases that would necessitate direct patient contact. To enhance public health preparedness and response for smallpox control, specific teams at the federal, state and local level should be established to investigate and facilitate the diagnostic work-up of the initial suspect case(s) of smallpox and initiate control measures. These Smallpox Response Teams might include persons designated as medical team leader, public health advisor, medical epidemiologists, disease investigators, diagnostic laboratory scientist, nurse vaccinators, and security/law enforcement personnel. Such teams may also include medical personnel who would assist in the evaluation of suspected smallpox cases. The ACIP recommends that each state and territory establish and maintain at least one Smallpox Response Team. Considerations for additional teams should take into account population and geographic considerations and should be developed in accordance with federal, state, and local bioterrorism plans. |
Designated Smallpox Healthcare Personnel at Designated Hospitals
|
Smallpox vaccination is recommended for selected personnel in facilities pre-designated to serve as referral centers to provide care for the initial cases of smallpox. These facilities would be pre-designated by the appropriate bioterrorism and public health authorities, and personnel within these facilities would be designated by the hospital. As outlined in the CDC Interim Smallpox Response Plan and Guidelines, state bioterrorism response plans should designate initial smallpox isolation and care facilities (e.g., type C facilities). In turn, these facilities should pre-designate individuals who would care for the initial smallpox cases. To staff augmented medical response capabilities, additional personnel should be identified and trained to care for smallpox patients. |
| The ACIP recognizes that the implementation of the supplemental recommendations presented in this document requires addressing a number of issues, and that this will take time. The issues include provider and public education, health care provider training, availability of vaccine and VIG, developing the appropriate investigational new drug protocols, screening, strategies to minimize vaccine wastage, vaccine adverse event surveillance, and other logistical and administrative issues. |
I'm sick and tired of bumblers in Washington DC and Sacramento telling me how to practice medicine. Tell these stooges to sit down and get out of the way! We need to reinitiate vaccine distribution in a better way!
With the amount of billions they best have all vaccines possibly imagined needed.
They do now... they are just not ordering all to get one at this time.
I just had a pharmicist say no availability of an anti biotic prescribed to me. I thought it was odd.
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