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Abbreviated Steps for Portacath Access

6 Jan

This is the list I kept at my side to keep me straight about the sequence of steps needed during the sterile procedures necessary when changing my huber needle until it became an ingrained routine.

  1. Supplies
    • Drape (S)
    • Saline (U)
    • Hep (U)
    • Skin Prep (U)
    • Huber Needle (S) but packaging (U)
    • Clave (U)
    • Cleansers (S)
    • Biopatch (S)
    • Op-Site (S)
    • Tegaderm (S)
  2. Lay out drape
  3. Open saline and hep; don’t put on drape
  4. Open needle; leave in packaging and don’t put on drape
  5. Open clave, put onto needle tubing, fill with saline, recap saline, let clave hang outside needle packaging
  6. Open skin prep; don’t put on drape
  7. Open cleansers, biopatch and tegaderm without touching contents and drop onto drape
  8. Put on gloves (first hand: only touch inside of glove and cuff with other hand; second hand: only touch outside of glove and under cuff with other hand)
  9. Swab port area with cleansers
  10. Insert needle
  11. Place biopatch between skin and needle, blue side out
  12. Flush with saline and then hep; close clamp!
  13. Apply skin prep and cover area with tegaderm

(S)=Sterile, (U)=Unsterile

Detailed steps can be found here.

More to Cinryze Than Meets the Eye

13 Jan

I received my second shipment of Cinryze today and I have more information and tips to share.

Unlike my first shipment, where the prescription label on the plastic bag encasing each dose (two vials in individual manufacturer’s boxes) of Cinryze read, “Store at Room Temperature,” this shipment arrived in a cardboard box with an “Immediately Refrigerate” sticker prominently displayed on the outside, but no storage instructions at all on the prescription label on the plastic bag encasing each dose.

Since I needed to discuss some supply issues with TheraCom anyway, I asked my Nursing Case Manager about her official stance on the subject of refrigeration. She agreed that “Store at Room Temperature” was ambiguous at best and that the Prescribing Information (see cinryze-prescribing-information-1) is technically correct: store between 36oF-77oF and do not freeze. Most refrigerators fit comfortably within this temperature range.

Now, most women out there going through peri-menopause or menopause with tell you, in no uncertain terms, the temperature of their homes are never higher than 68oF, no matter the time of year (that’s me over there, jumping up and down, raising my hand). As long as Cinryze is kept in its original manufacturer’s box (i.e., away from light), a house with a room temperature of 68oF makes a fine refrigerator and is safely within range.

Onward…

Your specialty pharmacy technician should call you before your shipment leaves their facility to confirm exactly which and how much supplies you need to administer your Cinryze. No matter how you administer, several kinds of supplies will be needed. When your shipment arrives, I highly recommend you sort them into kits using ziploc/plastic bags (or your favorite storage medium). If you do this upon receipt, you will (1) immediately know if you received everything you need and (2) have all the correct supplies in one place each time you need to infuse.

Since I have a portacath, I create two kits: The first I use in conjunction with one of the second (and then leave my port accessed for one month), and the second I use alone each time I administer Cinryze between port access:

Kit to Access Port:

  1. Sterile Drape (one)
  2. Sterile Gloves (one set)
  3. Transparent Dressing (Tegaderm) (one)
  4. Chloraprep or Betadine Swabsticks or Applicators (one set of 3)
  5. Alcohol Pad (one)
  6. Micro-Clave (one)
  7. Biopatch (one)
  8. Huber Needle with attached IV Line (one)
  9. Protective Skin Prep (one)

Note: Items 1 through 5 may be provided separately (as listed) or combined for you in a Central Line Change Dressing Kit

Kit to Administer Cinryze Through Port:

  1. Cinryze (two vials)
  2. Sterile Water (two vials)
  3. Pre-Filled Saline Flushes (two)*
  4. Pre-Filled Heparin Flush (one)*
  5. Mix2Vial (two)
  6. 10cc Syringe (one)
  7. Alcohol Pad (two)

If you don’t have a portacath, your single kit might consist of the following items:

Kit to Administer Cinryze w/o Port:

  1. Cinryze (two vials)
  2. Sterile Water (two vials)
  3. Pre-Filled Saline Flushes (two)
  4. Pre-Filled Heparin Flush (one)
  5. Syringe (one)
  6. Mix2Vial (two)
  7. Sterile Gloves (one set)
  8. Butterfly Safety Needle with attached IV Line (one)
  9. Alcohol Pad (two)

As you can see, there are quite a few pieces of the puzzle required to “pull off” an infusion, and trying to pull together 23, 12 or 14 items to do a “rescue” infusion could be life threateningly slow. Organization could save your, or your loved one’s, life.

*Needed to complete port access; however, I always do an infusion immediately following port access and combine this kit with the port access kit.

The Sticky World of the Huber Needle and Accessing Your Port

11 Jan

When accessing a portacath/med port, sterile procedures must be followed. The following steps reflect my personal training and the Phoenix Children’s Hospital Procedure Brochure #810 for steps I do not use. How you were or will be trained may differ.

1. If desired, 30 to 60 minutes prior to the procedures, put EMLA or L-M-X 4 cream on the skin over the port.

1.a. Some people use a numbing cream before inserting their Huber needle; I have never used a numbing cream. I normally use a 22 gauge needle, which I find to be practically painless. However, I have been needled and pricked so often, my tolerance could be higher than average.

1.b. A common cream used to numb the portacath area is AstraZeneca’s EMLA (Eutectic Mixture of Local Anesthetic) cream (non-brand generics are available). This cream contains 2.5% each of lidocaine and prilocaine. MLA is a local anaesthetic for topical application, developed to anaesthetise intact skin and often used to prevent pain associated with needle insertion. Local dermal anaesthesia is achieved after approximately 60 minutes and the duration of anaesthesia is approximately two hours. Source: Wikipedia

2. If the heparin is refrigerated, take it out of the refrigerator about ten (10) minutes before you use it. Let it warm to room temperature. Cold heparin will not harm you, but you may feel the heparin’s coldness when injected. (I do not refrigerate my heparin; pre-filled heparin syringes do not require refrigeration.)

3. If the Cinryze is refrigerated, take it out of the refrigerator about ten (10) minutes before you use it. Let it warm to room temperature. Cold Cinryze will not harm you, but you may feel the coldness when injected. Prescription literature states Cinryze should be stored at 36F-77F. (I do not refrigerate my Cinryze; my prescription label reads, “Store at room temperature.”)

4. Clean the work area with soap and water, and let it dry.

5. Wash your hands with antimicrobial scrub for 30 to 45 seconds. Wash the entire surface of your hands. Wash under your fingernails, the backs of your hands, your wrists and between your fingers. Rinse completely and dry your hands with a clean towel or paper towel.

6. Remember, as you open the supplies, touch only the outside packaging until your hands are gloved. Keep everything sterile. Sterile means there are no germs at all. Once you open a package, it is not sterile. Even though you washed your hands, they are not sterile until they are in sterile gloves.

7. Prepare your Cinryze. Make sure you have the right amount of the right medicine, and it is the right time to give it.

7.a. Wipe the top of each Cinryze bottle with an alcohol pad.

7.b. Wipe the top of each sterile water bottle with an alcohol pad.

7.c. If Using Transfer Needles:

7.c.(1) Uncap the shorter needle of the double-ended transfer needle (included with Cinryze prescription) and insert into a sterile water bottle (included with Cinryze prescription). Up-end the sterile water bottle, uncap the other end, and insert the longer needle into a Cinryze bottle. Vacuum pressure will draw the sterile water into the Cinryze bottle. Carefully withdraw the longer needle from the Cinryze bottle and recap it. Carefully withdraw the shorter needle from the sterile water bottle and recap it. Gently roll (DO NOT shake–you’ll create bubbles and foam) reconstituted Cinryze bottle between your palms to mix and set aside.

7.c.(2) Repeat with second set of sterile water and Cinryze.

7.c.(3) Wipe the top of the Cinryze bottle again with an alcohol pad. Put a clean unused needle on a clean unused 10cc syringe. Uncap the needle. Pull back on the plunger to fill the syringe with 2cc of air. Put the needle into the Cinryze bottle top, and push all the air into the bottle. Pull back on the plunger to fill the syringe with 5cc of Cinryze. To remove air bubbles from the syringe, (a) point the syringe up, (b) gently tap the side of the syringe with your finger, (c) large air bubbles will rise toward the needle, and (d) press the plunger until a tiny amount of Cinryze squirts out with the air bubbles. Any small air bubbles that stay attached to the inside of the syringe after you tap are safe.

7.c.(4) Repeat with second bottle of reconstituted Cinryze until you have 10cc of solution in the syringe. Recap the needle and set aside.

7.d. If Using Mix2Vials:

7.d.(1) Remove the cover from a Mix2Vial (included with Cinryze prescription) and place the unit over the top of one of the sterile water bottles, pressing down firmly. Holding the sterile water bottle, lift the Mix2Vial plastic packaging up and off of the bottle. Turn the unit over and fit the other end of the Mix2Vial over the top of one of the bottles of Cinryze, pressing firmly straight down. Vacuum pressure will draw the sterile water into the Cinryze bottle. The contents should be thoroughly mixed with little foaming; if not, gently roll (DO NOT shake–you’ll create bubbles and foam) the conjoined bottles between your palms to mix; set aside. Do not remove Mix2Vial apparatus.

7.d.(2) Repeat with second set of sterile water and Cinryze.

7.d.(3) Open a 10cc syringe. Pull back on the plunger to fill the syringe with 2cc of air. Using a twisting motion, separate the reconstituted bottle Cinryze and its half of the Mix2Vial from the empty sterile water bottle and its half of the Mix2Vial. Set the sterile water half aside for later disposal. Screw the syringe onto the nipple on the Mix2Vial apparatus attached to the bottle containing the reconstituted Cinryze. Push all the air into the bottle. Pull back on the plunger to fill the syringe with 5cc of Cinryze. Unscrew the Mix2Vial apparatus and set aside for later disposal. To remove air bubbles from the syringe, (1) point the syringe up, (2) gently tap the side of the syringe with your finger, (3) large air bubbles will rise toward the needle, and (4) press the plunger until a tiny amount of Cinryze squirts out with the air bubbles. Any small air bubbles that stay attached to the inside of the syringe after you tap are safe.

7.d.(4) Repeat with second bottle of reconstituted Cinryze until you have 10cc of solution in the syringe. Leave the empty bottle and Mix2Vial in place and set aside.

8. If you use pre-filled saline and heparin, remove them from their plastic wrapping and set aside with the filled Cinryze syringe. (I use pre-fills.)

9. If you do not use pre-filled saline and heparin:

9.a. Wipe the top of the saline bottle with an alcohol pad. Put a clean unused needle on a clean unused 10cc syringe. Uncap the needle. Pull back on the plunger to fill the syringe with 2cc of air. Put the needle into the bottle top, and push all the air into the bottle. Pull back on the plunger to fill the syringe with 10cc of saline. To remove air bubbles from the syringe, (1) point the syringe up, (2) gently tap the side of the syringe with your finger, (3) large air bubbles will rise toward the needle, and (4) press the plunger until a small amount of saline squirts out with the air bubbles. Any small air bubbles that stay attached to the inside of the syringe after you tap are safe. Recap the needle and set aside.

9.b. Repeat.

9.c. Wipe the top of the heparin bottle with an alcohol pad. Put a clean unused needle on a clean unused 10cc syringe. Uncap the needle. Pull back on the plunger to fill the syringe with 2cc of air. Put the needle into the bottle top, and push all the air into the bottle. Pull back on the plunger to fill the syringe with 5cc of heparin. To remove air bubbles from the syringe, (1) point the syringe up, (2) gently tap the side of the syringe with your finger, (3) large air bubbles will rise toward the needle, and (4) press the plunger until a small amount of heparin squirts out with the air bubbles. Any small air bubbles that stay attached to the inside of the syringe after you tap are safe. Recap the needle and set aside.

10. Open the package of the non-coring Huber needle, but do not take the Huber needle out of the package. (I use LifeGuard.)

11. Take the clave or micro-clave cap out of the package and remove the cover from the connector end. (I’ve used both; the micro-clave was developed for pediatrics.)

12. Without putting the micro-clave down, pick up the capped end of the Huber needle’s IV tubing, uncap it, and twist the micro-clave onto the IV tubing end. The micro-clave/IV tubing end is no longer sterile and CANNOT be placed back into the Huber needle package. Let the micro-clave/IV tubing end rest on or just over the edge of the packaging and be sure that it does not touch any of the other sterile needle components.

13. Wipe the tip of the micro-clave with an alcohol pad.

14. Uncap/remove the needle from one of the saline syringes and connect it to the micro-clave.

15. Push the plunger of the saline into the IV tubing until drops of saline come out of the end of the needle that is still INSIDE the Huber needle package. Leave the syringe connected to the micro-clave OUTSIDE the Huber needle package.

16. Open the Central Line Dressing Change Kit. DO NOT touch anything inside yet.

17. Open any remaining supplies and let the contents drop into the kit WITHOUT TOUCHING the contents. Examples include, but are not limited to: Biopatch, Chloraprep Sepp Applicators.

18. Use a gauze square to wipe the EMLA or L-M-X 4 cream off the port site.

19. Usually, the mask is on top in your dressing change kit; put it on if you are working on someone else or if you have a cold, cough, or snotty nose (I hardly ever use mine when working on myself).

20. Remove the waterproof drape next and, using your fingertips and touching the drape as little as possible, position it over your workspace, plastic/waterproof side up.

21. You are now ready to ENTER THE STERILE ZONE. If you accidentally touch any non-sterile surface, you must START OVER from this point forward. This includes touching yourself (don’t touch your face or absent-mindedly scratch that itch!), don’t touch the unprotected work surface or the arm of a chair to help yourself up, don’t touch the outside of any packaging, just DON’T TOUCH ANYTHING THAT ISN’T STERILE.

22. Take out the packet of sterile gloves and place them on the drape. They should be marked right side up, or left and right. Unfold the outer packaging in the proper orientation.

22.a. Starting with your preferred hand and touching ONLY the INSIDE of the folded cuff with your other hand, slide your first hand with your thumb in the indicated direction (usually means palm up and thumb facing outward) into the first glove. DO NOT TOUCH the OUTSIDE of the glove with your UNGLOVED hand. Your UNGLOVED hand is NOT STERILE. Touching only the INSIDE of the cuff, pull the glove on and up over your hand and pluck the cuff into an unfolded position. Your first hand is now STERILE.

22.b. Using your gloved and sterile hand, you are now ready to glove your other hand. Since you are going to place your non-sterile hand into the inside of the second glove, you DO NOT want your STERILE hand touching the INSIDE of the second glove. The trick is to slide your gloved hand UNDER the cuff of the second glove while your second hand is holding down the inside of the cuff to open up the second glove enough for your second hand to begin the slip inside (palm up, thumb out). Sometimes it helps to grab the sterile paper wrapper with your GLOVED hand and fold it over the second glove to give you some extra maneuverability with your GLOVED hand if you are having trouble getting the cuff to pull apart. Pull the glove on and up over your hand and pluck the cuff into an unfolded position. Both of your hands are now STERILE. Applaud yourself, but DON’T give yourself a clap on the back! (This was the second hardest part for me to get a grip on (yeah, I love bad puns and didn’t even TRY to resist).)

22.c. Place the paper wrapping to one side to keep your work area uncluttered.

23. Sterilize the port area using the method that you and your doctor determines is best for you (for instance, I am allergic to Betadine and that’s what comes in my kit). Here are some possible techniques:

23.a. Take three Chloraprep Sepp (2 percent chlorhexidine gluconate and 70 percent isopropyl alcohol) applicators out of their package. Hold each applicator upside-down and squeeze the applicator until the plastic cracks. This releases the contents into the pad. Scrub back and forth over the port site with the pad on the applicator for 30 seconds. Repeat twice. Place used applicators on the drape. Let the port site dry for 30 seconds.

23.b. Open the Chloraprep (2 percent chlorhexidine gluconate and 70 percent isopropyl alcohol) or PVP (10% PVP povidone iodine solution equivalent to 1% available iodine; i.e., brand name Betadine) swabstick packet using the tear-notch. Gently squeeze the some of the excess liquid from the cotton heads of the three swabsticks to prevent excessive dripping. Remove the first swabstick and, using a circular motion and starting at the center of the port, swab outward about 3 inches on either side while rotating the swab such that all sides of the swab are used ONCE. You DO NOT want to transfer any germs or skin cells from one area of the port to another area. Repeat twice. If excessive dripping occurs, use the gauze pad supplied in the kit to light pat away the “juiciness.” Placed used swabsticks and gauze on the drape. Let the port site dry for 30 seconds.

24. Pick up the Huber needle using only the wings. Remove the needle cover.

25. With your other hand, find the edges of the port. Use two fingers to frame the port and hold the port in place.

26. Push the needle into the center of the port. Press it through the skin until the needle touches the bottom of the port. Tip: If you are doing this yourself, it really helps to stand in front of a full-length mirror (no kidding! this was nearly my undoing and the tip came from, of all people, my psychiatrist–you just never know who is going to save your lily white butt or how).

27. If you are using a Biopatch, slide it over the needle between your skin and the needle housing, bluish side out.

28. The attached saline syringe (even when it was in its plastic packaging) is NOT STERILE and this next step will take you OUT OF THE STERILE ZONE.

29. Pull back on the plunger of the saline syringe until blood flashes into the IV tubing attached. This lets you know the needle is in the right place.

29.a. If you do not get a flashback, check to see if the IV line clamp is OPEN. Without touching your skin because you are no longer sterile, carefully check the needle placement. Is the needle in far enough? Is the needle in the center (sometimes the needle slips between the port’s portal and septum–I bent many Hubers this way when I was learning). Try carefully wiggling the needle back and forth, forward and back.

29.b. If you still cannot get a backflash, remove the needle using the procedures for your needle type (see here) and start over from Step 10 with a new needle and dressing change kit.

29.c. If you still cannot get a backflash after Step 29.b., call your Home Health Care Nurse or physician’s office. Your port may be clogged, broken or infected.

30. Push the full contents of the saline flush into the port and unscrew the syringe. Set it aside.

31. Unscrew the needle or Mix2Vial from the Cinryze syringe, set it aside the needle for disposal in a sharps box later, and screw the syringe onto the micro-clave. Using a timer, gently depress the plunger so the 10cc of Cinryze is administered over ten minutes.

32. Uncap/remove the needle from the second saline, screw it onto the micro-clave, push the full contents of the saline flush into the port, and unscrew the syringe. Set it aside.

33. Uncap/remove the needle from the heparin, screw it onto the micro-clave, push the full contents of the heparin flush into the port, keep pressure on the syringe, and CLOSE the CLAMP on the IV tubing.

34. IF LEAVING THE NEEDLE IN THE PORT: If using a product line Skin Prep, apply the pad around the outside perimeter of the dressing site.

35. IF LEAVING THE NEEDLE IN THE PORT: Put a transparent dressing on the port (usually included in the change kit). Tip: If not already folded, fold the dressing in half. Then peel the backing off one-half of the dressing to the fold. Place the fold line in the dressing over the centerline of the port and needle, and press the dressing in place. Peel the remaining backing from the other half and press that half into place. This method keeps the dressing from curling and sticking to itself.

36. Put all the needles, including the double-ended transfer needle, in the sharps box.

37. Other materials can be placed in the trash.

I can do Steps 1 through 30 in about 5 minutes, and if I can do it, you can, too. I’d say it took me about 2 months to become really comfortable and get up to that speed, and I’m a freakin’ big chicken, so I expect you all to surpass me!

I Am Happily Self-Infused!

23 Dec

Jackie, my nurse, called this morning to let me know that I have officially been “drummed out” of the clinical drug trial and didn’t have to come into the office today for my Cinryze infusion.  Yeah!  So I needled up and did my first official Cinryze infusion myself at home.  Double yeah!  And promptly fell back to sleep — how glorious not to have to get my sorry ass into a car while having an attack (moderate though it was) and drive 20 minutes to my doctor’s office to get it “fixed!”

I am officially the first person in the US to kick-off the use of Cinryze outside of the clinical trials AND I’m doing it at home WITHOUT supervision or oversight.  I am finally in charge of my health once again.  What a blessing and what a coup for the Hereditary Angio Edema (HAE) Association — it is thanks to their perseverance and dedication that this has happened — and I was no slouch either!  This has literally been a fight for my life.  Now I just have to scratch up $7,600 and life will be golden.  I hoped to hear from PSI before they shut down for the holiday season, but ce la vie!  Life is still GREAT!

My Personal Cinryze Launch Approaches

16 Dec

The next step in the process of getting my hands on Cinryze has just been completed.

The specialty pharmacy that will be providing me with Cinryze, CVS/Caremark, called today. My case manager there, Mary, did an exhaustive medical history in preparation to ship Cinryze to my house (yay!).  From all the questions she asked and the things we discussed, it appears that I have been granted permission to do my own infusions (yay!!) and she even said she will be able to put together a travel kit so I can fly out to see my grandmother (double yay!!!).

I still have no idea how any of this is going to be paid for, but I can’t worry about it. After I calculated that one month of Cinryze is going to cost over $43,000.00, I blew all the gaskets in my head so fast I haven’t been able to think about it since. It’s the job of my case manager at Viropharma, Shawney, to worry about how all of this gets paid for, so (although I’m extremely curious) I’m just not overly concerned.

Instead, I’m really pretty damn excited! There’s a very slight chance I might be in business before Yule.

Holy Cinryze, Batman!

Financial Ruin and Possible Sudden Death…How Fun Is My Life?

29 Sep

It looks like the FDA is going to announce their decision regarding approval of Cinryze, the C1 Inhibitor that I have been receiving as part of a drug trial for treatment of my Hereditary Angio Edema (HAE), on the 14th of October, 2008.

Since the committee who advises the FDA on such matters voted 100% to recommend approval, it is highly unlikely that the FDA will make a decision against their recommendation.  This means that Cinryze will be commercially available in the United States about 4-6 weeks afterwards (but I won’t be surprised if that lags into the New Year).

As part of their approval, it is anticipated that the FDA is going to require that patients be required to receive this treatment from an approved practitioner.  It was hoped that, although this treatment must be injected intravenously, patients with medi-ports or capable family members would be allowed to do home infusions.  The decision to require patients to go to a medical facility for this treatment presents several concerns for HAE sufferers:

1.  Immediate Availability:  For those sufferers, such as myself, who (without Cinryze) suffer nearly constant attacks of HAE, immediately availability of Cinryze is of utmost concern.  Having to transport a patient to a medical facility for treatment can be life threatening.  Further, if practitioners are not available 24/7 (as in my case, where my physician is only available during office hours and has no backup while on vacation), treatment is not just not timely, it isn’t even available.

2.  Financial Imposition:  Again, for sufferers like myself who need infusions every 2-3 days, the cost of office visits (even if paying only a co-pay of $15) which were covered by the drug company now become the burden of the patient.  For people on fixed incomes (like –you guessed it– me!), this can become a deal breaker.  For people without insurance, the deal is broken before it even gets on the table.

3.  Personal Inconvenience:  It takes about 15 minutes to do an infusion (5 minutes to reconstitute the blood product and 10 minutes to do the infusion).  It takes about an hour and a half to get a doctor’s office to do it, and you spend all the time in excess of the 10 minutes the doctor sits there with you slowly depressing the syringe plunger just waiting — usual doctor’s office bull****.  No one who had to give up their 9-to-5 job because of HAE-related absence is now going to be able to jump back into the job market if they are spending a great deal of their time sitting in their doctor’s office.

This is all in addition to the cost of the treatment itself.  When I was purchasing C1 Inhibitor for my personal consumption and bringing it in from abroad, it cost $800/vial.  I need 2 vials every 2-3 days.  That’s approximately $16,000/$24,000 a month!  And that’s what it costs in Europe, where drugs are generally cheaper.  The drug company is going to want to recoup all of its research costs and I have no idea how much Cinryze is going to cost on the US market.  I have good insurance and I hope to hell that I’ll be able to buy this under the “mail order” program, where it will only cost either $35 for a 3 month supply or at the most $35 per month.  But if they insist that I foot 25% of the cost, I’ll be out of the race.  This is the ONLY treatment in the WORLD that works for me and if I don’t have access or can’t afford it, I won’t survive.  Period.

So…

I’m very excited that this treatment is going to be made available to everyone who needs it in the United States…finally.

But…

I’m very afraid of what is going to happen to me when it is.  Will I be able to afford it?  Will I be able to get it when I need it?  Will my Grandmother die before I can have it at home, to give to myself and take with me wherever I want to go?

I needed to tell you, friends, about this mess, because I am trying very hard not to freakout.  Too much stress is very bad for anyone, but stress in even small amounts can be deadly for people with HAE; it just aggravates our condition.  I don’t think I’m handling my fears about this upcoming transition very well; it’s probably why I can’t seem to get my feet under me for any substantial length of time.  Sometimes my life just seems to suck.

I’m Ready for My So-Called “Vacation”

19 Jul

I’m happy to report that, despite an unusual 94 hour delay, I finally have on hand all the C1 Inhibitor I could possibly need for next week while my doctor is on vacation.

All non-FDA approved “medications” brought into the US must be accompanied by a “Certification of Compliance with FDA Personal Importation Policy” swearing I am an US citizen, were I reside, what potentially fatal disease I have, that the “medication” imported is the only treatment that provides relief, that it is not available for purchase within the US, that it has been available throughout the world for over a decade and has no safety issues, that I’m purchasing it for my own use and will not sell it, that I am not bringing in more than a 3 month supply, and the name and address of the prescribing physician.

When the refrigerated C1 Inhibitor is FedEx’d from Amsterdam, it goes to Memphis, TN, where it has to go through both Customs and FDA review.  The FDA has just instituted a random “FDA EXAM” and, yep, my shipment was randomly pulled for the EXAM.  The HAE Association has a FedEx Representative that takes care of getting our shipments through the two check points and everyone (including me) panicked when it first disappeared during the FDA review.

Every other time I have received C1 INH from overseas, neither the inner or outer boxes have been opened.  Only the packing slips have been opened and verified, so I expected that the FDA EXAM, taking 72 hours instead of a few minutes, would be to open the outer cardboard shipping box and the inner stryofoam packing box to see if there was really C1 INH inside.

Guess what?  No.  Neither box had been opened, but the coolant packing material was certainly nice and warm because it took seven days for them to deliver instead of three (by the time they finished their 72 hour EXAM, they’d missed the last flight out that day, which added another 24 hours)!  The only saving grace is that Lev Pharma is seeking a waiver in Europe to have the requirement to keep the unconstituted C1 INH powder refrigerated and they claim that, as long as you don’t “cook it,” it will be fine.  I’m still pissed at the FDA for the delay, though, if they didn’t do anything “value added” during the delay they caused [pout].

So wish me luck next week that the C1 INH didn’t get “cooked” in an overheated warehouse or FedEx delivery truck (it’s damn hot here in Florida) and that I don’t have any problems doing my own infusions.

I love you all who are keeping tabs on me and sending me healing love and prayers.

Faerie hugz back to all of you,

Kat

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