Wednesday, 20 May 2015 19:12

Is your TRT medication on backorder at the pharmacy?

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One of the most frustrating things for a guy on testosterone replacement therapy is when the pharmacy cannot refill medication due to it being on "back order". Back-order can of course mean many things, and since pharmacies sometimes fail to explain to the patient what is happening I thought I would post my understanding of what may be occurring, what to expect, and what to do. Things change rapidly within the US pharmaceutical pipeline resulting in limited access to some medications. This article is meant to provide a better understanding of the situation when specific medications are temporarily not available at the pharmacy.

One might wonder how a common medication like "testosterone cypionate" can all of a sudden be unavailable at the pharmacy.

Medication shortages can indeed happen even with common medications. The shortage can occur at different levels within the pipeline that delivers medications from the supplier to the pharmacy shelf. Where this shortage occurs will determine how many people are affected. I will briefly explain how the pipeline works. Drug manufacturers who make "brand name" drugs and compounding pharmacies who create customized generic drugs both purchase drugs in raw form from an FDA approved supplier. Once a drug is made into a finished product by the manufacture or compounder, it then must pass a series of regulatory protocols which include testing before becoming available to patients through a pharmacy.

So when it comes to raw material suppliers, if just one large supplier has a problem leading to a shortage of a specific raw material than it will certainly affect many pharmacies across the US who will be unable to obtain it from that supplier. Sometimes the shortage can affect all suppliers who carry that drug, or sometimes there is only one (or few) supplier who carries a particular drug- like testosterone esters. This can result in a nationwide shortage of a medication.

For example, there could be a delay with the supplier of the raw materials needed to make test cypionate which would mean that no pharmacy or manufacturer could obtain the needed ingredient to make a finished product. A delay can occur for a variety of reasons, including inability to pass an FDA inspection resulting in temporary or even permanent suspension. Usually there is enough stock left on the pharmacy shelf to be used while the shortage is resolved. Smaller pharmacies may not have stock and will be out completely so you would need to call around to see if another pharmacy may have your medication available.

Shortages can also occur down the chain at the pharmacy level- maybe the pharmacy simply forgot to order their supply or they underestimated the amount needed. Usually this level of shortage can be resolved in a day or two. Also at the pharmacy level, particularly compounders, there are different regulations including USP 797 which governs how injectable testosterone (and all injectables) are made. USP 800 which requires HCG and testosterone to be made in a separate negative flow "clean room" which some compounding pharmacies do not have. If the drug does not pass every test while being compounded or manufactured then it will be discarded instead of dispensed, causing a temporary delay as another batch is made. Another delay that may occur when obtaining your medication is the result of the additional steps needed to procure and fill a controlled substance. Dont forget that testosterone (and HCG in many states) is considered a controlled substance. All of these regulations are controlled by state and federal agencies who can pass legislation that limits access to certain medications. Any of this can cause a delay or lead to a shortage of testosterone or hcg.

I have wintessed an entire batch of test cypionate thrown out because it's potency was higher than the strength listed on the label. This caused the pharmacy to place test cyp on back order for 48 hours until they catch up on making more. The worst I have experienced while working at the pharmacy in 2009 is when compounded testosterone enanthate was on back order for 6 months before becoming available for most pharmacies to dispense again. In this case the shortage occurred at the supplier, reason unknown. I dont see this happening with cypionate as its very common in the US, but shortages may still occur for various reasons.

Brand name HCG is commonly in shortage at retail pharmacies as of 2015. Due to lack of insurance coverage and high price, men are much better off obtaining their HCG from a compounding pharmacy. Compounded HCG is less than half the price and rarely on back order at compounding pharmacies.

Suppliers and pharmacies usually work fast to resolve any delay unless it has to do with policy change or regulatory violation

What to do if your pharmacy is out of testosterone cypionate?

Contact other local pharmacies first to see if they have any in stock. Do not hesitate to ask them why there may be a shortage, but don't expect an answer because often they may not even know

Contact compounding pharmacies who supply injectable testosterones. Even if the compounder does not take insurance, they will charge you an affordable price. Paying for it is much better than missing your injection.

If the issue is related to a specific type of testosterone, like 'cypionate', you can then ask if another ester like 'enanthate' is available. Enanthate is close enough to cyp that you could substitute it if needed. Remember, you will have to get your doctor to 'okay' the change to enanthate first. Testosterone enanthate is usually available at retail pharmacies in 200mg/ml X 5ml bottles. It is also compounded at some pharmacies.

If there is ever an injectable testosterone apocalypse and no injectable versions are available (which should never happen), you can always temporarily change to a topical gel + HCG to maintain. Again, there many different brands/generics injectable testosterones that such a full shortage would be rare. At least there are options

If you ever find HCG on backorder at compounding pharmacies just sit tight, it will become available again soon. As stated before, I have never seen HCG in short supply on the compounding side and if there ever was a shortage it was only for a day or so.

Part of the high level of service Defy Medical strives towards for our patients includes maintaining communication with our pharmacies in order to prepare for any upcoming changes and requirements. This ensures that we can continue providing affordable access to these medications to our patients no matter where they happen to live.

Read 2869 times Last modified on Tuesday, 05 April 2016 05:03