Expiry Dates and Logic

Just the other day, my friends and I got into a discussion on the expiry date on medicines and the safety aspect of the same. It soon ballooned into all health products including face cream and bread!

I promised I would do some research and write about it, so, here it is.

Are your medicines safe to take post the expiry date stamped on the packaging? Probably yes. Should you consume said medicines knowingly. probably not! Allow me to explain.

There is a thought that Big Pharma uses expiry dates as a means to push out newer medicines thereby earning more money for drugs that would have otherwise also worked. Let's get into some details.

The process of finding out an expiry date. (I'm no expert here so bear with me)

Expiration dates are set on a particular drug by using the accelerated storage test. Since the rate of disintegration of most drugs are very small at room temperature, the rate of disintegration is determined at higher temperature and extrapolated back to room temperature. Knowing the rate helps to calculate how long it can stay on the shelf. The expiry date is that point in time when a pharmaceutical product is no longer within acceptable specifications for potency and stability

The stability of each drug varies across medicines and each product needs to be tested to see how it is impacted over time. However, this testing is expensive so it isn't done by the pharma companies to add to their costs!

Once the expiry date is set, it's function is to let you know that the drug is probably not going to be effective post that date. Now, since it's an extrapolated date, it isn't very accurate but has been put as a safeguard to the efficacy of the active component of the medication. This works in the favour of the drug companies as well since they are only required to periodically test their products upto the shelf life which is printed on. This means that they are not obligated to test beyond that date. A Propublica study done by the head of the department of poisons in the US showed the following result:

In a study, Dr. Cantrell and coauthor Ray Gerona, MS, PhD, a chemist at the University of California–San Francisco, tested 8 medications in their original packaging that were discovered in a retail pharmacy and that had expired 28 to 40 years before.3 Twelve of the 14 drug compounds were present in concentrations of at least 90% of the labeled amounts.

Perhaps it's time for a rethink. There was a time when Pfizer was in acute shortage of a few products. They did a retest and were able to extend the expiry date on many of their products by up to a year and this was approved by the FDA. Convenient. 

Just a small note on the flipside before you all think I'm pro using expired medication. A study in pediatric antibiotic usage for expired medication showed the following result:

Administration of expired antibiotics can lead to increased antibiotic resistance and clinical treatment failure, as well as adverse drug reactions.

Just one study, but significant nevertheless.

Logic! Use it and you should be fine. If the medicines you think are expired control simple things like pain, a runny nose, some mild cough, it mostly will be safe to take well beyod expiry if you have it on hand. Antibiotics, chemical formulations for kids and serious conditions like Parkinsons and Multiple Sclerosis should probably be best avoided post expiry date simply because they won't work.

An interesting observation: All expiry date publications only talk about the efficacy of drugs. Not one study discusses danger or safety of the drug with respect to it becoming toxic or poisonous to the user (these are regular drugs I'm talking about). So, even if you do take a medication which is expired, in error, do not panic. It may not work as desired but it certainly won't do any harm!

Online Pharmacies! Just a click away...

The world is changing and e-stores are taking over the online world. It isn't a wonder, then, that the online pharmacy business in India is already taking off and is expected to reach great heights.

However, as all things new, there are very few regulations and laws dealing with the same, with the result that some of them have already faced problems with the authorities over spurious drugs being sold without prescriptions etc etc.

The point of this blog is to let out a few ideas and suggestions as to how this can work, especially in a place like India, where we are so used to service and convenience that we feel it is our birthright to have everything delivered to our homes!! Of course, there are working couples, old and infirm grandparents who can't make the walk to the chemist but at the end it's just a matter of convenience and let's be honest about this point and just agree!

The simplest solution is what is being followed by most portals online today. Partner with a pharmacy which has its licenses in place and use the online portal as just a point of contact with the consumer to collect their orders. I see nothing wrong with this concept as long as the onus is on the pharmacy to maintain the prescriptions it claims is mandatory to be supplied to confirm the order. This puts the responsibility solely on the dispensing pharmacy and leaves the online portal to be free of lawsuits, at least to a point where prescriptions and documentations are concerned.

The other solution which I think is the right way forward is to have stand alone e-pharmacies tie up with Doctors in the area to form a network so as to be able to obtain and confirm prescriptions by them. The model is simple, fool proof and would probably even benefit all involved. An example to highlight this would be if you lived in my area, you visit an online pharmacy which operates/delivers to our area, click on the medications you need as per my prescription and the pharmacy because it has a tie up with me along with others in the area and has some method to receive my prescription in electronic format, digitally signed, so they can legally dispense the medication. There also will have to be a confirmation check in place either via a coded SMS or simply a call to the clinic asking whether the patient did indeed receive this prescription. The best thing would be for the pharmacy to collect the physical copy of the prescription from the patient at the time of delivery. A simple flow chart that Boots online pharmacy uses is shown below.

While this is all good and hearty, the problems that can come up are many. There has to be a regulation on all fronts, from the authorities, to the Doctors using these pharmacies to self regulation by them. Silly things like expired drugs, substitute medications, improperly labelled medications, delayed delivery etc just will not work. An easy and no questions asked return policy is a must in such cases. It will build trust in the consumer and ensure repeat visits and orders online.

The e-pharmacies regulating themselves is an interesting point from another point of view as well. Most e-commerce sites will go to the ends of the earth to provide 100% secure payment gateways to ensure the safety of the consumer. Why not invest the same amount in legal requirements for dispensing drugs. I'm sure the IITian and IIMians can come up with a secure way to obtain electronic prescriptions and keep a check on expired drug stock and illegal medications. We do have a few online pharmacies already who are doing a good job. Off the top of the head, netmeds, mchemsit, merapharmacy and 1mg come to mind.

Despite all this, we will still have problems, because, you know, this is India. Nothing is done without Jugaad!! So, we will have some players, trying to make a quick buck by selling over the counter drugs at lightening deals and discounts. We will have those festival specials where they try and get rid of their soon to expire stock. We will have 'performance enhancing' medications being sold 'exclusively' under the aegis of naturopathy and all herbal preparations. We will have a few shipping stones in place of medications. Look, there are bad eggs everywhere. This doesn't mean we give up. Look at the US. A study conducted by NABP in September 2013 found 96.7% online pharmacies there were 'rogue' meaning they did not comply with US laws and regulations. 

There is one more unique problem in India. We are the land of 'pathies'. We have ayurveda, homeopathy, allopathy, naturopathy, herbopathy, patni ka pati and a whole lot more! Most of these do not have separate regulations and dispensing guidelines. While I have nothing against other pathies, it's only the pharmaceutical problems I am highlighting here.

We also have a host full of quacks! Every neighbourhood white coat man prescribes medications right from a bone setter to a superspecialist PhD. A very eloquent lawyer who wished to remain unnamed laid this argument in court during one of these cases against online pharmacies. "When the physical pharmacies hardly ever follow rules regarding prescriptions and dispensing, how are the online pharmacies expected to fall in line."

 

Like most law and order problems in India, there are enough laws but not enough enforcement. Hopefully, this new turn of events will make the people in power see reason and bring about a new law and guideline for online pharmacies. Even if they don't, I see a bright future for them. They are here to stay and will probably do better than the online groceries out there. What do you think?