DAW...GEQ...OTC...FDA...WHO...WTO...THC...CBD...OMG!

First Dibs, Second Chances: "First Dibs Second Chances" is an eBay store, whereas "A Second Chance Couture" is a family owned and operated NYC based luxury reseller, whereas "1st Dibs" is an online furniture store website, whereas "Second Chance" was a 2016 TV series...There, I think I'm covered--at least I've complied with the spirit of the law, in acknowledging my sources, in not stealing or infringing on intellectual property, a topic I'm about to cover here...

       For it was just a matter of time, as I predicted in a few previous posts that, after assiduous effort over a protracted period of time successfully brought some vaccines to us, in combatting this dreadful CV-19, that people not getting it quickly enough or in sufficient numbers, would start loud protests to the World Health Organization, but also to the countries who invested an incredible amount of time, money, and other resources to bring them to market. This is, of course, understandable, as leaders of countries with less resources are calling on those with plenty to share, which is now also referred to as "vaccine diplomacy". Others have, as I predicted, filed law suits, at least formal petitions for a legal change in the status of vaccine ownership. For example, as recently as last week the prime minister of India petitioned the WTO to suspend intellectual property protection for the CV vaccines in particular, 'claiming' that undoing the IP protection will expand poorer countries' access. I say 'claiming', as other authorities on such matters have suggested the motives of the prime minister in question are less than genuine, that this is actually a veiled attempt to boost India's presence in the drug industry. Which prompts me to provide just a brief primer on mechanics, dynamics, economics, and even politics of how drugs and medicines go from being exclusive to more available, and to even more available (i.e., "Over-The-Counter").

First Dibs: When/if you invented a medicine that would do wonders for a condition ailing us, once you were able to get the venture capital to go through all the rigmarole required by the FDA (TG as it ends up protecting us from potential dangers), you get the exclusive rights to produce the medication in question, protected from others duplicating it, attempting to copy, package and sell it under another name. In most cases, the lifetime of a patent is for around 20 years, but since the company applies for a patent long before the "clinical trial" phase (a phrase you are now all familiar with), in which the safety and efficacy of a drug are established is completed, the effective patent period after the drug has finally received approval from the FDA is around 7 to 12 years...I've been quoting nine in conversations in my office, so I guess I'm 'in the ball park'...

Generically Speaking, Second Chances: Once the lifetime of a drug patent has run its course, generic drugs are allowed for sale, which are pharmaceutical drugs (still requiring prescription) that contains the same chemical substance as the drug that was originally protected by the patents. That is, it has the same active pharmaceutical ingredient (or API, one more abbreviation for your absorption) as the original, BUT it may differ in some characteristics such as the manufacturing process, formulation, excipients (an inactive substance that serves as the vehicle or medium for a drug or other active substance--getting confused yet?), color, taste, and packaging (TMI yet?). Further, the FDA requires generics to be identical or within an "acceptable bioequivalent of their brand-name counterparts, with respect to pharmacokinetic and pharmacodynamic properties"--Hmm...The introduction of generics effectively gives the consumer more choices as well as lowering costs, and insurance companies in most cases endorse them over the original--sometimes requiring a specific explanation from the prescriber as to why you have to take the original (or "DAW": "Dispensed As Written"). Most of us can respond to generic medications the same way as the originally patented medication but occasionally (which I have experienced with a few specific medications on behalf of those I see in my practice), due to sensitivity to the noted minor ways in which generics can differ, a person can experience either a less robust response or side effects they did not experience with the original (in which case the prescriber can probably make the case for you to take the "DAW" and the insurance company will eventually support it). 

Over (and Under?): "Over-the-Counter" (or "OTC's) are those you can pick up from your neighborhood drug or even grocery store, without a prescription from a health care professional. OTC meds save the U.S. health care system about 150 billion annually, according to a recent study by the CHPA ("Consumer Healthcare Products Association", just in case this is not readily familiar you, in case you haven't gotten a degree in pharmaceutical science or medical economics). But wait a minute before you rush to the store anticipating you'll be able to buy a medication OTC if it's not prescribed, as there are some subsets of OTC's that we as consumers (aka 'self-prescribing patients' here) need to be aware of, as well as the general process by which a drug can change its 'identity' from Rx to OTC. Since 1976, at least 106 ingredients, indications or dosage strengths have jumped off the prescription pad and made their way to the aisle in the store--700+ medicines are available as OTC's that used to be known as Rx's...and you thought all the pharmacist had to do was being able to read the doctor's chicken scratches (well, doctors don't actually write them anymore, it's electronic hieroglyphics they now have to decipher). Generally, drugs can become OTC if:

- they have low potential for misuse and/or abuse

- they are used for self-diagnosed conditions 

- they can but used safely and effectively without a health care provider's instructions

- they can be adequately labeled

Quite a lot of subjective words, room for interpretation, eh? That's why the FDA has strong job security, among other reasons. 

A more restricted class of OTC's, "behind-the-counter" meds also exist which, while being OTCs, are kept behind the pharmacy counter and dispensed by the pharmacist. For example, "Aleve Cold and Sinus", "Sudafed 12 Hour", and some other cold and allergy medications have been taken off the shelf and now reside behind the pharmacy counter as part of the fight against illegal drug production.

Newbies: If that wasn't enough for us consumers, prescribers, and pharmacists to 'absorb into our system', along comes the legalization of pot (aka THC) and the non-hallucinogenic part of the cannabis plant, the latter being marketed for everything that ales you...

Armed: Ok, now you're a well informed consumer (now that you know the ABC's of OTC's)--not only can you self-diagnose, but you can choose among over 700 medicines on the shelf in the aisle...no wonder when I get sent to the store for a specific medication for a family member, I get told three times before I leave, "stick to the list and if you're not sure, ASK the pharmacist!" This, knowing that us guys don't like asking for directions and think we can find a good substitute when something else is not available, rather than looking further, reading the fine print...after several return trips, I think I'm getting the message! Speaking of messages, as we have all become accustomed when calling our prescriber's office for any prescription, they need at least __ days notice, so don't wait until the last minute, or else you may find yourself making a plea to the pharmacist whose hands are tied here, who won't be able to simply reach under the counter for your refill. 

Next trip: reading labels, abbreviations on pill bottles...how to get the #@*^ things (the "human proof" bottles) opened as well!