It was the winter of the mid-eighties when our family visited a particular famous Kali temple in the interiors of West Bengal and the sight scared me so much that I started having frequent (almost daily) nightmares. While my mother resorted to holy remedies like keeping a rustic piece of iron (a key) below my pillow, but father simply decided to give me half of a Valium 5 Tablet for a couple of days which I believe eventually solved the matter. I was little and could not sallow a tablet or even half of it, so he would grind it with a mortar and pastel and mix it with one tablespoon of water and make me have it, and I would throw all the tantrums I could manage because it tasted severely bitter. It was my first memorable encounter with medicine where my father took a calculated risk by administering a prescription only medicine (POM) like an over the counter (OTC) drug to an underage kid. He could do so because he was well aware of that particular drug, it’s functioning and its side effects.
Medicines or drugs subsist to manage diseases/ailments that may occur in any organism like us humans, but they can be pretty harmful if not used correctly. Even as laypersons it is not enough to know when to take what medicine. We must take time to understand what medications are prescribed to us and for which purpose, their side effects, what happens if we miss doses, how they may interfere with the effectiveness of other medications and food and vice versa and many other things. Let us first get acquainted with questions we must ask our GP/Physician or Pharmacist before starting the course of any medicine.
- What is the name of the medicine?
- Why do I need to take it?
- When and how should I take it? With water? With food? On an empty stomach?
- How much should I take? What should I do if I miss a dose?
- What side effects could be caused by the medication? Which ones should I call the doctor about?
- Are there any foods or medicines I should avoid while taking this medicine?
- Will this medication change how my other medicines work?
- For how long should I take it?
- Is it habit forming?
- Will stopping it cause withdrawal syndrome, or is there a tapering off process?
The doctor’s prescription generally addresses question number 8, but sometimes there is confusion when the physician hasn’t advised a follow-up appointment or didn’t give instructions beyond the first course.
When a physician prescribes you medicines, it is your right to get complete exposure to the treatment details like why they are prescribing the drugs and how they will benefit you. Is there any alternative available in case your local chemist is unable to supply it? Also, it is in your power to make the final decision whether to accept any prescribed medicine.
Since I intend to limit the scope of this article to allopathic medicines only, we’ll not discuss Supplements (plant base/herbal), Homoeopathy or Ayurveda. Allopathic medicines are chemical compounds derived from one or more compounds (generally salts) – they are governed by the disciplines of medicinal chemistry or pharmaceutical chemistry, primarily synthetic organic chemistry and pharmacology. 99% of the human body comprises the six primary elements oxygen, hydrogen, nitrogen, carbon, calcium, and phosphorus – another five elements make up about 0.85% of the remaining mass: sulphur, potassium, sodium, chlorine, and magnesium. The rest 0.15% of the human body is made of trace elements. While the percentage bifurcation depicts a broad generic picture of the chemical composition of the human body, but these statistics cannot predict how each individual will respond to a particular medicine. Hence the selling of drugs is controlled by prescription.
A chemist can sell these drugs to a patient/consumer only when they produce a valid prescription written by a registered medical practitioner. The validity of a prescription varies per jurisdiction, but usually, it is 6 months from the date of issue unless the prescribed drug falls into the classification of controlled drug (Narcotic Drugs and Psychotropic Substances). The Valium 5 in my story is a POM.
These drugs are allowed to be sold over the counter and the buyer needn’t produce any prescription while ordering them. Paracetamols, cold & flu medicines, common painkillers are all available over the counter.
Understanding the structure of medicine – decoding terms like generic, branded, salt compositions, ATC codes, USP, Pharmacopeia et cetera
Disclaimer: Before I get into the design of a drug, I would like to inform my readers that whatever I’m explaining here is purely for general knowledge purposes. I have researched the data/insights from various authorised global sources (mentioned in the references section). You should not take any decision basis this information; instead, you must always consult a registered medical practitioner, a doctor or a nurse to treat ailments/diseases.
Let us first understand the three most commonly used OTC medicines in India Crocin Advance Tablet, Calpol 500 Table and Dolo 500 Tablet.
In the above example, paracetamol/acetaminophen is the name of the salt composition present in the drug – this name is referred to as the international non-proprietary name (INN), which is the official generic and non-proprietary name given to a pharmaceutical drug or an active ingredient. Every generic active ingredient has an ATC code attached to it which define its attributes/properties.
According to the World Health Organisation (WHO)…, “In the Anatomical Therapeutic Chemical (ATC) classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. Drugs are classified in groups at five different levels.”
Apart from ATC, there is USP-DC (United States Pharmacopeia Drug Classification) which divides the active ingredients into a slightly different hierarchy. The word Phar·ma·co·pe·ia was derived from two Greek words: pharmakon (medicine or charm) and poiein (to make). In modern times a Pharmacopeia is a book used by medical practitioners and drug makers to identify salt compositions/compound medicines. They are either published by a government authority or a pharmaceutical society. Examples of various Pharmacopeia are…, Indian Pharmacopeia (IP), British Pharmacopeia (BP), Pharmacopoeia of the People’s Republic of China (ChP/PPRC), German Pharmacopoeia (DAB).
Now let us get back to understanding Paracetamol (Acetaminophen) in better detail. According to NHS Paracetamol for Adults page…, “Paracetamol is a common painkiller used to treat aches and pain. It can also be used to reduce a high temperature.” It can take up to an hour to work. The usual dose is one or two 500mg tablets at a time for adults below 16 years (preferably 19 years for India). It should not be combined with other drugs containing Paracetamol. It is safe to take Paracetamol during pregnancy and while breastfeeding, at recommended doses. It is always advisable to consult your doctor if the patient in question has kidney disease, especially those suffering from End-Stage Renal Disease (ESRD).
The next in line for us is to understand Paracetamol from its ATC Code, i.e., N02BE01.
Level 1: N – Nervous System (Organ System)
Level 2: N02 – Analgesics (Pharmacological or Therapeutic subgroup)
Level 3: N02B – Other Analgesics and Antipyretics (Chemical, Pharmacological or Therapeutic subgroup)
Level 4: N02BE – Anilides (Chemical, Pharmacological or Therapeutic subgroup)
Level 5: N02BE01 – Acetaminophen (Chemical substance)
Detailed chemical composition of Acetaminophen can be found in the National Library of Medicines (NLM). According to their specification page…, “Acetaminophen is a p-aminophenol derivative with analgesic and antipyretic activities. Although the exact mechanism through which Acetaminophen exert its effects has yet to be fully determined, Acetaminophen may inhibit the nitric oxide (NO) pathway mediated by a variety of neurotransmitter receptors including N-methyl-D-aspartate (NMDA) and substance P, resulting in elevation of the pain threshold. The antipyretic activity may result from inhibition of prostaglandin synthesis and release in the central nervous system (CNS) and prostaglandin-mediated effects on the heat-regulating centre in the anterior hypothalamus.”
A USP monograph of Acetaminophen can be found here – as per the USP-DC, they fall under the category of Analgesics.
In July 2007, when my father had his first cardiac arrest, I learnt to manage hospitals and doctors from a patient’s family and caregiver perspective. In 2012 he developed Syncope. According to Heart.org, ” Syncope is a temporary loss of consciousness usually related to insufficient blood flow to the brain”. His cardiologist could not determine the exact root cause of the frequent syncope episodes and implanted a pacemaker to solve the issue. Unfortunately for us, father’s syncope episodes didn’t seem to cease; instead, they aggravated and became severe seizures. So, the cardiologist introduced us to a neurologist and stroke specialist. He prescribed Encorate Chrono, Syndopa 110 and Maxmala. That’s when my quest for understanding drug compositions started as my father’s health started deteriorating rapidly with those nervous system drugs. We lost him in 2018, and I primarily blame the neuro drugs. Though he became an ESRD patient in April 2017, he responded to dialysis well, even survived sepsis twice. His neuro issues never stopped, even with a 2200mg daily dose of nervous system drugs. During Covid-19 pandemic lockdown (waves 1 and 2), I had the opportunity to manage two ESRD patients closely (one with comorbidity), which further developed my interest in Pharmacology.
This year at Ebullientech, we started working on a healthcare product where the client outright refused to buy CIMS Drug Database for their pharmacy feature. I was forced to delve deep into the world of medicines and Pharmacology, which is tiring, tedious, exciting and enlightening all at the same time. Grasping the basic concepts of drugs was probably slightly more convenient for me because I studied pure science till graduation and kind of enjoyed both biology and chemistry. However, my consistent, drastically low scores/grades will tell otherwise! So, this was my attempt to share a piece of my mind currently succumbed in the ocean of Pharmacology!