Hazards Of Drugs
How drugs act after reaching the site of pain or the site of trouble and how they decipher actions or adverse reactions are the obsession of all concerned. This is the much debated topic in all seminars, meetings, or sessions yet no effort has been taken to investigate and alleviate the causes of adverse reactions of a drug. In order to approach the problem it would be right to start with three adjectives generally used to acclaim a drug such as spurious drugs, counterfeit drugs and Impure drugs.
These drugs do not comply any pharmacopoeia, neither comply in characters, description nor identification. These are based on false raw material hence show no therapeutic activity and are also not properly formulated hence fake.
These drugs imitate/mimic or impersonate so as to look like the real one. For example, buy a raw material from an unknown manufacturer pack and label it of a known one. The drug is sold as a genuine or original one but, in fact, it is not.
Any pharmaceutical substance which is mixed or has an additive of some other cheap pharmaceutical raw material, just to meet the weight requirements is regarded as impure. For example, 50gm of Paracetamol mixed with 50 gm of cheap and low priced Paracetamol or any other cheap material would not be identified as a pure Paracetamol by any analytical method. There are many related substances and impurities associated with the raw material, out of which final/finished drug is formed and there also exist many racemic compounds in the market which may or may not be true drugs.Any drug which is spurious, counterfeit and impure would definitely not comply with the UK and the US pharmacopoeia. Hence, it is branded as a sub-standard drug and/or a misbranded drug. For the last couple of years non-pharmacopoeia drugs both parenteral and oral have been allowed to formulate in various dosage forms including parenteral ones. But their specifications, testing and identification methods have not been issued by their regulating authorities. Conse-quently, their quality and the therapeutic efficacy may prove to be hazardous in various cases.One the other hand, a person by nature is programmed to accept or reject a particular kind of drug, take for example Paracetamol. It would have been noticed that some patients get relief from fever by taking in Dispirin, Ponstan, Bruffen or others. Whereas, a literature study reveals that Paracetamol (acetamide) is more useful for the relief from fever than others. This is likely to be a reason of a personal habit developed over the years.
Molecular paradigm of a drug
One of the basic tenets of drug is that, it must exert some biochemical influence on cells in order to produce pharmacological response. It requires distribution of drug molecules within the body or tissues. For every therapeutic aspect all the drugs after having ingested as a pill or with an injection bind to particular constituents of cells, and interact with nucleic acid (DNA) molecule which is situated in the nucleus of our cells, before doing a curative function.
To elaborate, DNA consists of four bases which are abbreviated as ATCG. These can accept hydrogen ion. The DNA receives the message of approaching foreign substance that is a drug and is motivated to transcribe its RNA which in turn translates the synthesis of specific protein with the help of ‘transfer RNA' (tRNA). This is the protein - a matter that binds a drug. It is formed from triplet coding system of DNA bases. If any aberration occurs in the bases of triplet coding the specific protein will not form and there will be no drug binding. As a result, the drug will not reach its target to cure.
Therefore, pain continues to aggravat owing to the formation of arachidonic acid, a compound derived from eicosanoid results in prostaglandins, thromboxanes and leukotrienes mediate inflammatory reactions with the help of an enzyme called cyclo-oxygenase. Anti-inflammatory action of non-steroidal anti-inflammatory drugs (NSAID) is due to the fact that they inhibit the action of this enzyme. It causes the release of prostaglandin in many tissues. Its physiological effects are produced by way of neurotransmission mechanism. These effects are also prevented by cyclooxygenase (COX) inhibitors. Hence a drug that inhibits the COX enzymes helps to inhibit the sensation of pain or trouble by inhibiting the products of arachidonic acid. Some people who do not get relief from any of the NSAIDS, have in reality either an altered gene function, or the drugs given to inhibit the COX enzyme are spurious, counterfeit or impure. The impure NSAID may wander and loiter in blood circulation. It might cause any damage to any cell, tissue or gland thereby causing adverse reaction, as we call it. In general, the NSAIDs and antibiotics are largely implicated for adverse reactions.
Role of excipients
There are many dosage forms of drugs such as tablets, syrups, capsules etc. commonly known as medicines. These are prepared with the help of some excipients. They perform a variety of functionality roles in any of the dosage form, but, unlike pharmacologically active entities, the excipients display either no pharmacological activity or very negligible activities. However, there are some risk factors of excipients which cannot be overlooked. Mere compliance of them with pharmacopoeia in terms of specifications, identification and assays does not mean that they would not interfere with efficacy of active substance or harm the physiological systems and intervene in biochemical reactions necessary for the perpetuation of life.
Apart from it, they also interfere in analysis of active substance if used without proper knowledge of their chemistry. According to the rule of biochemical system, the excipients, when enter any living system, undergo a metabolic process, but there is no metabolic rout for most of the excipients. Therefore, they sometime cause dysfunction of general metabolism particularly the compounds which we require for seeing, hearing and smelling senses; laughing and talking energy; thinking, memorising and cognition processes. If any of these processes is lost we call it due to adverse reaction of drugs.
Use of enormous excipients in the preparation of medicines such as saccharine and sodium saccharine which is an anhydride of O-sulfonamide benzoic acid is predominant in pharmaceutical industries. It is a non-nutritive sweetener but a potential human carcinogen. PVP (poly vinyl pyrrolidine) a synthetic polymer of vinyl compound used as dispersing or suspending agent is equally carcinogenic. Colours particularly of tetrazine family and flavours are also potential mutagenic agents. Hence adverse reactions are imminent.
Finally I would like to shed light on the environment of setting up a pharmaceutical industry. There are two kinds of environments such as outer and inner. Outer environment should be free from pollutants of other neighbouring industries, there should be no noise, smoke, hustle bustle of vehicular traffic. Whereas, inner environment must be free from dust, bacteria, unnecessary movement of peoples in production lines and analytical labs. Some of these aspects can be overcome if efficient exhaust and HVAC systems are provided. There should be no thoroughfare or interconnecting departments, rooms or chambers in production areas. Furthermore, there should be no colony forming bacteria in microbiological tests, during the production of any medicine. Bacteria generating in inner, and air pollution in outer environments may not only alter the drug molecule but also cause adverse reactions when taken orally or parenterally.