Ethical (prescription only) pharmaceuticals label is nothing but information compiled about a product that is provided by a manufacturer and approved by drug controller of India. The label would contain necessary information for safe and effective use of a drug and is written primarily for healthcare professionals. Pharmaceutical labels are important aspects of a product, as they carry information related to the product identity, product usage and shelf life, apart from source and regulatory information.
It is observed that in India the pharmaceutical labels are not comprehensive, as regulatory guidelines cover only partial aspects of labelling. For instance, it is optional to carry the product usage and related information for the patients. Besides, it was found that the labels in the Indian market are grossly and inadequate from the point of view of the patient and health care professional. Hence, there is a need to form national guidelines with proper regulations. The labeling guidelines should be implemented uniformly throughout the nation. This could help in avoiding medication error and assist in quality use of medicines.
According to the United States Pharmacopoeia (USP), the term "labeling" designates all labels and other written, printed, or graphic matter upon an immediate container of an article or upon, or in, any package or wrapper in which it is enclosed, except any outer shipping container. The term "label" designates that part of labeling upon the immediate container.
As per the Federal Food, Drugs and Cosmetics act (Section 201), the term "label" means a display of written, printed or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. However, the term "immediate container" does not include package liners. The term "labeling" means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.
Labelling entails much more than the information that appears on a bottle or package. It is a concise and comprehensive statement of the best information about a drug's quality, efficacy and safety. Quality refers to the precise chemical composition of the drug, the strength and physical form in which it is supplied and the rules for its storage and handling. Efficacy refers to the medical conditions for which it is indicated and the therapeutic effects of use, as well as the proper dosing for the accepted indications. Safety refers to potential side effects, contraindications and other consequences of use, including rules for monitoring patients with various special conditions.
Labelling is intended as a guide to patients and medical and health care professionals. It is presented as a textual narrative, but it also contains important detailed data elements. Labels are useful to the patients as they provide the patients with necessary information to understand the use of the product. As products are usually handled in the ambulatory/out patient care set-up, the primary aim should be to provide information to the patients. It was found that the labels in the Indian scenario are good only for the use of doctors and pharmacists who have background knowledge on the use of drugs.
A prescription drug product label (also known as a professional label, package insert, direction circular and package circular) is a compilation of information about a product written by the manufacturer and approved by food and drug administration (FDA). Labelling or prescription information is a requirement for all approved drug and biological drug products.
In most developed countries, the regulatory agencies have established comprehensive guidelines and rules for the content and format of labeling. For example in the United States these are set in the Code of Federal Regulations under Title 21 concerning the Food and Drug Act. 21 CFR 201.56 defines the major topical sections to be included as:
● Description
● Clinical pharmacology
● Indications and usage
● Contraindications
● Warnings
● Precautions
● Adverse reactions
● Drug abuse and dependence
● Over-dosage
● Dosage and administration
● Method of supply
FDA has designed new labeling to help health care practitioners to easily find, read and convey information that is important for the safe and effective use of prescription drugs.
In Great Britain, legal requirements for the labeling of medicines are explained in Medicines, Ethics and Practice: A Guide for Pharmacists. These regulations specify that the label must clearly state precise instructions for use by the patient and the cautionary and advisory labels, where appropriate.
In India, the labeling of ethical pharmaceuticals is in accordance with guidelines mentioned in the Drugs and Cosmetics Rules, 1945 and Drugs and Magic Remedies Act, 1954.
The Drugs and Magic Remedies (objectionable advertisements) Act, 1954 controls and prohibits certain classes of advertisements relating to drugs and magic remedies. According to the act, advertisement includes all notices, circulars, labels, wrappers or other documents and all announcements made orally or by means of producing or transmitting light, sound or smoke.
The rules specify the indication of the proper name of the drug in a more conspicuous manner than the brand name, correct statement of the net contents, details of active ingredients, address and name of the manufacturer, distinctive batch number, manufacturing license number, expiry particulars, information related to storage or manner of use and general information like physician's sample, not for sale. However, there is no specific rule regarding the inclusion of auxiliary (cautionary and advisory) labels, therapeutic indication, dose, side effects and other relevant information regarding the drug on the package label. The warning labels for prescription drugs include Schedule H: To be sold by retail on the prescription of a registered medical practitioner only.
Auxiliary labels (cautionary and advisory labels) are essential for avoiding hazards of medication errors, in order to achieve the desired therapeutic goals. Standard cautionary and advisory labels offer advice but are not exhaustive. The labels are not a substitute for adequate counselling by prescribers and dispensers (most medicines are dispensed by pharmacists) but are intended to reinforce essential information the patient needs to know.
Requirements of ideal labeling
Recommended label wording can offer advice about:
● Timing of doses in relation to food
● Completing the course of treatment
● What to do if a dose is missed
● The correct storage of a medicine
● Dissolution of the medicine in water before taking it
● Limits to the number of tablets that should be taken in a given time
Recommended label wording can offer warnings about:
● Effects of the medicine on driving or work (e.g. through drowsiness)
● Foods or medicines that should be avoided
● Avoidance of exposure of the skin to sunlight or sun lamps
● Medicines that can discolor the urine
● Medicines that can stain clothes or skin
It was found that most of the labels on the dispensed medications lacked cautionary and/or advisory labels with the exception of a few.
The absence of these linformation in abels can often leads to serious concequences and may also decrease the efficacy of the drug therapy. In some cases, the absorption of a drug might be affected due to drug-drug interactions or drug-food interactions of which the patient under the medication might be unaware of. For instance, consumption of calcium containing products renders the tetracyclin therapy a falure.
For those patients who are on asprin or paracetamol must be adviced not to take any other paracetamol containing products, as it might lead to overdose, which might ultimately lead to kidney damage due to over dosage.
Preparations that may cause the patient's urine to turn an unusual colour, like Rifampicin, must bear a label that cautions the patient of the same, which would otherwise lead to patient noncompliance and ultimately lead to failure of the therapy. Such errors in therapy can be avoided by including a simple advisory and/or cautionary label. The incorporation of these labels will not only reduce the occurance of errors, but also optimise the drug therapy.
Recommended wording of cautionary & advisory labels
Warnings
● May cause drowsiness
● May cause drowsiness. If affected do not drive or operate machinery
● Avoid alcoholic drink
● Follow the printed instructions you have been given with this medicine
● Causes drowsiness which may continue the next day. If affected do not drive or operate machinery. Avoid alcoholic drink
● This medicine may colour the urine
Instruction for usage
● Take at regular intervals. Complete the prescribed course unless otherwise directed
● Dissolve or mix with water before taking
● Allow to dissolve under the tongue. Do not transfer from this container. Keep tightly closed. Discard 8 weeks after opening.
● with or after food
● half to one hour before food
● an hour before food or on an empty stomach
● sucked or chewed
● swallowed whole, not chewed
● dissolved under the tongue
● with plenty of water
● To be spread thinly
Dos and don'ts
● Do not take indigestion remedies at the same time of day as this medicine
● Do not take indigestion remedies or medicines containing iron or zinc at the same time of day as this medicine
● Do not take milk, indigestion remedies, or medicines containing iron or zinc at the same time of day as this medicine
● Do not stop taking this medicine except on your doctor's advice
● Avoid exposure of skin to direct sunlight or sun lamps
● Do not take anything containing aspirin while taking this medicine
● Caution flammable: keep away from fire or flames
● Do not take more than…in 24 hours
● Do not take more than…in 24 hours or…in any one week
● Do not take more than 2 at any one time. Do not take more than 8 in 24 hours
● Do not take with any other Paracetamol products
● Contains aspirin and Paracetamol. Do not take with any other Paracetamol products
● Contains aspirin
● Contains an aspirin-like medicine
The absence of relevant information on the labels may lead the physician to prescribe multiple drugs which may interact with each other. This can lead to serious health hazards and patient non-compliance that may lead to ineffective therapy.
Labels of ethical pharmaceuticals in India are inadequate in terms of providing information to the patient and health care professionals. This can be the root cause of many medication errors and failure in therapy. In the developed countries, labels are being regulated to ensure a safe and quality use of medicines. However, labels in developing countries like India are not uniform. There is a need for upgrading the existent regulations to be at par with developing countries as the same pharmaceuticals are used in therapeutics. There should be stringent norms and regulations regarding the inclusion of dose, indications, appropriate auxiliary (cautionary and advisory) labels, side effects, contra-indications, interactions as part of a label on every package. This will help the physician to make rational decisions regarding drug use, reduce the non-compliance amongst patients, especially those in ambulatory care, and provide sufficient information to all other health care professionals to support and ensure quality use of medicines.
(The authors are with Department of Pharmaceutical Management, Manipal College of Pharmaceutical Sciences, Manipal, India)