Medication Errors

Labels and Drugs: Prescription Error

(Part 1 of 6 of Medication Errors)

On one hand the term “medication errors” is of wide amplitude and is extremely wide, especially with respect to issues of medical negligence and on the other some may not even know what the term actually constitutes or what is a medication error. Though the list of specific events that may be included in the definition of “Medication Errors” is long, the four blogs that follow will cover for six broad categories under which Medication Errors can be categorized.

This blog discusses the Medication Errors arising from Failure on the part of a medical professional in keeping up with the up-to-date warning and labeling on medicines which are intended to safeguard a patient consumption. 

All labels of a drug sold in India should conform as per the specifications under the Drugs and Cosmetics Rules 1945 which also means that no person can sell or distribute any drug unless it is labeled in accordance with the said Rules.

Labeling is the norm that provides comprehensive and concise statement of a drug’s Quality Safety and Efficacy. This sort of labeling includes information pertaining to indications, effects, dosage form, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions and other relevant information.

The safe use of all medicines depends on users reading the labeling and packaging carefully and accurately and being able to assimilate and act on the information presented and therefore it is mandatory that all labels must be clear and concise and must bear all necessary information regarding the safe use of a product.

A certain category of labeling is “Prescription Drug Labeling”. This sort of labeling is done for those products that cannot be used safely by consumer unless a physician diagnosis and supervises the administration of the said drug. The drugs in this category are those that have an unavoidably adverse effect if not used as per prescription and at the same time the benefits of using such drugs outweigh the accompanying risks.

It is the expert judgment of a practitioner to decide the use of a drug for a particular patient. Under Rule 97 the drug labeling regulations in India, requires specific caution statements to be present on label for the different drug schedules. Prescription drugs in India are categorized under Schedule H, Schedule G and Schedule X of the Drug and Cosmetics Rules, 1945.

• Schedule H Drugs carry the symbol “Rx” and the “Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only”
•  Schedule G Drugs carry the following mandatory label - “Caution: It is dangerous to take this preparation except under medical supervision”.
• Schedule X Drugs carry the symbol “XRx”. The container of a liniment, lotion, liquid antiseptic or other liquid medicine which is used for external application only shall carry the warning ‘For External use only’.

Thus, the manufacturer of a prescription is required to provide adequate labeling for practitioners to be able to administer or dispense the drug safely and for the purposes for which it is intended. Thereby meaning that the practitioner who prescribes a medicine shall at all times must have update information of the drug so prescribed in order to safeguard the patient against “medication errors”. Some cited examples of medication prescription errors have been:-

• Children being prescribed an adult dose of medication
• Repeat prescribing of medication without proper review
• Patients being prescribed the wrong dose
• Medication being given to patients who have symptoms that suggest the drug should not be given to them and the drug is contraindicated
• Chemists and pharmacists dispensing the wrong medication or an incorrect dose of drugs

A simple lack of care, an error of judgment or an accident, is not proof of medical negligence on the part of a medical professional only in case where the doctor has followed a practice acceptable to the medical profession. It is obvious that taking the wrong medication can cause serious side effects and in rare cases can also result in death. 

Although in most cases it is ideal to trust that one has been given the correct medication however, one must always check the packaging, contents and literature included with all medicines before taking it. If one has been issued with a prescription for medication by a hospital or a practitioner the one should check that the medication you are given by the chemist matches the prescription and also that the medication prescribed is the correct type and strength to treat the condition.