Drug labelling

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A typical drug label of prescription drugs from the Hospital Authority in Hong Kong. The details of label includes the name of preparation, quantity of drugs, instructions for patients, patient's name and the date of dispensing Drug-label-HA.jpg
A typical drug label of prescription drugs from the Hospital Authority in Hong Kong. The details of label includes the name of preparation, quantity of drugs, instructions for patients, patient's name and the date of dispensing

Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal. Since 1800s, legislation has been advocated to stipulate the formats of drug labelling due to the demand for an equitable trading platform, the need of identification of toxins and the awareness of public health. Variations in healthcare system, drug incidents and commercial utilization may attribute to different regional or national drug label requirements. Despite the advancement in drug labelling, medication errors are partly associated with undesirable drug label formatting.

Contents

Evolution

Walter G. Campbell, the first Commissioner of Food and Drugs, initiated the legal implementation of label labelling in USA. Walter G. Campbell.gif
Walter G. Campbell, the first Commissioner of Food and Drugs, initiated the legal implementation of label labelling in USA.

Past development

In the US, early regulations of food and drug quality were predominantly fostered by fair competition between entrepreneurs [1] and drug labelling was not legally mandatory until 1966. In 1906, the adoption of Food and Drugs Act in the US outlawed the business involving mislabeled, tainted or adulterated food, drinks, and drugs. [2] The Sherley Amendment was later introduced to prohibit fabricated medical claims in drug labels. [2] In 1937, misadventure of 107 persons as a consequence of tainted Elixir Sulfanilamide prescription initiated the requirement for prescription only medications. [2] Walter G. Campbell, one of the pioneers in the regulations of drug safety, launched the legal process against spurious drugs and took the stewardship in Food and Drug Administration (FDA) in 1940. [1] In 1950, a ruling in the U.S. Court of Appeals indicated the requirement of listing drug indication in drug labels. In 1962, a drug tragedy in Europe, thousands of defective infants as a result of the administration of thalidomide in pregnant women, [1] [2] dramatized the demand of drug safety profile prior to commercialization. Thousands of prescription medications were retreated as devoid of clinical evidence on effectiveness; [1] and drug labels were required to reflect known medical facts according to the Fair Packaging and Labeling Act in 1966. [1] [2]

Recent development

Drug labelling is undergoing dynamic changes which become more patient-based and individual-centred thanks to the increased clinical evidence development. In February 1999, the introduction of population pharmacokinetics (PPK) in drug labelling established the significance of dose individualization in relation to age, gender, concurrent medication, disease state etc. [3] The application of PPK became ubiquitous, particularly in pharmacological agents with narrow therapeutic index such as anticancer and anti-infective medications. [4] In the same year, the standard drug label format for over-the-counter (OTC) drugs was launched for easy interpretation. In 2004, the utilization of cox-2 inhibitors was discouraged due to increased risks of stroke and heart attack in prolonged use. [2] This commenced the addition of a precaution section in drug labels.

Functions

Drug labelling plays crucial roles not only in the identification of active ingredients or excipients of a known drug, but also the provision of guidance for patients to ensure safety and appropriate administration of medicine. In the prospective of patients, drug labelling acknowledges patients' right to know and achieve optimum utilization of medicine. For healthcare practitioners, it renders the essential information required in prescription and dispensing. For example, pharmacists may identify the drug-related problems of patients during admission from accompanying drug packages.

Requirements by countries or regions

Over the past centuries, drug incidents have been highly correlated to the imperfect or inadequate drug labelling, repercussions of which could be costly and deadly. Legal concerns of drug labelling was aroused in response to the public health crisis.

The United States

General requirements

As required by Title 21 of the Code of Federal Regulation, the established name of the drug and the name and quantity of each components should be conspicuously stated on the drug label. [5] The label shall contain information about the name and address of the manufacturer, packer, or distributor. [5] Besides, it shall contain adequate direction for use, including conditions and purposes, drug dosage, timing and route of administration. [5] In general, the expiry date of the drug is required and shall appear on the mediate container and the outer package. [5] Additional, label statements should be displayed with prominence and conspicuousness. The lot number, also called batch number, on the label should generate the full manufacturing history of the package. [5]

Requirements for OTC drugs

There shall be a warning about use during pregnancy or breast-feeding if they are used for systemic absorption. [5] Moreover, the label of oral OTC drugs should contain the contents of sodium, magnesium, calcium and potassium. [5] Readable drug interactions with intrinsic complexity and accuracy should be provided to healthcare practitioners who may not be expertise in clinical pharmacology. [6]

Requirements for prescription drugs

The label must state the recommended or usual dosage. [5] Warning statements are required if the drug contains sulphite. [5]

The United Kingdom

General requirements

Pursuant to article 54 of Council Directive 2001/83/EEC, the full registered name, dosage form, route of administration, posology and warnings of medicine should be incorporated in all drug labelling as regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom. [7] Such statutory descriptions should be given greater prominence, not being interrupted by supplementary messages or background graphics, particularly the full registered name should be displayed with a minimum of 3 non-opposing faces of carton presentations for effective identification. [8]

Requirements for OTC drugs

The labelling of OTC drugs should include registered indications as part of the statutory information for the self-selection by customers. Where a product relieves symptoms, any language guaranteeing the cure of conditions should not be applied, such as "stop coughing".

Requirements for prescription drugs

Unlike OTC medications, prescription medicine is not required to make reference to the approved indications.

Hong Kong

General requirements

In line with local legislations, a pharmaceutical product should fulfill several labelling requirements for the purpose of registration: the product name, the name and quantity of each active ingredient, the name and address of the manufacture, Hong Kong registration number, batch number, expiry date and storage instructions, if any. [9] Additional labelling may be required in certain drug classes; For example, angiotensin-converting enzyme (ACE) inhibitors such as linsinopril should be indicated with "Caution. Contraindicated in pregnancy". [9]

Requirements for sub-category

In Hong Kong, drugs are stratified as Non-Poisons , Part II Poisons, Part 1 only Poisons , Schedule 1 only Poisons, Schedule 3 Poisons , Schedule 5 Poisons, Antibiotics and Dangerous Drug. [10] For Non-poisons and Part 2 Poison, the dose regimen, route and frequency of administration of the product should be exhibited in both English and Chinese. [9] "Drug under Supervised Sales" should be displayed in medicines containing Part 1 Poisons, except Third Schedule Poison, which should be labelled as "Prescription Drug". [9]

Medication errors associated with drug labelling

A drug label retrieved from a random clinic in Hong Kong. Over-prominence of the logo of clinics may be susceptible to the poor interpretation of drugs by patients. Drug1-page0001 (2).jpg
A drug label retrieved from a random clinic in Hong Kong. Over-prominence of the logo of clinics may be susceptible to the poor interpretation of drugs by patients.

An effective drug label should demonstrate efficacy and safety. Imperfect drug label information or design may lead to misinterpretation and hence medication errors.

Non-standardized label format

Failure of drug identification by medical practitioners was reported in Hong Kong, [11] because of the adoption of non-standardized label formats by physicians in private clinics. In the incident, healthcare providers failed to recognize that 4-hydroxyacetanilide was identical to Paracetamol. Unknown medication history due to confusion amongst generic names, brand names and chemical names may place the security of patient in jeopardy. Standardized drug labelling not only nurtures the habits of label perusal by users, but also enhances patient safety.

Undesirable label design

Inappropriate information hierarchy may impede the prescription understanding by patients. This may lead to medication errors in drug prescribing, dispensing or administration, particularly in geriatric, illiterate, visually impaired or cognitively impaired population, [12] predisposing them to non-adherence.

Optimum design of drug labelling is an essential pharmacological goal which helps eradicate adverse events such as withdrawal symptoms, complications and misadventure. Therefore, multiple practices are recommended to modify drug labelling.

Tall Man lettering

Errors have been reviewed in certain drugs of similar registered name.[ citation needed ] Likelihood of dispensing error can be reduced by adopting Tall Man lettering or other means of highlighting the key component of the drug name. [8] Examples are as follows

Cephalosporins Tallman Labelling
cefadroxil cefADROxil
cefalexin cefALEXin
cefazolin cefAZOLin

Quick Response codes

Inclusion of Quick Response (QR) codes on labelling can be allowed only if the contents are compatible to the summary of product characteristics, practical for patients and non-promotional, [8] such as diseases information and recommendations for lifestyle modifications.

Future development

The benefit-risk profile of a drug varies in populations of different genomes, the study of which is known as pharmacogenomics. Pharmacogenomic testing can be performed to select patients for suitable clinical intervention. Incorporation of pharmacogenomic information in drug labels can help prevent adverse drug events and optimize drug dose. Such information may include the risks for adverse reactions, genotype-specific dosing, clinical response variability etc. [13] For example, Chinese patients possessing HLA-B*1502 who are using carbamazepine should not be administered phenytoin due to the strong evidence of developing lethal Stevens-Johnson Symptoms or toxic epidermal necrolysis. [13]

See also

Related Research Articles

<span class="mw-page-title-main">Pharmacology</span> Branch of biology concerning drugs

Pharmacology is a branch of medicine, biology, and pharmaceutical sciences concerned with drug or medication action, where a drug may be defined as any artificial, natural, or endogenous molecule which exerts a biochemical or physiological effect on the cell, tissue, organ, or organism. It is the science of drugs including their origin, composition, pharmacokinetics, therapeutic use, and toxicology. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals.

<span class="mw-page-title-main">Ibuprofen</span> Medication used for treating pain, fever, and inflammation

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to relieve pain, fever, and inflammation. This includes painful menstrual periods, migraines, and rheumatoid arthritis. It may also be used to close a patent ductus arteriosus in a premature baby. It can be used by mouth or intravenously. It typically begins working within an hour.

<span class="mw-page-title-main">Over-the-counter drug</span> Medication available without a prescription

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

<span class="mw-page-title-main">Pharmacy</span> Clinical health science

Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links health sciences with pharmaceutical sciences and natural sciences. The professional practice is becoming more clinically oriented as most of the drugs are now manufactured by pharmaceutical industries. Based on the setting, pharmacy practice is either classified as community or institutional pharmacy. Providing direct patient care in the community of institutional pharmacies is considered clinical pharmacy.

<span class="mw-page-title-main">Prescription drug</span> Medication legally requiring a medical prescription before it can be dispensed

A prescription drug is a pharmaceutical drug that is only permitted to be dispensed to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

<span class="mw-page-title-main">Naproxen</span> Nonsteroidal anti-inflammatory drug (NSAID) used to treat pain

Naproxen, sold under the brand name Aleve among others, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever. It is taken orally. It is available in immediate and delayed release formulations. Onset of effects is within an hour and lasts for up to twelve hours.

<span class="mw-page-title-main">Rosuvastatin</span> Statin medication

Rosuvastatin, sold under the brand name Crestor among others, is a statin medication, used to prevent cardiovascular disease in those at high risk and treat abnormal lipids. It is recommended to be used together with dietary changes, exercise, and weight loss. It is taken by mouth.

<span class="mw-page-title-main">Pharmacogenomics</span> Study of the role of the genome in drug response

Pharmacogenomics is the study of the role of the genome in drug response. Its name reflects its combining of pharmacology and genomics. Pharmacogenomics analyzes how the genetic makeup of a patient affects their response to drugs. It deals with the influence of acquired and inherited genetic variation on drug response, by correlating DNA mutations with pharmacokinetic, pharmacodynamic, and/or immunogenic endpoints.

<span class="mw-page-title-main">Regulation of therapeutic goods</span> Legal management of drugs and restricted substances

The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.

Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.

<span class="mw-page-title-main">Ranitidine</span> Medication that decreases stomach acid

Ranitidine, sold under the brand name Zantac among others, is a medication used to decrease stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. It can be given by mouth, injection into a muscle, or injection into a vein. In September 2019, the probable carcinogen N-nitrosodimethylamine (NDMA) was discovered in ranitidine products from a number of manufacturers, resulting in recalls. In April 2020, ranitidine was withdrawn from the United States market and suspended in the European Union and Australia due to these concerns. In 2022, these concerns were confirmed in a nationwide population study "ranitidine increased the risk of liver", lung, gastric and pancreatic cancer by 22%,17%, 26% and 35%, respectively. It increased overall cancer risk 10%, p < 0.001.

<span class="mw-page-title-main">Adverse drug reaction</span> Medical condition

An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as pharmacovigilance. An adverse event (AE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not the event is associated with the administration of the drug. An ADR is a special type of AE in which a causative relationship can be shown. ADRs are only one type of medication-related harm. Another type of medication-related harm type includes not taking prescribed medications, which is also known as non-adherence. Non-adherence to medications can lead to death and other negative outcomes. Adverse drug reactions require the use of a medication.

<span class="mw-page-title-main">New Drug Application</span> Request US FDA approve new medications

The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.

<span class="mw-page-title-main">Off-label use</span> Use of pharmaceuticals for conditions different from that for which they were approved

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.

<span class="mw-page-title-main">Armodafinil</span> Eugeroic medication

Armodafinil (trade name Nuvigil) is the enantiopure compound of the eugeroic modafinil (Provigil). It consists of only the (R)-(−)-enantiomer of the racemic modafinil. Armodafinil is produced by the pharmaceutical company Cephalon Inc. and was approved by the U.S. Food and Drug Administration (FDA) in June 2007. In 2016, the FDA granted Mylan rights for the first generic version of Cephalon's Nuvigil to be marketed in the U.S.

<span class="mw-page-title-main">Medication package insert</span> Document included in a package of medicine

A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user—the person who will take the drug or give the drug to another person, such as a minor. Inserts for over-the-counter medications are also written plainly.

In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis is the assessment that a particular [medical] condition is present while an indication is a reason for use. The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits.

Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug. As of Release 4 of the SPL standard, 22,000 FDA informational product inserts have been encoded according to the standard.

Over-the-counter counseling refers to the counseling that a pharmacist may provide on the subject of initiating, modifying, or stopping an over-the-counter (OTC) drug product. OTC counseling requires an assessment of the patient's self-care concerns and drug-related needs. The types of drugs that are involved in OTC counseling are, for example, used to treat self-diagnosable conditions like heartburn, cough, and rashes, though prescription drugs and professional diagnoses are also relevant to the recommendation process.

<span class="mw-page-title-main">Bar code medication administration</span>

Bar code medication administration (BCMA) is a bar code system designed by Glenna Sue Kinnick to prevent medication errors in healthcare settings and to improve the quality and safety of medication administration. The overall goals of BCMA are to improve accuracy, prevent errors, and generate online records of medication administration.

References

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