166:, the established name of the drug and the name and quantity of each components should be conspicuously stated on the drug label. The label shall contain information about the name and address of the manufacturer, packer, or distributor. Besides, it shall contain adequate direction for use, including conditions and purposes, drug dosage, timing and route of administration. In general, the expiry date of the drug is required and shall appear on the mediate container and the outer package. 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.
304:
17:
460:. 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. For example, Chinese patients possessing
44:
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.
208:(MHRA) in the United Kingdom. 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.
53:
238:
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
139:
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'
43:
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
140:
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.
348:
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, predisposing them to
93:
in pregnant women, dramatized the demand of drug safety profile prior to commercialization. Thousands of prescription medications were retreated as devoid of clinical evidence on effectiveness; and drug labels were required to reflect known medical facts according to the
216:
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".
148:
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.
110:(PPK) in drug labelling established the significance of dose individualization in relation to age, gender, concurrent medication, disease state etc. The application of PPK became ubiquitous, particularly in pharmacological agents with narrow
323:
Failure of drug identification by medical practitioners was reported in Hong Kong, because of the adoption of non-standardized label formats by physicians in private clinics. In the incident, healthcare providers failed to recognize that
178:
should contain the contents of sodium, magnesium, calcium and potassium. Readable drug interactions with intrinsic complexity and accuracy should be provided to healthcare practitioners who may not be expertise in clinical pharmacology.
89:(FDA) in 1940. 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
447:
on labelling can be allowed only if the contents are compatible to the summary of product characteristics, practical for patients and non-promotional, such as diseases information and recommendations for lifestyle modifications.
859:
MacLaughlin, Eric J.; Raehl, Cynthia L.; Treadway, Angela K.; Sterling, Teresa L.; Zoller, Dennis P.; Bond, Chester A. (1 March 2005). "Assessing
Medication Adherence in the Elderly. Which Tools to Use in Clinical Practice?".
68:
In the US, early regulations of food and drug quality were predominantly fostered by fair competition between entrepreneurs and drug labelling was not legally mandatory until 1966. In 1906, the adoption of
201:
583:
Ette, Ene I.; Williams, Paul J. (2000). "The Role of
Population Pharmacokinetics in Drug Development in Light of the Food and Drug Administration's 'Guidance for Industry: Population Pharmacokinetics'".
775:
287:, the dose regimen, route and frequency of administration of the product should be exhibited in both English and Chinese. "Drug under Supervised Sales" should be displayed in medicines containing
106:
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
627:
Watanabe-Uchida, Megum; Narukawa, Mamoru (14 November 2016). "Utilization of population pharmacokinetics in drug development and provision of the results to healthcare professionals".
284:
268:
264:
315:
An effective drug label should demonstrate efficacy and safety. Imperfect drug label information or design may lead to misinterpretation and hence medication errors.
340:
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.
276:
272:
204:, 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
292:
260:
280:
28:
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
205:
74:
256:
755:
288:
77:
was later introduced to prohibit fabricated medical claims in drug labels. In 1937, misadventure of 107 persons as a consequence of tainted Elixir
174:
There shall be a warning about use during pregnancy or breast-feeding if they are used for systemic absorption. Moreover, the label of oral
163:
85:, one of the pioneers in the regulations of drug safety, launched the legal process against spurious drugs and took the stewardship in
907:
495:
375:
Errors have been reviewed in certain drugs of similar registered name. Likelihood of dispensing error can be reduced by adopting
703:
Tran, Mongthuong T.; Grillo, Joseph A. (2019-04-09). "Translation of Drug
Interaction Knowledge to Actionable Labeling".
804:
679:
500:
187:
The label must state the recommended or usual dosage. Warning statements are required if the drug contains sulphite.
802:
357:
Optimum design of drug labelling is an essential pharmacological goal which helps eradicate adverse events such as
935:
95:
456:
The benefit-risk profile of a drug varies in populations of different genomes, the study of which is known as
239:
and storage instructions, if any. Additional labelling may be required in certain drug classes; For example,
225:
Unlike OTC medications, prescription medicine is not required to make reference to the approved indications.
479:
86:
82:
56:
361:, complications and misadventure. Therefore, multiple practices are recommended to modify drug labelling.
73:
in the US outlawed the business involving mislabeled, tainted or adulterated food, drinks, and drugs. The
107:
59:, the first Commissioner of Food and Drugs, initiated the legal implementation of label labelling in USA.
114:
such as anticancer and anti-infective medications. In the same year, the standard drug label format for
483:
70:
803:
Department of Health Drug Office Drug
Evaluation and Import/Export Control Division (December 2019).
505:
175:
127:
115:
930:
379:
or other means of highlighting the key component of the drug name. Examples are as follows
826:
8:
358:
885:
736:
609:
376:
370:
25:
569:
877:
873:
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728:
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597:
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in prolonged use. This commenced the addition of a precaution section in drug labels.
111:
889:
613:
869:
753:
712:
636:
593:
457:
510:
119:
773:
924:
724:
471:
385:
337:
240:
78:
539:
881:
845:
732:
648:
605:
333:
81:
prescription initiated the requirement for prescription only medications.
329:
325:
90:
754:
Medicines and
Healthcare products Regulatory Agency (31 December 2020).
395:
244:
716:
640:
475:
423:
409:
303:
52:
776:"Best Practice Guidance on the Labelling and Packaging of Medicines"
311:
may be susceptible to the poor interpretation of drugs by patients.
298:
756:"Medicines: packaging, labelling and patient information leaflets"
247:
should be indicated with "Caution. Contraindicated in pregnancy".
118:
was launched for easy interpretation. In 2004, the utilization of
905:
567:
461:
444:
858:
16:
629:
International
Journal of Clinical Pharmacology and Therapeutics
570:"A History of the FDA and Drug Regulation in the United States"
123:
352:
40:
307:
A drug label retrieved from a random clinic in Hong Kong.
805:"Guidelines on the Labelling of Pharmaceutical Products"
220:
626:
143:
908:"Table of Pharmacogenomic Biomarkers in Drug Labeling"
758:. Medicines and Healthcare products Regulatory Agency.
332:. Unknown medication history due to confusion amongst
182:
906:
774:
Medicines and
Healthcare products Regulatory Agency.
783:
Medicines and
Healthcare products Regulatory Agency
295:, which should be labelled as "Prescription Drug".
206:
Medicines and Healthcare Products Regulatory Agency
39:, is a written, printed or graphic matter upon any
922:
478:due to the strong evidence of developing lethal
318:
299:Medication errors associated with drug labelling
250:
211:
241:angiotensin-converting enzyme (ACE) inhibitors
169:
680:"CFR - Code of Federal Regulations Title 21"
582:
343:
202:article 54 of Council Directive 2001/83/EEC
702:
568:Federal Drug Administration (FDA) (2006).
537:
164:Title 21 of the Code of Federal Regulation
122:was discouraged due to increased risks of
540:"The Story of the Laws Behind the Labels"
233:
195:
705:Clinical Pharmacology & Therapeutics
353:Recommended practices for drug labelling
302:
51:
15:
747:
438:
157:
923:
309:Over-prominence of the logo of clinics
255:In Hong Kong, drugs are stratified as
901:
899:
812:Department of Health Drug Office Drug
451:
364:
190:
101:
798:
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152:
144:Requirements by countries or regions
221:Requirements for prescription drugs
183:Requirements for prescription drugs
63:
13:
896:
14:
947:
827:"Hong Kong Poison Classification"
789:
762:
655:
550:
538:F. Janssen, Wallace (June 1981).
522:
501:Drug policy of the United Kingdom
874:10.2165/00002512-200522030-00005
824:
598:10.2165/00003088-200039060-00001
496:Drug policy of the United States
852:
837:
818:
96:Fair Packaging and Labeling Act
696:
620:
576:
1:
843:
516:
319:Non-standardized label format
285:Non-poisons and Part 2 Poison
251:Requirements for sub-category
228:
134:
116:over-the-counter (OTC) drugs
87:Food and Drug Administration
47:
7:
489:
474:should not be administered
108:population pharmacokinetics
10:
952:
484:toxic epidermal necrolysis
368:
212:Requirements for OTC drugs
170:Requirements for OTC drugs
586:Clinical Pharmacokinetics
506:Medication package insert
445:Quick Response (QR) codes
480:Stevens-Johnson Symptoms
344:Undesirable label design
20:A typical drug label of
711:(6). Wiley: 1292–1295.
269:Schedule 1 only Poisons
936:Pharmaceuticals policy
684:www.accessdata.fda.gov
312:
60:
37:prescription labelling
29:
544:FDA Consumer Magazine
306:
293:Third Schedule Poison
55:
19:
439:Quick Response codes
326:4-hydroxyacetanilide
234:General requirements
196:General requirements
158:General requirements
35:also referred to as
359:withdrawal symptoms
265:Part 1 only Poisons
452:Future development
390:Tallman Labelling
377:Tall Man lettering
371:Tall Man lettering
365:Tall Man lettering
336:, brand names and
313:
279:, Antibiotics and
277:Schedule 5 Poisons
273:Schedule 3 Poisons
191:The United Kingdom
102:Recent development
83:Walter G. Campbell
71:Food and Drugs Act
61:
57:Walter G. Campbell
30:
26:Hospital Authority
22:prescription drugs
862:Drugs & Aging
436:
435:
328:was identical to
153:The United States
112:therapeutic index
75:Sherley Amendment
33:Drug labelling is
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717:10.1002/cpt.1427
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641:10.5414/CP202696
624:
618:
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458:pharmacogenomics
382:
381:
120:cox-2 inhibitors
64:Past development
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511:Auxiliary label
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349:non-adherence.
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321:
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261:Part II Poisons
253:
236:
231:
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214:
198:
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185:
172:
162:As required by
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137:
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66:
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12:
11:
5:
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868:(3): 231–255.
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695:
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619:
592:(6): 385–395.
575:
549:
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508:
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498:
491:
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470:who are using
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386:Cephalosporins
369:Main article:
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354:
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345:
342:
338:chemical names
320:
317:
300:
297:
289:Part 1 Poisons
281:Dangerous Drug
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847:
846:"政府應立例規管藥物標籤"
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472:carbamazepine
469:
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446:
443:Inclusion of
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334:generic names
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109:
99:
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88:
84:
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79:Sulfanilamide
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72:
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45:
42:
38:
34:
27:
23:
18:
911:
865:
861:
854:
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830:
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811:
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749:
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687:. Retrieved
683:
635:(1): 25–31.
632:
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589:
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455:
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429:
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314:
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224:
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200:Pursuant to
199:
186:
173:
161:
147:
138:
128:heart attack
105:
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36:
32:
31:
21:
931:Drug policy
330:Paracetamol
257:Non-Poisons
245:linsinopril
91:thalidomide
925:Categories
689:2020-03-30
517:References
396:cefadroxil
741:106409315
725:0009-9236
476:phenytoin
424:cefazolin
410:cefalexin
291:, except
229:Hong Kong
176:OTC drugs
135:Functions
98:in 1966.
48:Evolution
24:from the
890:32678863
882:15813656
733:30964943
649:27841154
614:25787275
606:11192472
490:See also
243:such as
844:吳, 劍華.
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283:. For
124:stroke
886:S2CID
808:(PDF)
779:(PDF)
737:S2CID
610:S2CID
463:HLA-B
41:drugs
878:PMID
831:MIMS
729:PMID
721:ISSN
645:PMID
602:PMID
467:1502
430:AZOL
416:ALEX
404:xil
402:ADRO
126:and
912:FDA
870:doi
713:doi
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432:in
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414:cef
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465:*
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