scholarly journals Analysis of package inserts of orally administered drugs available in the Indian market

2017 ◽  
Vol 5 (2) ◽  
pp. 529
Author(s):  
Maheshi U. Chhaya
Keyword(s):  
Shelf Life ◽  
Package Insert ◽  
Complete Information ◽  
Indian Market ◽  
Package Inserts ◽  
Source Of Information

Background: The package insert of a medication forms an important source of information to the patient while taking a drug. The package insert is expected to contain complete information regarding the drug aiding the patient to obtain additional knowledge regarding the drug.Methods: 100 package inserts of orally administered drugs were obtained from local chemists and were analysed according to the Sections 6.2 and 6.3 of Schedule D (II), Drugs and Cosmetics Act (1940) and Rules (1945).Results: The posology and contraindications were mentioned in 98% and 96% of the inserts, respectively, whereas the list of excipients, incompatibilities and shelf life was mentioned in 12%, 19%, 16% of the inserts, respectively.Conclusions: There is a wide variation in the information available on the package inserts of drugs available in the Indian market. The package inserts should be carefully scrutinized for completeness before the respective drug is marketed.

scholarly journals Status of package insert guidelines for drugs accessible as over the counter drugs

2018 ◽  
Vol 7 (2) ◽  
pp. 298
Author(s):  
Anuja Jha ◽  
Usha Joshi ◽  
Rajesh Hishikar ◽  
Manju Agrawal ◽  
Ajay Halwai
Keyword(s):  
Drug Administration ◽  
Package Insert ◽  
Sole Source ◽  
Over The Counter ◽  
Safety And Efficacy ◽  
Package Inserts ◽  
Otc Drugs ◽  
The Status ◽  
Effective Use ◽  
Source Of Information

Background: As per Indian pharmacopoeia, package inserts are part of a label that provides information on the article. It may be the sole source of information for drugs, which are available in the pharmacies without the prescription and it may include both prescription and over the counter (OTC) drugs. So, to aid in safety and efficacy of these drugs, package inserts must follow the standard guidelines (The Drugs and Cosmetics rule, 1945). The objective of this study was to observe the status of the standard guidelines for package insert in drugs accessible as OTC drugs.Methods: Based on the inquiries made with pharmacies, list of drugs commonly bought without prescription was made. 256 drugs were evaluated. Their package inserts were observed for the extent to which the guidelines given by The Drugs and Cosmetics rule 1945, section 6.2 and 6.3 are being followed. Secondary objectives were made to assess if package inserts are physician friendly or patients friendly.Results: Package inserts were missing in 180 (70%) of the drugs.  Therapeutic indications were present in 71% of the available package inserts (76). Pharmaceutical information was given in 57% of the package inserts. English was the preferred language and medicinal terms were used. Only one package insert was patient friendly.Conclusions: Package inserts should be made available in every drug. There should be a separate patient oriented package insert guideline, as per US food and drug administration (FDA), in India as well. This will aid in their safe and effective use.

scholarly journals Ontological Organization and Bioinformatic Analysis of Adverse Drug Reactions From Package Inserts: Development and Usability Study

10.2196/20443 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e20443
Author(s):  
Xiaoying Li ◽  
Xin Lin ◽  
Huiling Ren ◽  
Jinjing Guo
Keyword(s):  
Language Processing ◽  
Adverse Reactions ◽  
Package Insert ◽  
Bioinformatic Analysis ◽  
Two Dimensions ◽  
Semantic Relations ◽  
Semantic Retrieval ◽  
Formal Representation ◽  
Package Inserts ◽  
Drug Databases

Background Licensed drugs may cause unexpected adverse reactions in patients, resulting in morbidity, risk of mortality, therapy disruptions, and prolonged hospital stays. Officially approved drug package inserts list the adverse reactions identified from randomized controlled clinical trials with high evidence levels and worldwide postmarketing surveillance. Formal representation of the adverse drug reaction (ADR) enclosed in semistructured package inserts will enable deep recognition of side effects and rational drug use, substantially reduce morbidity, and decrease societal costs. Objective This paper aims to present an ontological organization of traceable ADR information extracted from licensed package inserts. In addition, it will provide machine-understandable knowledge for bioinformatics analysis, semantic retrieval, and intelligent clinical applications. Methods Based on the essential content of package inserts, a generic ADR ontology model is proposed from two dimensions (and nine subdimensions), covering the ADR information and medication instructions. This is followed by a customized natural language processing method programmed with Python to retrieve the relevant information enclosed in package inserts. After the biocuration and identification of retrieved data from the package insert, an ADR ontology is automatically built for further bioinformatic analysis. Results We collected 165 package inserts of quinolone drugs from the National Medical Products Administration and other drug databases in China, and built a specialized ADR ontology containing 2879 classes and 15,711 semantic relations. For each quinolone drug, the reported ADR information and medication instructions have been logically represented and formally organized in an ADR ontology. To demonstrate its usage, the source data were further bioinformatically analyzed. For example, the number of drug-ADR triples and major ADRs associated with each active ingredient were recorded. The 10 ADRs most frequently observed among quinolones were identified and categorized based on the 18 categories defined in the proposal. The occurrence frequency, severity, and ADR mitigation method explicitly stated in package inserts were also analyzed, as well as the top 5 specific populations with contraindications for quinolone drugs. Conclusions Ontological representation and organization using officially approved information from drug package inserts enables the identification and bioinformatic analysis of adverse reactions caused by a specific drug with regard to predefined ADR ontology classes and semantic relations. The resulting ontology-based ADR knowledge source classifies drug-specific adverse reactions, and supports a better understanding of ADRs and safer prescription of medications.

"THERAPEUTIC ORPHANS" AND THE PACKAGE INSERT

PEDIATRICS ◽  
1970 ◽  
Vol 46 (5) ◽  
pp. 811-813
Author(s):  
Keyword(s):  
Chemical Structure ◽  
Adverse Reactions ◽  
Package Insert ◽  
Drug Manufacturer ◽  
Full Disclosure ◽  
Package Inserts ◽  
Federal Food ◽  
The Status ◽  
Definition Of ◽  
Official Information

In the practice of pediatrics, drugs which are not approved by the Food and Drug Administration (FDA)* as safe and effective in children are prescribed daily. This is due in part to the fact that many drugs released since 1962 carry an "orphaning clause" in the package insert such as, "not to be used in children, since clinical studies have been insufficient to establish recommendations for its use." What is the status of the package insert? Is it a legal directive to the physician, or is it intended as a guide for the physician in prescribing a drug? The package insert, by legal definition of the Federal Food, Drug and Cosmetic Law, is the official information piece for a drug. The information it contains is derived from data supplied by investigators and submitted by the pharmaceutical firm to the FDA. The insert is written and printed by the drug manufacturer, but its contents must be approved by the FDA. The Food, Drug and Cosmetic Law, as amended in 1962, requires full disclosure of all known facts pertaining to the use of the drug. Therefore, a great deal of information is included in the insert, including the chemical structure of the drug, a summary of its pharmacological and toxicological action, its clinical indications and contraindications, precautions, reported adverse reactions, dosage recommendations, and available dosage forms. Many drugs have package inserts approved by the FDA before the Drug Amendments of 1962 when manufacturers were required to show the safety but not the effectiveness of their products.

scholarly journals Comparative Study of Developed Tomato Soup with Market Soup

2021 ◽  
Vol 10 (11) ◽  
pp. 188-191
Author(s):  
Seema Sonkar Usha Devi Gupta ◽  
Pragya Mishra Suman Devi ◽  
H. G. Prakash
Keyword(s):  
Comparative Study ◽  
Shelf Life ◽  
Nutritional Quality ◽  
Sensory Quality ◽  
Microbial Contamination ◽  
Storage Stability ◽  
Low Cost ◽  
Indian Market ◽  
Tomato Soup ◽  
Microbial Study

Streetfood has popular in Indian market and consumed as convenient to eat with reasonable price but sold open dirt areas that found unhygienic, not free from microbial contamination and having low nutritional quality. The present investigation was carried out to develop vegetable tomato soup and compare with street tomato soups and assess their sensory quality and microbial study. Microbial parameters were used to affect the shelf life of the products. The developed tomato soups were acceptable in comparison to Street tomato soups. Hence, low cost nutritious developed tomato soup can be acceptable with good storage stability.

scholarly journals Educational behaviors of pregnant women in the Bronx during Zika’s International emerging epidemic: “First mom … and then I’d Google. And then my doctor”

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Miguel Rodriguez ◽  
Antoinette A. Danvers ◽  
Carolina Sanabia ◽  
Siobhan M. Dolan
Keyword(s):  
Pregnant Women ◽  
Public Awareness ◽  
Healthcare Providers ◽  
Emerging Infectious Diseases ◽  
Complete Information ◽  
The Internet ◽  
Sources Of Information ◽  
Additional Information ◽  
Initial Source ◽  
Source Of Information

Abstract Background The objective of the study was to understand how pregnant women learned about Zika infection and to identify what sources of information were likely to influence them during their pregnancy. Methods We conducted 13 semi-structed interviews in English and Spanish with women receiving prenatal care who were tested for Zika virus infection. We analyzed the qualitative data using descriptive approach. Results Pregnant women in the Bronx learned about Zika from family, television, the internet and their doctor. Informational sources played different roles. Television, specifically Spanish language networks, was often the initial source of information. Women searched the internet for additional information about Zika. Later, they engaged in further discussions with their healthcare providers. Conclusions Television played an important role in providing awareness about Zika to pregnant women in the Bronx, but that information was incomplete. The internet and healthcare providers were sources of more complete information and are likely the most influential. Efforts to educate pregnant women about emerging infectious diseases will benefit from using a variety of approaches including television messages that promote public awareness followed up by reliable information via the internet and healthcare providers.

scholarly journals Do drug package inserts meet the rules and regulations of Iran’s Food and Drug Administration in terms of informing patients?

2019 ◽  
Vol 9 (3) ◽  
pp. 214-222
Author(s):  
Tahereh Eteraf-Oskouei ◽  
Saeid Abdollahpour ◽  
Moslem Najafi ◽  
Vahideh Zarea Gavgani
Keyword(s):  
Drug Administration ◽  
Mobile Apps ◽  
Food And Drug Administration ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Microsoft Excel ◽  
Cross Sectional ◽  
Reference Category ◽  
Package Inserts ◽  
Source Of Information

Background: Drug package inserts (PIs) are the most accessible source of information for users and are designed to aid the safe use of medicines and avert adverse events. This study measured the conformity of PIs with the health communications standards of Iran’s Food and Drug Administration (FDA). Methods: This descriptive cross-sectional study evaluated 92 PIs related to 22 best-selling neurological and psychiatric drugs in Iran based on criteria approved by Iran’s FDA. Six categories of criteria were considered in evaluating the extent of conformity: I) writing and formatting, II) references, III) drug description, IV) warnings and precautions, V) interactions, and VI) side effects. Each PI was scored based on observation of standards; data was analyzed using Microsoft Excel pivot tables. Results: In total, 2929 items from 92 PIs were evaluated, of which 37 (40.2%) were related to antidepressants, 31 (33.7%) to sedatives and hypnotics, and 24 (26%) to anticonvulsant drugs. The PI content was insufficient in various aspects of conformity with standards in each category. Among the six categories, the best match was found in warnings and precautions with 667 items (72.5%), followed by writing and formatting with 663 (69.1%). The lowest conformity was found in the reference category with 194 (26.4%) items. Conclusion: The PIs of Iranian neurological drugs do not fully meet Iran’s FDA standards. It is strongly recommended that smart PIs be developed using mobile apps to overcome this problem.

scholarly journals Medication package inserts: how far do they adhere to the guidelines?

2016 ◽  
Vol 6 (1) ◽  
pp. 133 ◽  
Author(s):  
Neha Deep ◽  
Roslin Jose ◽  
Ananya Chakrabo
Keyword(s):  
Package Insert ◽  
Clinical Information ◽  
Drug Usage ◽  
Over The Counter ◽  
Package Inserts ◽  
Chemotherapy Drugs ◽  
Cns Drugs ◽  
Effective Use ◽  
Ability To Drive ◽  
Respiratory Drugs

Background: Package Insert (PI) is a document that is provided with the package of a drug. It is chiefly directed at the prescribers and is set to provide information for the safe and effective use of the respective drug. This study was conducted to assess the completeness of clinical information provided in the currently available PIs.Methods: PIs were collected from pharmacies located at various parts of Bangalore over three months. A total of 310 drugs were checked for package inserts (PI) and 192 PI’s were collected. They were analysed based on the criteria mentioned in Schedule D of Drug and Cosmetic act 1945.Results: Out of 192 PIs, 33 were repeated and so were not taken into account. Hence, 159 PIs were analysed. Among 159 PIs, 43 (27.04%) were of Cancer chemotherapy drugs; 19 (11.94%) of antibiotics, 18 of anti-diabetic drugs, 13 (8.17%) of Vitamins and minerals, 10 (6.28%) of Cardiac drugs, 9 (5.66%) of Respiratory drugs, 6 (3.77%) of CNS drugs, 5 (3.14%) of Ophthalmic eye solutions, 4 (2.51%) of Hormones and reproductive system, 4 (2.51%) of GIT, 4 (2.51%) of Antifungals, 3 (1.88%) of steroids, and 21 (13.20%) of miscellaneous drugs respectively. Out of them, the PIs that belonged to “A”, “B”, and “C” categories were 5 (3.14%), 150 (94.33%), and 4 (2.51%) respectively. It was observed that the PIs were inadequate in many aspects. Majority of the PIs had unclear instructions about drug usage, special precautions, ability to drive and use machines and adverse effects to name a few.Conclusions: This study showed that many of the drugs now days come without PI. Also of the available ones, very few fulfil all the criteria mentioned in the guidelines. With the growing sales of over the counter drugs in India, it is important for companies to dispense PIs with all the drugs. PIs oriented toward educating the patient are the need of the hour.

scholarly journals Deprescribing benzodiazepines: Do Brazilian package inserts address this issue?

2021 ◽  
Vol 15 ◽  
Author(s):  
Marlon Silva Tinoco ◽  
Marcela Oliveira Baldoni ◽  
Ériks Oliveira Silva ◽  
Amanda Maria de Paiva ◽  
Paula Resende Daher Chaves ◽  
...  
Keyword(s):  
Health Professionals ◽  
Treatment Duration ◽  
Package Insert ◽  
Health Surveillance ◽  
Package Inserts ◽  
Length Of Treatment ◽  
Continuous Use ◽  
Benzodiazepine Drugs

OBJECTIVE: To analyze the presence and quality of content on drug deprescribing in Brazilian package inserts for benzodiazepine drugs. METHODS: Documentary study where we analyzed data on deprescribing extracted from electronic package inserts of drugs containing benzodiazepines; these documents were available at the Brazilian Health Surveillance Agency website. Our search was performed independently by 2 researchers who used the following keywords: “deprescription,” “withdrawal,” and “tapering.” The deprescribing plan, when presented by the package insert, was compared to deprescribing protocols for benzodiazepines found in the literature. Moreover, we assessed the presence of guidance on the maximum length of treatment and risks of long-term use. RESULTS: We found 12 package inserts for benzodiazepines and 100% of them suggested gradual withdrawal; only 1 (8.33%) suggested a systematized deprescribing plan. One document (8.33%) did not offer guidance on maximum treatment duration. Eleven (91.67%) had the information on long-term use possibly causing dependence or tolerance, and 1 (8.33%) did not describe the risks of continuous use. CONCLUSIONS: It is known that benzodiazepines should be withdrawn in a gradual and schematized manner, but package inserts do not currently bring this information in detail. It is of utmost importance that health professionals be educated on their conduct, hence the necessity for updating medication package inserts.

Package Inserts and Noncompliance With Doctor's Orders

PEDIATRICS ◽  
1973 ◽  
Vol 51 (2) ◽  
pp. 312-312
Author(s):  
Gary M. Gorlich
Keyword(s):  
Recent Literature ◽  
Package Insert ◽  
Pediatric Practice ◽  
Package Inserts ◽  
Patient Refusal

Noncompliance, i.e., patient refusal to take doctor-perscribed medication, is very important in pediatric practice. Recent literature in Pediatrics and other pediatric-oriented journals has addressed itself to the frequency and significance of this behavior. In recent discussions with colleagues in dermatology I have learned of another "etiology" for noncompliance and wish to bring it to the attention of those in pediatrics not familiar with it, to wit: physician samples of medications usually contain a package insert which is intended for the physician's knowledge of the preparation in question.1

Adr In Journals: Are They Translated Into Regulatory Frameworks?

2021 ◽  
Vol 16 ◽  
Author(s):  
Annapurna Kolupoti ◽  
Ananya Chakraborty ◽  
Shahistha K
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Case Reports ◽  
Package Insert ◽  
Geographic Location ◽  
Scientific Publication ◽  
Geographic Region ◽  
Package Inserts ◽  
Regulatory Authorities ◽  
The Uk

Introduction: An adverse drug reaction case report refers to a scientific publication that is written by a health care professional who suspects a causal relationship between a drug and an adverse drug reaction (ADR). ADR case reports help to identify potential risks associated with the use of the drug. Most of the case reports do not mention reporting the ADR to regulatory authorities. With this objective, the aim of this study was to analyze the number of Adverse Drug Reaction (ADR) published as case reports (PubMed indexed journals) from January 2018 to June 2019 and observe if they are translated into a regulatory framework like Vigibase and package inserts. Materials And Methods: 321 ADRs were obtained with the keywords “Adverse Drug Reaction.” Out of those, 158 were independently extracted by two investigators, observed and categorized according to classes of the drugs, geographic location, severity, hospitalization, completeness of ADR, and whether they were reported to the regulatory authority (VigiBase) or listed in the package insert. Literature review articles were excluded. Results: Out of the 158 ADRs, antibiotics accounted for 12.65%, CNS drugs and monoclonal antibodies accounted for 11.39%, anticancer drugs for 9.49%, CVS drugs for 4.43%, anti-virals for 3.79%, and the others for 45.56%. According to geographic region, 26 ADRs published were from USA, 4 from Australia, 3 from Italy, 17 from India, 9 from Turkey, 1 from Singapore and the UK, 20 from China, 2 from Denmark and Canada, 10 from Japan, 9 from France, 1 from Austria, 5 from Korea, 3 from South America, and 2 from Switzerland. Depending upon the severity, causality assessment was performed for 45 ADRs only; it was not performed for 113 ADRs. 41.13% of patients (from 65 case reports) were hospitalized. Among the 158 ADRs, 14 ADRs were not found in VigiBase. 32 ADRs were not mentioned in the drug package inserts. When categorized according to the completeness of case reports, weight accounted for 1.89%, lab values and procedure for diagnosis accounted for 96.8%, risk factors for 95.56%, prior exposure for 88.60%, post ADR status for 60.12%, and the start-stop medication, route of administration, first dose, last dose, and the duration of illness accounted for 100%. Conclusion: Depending upon our observation, we have noticed that there is a deficiency in reporting of suspected ADR to the regulatory authorities. Reporting can be included as mandatory criteria for ADR case reports. Also, there is an increased need for various healthcare workers to be aware about reporting ADR.

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