A review and analysis of product recall for pharmaceutical drug product

The pharmaceutical industry's primary concern is to provide high-quality drug products to the general public, so drug recalls play an important role in maintaining the quality system by removing defective products from the market. Pharmaceutical product recalls are increasing at an alarming rate as a result of increased inspection rates and the introduction of modernization and the digital world into the industry, raising concerns for regulatory agencies and public health to focus on more stringent regulations to control future recalls of defective drug products. This article will provide an overview of recall procedures, their impact on the pharmaceutical industry, and the various steps taken to reduce pharmaceutical recalls.

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Segmentasi Pelanggan Ritel Produk Farmasi Obat Menggunakan Metode Data Mining Klasterisasi Dengan Analisis Recency Frequency Monetary (RFM) Termodifikasi

Jurnal Teknologi Informasi dan Ilmu Komputer ◽

10.25126/jtiik.2020702925 ◽

2020 ◽

Vol 7 (3) ◽

pp. 573

Author(s):

Arief Wibowo ◽

Andy Rio Handoko

Keyword(s):

Data Mining ◽

Drug Product ◽

Pharmaceutical Products ◽

Pharmaceutical Product ◽

Customer Segmentation ◽

Selling Price ◽

Data Mining Algorithm ◽

Transaction Data ◽

Pharmaceutical Drug ◽

Drug Products

Secara umum, pembelian produk farmasi di Indonesia tidak memiliki pola. Pembelian produk farmasi seperti obat-obatan, dilakukan oleh individu bukan sebagai persiapan untuk menjaga kesehatan, namun sebagai respon terhadap penyakit yang sedang diderita. Di sisi lain, pelanggan retail produk farmasi obat biasanya dipengaruhi oleh faktor harga jual dan faktor kecocokan (sugesti) pada merk obat tertentu sewaktu melakukan pembelian. Berdasarkan kondisi itu maka pola pembelian obat bagi masyarakat Indonesia menjadi tidak dapat diprediksi. Hal tersebut membuat pelaku usaha di bisnis ritel produk farmasi obat, relatif sulit untuk meningkatkan nilai penjualan. Salah satu upaya yang bisa dilakukan pelaku bisnis untuk meningkatkan pendapatan adalah dengan melakukan promosi penjualan berdasarkan jenis kelompok pelanggannya. Transaksi pembelian produk farmasi obat dapat dianalisis untuk mengetahui segmentasi pelanggan berdasarkan pola pembelian. Riset ini telah berhasil memodelkan segmentasi pelanggan ritel apotek dengan teknik data mining klasterisasi. Metode yang digunakan adalah melakukan analisis data transaksi pembelian yang terdiri dari atribut Recency Frequency Monetary (RFM) termodifikasi. Analisis telah melibatkan atribut Kuantitas (Quantity) dari data transaksi pembelian produk farmasi obat sebagai eksperimen modifikasi model. Pada proses pemodelan klasterisasi, studi ini menggunakan algoritme data mining K-Means. Hasil penelitian menunjukkan bahwa segmentasi pelanggan yang optimal berada pada dua klaster berdasarkan hasil analisis QRF (Quantity, Recency dan Frequency) menggunakan evaluasi Davies Bouldin Indeks (DBI) dengan nilai 0,527. Kinerja model tersebut dibandingkan dengan algoritme K-Medoids. Hasil klasterisasi pelanggan pada dua kategori menggunakan K-Medoids memiliki nilai DBI sebesar 1.334. Berdasarkan nilai pembanding tersebut maka metode K-Means terbukti lebih baik dalam pembentukan klaster pelanggan ritel farmasi obat pada analisis atribut Quantity, Recency dan Frequency.; AbstractIn general, the purchase of pharmaceutical products in Indonesia has no pattern. The purchase of pharmaceutical products such as medicines, made by individuals not as preparation for maintaining health, but in response to the illness being suffered. On the other hand, retail customers of pharmaceutical drug products are usually influenced by selling price factors and suggestions for certain drug brands when making a purchase. Based on these conditions, the pattern of purchasing drugs for Indonesian people is unpredictable. This makes businesses in the retail business of pharmaceutical drug products, relatively difficult to increase sales value. One effort that businesses can do to increase revenue is to conduct sales promotions based on the type of customer group. Drug pharmaceutical product purchase transactions can be analyzed to determine customer segmentation based on purchase patterns. This research has successfully modeled the pharmacy retail customer segmentation with clustering data mining techniques. The method used is to analyze the purchase transaction data consisting of modified Recency Frequency Monetary (RFM) attributes. Analysis has involved the Quantity attribute (Quantity) of the transaction data of pharmaceutical drug product purchases as a model modification experiment. In the cluster modeling process, this study uses the K-Means data mining algorithm. The results showed that the optimal customer segmentation was in two clusters based on the results of the QRF (Quantity, Recency and Frequency) analysis using the Davies Bouldin Index (DBI) evaluation with a value of 0.527. The performance of the model is compared with the K-Medoids algorithm. The results of customer clustering in two categories using K-Medoids have a DBI value of 1,334. Based on these comparative values, the K-Means method is proven to be better in forming pharmaceutical drug retail customer clusters with analysis Quantity, Recency and Frequency attributes.

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3D Printing in Pharmaceuticals: Regulatory Perspective

Current Pharmaceutical Design ◽

10.2174/1381612825666181130163027 ◽

2019 ◽

Vol 24 (42) ◽

pp. 5081-5083 ◽

Cited By ~ 5

Author(s):

Mohd. A. Mirza ◽

Zeenat Iqbal

Keyword(s):

New Technologies ◽

Pharmaceutical Product ◽

Regulatory Agencies ◽

Major Research ◽

Data Bases ◽

Drug Products ◽

Regulatory Perspective ◽

Regulatory Guidelines ◽

Recent Developments ◽

Technical Issues

Background: The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, design and delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employed in fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into the pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of“personalized medicine”. Methods: Data bases and search engines of regulatory agencies like USFDA and EMA have been searched thoroughly for relevant guidelines and approved products. Other portals like PubMed and Google Scholar were also ferreted for any relevant repository of publications are referred to wherever required. Results: So far only one pharmaceutical product has been approved in this category by USFDA and stringent regulatory agencies are working over the drafting of guidelines and technical issues. Major research of this category belongs to the academic domain. Conclusion: It is also implicit to such new technologies that there would be numerous challenges and doubts before these are accepted as safe and efficacious. The situation demands concerted and cautious efforts to bring in foolproof regulatory guidelines which would ultimately lead to the success of this revolutionary technology.

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Rotulagem de medicamentos industrializados: uma análise das diretrizes legais brasileiras e contribuições para a qualidade de produtos

Revista de Administração em Saúde ◽

10.23973/ras.81.225 ◽

2020 ◽

Vol 20 (81) ◽

Author(s):

Márcia Lombardo

Keyword(s):

Drug Product ◽

Regulatory Agencies ◽

Quality And Safety ◽

Sources Of Information ◽

Normative Documents ◽

Drug Products ◽

Legal Provisions ◽

Product Surveillance ◽

Study Results ◽

Regulatory Knowledge

RESUMOObjetivos: a rotulagem é um aspecto de qualidade fundamental no uso de medicamentos, seja pelo profissional de saúde, seja pelo paciente. Este trabalho propôs uma análise crítica do tema com base na legislação em vigor, bem como a triagem de documentos normativos úteis no processo de elaboração ou de avaliação da conformidade da rotulagem de medicamentos. Métodos: foi realizada uma pesquisa documental empregando-se como fonte de informações os sítios eletrônicos oficiais do Ministério da Saúde e da Agência Nacional de Vigilância Sanitária. Os documentos contendo itens pertinentes a rotulagem de medicamentos e classificados como vigentes ou vigentes com alteração foram selecionados para a realização do estudo. Resultados: os quesitos mais relevantes das disposições gerais e das disposições específicas da norma vigente para rotulagem de medicamentos foram sistematizados, verificando-se suas contribuições na qualidade e segurança de produtos. Embora a padronização da rotulagem de medicamentos seja necessária, a ocorrência de elevados graus de semelhança entre rótulos, embalagens ou mesmo nomenclaturas é discutida no âmbito da prática clínica e esta questão merece atenção especial. A busca de material complementar à legislação vigente resultou no levantamento de um total de 20 documentos, incluindo normas, guias, bancos de consulta e planilhas, que podem auxiliar no cumprimento dos requisitos de rotulagem de medicamentos. Conclusão: rótulos de medicamentos são recursos técnicos que contribuem na eficácia e na segurança do tratamento. Os esforços das Agências Reguladoras têm permitido a consolidação de diretrizes legais para que informações e formatos adequados de rotulagem sejam aplicados nas embalagens de medicamentos industrializados. A elaboração ou a análise da rotulagem de medicamentos requer amplo conhecimento regulatório, o qual é dinâmico e, portanto, um grande desafio.Palavras-chave: Rotulagem de Medicamentos. Legislação de Medicamentos. Vigilância de Produtos Comercializados. Segurança do Paciente. ABSTRACTObjectives: the labeling of drug products is an aspect of quality that is fundamental to the use of medicines, whether by the health professional or by the patient. This work proposed a critical analysis of the current legislation on the labeling of drug products, as well as the screening of normative documents useful for the process of preparing or assessing the conformity of labels. Methods: a documentary research was carried out using the official websites of the Ministry of Health and the National Health Surveillance Agency (Brazil) as sources of information. The documents containing relevant items on labeling of drug products and classified as current or current with changes were selected for the study. Results: the most important requirements of the general and specific provisions from the current legislation have been systematized, and their contributions to the quality and safety of products have been verified. Although the standardization of the labeling is necessary, the occurrence of high degrees of similarity between labels, packaging or even nomenclatures is discussed in the context of clinical practice and this issue deserves special attention. The search for material complementary to the current legislation resulted in the collection of a total of 20 documents, including normative documents, guides, databases and spreadsheets, which might help in complying with the requirements for the labeling of drug products. Conclusion: the labeling of drug products are technical resources that contribute to the effectiveness and safety of treatment. The efforts of the Regulatory Agencies have allowed the consolidation of legal provisions for the dissemination of appropriate information and labeling formats in the packaging of drug products. The drafting or analysis of the labels requires extensive regulatory knowledge, which is dynamic and, therefore, a great challenge.Keywords: Drug Labeling. Legislation, Drug. Product Surveillance, Postmarketing. Patient Safety.

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Nitrosamine Impurities: Origin, Control and Regulatory Recommendations

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v9i2.472 ◽

2021 ◽

Vol 9 (2) ◽

pp. 77-80

Author(s):

Umesh Dobariya ◽

Narendra Chauhan ◽

Himani Patel ◽

Nidhi Pardeshi

Keyword(s):

Risk Assessment ◽

Pharmaceutical Product ◽

Regulatory Agencies ◽

Unexpected Finding ◽

Angiotensin Ii Receptor ◽

Drug Products ◽

Human Carcinogen ◽

Receptor Blockers ◽

Risk Assessment Strategy ◽

And Control

The unexpected finding of presence of nitrosamine impurities, by USFDA and EMA in year 2018, in drugs such as Angiotensin-II Receptor Blockers (ARBs), Ranitidine, Nizatidine and Metformin, has triggered the need for a risk assessment strategy for evaluation and control of these probable human carcinogen - nitrosamine in pharmaceutical product that are at risk. This finding leads to voluntarily recall of products worldwide. The finding of nitrosamines in some types of drug products led FDA and other international regulators to conduct a detailed risk assessment of these impurities in APIs and drug products. Although nitrosamine impurities have been found in only some drug products, regulatory agencies recommended to extend risk analysis in other chemically synthesized APIs and drug products also.

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Patient Centric Pharmaceutical Drug Product Design—The Impact on Medication Adherence

Pharmaceutics ◽

10.3390/pharmaceutics12010044 ◽

2020 ◽

Vol 12 (1) ◽

pp. 44 ◽

Cited By ~ 9

Author(s):

Enrica Menditto ◽

Valentina Orlando ◽

Giuseppe De Rosa ◽

Paola Minghetti ◽

Umberto Musazzi ◽

...

Keyword(s):

Medication Adherence ◽

Drug Product ◽

Fixed Dose ◽

Pharmaceutical Drug ◽

Drug Products ◽

The Individual ◽

The Impact ◽

Drug Product Design ◽

Patient Centric ◽

Adherence To Therapy

Medication adherence is a growing concern for public health and poor adherence to therapy has been associated with poor health outcomes and higher costs for patients. Interventions for improving adherence need to consider the characteristics of the individual therapeutic regimens according to the needs of the patients. In particular, geriatric and paediatric populations as well as dermatological patients have special needs/preferences that should be considered when designing drug products. Patient Centric Drug Product Pharmaceutical Design (PCDPD) offers the opportunity to meet the needs and preferences of patients. Packaging, orodispersible formulations, fixed dose combinations products, multiparticulate formulations, topical formulations and 3D printing are of particular relevance in a PCDPD process. These will be addressed in this review as well as their impact on medication adherence.

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EXPRESS: Regulating Product Recall Compliance in the Digital Age: Evidence from the “Safe Cars Save Lives” Campaign

Journal of Marketing ◽

10.1177/00222429211023016 ◽

2021 ◽

pp. 002224292110230

Author(s):

Sotires Pagiavlas ◽

Kartik Kalaignanam ◽

Manpreet Gill ◽

Paul D. Bliese

Keyword(s):

Media Coverage ◽

Digital Marketing ◽

Regulatory Agencies ◽

Product Recalls ◽

Product Recall ◽

Before And After ◽

Empirical Context ◽

The Impact ◽

The U.S

The unprecedented number of product recalls in recent years and subsequent low consumer recall compliance raise questions about the role of regulatory agencies in ensuring safety. In this study, the authors develop a conceptual framework to test the impact of a regulator-initiated digital marketing campaign (DMC) on consumer recall compliance. The empirical context is the launch of a nationwide DMC by the U.S. automobile industry’s regulator. The analysis utilizes recall completion data from 296 product recalls active both before and after the DMC’s launch. The results show that the DMC improves consumer recall compliance. In the first four quarters after it was introduced, the DMC increased the number of vehicles fixed, on average, by 20,712 per recall campaign over what was to be expected without the DMC. Regarding boundary conditions, the study finds that the DMC is more effective for recall campaigns with greater media coverage and for those with older recalled products. However, the DMC’s effect is weaker as the time needed to repair a defective component increases. The findings should help regulators make compelling cases for greater resource allocation toward digital initiatives to improve recall compliance.

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DIGITALISATION AND AUTOMATION IN PHARMACEUTICALS FROM DRUG DISCOVERY TO DRUG ADMINISTRATION

International Journal of Pharmacy and Pharmaceutical Sciences ◽

10.22159/ijpps.2018v10i6.24757 ◽

2018 ◽

Vol 10 (6) ◽

pp. 1

Author(s):

Abdul Mannan ◽

Hajera Mubeen

Keyword(s):

Drug Discovery ◽

Research And Development ◽

Drug Administration ◽

Manufacturing Systems ◽

Drug Product ◽

Pharmaceutical Product ◽

Drug Formulation ◽

Efficacy And Safety ◽

Rapid Progress ◽

Drug Products

The rapid progress in the pharmaceutical industry is due to the advancement in the digitalization and automation starting from the invention to the administration of the drug. Every advancement in the development of the pharmaceutical product is associated with progress in digitalization. A drug or a drug product to be administered safely and to provide efficacy it has to undergo a long journey from its discovery, including pre-clinical and clinical trials to further product development in the research and development. The production and manufacturing systems with appropriate digitalization and automation compile the drug formulation after the servitude of the research and development (RandD) department. Later, the quality control and quality assurance systems utilize digitalization to maintain the quality and standard of the drug product. Subsequently, packaging and labeling of the drug product are carried out with effective automation. Further, the marketing and supply of the drug products are digitally monitored and dispatched to the distributors and the pharmacies. Finally, the drug product will be dispensed to the patient for its administration with a concordance of digitally monitoring for enhanced efficacy and safety. Therefore, in this review article, various strategies for digitalization and automation in the pharmaceuticals from drug discovery to drug administration are briefly discussed.

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Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

BioMed Research International ◽

10.1155/2017/7894937 ◽

2017 ◽

Vol 2017 ◽

pp. 1-10 ◽

Cited By ~ 4

Author(s):

Ana Cerúlia Moraes do Carmo ◽

Stefânia Schimaneski Piras ◽

Nayrton Flávio Moura Rocha ◽

Tais Gratieri

Keyword(s):

Quality Control ◽

Drug Product ◽

Active Pharmaceutical Ingredient ◽

Drug Manufacturer ◽

Stability Study ◽

Marketing Authorization ◽

Pharmaceutical Drug ◽

Drug Products ◽

Control Drug ◽

Official Gazette

Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company’s administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal.Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015.Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015.Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.

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SIGNIFICANCE OF FORCED DEGRADATION STUDIES FOR DRUG SUBSTANCE AND DRUG PRODUCTS WITH REFERENCE TO ANTIHYPERTENSIVE AGENTS

INDIAN DRUGS ◽

10.53879/id.53.01.10467 ◽

2016 ◽

Vol 53 (01) ◽

pp. 5-17

Author(s):

J. G Modi ◽

◽

J. K Patel ◽

N. A Gohel ◽

K. G Modi ◽

...

Keyword(s):

Degradation Products ◽

Drug Product ◽

Antihypertensive Agents ◽

Active Pharmaceutical Ingredient ◽

Pharmaceutical Product ◽

Stress Conditions ◽

Drug Substance ◽

Forced Degradation ◽

Degradation Study ◽

Drug Products

Stability testing is used to provide evidence of how the quality of an Active Pharmaceutical Ingredient (API) or drug product varies with time under the infuence of a variety of environmental factors such as temperature, humidity and light. If drug product is not stable under various environmental conditions, it may affect the patient safety by formation of a toxic degradation product(s) or deliver a lower dose than expected. Stress testing of the API can help to identify the likely degradation products, which, in turn, can help to establish the degradation pathways and the intrinsic stability of the molecule. Forced degradation study is a process in which the natural degradation rate of a pharmaceutical product is increased by applying an additional stres by which stability of a drug substance or a drug product with effects on purity, potency and safety can be predicted. The present review summarizes the forced degradation study of antihypertensive agents, where degradation products for different stress conditions have been reported. As per review, maximum degradation products have been reported by alkaline, oxidative and photolytic stress conditions.

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Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process

Pharmaceutics ◽

10.3390/pharmaceutics13071051 ◽

2021 ◽

Vol 13 (7) ◽

pp. 1051

Author(s):

Jonattan Gallegos-Catalán ◽

Zachary Warnken ◽

Tania F. Bahamondez-Canas ◽

Daniel Moraga-Espinoza

Keyword(s):

New Technologies ◽

Innovation Process ◽

Cost Effective ◽

Regulatory Agencies ◽

Drug Products ◽

Effective Strategies ◽

Rate Analysis ◽

Orally Inhaled Drug Products ◽

Next Generation Impactor ◽

First Time

Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat pulmonary diseases. Over the past decade, this trend has broadened, increasing their use in other conditions such as diabetes, expanding the interest in this administration route. Thus, the bioequivalence of OIDPs is more important than ever, aiming to increase access to affordable, safe and effective medicines, which translates into better public health policies. However, regulatory agencies leading the bioequivalence process are still deciding the best approach for ensuring a proposed inhalable product is bioequivalent. This lack of agreement translates into less cost-effective strategies to determine bioequivalence, discouraging innovation in this field. The Next-Generation Impactor (NGI) is an example of the slow pace at which the inhalation field evolves. The NGI was officially implemented in 2003, being the last equipment innovation for OIDP characterization. Even though it was a breakthrough in the field, it did not solve other deficiencies of the BE process such as dissolution rate analysis on physiologically relevant conditions, being the last attempt of transferring technology into the field. This review aims to reveal the steps required for innovation in the regulations defining the bioequivalence of OIDPs, elucidating the pitfalls of implementing new technologies in the current standards. To do so, we collected the opinion of experts from the literature to explain these trends, showing, for the first time, the stakeholders of the OIDP market. This review analyzes the stakeholders involved in the development, improvement and implementation of methodologies that can help assess bioequivalence between OIDPs. Additionally, it presents a list of methods potentially useful to overcome some of the current limitations of the bioequivalence standard methodologies. Finally, we review one of the most revolutionary approaches, the inhaled Biopharmaceutical Classification System (IBCs), which can help establish priorities and order in both the innovation process and in regulations for OIDPs.

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