Peranan Badan Pengawas Obat dan Makanan dalam Perlindungan Konsumen Terhadap Obat Racikan Apotek Tanpa Resep Dokter

The rise of pharmaceutical business actors, in this case, is a pharmacy, in selling concoction drugs without a doctor's prescription in several regions in Indonesia causing losses in consumers. Consumer protection is regulated in Act Number 8 of 1999 concerning Consumer Protection, then consumer rights in the health sector are recognized by Act Number 36 of 2009 concerning Health. Both of these regulations require that at least the consumer is guaranteed his right to use the drug, including comprehensive information related to the drug obtained at the Pharmacy. This is not heeded by a number of pharmacies in Indonesia who pack concoction drugs in plastic packages and do not meet the information standards that must be listed. BPOM as an institution that is given authority in law enforcement for drug distribution that is not in accordance with standards can take product withdrawal as well as administrative sanctions against business actors. In addition, the Consumer Protection Act provides a platform for consumers who are disadvantaged to be able to file liability through the Consumer Dispute Resolution Agency (BPSK).Keywords: BPOM; BPSK; Compounding Drugs; Consumer Protection.AbstrakMaraknya pelaku kegiatan usaha kefarmasian, dalam hal ini adalah apotek, dalam menjual obat racikan tanpa resep dokter di beberapa daerah di Indonesia menimbulkan kerugian-kerugian dalam diri konsumen. Perlindungan konsumen diatur dalam Undang-Undang Nomor 8 Tahun 1999 tentang Perlindungan Konsumen, kemudian mengenai hak konsumen dalam bidang kesehatan diakui oleh Undang-Undang Nomor 36 Tahun 2009 tentang Kesehatan. Kedua peraturan tersebut mengharuskan setidaknya konsumen terjamin hak nya dalam penggunaan obat, termasuk pula informasi lengkap terkait obat yang didapatkan di Apotek. Hal ini tidak diindahkan oleh beberapa apotek di Indonesia yang mengemas obat racikan dalam kemasan plastik dan tidak memenuhi standar informasi yang harus dicantumkan. BPOM sebagai lembaga yang diberi kewenangan dalam penegakan hukum terhadap peredaran obat yang tidak sesuai dengan standar dapat melakukan tindakan penarikan produk serta sanksi administratif kepada pelaku usaha. Selain itu, UU Perlindungan Konsumen memberikan wadah bagi konsumen yang dirugikan untuk dapat mengajukan pertanggung gugatan melalui Badan Penyelesaian Sengketa Konsumen (BPSK).Kata Kunci: BPOM; BPSK; Obat Racikan; Perlindungan Konsumen.

Regulatory approaches: Global medical device tracking advancement in USA, EU and India

Advancement in science & technology of medical industry is coming up with innovations. Medical devices play a vital role. Real Time Location System (RTLS) which includes Radio Frequency Identification (RFID) device, Wi-Fi technology that helps to look after adverse events and recall products when required, thereby, prevent theft by keeping regular check on their movement with location sensors. In 19th century two products of United States faced product withdrawal. After that, US felt the need to develop system for product record management and tracking. In 2004, FDA introduced Unique Device Identifier (UDI) for medical device tracking. With time, GHTF came up with UDI working groups and in 2013, new version of UDI guidelines for globally harmonized use was generated. In this article study about various countries has been done. It was found that countries like United States and Europe have introduced medical device tracking system and by 2022 this will be implemented in India.

A Plasmid-Encoded Putative Glycosyltransferase Is Involved in Hop Tolerance and Beer Spoilage in Lactobacillus brevis

ABSTRACT Lactobacillus brevis beer-spoiling strains harbor plasmids that contain genes such as horA, horC, and hitA which are known to confer hop tolerance. The L. brevis beer-spoiling strain UCCLBBS124, which possesses four plasmids, was treated with novobiocin, resulting in the isolation of UCCLBBS124 derivatives exhibiting hop sensitivity and an inability to grow in beer. One selected derivative was shown to have lost a single plasmid, here designated UCCLBBS124_D, which harbors the UCCLBBS124_pD0015 gene, predicted to encode a glycosyltransferase. Hop tolerance and growth in beer were restored when UCCLBBS124_pD0015 was introduced in one of these hop-sensitive derivatives on a plasmid. We hypothesize that this gene modifies the surface composition of the polysaccharide cell wall, conferring protection against hop compounds. Furthermore, the introduction of this gene in trans in L. brevis UCCLB521, a strain that cannot grow in and spoil beer, was shown to furnish the resulting strain with the ability to grow in beer, while its expression also conferred phage resistance. This study underscores how the acquisition of certain mobile genetic elements plays a role in hop tolerance and beer spoilage for strains of this bacterial species. IMPORTANCE Lactobacillus brevis is a member of the lactic acid bacteria and is often reported as the causative agent of food or beverage spoilage, in particular, that of beer. Bacterial spoilage of beer may result in product withdrawal or recall, with concomitant economic losses for the brewing industry. A very limited number of genes involved in beer spoilage have been identified and primarily include those involved in hop resistance, such as horA, hitA, and horC. However, since none of these genes are universal, it is clear that there are likely (many) other molecular players involved in beer spoilage. Here, we report on the importance of a plasmid-encoded glycosyltransferase associated with beer spoilage by L. brevis that is involved in hop tolerance. The study highlights the complexity of the genetic requirements to facilitate beer spoilage and the role of multiple key players in this process.

Challenges and Opportunities in the Design of Liver-on-Chip Microdevices

The liver is the central hub of xenobiotic metabolism and consequently the organ most prone to cosmetic- and drug-induced toxicity. Failure to detect liver toxicity or to assess compound clearance during product development is a major cause of postmarketing product withdrawal, with disastrous clinical and financial consequences. While small animals are still the preferred model in drug development, the recent ban on animal use in the European Union created a pressing need to develop precise and efficient tools to detect human liver toxicity during cosmetic development. This article includes a brief review of liver development, organization, and function and focuses on the state of the art of long-term cell culture, including hepatocyte cell sources, heterotypic cell–cell interactions, oxygen demands, and culture medium formulation. Finally, the article reviews emerging liver-on-chip devices and discusses the advantages and pitfalls of individual designs. The goal of this review is to provide a framework to design liver-on-chip devices and criteria with which to evaluate this emerging technology.

Synergy in Leak Detection: Combining Leak Detection Technologies That Use Different Physical Principles

Different leak detection technologies offer different benefits and limitations. Popular options include real-time transient models, statistical volume balance analysis and negative pressure wave systems. Atmos offers a combination of different systems to improve the leak detection performance on a pipeline. This paper outlines the very successful integration of a Statistical Volume Balance System and a Negative Pressure Wave System on a crude oil pipeline. The live product withdrawal tests demonstrated that the combined system maximized the reliability, detection speed, location accuracy and sensitivity of the overall leak detection system. This paper will examine the benefits and technical challenges of combining these two leak detection technologies. The integrated solution delivers the reliability and robustness of the Statistical Volume Balance System together with the rapid response time and location accuracy of the Negative Pressure Wave System. The field application of the two systems integrated on a 170 kilometer crude oil pipeline will be explained in detail, along with the results of some actual controlled product withdrawal tests on the pipeline.

Two cases of poisoning by raw taro leaf and how a poison control centre, food safety inspectors, and a specialty supermarket chain found a solution

Although the taro plant, Colocasia esculenta, is commonly consumed throughout Asia, Africa, the Pacific Islands, and the Caribbean, its consumption is less common in North America. Exposure to raw or improperly prepared taro is associated with oropharyngeal irritation and swelling and, rarely, airway obstruction. Although cases of toxicity in countries where taro is a staple have been reported, cases in North America have not been described. Here, two cases of oral irritation and swelling in BC residents who ate raw taro leaf, were reported to the British Columbia Drug and Poison Information Centre (BC DPIC) and triggered an investigation involving a regional health authority and the Canadian Food Inspection Agency. Investigators found that the vendor, a chain of ethnic supermarkets, offered no point of sale preparation instructions. The vendor responded initially by posting instructional signage and later by voluntary product withdrawal. Analysis of BC DPIC records between 1 November 2011 and 20 December 2013 identified 11 cases of symptomatic taro exposure, five to the leaf and six to the corm. The two index cases and subsequent investigation illustrate how new foods or foods in unfamiliar contexts may present as calls to a poison control centre and that prevention requires collaboration among public and corporate stakeholders.

The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk

Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy.