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Repurposing generic drugs as new treatments for life-threatening diseases such as cancer is an exciting yet largely overlooked opportunity due to a lack of market-driven incentives. Nonprofit organizations and other non-manufacturers have been ramping up efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients. However, these nonmanufacturers find it difficult to obtain regulatory approval in the U.S. Without a straightforward path for approval and updating drug labeling, non-manufacturers have relied on off-label use of repurposed drugs. This limits the broad clinical adoption of these drugs and patient access. In this paper, we explore the regulatory landscape for repurposing of small molecule generic drugs within the U.S. We describe case studies of repurposed drugs that have been successfully incorporated into clinical treatment guidelines for cancer without regulatory approval. To encourage greater adoption of generic drugs in clinical practice-that is, to encourage the repurposing of these drugs-we examine existing Food and Drug Administration (FDA) pathways for approval of new uses or indications for generic drugs. We show how non-manufacturers, who are generally more active in generic drug repurposing than manufacturers, could utilize existing regulatory authorities and pathways, and we describe the challenges they face. We propose an extension of the existing 505(b)(2) new drug application (NDA) approval pathway, called a "labeling-only" 505(b)(2) NDA, that would enable non-manufacturers to seek approval of new indications for well-established small molecule drugs when multiple generic products are already available. It would not require new chemistry, manufacturing, and controls (CMC) data or introducing new drug products into the marketplace. This pathway would unlock innovation broadly and enable patients to benefit from the enormous potential of low-cost generic drugs. [ABSTRACT FROM AUTHOR]

Generic drugs seem a promising alternative to decrease healthcare costs. However, on one hand, doctors express reluctance toward this kind of drug, and on the other hand, existing literature remains silent about factors explaining their prescribing behavior. The current study mobilizes the Health Belief Model to offer a better understanding of the factors that hinder the prescription of generic drugs by doctors in terms of benefits, barriers, perceived susceptibility, perceived severity, self-efficacy, and action cues. Twenty-four in-depth interviews were conducted with doctors from different specialties. Projective techniques were used including Chinese portrait, completion test, completion task, and association tests. Data analysis was processed using Sphinx software. The paper offers practical recommendations for health authorities and pharmaceutical firms to better promote generics. Increasing the prescription of generic drugs, compared to branded drugs, may increase patient access to affordable drug treatments, decrease healthcare costs and establish rational utilization of medicines. Generic drugs prescription may consequently play an essential role in improving the quality of life. [ABSTRACT FROM AUTHOR]

Objectives: Cancer diagnosis is increasing day by day all over the world. Deaths due to cancer are among the most common causes of death. Access to cancer drugs is a priority of health policies. The aim of this study is to evaluate access to cancer drugs through drug box sales data by modeling population growth, cancer incidence, and Fixed Euro Exchange (FEE) rate parameters used in drug pricing in Türkiye. Methods: Access to cancer drugs was evaluated by drug box sales figures obtained from IQVIA. Box sales data were classified according to diagnosis codes (ICD-10), reference, or generic status. Consumption of cancer drugs was examined over time with panel regression analysis, taking into account variables of population growth, cancer incidence, and the FEE rate in drug pricing in Türkiye. Results: The incidence of cancer in Türkiye was 215.1 in 2010 and 223.1 (per hundred thousand) in 2017. Whereas there was a 127.02% increase in the real euro exchange rate, there was an 89.6% increase in the FEE rate. With the regression approach, there is a negative relationship between the real and fixed exchange rate difference (RFED) and reference and generic drug consumption data. Medicine access is affected depending on diagnosis codes at different levels. Colorectal cancer medicine sales had negative correlations for each variable, namely, exchange rate, population growth, and cancer incidence. On the contrary, there was a positive correlation between non-small-cell lung cancer and relevant variables. Innovative medicine groups such as monoclonal antibodies and protein kinase inhibitor consumption showed a negative correlation. Conclusion: According to our results, pricing strategy may be an access barrier for oncology medicines in Türkiye. It should be reviewing the pricing policy that is beneficial for oncology medicine access in Türkiye. [ABSTRACT FROM AUTHOR]

Background: Generic drug legislation, i.e., simultaneously banning groups of drugs, has been introduced worldwide to counteract the trade and use of emerging "new psychoactive substances" (NPSs) more effectively. Summary: The potential and de facto positive and negative effects of generic drug legislation have been described using an analysis based on documented evaluations of the experiences in the UK and Germany, supplemented with data from other publicly available sources. In particular, the effects of generic drug legislation on availability, use, sales, and overall health harms of NPS, and switches from NPS to traditional (classical) drugs are addressed. The results show that the introduction of generic drug legislation in the UK and Germany has enabled stricter regulation of NPS but has also led to some major harms within the domain of public health. Depending on the population considered, the rate of NPS use remained stable, slightly declined, or increased following the banning of NPS. Once banned, NPSs were more often purchased on the black market, often together with other (more harmful) drugs. Moreover, NPS-related harms did not reduce following the ban, and in some cases even increased. Finally, when harmful NPS, like potent synthetic opioids and cannabinoids, become substantially used and endanger public health, legislators already have the legal means to ban the problem drug, thus overruling the need for a generic ban. Key Messages: Generic drug legislation may facilitate drug law enforcement, but it is not (very) effective in counteracting NPS use and it may increase NPS-related public health problems. It is concluded that, overall, the advantages of generic drug legislation are overshadowed by its serious disadvantages. [ABSTRACT FROM AUTHOR]

Introduction: The drugs approved by the Food and Drug Administration (FDA) in 2022, for the first time for any indication or under any brand, were studied under the contexts of indications, mechanism of action, and side effects. Primary care practitioners with considering patients as a composite whole will benefit by acquainting themselves with these drugs and their indications and adverse effects. Observations: The drugs were approved in all, 11 for the management of neoplasia, and 5 each for hematological, neurological, and dermatological conditions. 11 of the approved drugs are monoclonal antibodies and six are small molecule inhibitors. Conclusion: Although the FDA’s expedited approval program allows rapid market availability of drugs for difficult to treat conditions, a quarter of the globe does not have access to essential medicines, primarily due to cost. In light of this, approval agencies must reorient approval processes to improve accessibility. [ABSTRACT FROM AUTHOR]

High generic drug prices affect patient access to health care. This is not only detrimental to individual members of the public but is also a problem for the entire healthcare system. Market conditions in the pharmaceutical industry as well as anticompetitive behavior by pharmaceutical companies can directly produce high drug prices. This Note argues that the government should go beyond the regulation of the pharmaceutical industry to lower drug costs and instead become a market player, adding competition to the generic drug market. The public manufacturing of drugs is likely an effective policy solution for the federal government or state governments to implement in addressing the multifaceted problem of rising generic drug costs. Public manufacturing avoids the most common legal challenges to state regulation and is the most direct way to improve patient access to necessary prescriptions. [ABSTRACT FROM AUTHOR]

The given text provides information on various developments in the pharmaceutical industry in India. The Indian Government has implemented new rules to fast-track the launch of breakthrough drugs, while the US House of Representatives has passed a bill to improve access to orphan drugs. Indian companies are also succeeding in patent litigations against global pharmaceutical giants, indicating a more balanced approach to patent rights and patient access to healthcare. The text also mentions the High Court of Madras directing an enquiry about a banned anti-diabetic drug and highlights the potential for discovering new drugs from herbal resources. Additionally, it briefly mentions Dr. Gopakumar G. Nair, the editor of Indian Drugs, without providing specific information about the content of the publication. [Extracted from the article]

The economic downfall in Lebanon and the destruction of the Beirut Port have had a crippling effect on all players in the health sector, including hospitals, healthcare providers, and the pharmaceutical and medical supply industry. The outbreak of COVID-19 has further aggravated the crisis. To address the challenges facing the pharmaceutical industry, Lebanon must create a stable and secure source of prescription drug production. Two alternative approaches are presented to address the crisis: (1) amending the subsidy system and supporting local pharmaceutical production, and (2) promoting the prescription and use of generic drugs. Investing in local production is promising and can lead to establishing trust in the quality of drugs produced locally. These efforts can be complemented by promoting the prescription and use of generic drugs at a later stage, after having had established a well-operating system for local drug production. [ABSTRACT FROM AUTHOR]

Introduction: rational drug use prevents wastage of resources, loss of confidence in healthcare system and drug-related morbidity and mortality. This study aims to assess drug use in Primary Health Centers (PHCs) in Lagos State, Nigeria using the World Health Organization in collaboration with the International Network of Rational Use of Drugs core drug use indicators. Methods: the study was conducted between February to October 2021 as a comparative observational survey of selected PHCs. It included a retrospective and prospective cross-sectional design for prescribing and patient care indicators assessing 2640 prescriptions and clients respectively. Data were analyzed and presented as frequency with percentage or mean with standard deviation, as applicable. The performances of the types of PHCs were compared using two-sample t-test. A 2-tailed p-value < 0.05 was considered statistically significant. Results: average number of drugs per prescription, drugs prescribed by the generic name, percentage of encounters with prescribed antibiotics and injections were 3.6 ± 0.9%, 76.5 ± 18.5%, 63.3 ± 19.1% and 21.1 ± 24.1% respectively with no significance difference between the comprehensive and basic PHCs. For all the facilities, the average consultation and dispensing times were 10.5 ± 6.0 minutes, 244.9 ± 179.2 seconds respectively. In this study, the percentage of patients' knowledge of the correct dosage was 72.4 ± 38.3%. There is statistically significant difference in availability of key drugs in stock between the comprehensive and basic PHCs (p-value 0.0001). Conclusion: irrational drug use practices exist in comprehensive and basic PHCs. There is a need to implement interventions aimed at strengthening good prescribing and patient-care practices across the PHCs in Lagos State. [ABSTRACT FROM AUTHOR]

Background: Improving drug accessibility and rational drug use are major challenges for China's healthcare reform. In 2018, the Chinese government introduced a novel nationwide policy of centralized drug procurement for off-patent drugs, focusing on improving drug utilization patterns of public medical institutions. Objective: To estimate the impacts of the Chinese centralized drug procurement policy (the so-called "4 + 7" policy) on drug utilization in public medical institutions. Methods: A retrospective natural experimental design and difference-in-difference method were applied using cross-region data extracted from the national procurement database. Eleven "4 + 7" pilot cities (intervention group) and eleven non-pilot provinces (control group) were matched. In addition, "4 + 7" policy-related drugs (n = 116) were selected as study samples, including 25 drugs in the 4 + 7" procurement List ("4 + 7" List drugs) and their alternative drugs (n = 91) that have not yet been covered by centralized procurement policy. Then, the "4 + 7" List drugs were divided into bid-winning and non-winning drugs according to the bidding results, and they were sorted into generic and original drugs. Defined daily dose (DDD) was used to standardize the quantity of drugs used. Results: In the 1-year procurement period, the overall completion rate of agreed procurement volume reached 191.4% in pilot cities. Owing to policy impact, the consumption increased by 405.31% in bid-winning drugs (β = 1.62, p < 0.001) and decreased by 62.28% (β = -0.98, p < 0.001) in non-winning drugs. The overall use proportion of bid-winning drugs increased from 17.03% to 73.61% with statistical significance (β = 1.48, p < 0.001), and increments were also detected in all healthcare settings, regions, and anatomical therapeutic chemical (ATC) categories (all p-values < 0.05). Generics and originators were detected with 67.53% increment (β = 0.52, p < 0.001) and 26.88% drop (β = -0.31, p = 0.006) in consume volume. The use proportion of generics increased from 59.23% to 78.44% with significance (β = 0.24, p < 0.001), as well as in tertiary hospitals (β = 0.31), secondary hospitals (β = 0.23), and primary healthcare centers (β = 0.11) (all p-values < 0.001). The use proportion of relatively quality-guaranteed drugs (i.e. bid-winning and original drugs) increased from 56.69% to 93.61% with significance (β = 0.61, p < 0.001), and similar increments were also detected in all healthcare settings, regions, and ATC categories (all p-values < 0.05). Conclusion: Healthcare providers demonstrated good compliance with the "4 + 7" policy in completing contracted procurement volume. Centralized drug procurement policy promoted drug consumption gradually concentrated on bid-winning drugs, generic drugs, and more importantly, quality-guaranteed drugs. [ABSTRACT FROM AUTHOR]

Objectives: Access to health care is a basic right of population. Essential medicines are those which satisfy the priority of health care needs and intended to be available at all times. Hence prices and availability need to assess periodically. The objective of the study was to measure the variation in prices of selected medicines, to measure the availability of some selected medicines used for treating common diseases/ailments and to compare the prices and availability of medicines among the sectors. The present survey is conducted for 20 essential medicines in Hyderabad, Telangana. Methods: Medicines were selected based on the criteria of WHO/HAI methodology. Data was collected during October 2019 to March 2020 for originator brands and lowest priced generics in 60 medicine outlets. Prices were compared to international reference prices and expressed as median price ratio. Percent availability computed only on the day of data collection. Results: Median MPRs for originator brands and lowest priced generics were 2.20 and 1.53 in independent outlets, 2.20 and 1.61 in chain pharmacies respectively. Median MPR for generics in Jan Aushadhi Kendra was 0.38 i.e., all available medicines were priced less than international reference prices. Availability was 95.8%, 95.4% and 67.5% for generics and 12% and 13.3% for originator brands respectively. Conclusion: The survey revealed reasonable prices and high availability in private sectors but in JanAushadhi Kendra, prices are flattened with good availability. The maximum applicable Goods and Services Tax rate is 12% for medicines under price control and life-saving drugs resulted in 2.3% increase in tax rate ultimately causing burden to patients. Government should ensure certain policies about importance of generic drugs and their availability in Jan Aushadhi Kendra. [ABSTRACT FROM AUTHOR]

Background: The United States requires a patent linkage system in other countries as part of free trade agreements. However, introducing a patent linkage system could be a significant barrier to the timely approval of generic drugs. This study aimed to evaluate the perceived impact of the patent linkage system in South Korea held by domestic manufacturers and analyze variations in evaluating the system according to the characteristics of domestic manufacturers.Methods: In 2020, we conducted a questionnaire survey of 39 domestic manufacturers. The survey consisted of perceptions of the system, factors affecting patent challenges, and the perceived impact of the system. A 5-point Likert scale was used to rate each item. Domestic manufacturers were categorized into three groups based on their experience of listing a patent and acquiring first generic exclusivity.Results: More than half of the manufacturers surveyed had experience of listing a patent. The patent linkage system could protect the involved patents. However, manufacturers perceived that they could successfully challenge the validity of the involved patents and then obtained market approval for generic drugs. Manufacturers responded that market size, expectations for succeeding in litigation, and expectations for manufacturing the drug were the most relevant factors when they initiated patent challenges. Manufacturers reported that the system, in particular the first generic exclusivity, enhanced the research and development capability of generic manufacturers, increased their domestic sales, and improved access to generic drugs.Conclusions: The perceived impact of the patent linkage system was limited to the domestic market and generic drugs. In narrowing the impact to the effects on the domestic industry, the system had positive impacts of the system on generic manufacturers. The first generic drug exclusivity lies at the center of this positive perception. However, manufacturers perceived that the current system did not provide enough incentives for domestic manufacturers to be granted first generic drug exclusivity through patent challenges. [ABSTRACT FROM AUTHOR]

Some brand drug companies have stymied attempts by generic drug companies to obtain samples of brand drugs needed to develop and gain regulatory approval for their generic products. This conduct, which has been reported in both the US and Canada, raises drug costs to drug plans and other payors and can lessen competition. The literature to date contains little empirical evidence on the prevalence of this conduct, the attendant effects on generic drug market launches and costs incurred by drug payors. This paper addresses these questions for Canada, using data on the drug development projects undertaken by the members of the Canadian Generic Pharmaceutical Association over the period 2015–2019. I found that about 16% of generic drug development projects were delayed due to originator firm efforts to impede access to samples of their drugs. The median generic drug launch delay (among affected drugs) attributable to the challenged conduct was 6 months. The additional costs to drug payors from the resulting delays in generic drug launches over the analysis period was in the order of $284 million, or $57 million annually. This study did not explore the additional generic drug development costs attributable to the challenged conduct. [ABSTRACT FROM AUTHOR]

In 2018, the Chinese government identified four municipalities and seven sub-provincial cities for the implementation of the National Drug Pooled Procurement (NDPP) pilot program (the "4 + 7" policy). In the present study, we analyzed the effects of the "4 + 7" policy with data of 25 pilot drugs from the National Healthcare Security Administration (NHSA) from the aspects of drug price, volume, and expenditure. After the implementation of the policy, the average price of total and winning drugs was decreased by 54.47% and 73.82%, respectively, while the DDDc of non-winning drugs was decreased by only 1.54%, and the DDDc of uncertificated generic drugs was increased 83.18%. The DDDs indicating the volume of total and winning drugs was increased by 21.18% and 353.98%, respectively, and the DDDs of non-winning drugs was decreased by 61.35%. The costs of total and non-winning drugs were decreased by 44.83% and 61.94%, respectively, and the cost of winning drugs was increased by 18.87%. The "4 + 7" policy reduced the price and cost of pilot drugs and improved the affordability and accessibility of drugs. However, there were also problems with unexpected excessive price increases of uncertificated generic drugs and relatively high prices of non-winning products. Therefore, we highly suggested promoting the normalization and institutionalization of pooled drug procurement, enhancing the administrative capacity of local procurement platforms, and strengthening monitoring the price of non-winning, especially for the uncertificated generic drugs. [ABSTRACT FROM AUTHOR]

Evergreening -- the act of improving preexisting technology and patenting those improvements -- is beneficial. This Comment focuses on the concept of evergreening, a negative term generally used to criticize the patenting practices of pharmaceutical companies. As explained herein, the term, which is of little analytical value given the absence of the concept from judicial opinions, is conceptually directed to a societally beneficial practice. If used at all, evergreening should be viewed as a positive act. Yet, critics use the term evergreening to argue that patent owners improperly extend the term of an original patent by filing a subsequent patent. According to critics, this strategy hinders generic competition and creates higher priced pharmaceuticals, because patents are issued for "slight" modifications to preexisting drugs. Generic drug manufacturers have recently proposed legislation aimed at reducing the cost of drugs and improving drug access purportedly by curbing evergreening. The proposed legislation will inhibit permissible evergreening and negatively impact drug development. Courts of authority already disincentivize and prohibit meritless evergreening when interpreting Sections 102 and 103 of the Patent Act. To the extent reducing drug prices is the goal, different legislation can accomplish the task more effectively. [ABSTRACT FROM AUTHOR]

Background: The promotion of generic medicines in developing nation like India plays a crucial role in the availability of essential drugs for everyone. The main objective of this survey is to understand the knowledge and perception of the pharmacy student about generic medicine along with its safety and efficacy profile. Methods: The web-based cross-sectional study was carried out from September 2020 to February 2021 utilizing the Google form. The google form had four questionnaire sections, i.e., socio-demographic section, overall knowledge section, knowledge regarding safety and efficacy section, and perception section. Results: Most students believe they require additional knowledge regarding how bioequivalence tests are performed for generic drugs. Of 463 students, 419 students (88%) agrees generic medicine is cheaper than branded medicines, and 339 students (73%) agrees wider use of generic medicines in India helps in decreasing health care cost whereas 215 students (45%) are not aware generics are only marketed after the patent expiry of the branded medicine. Of 441 students, 127 students (27%) wrongly agree that generic medicines are less effective than branded medicine, and 196 students (43%) wrongly agree that generic medicine costs less because they are inferior to branded medicine. Most pharmacy students believe doctors and patients should be given enough knowledge about generic medicine and that branded medicine use is influenced by advertisements. Conclusion: This study concludes that there is a gap in knowledge among pharmacy students about generic medicine. The responsible authorities should establish relevant curriculum revisions to increase students' knowledge about generic medications. [ABSTRACT FROM AUTHOR]

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[Display omitted] Over the past decade, topically applied drug products have experienced extraordinary price increases, due to the shortage of multisource generic drug products. This occurrence is mainly related to the underlying challenges evolved in topical bioequivalence documentation. Although there has been continuing regulatory efforts to present surrogate in vitro methods to clinical endpoint studies, there is still a continued need for cost- and time-efficient alternatives that account for product specificities. Hence, this work intended to expose bioequivalence assessment issues for complex topical formulations, and more specifically those related with product efficacy guidance. As a model drug and product, a bifonazole 10 mg/g cream formulation was selected and two different batches of the commercially available Reference Product (RP) were used: RP1 that displayed lower viscosity and RP4 which presented high, but not the highest, viscosity. In vitro human skin permeation testing (IVPT) was carried out and the results were evaluated by means of the traditional bioequivalence assessment approach proposed by the EMA, as well as by the Scaled Average Bioequivalence assessment approach proposed by the FDA. Based on previous experience, there was an expectation of a high level of variability in the results, thus alternative methods to evaluate local drug skin availability were developed. More specifically, an infected skin disease model, where ex vivo human skin was infected and ATP levels were used as a biological marker for monitoring antifungal activity after product application. The results showed that permeation equivalence could not be supported between the different RP batches. In contrast, this statistical difference between the formulation batches was not indicated in the disease model. Nevertheless, in pivotal IVPT studies, the lowest permeant formulation (RP4) evidenced a higher antifungal in vitro activity as reported by the lower levels of ATP. A critical appraisal of the results is likewise presented, focusing on an outlook of the real applicability of the regulatory guidances on this subject. [ABSTRACT FROM AUTHOR]

Objectives: As economic globalisation develops in‐depth, infectious diseases that occur in a country or region no longer remains a regional issue. Antibiotics and antiviral medicines are essential medicines for the therapy of infectious diseases. This study aims to evaluate their availability, cost and affordability of AaAMs against infectious diseases in 41 public hospitals from 2013 to 2019 in Nanjing, China. Methods: Data on the availability and price of 17 antibiotics and 6 antiviral medicines in 41 public hospitals were obtained from the Jiangsu Institute of Medicine Information. We adopted the WHO/Health Action International method to measure the availability, cost and affordability of these medicines. Results: The availability of selected medicines against infectious diseases was relatively low; the median availability of originator brands was near‐zero and that of lowest‐priced generics during the survey period less than 50%. The total availability of medicines was poor in primary hospitals as compared to secondary and tertiary hospitals. The median daily‐defined dose cost of originator brands was expensive (range from 66.11 RMB to 107.83 RMB), whereas that of lowest price generics was fairly acceptable at < 8 RMB. The affordability of most surveyed medicines was reasonable, which showed significant improvement over time, but the daily cost of a few medicines for originator brands exceeded the average daily wage. Conclusions: In general, the affordability of medicines surveyed was acceptable, while the availability was too low. There should be a great concern for improving the reserve system of anti‐infective medicines in healthcare institutions. Policy should focus on improving the availability of generic drugs in hospitals and encouraging preferentially prescribed. [ABSTRACT FROM AUTHOR]

In contrary to the WHO method of doing such studies where information about only 30 drugs is asked to ascertain the availability of essential medicines, we asked for all drugs and that too from both the lists which is the strength of this study. World Health Organization (WHO) defines essential drugs or medicines as "those drugs that satisfy the healthcare needs of majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford."[1] Since 1975, the WHO has taken over its role on the essential drugs, which was initially a mere concept to a well-established policy.[2] In the year 1977, the WHO decided to make this concept more concrete, and thus prepared and published a model list of essential drugs which had around 200 drugs including the vaccines.[3] The WHO model of the essential medicine list (EML) thus came into force in 1977 and is being updated every two years since then.[4] The current version of the list is in its 21st edition, and the essential medicine list for children is in its seventh edition which was last updated in the month of June in the year 2019.[5] In the case of India, the first EML was published in 1996.[3] The latest list was published in 2015 with 376 drugs.[6] Many states also have their respective EML. [Extracted from the article]

Antiepileptic drugs (AEDs) treatment is a treatment that most patients receive due to its effective results. In addition, most patients are comfortable with AEDs treatments. Today, there are a variety of AEDs available. Levetiracetam (LEV), which is one of new generation of AEDs (new AEDs) being widely used today, is based on the following: good pharmacological properties, good performance, a relatively low number of side-effects when compared to other AEDs, and low levels of drug interaction with other drugs or with food. It can also be used to treat epileptic patients with comorbidity diseases, as well as the elderly and pregnant women. Although LEV is well-recognized as a good medicine and has been included in the Thai national essential drug list, there are restrictions on the accessibility of this AED. This is especially true given that the price of the drug is higher than many other types of AEDs. This factor makes it impossible for most patients, who basically rely on the right to the universal health care coverage (gold card) treatment, to gain access to this type of AED. The principles for consideration surrounding the use of AEDs are as follows:. 1) Indications of drug use and evidence of studies carried out on the effectiveness of the drug. 2) Patient factors, such as age, occupation, underlying diseases, regular medications, the patients' needs, and the patients' treatment rights. 3) Drug types, including pharmacological properties, histories of drug allergies, drug interactions, and drug accessibility. 4) The worthiness and effectiveness of the drug. The Medicines and Healthcare Products Regulatory Agency (MHRA) of England has divided AEDs into the following 3 groups. AEDs are safe to change from the original to generic drugs in case that the AEDs are in Group 3 as follows: levetiracetam, lacosamide, gabapentin, pregabalin, and vigabatrin. [ABSTRACT FROM AUTHOR]

Background: Accessibility to essential medicines is a major challenge in developing countries, including in Indonesia health care system. Assessment of medicines availability and affordability is needed to become a baseline infomation for further health policies. The present study was aimed to investigate the availability and price of essential medicines in both public and private health facilities in Indonesia. Methods: The cross-sectional study was carried out using the World Health Organization (WHO) and Health Action International (HAI) methodology. Availability data for 50 medicines of global, regional, and supplementary list of medicines was collected from six health facilities, consisted of public and private hospitals and retail pharmacies in Yogyakarta region. Medicine price ratios were calculated using international reference prices (IRPs). Results: The mean availability of generic essential medicines in public healthcare facilities and private sectors was 76.6% and 60.58%, respectively. Availability of generic medicines was much higher in the public sector. Four medicines had zero availability were atenolol tablet, enalapril tablet, beclometason inhaler, and clotrimazole topical cream. The procurement price in public sector was 0.98, while in private sector was 2.46 times the IRP. Findings of Median MPR of lowest-priced generic (LPG) in the private sector for ceftriaxone was 5.64, ranitidine was 4.35, and salbutamol was 4.19 times higher than international price. In public health facilities, ceftriaxone injection was 2.19 times compared to international price. Conclusion: This study revealed that availability of essential medicines was inadequate, but procurement prices of surveyed medicines were considered efficient, especially in public sector. However, variation in procurement prices of selected medicines was noted. These evidences impose significant policy implications that could help in formulating policies to optimize the access to essential medicines for patients. [ABSTRACT FROM AUTHOR]

Irrational usage of medications is becoming a global problem. India majorly faces the concern for the irrational manufacturing, prescriptions and usage of medicines. Skin diseases or dermatology related issues are one of the major contributors to the disease burden. The ultimate goal in dermatological therapy is achieved by prescribing the safest and minimal number of medicines. The objective of the study was to assess the drug prescribing pattern in dermatology outpatient department (OPD) using WHO drug use indicators, to determine patterns of skin diseases and to describe current treatment practices. A cross sectional prospective study was carried out in the dermatology OPD for six months from March 2018 to August 2018. Prescriptions from patients were collected directly by taking images. About five hundred encounters were reviewed. The results revealed that male patients were more: 261 patients (52%). Most patients belonged to the age category of 20-29 years (139 patients) and 10-19 years (94 patients). A total of 1706 medications were prescribed. The average number of medications prescribed were 3.41/prescription. The number of generic drugs prescribed was comparably lower than branded; a total of 29.01% of prescriptions were prescribed with antibiotics. The health facility indicators were assessed by confirming key drug availability. On the whole, 26.9% drugs were prescribed from WHO EDL (essential drug list). It was concluded that fungal infections were the highest presentation and antihistamines were the most commonly prescribed drugs. [ABSTRACT FROM AUTHOR]

The provisions of section 3(d) of the Indian Patent Act, 1970, were designed to promote and protect the manufacturing of low cost generic medicines in the country. Along with other changes and amendments, they were assumed to benefit the states equally without taking into account the inter-state economic inequalities. The provisions were set forth to secure production of inexpensive generic drugs for easy accessibility at affordable prices across the states. The paper assumes states whose per capita net state domestic product is lower than the per capita net national product, and thus do not get full benefit of inexpensive generic drugs. The section patronises domestic generic drug manufacturers and users from coercive provisions of Trade Related Aspects of Intellectual Property Rights Agreement and foreign patent holder's aggressive monopoly price. However, it does not guarantee the availability of price effective generic drugs for the people of backward states. Hence, some states need additional attention to make the generic drugs affordable and accessible. The paper has investigated into the intra-molecular price variation of generic drugs and its impact on their affordability in backward states. It aims to find out whether all Indian states equally benefit from the IP Act, or some states are unable to reap its benefit because of the lack of proper policy measures. The analysis is based on both descriptive and analytical methods. It has applied ratio analysis with the data on per capita net state domestic product (proxy of the purchasing capacity) of selected backward states with price data of generic drugs prescribed for major death-causing diseases. [ABSTRACT FROM AUTHOR]

Yet, we found that brand-name Percocet (9% of all brand-name oxycodone-acetaminophen prescriptions) and Vicodin (28% of all brand-name hydrocodone-acetaminophen prescriptions) continued to be widely dispensed despite the existence of interchangeable generic versions. Graph: Figure 1 State-level variation in generic proportions of oxycodone-acetaminophen tablet and capsule opioid formulations and hydrocodone-acetaminophen tablet and capsule opioid formulations, 1991 to 2018. RESULTS Ten brand-name formulations containing oxycodone-acetaminophen and 19 containing hydrocodone-acetaminophen were prescribed in Medicaid during the study period. [Extracted from the article]

Background: Higher income population tend to prefer brand-name to generic drugs, which may cause disparity in access to brand-name drugs among income groups. A potential policy that can resolve such disparity is imposing a greater co-payment rate on high-income enrollees. However, the effects of such policy are unknown. We examined how patients' choice between brand-name and generic drugs are affected by the unique income-based co-payment rates in Japan; 10% for general enrollees and 30% for those with high income among the elderly aged 75 and over.Methods: We drew on cross-sectional price variation among commonly prescribed 311 drugs using health insurance claims data from a large prefecture in Japan between October 2013 and September 2014 to identify between-income-group differences in responses to differentiated payments.Results: Running 311 multivariate logistic regression models controlling individual demographics, the median estimate indicated that high-income group was 3% (odds ratio = 0.97) less likely to choose a generic drug than the general-income group and the interquartile estimates ranged 0.92-1.02. The multivariate feasible generalized least squares model indicated high-income group's higher likelihood to choose brand-name drugs than the general-income group without co-payment rate differentiation (p < 0.001). Such gap in the likelihood was attenuated by 0.4% (p = 0.027) with an US$1 increase in the difference in additional payment/month for brand-name drugs between income groups - no gap with US$10 additional payment/month. This attenuation was observed in drugs for chronic diseases only, not for acute diseases.Conclusions: Income-based co-payment rates appeared to reduce disparity in access to brand-name drugs across income groups, in addition to reducing total medical expenditure among high-income group who shifted from brand-name drugs to generic ones due to larger drug price differences. [ABSTRACT FROM AUTHOR]

Sudan has re-opened negotiations into acceding to WTO and is also gearing up to he a part of the TRIPS family. This article recommends steps that Sudan can lake to improve its access to medicines before acceding to WTO and TRIPS and signing free trade agreements. Sudan has the benefit of learning from developing countries as well as LDCs to develop its manufacturing capabilities and further assist the country's healthcare needs. Sudan's representatives should also ensure that the terms of accession into WTO are not onerous on access to medicine. [ABSTRACT FROM AUTHOR]

Rare diseases are an important global public health issue. One significant challenge is to ensure the access to orphan drugs for patients with rare disease. This study aims to evaluate the accessibility of orphan drugs in China. Information pertaining to the availability and costs of each orphan drug in each hospital was obtained from the Chinese Medicine Economic Information database during 2011-2017. We measured the accessibility of orphan drugs from 3 aspects: availability, daily costs, and affordability to patients.The market availability rate of orphan drugs in China was 28.8% by June 30, 2017. The median availability rate at the hospital level was less than 15% but was increasing over time. The cost of a defined daily dose of orphan drugs varied significantly with a decreasing trend in all areas. Less than half of all surveyed orphan drugs had a cost of a defined daily dose no more than residents' average daily income.This study reveals the challenges of access to orphan drugs in China. The availability of marketed orphan drugs in China was relatively low and most orphan drugs placed a heavy financial burden on patients with rare disease. It is necessary to develop legislation for orphan drugs and encourage domestic generics. [ABSTRACT FROM AUTHOR]

Evergreening of pharmaceutical patents has emerged as a serious challenge for access to affordable drugs as it aims to delay the generic competition by extending the length of the exclusivity period beyond the legitimate patent term without any considerable improvement in therapeutic benefits of the already patented pharmaceutical drug. This paper endeavours to question the legitimacy of the evergreening of pharmaceutical patents. This study applies all the recognized theories in support of the patent system – namely the 'natural law' or 'natural rights' theory, the 'reward by monopoly' theory, the 'monopoly-profit incentive' theory, the 'exchange for secrets' theory or the 'contract' theory, and the 'prospect' theory – to the practice of evergreening of drug patents in order to check whether or not any of these theories can be used to justify the practice. The study concludes that the practice of evergreening is not consistent with any of these theories and therefore lacks any plausible justification. [ABSTRACT FROM AUTHOR]

Drugs are vital to saving and improving public health. However, medicines are often not available at the facility because stocks run out or in particular, pharmaceuticals are not available due to a shortage of supplies. Implementation of pharmacy services should ensure safe, quality, usable and affordable availability drug. A systematic review was conducted to identify related studies. Electronic databases used to identify relevant studies are, ScienceDirect, Plos, PubMed and Google Scholar. This study is limited to English and publications from 2007 to 2017. The electronic database search earned 33 articles while only six studies met the criteria for review. There is the relatively low availability of drugs in some developing countries and the average availability of generic drugs is better than Innovator Brand drugs, especially in the public sector. Most of the factors that may affect drug availability are related to government policies to improve drug access and lower prices so that national drug policy review in each country is required. Overall, the method used to measure the availability of drugs using a reference method used by WHO Health Action International. The availability of drugs in low, lower and upper middle countries still need to be improved by increasing drug access and enhancing prices by using appropriate government policies. The WHO HAI method is effectively used to measure the availability of drugs by using the core drug and supplementary drug references by the established reference. [ABSTRACT FROM AUTHOR]

Infliximab (IFX) is an important tool in the treatment and maintenance of chronic inflammatory diseases (CIDs). Impact of switching to infliximab biosimilars on treatment patterns among US veterans receiving innovator infliximab. The trial "Switching from originator IFX to biosimilar CT-P13 compared with maintained treatment with originator infliximab" (NOR-SWITCH), published in 2017, compared patients who continued on IFX originator to those who switched to CT-P13 (IFX dyyb)[3]. [Extracted from the article]

The United Nations-affiliated Stop TB Partnership's Global Drug Facility, which announced the deal with J&J, now sells the drug in LMICs for $45 per month for a 6-month course; generic versions are estimated to cost $8 to $17 per month. J&J said it would allow competitors to market generic versions of the lifesaving drug, bedaquiline, in 44 low- and middle-income countries (LMICs) where the company has active patents. The pharmaceutical company Johnson & Johnson (J&J) last week agreed to help make a therapy critical to fighting drug-resistant tuberculosis (TB) more widely available and affordable. [Extracted from the article]

The article reports the need to investigate the impact of pharmacy benefit managers (PBMs) and their unfair practices that effect patient access to safe and affordable pharmaceutical care by Federal Trade Commission (FTC). Topics discussed include that the Association for Accessible Medicines (AAM) points out unfair trade practices by PBM that effects adversely to America's patients, PBM practices harm patient access to low-cost medicine and effects economically to America's healthcare system.

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional 'regulatory' protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from 'free-riding' encounters some important problems: Neither legitimize excluding all others. [ABSTRACT FROM AUTHOR]

High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented. [ABSTRACT FROM AUTHOR]