High Prescribing and State-Level Variation in Z-Drug Use Among Medicare Patients.

BACKGROUND: Z-drugs are nonbenzodiazepine hypnotics used for sleep initiation and maintenance; these drugs increase the risk of fall-related injuries in older adults. The American Geriatrics Society's Beers criteria classifies Z-drugs as high-risk and strongly recommends avoiding prescribing Z-drugs to older adults due to adverse effects. The study objectives were to determine the prevalence of Z-drug prescribing among Medicare Part D patients and identify state or specialty-dependent prescribing differences. This study also aimed to determine prescribing patterns of Z-drugs to Medicare patients. METHODS: Z-drug prescription data was extracted from the Centers for Medicare and Medicaid Services State Drug Utilization Data for 2018. For all 50 states, the number of prescriptions per 100 Medicare enrollees and days-supply per prescription was determined. The percentage of total prescriptions prescribed by each specialty and the average number of prescriptions per provider within each specialty was also determined. RESULTS: Zolpidem was the most prescribed Z-drug (95.0%). Prescriptions per 100 enrollees were significantly high in Utah (28.2) and Arkansas (26.7) and significantly low in Hawaii (9.3) relative to the national average (17.5). Family medicine (32.1%), internal medicine (31.4%), and psychiatry (11.7%) made up the largest percentages of total prescriptions. The number of prescriptions per provider was significantly high among psychiatrists. DISCUSSION: Contrary to the Beers criteria, Z-drugs are prescribed to older adults at high rates.

Global access to affordable direct oral anticoagulants.

Poor control of cardiovascular disease accounts for a substantial proportion of the disease burden in developing countries, but often essential anticoagulant medicines for preventing strokes and embolisms are not widely available. In 2019, direct oral anticoagulants were added to the World Health Organization's WHO Model list of essential medicines. The aims of this paper are to summarize the benefits of direct oral anticoagulants for patients with cardiovascular disease and to discuss ways of increasing their usage internationally. Although the cost of direct oral anticoagulants has provoked debate, the affordability of introducing these drugs into clinical practice could be increased by: price negotiation; pooled procurement; competitive tendering; the use of patent pools; and expanded use of generics. In 2017, only 14 of 137 countries that had adopted national essential medicines lists included a direct oral anticoagulant on their lists. This number could increase rapidly if problems with availability and affordability can be tackled. Once the types of patient likely to benefit from direct oral anticoagulants have been clearly defined in clinical practice guidelines, coverage can be more accurately determined and associated costs can be better managed. Government action is required to ensure that direct oral anticoagulants are covered by national budgets because the absence of reimbursement remains an impediment to achieving universal coverage. Tackling cardiovascular disease with the aid of direct oral anticoagulants is an essential component of efforts to achieve the World Health Organization's target of reducing premature deaths due to noncommunicable disease by 25% by 2025.

L'absence de lutte efficace contre les maladies cardiovasculaires contribue grandement à la charge de morbidité pesant sur les pays en développement. Pourtant, les anticoagulants essentiels permettant d'éviter les accidents vasculaires cérébraux et les embolies sont souvent difficiles à obtenir. En 2019, les anticoagulants oraux directs ont été ajoutés à la Liste modèle des médicaments essentiels publiée par l'Organisation mondiale de la Santé. Le présent document vise à résumer les avantages des anticoagulants oraux directs pour les patients souffrant d'une maladie cardiovasculaire, et à évoquer les moyens d'encourager leur utilisation au niveau international. Bien que le coût des anticoagulants oraux directs ait fait débat, intégrer ces médicaments dans la pratique clinique les rendrait plus abordables grâce à diverses méthodes: négociation des prix; achats groupés; appels d'offres concurrentiels; communautés de brevets; et recours accru aux alternatives génériques. En 2017, seulement 14 des 137 pays ayant adopté des listes nationales de médicaments essentiels y avaient inclus des anticoagulants oraux directs. Ce chiffre pourrait augmenter rapidement si les problèmes de disponibilité et d'accessibilité peuvent être résolus. Dès que les profils des patients susceptibles d'être traités par des anticoagulants oraux directs sont clairement établis dans les directives de pratique clinique, la couverture peut être définie avec plus de précision et les dépenses correspondantes, mieux gérées. Les gouvernements doivent s'assurer que ces médicaments sont bien pris en compte dans les budgets nationaux, car l'absence de remboursement demeure un obstacle à la couverture maladie universelle. La lutte contre les maladies cardiovasculaires à l'aide des anticoagulants oraux directs est un élément essentiel des efforts destinés à atteindre l'objectif de l'OMS: faire baisser de 25% d'ici 2025 les décès prématurés dus aux maladies non transmissibles de 25% d'ici 2025.

El mal control de las enfermedades cardiovasculares representa una proporción importante de la carga de enfermedades en los países en desarrollo, y a menudo los medicamentos anticoagulantes esenciales para prevenir los accidentes cerebrovasculares y las embolias no son fácilmente accesibles. En 2019, los anticoagulantes orales directos se añadieron a la lista modelo de medicamentos esenciales de la Organización Mundial de la Salud. Los objetivos del presente artículo son resumir los beneficios de los anticoagulantes orales directos para los pacientes con enfermedades cardiovasculares y discutir las formas de aumentar su uso a nivel internacional. Aunque el coste de los anticoagulantes orales directos ha suscitado debate, la asequibilidad de introducir estos medicamentos en la práctica clínica podría aumentarse al: negociar precios; hacer adquisiciones conjuntas; hacer licitaciones competitivas; utilizar consorcios de patentes; y ampliar el uso de genéricos. En 2017, solo 14 de los 137 países que habían adoptado listas nacionales de medicamentos esenciales incluían un anticoagulante oral directo en sus listas. Este número podría aumentar rápidamente si se pueden abordar los problemas de disponibilidad y asequibilidad. Cuando los tipos de pacientes que pueden beneficiarse de los anticoagulantes orales directos se hayan definido claramente en las directrices de la práctica clínica, la cobertura podrá determinarse con mayor precisión y los costes asociados podrán gestionarse mejor. Es necesario que los gobiernos actúen para garantizar que los anticoagulantes orales directos estén cubiertos por los presupuestos nacionales, ya que la ausencia de reembolso sigue siendo un impedimento para lograr la cobertura universal. La lucha contra las enfermedades cardiovasculares con la ayuda de los anticoagulantes orales directos es un componente esencial de los esfuerzos por alcanzar el objetivo de la OMS de reducir las muertes prematuras debidas a enfermedades no transmisibles en un 25 % para 2025.

The Evolution of Supply and Demand in Markets for Generic Drugs.

Policy Points Much concern about generic drug markets has emerged in recent policy debates. Important changes in regulations, the structure of purchasing, and the length of the drug supply chain have affected generic drug markets. Effective price competition remains the rule in generic markets for large-selling drugs. Smaller markets and those for injectable products often have less price competition and are more susceptible to supply disruptions. CONTEXT: The image of generic drugs as a commodity sold in competitive markets is an oversimplification, as evidenced by increasing accounts of price spikes, sustained high price-cost margins, and market disruptions. The mismatch between the canonical economic model of generic drug markets and reality motivated our empirical project. METHODS: To explore recent changes in those factors impacting the supply and demand for generic drugs, we studied, from a variety of sources, the data on price, competition, supply disruptions and recalls, changes to the supply chain, and buy-side concentration. We examined quarterly data through 2018 for a cohort of 77 molecules that lost patent protection during the so-called patent cliff between 2010 and 2013. FINDINGS: On the supply side, we found that for large-market oral solids, generic entry and price declines were consistent with past studies showing a significant number of market entrants and substantial reductions in the average price of a molecule. In smaller markets for oral solids and injectable products, we observed fewer entrants, higher rates of exit, smaller price reductions, and, in some cases, considerable price instability. The number of reported shortages increased across all generic market types over time, with the rate of shortage increases especially pronounced in markets for injectable products. The number of product recalls also rose over our study period. Although we did not estimate causal effects, we did find several changes in the market environment for generic drugs that may contribute to these phenomena. The demand side for generics has become more concentrated. Supply chains rely more on producers outside the United States (particularly from China and India). Contracting practices have undergone changes that may inhibit competition in product supply. FDA regulatory scruitiny has increased. CONCLUSIONS: Competition in generic drug markets varies widely by market size and product form. Recent changes in demand-side market structure imply more downward pressure on prices stemming from buy-side concentration. The FDA's greater regulatory oversight puts upward pressure on costs, and the lengthening of the supply chain increases production uncertainty for producers. Demand and supply-side changes point to further market instabilities across all generic markets due to producers' changing economic position.

Generic Drugs Not as Safe as FDA Wants You to Believe.

Food and Drug Administration (FDA) rules for the production of prescription drugs are very rigorous and, if followed, guarantees a safe drug supply. For many years, foreign manufacturers have produced substandard generic products and active pharmaceutical ingredients and shipped them into the United States. If the FDA had inspected them with the same rigor as they do domestic manufacturers, they would have found many of these egregious deviations from ethical manufacturing much earlier. Although the FDA is finally stepping up the number of inspections, their current processes still rely on preannounced inspections with long time horizons, so quality issues can be temporarily corrected and documents altered or destroyed.

Relationship between pharmaceutical pricing strategies with price, availability, and affordability of cardiovascular disease medicines: surveys in Qatar and Lebanon.

BACKGROUND: Cardiovascular diseases are the leading cause of death in Lebanon and Qatar. When lifestyle modifications prove insufficient, medication becomes a cornerstone in controlling such diseases and saving lives. Price, availability, and affordability hinder the equitable access to medicines. The study aimed to assess prices, availability, and affordability of essential cardiovascular disease medicines in relation to pricing strategies in Qatar and Lebanon. METHODS: A cross-sectional survey using a variant of the World Health Organization and Health Action International (WHO/HAI) methodology as outlined in "Measuring medicine prices, availability, affordability and price components" (2008), second edition, was adopted. Prices and availability of 27 cardiovascular medicines were collected from public and private dispensing outlets. For international comparison, prices were adjusted to purchasing power parity. Data was analyzed across multiple sectors, within and across countries. RESULTS: A total of 15 public and private outlets were surveyed in each country. Prices were more uniform in Qatar than in Lebanon. In the public sector, medicines were free-of-charge in Lebanon and priced lower than the international reference prices in Qatar. The ratio of medicine unit price to international reference price in the private sectors surveyed are significantly higher than the acceptable threshold of 4. This ratio of originator brands and lowest priced generics in Qatar were up to two and five times those in Lebanon, respectively, even after adjusting for purchasing power parity. However, prices of lowest priced generics in the private sector were at least 35% cheaper in Qatar and 65% cheaper in Lebanon than their comparative originator brands. Medicines were more available in the private sector in Lebanon than in Qatar, but only the originator brand availability in the public sector in Qatar exceeded the WHO target of more than 80%. While affordable in the public sector in Qatar, four out of thirteen medicines exceeded the threshold in all private sectors covered. Hence, only the public sector in Qatar had a satisfying level of availability and affordability. CONCLUSIONS: Except for the Qatari public sector, medicine prices, availability, and affordability are falling short from targets. Key policy decisions should be implemented to improve access to medicines.

Global Production of Active Pharmaceutical Ingredients for US Generic Drugs Experiencing Shortages.

This study evaluates the characteristics of generic active pharmaceutical ingredients (APIs) used to manufacture drugs with shortages in the US and facilities producing APIs worldwide.

Cancer drug shortages: Awareness and perspectives from a representative sample of the US population.

BACKGROUND: Although cancer drug shortages are a persistent problem in oncology, little is known about the awareness and perspectives of the US population with respect to shortages. METHODS: In 2016, we administered a 13-item cross-sectional survey to 420 respondents who were randomly selected from an online, probability-based sample demographically representative of the adult US population with respect to sex, age, race/ethnicity, education, geography, and income. Analyses applied poststratification sampling weights to draw national inferences. RESULTS: Overall, 16% of respondents reported being aware of drug shortages. Those with a personal history of cancer were more likely to be aware (31% vs 14% [P = .03]). In the overall cohort, most reported wanting to be informed about a substitution due to shortage: 87% and 82% for major or minor differences in efficacy, and 87% and 83% for major or minor differences in side effects. Most also reported they would transfer care to avoid a substitution: 72% for major differences in efficacy, and 61% for major differences in side effects. Black respondents, the uninsured, the unemployed, those with lower income, and the less well-educated were all less likely to report that they would transfer care to avoid major differences in efficacy (all P < .05). CONCLUSION: These data suggest that the US population is largely unaware of cancer drug shortages. Moreover, if being treated for cancer, most people would want to know about drug substitutions, even if it were to result in only minor differences in efficacy or side effects. With more significant differences, many would transfer care. Cancer 2018;124:2205-11. © 2018 American Cancer Society.

Strategies that delay or prevent the timely availability of affordable generic drugs in the United States.

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.

Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016.

Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.

Des millions de personnes, en particulier dans les pays à revenu faible et intermédiaire, ne peuvent accéder à des produits pharmaceutiques efficaces, souvent en raison de leur prix trop élevé. La Conférence ministérielle de 2001 de l'Organisation mondiale du commerce (OMC) a adopté la Déclaration de Doha sur l'Accord sur les ADPIC (aspects des droits de propriété intellectuelle qui touchent au commerce) et la santé publique. Cette déclaration a reconnu les implications des droits de propriété intellectuelle, aussi bien pour le développement de nouveaux médicaments que pour le prix des médicaments. Elle a détaillé des mesures, appelées flexibilités des ADPIC, que peuvent prendre les Membres de l'OMC pour assurer l'accès de tous aux médicaments, comme l'octroi de licences obligatoires aux brevets de médicaments et la mesure de transition pharmaceutique des pays les moins avancés. Le but de cette étude était d'examiner le recours aux flexibilités des ADPIC pour accéder à des médicaments génériques moins coûteux entre 2001 et 2016. Dans l'ensemble, 176 cas de recours possible aux flexibilités des ADPIC par 89 pays ont été relevés: 100 (56,8%) concernaient des licences obligatoires ou des licences d'utilisation publique à des fins non commerciales et 40 (22,7%) concernaient la mesure de transition pharmaceutique des pays les moins avancés. Quant aux autres, il s'agissait d'un cas d'importation parallèle, de 3 exceptions de recherche et de 32 mesures sans lien avec des brevets. Sur ces 176 cas, 152 (86,4%) ont été mis en œuvre. Ils portaient sur des produits destinés à traiter 14 maladies différentes. Cependant, 137 (77,8%) concernaient des médicaments contre le virus de l'immunodéficience humaine et le syndrome d'immunodéficience acquise ou des maladies apparentées. Le recours aux flexibilités des ADPIC s'est révélé plus fréquent que ce que l'on supposait. Étant donné les problèmes que rencontrent actuellement certains pays pour se procurer des médicaments brevetés à prix élevé, le cadre pratique et juridique offert par les flexibilités des ADPIC pour accéder à des équivalents génériques moins coûteux revêt une importance de plus en plus capitale.

Millones de personas, particularmente en países de ingresos bajos y medios, carecen de acceso a medicamentos efectivos, habitualmente porque no pueden pagarlos. La Conferencia Ministerial de 2001 de la Organización Mundial del Comercio (OMC) adoptó la Declaración de Doha relativa al Acuerdo sobre los ADPIC (Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio) y la Salud Pública. La declaración reconoció las implicaciones de los derechos de propiedad intelectual para el desarrollo de nuevos medicamentos y el precio de los mismos. La declaración describió medidas, conocidas como flexibilidades de los ADPIC, que los Miembros de la OMC pueden tomar con el objetivo de asegurar el acceso a los medicamentos para todos. Estas medidas incluyen concesión obligatoria de licencias de patentes de medicamentos y la medida de transición farmacéutica de países menos desarrollados. El objetivo de este estudio fue documentar el uso de las flexibilidades de los ADPIC para acceder a medicamentos genéricos de precio inferior entre el 2001 y el 2016. En general, se identificaron 176 casos de posibles usos de las flexibilidades de los ADPIC: 100 (56.8%) implicaron licencias obligatorias o licencias de uso público no comercial y 40 (22.7%) apelaron a la medida de transición farmacéutica de países menos desarrollados. El resto fue: 1 caso de importación paralela; 3 excepciones de investigación; y 32 medidas no relacionadas con patentes. De los 176 casos, 152 (86.4%) se implementaron. Cubrieron productos para tratar 14 enfermedades diferentes. Sin embargo, 137 (77.8%) implicaron medicamentos para la infección del virus de inmunodeficiencia humana y el síndrome de inmunodeficiencia adquirida o enfermedades relacionadas. Resultó que el uso de las flexibilidades de los ADPIC fue más frecuente de lo que comúnmente se espera. Dados los problemas que enfrentan hoy los países en la adquisición de medicamentos de alto precio y patentados, el camino práctico y legal que ofrecen las flexibilidades de los ADPIC para acceder a equivalentes genéricos de costo inferior es cada vez más importante.

The effects of state-level pharmacist regulations on generic substitution of prescription drugs.

Substituting generic for brand name drugs whenever possible has been proposed to control prescription drug expenditure growth in the United States. This work investigates two types of state laws that regulate the procedures under which pharmacists substitute bioequivalent generic versions of brand name drugs. Mandatory substitution laws require pharmacists to use the generic as a default, and presumed consent laws allow them to assume that the patient agrees to the substitution. Both situations can be overruled by the patient. Using plausibly exogenous changes in states' laws, we use difference-in-differences and a discrete choice model to show that although the mandatory switching laws have little effect, the presumed consent laws reduce consumers' probability of purchasing brand name drugs by 3.2% points. The differential effectiveness of the laws is likely caused by pharmacists' profit motives. These results offer important implications for policies that seek to reduce drug expenditures by incentivizing the use of generic drugs.

Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States.

BACKGROUND: The inclusion of patent linkage mechanisms in bilateral and plurilateral trade and investment agreements has emerged as a key element in the United States' TRIPS-Plus intellectual property (IP) negotiating agenda. However, the provisions establishing patent linkage mechanisms in several agreements appear to reflect a degree of ambiguity, potentially enabling some flexibility in their implementation. In this study, we reviewed the features of the prototypic patent linkage mechanism established by the Hatch-Waxman Act in the United States, and compared these with the implementation of systems in three countries whose agreements with the US include patent linkage obligations. From these analyses, we draw lessons for moderating the impact of these mechanisms on access to generic medicines. METHODS: We reviewed the features of the patent linkage mechanism in the US, and undertook a detailed analysis of relevant treaty provisions and the manner of implementation in Canada, Australia, and South Korea. RESULTS: A key difference between the US implementation of patent linkage and that of its trading partners is the disparate treatment afforded to biologics. Because of the significant differences in the regulatory frameworks applying to small molecule and biologic medicines in the US, the Hatch- Waxman provisions do not apply to biologics and they are not subject to patent linkage. By contrast, the regulatory frameworks in Canada, Australia and South Korea do not reflect similar distinctions and thus patent linkage mechanisms also capture biologics. Additional variations in implementation, mainly the result of constructive ambiguities in the respective treaty texts, offer potential opportunity for mitigating the adverse impact of patent linkage provisions on market entry of generic medicines. Practical measures include ensuring the availability of an accessible, transparent and easily searchable database of patent information; avoiding automatic stays of generic marketing approval where possible; and requiring certification by rights holders to prevent abuse of the system. CONCLUSIONS: Where countries accept treaty obligations to establish patent linkage mechanisms, the impact on access to generic medicines may be moderated to a degree by retaining and exploiting constructive ambiguities in the treaty text and addressing practical aspects of implementation.

Development of multi-criteria decision analysis (MCDA) framework for off-patent pharmaceuticals - an application on improving tender decision making in Indonesia.

BACKGROUND: Off-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited. OPPs are comprised of off-patent originals, branded generics and unbranded generics; nonetheless, these products are not identical and often there are differences in their equivalence, manufacturing quality standards and reliability of supply. This necessitates reconsideration of the lowest price policy objective in pharmaceutical decision making. The aim of this study was to develop a Multi-Criteria Decision Analysis (MCDA) framework through a pilot workshop to inform the national procurement of OPPs in Indonesia. METHODS: An initial list of potentially relevant criteria was identified based on previous work and a literature review. In a 2-day pilot policy workshop, twenty local experts representing different stakeholder groups and decision-making bodies selected the final criteria, approved the scoring function for each criterion, and assigned weights to each criterion. RESULTS: An MCDA framework was proposed for OPP drug decision making in developing countries, which included price and 8 non-price criteria. Based on the pilot policy workshop 6 + 1 criteria were considered relevant for Indonesia: pharmaceutical price (40% weight), manufacturing quality (18.8%), equivalence with the reference product (12.2%), product stability and drug formulation (12.2%), reliability of drug supply (8.4%), real world clinical or economic outcomes, such as adherence or non-drug costs (4.2%) and pharmacovigilance (3.6%). CONCLUSIONS: According to the pilot policy workshop, other criteria apart from price need to be strengthened in the tendering process. The introduction of additional criteria for OPP procurement in an MCDA framework creates incentives for manufacturers to invest into improved manufacturing standards, equivalence proof, product quality, reliability of supply or even additional real-world data collection, which ultimately may result in more health gain for the society.

Availability, prices and affordability of selected essential medicines in Jordan: a national survey.

BACKGROUND: Free access to essential medicines is a fundamental right. Governments should provide accessible and affordable medicines to people. The purpose of this study was to evaluate medicines' prices, availability and affordability in Jordan. METHOD: Data was collected from 30 public sectors and 30 private sectors in 6 regions in Jordan. At each institution, the availability and prices data of 50 originator brand (OB) medicines and lowest-price generic (LPG) equivalent medicines were collected. Medicines' prices were compared with international reference prices (IRPs) to obtain a median price ratio (MPR). Availability of medicines was determined on the day of data collection. Affordability was calculated with regards to the daily income of the lowest-paid unskilled government employee. RESULT: Availability of medicines in public and private sectors was 72% and 76% for LPGs, respectively. Median MPRs of procurement prices for OBs and LPGs in the public sector were 1.1 and 5.5 times the IRPs, respectively. Private sector OB medicines were priced 4.8 times higher than IRPs, whereas LPGs were 3.8 times higher. OBs cost 14% more than LPGs in private sector. The median MPRs of patient prices for LPGs in the public sector were lower than in the private sector (1.1 versus 7.6). Generally, medicines' prices are affordable in public sector that the lowest paid unskilled government employee need less than a 1 day income to purchase the LPGs. While in private sector, the medicine prices are not affordable. For example, the treatment of hypertension either by LPGs or OBs needs more than 1 day income by lowest paid unskilled government employee. CONCLUSION: This study showed good availability of LPGs in the public sector. In private sector, it showed good availability of LPGs and OBs with higher patient prices. The procurement prices in the public sector were reasonable in comparison to IRPs. Policy evaluation efforts must be directed to cut medicines prices and to improve affordability in private sector.

The Problem of Limited-Supply Agreements for Medicare Price Negotiation.

This Viewpoint discusses how limited-supply agreements (introduction of generic products in reduced volumes) might thwart efforts to negotiate lower prices on prescription drugs in the US.

Assessment of drug prescribing pattern using world health organization indicators in a tertiary care teaching hospital.

This cross-sectional study was carried out to assess drug prescribing pattern at a tertiary care teaching medical institute. One thousand prescriptions were randomly collected and analyzed using the world health organization prescribing indicators. The average number of drugs per prescription was 2.91. The percentage of drugs prescribed by generic name, from the essential drug list (National) and as fixed dose combinations (FDCs) was 10.05%, 22.57%, and 49.22%, respectively. The total percentage of encounters with antibiotics, injectables, and FDCs was 19.70%, 2.20%, and 73.60%, respectively. The most common group of drug prescribed was gastrointestinal tract drugs (26.38%) followed by Vitamins and Minerals (23.12%), cardiovascular system drugs (11.56%) and antimicrobials (9.63%). The prescribing practices were not appropriate as they consist of polypharmacy, lesser prescription by generic name, and overprescription of FDCs. There is a need for improvement in the standards of prescribing patterns in many aspects.

Trans-Pacific Partnership Provisions in Intellectual Property, Transparency, and Investment Chapters Threaten Access to Medicines in the US and Elsewhere.

Brook Baker describes the potential harms to global health from the Trans Pacific Partnership Agreement and its failure to balance the interests of patients and the public with those of industry.

Chemotherapy drug shortages in paediatric oncology: A 14-year single-centre experience in Belgium.

Shortages of chemotherapy are a growing challenge for the healthcare system. We present the burden of drug shortages of chemotherapeutics in the paediatric hemato-oncology unit of a tertiary care hospital and solutions that were used to manage them. Between January 2001 and December 2014, 54 individual shortages were detected, affecting a total number of 21 different drugs. In total, 4127 shortage days were registered with a mean duration of 196.5 SD ± 144.0 days per individual drug shortage. Methotrexate, doxorubicin and carboplatin had the longest supply disruptions. Solutions to address the problems were purchase of a generic alternative, a change of individual treatment plans, cohorting of patients and import from abroad.