Summary Background Cancer drugs challenge health-care systems because of their high prices. No cross-country price comparison of cancer drugs for a large number of countries has been published. We ...aimed to survey the prices of cancer drugs in high-income countries (Europe, Australia, and New Zealand). Methods Based on comparability in terms of the economic situation and of the pharmaceutical system, we surveyed official list prices per unit at ex-factory price level of 31 originator cancer drugs in 16 European countries, Australia, and New Zealand as of June, 2013. Drug price data for the European countries were provided by the Pharma Price Information (PPI) service; Australian and New Zealand drug price data were retrieved from the respective pharmaceutical schedules. Findings In Austria, Denmark, Finland, Germany, Italy, Norway, Sweden, and the UK, price information was available for all or all but one drug surveyed whereas the availability of price data was restricted for some drugs in other countries, especially in New Zealand and Portugal. The difference of a drug price between the highest priced country and the lowest priced country varied between 28% and 388%. A few drugs had lower outliers, especially Greek and UK prices, and upper outliers (particularly prices in Switzerland, Germany, and Sweden). Overall, Greek prices ranked at a low level, whereas Sweden, Switzerland, and Germany showed price data in similarly high ranges. Interpretation Our results showed variations in ex-factory prices of originator cancer drugs in the 18 surveyed countries. However, the surveyed prices do not include discounts negotiated by funding organisations because these discounts are confidential. Because pricing authorities can also only use these official undiscounted prices when they set prices through the common policy of external price referencing, they risk overpaying. Our findings provide an evidence base for policy makers to decide whether further policy measures related to drug prices are needed. Funding None.
Although gastro-oesophageal reflux disease (GORD) is a common medical complaint, there is currently no consensus on the global prevalence of GORD. The aim of this study was to conduct a systematic ...review and meta-analysis on GORD prevalence and risk factors at a global level. MEDLINE, EMBASE, CINAHL, Scopus, Cochrane library, and Google Scholar were systematically searched, without language restrictions, for studies on the prevalence and risk factors of GORD. Data were pooled using a random effects model (95% confidence interval), and the odds ratio and relative risk for each risk factor were calculated. Out of 34,355 search results, 96 records reporting the results from 102 studies fulfilled the inclusion criteria, representing 37 countries and all regions of the UN geoscheme. The global pooled prevalence of GORD was 13.98% and varied greatly according to region (12.88% in Latin America and the Caribbean to 19.55% in North America) and country (4.16% in China to 22.40% in Turkey). Using the United Nations 2017 Revision of World Population Prospects, the estimated number of individuals suffering from GORD globally is 1.03 billion. Multiple risk factors associated with a significant increase in the risk of GORD were also identified. This systematic review and meta-analysis revealed that although a substantial proportion (13.98%) of the global population suffers from GORD, there are significant variations between regions and countries. Risk factors for GORD were also identified which may allow clinicians to recognise individuals most at risk.
To review existing regulations and policies utilised by countries to enable patient access to orphan drugs.
A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed ...articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country.
Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country's pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access.
Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.
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Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
As the lockdowns are being observed all over the globe and the national level pharmacy professionals are performing frontline roles, this editorial highlights the role of pharmacists in the COVID - ...19 pandemic. Pharmacists globally are providing services amidst pandemic, including TRIAGE services, seeing patients and reducing the patients' burden on health care facilities such as hospitals and GP practices. Pharmacists are also working to providing home deliveries, as well as dealing with the increasing number of patients coming through to pharmacies with the other ailments. Pharmacy associations have issued their guidelines and in this editorial, several global examples of pharmacists' role in the COVID 19 are being discussed. Pakistan is used as a country case study in this editorial. The editorial also elaborates how pharmacists in the UK and Pakistan have teamed up together to compile 10-steps protection guidelines for the pharmacy teams in Pakistan in English and Urdu language. This 10-point guidance educates community pharmacies for safety and standard operation as the number of patients in the country continues to rise. These guidelines are endorsed by the government and private bodies. These can be adopted and adapted by any country; keeping in view their laws and regulations.
Drug shortage is a global issue affecting low, middle, and high-income countries. Many countries have developed various strategies to overcome the problem, while the problem is accelerating, ...affecting the whole world. All types of drugs, such as essential life-saving drugs, oncology medicines, antimicrobial drugs, analgesics, opioids, cardiovascular drugs, radiopharmaceutical, and parenteral products, are liable to the shortage. Among all pharmaceutical dosage forms, sterile injectable products have a higher risk of shortage than other forms. The causes of shortage are multifactorial, including supply issues, demand issues, and regulatory issues. Supply issues consist of manufacturing problems, unavailability of raw materials, logistic problems, and business problems. In contrast, demand issues include just-in-time inventory, higher demand for a product, seasonal demand, and unpredictable demand. For regulatory issues, one important factor is the lack of a unified definition of drug shortage. Drug shortage affects all stakeholders from economic, clinical, and humanistic aspects. WHO established global mitigation strategies from four levels to overcome drug shortages globally. It includes a workaround to tackle the current shortage, operational improvements to reduce the shortage risk and achieve early warning, changes in governmental policies, and education and training of all health professionals about managing shortages.
Direct-acting oral anticoagulants (DOACs) are replacing conventional VKA (vitamin K antagonist, i.e., warfarin) for various indications where a therapeutic anticoagulant effect is desired. We ...evaluated the prescribing patterns of the DOACs and warfarin, cost implications of the increasing DOACs prescribing, and deduce the reporting of serious and fatal events, during 2009–2019 in primary care England. Prescriptions and fatal or serious adverse events reporting data, between 2009 and 2019 were analysed, using linear regression to examine the trends in prescriptions, costs, and serious and fatal events reporting. We also compared the prescribing trends of four direct-acting oral anticoagulants and warfarin, normalised to per 1000 clinical commissioning group (CCG) patient population for the year 2019 to better understand the regional differences in DOACs prescribing. The overall use of any DOACs (as a proportion of total anticoagulants) increased from 16% in 2015 to 62% in 2019 with an average increase of 87% (95% CI 83.1, 90.5) per year. The reporting of serious and fatal events associated with DOACs decreased by 6% (95% CI 12.5, − 0.1) per year. Apixaban is by far the most prescribed with an average drug cost increasing to 156% (95% CI 140, 172) per year. In England, the lowest anticoagulant prescribing region was Greater London whereas the highest prescribing regions were Yorkshire and Humber for DOACs and the East Midlands for warfarin. Interestingly, Lancashire, Merseyside, and Cheshire showed a higher usage for warfarin over DOACs. The differing prescription patterns could be a result of changes in national guidelines and increasing population. Nevertheless, DOACs appear to make an increasing contribution to total anticoagulant prescription items and costs.
Aims
Patient‐reported outcomes (PROs) are a distinctive method of evaluating patient response to health care or treatment. This systematic review aimed to analyse the impact of PROs in patients on ...direct oral anticoagulant (DOAC) treatment, prescribed for any indication (e.g. venous thromboembolism treatment or atrial fibrillation) using controlled trials (CT) and real‐world observational studies (OS).
Methods
A systematic search of articles was conducted according to PRISMA guidelines using databases, with the last update in November 2018. The Cochrane Collaboration tool for assessing bias in randomized CTs and the Newcastle‐Ottawa Scale adapted for cross‐sectional studies were used. Outcomes evaluated were related to health‐related quality of life (HRQoL), satisfaction, adherence and compliance.
Results
Twenty‐one original studies (6 CT, 15 OS) were included. HRQoL was assessed by 6 (1 CT, 5 OS) studies and reported that HRQoL scores were similar in patients on DOACs and warfarin. Patients prescribed DOACs presented higher HRQoL scores which were attributed to lack of intense monitoring required compared with warfarin but this was not statistically significant. The majority of studies (5 CT, 9 OS) investigated patient‐reported satisfaction, indicating greater satisfaction with DOACs with significantly lower burden and increased benefit scores for patients on DOACs. Patient‐reported expectations, compliance and adherence were similar for patients on DOACs and warfarin.
Conclusion
Patients appear to prefer treatment with DOACs vs warfarin. This is shown by the higher quality of life, satisfaction and adherence described in the studies. However, heterogeneity in the analysed studies does not allow firm conclusions.
Inadequate access to medicines affected by un-controlled prices is a major concern in developing countries, including Pakistan, which lacks comprehensive data on medicine prices. Thus, the objective ...of this study was to evaluate the prices, availability and affordability of essential medicines in Lahore division, Pakistan. The survey was undertaken from November, 2016 till March, 2017 by including 50 medicines, 14 from the WHO/HAI core list and 36 supplementary medicines from national essential medicine list (NEML) at public (n = 16) and private (n = 16) health facilities. The prices, availability and affordability of selected medicines were measured using a variant of the WHO/HAI standard methodology available on HAI website and WHO/HAI manual. A questionnaire was used for data collection from Lahore division. The prices were compared to International reference prices (IRPs) and the daily wage of a lowest paid unskilled government worker was used to calculate medicine affordability. Data suggested poor availability of originator brands (OB) in public and private sector facilities, i.e., 6.8% and 55.0%, respectively. Similarly, low availability was observed for lowest price generics (LPGs), both in public (35.3%) and private sector (20.3%) facilities-far below the WHO global action plan targets of 80% availability of essential medicines by 2025. In private sector, 53% OB and 38% LPG medicines were found excessively priced. The cost of standard treatment with OBs was unaffordable, i.e., above a single daily wage (1.4 day's wages) was demanded to purchase the standard treatment for the selected diseases in case of OBs medicines. Whereas, the cost of LPGs medicine required to purchase the standard treatment of the selected diseases was 0.6 day's wage (median), below a single daily wage. In conclusion, access to essential medicines, especially at public sector facilities was affected by low availability, particularly of OBs in comparison to LPGs. Thus, the better availability of LPGs might be a rational basis of transition into a generic system of prescribing that may improve the availability and accessibility of essential medicines in Lahore division. Medicine prices in Lahore division were found higher in comparison to IRPs. Thus, the efforts must be made to formulate patient's pocket friendly drug pricing policy that favors price cuts and improves affordability.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
In Ghana, prices for cancer medicines are characterized by high retail markups, forex fluctuations and high variation in prices of medicines. Most patients cannot afford the cancer medicines. There ...is a problem of unaffordability and limited availability of essential cancer medicines which suggests potential inequity in patient access to cancer medicines. The study objective was to assess the prices, availability, and affordability of cancer medicines in Ghana. Prices of cancer medicines are a major contributor to the cost of treatment for cancer patients and the comparison of these cost was assessed to determine the affordability.
The methods developed and standardized by the World Health Organization (WHO) in collaboration with the Health Action International (HAI), was adapted and used to measure prices, availability, and affordability of cancer medicines in Ghana. The availability of cancer medicines was assessed as percentage of health facilities stocked with listed medicines. The price of cancer medicines (of different brands as well as the same medicine manufactured by different pharmaceutical industries) available in the public hospitals, private hospitals, and private pharmacies was assessed, and the percentage variation in prices was calculated. Medicine prices were compared with the Management Sciences Health's International Reference Prices to obtain a Median Price Ratio (MPR). The affordability of cancer medicines was determined using the treatment cost of a course of therapy for cancer conditions in comparison with the daily wage of the unskilled Lowest-Paid Government Worker.
Overall availability of cancer medicines was very low. The availability of Lowest Priced Generic (LPG) in public hospitals, private hospitals, and private pharmacies was 46%, 22%, and 74% respectively. The availability of Originator Brand (OB) in public hospitals, private hospitals, and private pharmacies was 14%, 11%, and 23% respectively. The lowest median price United States Dollars (USD) for the LPG was 0.25, and the highest median price was 227.98. For the OB, the lowest median price was 0.41 and the highest median price was 1321.60. The lowest and highest adjusted MPRs of OBs and LPGs was 0.01 and 10.15 respectively. Some prices were 20.60 times more expensive. Affordability calculations showed that patients with colorectal and multiple myeloma cancer would need 2554 days wages (5286.40 USD) and 1642 days wages (3399.82 USD) respectively to afford treatment.
The availability of cancer medicines was very low, and less than the WHO target of 80%. There were considerable variations in the prices of different brands of cancer medicines, and affordability remains suboptimal, as most patients cannot afford the cancer medicines. Comprehensive policies, regulations and multifaceted interventions that provides tax incentives, health insurance, and use of generics to improve cancer medicines availability, prices, and affordability, for the masses should be developed and implemented in Ghana.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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