Changes in roll-your-own tobacco and cigarette sales volume and prices before, during and after plain packaging legislation in the UK.

BACKGROUND: Plain packaging and minimum pack size legislation for tobacco products was introduced in the UK in May 2016, with a 1-year sell-off period until May 2017, during which both fully branded and plain packs of various sizes were legally available. This study investigates trends in prices of roll-your-own tobacco (RYO) before, during and after implementation of this legislation, and compares trends with those observed in the cigarette market. METHODS: We used Nielsen Scantrack data for the period from March 2013 to June 2018 to describe trends in UK inflation-adjusted prices and volumes of both RYO and cigarettes, and linear regression to estimate changes in prices associated with the introduction of plain packaging and the minimum pack sizes of 30 g RYO and 20 cigarettes. RESULTS: In contrast to a downward trend in cigarette sales volumes, RYO volumes rose throughout the study period. By the time plain packs accounted for 75% or more of sales, the average price of products sold in equivalent pack sizes had increased, relative to average prices in the year before implementation and with adjustment for tax changes, from 34.9 to 38.8 pence per gram for RYO (mean difference 4.26, 95% CI 3.99 to 4.53 pence, 12% increase), and from 38.6 to 41.13 pence for cigarettes (mean difference 2.53, 95% CI 2.24 to 2.83 pence, 7% increase) per cigarette. CONCLUSIONS: New legislation resulted in higher prices for RYO and manufactured cigarettes. However, sales volumes of RYO continued to increase throughout the study period, perhaps because RYO remains a less expensive means of smoking tobacco.

Little filtered cigars: US sales, flavours, package sizes and prices.

OBJECTIVE: At least four varieties of little filtered cigars (LFCs) violate the US prohibition on flavoured cigarettes other than menthol. This study characterises the sales of prohibited products and other LFCs by flavour category and pack size, as well as the price of LFCs relative to cigarettes. METHODS: Using retail sales data for 2016, we computed the sales volume in dollars and equivalent units and the percentage of total sales by flavour and pack size for the USA by region and state. Paired t-tests compared the prices for LFCs and cigarettes sold in same-sized packs and cartons. RESULTS: LFC sales totalled 24 033 equivalent units per 100 000 persons in 2016. Flavoured LFC varieties accounted for almost half (47.5%) of the total sales. LFCs were sold in 12 different pack sizes, but 79.7% of sales were packs of 20. The price of 20-packs averaged $2.41 (SD=$1.49), which was significantly less than cigarettes (M=$5.90, SD=$0.85). Regional differences suggest a greater proportion of menthol/mint LFCs and lower prices in the South than in other regions. CONCLUSION: Classifying all LFCs as cigarettes would require that they be offered in a minimum package of 20, eliminate flavoured varieties other than menthol and increase prices through applicable state and local cigarette taxes.

Challenges of dispensing costly tablets with short shelf-life.

Afatinib, trametinib and regorafenib are three costly oral oncology drugs with a short shelf-life after the original container has been opened. Their short shelf-lives are due to degradation on exposure to moisture. Therefore, manufacturers recommend them to be dispensed in the original packaging with the desiccant. However, the prescribed quantities do not always match the quantities in the original packaging, usually because of dose modifications for toxicities. This leads to potentially significant drug wastage and financial losses. We describe some potential approaches to this issue.

Opportunities to significantly reduce expenditure associated with cancer drugs.

AIM: To identify cancer drugs amenable to strategies for reducing expenditure and avoiding drug wastage. METHODS: Information was sourced from product information in 20 countries on parenteral cytotoxic agents, and cancer and noncancer monoclonal antibodies. Data were collected on vial sizes, overage, stability and presentation forms. RESULTS: Vial size availability varied significantly between countries, with often only single vial sizes for numerous medications. Overage was poorly reported. Stability data were inconsistent and variable between countries, with most drugs only having a 24 h expiry. Three cancer-indicated monoclonal antibodies, thought suitable for prefilled syringe administration, were only available as vials. CONCLUSION: Many expensive cancer drugs are suitable for global cost-reduction strategies. Collaboration is vital to affecting change and reducing expenditure.

The effectiveness bundling of zinc with Oral Rehydration Salts (ORS) for improving adherence to acute watery diarrhea treatment in Ethiopia: cluster randomised controlled trial.

BACKGROUND: Presumably bundling/co-packaging of zinc with ORS encourages the combined use of the products for diarrhea treatment; however, empirical evidences are scarce. The purpose of this work is to evaluate whether co-packing using a plastic pouch can enhance the joint adherence to the treatment or not. The study also compares the cost effectiveness (CE) of two co-packaging options: 'central' and 'health center (HC)' level bundling. METHODS: This cluster-randomised controlled trial was conducted in 2015 in eight districts of Ethiopia. Thirty two HCs were randomly assigned to one of the following four intervention arms: (i) 'Central bundling' (zinc and ORS bundled using a pouch that had instructional message, distributed to HCs); (ii) 'HC level bundling' (zinc, ORS and a similar pouch distributed to the HCs and bundled by health workers); (iii) 'Bundling without message' (zinc, ORS and plain pouch distributed and bundled by the health workers); and, (iv) 'Status quo' (zinc and ORS co-administered without bundling). In each of the four arms, 176 children 6-59 months of age, presented with acute diarrhea were enrolled. Twelve days after enrollment, level of adherence was assessed. A composite scale of adherence was developed and modeled using mixed effects linear regression analysis. The unit costs associated with the arms were estimated using secondary data sources. Incremental CE analysis was made by taking the cost and level of adherence in fourth arm as a base value. RESULTS: The follow-up rate was 95.6 %. As compared with the 'status quo' arm, the joint adherences in the 'central' and 'HC level' bundling arms raised substantially by 14.8 and 15.7 percentage points (PP), respectively (P < 0.05). No significant difference was observed between 'bundling without message' and the 'status quo' arms. The unit cost incurred by the 'central bundling' is relatively higher (USD 0.658/episode) as compared with the 'HC level bundling' approach (USD 0.608/episode). The incremental CE ratio in the 'central bundling' modality was two times higher than in the 'HC based bundling' approach. CONCLUSION: Bundling zinc with ORS using a pouch with instructional messages increases adherence to the treatment. 'HC level bundling' is more CE than the 'central bundling' approach.

[Suggestions to strengthen quality management of herbal decoction pieces--based on production chain of herbal decoction pieces].

With the development of society and the improvement of people's living standards, the effect of Chinese medicine in treatment and health care is more and more prominent. The herbal decoction pieces are the important part of Chinese medicine,it can be applied directly to clinical treatment and it's also the raw material of Chinese patent medicine. Therefore, the quality of herbal decoction pieces is quite important. The parts of the production of herbal decoction pieces are numerous, and there are possibilities of adverse effects on the quality of the herbal decoction pieces in every part. In this paper, we based on the production chain of herbal decoction pieces, analyzed the main problem that affect the quality of herbal decoction pieces in the part of selection of Chinese herbal medicines, planting, purchasing, processing, packaging, storage and transport, such as the poor quality of seed and seedlings of plant-based Chinese medicines, some plants left their place of origin and have been introduced in the place that is not suitable for this kind of plant, the insufficient growth time and the excessive harmful substances. The purchasers and the accepters lack of professional knowledge and professional ethics. The mechanism of processing is not clear, the standards can not be uniformed, and lack of qualified person in processing, etc. So we suggest: intensify the basic research of key scientific issues. Improve the quality of persons who work in herbal decoction pieces; Establish an "integration" mode of operation in herbal decoction pieces enterprise; Breeding high quality plant resources, establish the large-scale planting basement; Make the packing of herbal decoction pieces standard; Establish the modernization traditional Chinese medicine logistics enterprise.

A comprehensive analysis of selected medicines collected from private drug outlets of Dhaka city, Bangladesh in a simple random survey.

Comprehensive data are needed to prevent substandard and falsified (SF) medicines as they pose a major risk to human health. To assess the quality of selected medicines, samples were collected from random private drug outlets of Dhaka North and South City Corporation, Bangladesh. Sample analysis included visual observation of the packaging, authenticity of the samples, legitimacy and registration verification of the manufacturer, physicochemical analysis, and price. Chemical analysis of the samples was performed using a portable Raman spectroscopy and high-performance liquid chromatography according to the pharmacopoeia. Several discrepancies were noted in the visual observation of samples. Among the 189 collected samples of esomeprazole (ESM), cefixime (CFIX), and amoxicillin-clavulanic acid (CVA-AMPC), 21.2% were confirmed to be authentic, 91.3% manufacturers were confirmed legitimate, and 2.1% of all samples were unregistered. Chemical analysis of the samples revealed that 9.5% (95% CI 5.7-14.6) of samples were SFs. Falsified samples and quality variation in the same generic branded samples were both detected by Raman spectroscopic analysis. Overall, sample prices were satisfactory relative to the international reference price. This study documents the availability of poor-quality medicines, demonstrating the need for immediate attention by the national medicine regulatory authority.

Ideal vial size for bortezomib: real-world data on waste and cost reduction in treatment of multiple myeloma in Brazil.

OBJECTIVES: Single-size vials of drugs may be a source of waste and increase in treatment costs. Bortezomib, indicated for multiple myeloma (MM) treatment, is available in 3.5-mg vials, a quantity higher than the average dose commonly prescribed. This analysis aimed to demonstrate, through real-world data, which would be the optimal vial presentation for bortezomib in Brazil and quantify the reduction in medication waste related to this option. METHODS: From November 2007 to October 2009 all patients with MM treated with bortezomib were identified via the Evidências database. Analysis of prescribed, dispensed, and wasted doses, their costs and projections of the ideal vial size were performed. RESULTS: Thirty-five patients (mean body surface area of 1.73 m(2)) received 509 infusions in 131 cycles of treatment (average of 3.77 cycles per patient). The average dose prescribed was 2.1 mg per infusion (95% confidence interval [CI] 1.97-2.26) with average waste of 39.5% of the vial content (95% CI 35.35-43.76). The mean waste per patient per day was 1.38 mg (95% CI 1.24-1.52). If a 3-mg vial were available, the average drug waste per patient per day would be 0.88 mg (95% CI 0.74-1.03) or 36.2% less. With a 2.5-mg vial the waste would be 1.05 mg (95% CI 0.81-1.29) or 23.9% less. If two presentations were available (2.5 mg and 0.5 mg), the waste would be 0.52 mg (95% CI 0.4-0.63) or 62.5% less. Considering the price of the different vials to be proportional to the original 3.5-mg vial, the cost would be also reduced by the same rates described above. CONCLUSIONS: A simple adjustment in vial size may reduce the waste of bortezomib by 36% to 62% and can also reduce the cost of treatment.

Current challenges in European oncology pharmacy practice.

BACKGROUND: The demand for pharmacy cancer services is expected to at least double over the next 10 years, as the population ages and new treatments are introduced. Safe and efficient handling of cytotoxic products minimises risks to staff and reduces medication errors. OBJECTIVES: To identify and describe strategies for coping safely and effectively with heavier workloads in the hospital oncology pharmacy, currently and in the future. METHODS: The PubMed database was searched for literature on approaches to safe handling of antineoplastic agents and to decreasing medication errors in the hospital pharmacy. Articles that were judged to be of prime importance to the hospital oncologist were reviewed. These safety concepts are put into the context of contemporary hospital oncology pharmacy practice through discussion of key issues, including increased demand, the role of the pharmacist in determining the hospital formulary, and growth in patient preferences for oral chemotherapy. Recommendations on best practices are also provided, based on relevant literature and author experience. CONCLUSIONS: Efficient, safe hospital pharmacy operations can be aided by capacity planning, dose banding, and knowledge of novel products and procedures that can reduce risks to health while increasing the number of patients who are safely treated. Consideration may also be given to the economic role of oncology pharmacists in formulary development.

[Effects of different package materials and storage methods on quality and shelf life of Angelica sinensis].

OBJECTIVE: To explore an economical and practical storage method for angelica roots (Angelica sinensis). Various treatments were used in packaging and storing dry and fresh angelica roots. METHOD: The experiment was designed in single-factor completely random as compared with the traditional stack without package. The character, weight, extract contents and volatile oil were measured within the storage process. RESULT: If stored for long-term use, the dried angelica roots should be packaged with vacuum-exhausted bags cleaned with water, which resulted in less loss in weight, higher extracts and volatile oil. However, if stored for fresh use, the fresh angelica roots should be packaged in vacuum-exhausted bags after cleaned with sorghum alcohol and stored under low temperatures if possible, which resulted in less loss in weight and longer fresh time. Considering volatile oil and extract contents, it is better to use the dried angelica roots for storage. CONCLUSION: If stored for long-term use the dry angelica roots should be packaged with vacuum-exhausted bags cleaned with water, while for fresh use the fresh angelica roots should be packaged with vacuum-exhausted bags cleaned with sorghum alcohol and stored under low temperatures if possible.

Review of economic data on closed system transfer drug for preparation and administration of hazardous drugs.

OBJECTIVES: The objectives of this study were to review economic data on the use of closed system drug transfer devices (CSTDs) for preparing and administering hazardous drugs, and to evaluate the quality of data reporting as defined by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). METHODS: All references from a recent Cochrane review about CSTDs were evaluated for inclusion. A literature review was also conducted. Articles containing economic data about the use of CSTDs were retained for analysis. Two researchers independently graded the articles according to the 24-item CHEERS checklist. RESULTS: Of the 138 articles identified initially, 12 were retained for analysis. Nine of these studies did not report acquisition costs or did not detail acquisition costs. Six studies reported economic benefits associated with the used of CSTDs, all related to extending the beyond-use date. The mean number of CHEERS criteria fulfilled by the included articles was 9.2 (SD 2.4). CONCLUSIONS: CSTDs are costly to acquire. However, few studies have examined the economic impact of these devices, and the existing studies are incomplete. As a result, hospitals planning to implement these devices will be unable to make a sound economic evaluation. Robust economic evaluation of CSTDs is needed.

Effect of a Smart Pill Bottle and Pharmacist Intervention on Medication Adherence in Patients with Multiple Myeloma New to Lenalidomide Therapy.

BACKGROUND: U.S. specialty drug spend is expected to reach $400 billion by 2020, with significant growth in oncology. New oral oncology approvals have allowed for more convenient outpatient administration compared with physician-administered chemotherapies; however, patients may encounter challenges with adherence when taking medications at home. Emerging medication adherence technology (MAT) attempts to provide at-home adherence support, and while one such technology, smart pill bottles (SPB), claims to improve medication adherence, few studies have formally assessed their effects. OBJECTIVES: To assess the effect of an SPB with pharmacist intervention on medication adherence in adult patients with multiple myeloma (MM) new to lenalidomide therapy (≤ 5 cycle dispenses). Secondary objectives were to evaluate treatment cycles completed, evaluate the significance of real-time pharmacist engagement (intervention group only), determine the incremental cost-effectiveness ratio (ICER), and evaluate patient satisfaction and likelihood to use an SPB. METHODS: This prospective, random assignment, single-site, and single-blinded study recruited 40 adult patients diagnosed with MM new to lenalidomide at a specialty pharmacy. Recruitment was completed January-February 2016, and the length of study was 6 months. Participants were randomized 1:1 between the intervention and control groups. The intervention group received lenalidomide in activated SPBs with light, chimes, text message reminders, and pharmacist follow-up if weekly SPB adherence rates dropped below 80%. The control group received lenalidomide in identical SPBs with all alerts deactivated. SBPs contained cellular capabilities, enabling around-the-clock data transmission and captured data upon bottle-uncapping events. Patient adherence was calculated by dividing the number of bottle-uncapping events by the total number of doses supplied for each dosing cycle. Lenalidomide cycles completed and pharmacist outreach to the same patient were counted to determine pharmacist intervention. The ICER was calculated to determine SPB cost-effectiveness, and a Likert scale survey was given to the intervention group to evaluate patient satisfaction with the full-service SPB. RESULTS: Sixteen participants in each arm completed the study; 4 patients in each arm were lost to follow-up. Median adherence was improved for the intervention group compared with the control group (median = 100% vs. 87.4%; P = 0.001). The ICER per patient percentage adherence increase was found to be $96.03. Sixty percent of patients in the intervention group who responded to the post-satisfaction survey rated the full SPB service very positively. CONCLUSIONS: In this study, SPB interventions were associated with increased medication adherence and patient satisfaction. This pilot also provides empirical data on the cost-effectiveness of adherence technology used in a specialty pharmacy oncology setting. DISCLOSURES: This study was supported by Avella Specialty Pharmacy and AdhereTech. All authors are employees of Avella; Eric Sredzinski was an option holder of Avella; and none of the Avella authors had a financial interest in AdhereTech. AdhereTech provided the SPBs and data services for the duration of this study. The authors report no other potential conflicts of interest. Interim study data were presented at the 2016 Southwestern States Residency Conference (SSRC) on June 20, 2016, in Phoenix, AZ.

Multidose Botulinum Toxin A for Intralaryngeal Injection: A Cost Analysis.

OBJECTIVES: Botulinum toxin A (BtxA) injection is the mainstay treatment for laryngeal dystonias. BtxA product labeling states that reconstituted toxin should be used within 4 hours on a single patient despite several studies that have demonstrated multidose BtxA to be safe and effective. Many insurance carriers mandate the use of an outside pharmacy which necessitates a single-use approach. This study compares the cost savings of multidose BtxA for laryngeal dystonia compared to single-use. STUDY DESIGN: This is a retrospective review and projected cost savings analysis. METHODS: Records and billing information were reviewed for patients receiving BtxA for intralaryngeal injection at a single laryngology division in 2015. Inclusion criteria included CPT 64617 or J0585; exclusion criteria included CPT 64616. The price of BtxA 100 unit vial for calculation was $670. RESULTS: A total of 142 patients were seen for intralaryngeal BtxA injection resulting in 337 visits over 1 year. The average BtxA dose per visit was 2.86 units with an average of 3.06 procedure visits per year. The calculated cost of BtxA treatment using a single vial approach was found to be $2,050 per patient per year. If billed instead for $7/unit with 5 units wastage charge per visit, the yearly per patient charge is $168. Single vial-use of BtxA injection thus represents a 1,118% price increase versus multidose use. When estimated for yearly prevalence of spasmodic dysphonia, multidose BtxA use would save almost $100 million annually. CONCLUSIONS: Multidose botulinum toxin A application utilizing per unit billing is significantly less expensive than per single-use vial billing and would save the health-care system significant amount of money without any sacrifice in safety or effectiveness.

Comparison of simvastatin tablets from the US and international markets obtained via the Internet.

BACKGROUND: Convenient access to prescription drugs produced outside the US has been facilitated by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The Food and Drug Administration has issued warnings to potential buyers that the safety of drugs purchased through the Internet cannot be guaranteed and may present consumers with a health risk from substandard products. OBJECTIVE: To determine whether generic simvastatin tablets and capsules obtained via the Internet from international markets are equivalent to the US innovator product regarding major aspects of pharmaceutical quality. METHODS: Twenty simvastatin tablets and capsules were obtained for pharmaceutical analysis: 19 generic samples from international Internet pharmacy Web sites and the US innovator product. Tablet samples were tested according to US Pharmacopeial (USP) guidelines where applicable, using high-performance liquid chromatography, disintegration, dissolution, weight variation, hardness, and assessment of physical characteristics. These tests are often used to detect formulation defects of drug products during the manufacturing process. RESULTS: Several international samples analyzed were not comparable to the US product in one or more aspects of quality assurance testing, and significant variability was found among foreign-made tablets themselves. Five samples failed to meet USP standards for dissolution and 2 for content uniformity. Among all samples, variability was observed in hardness, weight, and physical characterization. CONCLUSIONS: Results suggest that manufacturing standards for the international generic drug products compared with the US innovator product are not equivalent with regard to quality attributes. These findings have implications for safety and effectiveness that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-manufactured drugs via the Internet.

Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market.

BACKGROUND: Availability of correct and adequate information about medicines is an important aspect in ensuring rational use of medicines and hence facilitating safety and expected efficacy of medicines during therapy. Package inserts have proven to be a good source of information to the prescribers and patients whereby they have been useful in highlighting important information pertaining proper use and handling of the medicines. The present study was aimed at establishing the extent to which package inserts of medicines circulating on the markets of the East African Community (EAC) Partner States conform to medicines information requirements as established in the harmonized guidelines as well as national guidelines. METHODS: A total of 99 package inserts from six (6) types of medicines namely Albendazole, Artemether/Lumefantrine (ALu), Ciprofloxacin, Paracetamol, Amoxicillin and Metronidazole were purposefully collected from three EAC Partner States: Kenya, Tanzania and Uganda. The medicines were selected based on their indications as first line treatments, high rates of utilization within the medicines supply system and their positions in treatment of diseases of public importance across EAC Partner States. The inserts were evaluated on the availability of information regarding fifteen (15) parameters as extracted from the EAC harmonized guidelines for registration of medicines. Moreover, comparisons were made between the percentage conformity of the branded versus generic products, markets from which the samples were collected, origin of the manufacturer and type of medicine. RESULTS: Majority (93.9-100%) of the medicines' package inserts highly conformed to the inclusion of the information regarding the description and composition of the medications, indications, dosage and methods of administration, warnings and precautions, contraindications and storage conditions. However, the information on handling and disposal, container package description, excipients used, clinical pharmacology of the medicines, and directions regarding overdose ranked the least in conformance with conformity ranging from 13.1-52.5%. The parameter with the lowest observed percentage conformity among the branded products scored 50% as compared to 10.8% among the generic products. Moreover, there was no significant difference (P<0.05) in the percentage conformity of the package inserts collected from each of the three Partner States as compared to the average from studied medicines. A generally good conformity was observed among medicines manufactured by European based manufacturers as compared to those based in Asia and EAC Partner States. In addition, PIs of Albendazole, Ciprofloxacin, Amoxicillin and Artemether/Lumefantrine did show overall high conformity across most of the product information requirements. CONCLUSION: Our study revealed the existence of a significant number of medicinal products circulating on the markets of EAC Partner States without necessary compliance with all product information requirements. We therefore recommend that NMRAs ensure thorough pre-market assessment of product information as well as strengthening their post marketing surveillance to ensure that medicines circulating on the market comply to medicines information requirements at all times. Emphasis should also be given to manufacturers on the importance of inclusion of appropriate and adequate product information for the safety of patients, including advocating for inclusion of patient-friendly and easy to understand medicines information.

Drug wastage and costs to the healthcare system in the care of patients with non-small cell lung cancer in the United States.

BACKGROUND: Lung cancer is one of the most prevalent cancers in the US. This study was designed to evaluate the actual drug wastage and cost to the healthcare system using patient-level retrospective observational electronic medical record (EMR) data from a cohort of lung cancer patients in the US. METHODS: Data from the Flatiron Health advanced non-small cell lung cancer (NSCLC) cohort was used for this study. Drug administered amount (in mg) was used to determine an optimal set of available vial sizes to minimize waste. Drug wastage was defined as the difference between the drug amount in the optimal set of vials and the administered amount. Wholesale acquisition costs were used to value the cost of drugs, with and without vial sharing assumptions. The amount and cost of waste were quantified over the 2-year study period (January 2015-December 2016). RESULTS: There were 8,467 eligible patients included in this study, providing data from 103,826 unique drug administrations across multiple lines of therapy. Overall wastage was 4.37% of the total medication used to care for patients. While costs per administration were low, the total cost of wastage for the study population represented $16,630,112 across the 2-year study period. Assuming that vial sharing occurred at the site level slightly reduced waste to 3.74% (reducing costs to $15,953,212 over 2 years). CONCLUSIONS: Drug wastage is an important concern and has implications on healthcare costs in NSCLC. Evaluation of these real-world data suggest that pharmacists and physicians are able to reduce drug wastage by optimizing vial combinations and sharing vials among patients. Even small amounts of reduction in wastage could be useful in reducing healthcare costs in the US; however, caution is needed with drug rounding efforts to ensure patients do not receive a sub-optimal dose of medication.