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Purpose: To examine HMG-CoA reductase inhibitor (statin) drug dispensing patterns to Nova Scotia Seniors' Pharmacare program (NSSPP) beneficiaries over a 14-year period in response to: 1) rosuvastatin market entry in 2003, 2) JUPITER trial publication in 2008, and 3) generic atorvastatin availability in 2010., Methods: All NSSPP beneficiaries who redeemed at least one prescription for a statin from April 1, 1999 to March 31, 2013 were included. Aggregated, anonymous monthly prescription counts were extracted by the Nova Scotia Department of Health and Wellness (Nova Scotia, Canada) and changes in dispensing patterns of statins were measured. Data were analyzed using descriptive analyses and interrupted time series methods., Results: The percentage of NSSPP beneficiaries dispensed any statin increased from 5.3% in April 1999 to 20.7% in March 2013. In 1999, most NSSPP beneficiaries were dispensed either simvastatin (29.5%) or atorvastatin (28.7%). When rosuvastatin was added to the NSSPP Formulary in August 2003, prescriptions dispensed for simvastatin, lovastatin, pravastatin, and fluvastatin declined significantly (slope change, -0.0027; 95% confidence interval (CI), (-0.0046, -0.0009)). This significant decline continued following the publication of JUPITER (level change, -0.1974; 95% CI, (-0.2991, -0.0957)) and the availability of generic atorvastatin (level change, -0.2436; 95% CI, (-0.3314, -0.1558)). Atorvastatin was not significantly affected by any of the three interventions, although it maintained an overall decreasing trend. Only upon the availability of generic atorvastatin did the upward trend in rosuvastatin use decrease significantly (slope change, -0.0010, 95% CI, (-0.0015, -0.0005))., Conclusions: The type and rate of statins dispensed to NSSPP beneficiaries changed from 1999 to 2013 in response to the availability of new agents and publication of the JUPITER trial. The overall proportion of NSSPP beneficiaries dispensed a statin increased approximately 4-fold during the study period. In 2013, rosuvastatin was the most commonly dispensed statin (44.1%) followed by atorvastatin (39.1%).

Objective: Prescription drug take-back programs provide a safe and convenient way to dispose of expired, unwanted, or unused medications that people store in homes, thus limiting the potential misuse of prescription drugs. This study evaluated public response to a social marketing campaign promoting a community-based drug take-back program, the American Medicine Chest Challenge., Method: A telephone survey was conducted with a representative sample of adults in New Jersey (N = 906) 2 weeks following the conclusion of the statewide collection day event in November 2010. The survey assessed public exposure to the campaign and the extent to which it is associated with public perceptions and behaviors the campaign was designed to influence., Results: The campaign, which relied heavily on community channels for the dissemination of messages, was able to reach directly more than 60% of its target audience. When potential confounders were controlled for, campaign exposure was a strong predictor of a respondent having one or more conversations with others about medicine disposal (odds ratio [OR] = 2.4, 95% CI [1.5, 3.6]); actually disposing of expired, unwanted, or unused medicine in a collection site (OR = 2.14, 95% CI [1.15, 3.9]); and talking to kids about the dangers of prescription drug abuse (OR = 1.65, 95% CI [1.1, 2.45])-all of which were exclusively promoted through the campaign., Conclusions: This case illustrates the potential efficacy of community-based prevention marketing efforts to stimulate community discourse regarding the dangers of prescription drug misuse and to decrease the availability of expired, unwanted, or unused medicine in the community.

Objective: To explore the perceptions and knowledge of school teachers and students about antibiotic use, resistance, and suggestions for practical interventions for the rational use of antibiotics., Methodology: Five focus group discussions (FGDs) with high school students (Class: 9-11) and five with teachers were conducted in two private and three public schools (one teacher and one student FGD per school) in five municipal wards of Delhi. Qualitative data on antibiotic knowledge, resistance, and behaviors with respect to antibiotics use were collected. There were 4-8 persons per teacher FGD and 15-20 persons per student FGD. FGDs were analyzed using "thematic analyses.", Results: Students had poor knowledge regarding antibiotics and antibiotic resistance, while only some teachers had a basic understanding. Four broad themes needing attention emerged: definition of antibiotic and antibiotic resistance, antibiotic use behavior, doctor-patient relationship, and interventional strategies suggested to curtail the misuse of antibiotics and to spread awareness. In order to tackle these problems, both groups suggested a multipronged approach including robust public awareness campaigns also involving schools, better doctor-patient relationships, and stronger regulations., Conclusions: Although students and teachers exhibited poor knowledge about antibiotic use and resistance, they were keen to learn about these issues. School education programs and public education could be used to shape correct perceptions about antibiotic use among all stakeholders including children. This may help in the containment of antibiotic resistance and thus preservation of antibiotics for future generations.

In the past year, the Federal Drug Administration (FDA) approved many new drugs for treating a wide variety of patient health problems. In a previous article, examples of approvals for the early part of last year were addressed. In this article, selected new FDA approvals through January 2016 are discussed. Nurses who are knowledgeable and informed about these new drugs will be able to answer patients' questions, clarify misunderstandings, and reduce the potential for medication misadventures.

Objectives: Pharmacists are one of the crucial focal points for health care in the community. They have tremendous outreach to the public as pharmacies are often the first-port-of-call. With the increase of ready-to-use drugs, the main health-related activity of a pharmacist today is to assure the quality of dispensing, a key element to promote rational medicine use., Materials and Methods: A cross-sectional study of 200 pharmacies, 100 each in various residential (R) and commercial (C) areas of Bengaluru, was conducted using a prevalidated questionnaire administered to the chief pharmacist or the person-in-charge by the investigators., Results: Dispensing without prescription at pharmacies was 45% of the total dispensing encounters and significantly higher (χ 2 = 15.2, P < 0.001, df = 1) in pharmacies of residential areas (46.64%) as compared to commercial areas (43.64%). Analgesics were the most commonly dispensed drugs (90%) without prescription. Only 31% insisted on dispensing full course of antibiotics prescribed and 19% checked for completeness of prescription before dispensing. Although 97% of the pharmacies had a refrigerator, 31% of these did not have power back-up. Only about 50% of the pharmacists were aware of Schedule H., Conclusion: This study shows a high proportion of dispensing encounters without prescription, a higher rate of older prescription refills, many irregularities in medication counseling and unsatisfactory storage practices. It also revealed that about half of the pharmacists were unaware of Schedule H and majority of them about current regulations. Hence, regulatory enforcement and educational campaigns are a prerequisite to improve dispenser's knowledge and dispensing practices.

Background: Among the most vulnerable people in society are children and this is especially so in their access to health care Off-label prescription of paediatric medicines is known to be associated with safety outcomes some of which may be serious. This study identifies frequently prescribed children's medicines that are not readily available in Ghana and are prepared extemporaneously., Method: All prescriptions for extemporaneous oral preparations for children presented to the local production unit of the Korle-Bu Teaching Hospital from November, 2013 were eligible for the study. Information from such prescriptions was recorded in a systematic format. Presence of the prescribed medicine on the World Health Organization Children's Medicine List was ascertained in addition to the anatomical and therapeutic classification code. The registration of the prescribed medicine for paediatric use by the Food and Drugs Authority, Ghana was also checked. Descriptive statistics of the data was presented., Results: In all 622 prescriptions for 35 different paediatric formulations were served. Prescriptions from several health facilities including government hospitals (6.6 %, N = 622), private hospitals (2.4 %, N = 622) and the University of Ghana hospital (1.1 %, N = 622) were all honoured. Some of the prescribed medicines (Baclofen, Clonazepam, Hydroxyurea and Lamotrigine) were neither on the World Health Organization Children's Medicine list nor registered with the Food and Drugs Authority, Ghana. Most prescribed medicines (88.6 %, N = 35) were for non-communicable diseases., Conclusion: Paediatric prescriptions including off-label medicines are prescribed and formulated extemporaneously in this setting. Steps should be taken to improve access and monitor benefit-risk profiles of paediatric medicines in order to improve treatment outcomes among children.

Background: Amidst the rise of e-commerce, there has been a proliferation of illicit online pharmacies that threaten global patient safety by selling drugs without a prescription directly to the consumer. Despite this clear threat, little is known about the key risk characteristics, central challenges and current legal, regulatory and law enforcement responses., Sources of Data: A review was conducted of the English literature with search terms 'online pharmacies', 'Internet pharmacies', 'cyber pharmacies', 'rogue pharmacies', and 'e-pharmacies' using PubMed, JSTOR, and Google Scholar from 1999-2005., Areas of Agreement: Illicit online pharmacies are a rapidly growing public health threat and are characterized by a number of complex and interrelated risk factors., Areas of Controversy: Solutions are varied and are of questionable utility in the face of evolving technology that enables this form of transnational cybercrime., Growing Points: Legal, regulatory and technology solutions must address the entire illicit online pharmacy ecosystem in order to be effective., Areas Timely for Developing Research: There is a critical need to build international consensus, conduct additional research and develop technology to combat illicit online pharmacies., (© The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

We determine the optimal health policy mix when the average utility of patients increases with the supply of drugs available in a therapeutic class. Health risk coverage relies on two instruments, copayment and reference pricing, both of which affect the risk associated with health expenses and diversity of treatment. For a fixed supply of drugs, the reference pricing policy aims at minimizing expenses, in which case the equilibrium price of drugs is independent of the copayment rate. However, with an endogenous supply of drugs, diversity of treatment may susbtitute for insurance so that the reference pricing may depart from maximal cost-containment in order to promote entry. We next analyze the determinants of the optimal policy. While an increase in risk aversion, or in the side effect loss, increases diversity and decreases the copayment rate, an increase in entry cost decreases both diversity and the copayment rate., (Copyright © 2016. Published by Elsevier B.V.)

Early evidence suggests that provisions of the Food and Drug Administration Safety and Innovation Act of 2012 are associated with reductions in the total number of new national drug shortages. However, drugs frequently used in acute unscheduled care such as the care delivered in emergency departments may be increasingly affected by shortages. Our estimates, based on reported national drug shortages from 2001 to 2014 collected by the University of Utah's Drug Information Service, show that although the number of new annual shortages has decreased since the act's passage, half of all drug shortages in the study period involved acute care drugs. Shortages affecting acute care drugs became increasingly frequent and prolonged compared with non-acute care drugs (median duration of 242 versus 173 days, respectively). These results suggest that the drug supply for many acutely and critically ill patients in the United States remains vulnerable despite federal efforts., (Project HOPE—The People-to-People Health Foundation, Inc.)

Until 1994, pharmaceutical products seeking market authorisation in Norway were required to demonstrate a fulfilment of unmet medical need. This clause enabled the national regulator to dramatically limit the number of products on the market whilst encouraging price competition to keep drug expenditure low and was credited with encouraging the development of drugs with genuine added therapeutic value and reducing the incidence of antimicrobial resistance. Norway was forced to abandon its Medical Need Clause (MNC) when it joined the European Economic Area as it was incompatible with the acquis communautaire of the European Union. This article reviews Norway's experience with its MNC in light of contemporary debates in European health policy. It discusses the potential contribution of an MNC-style regulation to improving health, reducing illness, ensuring sustainable health systems and fostering pharmaceutical innovation. It concludes by asking how these findings can inform current European Union debates over the growing cost of prescription drugs and direction of pharmaceutical development., (© 2015 Foundation for the Sociology of Health & Illness.)

Objective: Pharmacists have a crucial role to ensure regulated public access to prescription drugs. The study aimed to investigate the views of community pharmacists practising in Saudi Arabia on their role in the unauthorised supply of prescription drugs, consider the possible contributory factors and report pharmacists' suggested strategies to regulate supply., Methods: One hundred community pharmacists were invited to participate in an interview-based survey, including questions on demographic characteristics, and the unauthorised supply of prescription drugs. Descriptive statistics were conducted, and associations between categorical responses tested; a P value of ≤0.05 was considered significant. Responses to open questions were analysed thematically., Key Findings: In Saudi Arabia, there is widespread unregulated supply of prescription drugs; pharmacists are under pressure from patients to provide prescription drugs for a wide range of clinical conditions. There are safety and appropriateness concerns when drugs are provided based on patient demand rather than clinical need. Pharmacists do not maintain patient records with information on drugs supplied and associated actions., Conclusion: While most pharmacists supply prescription drugs without the necessary prescriber authorisation, they also this may jeopardise patients safety. While we have many concerns about this practice its present form, we believe pharmacists should have certain prescribing privileges within their areas of competence. A legal framework is needed to guarantee proper pharmacists' training, support, mentorship and access to the tools required to provide safe pharmacy practice., (© 2015 Royal Pharmaceutical Society.)

Background: Manufacturer prescription assistance programs (PAPs) have been developed to provide medications at little or no cost to eligible patients. There are over 200 PAPs available from pharmaceutical companies, and each may have different eligibility requirements and assistance guidelines. A formalized community-based patient prescription coordinator can help patients navigate these programs by reviewing an applicant's financial information and medication requirements to identify which PAPs are most appropriate. Little is known, however, about whether providing such guidance is associated with a reduction in acute care utilization., Objective: To evaluate changes in emergency department and hospital utilization among patients who received care coordination and financial assistance with prescribed medications., Methods: This single-cohort interrupted time-series study included participants in eastern Washington state who enrolled in the Spokane Prescription Assistance Network (SPAN) program between March 1, 2009, and August 31, 2012. Referrals to the SPAN patient prescription coordinator were made by a social service agency or medical provider for patients who may have difficulty paying for prescribed medications. Initial patient contact occurred while the patient was still being treated in a clinic or hospital or through a direct visit to the coordinator's community-based office. Participants were contacted 6 months after the initial appointment and then annually thereafter to review current medications and health status. A review of electronic health records provided information on hospitalizations and emergency department visits in the 12 months before and after program entry., Results: Among SPAN participants (n = 310), emergency department and hospital encounters declined from 0.38 per participant in the year before enrollment to 0.20 encounters in the year following program entry. A repeated-measures mixed-effects model indicated SPAN participation was associated with a 51% decline in the rate of emergency department and hospital utilization (incidence rate ratio [IRR] = 0.49; 95% CI = 0.31-0.77; P = 0.002). Observed effects differed by prescription class. Factor interactions revealed significant reductions in utilization for participants with prescribed pulmonary medications (IRR = 0.58; 95% CI = 0.37-0.92; P = 0.019). Assistance with mental health (psychotropic) medications was associated with increased incidence of utilization (IRR = 2.07; 95% CI = 1.32-3.24; P = 0.001). At the time of SPAN enrollment, 60% of participants had prescriptions for psychotropic medications., Conclusions: A formalized patient prescription coordinator can help patients access prescribed medications at low cost and remain compliant with treatment plans. In a study of a coordination pilot program, reductions in hospital admissions and emergency department visits were observed following program participation., Disclosures: This study was not supported by any outside funding. The authors declare no conflicts of interest. Study design was created by Burley, McPherson, and Daratha. Burley Daratha, Selinger, and Armstrong collected the data, with interpretation performed by Burley, Daratha, and Tuttle, assisted by McPherson. The manuscript was written by Burley, Daratha, and Selinger, with assistance from White, and revised by Burley, White, and Selinger, with assistance from Daratha and Tuttle.

Objective: To characterize patent and proprietary medicine vendors and shops in Nigeria and to assess their ability to help improve access to high-quality, primary health-care services., Methods: In 2013 and 2014, a census of patent and proprietary medicine shops in 16 states of Nigeria was carried out to determine: (i) the size and coverage of the sector; (ii) the basic characteristics of shops and their staff; and (iii) the range of products stocked for priority health services, particularly for malaria, diarrhoea and family planning. The influence of the medical training of people in charge of the shops on the health-care products stocked and registration with official bodies was assessed by regression analysis., Findings: The number of shops per 100,000 population was higher in southern than in northern states, but the average percentage of people in charge with medical training across local government areas was higher in northern states: 52.6% versus 29.7% in southern states. Shops headed by a person with medical training were significantly more likely to stock artemisinin-based combination therapy, oral rehydration salts, zinc, injectable contraceptives and intrauterine contraceptive devices. However, these shops were less likely to be registered with the National Association of Patent and Proprietary Medicine Dealers and more likely to be registered with the regulatory body, the Pharmacist Council of Nigeria., Conclusion: Many patent and proprietary medicine vendors in Nigeria were medically trained. With additional training and oversight, they could help improve access to basic health-care services. Specifically, vendors with medical training could participate in task-shifting interventions.

Innovation in the development of new drugs has to balance the needs of health actors and administrators, the pharmaceutical industry and patients. Differing perspectives on what constitutes an innovation, where research and development should be directed and how new drugs should be evaluated and priced cause ongoing tensions within the regulatory framework. In the current climate, where Europe's health systems face rising demand for health services and increasingly restricted resources, the efficiency of pharmaceutical regulation and drug development is under even greater scrutiny. How can regulation foster innovation and industry growth while also serving the public health needs of society, and what is the EU's role in pursuing this objective? Drawing on a provision which formerly existed in Norwegian pharmaceutical legislation, this article explores the potential of a medical need clause (MNC) in addressing these issues. In restricting market authorisations to those drugs that offer an added therapeutic value, might a MNC foster innovation and spending efficiency in Europe's health systems?

Background: There is increasing use of online pharmacies to purchase prescription drugs. While some online pharmacies are legitimate and safe, there are many unsafe and illegal so-called "rogue" online pharmacies. This study investigated the availability of psychotropic drugs online to consumers in the US, using 5 commonly prescribed drugs for bipolar disorder., Methods: Using the search term "buy [drug name]" in the Google, Yahoo and Bing search engines, the characteristics of the online pharmacies found on the first two pages of search results were investigated. The availability of the requested dosage and formulations of two brand (Seroquel XR, Abilify) and three generic drugs (lamotrigine, lithium carbonate and bupropion SR) were determined., Results: Of 30 online pharmacies found, 17 (57%) were rated as rogue by LegitScript. Of the 30 pharmacies, 15 (50%) require a prescription, 21 (70%) claim to be from Canada, with 20 of these having a Canadian International Pharmacy association (CIPA) seal on the website. Only 13 of the 20 sites with a CIPA seal were active CIPA members. There were about the same number of trust verification seals on the rogue and legitimate pharmacy sites. Some rogue pharmacies are professional in appearance, and may be difficult for consumers to recognize as rogue. All five brand and generic drugs were offered for sale online, with or without a prescription. However, many substitutions were presented such as different strengths and formulations including products not approved by the FDA., Limitations: No evaluation of product quality, packaging or purchasing., Conclusions: Psychotropic medications are available online with or without a prescription. The majority of online pharmacy websites were rogue. Physicians should ask about the use of online pharmacies. For those who choose to use online pharmacies, two measures to detect rogue pharmacies are recommended: (1) only purchase drugs from pharmacies that require a prescription, and (2) check all pharmacy verification seals directly on the website of the certifying organization, every time, before purchase., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Objectives: The burden of visiting pharmacies to fill medications is a central contributor to nonadherence to maintenance medications. Recently, pharmacies have begun offering services that align prescription fill dates to allow patients to pick up all medications on a single visit. We evaluated the prevalence and structure of synchronization programs and evidence of their impact on adherence and clinical outcomes., Study Design: Mixed-methods approach consisting of semi-structured interviews, data from surveillance activities, and a systematic literature review., Methods: We conducted interviews with opinion leaders from nonprofit advocacy organizations and exemplary synchronization programs. Program prevalence was determined using data from regular surveillance efforts. A literature review included Medline, EMBASE, Google Scholar, and general Internet searches., Results: Synchronization programs exist in approximately 10% of independent, 6% of stand-alone chain, and 11% of retail store pharmacies. The majority of programs include a monthly pharmacist appointment and reminder communication. Programs reported the importance of pharmacist buy-in, technology to track and recruit patients, links to other healthcare services, and flexible solutions for managing costs and communication preferences. Although existing peer-reviewed literature suggests that synchronization improves adherence, more evidence is needed to evaluate its impact on patient-centered outcomes., Conclusions: As medication synchronization programs shift directions and compete for patients and payer resources, it will be more important than ever to rigorously evaluate their ability to improve clinical outcomes while also providing the growing number of patients managing multiple chronic conditions with the highest level of patient engagement and consumer choice.

Resistance to antibiotics is increasing globally and is a threat to public health. Research has demonstrated a correlation between antibiotic use and resistance development. Developing countries are the most affected by resistance because of high infectious disease burden, limited access to quality assured antibiotics and more optimal drugs and poor antibiotic use practices. The appropriate use of antibiotics to slow the pace of resistance development is crucial. The study retrospectively assessed antibiotic prescription practices in four public and private primary health-care facilities in Eastern Region, Ghana using the WHO/International Network for the Rational Use of Drugs rational drug use indicators. Using a systematic sampling procedure, 400 prescriptions were selected per facility for the period April 2010 to March 2011. Rational drug use indicators were assessed in the descriptive analysis and logistic regression was used to explore for predictors of antibiotic prescription. Average number of medicines prescribed per encounter was 4.01, and 59.9% of prescriptions had antibiotics whilst 24.2% had injections. In total, 79.2% and 88.1% of prescribed medicines were generics and from the national essential medicine list, respectively. In the multivariate analysis, health facility type (odds ratio [OR] = 2.05; 95% confidence interval [CI]: 1.42, 2.95), patient age (OR = 0.97; 95% CI: 0.97, 0.98), number of medicines on a prescription (OR = 1.85; 95% CI: 1.63, 2.10) and 'no malaria drug' on prescription (OR = 5.05; 95% CI: 2.08, 12.25) were associated with an antibiotic prescription. A diagnosis of upper respiratory tract infection was positively associated with antibiotic use. The level of antibiotic use varied depending on the health facility type and was generally high compared with the national average estimated in 2008. Interventions that reduce diagnostic uncertainty in illness management should be considered. The National Health Insurance Scheme, as the main purchaser of health services in Ghana, offers an opportunity that should be exploited to introduce policies in support of rational drug use., (© The Author 2015. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.)

Background: Access to contraception is a vital component of preventing unintended pregnancies. This study was conducted to assess the prevalence of and factors associated with U.S. women's difficulty accessing prescription contraception (pill, patch, or ring)., Materials and Methods: We performed a nationally representative survey of adult women at risk of unintended pregnancy (aged 18-44, not pregnant or seeking pregnancy, sexually active, not sterilized) using a probability-based web panel. In November to December 2011, 2046 women completed the survey. Weighted proportions were calculated and logistic regression was used to identify covariates associated with difficulty obtaining or refilling prescription contraception., Results: A total of 1385 (68%) women had ever tried to get a prescription for hormonal contraception. Among this population, 29% reported ever having problems obtaining a prescription or refills. In multivariable regression, uninsured (vs. privately insured) and Spanish-speaking (vs. English-speaking) women were significantly more likely to report difficulties; women with a high school degree and those with some college (vs. a college degree or higher) were significantly less likely to report difficulty. Difficulties included cost barriers or lack of insurance (14%), challenges obtaining an appointment or getting to a clinic (13%), the clinician requiring a clinic visit, exam, or Pap smear (13%), not having a regular doctor/clinic (10%), difficulty accessing a pharmacy (4%), and other reasons (4%)., Conclusions: One-third of adult U.S. women who have ever tried to obtain prescription contraception reported access barriers. While the Affordable Care Act may resolve some of these issues, these data indicate that additional factors may still need to be addressed.

With ever-increasing total healthcare expenditures and expenditures on new pharmaceuticals, there is a temptation to enact relatively simple silo-based, cost-control measures such as attempts to control a burgeoning health-system medication budget by limiting physician and ultimately patient access to medications without considering cost-effectiveness or overall value. Such an approach with a singular focus on dollars does not make sense. The challenge is to think beyond a pure dollars approach in a specialty of health care where the high cost of care is acknowledged but the dynamics are not always understood. This will take a thoughtful, coordinated effort by a team of dedicated health professionals that includes a clinical pharmacist with expertise in optimal and comprehensive medication management.

Objectives: This was a study of longitudinal trends in U.S. drug shortages within the scope of emergency medicine (EM) practice from 2001 to 2014., Methods: Drug shortage data from the University of Utah Drug Information Service were analyzed from January 2001 to March 2014. Two board-certified emergency physicians classified drug shortages based on whether they were within the scope of EM practice, whether they are used for lifesaving interventions or high-acuity conditions, and whether a substitute for the drug exists for its routine use in emergency care. Trends in the length of shortages for drugs used in EM practice were described using standard descriptive statistics and regression analyses., Results: Of the 1,798 drug shortages over the approximately 13-year period (159 months), 610 shortages (33.9%) were classified as within the scope of EM practice. Of those, 321 (52.6%) were for drugs used as lifesaving interventions or for high-acuity conditions, and of those, 32 (10.0%) were for drugs with no available substitute. The prevalence of EM drug shortages fell from 2002 to 2007; however, between January 2008 and March 2014, the number of EM drug shortages sharply increased by 435% from 23 to 123. From January 2008 to March 2014 shortages in drugs used as a direct lifesaving intervention or for high-acuity conditions increased 393% from 14 to 69, and shortages for drugs with no available substitute grew 125% from four to nine. Almost half (46.6%) of all EM drug shortages were caused by unknown reasons (the manufacturer did not cite a specific reason when contacted). Infectious disease drugs were the most common EM drugs on shortage, with 148 drug shortages totaling 2,213 months during the study period., Conclusions: Drug shortages impacting emergency care have grown dramatically since 2008. The majority of shortages are for drugs used for lifesaving interventions or high-acuity conditions. For some, no substitute is available., (© 2015 by the Society for Academic Emergency Medicine.)

Access to essential medicines in low-and middle-income countries is affected by market failures and government failures. This paper review the design and lessons learned from the multi-country Phase I of the Affordable Medicines for Malaria (AMFm), and the political economy of decision making around findings from its independent evaluation. It concludes with reflections on lessons learned, the potential applicability of the private-public approach to other health commodities and countries, and the implications of this experience for evidence-based decisions in global health and development assistance.

The use of medicines is influenced by different factors. This study aimed to analyze the use of medicines and identify the sources for obtaining them and associated factors, using a population-based cross-sectional design with two-stage cluster sampling in Campinas, São Paulo State, Brazil, in 2008. Prevalence of use of at least one drug in the 3 previous days was 57.2% and prevalence of obtaining the drug from the Brazilian Unified National Health System (SUS) was 30%. 47.8% of individuals with no health insurance had to pay out-of-pocket for their medication, and 10.9% of individuals with insurance nevertheless obtained their medication from the SUS. Use of medicines obtained from the SUS was associated with older age, widowhood, black or brown skin color, lower schooling and income, and lack of insurance. Only 2.1% reported not being able to obtain the prescribed medication, and the main reasons were lack of availability in the public system and lack of money for out-of-pocket purchases. The study identified the subgroups that obtained most of their medicines in the SUS and showed that these were the subgroups with the lowest use of medicines in the system.

Objectives: To investigate the effects of number of medications and Drug Burden Index (DBI) on transitions between frailty stages and death in community-dwelling older men., Design: Cohort study., Setting: Sydney, Australia., Participants: Community-dwelling men aged 70 and older (N=1,705)., Measurements: Self-reported questionnaires and clinic visits were conducted at baseline and 2 and 5 years. Frailty was assessed at all three waves according to the modified Fried frailty phenotype. The total number of regular prescription medications and DBI (a measure of exposure to sedative and anticholinergic medications) were calculated over the three waves. Data on mortality over 9 years were obtained. Multistate modeling was used to characterize the transitions across three frailty states (robust, prefrail, frail) and death., Results: Each additional medication was associated with a 22% greater risk of transitioning from the robust state to death (adjusted 95% confidence interval (CI)=1.06-1.41). Every unit increase in DBI was associated with a 73% greater risk of transitioning from the robust state to the prefrail state (adjusted 95% CI=1.30-2.31) and a 2.75 times greater risk of transitioning from the robust state to death (adjusted 95% CI=1.60-4.75). There was no evidence of an adjusted association between total number of medications or DBI and the other transitions., Conclusion: Although the possibility of confounding by indication cannot be excluded, additional medications were associated with greater risk of mortality in robust community-dwelling older men. Greater DBI was also associated with greater risk of death and transitioning from the robust state to the prefrail state., (© 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.)

Stock-outs, also known as shortages or complete absence of a particular inventory, in public health facilities have become a hallmark in Uganda's health system making the notions of persistent doubt in access to healthcare - uncertainty, and doing more with less - 'improvisation', very pronounced. The situation becomes more critical in post-conflict areas with an over whelming burden of preexisting and conflict-related ailments amidst weak health systems. Particularly in the war-torn Northern Uganda, the intersection between the effects of violent conflict and shortage of medications is striking. There are problems getting the right type of medications to the right people at the right time, causing persistent shortages and uncertainty in access to healthcare. With reference to patients on Antiretroviral Therapy (ART), we present temporal trends in access to healthcare in the context of medication shortages in conflict-affected areas. We examine uncertainties in access to care, and how patients, medical practitioners, and the state - the key actors in the domain of supplying and utilizing medicines, respond. Our observation is that, while improvisation is a feature of biomedicine and facilitates problem solving in daily life, it is largely contextual. Given the rapidly evolving contexts and social and professional sensitivities that characterize war affected areas, there is a need for deliberate healthcare programs tailored to the unique needs of people and to the shaping of appropriate policies in post-conflict settings, which call for more North-South collaboration on equal terms., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: The integrated Community Case Management (iCCM) of childhood illnesses strategy has been adopted world over to reduce child related ill health and mortality. Community Health workers (CHWs) who implement this strategy need a regular supply of drugs to effectively treat children under 5 years with malaria, pneumonia and diarrhea. In this paper, we report the prevalence and factors influencing availability of medicines for managing malaria, pneumonia and diarrhea in communities in central Uganda., Methods: A cross sectional study was conducted among 303 CHWs in Wakiso district in central Uganda. Eligible CHWs from two randomly selected Health Sub Districts (HSDs) were interviewed. Questionnaires, check lists, record reviews were used to collect information on CHW background characteristics, CHW's prescription behaviors, health system support factors and availability of iCCM drugs. Multivariable logistic regression analysis was done to assess factors associated with availability of iCCM drugs., Results: Out of 300 CHWs, 239 (79.9%) were females and mean age was 42.1 (standard deviation =11.1 years). The prevalence of iCCM drug availability was 8.3% and 33 respondents (11%) had no drugs at all. Factors associated with iCCM drug availability were; being supervised within the last month (adjusted OR = 3.70, 95% CI 1.22-11.24), appropriate drug prescriptions (adjusted OR = 3.71, 95% CI 1.38-9.96), regular submission of drug reports (adjusted OR = 4.02, 95% CI 1.62-10.10) and having a respiratory timer as a diagnostic tool (adjusted OR =3.11, 95% CI 1.08-9.00)., Conclusions: The low medicine stocks for the community management of childhood illnesses calls for strengthening of CHW supervision, medicine prescription and reporting, and increasing availability of functional diagnostic tools.

In spite of its demonstrated benefits, many women do not initiate hormonal therapy, and among those who do, many discontinue it prematurely. We examined whether differences in hormonal therapy adherence may be at least partially explained by the availability of prescription drug coverage. Women aged 20-79 years diagnosed with stage I-III breast cancer between June 2005 and February 2007 were enrolled in the study. Women completed a mailed survey, on average 9 months after diagnosis, and again approximately 4 years later (N = 712). Adjusted logistic regression was used to predict the likelihood of initiating hormonal therapy and hormonal therapy continuation. Women who had prescription drug coverage were more likely to initiate hormonal therapy relative to women without prescription drug coverage (OR 2.91, 95 % CI 1.24-6.84). Women with prescription drug coverage were also more likely to continue hormonal therapy (OR 2.23; 95 % CI 0.99-5.05, p = 0.0543). The lowest income women were also less likely to continue hormonal therapy relative to women with annual household income that exceeded $70,000 (OR 0.55; 95 % CI 0.29-1.04) with a borderline significance of (p = 0.08). This study demonstrates the critical role of prescription drug coverage in hormonal therapy initiation and continuation, independent of health insurance coverage. These findings add to the body of literature that addresses medication adherence. Financial factors must be considered along with behavioral factors that influence adherence, which is becoming increasingly relevant to oncology as treatments are shifted to oral medications, many of which are very expensive.

Objectives: Automatic prescription refill programs are a popular means of improving medication adherence. A concern is the potential for prescription drug wastage and unnecessary healthcare spending. We evaluated the impact of an automatic refill program on patterns of medication use., Study Design: Retrospective propensity score matched cohort study with multivariable generalized linear modeling., Methods: The setting of the study was a pharmacy benefit manager administering benefits for patients of retail pharmacies. Participants included patients on medication for chronic conditions; those receiving a 30-day supply (n = 153,964) and a 90-day supply (n = 100,394) were analyzed separately. The intervention was the automatic prescription refill program. Measures included medication possession ratio (MPR) and average days excess at the time of refill. The results are reported across 11 therapeutic classes., Results: Overall, patients receiving 30-day supplies of medication in the automatic refill program had an MPR that was 3 points higher than those not in the refill program; among those receiving 90-day fills and in the refill program, the MPR was 1.4 points higher (P < .001 for both 30- and 90-day fills). The MPR was higher for members in the refill program across all therapeutic classes. Limiting our analysis to members receiving more than 365 days of medication, we found that patients who received 30-day fills and enrolled in the automatic refill program had 2.5 fewer days' oversupply than those in the control group, whereas automatic refill patients receiving 90-day supplies had 2.18 fewer days' oversupply than the controls (P < .001 for both 30- and 90-day fills)., Conclusions: For this pharmacy provider, automatic refill programs result in improved adherence without adding to medication oversupply.

Introduction: After the release of CDC's revised gonorrhea treatment guidelines in April 2007, a study reported the declining use of fluoroquinolones to treat gonorrhea among health departments participating in the Sexually Transmitted Disease Surveillance Network. In this study, we examine the proportion of fluoroquinolone claims among gonorrhea-associated prescription drug claims from a large insurance database from 2000 through 2010., Methods: We extracted drug claims associated with gonorrhea diagnosis claims from the MarketScan database for 2000-2010 and calculated the proportion of the drug claims for fluoroquinolones on a monthly basis. We then used an interrupted time series analysis to investigate trend characteristics of fluoroquinolone claims before and after the gonorrhea treatment guidelines were revised in April 2007., Results: Although there was a monthly decline in the proportion of fluoroquinolone claims before April 2007 (-0.11 percentage points, p<0.01), results indicate a sevenfold (-0.78 percentage points, p<0.01) increase in the rate of decline after the revised guidelines were released in April 2007. We did not find any sudden drop (immediate or delayed) in the proportion of fluoroquinolones after April 2007, implying a gradual permanent decline over the analytic period., Conclusions: Our results are consistent with the findings of the previous study and indicate a gradual and permanent decline (over the analytic period) in the proportion of fluoroquinolone claims among gonorrhea-associated prescription drug claims. However, because this is a convenience sample of claims data, these findings cannot be generalized to the entire privately insured population in the U.S., (Published by Elsevier Inc.)

The social and institutional environments in which informal healthcare providers operate shape their health and business practices, particularly in contexts where regulatory enforcement is weak. In this study, we adopt a social capital perspective to understanding the social networks on which proprietary and patent medicine vendors (PPMVs) in Nigeria rely for support in the operation of their shops. Data are drawn from 70 in-depth interviews with PPMVs in three states, including interviews with local leaders of the PPMV professional association. We find that PPMVs primarily relied on more senior colleagues and formal healthcare professionals for informational support, including information about new medicines and advice on how to treat specific cases of illness. For instrumental support, including finance, start-up assistance, and intervention with regulatory agencies, PPMVs relied on extended family, the PPMVs with whom they apprenticed, and the leaders of their professional association. PPMVs' networks also provided continual reinforcement of what constitutes good PPMV practice through admonishments to follow scope of practice limitations. These informal reminders, as well as monitoring activities conducted by the professional association, served to reinforce PPMVs' concern with avoiding negative customer health outcomes, which were perceived to be detrimental to their business reputations. That PPMVs' networks both encouraged practices to reduce the likelihood of poor health outcomes, and provided advice regarding customers' health conditions, highlights the potential impact of informal providers' access to different forms of social capital on their delivery of health services, as well as their success as microenterprises., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Free access to medicines is an important element in the implementation of health care access policies. Paradoxically, this aspect is rarely addressed in the literature on this subject. The Ville-Evrard psychiatric hospital introduced so-called "poverty prescriptions" allowing free drug dispensing, independently of specific PASS (Permanent Access to Health&#95; Care) systems. This paper presents the results of a study of all poverty prescriptions issued by the facility in 2011./t provides an analytical description of this system and shows that, despite the absence of strict controls, it was used relatively rarely.

Background: We review procurement and pricing transparency practices for pharmaceutical products. We specifically focus on Brazil and examine its approach to increasing pricing transparency, with the aim of determining the level of effectiveness in lower prices using a tool (Banco de Preços em Saúde, BPS) that only reveals purchase prices as compared to other tools (in other countries) that establish a greater degree of price transparency., Methods: A general report of Preços em Saúde (BPS) and Sistema Integrado de Administração de Serviços Gerais (SIASG) pricing data was created for 25 drugs that met specific criteria. To explore the linear time trend of each of the drugs, separate regression models were fitted for each drug, resulting in a total of 19 models. Each model controlled for the state variable and the interaction between state and time, in order to accommodate expected heterogeneity in the data. Additionally, the models controlled for procurement quantities and the effect they have on the unit price. Secondary analysis using mixed effects models was also carried out to account for the impact that institutions and suppliers may have upon the unit price. Adjusting for these predictor variables (procurement quantities, supplier, purchasing institution) was important to determine the sole effect that time has had on unit prices. A total of 2 x 19 = 38 models were estimated to explore the overall effect of time on changes in unit price. All statistical analyses were performed using the R statistical software, while the linear mixed effects models were fitted using the lme4 R package., Results: The findings from our analysis suggest that there is no pattern of consistent price decreases within the two Brazilian states during the five-year period for which the prices were analyzed., Conclusions: While the BPS does allow for an increase in transparency and information on drug purchase prices in Brazil, it has not shown to lead to consistent reductions in drug purchase prices for some of the most widely used medicines. This is indicative of a limited model for addressing the challenges in pharmaceutical procurement and puts into question the value of tools used globally to improve transparency in pharmaceutical pricing.

One of the overriding interests of the literature on health care economics is to discover where personal choice in market economies end and corrective government intervention should begin. Our study addresses this question in the context of John Stuart Mill's utilitarian principle of harm. Our primary objective is to determine whether public policy interventions concerning more than 35,000 online pharmacies worldwide are necessary and efficient compared to traditional market-oriented approaches. Secondly, we seek to determine whether government interference could enhance personal  utility maximization, despite its direct and indirect (unintended) costs on medical e-commerce. This study finds that containing the negative externalities of medical e-commerce provides the most compelling raison d'etre of government interference. It asserts that autonomy and paternalism need not be mutually exclusive, despite their direct and indirect consequences on individual choice and decision-making processes. Valuable insights derived from Mill's principle should enrich theory-building in health care economics and policy.

Objective: To evaluate and inform emergency supply of prescription-only medicines by community pharmacists (CPs), including how the service could form an integral component of established healthcare provision to maximise adherence., Design: Mixed methods. 4 phases: prospective audit of emergency supply requests for prescribed medicines (October-November 2012 and April 2013); interviews with CPs (February-April 2013); follow-up interviews with patients (April-May 2013); interactive feedback sessions with general practice teams (October-November 2013)., Setting: 22 community pharmacies and 6 general practices in Northwest England., Participants: 27 CPs with experience of dealing with requests for emergency supplies; 25 patients who received an emergency supply of a prescribed medicine; 58 staff at 6 general practices., Results: Clinical audit in 22 pharmacies over two 4-week periods reported that 526 medicines were requested by 450 patients. Requests peaked over a bank holiday and around weekends. A significant number of supplies were made during practice opening hours. Most requests were for older patients and for medicines used in long-term conditions. Difficulty in renewing repeat medication (forgetting to order, or prescription delays) was the major reason for requests. The majority of medicines were 'loaned' in advance of a National Health Service (NHS) prescription. Interviews with CPs and patients indicated that continuous supply had a positive impact on medicines adherence, removing the need to access urgent care. General practice staff were surprised and concerned by the extent of emergency supply episodes., Conclusions: CPs regularly provide emergency supplies to patients who run out of their repeat medication, including during practice opening hours. This may aid adherence. There is currently no feedback loop, however, to general practice. Patient care and interprofessional communication may be better served by the introduction of a formally structured and funded NHS emergency supply service from community pharmacies, with ongoing optimisation of repeat prescribing., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

This study aimed to assess the prevalence of access to continuous prescription drugs for a group of chronic diseases and to investigate the existence of socioeconomic inequalities in access. The data are from the Brazilian National Demographic and Health Survey on Women and Children (2006), with a sample of 15,575 women 15 to 49 years of age. Among these women, 7,717 were diagnosed with a chronic disease that required acquiring medicine and were considered eligible for the study. The dependent variable was defined as the diagnosis of a chronic disease and the need to obtain medication for treatment. Multivariate analysis used Poisson regression. Higher access was associated with residence in a rural area, having one or two chronic diseases, and higher socioeconomic status. Prevalence of access to medication was high, but the analysis revealed socioeconomic inequality in access to medicines in favor of the wealthy, while identifying the most vulnerable groups as the poorest and those with more chronic diseases.

Objectives: Internet and social networking sites play a significant role in the marketing and distribution of recreational/prescription drugs without restrictions. We aimed here at reviewing data relating to the profile of the online drug customer and at describing drug vending websites., Methods: The PubMed, Google Scholar, and Scopus databases were searched here in order to elicit data on the socio-demographic characteristics of the recreational marketplaces/online pharmacies' customers and the determinants relating to online drug purchasing activities., Results: Typical online recreational drugs' customers seem to be Caucasian, men, in their 20s, highly educated, and using the web to impact as minimally as possible on their existing work/professional status. Conversely, people without any health insurance seemed to look at the web as a source of more affordable prescription medicines. Drug vending websites are typically presented here with a "no prescription required" approach, together with aggressive marketing strategies., Conclusions: The online availability of recreational/prescriptions drugs remains a public health concern. A more precise understanding of online vending sites' customers may well facilitate the drafting and implementation of proper prevention campaigns aimed at counteracting the increasing levels of online drug acquisition and hence intake activities., (Copyright © 2015 John Wiley & Sons, Ltd.)

Context: Drug shortages have significantly increased over the past decade. There are limited data describing how shortages impact medical toxicology of drugs., Objective: To characterize drug shortages affecting the management of poisoned patients., Materials and Methods: Drug shortage data from January 2001 to December 2013 were obtained from the University of Utah Drug Information Service. Shortage data for agents used to treat poisonings were analyzed. Information on drug type, formulation, reason for shortage, shortage duration, marketing, and whether the drug was available from a single source was collected. The availability of a substitute therapy and whether substitutes were in shortage during the study period were also investigated., Results: Of 1,751 shortages, 141 (8.1%) impacted drugs used to treat poisoned patients, and as of December 2013, 21 (14.9%) remained unresolved. New toxicology shortages increased steadily from the mid-2000s, reaching a high of 26 in 2011. Median shortage duration was 164 days (interquartile range: 76-434). Generic drugs were involved in 85.1% of shortages and 41.1% were single-source products. Parenteral formulations were often involved in shortages (89.4%). The most common medications in shortage were sedative/hypnotics (15.6%). An alternative agent was available for 121 (85.8%) drugs; however, 88 (72.7%) alternatives were also affected by shortages at some point during the study period. When present, the most common reasons reported were manufacturing delays (22.0%) and supply/demand issues (17.0%). Shortage reason was not reported for 48.2% of drugs., Discussion: Toxicology drug shortages are becoming increasingly prevalent, which can result in both suboptimal treatment and medication errors from using less familiar alternatives., Conclusion: Drug shortages affected a substantial number of critical agents used in the management of poisoned patients. Shortages were often of long duration and for drugs without alternatives. Providers caring for poisoned patients should be aware of current shortages and implement mitigation strategies to safeguard patient care.

Background: Local pharmaceutical production has been endorsed by the WHO as a means of addressing health priorities of developing countries. However, local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. These standards determine production rights for on-patent and off-patent medicines, and guide international procurement of medicines. We reviewed the literature on the impact of Good Manufacturing Practice (GMP) on local production; a gap analysis from the literature review indicated a need for further research. Over sixty interviews were conducted with people involved in the Nepali pharmaceutical production and distribution chain from 2006 to 2009 on the GMP areas of relevance: regulatory capacity, staffing, funding and training, resourcing of GMP, inspectors' interpretation of the rules and compliance., Results: Although Nepal producers have increased their overall share of the domestic market, only the public manufacturer, Royal Drugs, focuses on medicines for public health programmes; private producers engage mainly in brand competition for private markets, not essential medicines. Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital. The transition period to mandatory compliance with WHO GMP rules is lengthy. Less than half of private producers had WHO GMP in 2013. Producers are not directly affected by international harmonisation of standards as they do not export medicines and the Nepali regulator does not enforce the WHO standards strictly. Without an international GMP certificate they cannot tender for donor dependent health programmes., Conclusions: In Nepal, local private manufacturers focus mainly on brand competition for private consumption not essential medicines, the government preferentially procures essential medicines from the only public producer while donor funded programmes rely on international manufacturers compliant with international GMP standards. We also found evidence of private hospitals bypassing national medicines approvals process. Policies in support of local pharmaceutical production in developing countries as a source of essential medicines need to examine carefully how GMP regulations impact on regulators, local industry and production of essential medicines in practice.