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The COVID-19 pandemic has revealed the vulnerability of the US generic drug supply chain to foreign production. Many policies have been proposed to mitigate this vulnerability. In this article, we argue that nonprofit drug manufacturers have the potential to make important contributions.

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?

Objective: This study was conducted to test the ability of the St Louis County Department of Health to efficiently dispense medication to individuals with functional needs during a public health emergency and develop new guidelines for future emergency planning. Historically, people with functional needs have been vulnerable in emergency situations, and emergency planners are responsible for creating equal access for mass prophylaxis events., Methods: Measures to create access for individuals with functional needs were tested in a countywide exercise in which 40 volunteers with functional needs walked through an open point of dispensing location to collect medication as if it were a real emergency. Actions were informed by representatives from the functional needs community in the St Louis area., Results: During the exercise, medications were successfully dispensed to all participants. Many participants offered feedback for future program design., Conclusions: Outcomes indicated the importance of working closely with the community organizations that serve people with functional needs in designing appropriate response measures, providing sensitivity training to staff members, employing useful technology, and using visual and verbal cues. The lessons learned from this exercise apply to emergency planning nationwide, as planning efforts for persons with functional needs still lag significantly.(Disaster Med Public Health Preparedness. 2014;0:1-9).

Background: Recent US disasters highlight the current imbalance between the high proportion of chronically ill Americans who depend on prescription medications and their lack of medication reserves for disaster preparedness. We examined barriers that Los Angeles County residents with chronic illness experience within the prescription drug procurement system to achieve recommended medication reserves., Methods: A mixed methods design included evaluation of insurance pharmacy benefits, focus group interviews with patients, and key informant interviews with physicians, pharmacists, and insurers., Results and Discussion: Most prescriptions are dispensed as 30-day units through retail pharmacies with refills available after 75% of use, leaving a monthly medication reserve of 7 days. For patients to acquire 14- to 30-day disaster medication reserves, health professionals interviewed supported 60- to 100-day dispensing units. Barriers included restrictive insurance benefits, patients' resistance to mail order, and higher copay-ments. Physicians, pharmacists, and insurers also varied widely in their preparedness planning and collective mutual-aid plans, and most believed pharmacists had the primary responsibility for patients' medication continuity during a disaster., Conclusions: To strengthen prescription drug continuity in disasters, recommendations include the following: (1) creating flexible drug-dispensing policies to help patients build reserves, (2) training professionals to inform patients about disaster planning, and (3) building collaborative partnerships among system stakeholders.

Aim: This study aims to evaluate changes in the durations of English National Health Service prescriptions, as indicated by the volumes of unit doses supplied between 1998 and 2009, and consider relevant policy implications., Background: Around the world, countries are seeking to manage the increase in medicines prescribing. In England, many primary care organisations, using limited supporting evidence of cost-effectiveness and clinical improvement, have sought to restrict the number of dosage units on a prescription to 28 days supply. This is based on a conviction that this reduces wastage costs., Methods: Prescription Cost Analysis (PCA) statistics for England for the period January 1998 to December 2009 were used to analyse trends in the average number of unit doses (tablets or capsules) supplied per prescription for 11 drugs supplied in 34 different presentations., Findings: The changes in prescription lengths observed between 1999 and 2009 ranged from +4.2% in the case of Amoxicillin 500 mg capsules to -41.3% in the case of Levothyroxine 50 μg tablets. All but four of the medicines selected showed statistically significant negative correlations (r > 0.8, P < 0.001) between the year of prescribing and the prescription length. If prescription lengths had been the same in 2009 as they were in 1999, then 33 million fewer prescription items would have been written for the preparations in this analysis. This shift across a range of medications suggests a generalised change in prescribing behaviour. The full balance of benefits and costs associated with this trend, as expressed via drug wastage avoided, patient (in)convenience experienced, professional time costs incurred or saved and positive or negative health outcome impacts, is not known. Although this study does not provide a definitive answer favouring prescription duration individualisation as opposed to standardisation, the available evidence indicates that policies that rigidly favour 28-day standard periods may require review.

Introduction: In December 2007, civil disruption and violence erupted in Kenya following national elections, displacing 350,000 people and affecting supply chains and services. The Kenyan government and partners were interested in assessing the extent of disruption in essential health services, especially HIV treatment., Methods: A two-stage cluster sampling for patients taking antiretroviral therapy (ART) was implemented ten weeks after elections, March 10-21, 2008, at twelve health facilities providing ART randomly selected in each of the three provinces most affected by post-election disruption-Rift Valley, Nyanza, and Central Provinces. Convenience samples of patients with tuberculosis, hypertension, or diabetes were also interviewed from the same facilities. Finally, a convenience sampling of internally displaced persons (IDPs) in the three provinces was conducted., Results: Three hundred thirty-six IDPs in nine camps and 1,294 patients in 35 health facilities were interviewed. Overall, nine percent of patients reported having not returned to their routine health care facility; 9%-25% (overall 16%) reported a temporary inability for themselves or their children to access care at some point during January-February 2008. Less than 15% of patients on long-term therapies for HIV, tuberculosis, diabetes, or hypertension had treatment interruptions compared with 2007. The proportion of tuberculosis patients receiving a ≥45-day supply of medication increased from five percent in November 2007 to 69% in December 2007. HIV testing decreased in January 2008 compared with November 2007 among women in labor wards and among persons tested through voluntary counseling and testing services in Nyanza and Rift Valley Provinces. Patients and their family members witnessed violence, especially in Nyanza and Rift Valley Provinces (54%-59%), but few patients (2.5%-14%, 10% overall) personally experienced violence. More IDPs reported witnessing (80%) or personally experiencing (38%) violence than did patients. About half of patients and three-quarters of IDPs interviewed had anxiety or depression symptoms during the four weeks before the assessment. There was no association among patients between the presence of HIV, tuberculosis, diabetes, and hypertension and the prevalence of anxiety or depression symptoms., Conclusion: More than 85% of patients in highly affected provinces avoided treatment interruptions; this may be in part related to practitioners anticipating potential disruption and providing patients with medications for an extended period. During periods of similar crisis, anticipating potential limitations on medication access and increased mental health needs could potentially prevent negative health impacts.

Objective: During fall 2005, personal stockpiling of oseltamivir for use during an outbreak of H5N1 influenza virus infection was widely reported. The present study aimed to identify indications for oseltamivir prescriptions to determine whether oseltamivir that was not intended for seasonal influenza was inappropriately consumed and to compare persons who were likely to have stockpiled oseltamivir and those who did not with respect to their knowledge, understanding, concerns, and expectations regarding avian influenza., Design: Survey to evaluate usage patterns for oseltamivir and assess views about avian influenza., Subjects: A total of 109 outpatients who received a prescription for oseltamivir between September 1, 2005, and December 31, 2005, and 825 matched control subjects., Results: Of 109 prescriptions, 36 (33.0%) were prescribed for patients with appropriate indications. Sixty-eight (62.4%) of 109 patients identified as having received oseltamivir and 440 (53.3%) of 825 individuals identified as not having received it responded to the questionnaire. Only 2 prescription recipients whose oseltamivir was not intended for immediate consumption reported that they had consumed the oseltamivir. Persons who probably intended to stockpile oseltamivir were older and more often white than those unlikely to stockpile it. They also reported greater worry about avian influenza and more often expected avian influenza to spread to the United States than those unlikely to stockpile, but there were no significant differences in responses to other questionnaire items., Conclusions: A large proportion of the oseltamivir prescriptions written in fall 2005 were probably intended for personal stockpiling. Similarities in participants' responses to questionnaire items suggest that educational campaigns may not be an effective method to curtail stockpiling of antimicrobial medications during an infectious threat. Promoting appropriate prescribing practices among providers may be a better means by which to minimize personal stockpiling.