Marvin Shepherd

Within recent months, the U.S. has opened up the possibility for Americans to import prescription pharmaceuticals from Canada. The U.S. FDA is now accepting proposals for both personal and commercial drug importation from Canada. Importers can be individuals, wholesalers, pharmacies, and governments. This research examines the impact U.S. drug importation will have on the Canadian prescription drug supply. Using the total number of prescriptions dispensed in 2018 for Canada and the U.S., models were developed to estimate the number of days before the Canadian drug supply would be exhausted. The model included variations in the demand for prescriptions from the U.S. and included a safety stock of 10%. Models were developed for both total drugs and for just brand name pharmaceuticals. The study shows that U.S. commercial importation will enhance the risk to the Canadian health care system. Serious drug shortages are predicted unless Canada puts a halt to exporting drugs to the U.S.

New pathways for U.S. importation threaten Canadian prescription drug supply.
AUTHOR
Marv Shepherd, Ph.D. Professor Emeritus, College of Pharmacy, University of Texas at Austin; Board Member Partnership for Safe Medicines.
ABSTRACT
Within recent months, the U.S. has opened up the possibility for Americans to import prescription pharmaceuticals from Canada. The U.S. FDA is now accepting proposals for both personal and commercial drug importation from Canada. Importers can be individuals, wholesalers, pharmacies, and governments. This research examines the impact U.S. drug importation will have on the Canadian prescription drug supply. Using the total number of prescriptions dispensed in 2018 for Canada and the U.S., models were developed to estimate the number of days before the Canadian drug supply would be exhausted. The model included variations in the demand for prescriptions from the U.S. and included a safety stock of 10%. Models were developed for both total drugs and for just brand name pharmaceuticals. The study shows that U.S. commercial importation will enhance the risk to the Canadian health care system. Serious drug shortages are predicted unless Canada puts a halt to exporting drugs to the U.S.

ABSTRACT A study of 1290 students in four New England colleges of pharmacy has demonstrated that the preferred practice (or nonpractice) setting of students is influenced by the college of pharmacy attended, year in school, grade point average, sex, and the nature and extent of internship and externship experience. (Author)

Existing federal law requires that a 72-hour emergency supply of a prescription drug be dispensed to Medicaid patients when prior authorization (PA) is not available and the medication is needed without delay. The pharmacist's role is to contact prescribers and inform them that PA is needed. If the prescriber cannot be reached, the pharmacist can dispense a 72-hour emergency supply. To determine (a) the reasons why some community pharmacy owners/managers, staff pharmacists, and technicians are not compliant with the law; (b) how often the decision is made; and (c) estimate how often pharmacies do not dispense the 72-hour emergency supply when PA is not available. A questionnaire was mailed to selected Texas community pharmacies. The instrument was developed by the researcher and reviewed by the Texas Medicaid Vendor Drug Program staff. The University of Texas, Office of Survey Research collected the data in September and October of 2011 by mail and online. The data were forwarde...

... and one of the most commonly used drugs in the United States for many years.4 Unithroid (Jerome Stevens), formerly ... 6 A parallel matter involving the combination product, esterified estrogens and methyltestosterone (Estratest and Estratest HS, Solvay Pharmaceuticals), is ...

ABSTRACT Statins are commonly used for treating the elevation of lipids in the blood stream, also known as hyperlipidemia. Statins are considered to be an economical and effective way to achieve desirable long-term health outcomes for hyperlipdemic patients, however, ensuring adequate adherence to statin medications is often difficult as hyperlipidemia is an asymptomatic condition and patients sometimes fail to recognize the importance of being adherent to their statin medications. The purpose of this study was to evaluate impact of enrollment under Medicaid and Medicare Part D and patient out-of-pocket costs on patient statin adherence, persistence, and mean number of gap days per claim. A retrospective claims database was used in this study to conduct repeated measures analyses on statin prescription claims from independent community pharmacies in Texas. The pre-period in this study extended from January 1, 2005 to September 30, 2005 (Medicaid period) and the post-period extended from January 1, 2006 to September 30, 2006 (Medicare period). The study population consisted of dual-eligible beneficiaries in Texas who had at least two stain claims in the pre and post-periods each. The final study population comprised of 1734 Texas dual-eligible beneficiaries with 6064 statin claims during the pre-period and 7956 claims during the post-period. Patients had an average of 3.49 statin claims during the pre-period and 4.58 statin claims during the post-period. Patients were dispensed an average of 57.34 days of drug supply per claim during the pre-period and 42.02 days of drug supply per claim during the post-period. The results from this study showed that out-of-pocket costs for patients increased from $0.39 per claim under Medicaid to $13.36 per claim under Medicare Part D. Patient adherence to statins was assessed by calculating medication possession ratio (MPR). The results showed that mean patient MPR increased from 75.71 percent under Medicaid to 79.37 percent under Medicare. Results from generalized estimating equations showed that odds of being adherent (i.e., MPR ≥ 80 percent) to statins increased by 36 percent when patients were covered under Medicare Part D. Linear mixed model analysis showed that MPR increased by 3.66 percent when patients were covered under Medicare Part D compared to Medicaid. Also, patient MPR was found to increase by 0.13 percent when patient out-of-pocket payment increased by $1.00. Patient persistence was calculated by measuring gaps in therapy and patients with a gap of 60 or more days were considered to have discontinued therapy. Patients were found to be persistent to their drug therapy for an average of 151.76 days under Medicaid and 159.75 days under Medicare. Linear mixed model analysis showed that patient persistence increased by 7.99 days when patients were enrolled under Medicare Part D compared to Medicaid. Days of persistence was also found to increase by 0.41 days when patient out-of-pocket costs increased by $1.00. Mean number of gap days per claim during the Medicaid period was 11.91 days and decreased to 8.38 days during the Medicare period. Linear mixed model analysis showed that mean number of gap days per claim decreased by 3.52 days when patients were enrolled under Medicare Part D compared to Medicaid. Mean number of gap days in therapy were found to decrease by 0.10 days when patient out-of-pocket costs increased by $1.00. The results of this study showed that implementation of Medicare Part D resulted in an increase in MPR and persistence and a decrease in mean number of gap days per claim for Texas dual-eligible beneficiaries. The results also suggest that increased out-of-pocket costs under Medicare Part D may not have had a negative impact on statin drug utilization by dual-eligible beneficiaries in Texas.

Background and objectives: In 2010, I published an article addressing the impact U.S. drug importation will have
on the Canadian prescription drug supply. In this article, I reported that only a small proportion of the U.S> prescription
volume will have a severe impact on Canadian drug supplies. Currently many U.S. politicians have renewed their
interest and are strongly advocating the legalization of prescription drug importation. The objective of this research is to
re-examine the issue and estimate the impact U.S. drug importation from Canada will have on the Canadian prescription
drug supply.
Methods: Like the 2010 article, the forecasting model created uses baseline numbers for the number of Canadian
and U.S. prescriptions dispensed in 2015. Two models were employed: one for all prescriptions and one for only brand
name prescriptions dispensed. The number of days to exhaust the Canadian prescription drug supply was estimated by
varying the proportion of U.S. prescriptions demanded from Canada.
Results: The model found that if 20% of the U.S. prescriptions were filled using Canadian prescription drug sources,
the 2015 Canadian drug supply would be exhausted in 183 days and this is calculated using an additional supply of
20%. It was believed that U.S. demand for Canadian brand name drugs will be much higher than for generic drugs
since generic drugs are substantially cheaper in the U.S. than Canada. Thus, a Canadian brand name drug model was
constructed. The results showed that a 20% demand from the U.S. would deplete the Canadian 2015 brand name drug
supply in 201 days.
Conclusion: The results show the risks are high for the Canadian health system if the U.S. were to legalize drug
importation. Canada will need to either have a major increase in drug imports or dramatically increase their domestic
drug manufacturing. The paper discusses four possible options for Canada to avert a prescription drug shortage.

BACKGROUND AND OBJECTIVES: Diet plays an important role in the management of diabetes, and a suboptimal diet is a commonly identified problem. Family support may be important in overcoming barriers to good diet. We conducted this study to examine the role of the family in overcoming barriers to diet self-care among older Hispanic patients with diabetes.METHODS: We performed a cross-sectional survey of 138 older Hispanic adults seeking care at an outpatient university clinic. Patients reported on their perception of family functioning, family support for diet, and barriers to diet self-care.RESULTS: Level of family functioning was related to family support for diet self-care, and family support for diet was related to perceived barriers to diet self-care. Scores for family support were higher for those who perceived their family as functional compared to those who perceived their family as mildly dysfunctional or dysfunctional. As family support for diet increased, perceived barriers to diet self-care decreased.CONCLUSIONS: To fully understand difficulties encountered by older Hispanic adults with adherence to a diabetic diet, primary care physicians should explore the role of family support and family functioning. For those with poorly functioning families or low levels of family support, family-level interventions may need to be considered.

The incidence of deliberate self-harm (DSH) in Britain has increased markedly over the last 30 years. Reasons for this rise are not clear. We have investigated whether changes in the social and economic environment underlie any of the recent increase in DSH incidence. An ecological analysis was used to assess associations between changes in census-based measures of the social and economic environment--the Townsend Deprivation Index and a three-factor social fragmentation index--and changes in age- and sex-specific hospital attendance rates for DSH for the 28 wards of the city of Bristol between 1972-3 and 1995-6. There were significant cross-sectional associations between the Townsend Index and rates of DSH in both males and females in both time periods. Increases in Townsend Index were also associated with increases in DSH. This association was statistically significant at the 5% level in 25-34 year-old females. Associations with the social fragmentation index were weak, although our index was based on rather limited data. This analysis suggests that changes in levels of socio-economic deprivation may influence area-specific patterns of DSH and such changes may have contributed to recent rises in DSH.

... 36 are coming from Brazil, India, Pakistan, the Netherlands, Spain, China, Portugal, Canada, the United Kingdom ... That is, the domain name deceives one to think that the phar-macy is a ... As-sistant Comm'r, Office of Field Operations, Bureau of Customs and Border Protection). ...

BACKGROUND: Pharmacy benefit managers (PBMs) play a major role in administering prescription drug benefit programs for health plans and employers. PBMs have often encouraged the use of self-owned mail-order pharmacy services with the promise to plan sponsors of lower prescription drug costs compared with those of the community pharmacy network. Some plan sponsors have requested a higher degree of disclosure of contract relationships and transparency in pricing. Unfortunately, little research exists based on empirical data to determine the net plan cost and member cost for mail-order drugs, as opposed to having these drugs dispensed by community pharmacies.OBJECTIVES: To determine the difference between mail-order and community pharmacy in the (1) payment (cost) per day of drug therapy for the plan sponsor and for the member for the highest expenditure therapeutic classes, (2) generic dispensing ratios for all drugs and for a comparative market basket of drugs, and (3) cost per unit for the top 20 generic drugs dispensed through the mail-order channel.METHODS: Pharmacy claim records were obtained from 2 publicly financed pharmacy benefit plans in Texas for fiscal year 2004 (September 1, 2003, through August 31, 2004). There were approximately 460,000 members in Plan A and 177,000 members in Plan B. Pharmacy cost per day (product costs plus dispensing fees, divided by days supply) was calculated for each drug in the 30 highest expenditure therapeutic categories and aggregated for mail-order and community pharmacy channels for each plan. Differences in the mail-order and community pharmacy cost per day were calculated for each drug (adjusted for dosage) in the therapeutic category and weighted by the product's share of mail-order therapy days within the therapeutic category. A weighted cost per day for each therapeutic category was calculated with a comparison of what the cost would have been for plan cost and member cost if all mail claims had been paid based on the community pharmacy cost per day. Comparison of the cost per day helped control for differences in quantity dispensed per day per product and for product mix within each therapeutic category. Descriptive analyses were conducted to compare generic dispensing ratios between (1) all mail-order and community pharmacy claims, and (2) a market basket of therapeutic categories most commonly found within the mail-order channel. Finally, the difference in price per unit was calculated between mail-order and community pharmacy channels for the top 20 generic drug products.RESULTS: Mail-order drugs accounted for 34.4% of overall pharmacy benefit spending, including plan cost and member cost, in Plan A and 43.4% for the market basket of drugs compared with 56.0% of overall spending and 63.1% for the market basket in Plan B. When comparing the cost per day for the top therapeutic categories, the authors found the plan sponsor cost was higher for mail-order than for the community pharmacy channel for approximately half of the top therapeutic categories. This result contributed to a 0.5% higher plan cost per day for mail-order ($1.24) than for community pharmacy ($1.23) for Plan A but a 0.4% lower plan cost per day for Plan B ($1.43 for mail-order vs. $1.44 for community pharmacy). The member cost was lower for mail-order than for community pharmacy for almost every therapeutic category, and overall was 29% lower in Plan A ($0.73 per day for mail-order vs. $1.03 for community pharmacy) and 37% lower in Plan B ($0.52 for mail-order vs. $0.82 for community pharmacy). For all claims, the generic dispensing ratios were lower in the mail-order channel than in the community pharmacy channel (37.7% vs. 49.0% for Plan A and 34.7% vs. 45.0% for Plan B). The cost per unit (tablet, capsule, etc.) for the top 20 generic drug products dispensed by mail order was 16.5% lower than community pharmacy for the plan sponsor in Plan A but 18.0% higher in Plan B; member cost was 29.9% lower in Plan A for mail order and 34.0% lower in Plan B. Comparing plan and member costs combined, 9 of 20 (45%) of the generic prices were higher through mail order in Plan A, and 10 of 20 (50%) were higher through mail order in Plan B.CONCLUSIONS: Overall, savings from lower unit pricing through the mail-order channel benefited the member and did not translate into significant cost reductions for the plan sponsor. In both pharmacy benefit plans, the plan sponsor either realized small savings or incurred slightly higher costs when paying for drugs in the top therapeutic categories through the mail-order channel. Some generic drug prices are higher through mail-order pharmacy than through community pharmacy, and 1 of the 2 plans in this study paid higher net costs after member cost share for generic drugs through mail order.

ABSTRACT A questionnaire was mailed to nearly 1,400 elderly Texans. Independently owned pharmacies were shopped by the elderly consumers at a somewhat higher rate than were chains. Convenience was cited most often as a reason for selecting a pharmacy when practice setting was held constant. Two out of three patronized a single pharmacy, but only one of three usually purchased their nonprescription drugs at the same place where they obtained their prescriptions. The majority wanted more written information about their medication, but only one of three felt strongly that there should be a legal requirement that the pharmacist provrde such information.

... By Ava-Gaye Tania Rhule Bachelor of Sciences, University of the West Indies, Kingston, Jamaica, 2001 ... NFκB is a family of transcription factors involved in stress-induced, immune and inflammatory responses (Dixit and Mak, 2002). These molecules also play important ...

This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated with market success of original brand-name drugs before generic drug entry, and (2) whether original brand-name drugs exhibit price rigidity to generic entry only when they are extended. The design is a retrospective follow-up study for the prescription drug brands that lost their patents between 1987 and 1992. The drug brands were limited to nonantibiotic, orally administered drugs containing only 1 active pharmaceutical ingredient. Information on patent expiration, entry of a product extension, and market success were determined from the U.S. Food and Drug Administration.s Orange Book, First DataBank, an...

Statins are commonly used for treating the elevation of lipids in the blood stream, also known as hyperlipidemia. Statins are considered to be an economical and effective way to achieve desirable long-term health outcomes for hyperlipdemic patients, however, ensuring adequate adherence to statin medications is often difficult as hyperlipidemia is an asymptomatic condition and patients sometimes fail to recognize the importance of being adherent to their statin medications. The purpose of this study was to evaluate impact of enrollment under Medicaid and Medicare Part D and patient out-of-pocket costs on patient statin adherence, persistence, and mean number of gap days per claim. A retrospective claims database was used in this study to conduct repeated measures analyses on statin prescription claims from independent community pharmacies in Texas. The pre-period in this study extended from January 1, 2005 to September 30, 2005 (Medicaid period) and the post-period extended from Janu...

Pharmacy benefit managers (PBMs) play a major role in administering prescription drug benefit programs for health plans and employers. PBMs have often encouraged the use of self-owned mail-order pharmacy services with the promise to plan sponsors of lower prescription drug costs compared with those of the community pharmacy network. Some plan sponsors have requested a higher degree of disclosure of contract relationships and transparency in pricing. Unfortunately, little research exists based on empirical data to determine the net plan cost and member cost for mail-order drugs, as opposed to having these drugs dispensed by community pharmacies. To determine the difference between mail-order and community pharmacy in the (1) payment (cost) per day of drug therapy for the plan sponsor and for the member for the highest expenditure therapeutic classes, (2) generic dispensing ratios for all drugs and for a comparative market basket of drugs, and (3) cost per unit for the top 20 generic ...

All health care is delivered to patients through an assemblage of minisystems. (A minisystem is the smallest system that can deliver a single clinical benefit.) It is the failure of these minisystems that reportedly results in between 44,000 and 98,000 iatrogenic deaths in the United States, annually. Device-related, accident investigations are intended to identify the latent defects within these minisystems and to recommend corrective actions that will prevent a recurrence. A generic, system's risk model has been developed for analyzing the performance of these minisystems. It provides the investigator with a mental model of the interacting components of the minisystem and provides a logical pathway toward the root causes of an adverse event. Of practical importance in using this model, is that operator error contributes to approximately 69% of the failures of health care minisystems and a fundamental understanding of human factors and human error is required.

This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated with market success of original brand-name drugs before generic drug entry, and (2) whether original brand-name drugs exhibit price rigidity to generic entry only when they are extended. The design is a retrospective follow-up study for the prescription drug brands that lost their patents between 1987 and 1992. The drug brands were limited to nonantibiotic, orally administered drugs containing only 1 active pharmaceutical ingredient. Information on patent expiration, entry of a product extension, and market success were determined from the U.S. Food and Drug Administration.s Orange Book, First DataBank, an...

Diet plays an important role in the management of diabetes, and a suboptimal diet is a commonly identified problem. Family support may be important in overcoming barriers to good diet. We conducted this study to examine the role of the family in overcoming barriers to diet self-care among older Hispanic patients with diabetes. We performed a cross-sectional survey of 138 older Hispanic adults seeking care at an outpatient university clinic. Patients reported on their perception of family functioning, family support for diet, and barriers to diet self-care. Level of family functioning was related to family support for diet self-care, and family support for diet was related to perceived barriers to diet self-care. Scores for family support were higher for those who perceived their family as functional compared to those who perceived their family as mildly dysfunctional or dysfunctional. As family support for diet increased, perceived barriers to diet self-care decreased. To fully unde...

The transition of prescription drugs (Rx) to over-the-counter (OTC) status is a very complex and multifaceted process involving many parties and many issues. This article examines the regulatory history and process and presents a review of the issues involved, using recent Rx-to-OTC conversions as examples. Data are presented on the growth of the OTC market and the impact recently switched products have had on this market growth. Drug product characteristics that make drug products amenable to OTC conversion are described. Reasons are presented for why more and more prescription drug products are being reviewed as candidates for OTC conversion. A list of high-profile Rx-to-OTC products is provided, along with a discussion of new proposals for OTC conversions and those products that have not been approved for OTC conversion. Conversion of prescription products to over-the-counter availability can have an impact on prescription-drug-benefit costs and on total health care costs. There ...

The goal of a health maintenance organisation (HMO) is to provide high quality, cost-effective healthcare services and products which meet the needs of the membership. Providing and managing pharmaceutical products and services within the HMO is a major aspect of accomplishing this goal. Several decisions must be made in developing, implementing and maintaining a formulary system. The numbers of people seeking their healthcare from HMOs in the US has increased 4-fold in 10 years, and several model types of HMOs have developed, including network HMOs, group HMOs, independent practitioner associations and staff models. HMOs utilising formulary systems provided cover to 76% of enrollees in 1992. Formulary system management and decision making entails the use of open vs closed formularies and the role of the pharmacy and therapeutics (P & T) committee. Product selection takes into account efficacy, safety, costs, patient acceptance, ease of use, dosage forms, preparation requirements, s...