Antranig Dereyan, Associate Editor

 are helping out the Cedar Medical Clinic in Ghana by raising money for equipment and creating formularies.

Last year, students raised money for equipment like an ultrasound machine for the diagnostic clinic located in Hohoe, Ghana.

This year, P3 students Jordan Long, Trevor Stump, and Mallory Thompson got involved in developing and optimizing formularies for the clinic, according to a school press release.

Phil Black, a retired pharmacist and advisory council member for Cedarville’s School of Pharmacy, will provide the formularies to the clinic when he leads a 10-day mission trip later this month, according to the school release.

Long said in the release that he hoped Cedarville students will be able to join Black on his trips in the future, “so that they can see the impact they are having on the people in Ghana.”

“We continue to stress one of our missions to serve the underserved and how we can use our resources to reach others for the Gospel,” said Phillip Thornton, PhD, vice chair and associate professor of pharmacy practice, in a press release.

Articles

Students at Cedarville University School of Pharmacy are helping out the Cedar Medical Clinic in Ghana by raising money for equipment and creating formularies.


Pharmacy Students Provide Assistance to Clinic in Ghana

The FDA does not effectively track potential safety issues with drugs granted expedited approval after they reach the market, according to a report from the US Government Accountability Office (GAO).

Between 2006 and 2014, the FDA’s Center for Drug Evaluation and Research (CDER) received about 1000 requests for fast-track and breakthrough therapy designation, both of which require manufacturers to submit formal requests for expedited review.

When the FDA grants a new drug accelerated approval, it is required to monitor and report on potential safety issues such as serious adverse events and medication errors. This is because expedited drugs are not subject to the standard review process, so there is less information available on their clinical effectiveness, as well as some risk.

The FDA keeps track of these potential safety issues through postmarket study data captured in its internal database known as the Document Archiving, Reporting, and Regulatory Tracking System.

However, CDER’s internal evaluations of the postmarket study data collected in this database showed that they contained inaccuracies and were outdated, partly as a result of delays in staff review of submissions from drug manufacturers. In fact, more than half of drug sponsors’ submissions involving about 1400 postmarket studies required or requested from the FDA between March 2008 and September 2013 were delayed or overdue.

Furthermore, GAO uncovered that the all of the FDA’s tracking data has to be entered manually, which essentially renders the software inadequate. In addition, the database cannot be queried to determine characteristics of tracked safety issues, such as the population affected, therapeutic area, or past regulatory actions.

In light of this, the GAO report concluded that the “FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight.” The GAO recommended that the FDA develop plans to correct problems with its postmarket safety database and ensure that the data can be easily used for oversight. The US Department of Health and Human Services (HHS) agreed with GAO's recommendations and provided additional information on FDA's postmarket safety efforts.

The GAO also suggested that HHS order the FDA commissioner to develop a comprehensive plan to address the identified problems, and that the FDA upgrade its information technology system.

US Government Accountability Office. FDA expedites many applications, but data for postapproval oversight need improvement. http://www.gao.gov/assets/680/674183.pdf. Published December 2015. Accessed January 27, 2016.

Research suggests FDA does not effectively track potential safety issues with drugs granted expedited approval.

FDA Deficient in Postmarket Drug Surveillance, GAO Reports

The FDA does not effectively track potential safety issues with drugs granted expedited approval after they reach the market, according to a report from the 

, the FDA’s Center for Drug Evaluation and Research (CDER) received about 1000 requests for fast-track and breakthrough therapy 

, both of which require manufacturers to submit formal requests for 

However, CDER’s internal evaluations of the postmarket study data collected in this database showed that they contained inaccuracies and 

outdated, partly as a result of delays in staff review of submissions from drug manufacturers. In fact, more than half of drug sponsors’ submissions involving about 1400 postmarket studies required or requested from the FDA between March 2008 and September 2013 were delayed or overdue.

In light of this, the GAO report concluded that the 

“FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight.” 

The GAO recommended that the FDA develop plans to correct problems with its postmarket safety database and ensure that the data can be easily used for oversight. The US Department of Health and Human Services (HHS) agreed with GAO's recommendations and provided additional information on FDA's postmarket safety efforts.

FDA expedites many applications, but data for postapproval oversight need improvement

. http://www.gao.gov/assets/680/674183.pdf. Published December 2015. Accessed January 27, 2016.

The FDA does not effectively track potential safety issues with drugs granted expedited approval after they reach the market, according to a report from the US Government Accountability Office. 


bill advancing in Indiana would give pharmacists the legal right to stop suspicious customers from buying certain cold medications that are used to cook methamphetamine.

 for the last 3 years, according to Drug Enforcement Administration figures. Police seized a total of 1471 meth labs in the state in 2014 alone.

“The heart of this meth crisis is pharmacies in every county sell pseudoephedrine daily and knowing[ly] to smurfs, who sell it to cooks, who use it to immediately manufacture meth,” explained Harry Webb, 

, owner of Webb’s Family Pharmacy in Fulton County, Indiana. “Pharmacy needs to step up and start legitimizing all pseudoephedrine sales, instead of turning a blind eye and trying to sell as much as possible.”

To give pharmacists the authority to do so, the Indiana Senate Committee on Corrections and Criminal Law has cleared 

, which would allow pharmacists to require customers who they suspect of making meth to present a prescription when attempting to purchase medicine containing the key meth ingredient, pseudoephedrine.

A similar measure in the state House of Representatives, known as 

, defines this process further and requires “patients of record” to be able to buy pseudoephedrine products at current National Precursor Log Exchange (NPLEx) limits if the pharmacist legitimizes the sale, Webb explained. Under HB 1390, non-patients would be offered meth-deterrent products or required to obtain a prescription upon their request for medicine containing pseudoephedrine.

If either version of this legislative effort becomes law, Webb hopes that it will expand the pharmacist’s role 

in preventing drug abuse while providing informed care to patients.

“I believe this is a great opportunity for pharmacy to solve a state crisis that is costing each county millions of dollars and demonstrate they [pharmacists] can treat their patients’ acute sinus symptoms…improving the pharmacist-patient relationship,” Webb told 

. “Our profession seeks increased recognition for pharmacist services and possibly provider status, but if we cannot demonstrate the ability to properly handle pseudoephedrine sales, how can we possibly ask for additional authority?”

Webb noted that patients in need of medicines containing pseudoephedrine shouldn’t worry about the pharmacist legitimization process.

“Patients will be able to get any of cold medicine containing pseudoephedrine like they do now, but pharmacists will be required to authorize the purchase in an effort to eliminate the large amount being diverted into meth making,” Webb said. “If you know your pharmacist, I would doubt you would experience any issues.”

SB 80 and HB 1390 aren’t the only measures on the table to fix the state’s meth problem.

SB 161, which passed the state Senate last year but failed in the House, is essentially an enhancement to NPLEx that would prevent all convicted drug offenders from purchasing pseudoephedrine products. According to Webb, SB 161 is currently assigned to an appropriations committee to determine whether it can be funded.

Webb believes the 2 Senate measures would complement each other.

However, he stated, “I believe our [pharmacists] best solution is SB 80.”

A bill advancing in Indiana would give pharmacists the legal right to stop suspicious customers from buying certain cold medications that are used to cook methamphetamine.

Indiana Pharmacists Could Soon Snub Suspicious Pseudoephedrine Seekers

Pharmacists in Texas can now legally provide and administer epinephrine auto-injectors to patients experiencing anaphylaxis, under a state law effective January 1, 2016.

“Prior to the passage and implementation of this new law, pharmacists were legally prohibited from administering epinephrine and could only help their patient by calling 911, even when the pharmacist had the lifesaving epinephrine sitting on the shelf only feet away,” Texas Pharmacy Association spokesman Justin Hudman explained to 

 “The most critical piece right now is assuring that pharmacists are aware of this new authority.”

Before Texas House Bill 1550 was implemented, the state’s pharmacists felt forced to decide between treating a patient experiencing severe, potentially life-threatening allergic reaction or risk losing their jobs. Hudman made clear that the new law is really about allowing the state’s pharmacists to put patients first and act when seconds truly matter.

“This law did not come about as a response to any specific issue related to a pharmacist’s actions, but instead as a result of pharmacists seeing a significant need within their communities and realizing that they were legally prohibited from saving their patients’ lives,” Hudman said.

He noted that the law also raises awareness of pharmacists as health care providers, rather than merely drug dispensers.

“Now, the public can start to see that pharmacists are highly educated and trained individuals who do in fact have an important role within the health care team,” Hudman said. “In addition, this [state epinephrine law] provides a means for the public to see the pharmacist move beyond the counter and into a much more publicly active role of patient services.”

He believes that this law will show patients that “our pharmacists and pharmacies are well positioned to play an ever-increasing role in meeting the demands and needs of patients in need of health care services.”

“The Texas Pharmacy Association and our pharmacists are excited by the knowledge that as a result of this law and the part that our pharmacists can now play, countless people, including in large part children, will have improved access to this life-saving treatment,” Hudman told 

Other states are currently in the process of passing or implementing similar epinephrine laws. For instance, Michigan House Bill 4438 was signed into law by Governor Rick Snyder on December 18, 2015, and it will go into effect 90 days from that date.

Michigan Pharmacy Association director of professional practice Eric Roath, PharmD, said the state’s epinephrine law differs from the one implemented in Texas in that it will “allow pharmacists to dispense the first dose of epinephrine to an authorized entity with a prescription, such as a school, so it can be available in more public places for administering when needed,” but the pharmacist cannot administer it.

Pharmacists in Texas can now legally provide and administer epinephrine auto-injectors to patients experiencing anaphylaxis, under a state law effective January 1, 2016.


Pharmacists Allowed to Administer Epinephrine in Texas

How is your pharmacy’s influenza vaccine supply looking throughout this year’s 

Even pharmacies with abundant supplies could see a major shortage of flu shots due to late delivery, according to a recent paper published by 

It is imperative to coordinate the influenza vaccine supply chain to avoid 

, but because no contract currently in play can fulfill this need, a change to the current business model is in order, the paper concluded.

The researchers observed the following 3 common types of flu vaccine supply chain contracts:

This is a simple type of contract stating that both manufactures and retailers gain marginalized profits. However, the gains are dependent on the retailer’s order number, which in turn makes early production more beneficial to the manufacturer.

This might sound like a win-win situation, but according to the paper, this type of contract “lacks the incentive to improve the delivery performance, which leads to potential 

…[and] the demand loss induces the retailer to reduce its order quantity, which further discourages the manufacturer from making an effort to improve on-time delivery.”

2. Delivery-Time-Dependent Quantity Flexibility Contract

This contract allows a retailer to return its leftover inventory at full price up to some level, which is referred to as “return allowance” that depends on the timing of delivery. Although it provides the manufacturer with some degree of incentive to undertake at-risk early production, it is reliant upon the incentive being substantial enough to motivate the manufacturer to do so.

This contract offers a rebate for orders shipped after the ideal vaccination period. However, it leans favorably towards the manufacturer because it transfers all the risk from early production to the retailer.

To avoid the pitfalls that each of these contract types contains—most notably, eliminating double marginalization and incentivizing the manufacturer’s at-risk early production&mdash;the paper authors conceptualized a Buyback-and-Late-Rebate contract, which combines a late-rebate term with a buyback term.

If implemented correctly, this type of contract could coordinate the supply chain and keep the rebate aspect of the Late-Rebate contract in place. The buyback component is a variant of the Delivery-Time-Dependent Quantity Flexibility contract in that it provides a partial buyback credit.

Thus, the Buyback-and-Late Rebate contract offers partial-credit, full-quantity buyback of leftover inventory and a rebate for flu vaccines delivered late.

“The biggest problem pharmacists face with the current influenza vaccine supply chain is that the delivery performance of influenza vaccine is less certain than desired. This problem is exacerbated by the time sensitivity of demand for influenza vaccine: there is a very tight time window for it, typically from late September to early November,” lead paper author Tinglong Dai told 

“When you receive only a fraction of your order by October, few unserved customers are willing to wait. In certain cases, customers may become doubtful of the reliability of the health provider simply because of unavailability of flu shots.” 

Dai pointed to the long and uncertain vaccine production and distribution process—which includes strain selection, production, inspection, and delivery&mdash;as a major source of frustration for pharmacists, largely because it is completely out of their hands.

Dai believes that the Buyback-and-Late Rebate contract will be beneficial to the pharmacist.

“At a conceptual level, the Buyback-and-Late Rebate contract provides dual assurance to pharmacists in that the vaccine manufacturer provides a rebate for late-delivered vaccines and partial-credit refunds for unused leftover products at the end of the flu season,” Dai said. “In the largest sense, the contract is welfare-enhancing because it brings solid values to patients as well manufacturers and pharmacists.”

How is your pharmacy's influenza vaccine supply looking throughout this year's flu season?