The most recent DEA National Prescription Drug Take-Back Day on April 30th was the most successful event in the history of the program. Expectations were far surpassed as a total of 893,498 pounds or 447 tons of prescription medication were recovered across the country. The states with the most amounts of medications surrendered included Texas with roughly 40 tons followed by California, Wisconsin, Illinois, and Massachusetts. Pennsylvania collections were also highly successful with a total weight of 22 tons of disposed drugs. “These results show that more Americans than ever are taking the important step of cleaning out their medicine cabinets and making homes safe from potential prescription drug abuse or theft,” said DEA Acting Administrator Chuck Rosenberg. It is safe to say that the value of these events continues to grow and this record will hopefully be eclipsed in the near future.
The National Prescription Drug Take-Back Day sponsored by the Drug Enforcement Administration (DEA) is scheduled for Saturday, April 30, 2016 from 10:00 am to 2:00 pm at participating locations.
Visit the DEA website at http://www.deadiversion.usdoj.gov/drug_disposal/takeback to find a disposal site near you.
Bring your unused, expired, and unwanted medication to a site near you. It is important to dispose of medication properly to reduce the risk of harm from taking an expired medication, accidental exposure, and intentional misuse.
Different medications can be disposed of in different ways. Most medication can be disposed of at registered take-back locations. Some locations may have individual limitations on medication that they can accept, but medications and supplies that should be excluded from this process include:
Diabetic testing supplies and needles can be disposed of at home using an opaque container such as a laundry detergent bottle. Make sure the bottle is sealed tightly and dispose of it in the trash.
Some medications are recommended to be flushed down the toilet for quick disposal due to the increased risk associated with these medications. These medications include opiates and other controlled substances.
If you are unable to make it to a location on National Prescription Drug Take-Back Day, two of the local universities with pharmacy schools will be sponsoring drug take-back programs on different days.
April 21, 2016 from 9:00 am to 3:00 pm
University of Pittsburgh
103 University Place
Pittsburgh, PA 15213
April 29, 2016 from 10:00 am to 2:00 pm
Bayer Learning Center
600 Forbes Ave.
Pittsburgh, PA 15282
Pharmacists’ services continue to expand as pharmacists are getting involved in prescribing and/or furnishing certain medications, such as hormonal contraceptives, in several states. Listed below is the latest information on initiatives underway in Oregon and California.
Pharmacists in Oregon can now prescribe and dispense hormonal contraceptives, both oral and transdermal. While the Oregon Board of Pharmacy is expected to establish permanent rules based on public input and will consider adoption of the Permanent Rules at their April 7, 2016 Board meeting, they have established temporary rules to enable pharmacists and pharmacies to prepare for implementation of the law. For each patient, pharmacists are required to obtain a completed Oregon Self-Screening Risk Assessment Questionnaire and to follow the Oregon Standard Procedures Algorithm to perform the patient assessment before prescribing a contraceptive. If the pharmacist determines that it is not clinically appropriate to prescribe the contraceptive, he or she is required to refer the patient to a healthcare practitioner. Patients under 18 can only receive a pharmacist prescribed contraceptive if the patient has evidence of a prior prescription from a primary care practitioner or women’s health care practitioner for an oral contraceptive or contraceptive patch. Additional Board approved training is required for pharmacists who want to participate in prescribing contraceptives. It is a five credit hour course available online for $250, available at https://pace.oregonstate.edu/catalog/comprehensive-contraceptive-education-and-training-prescribing-pharmacist.
Oregon law requires insurance coverage for prescription contraceptives. Only religious employers are exempt from the requirement. A new law extends that requirement to “apply to hormonal contraceptive patches and self-administered oral hormonal contraceptives prescribed by a pharmacist.” Individual insurers may still have formulary limitations on the specific brands of contraceptives that are covered. PHSI has heard that Oregon Medicaid is already providing coverage, but it’s unclear if commercial payers have begun providing this specific coverage in the middle of a benefit year.
A similar law in California is expected to be enacted on April 1, 2016. The law permits pharmacists to furnish contraceptives (which can include contraceptives that are administered vaginally and by depot injection), and to “order and interpret tests to monitor drug safety.” California’s law only permits furnishing by pharmacists who the Board of Pharmacy recognizes as advanced practice pharmacists (APP), which can be gained in as little as a one hour Continuing Education program. Accredited California schools of pharmacy may also offer an “equivalent curriculum-based training program completed on or after the year 2014” which would also count as sufficient training to participate.
Missing from the discussion has been reimbursement for the pharmacist’s services. California’s law specifically calls out that, for furnishing emergency contraception drug therapy (ECDT) the “pharmacist, pharmacist’s employer, or pharmacist’s agent may charge a patient an administrative fee of up to $10 above the retail cost of the drug but may not charge a patient a separate consultation fee for ECDT services.”
Colorado, Hawaii, and Washington state legislatures have introduced bills that would allow pharmacists to effectively prescribe contraceptives.
PHSI envisions state-by-state growth similar to the now nationwide availability of pharmacist administered immunizations and the growing number of states allowing pharmacists to provide emergency contraception to patients under certain requirements. Certain states have begun to allow pharmacists to dispense naloxone to patients and/or caregivers without a doctor’s prescription. As we’ve seen with other clinical initiatives, some pharmacies will evaluate the most effective (profitable) use of their time – be it dispensing other prescriptions or initiating prescriptions for products such as contraceptives. As pharmacy practice continues to evolve, PHSI envisions a future where pharmacists are compensated for the clinical services they are providing to patients.
Pharmacist prescriptive authority for contraceptives was recently discussed in the PHSI Winter 2016 Newsletter. The updates above were initiated by feedback from you. For your reference, the initial article can be found here.
2015 was a banner year for novel drugs approved. There were 45 novel drugs approved as new molecular entities (NME) under New Drug Applications (NDAs) or Biologics License Applications (BLAs) in 2015, up from 41 novel drugs approved in 2014. As a comparison, the FDA has averaged 28 novel drug approvals per year in the 2006 to 2014 timeframe.
Pharmacists and healthcare providers should be aware of new drugs that may be seen in practice. While many of these new approvals are for specialty drugs or orphan drugs with a small patient population that may not be seen in a pharmacy, it is still advisable to recognize and review new products. Questions may arise from patients or caregivers regarding these new products, their administration, dosage, side effects or drug interactions.
The FDA’s Center for Drug Evaluation and Research (CDER) publishes an annual summary of novel drugs, which is an excellent source for newly approved novel drugs. Oncology products led the way with nine newly approved novel drugs. Twenty-nine of the 45 drug products were approved in the US before receiving approval in any other country. Sixteen of the novel drugs approved in 2015 were deemed “first in class”, often with a new mechanism of action, an indication of innovation in the US drug market. Twenty-one novel drugs approved in 2015 were approved to treat rare or “orphan” diseases that impact fewer than 200,000 patients in the US.
The FDA CDER report cited above also focuses on the high level of innovation in 2015 drug approvals. Twenty-seven of the 45 novel drugs approved in 2015 fell into one or more expedited categories, demonstrating that pharmaceutical manufacturers and the FDA are working to bring valuable life-saving medications to market.
This was demonstrated by the following approval categories:
As novel drug approvals become more innovative and provide breakthrough care, expect the value of drugs in relation to other healthcare expenditures to rise even more. How do you keep up to date on new and novel drug approvals?
To view the FDA’s CDER Novel Drugs Summary report, visit http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM481709.pdf.
These days, you can find just about everyone on at least one form of social media. Whether it’s Twitter, LinkedIn, or even YouTube, we all want to stay connected and up-to-date with others. The same holds true for drug manufacturers. PHSI researched how drug manufacturers use social media to communicate with patients, healthcare professionals, and employees. Here’s a brief breakdown of manufacturer presence on different social media platforms:
FDA Social Media Guidance
The FDA released three draft guidance documents in 2014 for manufacturers using social media.
Refer to the following websites to read the complete FDA draft guidance:
Although there is an opportunity to use social media outlets for advertising, manufacturers are hesitant to use social media for this purpose. The FDA has already issued warning letters to some firms that they are inappropriately using social media. Once the FDA releases final guidance, manufacturers may be more likely to use social media as a way to reach patients and providers.
PulsePoint Respond app allows citizens trained in cardiopulmonary resuscitation (CPR) to locate and assist nearby victims of a cardiac emergency. It alerts CPR-trained users when someone nearby requires CPR, providing the locations of the victim and closest public access Automated External Defibrillator (AED). PulsePoint Respond currently covers hundreds of cities by partnering with local fire departments or emergency response agencies.
PulsePoint Respond is intended for anyone willing to report a person in need of CPR, and people who are CPR-trained. PulsePoint Respond is maintained through the PulsePoint Foundation, and is free to anyone who wishes to download it. The PulsePoint Foundation also offers PulsePoint AED, which is a comprehensive registry of AEDs available for emergency use. By downloading the PulsePoint AED app, users can report AED locations to help local responders and citizens utilizing the PulsePoint Respond app.
Upon download, the app allows a user to follow local emergency response agencies. Following the agencies will provide a newsfeed on current emergency events and what responses have been already taken. There is also educational information on CPR, AED use, and unit identifiers for dispatch statuses available on the app.
A limitation associated with this app is the delayed uptake by local agencies. There has been some delay in establishing coverage, and the PulsePoint Foundation is placing responsibility upon users to approach local authorities for initiation into new areas. Local agencies may be wary of non-professionals intervening in emergency situations where they are not trained for when a professional is on the way to the scene. On the other hand, PulsePoint Respond is addressing a legitimate need, as heart disease is the leading cause of death in the United States.
Most pharmacists are trained in CPR, and all pharmacists act in a manner to improve patient lives. That being said, this app provides an opportunity for pharmacists to further extend their knowledge and training for the betterment of the surrounding community.
PulsePoint Respond and PulsePoint AED are currently available for both iOS and Android systems.
More information on both apps can be found at: http://www.pulsepoint.org/
The appeal of online pharmacies include low cost and ease of access, but these factors come at a high risk to patient safety. Investigations of online pharmacies have found counterfeit drugs, potentially dangerous contaminants, and pharmaceutical products sourced from locations other than the proclaimed source. One 2013 investigation by the National Association of Boards of Pharmacy® (NABP®) found nearly 97% of online pharmacies distributing drugs in the United States to be non-compliant with safety laws and regulations, with 48% selling non-FDA approved drugs and nearly 90% not requiring a valid prescription.
While many laws exist to regulate pharmacies and protect patient safety, illegal Internet pharmacy operations do not usually comply with these regulations. It is important for consumers to be able to identify a valid online pharmacy, but this has proven challenging for consumers.
Even if a patient is fully aware of the risks of online pharmacies, it is often difficult to discern which are legitimate; various global efforts are now being made to target unsafe drug sales. The NABP® created an online pharmacy accreditation program, called Verified Internet Pharmacy Practice SitesCM (VIPPS®). A supplementary program for limited-service online pharmacies, NABP e-Advertiser Approval ProgramCM, enables advertising through major search engines such as Google and Yahoo, as the site must be accredited through one of these programs. Some websites such as www.AWARErx.org and www.legitscript.com provide information about safe online pharmacies.
In another step towards improving patient safety and understanding, a top level domain (just like .com, .net, or .org), .pharmacy, has been created with tight restrictions on domain use. This domain is limited to use by:
To register a .pharmacy domain name, the organization must apply through NABP, providing proof that they are operating legally and complying with all safety regulations. More information about the .pharmacy domain and websites registered with this domain can be found at www.safe.pharmacy. The application period began in April 2015 for dispensing pharmacies and June 3, 2015 for all other eligible applicants.
There is a $2,000 fee for the review process that is paid at the time of application and yearly upon renewal. NABP also provides a list of registrars partnering with the .pharmacy program to provide domain name registration services. The costs to register a .pharmacy domain is $1,049 for two of the companies operating in the United States. The .pharmacy domain is not required, but it can be used to signal a safe, legal internet site. One cannot purchase a .pharmacy domain and sell it to anyone else. The .pharmacy domain is not limited to entities within the United States; it is open as well to Canada, Great Britain, Ireland, Spain and Australia.
Currently, there are 19 State Boards of Pharmacy that have a .pharmacy domain. Pharmacies such as CVS and Target, as well as pharmacy organizations and pharmacy information site also have been approved for .pharmacy domains. Visit www.safe.pharmacy to find a complete list of .Pharmacy websites.
PHSI applauds the creation of .pharmacy for the internet and expects adoption by the internet-focused pharmacies.
Will you acquire a .pharmacy domain, and how will you promote it?
On July 13, the Drug Enforcement Administration (DEA) announced the reinstatement of Drug Take-Back Days, with the 10th Take-Back Day scheduled for September 26, 2015 in 48 states; Take-Back Days in Pennsylvania and Delaware will take place on September 12. Visit https://www.deadiversion.usdoj.gov/SEARCH-NTBI/ to locate a collection site near you.
Termination and Reinstatement of DEA-Sponsored Take-Back Days
In September 2014, the DEA expanded the Secure and Responsible Drug Disposal Act of 2010. The act as signed in 2010 permitted law enforcement agencies to collect medications through drop-off boxes and take-back events. With the 2014 expansion, which intended to increase ongoing collection, other agencies such as pharmacies and hospitals could voluntarily be authorized collection sites as well; however, it also terminated the DEA-sponsored nationwide take-back events.
In May of 2015, ten US Senators petitioned the Attorney General to continue sponsoring nationwide Drug Take-Back Days, stressing that widespread collection methods were not yet established enough to make the transition away from DEA-sponsored Take-Back Days. The request was met with the reinstatement of the DEA-sponsored events. The 2014 expansion of the Secure and Responsible Drug Disposal Act of 2010 was not revoked, and the expansion of drug collection options is still continuing.
Also in May of 2015, President Obama appointed new DEA chief Chuck Rosenberg to replace Michele Leonhart, who departed in April 2015. In the first few months in office, Rosenberg has raised attention for reinstating Drug Take-Back Days. In his first interview as chief, Rosenberg noted his shock at the rates of drug overdose. Regarding the reinstatement of the drug take-back days, Rosenberg stated “We need you to clean out your medicine cabinet; we need you to give us the stuff in your medicine cabinet that can hurt you or your loved ones…More to come but we’re going to revive that program and we’re going to do it in every state in the country.”
State Responses to the 2014 Expansion
Following the 2014 expansion, various state-wide and county-wide policies were developed. Most notably, California’s Alameda County mandated for pharmaceutical manufacturers distributing within the county to be required to fund take-back. The industry PAC (PHRMA) challenged this in US Supreme Court, who refused to consider the case. By this mandate pharmaceutical manufacturers would be permitted to run disposal programs independently or in conjunction with other companies, and each manufacturer would have autonomy in designing their collection programs.
Following the US Supreme Court refusal to hear the case, other California counties are predicted to pass similar legislation. California state senate bill SB1014 would pass a statewide ordinance placing disposal responsibility on the pharmaceutical manufacturers.
Another bill in consideration in California, AB45, would put cost of take-back programs in pharmacies as a small tax on all consumer and business sanitation bills and establish a statewide mail-back program.
Other states have also continued working with local law enforcement to host publically-funded Drug Take-Back Days, and these efforts are expected to continue to expand.
The original petition letter from the ten senators to the DEA can be found here: http://www.upstate.edu/poison/pdf/schumer-drug-take-back.pdf.
The DEA website has a locator tool for authorized drug collection sites, where citizens can leave unwanted medications throughout the year: https://www.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1
On May 20, 2015, Dr. Karen Thacker of the Allegheny County Health Department issued a press release announcing a standing order to allow pharmacists in Allegheny County (Pennsylvania) to dispense intranasal and injectable naloxone without a prescription to at-risk patients and caregivers. This standing order is allowed by Pennsylvania Act 139, which was passed in late September 2014. This act allows:
This legislation does not mandate the administration by these providers, but rather allows first responders and pharmacists to administer it at their discretion.
What is Naloxone?
Naloxone (Narcan®) is an opioid antidote, which binds to the same receptors in the brain as narcotic drugs such as heroin or oxycodone. It binds these receptors more strongly than the narcotics, but does not elicit the same response; rather, it blocks the drugs’ response. When given to an overdosing patient, the naloxone will “kick off” the drug from the receptors and help the patient to stop overdosing.
How does Pennsylvania compare to other states?
In recent years, overdose deaths from narcotics and prescription opioids have increased greatly. Increasing naloxone availability can help reduce the risk of overdose death. Some opponents argue that providing a greater safety net through legislation such as Act 139 can lead to increased risk of opioid use, since narcotic users will feel that they can get away with using higher doses and falling back on naloxone if necessary. To the contrary, many studies have shown that harm-reduction practices such as needle exchange and increasing naloxone availability do not promote higher drug use, but rather promote lower opioid use and increased willingness to participate in rehabilitation and addiction treatment.
Pennsylvania is among a growing number of states allowing greater access to naloxone. Currently, 34 total states and the District of Columbia have passed legislation allowing increased access to naloxone; 26 states and the District of Columbia have passed Good Samaritan laws to those administering naloxone or summoning medical aid in an overdose emergency. The following map shows the current distribution of naloxone policy in the continental states. Additionally, Alaska has the Good Samaritan law but not increased access to naloxone and Hawaii does not have either.
PHSI sees the change to naloxone laws as another step forward for pharmacy. Not every pharmacist or pharmacy will need to provide naloxone, but being prepared through education and training is prudent. These opportunities will continue to guide pharmacy into being healthcare providers.
If you have provided naloxone to a patient, which product/dosage form was it?
The Centers for Medicare & Medicaid Services (CMS) issued a new guidance on biosimilar reimbursement on March 30, 2015 was needed based on FDA approval of the biosimilar Zarxio™ (filgrastim-sndz). The guidance describes the Medicare Part B reimbursement for biosimilars.
Reimbursement for drugs provided through Medicare Part B uses Average Sales Price (ASP) as the cost basis plus a markup. Since biosimilars are expected to have lower prices than the originator, Medicare is expecting to save money with biosimilars. The challenge seen by providers is that with a lower ASP for the biosimilar, the markup provides the same percentage but a lower dollar value margin than the originator. The incentive for the provider is to use the originator product with the higher dollar markup.
The CMS guidance changes this incentive by making the biosimilar reimbursement use the biosimilar ASP but the originator ASP markup. This keeps the markup the same and incentivizes the use of the lower cost product.
It may sound easy, but how do you add the markup factor from one drug to another? With only a few biosimilars, this could certainly be handled manually. As more and more biosimilars launch, this will be a daunting task. All the more reason for the drug compendia to group the biosimilar with the originator. The drug compendia will most likely try to fit the biosimilars into their current groupings. Even if the compendia don’t link biosimilars to the originator product using the current methods, they may be influenced to add a new biosimilar specific linking mechanism.
Thinking ahead, when will CMS release the next guidance to account for the scenario that the originator has exited the market and only the biosimilar(s) are left? Without the ASP from the originator, the provider markup could change to the biosimilar ASP. This scenario may not be required for years.
PHSI experts understand the drug compendia and the impacts on pharmaceutical manufacturers, PBMs, and pharmacies. The expectations for biosimilars are uncertain but will become clearer with additional guidances expected in 2015. Please contact us to discuss the biosimilar impacts and challenges you are experiencing or expecting.biosimilar
The Drug Enforcement Agency (DEA) began sponsoring the National Prescription Drug Take-Back Day in September 2010, with bi-annual Take-Back Days in April and September, running through September 2014. Over a five year period, the DEA sponsored nine total Drug Take-Back Days and collected over 4 million pounds of prescriptions drugs. The DEA originally created the events to provide patients with an opportunity to get rid of unwanted controlled substances without throwing them in the trash or flushing them down the toilet. The DEA has no plans to sponsor more nationwide Take-Back Days in order to give authorized collectors the opportunity to provide the service to their communities.
The 2010 Secure and Responsible Drug Disposal Act of 2010 developed regulations allowing authorized collectors to dispose of prescription drugs. The DEA’s final regulations were published in September 2014, making the need for bi-annual Take-Back Days unnecessary. New disposal rules provide for convenient, ongoing disposal opportunities for patients’ unwanted medications. The Final Rule authorizes certain DEA registrants, including manufacturers, distributors, reverse distributors, narcotic treatment programs, retail pharmacies, and hospitals/clinics with an on-site pharmacy, to become authorized collectors. Any organization may still partner with law enforcement to conduct take-back events.
PHSI spoke with a local pharmacy registered with the DEA as an authorized controlled substance disposal location. The pharmacy does not have the appropriate system to support the disposal of medications yet, but is actively working to set it up. The pharmacist indicated that the owner of the medication or someone authorized to handle the medication must be present to dispose of the drug product. There will be no charge to drop off the medication for disposal. The pharmacy offered two alternative solutions for drug disposal until their system is available to accept drugs for disposal:
Nearby collection sites can be found by visiting the DEA’s website at www.deadiversion.gov, clicking on the “Got Drugs?” icon, selecting “Search for an Authorized Collection Location” and entering their zip code. Even though the DEA is no longer sponsoring Prescription Drug Take-Back days, many local communities continued the tradition by holding their own events in April 2015. Publicizing local events any time throughout the year may be a good way for communities to ensure that the public is aware of a safe way to dispose of their prescription medications.
Although it is discouraging that the national effort has ended, PHSI sees this as an opportunity for pharmacies. As the medication experts, pharmacists should be involved in all aspects of medication use, including disposal of expired and unused prescription products. Pharmacies that offer this service can initiate a discussion with the patient/authorized individual about their current medications and market to new potential patients. PHSI believes that it should be the individual pharmacy’s decision to charge or not charge a fee to take back expired medications to offset their cost for drug disposal. What discussions about drug take-backs have you had? If your pharmacy is an authorized collection location, what impact have you seen from this initiative?