- Substances Doubtful for Bulk Drug Substances List Could Be INDs (ashp.org)Individual Patient Expanded Access Applications: Form FDA 3926 (fda.gov)
Pharmacists, physicians, and advocacy groups that want patients to use substances unlikely to be on the upcoming "bulk drug substances list" for compounders should consider submitting "treatment" investigational new drug applications, FDA personnel recently suggested...FDA-cleared treatment IND applications...offer a legal workaround that can benefit many patients...a compounding pharmacy, could submit a treatment IND, which once that was in place could be expanded to treat a large number of patients...ASHP stated, absent "significant" revision, FDA's current expanded-access IND application process will not facilitate access to any drug available only from compounders...Jarow (Jonathan Jarow, from the Center for Drug Evaluation and Research)...acknowledged that submission of an IND application has seemed difficult to many individual healthcare providers seeking a drug for a single patient..."There's now a special form in development that has not been finalized—it's available in draft form—that caters to that specific type of IND rather than the general form that's used for all types of INDs, which looks very complicated," he said...Form FDA 3926, also known as "Individual Patient Expanded Access Investigational New Drug Application," went on display in February 2015 as part of a draft guidance for the pharmaceutical industry....
- How Pharmacists Can Help Prepare Patients for Natural Disasters (pharmacytimes.com)
Jon Roth, CEO of the California Pharmacists Association, explains how pharmacists can help prepare their patients for natural disasters.
- Drug spending increase slowed to 5.2 percent last year, Express Scripts says (statnews.com)
Despite rising prices for prescription medicines, Express Scripts released data today showing spending for its health plans rose 5.2 percent in 2015, roughly half of what was seen the year before...the average price of brand-name drugs rose 16.2 percent in 2015...Most of the increased spending was for specialty medications — such as those for hepatitis C, cancer, and other hard-to-treat diseases. Spending for these drugs rose nearly 18 percent, compared with a 0.1 percent drop for traditional drugs for chronic conditions...usage rose nearly 7 percent for specialty medicines, compared with 2 percent for other drugs...Express Scripts boasted that it has successfully used various techniques to manage drug costs. These include formularies with various so-called tiers, which are lists of preferred drugs that require consumers to pay varying amounts. Another tactic is prior authorization, which involves requiring consumers to try different treatments before a more expensive medicine...Another move...was...to curtail coverage of many compounded medications...Total spending on compounded treatments for pain and skin conditions fell 54 percent as usage dropped 56 percent.
- APhA releases 2016 edition of the APhA Pharmacists’ Patient Care Services Digest (drugstorenews.com)Pharmacist's Patient Care Services Digest (media.pharmacist.com)
The American Pharmacists Association...released the 2016 edition of the APhA Pharmacists’ Patient Care Services Digest. The publication shows the continued growth of pharmacists’ patient care services and highlights the expanded roles pharmacists have in the health care system... Overall, findings from the survey indicate that there is a continued expansion of pharmacist-provided patient care; confidence in pharmacists as care providers continues to grow; pharmacists are reducing gaps in care and improving performance for health plans; and work systems and processes are being aligned with desired outcomes of care...
- DH launch consultation on hub and spoke and prices on labels (psnc.org.uk)Is hub and spoke really the answer for pharmacy? (pharmacymagazine.co.uk)
The Department of Health and the Medicines and Healthcare products Regulatory Agency have launched a consultation on changes to the Human Medicines Regulations and the Medicines Act...The consultation seeks views on the following proposed changes:
- allowing independent pharmacies to make use of ‘hub and spoke’ dispensing models – a ‘hub’ pharmacy dispenses medicines on a large scale, often by making use of automation, preparing and assembling the medicines for regular ‘spoke’ pharmacies that supply the medicines to the patient;
- allowing the price of medicines and a statement on how the costs of medicines are met to be published on dispensing labels should this be required for NHS medicines dispensed as part of NHS pharmaceutical services;
- clarifying the current dispensing label requirements for monitored dosage systems and medicines supplied under patient group directions; and
- amending the pharmacists’ exemption in section 10 of the Medicines Act, regarding the preparation and assembly of medicines, following a judgment of the Court of Justice of the European Union.
- Using a Mail Order Pharmacy Doesn’t Always Save You Money (news.yahoo.com)
Hoping to save a few bucks on your prescription, or just trying to avoid a trip to the drugstore?...While mail order can be a good option, it can also be a hassle, and savings aren’t guaranteed...using mail order can be easy, it could lead to communication errors or safety problems...The problem...is that medications may not arrive on time, which can be dangerous for people who rely on lifesaving drugs...The opposite problem can happen, too: Mail order pharmacies might auto-renew your prescriptions without confirming you’re still taking a drug or whether your dosage has changed. When possible, pick a service that will alert you before they ship out any medication...Medicare Part D drug plans require mail order pharmacies to get the okay from a patient or caregiver before shipping a new prescription or refill...Whether you shop in store or by mail order, once you find a pharmacy that fits your needs, our medical consultants strongly recommend you fill all your prescriptions there whenever possible. That way one pharmacy has a complete record of what you’re taking and can flag any potentially dangerous interactions. That might not be feasible, say, if you get your blood pressure drug through mail order and your doctor prescribes a post-surgery pain medicine that you need right away. When that happens, let each pharmacy know all the medications you're taking and update them regularly on any changes.
- PillDrill named ‘Best New Product’ at ECRM’s Home Health Care EPPS event (drugstorenews.com)
PillDrill won this year’s Drug Store News/ECRM Most Innovative Product Award...PillDrill was developed to be a smart, friendly medication tracking system that simplifies the task of everyday pill taking. It gives reminders when pills need to be taken, tracks what’s being taken with a quick scan and sends real-time adherence updates to those people involved in the patients' well-being...We learned early on that medication adherence is not a technology problem, it’s a human problem...So what makes PillDrill special is that it’s completely user-centric. It’s not some complicated piece of hardware, and it’s not an app; those things don’t really work for people in their everyday context…PillDrill is a light overlay onto an existing routine that provides all the benefits of a technology product without any of the hassles.
- Lawyers consider judicial review of consultation on community pharmacy (pharmaceutical-journal.com)Hundreds of local chemists set to close leaving sick and elderly without vital lifeline (express.co.uk)
Lawyers have given health minister Alistair Burt a deadline of 4pm on 18 March 2016 to respond to claims that the consultation on proposed cuts to the pharmacy budget in England is illegal and should be abandoned...If the government does not accept that the consultation is illegal then lawyers will consider going to the High Court to seek a judicial review of the consultation process and the content of the consultation document...The prospect of legal action comes three months after the Department of Health first outlined its proposals for the community pharmacy sector in England in a letter to the Pharmaceutical Services Negotiating Committee. The letter...set out plans to cut the community pharmacy contractual framework by 6.1% in 2016. As well as the funding cuts, the proposals include a range of measures to make efficiency savings in the sector while extending clinical roles for the profession...Healthwatch England told the government that there is a "clear appetite" for community pharmacy to play a greater role in health prevention, the treatment of minor ailments and supporting people with long-term conditions. It says consumers value pharmacy’s accessibility and some believe co-locating pharmacies to GP surgeries makes sense...However, the organisation gives a cautious welcome to the idea of ‘hub-and-spoke’ dispensing and says that where medicines are assembled centrally, patients will still need local access to expert pharmacy advice.
- 3 Legislative and Regulatory Updates Pertinent to Pharmacists (pharmacytimes.com)
...at APhA’s 2016 Annual Meeting & Exposition...they discussed...the proposed nondiscrimination rule, pending pharmacist provider status legislation, and draft guidance on prescription drug abuse...
- Proposed Nondiscrimination Rule - Under this proposed rule, pharmacies would be required to offer language assistance services to patients with limited English, unless the pharmacy would face "undue financial burden," or if doing so would "result in a fundamental alternation in an entity’s health program or entity,"...also applies to the requirement that pharmacies provide auxiliary aids and services and the accessibility of programs through electronic and information technology...HHS does not expect compliance with the proposed rule to cost too much, and training employees on these new requirements is voluntary.
- Pharmacist Provider Status Legislation - legislation would allow pharmacists to be reimbursed for their services as long as the pharmacist serves in medically underserved areas, health professional shortage areas, or for medically underserved populations and follows the state’s scope of practice laws...there has been no opposition to the proposed legislation...cost will be a challenge...The next steps are getting a Congressional Budget Office score, meaning a cost estimate for the bill...they hope to see a score within a few weeks, and then a few weeks later, they can expect a House hearing.
- Draft Guidance on Prescription Drug Abuse - the Centers for Disease Control and Prevention issued draft guidance for prescribing opioids for chronic pain, which were fairly controversial...APhA’s comments on the guidelines included the fact that a team-based approach to care including pharmacists was needed. In addition, the guidelines should mention that the lowest-effective dose should be patient-specific, and more education is needed for health care professionals.
- FlavoRx unveils new FlavorMaster (drugstorenews.com)
FlavoRx debuted its newest piece of pharmacy equipment — the FlavorMaster — the reconstituting and flavoring device...The FlavorMaster uses FlavoRx’s Fillmaster water dispensing technology and its flavors, making reconstitution available with the press of a button...pharmacies have the power to boost pediatric adherence and improve a child’s health outcome...