What I learned week 10

What I learned week 10

This week Dr. Baker talked to us about the changing pharmaceutical industry focusing on the law aspects. Dr. Baker is a pharmacist he also has a law degree, so he has an inside perspective on how the law implications apply to pharmacy. It’s interesting to me because out of all the healthcare providers, physicians, nurses, pharmacists, pharmacy techs etc. pharmacists are the most educated on law. They are the only healthcare providers who are required to take a law class for their graduation requirements. Dr. Baker kicked off the discussion by discussing some crucial laws and amendments passed by the U.S government which established rules and regulations for the pharmaceutical industry that we still use today. For example, the Durham-Humphrey Amendment or Prescription Drug Amendment of 1951 (amendment to the Food, Drug & Cosmetic Act of 1938). The purpose of this amendment was to standardize what a “drug” is, which thus established the requirements of medical supervision to obtain. It’s interesting because Dr. Baker emphasized that anything that you take that causes a biological reaction in the human body is considered a drug, but that does not describe the law definition of what a drug is. Herbal preparations, vitamins, minerals and other nutritionals are termed “food supplements” or sometimes “herbals,” and are not regulated by the FDA and are not classified as drugs. All such products must bear a warning that such products were not reviewed or approved by the FDA for safety or effectiveness. Accordingly, the individual consumer must be aware of the potential negative effects of using these preparations and the potential interactions with prescription drugs they may be taking. The amendment established two classes of drugs, prescription and over the counter, and methods by which consumers could obtain each. This amendment also established label and labeling requirements unique to prescription drugs. Moving on, a trend that Dr. Baker talked about was the popular move by pharmaceuticals manufacturers to make their prescription drugs OTC. As drugs hit their patent cliffs, many manufacturers are pushing to get their drugs on the shelves of pharmacies instead of being prescription only. As the role of the pharmacist becomes more patient and counseling-centered, the healthcare market is changing to keep pace with more modern needs, such as self-treatment. Self-treatment provides patients the ability to diagnose their own conditions and pick an appropriate medication from the pharmacy to treat their symptoms. This process allows a certain freedom for consumers to actively engage in their own health. For patients who self-treat, access to OTC medication is of prime importance. Many medications that are available as OTC today were previously labeled as prescription medications such as Flonase, a common antihistamine even I use regularly. As more safety studies and trials are conducted for different drugs, they can be deemed appropriate for use without a prescription. I researched what it takes to make this switch and discovered there are three main factors to take into consideration

1.     Benefit-risk comparison

2.     Consumer-friendly labeling

3.     How to make the drug a good choice as an alternative to prescription medication

Because Dr. Baker emphasized the push for prescription drugs moving towards OTC, he brought up the morning after pill we know as Plan B. Plan B wanted their drug to no longer be prescription only, but OTC. In the end, Plan B became OTC with no age restriction. So basically 13-year-old with $40 in their pocket can walk into their corner CVS and buy Plan B. For over a decade, reproductive rights advocates, politicians, the FDA, and Plan B manufacturers have clashed back and forth about the regulation and restriction with advocates for the pill pushing for the greater availability. Opponents were arguing for limited access for girls considered by some to be too young to understand the risks. I find this topic very interesting because I am an advocate for the right to emergency contraception. Now the fact that there is no age limit I question, but I am proud that our government has taken the steps to make Plan B and its generics available to everyone. The timeline is interesting an important to myself because it outlines a unique law perspective for a drug.

Another question I asked was “what continuing education needs does a pharmacist need?” Dr. Baker emphasized that this varies state to state. Many regulations and laws are created by the state for the pharmacist to follow. He took Massachusetts for example because apparently, we are very strict with our rules and guidelines because of a pharmacist crisis back in 2012. A New England Compounding Center meningitis outbreak which began in September 2012 sickened over 800 individuals and resulted in the death of 76. In September 2012, an outbreak of fungal meningitis was reported in the United States. The U.S. Centers for Disease Control and Prevention traced the outbreak to fungal contamination in three lots of a medication called methylprednisolone used for epidural steroid injections. The medication was packaged and marketed by the New England Compounding Center (NECC), a compounding pharmacy in Framingham Massachusetts. Because of this crisis, the Massachusetts Board of Pharmacy bolstered up their requirements. Effective for the renewal period beginning January 1, 2015, a registrant seeking renewal of a personal registration must complete a minimum of 20 contact hours of continuing education each calendar year of the two-year renewal cycle; total 40 contact hours every two years All registrants must complete:

·       2 contact hours per calendar year in pharmacy law

·       15 contact hours maximum toward the 20-contact hour minimum per calendar year through home study

·       5 contact hours per calendar year in the area of sterile compounding if the registrant oversees or is directly engaged in the practice of sterile compounding or who practices in a pharmacy licensed pursuant to M.G.L. c. 112, § 39G or 39I

·       3 contact hours per calendar year in complex non-sterile compounding if the registrant oversees or is directly engaged in the practice of complex non-sterile compounding or who practices in a pharmacy licensed pursuant to M.G.L. c. 112, § 39H

References

Chang, Jongwha et al. “Prescription to over-the-Counter Switches in the United States.” Journal of Research in Pharmacy Practice 5.3 (2016): 149–154. PMC. Web. 6 Nov. 2017.

http://www.continuingeducation.com/pharmacy/state-ce-requirements/massachusetts