Less Speed, More Quality: The Integrity of In-Office Compounding

Less Speed, More Quality: The Integrity of In-Office Compounding

i-clipboardIn today’s world of nonstop acceleration and ready-made merchandise ripe to be picked off the shelves, consumers have become acclimated to almost immediate delivery of whatever services they seek. High-speed, however, is not always synonymous with high-quality; in fact, the two often are at odds. Consider this: which is quicker — a cheeseburger from a McDonald’s drive-thru, or one eaten hot off the grill in your buddy’s backyard?

Why So Slow? Compounding Requires Mindfulness

Compounding pharmacists often face the question of why it takes them so long to prepare prescriptions, with so long generally meaning a day. Compounding pharmacies routinely ask that patients drop prescriptions off 24-48 hours prior to when they’ll actually need the treatments. This stands to reason, given that the process of compounding is inherently time-consuming — the final products are medications made by hand and individualized to specific patients, rather than mass-manufactured drugs already sitting on shelves in backstock.

In-office compounding pharmacists’ adherence to high standards of training, sterility, and interpersonal relations, as well as to legal regulations that govern their facilities, also require close attention to detail. For example, pharmacists must ensure that ingredients for these made-from-scratch medications originate from facilities that heed specific guidelines, where products are manufactured in accordance with cGMP and CFR codes.

The “Slow Medicine” Movement

The term ‘slow medicine’ arose from a series of discussions among students, residents, and faculty at the Cambridge Health Alliance and Harvard Medical School. These discussions led to regular email posts that gained a following among program graduates, colleagues, and eventually physicians throughout the U.S.1 Now entitled “Updates in Slow Medicine,” this same discussion currently takes place on a live social media page, and emphasizes thoughtful clinical reasoning, evidence-based practice, and the importance of lifestyle changes for improving health2.

As Krista Shaffer, Outreach Director at Koshland Pharmacy, put it, “Much like the slow food movement, the ‘slow medicine’ movement prioritizes processes that sometimes take longer but lead to successful health outcomes.”3

Compounding pharmacies that take time to adhere only to the highest industrial standards, so that they can ensure the highest quality for their patients, are part of this “slow medicine” philosophy4 — as are the pharmaceutical companies that enable their clients to continue the time-honored tradition of compounding.

Federal Standards of Sterility

Those highest industrial standards that ensure quality go hand-in-hand with legal regulations that compounders must observe. Adherence to regulations enacted by the FDA within the past year requires diligent attention to detail. These guidelines address issues of sterility during the development of CSPs in compounding pharmacies.

State Regulations — From Licenses to Notepads

Compounding pharmacies must also observe policies enforced by state boards of pharmacy. State jurisdictions mandate the licenses that are required for facilities, for pharmacists, and for the other employees working at compounding facilities. State jurisdictions also regulate virtually every other matter relating to CPUs, ranging from the origins of ingredients to the forms and pads used for patients’ prescriptions.5  As far as origins go, finding a supplier of raw APIs who invests time in innovative research is critical to ensure that medications are ultimately safe and effective.

Logistical Interplay

When adherence to detail is valued, interpersonal communications take time every step of the way. As more patients are seeking that personal approach when it comes to healthcare — not only as in-patients, but as consumers of prescription and OTC medications — the importance of building lasting relationships with suppliers and with clients is just as crucial for pharmaceutical producers.

In turn, once compounding pharmacists have their APIs, they sometimes then need to speak with prescribing doctors to adjust or clarify individual orders. This all can make the process take longer.6

Talking with Patients

Because compounding pharmacists make everything by hand and per order, they only proceed to do so once receiving the go-ahead from patients. As far as slower-paced communications go, it’s also worth bearing in mind that many a compounding pharmacist pursues that particular field because they are interested in working as more than a pill-vending dispenser standing at a window.

An increasing number of highly respected doctors report that, in their own experiences, they find the more careful and mindful interviewing and observation of patients to be the strongest, safest, and most effective method of practicing medicine7. Because compounding pharmacists have a wealth of knowledge to share as practitioners, it is becoming increasingly popular for them to take the time to offer individualized counseling to patients, particularly as the industry heads toward the accountable care model.

At PNA, we focus on innovative research and first-class customer service. Wed like to be your source for the highest-quality pharmaceutical ingredients available, so that you can meet each patients individual needs. Contact us today so that we can help your pharmacy meet legal and industrial standards regarding compounded medications.

Show 7 footnotes

  1. “50 Studies Every Doctor Should Know”, 2012, http://50studies.com/slow-medicine/
  2. “Updates in Slow Medicine”, 2015, https://www.facebook.com/pages/Updates-in-Slow-Medicine/1485271971725627
  3.  “Why Compounded Medications Take Longer than Regular Prescriptions”, 2015, https://thecompounder.wordpress.com
  4. “Should a Doctor Be Like a Gardener?”, 2012, http://blogs.wsj.com/speakeasy/2012/04/25/should-a-doctor-be-like-a-gardener/?mod=google_news_blog
  5. “State Regulation of Compounding Pharmacies”, 2014, http://www.ncsl.org/research/health/regulating-compounding-pharmacies.aspx
  6.  “Why Compounded Medications Take Longer than Regular Prescriptions”, 2015, https://thecompounder.wordpress.com
  7. “If Slow is Good for Food, Why Not Medicine?”, 2015, http://www.npr.org/sections/health-shots/2014/12/05/368736643/if-slow-is-good-for-food-why-not-medicine

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