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Editorial: Looking Forward 2012, Part IV

Pharmacy Student, Pharmacy Intern, OR Intern Pharmacist

This is the fourth in our series on issues involving pharmacy and pharmacy compounding. In this issue, we will briefly discuss the designations "Pharmacy Student," "Pharmacy Intern," or "Intern Pharmacist"; which is it or when is each one the appropriate designation?

Attending national meetings, I've noticed students wearing nametags with various designations. Which of these designations is more correct? This is an issue that really should be addressed for accuracy, and it is not a new issue. Let's look at the differences in the designations for one who is in training to become a pharmacist.

Pharmacist: According to Stedman's Medical Dictionary, 26th edition (Dictionary 1) , a "pharmacist" is "One who is licensed to prepare and dispense drugs and compounds and is knowledgeable concerning their properties." According to The American Heritage Dictionary, 2nd College Edition (Dictionary 2), a "pharmacist" is a person trained in pharmacy. Wikipedia (Dictionary 3) defines "pharmacists" as allied health professionals who practice in pharmacy, the field of health sciences focusing on safe and effective medication use.

Intern: According to Dictionary 1, an "intern" is "An advanced student or recent graduate undertaking further education by assisting in the medical or surgical care of hospital patients, with supervision and instruction." In Dictionary 2, we find an "intern" defined as "An advanced student or recent graduate undergoing supervised practical training."

Pharmacy: According to Dictionary 1, "pharmacy" is defined as "The practice of preparing and dispensing drugs." According to Dictionary 2, "pharmacy" is defined as "The art of preparing and dispensing drugs." Dictionary 3 defines pharmacy as the health profession that links the health sciences with the chemical sciences, and it is charged with ensuring the safe and effective use of pharmaceutical drugs.

Back in the 1960s, when I was a student at the University of Oklahoma College of Pharmacy, we designed a patch for our jackets that said "Intern Pharmacist" and asked for approval. It was denied, as we were told that we were not pharmacists yet. The correct way to have them made was to say "Pharmacy Intern," which we did.

According to the definitions given above and current practice, those in training and not yet licensed as pharmacists but registered with the boards should be designated as "Pharmacy Interns." How about "Pharmacy Student," which correlates with "Medical Student" (MS1, MS2, MS3, MS4, etc.). I assume a "pharmacy student" is one that has not registered as a "pharmacy intern" with the state board of pharmacy to start accumulating hours to take the NAPLEX exam.

I do need to add that at least one state does define an "Intern Pharmacist" as a person registered with the board who has completed the educational requirements determined by the board. An intern pharmacist may perform any activity restricted to a pharmacist while under the supervision of a registered pharmacist. Of note here is that the individual has "graduated" and is "registered" with the board.

In summary, is it appropriate to designate a "pharmacy student" as one enrolled in a college of pharmacy; a "pharmacy intern" as one that has registered with the state board of pharmacy as an intern; and a "pharmacist intern" as one that has graduated and met all educational requirements along with registration with the state board and awaiting to take the NAPLEX exam?

One historical note, a "pharmacy extern" was a term used years ago to designate a pharmacy student obtaining hours toward licensure prior to graduation, and a "pharmacy intern" as one that was obtaining hours toward licensure after graduation.


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

FDA Staffers Sue Agency Over Surveillance of Personal E-mail
The FDA secretly monitored personal e-mail of a group of its own scientists and doctors for whistleblowing after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients. The FDA surveillance consisted of detailed e-mails and memos. The events in question occurred over two years as the employees accessed their personal Gmail accounts from government computers.

The startup screen on FDA computers warns employees, "you have no reasonable expectation of privacy," including any communication accessed or sent from the machine. This message has appeared since at least "December 2010." However, copies of the e-mails show that, starting a year earlier, in "January 2009," the FDA intercepted communications with congressional staffers and draft versions of whistleblower complaints complete with editing notes in the margins.

The doctors and scientists filed suit claiming the government violated their constitutional privacy rights by looking at "personal" e-mail for the purpose of monitoring lawful activities. One plaintiff stated, "Who would have thought that they would have the nerve to be monitoring my communications to Congress?"
http://www.washingtonpost.com/world/national-security/fda-staffers-sue-agency-over-surveillance-of-personal-e-mail/2012/01/23/gIQAj34DbQ_story.html?wprss=rss_linkset&utm_medium=twitter&utm_source=twitterfeed

Grassley Investigates FDA Surveillance of Doctors and Scientists
Sen. Charles E. Grassley (R-Iowa) demanded that FDA Commissioner Margaret A. Hamburg disclose who authorized the monitoring of FDA scientists and doctors, how many employees were targeted, and whether the agency obtained passwords to personal e-mail accounts, allowing communications on private computers to be intercepted. He also wants to know whether the two-year surveillance campaign is ongoing and stated the following:

"I write to express my concerns over your agency's treatment of whistleblowers as a result of their disclosures to Congress, and specifically disclosures to my office," Grassley, the ranking member on the Finance Committee, told Hamburg. "Whistleblowers�are often treated like skunks at a picnic."

A similar conclusion was reached about four civilian whistleblowers at Dover Air Force Base who reported missing body parts and other management failures at the mortuary that handles the remains of fallen soldiers. The independent Office of Special Counsel concluded that the workers' supervisors retaliated against them for going public, tried to fire two, and placed the others on suspension and indefinite leave.
http://www.washingtonpost.com/politics/fda-monitoring-of-whistleblowers-probed/2012/02/01/gIQAqjc2iQ_story.html

More Money for FDA! Medical Device Approval Fees Double
The medical device industry and the FDA signed off on a tentative agreement for the next 5 years of med-tech user fees, nearly doubling the industry's expected buy-in. The deal raises user fees to $595 million over 5 years. The FDA had asked for an increase from the $295 million to $730 million to $805 million over the next 5 years. The industry balked at that number.

(Editor's Note: See CompoundingToday.com Newsletter of December 2, 2011.)
http://www.massdevice.com/news/advamed-chief-ubl-mdufma-deal-game-changer

Ad Visual Distractions to be Investigated by FDA
Pharmaceutical television commercials contain a segment at the end while a voiceover intones a litany of potential side effects and drug warnings likely to startle anyone. However, that's when the video usually begins a leisurely view of a sailboat or a walk in the woods with a golden lab. Millions of people are apparently more tuned in to the pictures than the cautionary message inserted into the promo. The tranquil scenes are used to lessen the impact of the adverse effects of the drug being advertised.

The FDA is taking public comments on a proposed rule that would ban "distracting images" while the side effect treatise is being read and that has spurred quite a debate over just how these commercials are presented to consumers.

Lunesta, a sleep aid, is an example. A glowing, green butterfly glides serenely through a darkened city while a female voice warns of possible side effects such as walking, eating or driving, aggression, agitation, hallucinations, confusion, worsening depression including risk of suicide, and rare allergic reactions such as tongue and throat swelling that might be fatal.

One cannot forget, the point of the ads is not to educate, it's to sell a product, and we are easily manipulated.
http://www.miamiherald.com/2012/01/28/2613795/cue-the-puppies-how-drug-ads-downplay.html#storylink=cpy

Pfizer Recalls 1 Million Birth-control Packs on Wrong Dosage
Pfizer recalled 1 million birth-control packs after discovering that the tablets were mixed up inside the packages. This could possibly put women at risk for unintended pregnancies.

The company recalled 14 lots of Lo/Ovral-28 tablets and 14 lots of the generic version; about 1 million packs of 28 tablets were withdrawn. Each pack contains 21 white tablets that contain norgestrel and ethinyl estradiol, and the remaining seven tablets are inactive pink tablets. Pfizer found that some blister packs may contain an inexact count of inert or active ingredient-tablets and that the tablets may be out of sequence, which could cause women to take an incorrect daily dosage and increase the risk of accidental pregnancy.
http://www.bloomberg.com/news/2012-01-31/pfizer-recalls-1-million-birth-control-packs-after-mix-up-in-pill-dosages.html

�that because pharmaceutical manufacturers are now having so many products manufactured in other countries to save money, we U.S. taxpayers are spending more and more and more to enable FDA to inspect these facilities? The manufacturers WIN and the taxpayers/patients LOSE. This is called "cost shifting," where the burden is shifted from the manufacturers to the taxpayers so the manufacturers can make more profit! Should the manufacturers not bear the total burden of these inspections?

Upcoming RxTriad
The next RxTRIAD is on "Drug Shortages and Your Compounding Pharmacist." This excellent brochure is prepared in batches so you can mail them to your physicians (and provide them to patients) to inform them that you are their resource for many drug shortages that are now occurring. For details, contact Deb at 800-757-4572, 405-330-0094 extension 1, or dmehlhaff@ijpc.com

Minor Illness or Major Disease?
5th Edition
Addison B, Brown A, Edwards R, Gray G
January 2012; Paperback; $55.00; 256 pages

As pharmacists are on the frontline of health care and are often presented with questions from patients about minor or major problems before the patient goes to a physician, this book discusses the issue of differentiation between a minor illness and a major disease. It explores the range of illnesses encountered in a community pharmacy that can be effectively treated with a wide range of nonprescription medications. The chapters include (1) Introduction, (2) Gastrointestinal Illnesses, (3) Respiratory Systems, (4) Central Nervous System, (5) Infections and Infestations, (6) Obstetrics, Gynecology, and Urinary, (7) Eyes ears and oral health, (8) Nutrition and (9) Dermatology. This can be a valuable textbook for pharmacists and pharmacy students.

A guy who drives
A car wide open
Is not thinkin'
He's just hopin'
      Burma Shave

PCAB is proud to announce the accreditation of the following pharmacy:

Wedgewood Pharmacy; Swedesboro, New Jersey - Initial Accreditation: George Malmberg RPh, Owner; gmalmberg@wedgewoodpharmacy.com