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Each issue will include an editorial on a topic that is important for the profession of pharmacy, as well as a review of a new drug that includes a comparison of the new drug with previously marketed drugs that are most similar in activity, and a New Drug Comparison Rating (NDCR) for the new drug. Read on for this month's issue.

May 2019 Issue [Download PDF format]
In this issue:
EditorialNew Drug Review
EDITORIAL:

"I believe I am a danger to the public working for CVS."

- Anonymous CVS Pharmacist

Background

I have been a pharmacist long enough to remember the time when CVS was first started. Its leadership demonstrated a strong commitment to the professional role of pharmacists and their communication with patients. Television advertisements featured pharmacists counseling patients. I encouraged my students who were interested in a position in a chain pharmacy to seek an opportunity with CVS.

Very unfortunately, for both pharmacists and consumers, things have radically changed. Yes, smiling pharmacists are still featured in CVS advertisements. However, the reality of the employment experience of many CVS pharmacists has markedly deteriorated, even to the point of being dangerous.

The anonymous pharmacist (AP) who made the comment that is the title of this editorial is not one of my former students, but is known to me as an individual who is very caring and has the courage to communicate concerns. When AP learned that the Board of Pharmacy was holding a meeting at which pharmacy policies and working conditions would be discussed, AP submitted a letter. AP's letter had to be submitted anonymously because, as AP stated in a separate message to me, "I know I would be terminated immediately for speaking against my employer." The letter AP sent to the Board of Pharmacy includes the following statements:

"Since the Aetna buyout we have noted increased pressure to provide pharmacy services with reduced staffing. This includes both pharmacists and technicians."

"The company routinely ignores pharmacist to technician ratio."

"Technicians and pharmacists are required to sign up people for refill or 90 days prescriptions or scriptsync without their permission. This causes unwanted prescriptions to be sold and then they are brought back and yes we give them their money back and some of the drugs make it back on the shelf, especially inhalers and high dollar items. CVS management will lie about this. Sit a few of them down and administer a polygraph test and watch them squirm."

"Requiring pharmacists and technicians to work off the clock is a common practice…Most pharmacists come in early, stay late, and, if we complain, we are told the job needs to be done, just work faster, watch your dashboard, and stay out of the red."

"We keep the fast food places in business because the pharmacists are always buying lunches for the techs and they cannot take lunch because we are behind. They never get their break that is also required by law.

"I invite the regulator agents to visit and check a few profiles and see how many customers have no allergy information entered. CVS is more interested in the metrics, converting to the drug that costs CVS the least. We have been instructed by district leaders to scan our credentials when it appears in the QV screen to indicate we have talked to a patient."

"Please take action. I am speaking for many silent pharmacists."

This pharmacist must remain anonymous because, as difficult as AP's working conditions are, AP must keep the position with CVS as there are not other employment opportunities for pharmacists available in that geographical area, a situation that now exists in many parts of the country. I am not in a position to judge, and do not fault any pharmacist for her or his decision regarding employment. However, when circumstances arise which place patients at risk, pharmacists must have the courage demonstrated by this pharmacist in making concerns known, even when it must be done anonymously. I was motivated by AP's action and I have also written a letter to that Board of Pharmacy.

* * * * * * *

April 29, 2019

To the Members of the _________ State Board of Pharmacy:

It is my understanding that you will be discussing policies and working conditions in pharmacies, and I wish to share my concerns that are based on information communicated to me by pharmacists who are employed in chain pharmacies. I am a pharmacist, and recently retired after 52 years as a member of the faculty at the Philadelphia College of Pharmacy at the University of the Sciences. I continue to write a monthly newsletter, The Pharmacist Activist (www.pharmacistactivist.com) in which I provide editorials and reviews of new drugs. Many of my editorials address concerns regarding patient safety in the use of medications, and the working conditions of pharmacists and pharmacy technicians.

I have received hundreds of responses to my editorials from pharmacists with whom I speak at meetings of pharmacy organizations, and via email and telephone communications. In addition, I have served as an expert witness in a number of lawsuits in which patients have been harmed because of dispensing errors or other medication-related problems. By far, the largest number of concerns of which I have been made aware are communicated to me by pharmacists working at CVS stores. The most common concerns that are provided include the following:
  1. Concerns about patient safety and errors that are attributable, at least in part, to management-imposed policies, quotas, and working conditions.

  2. Understaffing of pharmacists and pharmacy technicians that results in a stressful and error-prone workplace environment.

  3. Policies and metrics that emphasize numbers (e.g., prescriptions, immunizations) and how quickly responsibilities can be completed (e.g., time to dispense a prescription).

  4. Insufficient time to speak with patients about medications dispensed.

  5. Policies and procedures with respect to how dispensing errors are to be handled.

  6. Inadequate compensation for pharmacy technicians that results in frequent turnover and extra time required to train new technicians. As one example, a pharmacy manager informed me that when a Wendys restaurant opened nearby, five of the technicians left to work at Wendys because of its higher hourly wage.

  7. No or insufficient authority to fire technicians who make frequent mistakes or who otherwise perform inadequately.

  8. Having supervisors who are not pharmacists, that is occurring with increasing frequency.

  9. Work schedules (e.g., 12- and 14-hour days with no or limited breaks; difficulty in scheduling days off/vacation time) that contribute to stress and errors. I often hear comments such as, "When I finish a long shift at the pharmacy, I am so tired that the specific activities of the day are a blur, and I only pray that there were no serious errors."

  10. Having to designate customers to receive automatic refills when they do not request it or even decline it.

  11. Having to work "off the clock" without pay to complete activities the company expects to be done within defined time periods.

  12. Fear of termination or retaliation if concerns are voiced. An increasingly frequent response from a supervisor is the following: "If you don't like the way things are done here, I have five applications from pharmacists who would love to have your job, and maybe you should consider another opportunity." Forms of retaliation have included assignment to another pharmacy with the chain that is a farther distance from the pharmacist's home, or assignment to be a "floater" among several pharmacies on an unpredictable schedule. One chain pharmacist has told me that if a concern was voiced about working conditions at a meeting of the Board of Pharmacy, the pharmacist would be terminated before leaving the room.
I have written in greater depth regarding some of these concerns in many of my editorials. I would be glad to provide copies if it would be helpful.

There is information that chain pharmacies would have available that would be of value in your consideration of these matters. This information includes:
  • the criteria for determination of the number of pharmacist hours and pharmacy technician hours for a pharmacy;

  • the metrics that are used in the procedures for processing and dispensing prescriptions;

  • the time within which a prescription is expected to be dispensed following receipt (including warnings/signals about the amount of time elapsed);

  • procedures in which pharmacists at remote sites are involved in the review and processing of prescriptions;

  • bonuses that are based on the number of prescriptions completed, and;

  • records of dispensing and other errors, as well as resultant reports (e.g., to the Board of Pharmacy) and actions taken.
If I can be of assistance, please feel free to contact me.

Sincerely,
Daniel A. Hussar
Author/editor of The Pharmacist Activist

* * * * * * *

More action needed

I have intentionally not identified the state in which this pharmacist practices or the specific board of pharmacy because I believe that the situations and concerns are of the greatest importance and exist in every state. If the concerns identified are ones you have experienced or otherwise share, I encourage you to communicate them to your State Board of Pharmacy or other appropriate authorities. If it will help, provide a copy of this issue of The Pharmacist Activist in support of your concerns. If you wish to do so, please use all or part of the above information verbatim as your own message – it is not necessary to identify me or the anonymous pharmacist as the source, and this statement provides permission to do that.

If you have had personal experiences or are otherwise aware of situations that are pertinent with respect to the matters addressed, I am interested in learning about them, as well as actions you are taking.

Daniel A. Hussar
danandsue3@verizon.net


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NEW DRUG REVIEW:

Lofexidine hydrochloride
(Lucemyra – US WorldMeds; Salix)
Agent for Opioid Withdrawal

New Drug Comparison Rating (NDCR) = 4
(significant advantages)

in a scale of 1 to 5, with 5 being the highest rating

Indication:
Mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

Comparable drugs:
Buprenorphine, methadone (although the properties of lofexidine are most similar to those of clonidine, the latter agent does not have a labeled indication for the management of opioid withdrawal symptoms).

Advantages:
  • Is the first non-opioid treatment for the management of opioid withdrawal symptoms;
  • Increases the likelihood of successful opioid discontinuation;
  • May reduce the need for continued use of opioid agonist substitutes (i.e., buprenorphine, methadone);
  • Is not a controlled substance.
Disadvantages:
  • Greater risk of cardiovascular adverse events (e.g., hypotension);
  • Is administered frequently (4 times a day).
Most important risks/adverse events:
Hypotension/orthostatic hypotension, bradycardia, syncope (should be avoided in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, chronic renal failure, those with marked bradycardia, and those taking other medications that decrease pulse or blood pressure); prolongation of QT interval (should be avoided in patients with congenital long QT syndrome, and should be closely monitored in patients with other risk factors including concurrent use of other medications that may cause QT prolongation [e.g., methadone, moxifloxacin]; hypokalemia or hypomagnesemia should be corrected prior to initiating treatment); may increase the CNS depressive effect of benzodiazepines, barbiturates, alcohol, and other sedating agents (patients should be cautioned about activities such as driving or operating machinery); action may be increased by the concurrent use of a CYP2D6 inhibitor (e.g., paroxetine); efficacy of orally-administered naltrexone may be reduced if it is administered within 2 hours of lofexidine.

Most common adverse events:
Hypotension (30%), orthostatic hypotension (29%), bradycardia (24%), dizziness (19%), sedation (13%), somnolence (11%), dry mouth (10%).

Usual dosage:
Recommended starting dosage – 0.54 mg (3 tablets) 4 times daily during the period of peak withdrawal symptoms (e.g., the first 5 to 7 days following the last dose of the opioid); a period of 5 to 6 hours should separate doses; no single dose should exceed 0.72 mg (4 tablets) and the total daily dosage should not exceed 2.88 mg (16 tablets); dosage adjustments should be guided by the symptoms, and treatment may be continued for up to 14 days; when treatment is to be discontinued, the dosage should be reduced gradually over a 2- to 4-day period to mitigate withdrawal symptoms of the drug (e.g., reducing by 1 tablet per dose every 1 to 2 days); product labeling should be consulted for dosage recommendations for patients with impaired hepatic or renal function.

Products:
Film-coated tablets – 0.18 mg lofexidine.

Comments:
Opioids (e.g., morphine) reduce norepinephrine concentrations and, with continued use, the brain establishes a new equilibrium by increasing norepinephrine production in order to maintain normal functioning. When the use of an opioid is discontinued or its dosage is significantly reduced, the brain's increased norepinephrine concentrations are no longer offset by the presence of the opioid. This results in a norepinephrine surge that produces the acute symptoms of withdrawal (e.g., pain, muscle spasms, stomach cramps, nausea, agitation, drug craving). For patients with opioid use disorder, addiction and withdrawal are often managed with the partial opioid agonist buprenorphine (e.g., Suboxone) or the opioid agonist methadone. The central alpha-2 adrenergic agonist clonidine has also been used in the management of withdrawal symptoms but this is not a labeled indication.

The actions of lofexidine are most similar to those of clonidine. It binds to receptors on adrenergic neurons and reduces the release of norepinephrine. It is used as part of a broad, long-range treatment plan. Its effectiveness was evaluated in two placebo-controlled studies and patients treated with lofexidine experienced less severe withdrawal symptoms, and a higher proportion of patients completed the period of treatment.

Daniel A. Hussar
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