Should the following drugs be switched from Rx to OTC, moved behind the counter where an R.Ph. would dispense without an
Rx, or remain Rx-only?
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Like wardens guarding the right-of-way, community pharmacists are going to see a lot more traffic traipse through their pharmacies.
The reason? An increasing number of states have passed laws or regulations requiring cold medicine containing pseudoephedrine
to be placed behind the pharmacy counter, creating a de facto third class of drugs. Additionally bolstering the power of pharmacists
is the possible approval of emergency contraception for sale without a prescription.
Make no mistake about it. Pharmacists are fast becoming the gatekeepers to a new class of drugs—one between prescription drugs
and OTCs. Meanwhile, a host of potential prescription drugs eagerly wait in the wings to make the switch to OTC status.
Which is the best Rx-to-OTC switch to date?
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Drug Topics conducted an exclusive survey of 1,000 pharmacists to find out how they feel about past and potential Rx-to-OTC switches
as well as the creation of a third class of drugs. A four-page questionnaire was mailed to them this past April. When fieldwork
was closed, usable replies had been received from 210 pharmacists, yielding a 21% response rate.
Just say No
Which is the worst Rx-to-OTC switch to date?
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The majority of pharmacists gave a thumbs-down to an Rx-to-OTC switch for Plan B (levonorgestrel Duramed Pharmaceuticals,
for emergency contraception), statins, antiobesity drugs, and corticosteroids. Sixty percent of respondents said Plan B should
remain Rx-only, 31% said it should be moved behind the counter where a pharmacist would dispense the drug without a prescription,
only 9% said it should be switched to OTC.
When it comes to statins, 88% of respondents said statins should remain prescription-only, 10% said statins should be moved
behind the counter, and 2% believe statins should be switched to OTC. The majority of respondents (84%) said antiobesity drugs
should remain Rx-only, 11% asserted that these drugs should be moved behind the counter, and 5% approved of an OTC switch.
Is there a need for a third class of drugs?
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Eighty percent of respondents said corticosteroids should remain Rx, 16% were in favor of moving these drugs behind the counter,
and only 4% were in favor of OTC status.
When asked what their biggest concerns were about switching Rx drugs to OTC status, 47% mentioned that patients may not correctly
follow dosing instructions and 37% were worried that patients may experience adverse effects from improper use. Meanwhile,
9% were concerned that the pharmacist may be liable if the patient suffers any adverse effects, while another 9% held the
opinion that in an effort to save on out-of-pocket costs, patients may request another drug—which could be a prescription
drug—that is covered by their insurance provider.
Are R.Ph.s in favor of FDA creating a third class of drugs?
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Pharmacists were more supportive of Plan B going OTC than the other drugs. Among the eight pharmacists who gave a thumbs-up
to this switch, five respondents gave quick access as their reason, two respondents mentioned fewer unwanted pregnancies and
abortions. One respondent said his approval is based on ethical reasons.
Among the 31% of pharmacists who gave the nod to moving Plan B behind the counter and dispensing it without a prescription,
more than half (57%) attributed their response to the need for pharmacist counseling, followed by 38% who said quick access.
Five percent of respondents felt that increased access would make for fewer unwanted pregnancies/abortions. Three percent
were in favor of a switch for "safety reasons/side effects."
What impact have Rx-to-OTC switches had on patients?
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Sixty percent of respondents favored keeping Plan B's status as Rx-only. Among those who said they were in favor of maintaining
this status, 26% mentioned the need for a physician's counseling and 24% noted a concern for safety/side effects. Meanwhile,
20% stated that easier access may lead to excessive use, while 16% cited ethical and moral reasons stemming from easier access
to Plan B. Fifteen percent were worried that if Plan B were an OTC, it would encourage unsafe behavior, and 4% were nervous
about liability issues.
A whopping 96% of respondents who favored maintaining Rx-only status for statins had concerns about patient safety. Twenty-four
percent cited the importance of pharmacists being able to closely monitor patients' activities. Concern over patient safety
was also the reason named by 98% of respondents who argued that antiobesity drugs should remain Rx. Not surprisingly, 99%
of respondents identified patient safety as the reason for keeping corticosteroids from going OTC.
The future of switches
Have switches increased the need for patient counseling?
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Slightly more than half (54%) of respondents remarked that there are more prescription drugs that could be safely switched
to OTC, while 46% disagreed. Fifty-eight percent of pharmacists with fewer than 11 years of experience were slightly more
likely to contend that more Rx drugs could be safely switched, compared with those who had 11 to 20 years of experience (53%)
and those with 21 or more years of experience (52%).
Allegra (fexofenadine HCl, Aventis), Zyrtec (cetirizine HCl, Pfizer), and antihistamines were most frequently named as drugs
that could be safely switched to OTC status.
And the winner is ...
When it comes to rating the best Rx-to-OTC switch, allergy drugs took first place. Half of the respondents applauded allergy
medications as the best switch. The most common reason among those selecting allergy medications is that they perceived these
drugs to be safe for consumers to acquire and administer on their own. Heartburn medications took second place, with more
than one-third (36%) of those polled voting for this category, followed by smoking-cessation products, which were selected
by 28% of respondents.
Bad news
Which category of drugs do pharmacists rate as the worst switch? Nearly half of pharmacists polled (46%) singled out heartburn
drugs as the worst Rx-to-OTC switch. The most common reason cited for this was the concern that heartburn symptoms might be
masking a more serious problem, and that patients may experience more severe problems by avoiding a visit to their physician.
One respondent said that the switch "allowed patients to treat a potentially serious condition without seeking medical help.
The seriousness of the conditions would be masked." Another pharmacist remarked, "Insurers stopped paying for all prescription
drugs in this class." Yet another R.Ph. pointed out that "some gastrointestinal or esophageal problems are not diagnosed or
treated properly." Finally, a respondent blurted out, "People can't keep up with all these changes, much less read [the directions]."
Nearly one-quarter (23%) of the respondents selected smoking-cessation products as the worst switch. Several pharmacists cited
low sales. One pharmacist said he believed that the product wasn't backed by enough advertising. Another pharmacist lamented,
"People really don't want to spend the time to quit smoking."
Eighteen percent of respondents rated allergy medications as the worst switch. One pharmacist said this switch greatly increased
patients' out-of-pocket expenses.
Then there were comments along these lines: "All switches have been good." Another respondent remarked, "I don't feel any
of the switches have been bad." Still another pharmacist asserted, "I feel that all of the switches have been appropriate."
More to come
Nearly all of the R.Ph. respondents (95%) believe that more prescription drugs will be switched to OTC over the next five
years. Roughly three-quarters of pharmacists (74%) are satisfied with the current pace of switch approvals. Of those who are
not content with the pace, 68% think that the pace is too fast and 32% noted that the pace is too slow.
Respondents with less experience on the job are more pleased with switches than are their more experienced counterparts. Sixty-nine
percent of respondents with 21 or more years of experience are happy with the pace of switches, compared with 83% of respondents
who have been wearing a white jacket for 11 to 20 years and 83% who have been practicing fewer than 11 years.
More female pharmacists (84%) than male pharmacists (68%) are satisfied with the pace of Rx switches.
The bottom line
When it comes to their pharmacy's bottom line, one-third of pharmacists (34%) report that Rx-to-OTC switches have been a boon
for them. Nineteen percent claimed that these switches have hurt their pharmacy's bottom line, and nearly half (47%) reported
that switches have not had any financial impact on their pharmacy's income.
Drugs going OTC have had the least impact on independent pharmacies, as 58% reported that there has been no effect on their
bottom line. In contrast more than four out of 10 respondents from discount stores and chains reported that the switches have
improved their pharmacies' bottom line.
How much does it cost? What impact have the Rx-to-OTC switches had on patients? Eighty-four percent of respondents expressed the view that switches
have improved convenience and patients' access to products; 58% indicated that switches decreased their patients' visits to
doctors. Although 38% mentioned switches decreased patients' out-of-pocket costs, 37% reported that switches increased patients'
costs.
Obviously, when it comes to the impact that switches have had on patients, pharmacists have mixed feelings. One pharmacist
said switches "allowed [patients] to hurt themselves at an accelerated pace," while another pharmacist said he believes, "switches
have made the pharmacist their respected consultant."
Asked what impact Rx-to-OTC switches have had on the cost of health care for patients, 43% indicated that switches have decreased
patients' healthcare costs, while the same percentage said switches hiked patients' healthcare costs. Fourteen percent of
the respondents said switches haven't had any impact on their patients' healthcare costs.
Can we talk? Almost three-quarters (72%) of the respondents asserted that Rx-to-OTC switches have increased the need for them to counsel
patients. Ten percent said the switches have decreased the need for them to counsel patients, and 18% said the switches have
not had any effect.
What about the impact of switches on the cost of health care for insurers and third parties? Seventy-nine percent of pharmacists
indicated that the Rx-to-OTC switches have decreased the cost of health care for insurers and third parties. Only 6% said
the switches have increased insurers' and third parties' healthcare costs, and 15% said the switches have not had any impact
on the cost of health care for insurers and third parties.
A whopping 97% of respondents reported that most insurance companies do not cover OTCs. Three-quarters of respondents noted
that there is a growing trend among insurers not to cover OTCs. Only 10% responded that the trend among insurers is to cover
OTCs, and 14% were not sure.
A majority of pharmacists (92%) have come across patients who have opted for another Rx drug when their insurer wouldn't pay
for a recently switched Rx-to-OTC drug. Seventy-five percent of those pharmacists predicted that this will be a growing trend.
Pharmacists were asked whether insurers should cough up money to pay for nonprescription drugs. Fifty-five percent said insurers
should not open their wallets to pay for OTCs, while 45% said that insurers should pay.
It appears that practice setting may make a difference when it comes to whether R.Ph.s support insurers covering OTCs: 56%
of respondents in independent pharmacies supported the idea, while roughly six in 10 respondents working in either a supermarket
(67%), discount store/mass-merchandiser (64%), or chain pharmacy (60%) opposed the idea. (Caution: Extremely low bases were
reported for discount store/mass-merchandisers and supermarkets.)
Put out the welcome mat
Fifty-two percent of respondents believe there is a need for the United States to set up a third class of drugs consisting
of pharmaceuticals kept behind the counter and dispensed by pharmacists without a prescription. Twenty-seven percent did not
feel there is a need for this drug class, and 21% were not sure.
More than half of male respondents (58%) think that there is a need for a third class of drugs, compared with 40% of female
respondents. More than half of pharmacists with 21 or more years of experience were more likely to believe there is a need
for a third class of drugs, compared with 37% of respondents with 11 to 20 years of experience and 46% of respondents who
have worked for less than 11 years.
Thirty-five percent of respondents who think there is not a need for a third class of drugs said they are overworked and do
not have time to oversee it. Twenty-seven percent of these same respondents said patients need physician counseling and monitoring,
while 19% gave pharmacists' liability as the reason why they believe there is not a need for a third class of drugs. Again
these findings come from low bases.
More than half of the respondents who feel there is a need for a third class attributed this to the fact that they believe
pharmacists can successfully counsel and instruct patients. Ten percent who said there is a need for this class said it can
help reduce drug abuse and illegal drug labs.
When it comes to actually creating a third class of drugs, nearly six in 10 pharmacists (57%) said that they are in favor
of a Food & Drug Administration-created third class of drugs, while 43% oppose it. More male pharmacists are in favor of creating
a third class than female pharmacists, 67% versus 41%, respectively. Sixty-four percent of pharmacists with 21 or more years
of experience were more likely to favor this than those with 11 to 20 years of experience (37%) or less than 11 years experience
(53%).
One-third of respondents said they are in favor of the FDA creating a third class of drugs because R.Ph.s can instruct and
counsel patients. Sixteen percent asserted that the creation of a third class would increase/ accelerate patient access to
these drugs, while 12% believe that a third class would help increase compliance and provide better patient care. Another
12% reported that having a third class of drugs would help improve safety, while 9% believe it would reduce costs, and 9%
claim that it would add to pharmacists' professionalism.
What reasons did respondents give for opposing the creation of a third class of drugs by the FDA? Thirty-nine percent of respondents
listed pharmacists' liability as their main concern, while 30% feel that pharmacists are overworked and don't have time. Each
of the following reasons was cited by 9% of respondents: pharmacists are not paid for it; patients need physician counseling
and monitoring; there is a greater chance of abuse and misuse; R.Ph.s don't have the means to monitor patient activities;
and concern for safety.
What are pharmacists' biggest concern about the creation of a third class of drugs? Nearly one-third (32%) of those polled
said they may be liable if the patient suffers any untoward effects; 27% of respondents said their workloads may increase
significantly; 20% said the patient may experience adverse effects from improper use; and 15% replied that the patient may
not correctly follow dosing instructions.
Other roadblocks
States passing rules restricting the sale of products containing pseudoephedrine was identified by 52% of respondents as a
step in the direction of a third drug class. Twenty-seven percent did not perceive this development as a push in that direction,
and 21% were not sure.
Nearly half of the respondents (48%) have the opinion that the pharmacist shortage will not be a barrier to patients obtaining
a third class of drugs. One-third of those polled feel that the shortage will be a barrier, and 19% were not sure.
Almost half (48%) of female respondents perceive the shortage of pharmacists as a barrier to a third class of drugs, compared
with 23% of male respondents.
English lesson
Nearly three-quarters of pharmacists (72%) believe the United States can learn from Britain's experience with setting up a
third class of drugs. Thirty percent of responding pharmacists said Britain's experience would make it easier for the United
States to create this category of drugs. Only 14% indicated that Britain's experience would not have any impact on U.S. actions.
In your lifetime
Half of pharmacists (49%) believe there will be a third class of drugs set up in the United States in our lifetime. One-fifth
said that they do not believe this will be a reality in this timeframe. Nearly one-third said they are not sure.
Among those who do not believe a third class of drugs will be established in our lifetime, 62% pointed a finger at FDA resistance,
60% blamed manufacturer resistance, 55% reasoned that legislation must first be passed, and 33% blamed pharmacists' lack of
time to provide patient counseling as the reasons this drug class won't come to fruition.
Male R.Ph.s are slightly more likely than females to believe there will be a third drug class in our lifetime (51% versus
46%). On average, respondents who believe there will be a third drug class in our lifetime believe it will take about five
years for it to come to pass.
Pharmacists foresee positive and negative consequences resulting from the creation of a third drug class. Seventy-nine percent
of those who look at the glass as half empty think that the creation of a third class will cause them to have to spend more
time counseling patients, and 72% said it would increase their exposure to liability.
On the bright side, more than half (57%) said that the creation of a third drug class may increase pharmacists' standing in
health care, 56% believe it may bring in more walk-in traffic, and 54% said it may increase their pharmacy's sales and profits.
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