Loperamide (Imodium®) moved to unscheduled status in the National Drug Schedule. As of January 17th, 2003, Loperamide can be sold at any retail outlet.

As a pharmacist, how does that make you feel? How well do you counsel patients on Loperamide when they come into your pharmacy? Are you available to give them advice and answer their questions? Are you documenting the use of Loperamide and sending the patients for further assessment when warranted?
Schedule II and Scope of Practice
The Standards of Practice Working Group, in conjunction with a subgroup looking at the scope of practice, has been researching and exploring opportunities for an expanded role for pharmacists.

In their report to Council in March 2002, the Working Group brought forward several recommendations for expanding the scope of practice for pharmacists, but foremost in the report was the point that, along with expanding the scope of practice, we must also ensure that pharmacists are practicing optimally within the current scope.

At the same time, the Working Group identified Schedule II products as a category of drugs that pharmacists often ignore the rights and responsibilities that the schedule provides.

The Working Group recommended:
“In order to ensure consistent application of Standards of Practice of products in Schedule II, the Standards of Practice Working Group should develop a process for applying the standards to Schedule II products, particularly when the product originally had status in Schedule I and requires more pharmacist intervention and counselling.”

The above recommendation was made in light of the numbers of medications which are either being removed from prescription status and put into Schedule II or III, or have even become unscheduled and can now be sold anywhere.

The Standards of Practice Working Group urges members to take their role seriously in assisting patients with drug therapy or medications in Schedules II and III. The Standards (see Operational Component 4.4 on page 10) emphasize the role of pharmacists in drug therapy— no matter which schedule the drug is listed. Patients often require more advice and counselling for Schedule II and III products as they usually have not consulted another health care provider in these instances.

Pharmacists can provide vital information to patients needing medication for acute, self-limiting conditions such as diarrhea, headache, heartburn, coughs and colds and allergies. As the most accessible health care provider, the community pharmacist assesses patients every day and makes recommendations for safe medication use for symptomatic relief.

It is a standard of practice that as the pharmacist, you must be clearly identifiable and available, accessible and approachable to consult with a patient who seeks to self-medicate. You must take reasonable steps to enter into a dialogue with such a patient to assess their medication needs.
You also have an even greater opportunity to assure safe and effective use of Schedule II products such as Acetaminophen with Codeine 8 mg preparations, head lice products, pin worm treatments and high potency iron products. Schedule II products must be kept in an area that does not allow self-selection by the patient and it is a standard of practice that the pharmacist must always be involved in the decision to sell a Schedule II product.

We all remember the investigative journalism conducted some years ago when Terfenadine and Astemizole were made Schedule C (the historic equivalent of today’s Schedule II) products. The journalists found that many pharmacists provided Astemizole and Terfenadine to patients without any of the required dialogue.

How well do you counsel patients on Schedule II Drugs?
How do you handle Schedule II products in your practice now? How many times in your day is the “point and nod” method or “raised eyebrows from 20 feet” is your only interaction with a patient requesting a Schedule II product? For how many Schedule II products do you also provide your patient with written information to reinforce your counselling?

Every time you exercise the “point and nod” to give your approval to sell a Schedule II medication, your patient is denied your valuable knowledge and judgement. Couldn’t the corner gas station attendant provide the same level of care as your raised eyebrows from 20 feet? Is it any wonder that there is no public outcry as potent medications such as Loperamide slide into general public access?

The next time someone requests Tylenol® #1, take the reasonable required steps to dialogue with the patient. Assess their need for pain relief and provide alternative choices and appropriate treatments. Ask yourself: Am I assessing for medication-induced headache? Do I have literature available to assist and educate my patients about medication-induced headaches? Do I feel it’s appropriate to sell 200-tablet-size bottles of a Codeine-containing product to anyone who requests it? Have I considered whether a large-volume bottle might contribute to a patient’s inappropriate or overuse of a medication? What is a reasonable quantity for occasional personal or family needs and for safe storage?

If your patient suffers frequent migraines, have they been assessed recently by a physician for preventative therapies? If patients ask frequently about relief for dental pain, have they been assessed by their dentist? Pharmacists are not only skilled and knowledgeable about advising patients about their medications, but are also able to assess whether the patient needs further assessment by another health care professional. This triage role is invaluable to the patient’s overall care.

Documentation is Integral
Documenting your recommendations, along with the products used by your patients, is integral to overall therapy. You should be documenting the recommendations you make, as well as referrals to other health care providers, to ensure continuity of care for your regular patients.

Remember the Standard of Practice requiring you to “endeavour to enhance patient awareness of the benefits, limitations appropriate use and risks associated with nonprescription products.”

Also ensure that your staff know that only a pharmacist, intern or registered pharmacy student (under the direct supervision of a pharmacist) may provide information or advice on non-prescription medications, natural health products or complementary medications.

Working Group to Set Documentation Guidelines
The Standards of Practice Working Group recognizes that pharmacists have traditionally been documenting prescription information rather than patient information. The Working Group is currently working with the Professional Practice Committee to develop a set of guidelines that will assist pharmacists in further developing their documentation skills.

The Working Group sees many existing opportunities for pharmacists to evaluate and make recommendations on Schedule II and III products. Furthermore, the College’s Pharmacy Practice field inspectors report that pharmacists’ application of the Standards of Practice for Schedule II products remains inconsistent.

The Working Group wants to stress that if we, as a profession, wish to advance our scope of practice, we need to maximize opportunities to deliver patient care within the scope that we currently have.

I challenge you to make Schedules II and III the first frontier for advancing the scope of practice by fully applying all the standards in your practice.

If the Standards of Practice Working Group can assist you with implementing these standards in your pharmacy, let us know. If you have some success stories you can share with others, please let us know those too. If we as pharmacists wish to expand our role, it is important that we first ensure that we have solidly implemented the current standards for all patients — regardless of the category of medication they might need.