Frequently Asked Questions
Questions and Answers for Pharmacists and Pharmacies
July 10, 2003
The New York State Education Department and the State Board of Pharmacy are pleased to provide you with information on new rules and regulations that will affect your practice and provide for greater public protection.
- Are all pharmacy establishments located in other states
now required to register to do business in New York State?
Answer: Yes. Any establishment that routinely ships or delivers prescription drugs to professionals or patients in New York State must register with the Education Department through the State Board of Pharmacy. This includes manufacturers and wholesalers of drugs and registered pharmacies.
- Do the new law and regulations apply to mail order
and "Internet" pharmacies?
- Are there any exceptions to this requirement?
Answer: Yes, when transactions are isolated, the registration requirement may be waived. New regulations define isolated transactions as fewer than 600 prescriptions per year for pharmacies or sales that total less than $10,000 at wholesale, per calendar year. The Board of Pharmacy may also waive the registration requirement in an emergency.
- Is there a way to confirm that out-of-state establishments,
including "Internet" pharmacies are properly registered?
Answer: Yes. You can search for manufacturers, wholesalers and pharmacies by name or registration number on our Web site. You can search for establishments located within New York State as well as those located elsewhere. You can also verify that a pharmacy establishment is registered by calling 518-474-3817.
- What should I do if an out-of-state firm that routinely
ships or delivers prescription drugs to professionals or patients
in New York State is not listed among registered firms on the
Answer: Please notify the Office of the State Board of Pharmacy by phone at 518-474-3817 ext. 130 or by e-mail at firstname.lastname@example.org.
- When is a pharmacist or registered pharmacy intern
actually required to counsel a patient?
Answer: A pharmacist or pharmacy intern must actually provide patient education (counseling):
- Before dispensing a medication to a new patient of the pharmacy;
- Before filling a new prescription for an existing patient of the pharmacy; and
- If the dose, strength, route of administration, or directions for use has changed for an existing prescription previously dispensed to an existing patient of the pharmacy.
- Are New York State registered mail order and "Internet" pharmacies
required to provide counseling to patients?
Answer: Registered pharmacies that conduct business through the mail or by common carrier must include written notification that counseling is available and provide a toll-free number where the pharmacist or pharmacy intern can be readily reached. A pharmacist or pharmacy intern must be available to provide counseling.
If the pharmacist or pharmacy intern determines that there are potential drug therapy problems which could endanger the health of the patient, including but not limited to: therapeutic duplication, drug-drug interactions and drug-allergy interactions, the patient must be contacted prior to filling the prescription. Alternatively, the pharmacist or pharmacy intern may contact the prescriber and obtain permission to dispense an alternative drug.
If a prescriber gives approval for the dispensing of an alternative drug, the pharmacist must include a notice of the change with the order and make two documented attempts to telephone and inform the patient of the change within 48 hours of mailing or delivery. A telephone call is not required for generic substitution.
- Is a refill authorization or a new prescription for
a drug a patient has recently been treated with considered
a new prescription?
- If a patient is having a prescription refilled or having
a prescription filled for medications previously received,
are we still required to offer to provide counseling?
Answer: Yes. An offer to provide counseling must be made every time a patient has a prescription re-filled or has a prescription filled for a medication therapy that has been re-authorized by a prescriber. Any member of the pharmacy staff can make the offer to counsel on behalf of a pharmacist, including pharmacy interns, clerks, "technicians", etc. If a patient requests to be counseled, a pharmacist or pharmacy intern must be available to provide counseling.
If prescription drugs have been ordered through a registered pharmacy by mail or on the Web, the pharmacist must provide the patient with a written offer to counsel and a toll-free number where the pharmacist or pharmacy intern can be readily reached.
- When a pharmacist or pharmacy intern provides counseling,
what aspects of medication therapy should be covered?
Answer: A pharmacist or pharmacy intern should use his/her professional judgment when deciding what to discuss with a patient during counseling. Depending on the situation, you may choose to discuss among the following:
- the name and description of the medication and known indications;
- dosage form, dosage, route of administration and duration of drug therapy;
- special directions and precautions for preparation, administration and use by the patient;
- common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
- techniques for self-monitoring drug therapy;
- proper storage;
- prescription refill information;
- action to be taken in the event of a missed dose.
Pharmacists, pharmacy interns and all health care practitioners are required to provide patient education in a confidential manner.
- Can I dispense a prescription to a patient if the patient
declines counseling or simply refuses to be counseled?
Answer: Yes, but you must document the patient's decision to decline or refuse counseling in your pharmacy's records.
- How will counseling requirements be monitored and enforced?
Answer: The Education Department and the Board of Pharmacy appreciate the vital role pharmacists play in the health care system. Counseling provides an opportunity for pharmacists to provide consumers with information necessary to comply with medication regimens or avoid potentially harmful interactions. Good patient counseling also helps to reduce prescription and medication errors. The Department will enforce this provision by incorporating observation of counseling in our routine inspections of pharmacies. We will also review counseling procedures whenever a prescription error is brought to our attention.
- Is there a limit to the number of unlicensed personnel
(frequently called "pharmacy technicians") that may assist
Answer: Yes. Up to two unlicensed persons may assist a pharmacist with filling prescriptions. Staff involved in other duties not directly related to the filling of prescriptions are NOT counted in the 2:1 ratio.
- What is the effect of the recent change in the Rule
of the Board of Regents that defines which functions unlicensed
personnel may perform under the supervision of a pharmacist?
Answer: In the past, the rule was occasionally misunderstood to include cashiers, delivery staff, etc. in the 2:1 ratio. The revision clarifies that staff not directly related to the filling of prescriptions are NOT counted in the ratio.
- Are registered pharmacy interns included in the 2:1
- What is the Drug Retail Price List?
Answer: The Drug Retail Price List is list of the 150 most frequently prescribed drugs, in the most common quantities. The list of 150 drugs will be updated annually by the State Board of Pharmacy and distributed to every New York State registered pharmacy.
- How will we receive a copy of the Drug Retail Price
Answer: The State Education Department will distribute a paper copy to every pharmacy annually. Electronic versions will also be available. To request a copy, e-mail the State Board of Pharmacy at email@example.com. Additionally, we will make copies available to computer software vendors for pharmacies.
- Are New York State registered pharmacies required to
make their Drug Retail Price List available to consumers?
Answer: Yes. Every pharmacy that sells drugs at retail must make Drug Retail Price Lists available with prices of the 150 most frequently prescribed drugs. The pharmacy must also display a sign in bold, block letters at least one inch in height that states "Drug Retail Price List Available Upon Request". Consumers may request a computer-generated list to take with them when they leave the pharmacy.
Pharmacies offering to dispense prescription drugs to consumers in New York State through the Internet are required to post a notice of availability of the drug retail price list and a toll-free number to obtain the list on your Web site. Pharmacies offering to dispense prescription drugs to consumers in New York State through mail order are required to include a printed notice with each delivery of a prescription drug informing the consumer of the availability of the drug retail price list and a toll-free telephone number to obtain the list.
- Does the Drug Retail Price list replace the Prescription
- How often is a pharmacy required to update the selling
price of the drugs on the list?
Answer: You must update the list at least weekly.
- If our selling price changes during the week, can we
legally charge the new price?
- Are we allowed to quote prescription prices over the
Answer: Yes, but you are not required to do so.
- Are New York State licensed pharmacists required to
complete formal continuing education on medication safety?
Answer: Yes. Beginning September 1, 2003 and for each registration period thereafter, you will be required to complete at least three hours of formal continuing education on strategies and techniques to reduce medication and prescription errors.
- Why is this new regulation important?
Answer: Every pharmacist must be committed to reducing errors. Many pharmacists and pharmacies have made good efforts to develop strategies that provide new checks on the safety of the dispensing process. It is the intent of the Education Department and the State Board of Pharmacy that this initiative will encourage every pharmacist to internalize new safety strategies and to develop process improvement systems for their practice.
- Will I be required to complete the three hours of continuing
education on medication safety in addition to the existing
45-hour mandatory continuing education requirement?
Answer: No. Coursework on reducing medication and prescription errors can be applied to the 45 hours of continuing education each pharmacist must complete every three years.
- Are courses on medication safety and reducing medication
and prescription errors readily available?
Answer: Yes. Courses are now available through national associations. The colleges of pharmacy in New York State and professional societies have begun planning to offer courses in this important area as well.
- Do I have to complete coursework in this area through
Answer: No. You can take either "live" or "home study" courses.
- Will I be required to complete coursework on medication
safety and reducing medication and prescription errors during
every three-year registration period?
- Who do I contact if I have additional questions or
need more information?
Answer: Please contact the State Board of Pharmacy by phone at (518) 474-3817 ext. 130; fax at (518) 473-6995; or by e-mail at firstname.lastname@example.org.