NEW JERSEY REGISTER
Proposed Amendments: N.J.A.C. 13:39-3.18 and 5.9
Proposed New Rule: N.J.A.C. 13:39-5.10
Authorized By: Board of Pharmacy, Joanne Boyer, Executive Director.
Authority: N.J.S.A. 45:14-32, 45:14-33, 45:14-36 and 45:14-36.1.
Submit comments by March 5, 2004 to:
Joanne Boyer, Executive Director
Board of Pharmacy
PO Box 45013
Newark, NJ 07101
The agency proposal follows:
The New Jersey Board of Pharmacy (the Board), pursuant to its authority at N.J.S.A. 45:14-36, proposes new rule N.J.A.C. 13:39-5.10 to establish procedures for regulating the handling of prescriptions by centralized pharmacies, commonly known or referred to as "central fill" pharmacies and/or "central processing" pharmacies. The Board also proposes to amend N.J.A.C. 13:39-3.18 which delineates the duties of the registered pharmacist-in-charge and N.J.A.C. 13:39-5.9 which regulates the labeling of medication containers.
With this proposal, the Board authorizes the designation and use of pharmacies as "central fill" pharmacies. A central fill pharmacy provides the packaging, labeling and delivery of a prescription to another pharmacy for the purpose of filling or refilling that prescription on behalf of that other pharmacy which then dispenses the prescription to the patient. To understand this concept, the Board has, at subsection (a) of proposed new rule N.J.A.C. 13:39-5.10, identified four basic components involved in the handling of a prescription which are: intake, processing, fulfillment and dispensing. The handling of a prescription through a central model requires two or more pharmacies to share responsibility for performing the component functions of intake, processing, fulfillment and dispensing the prescription (subsection (b) of the new rule). The Board, at subsection (c) of the new rule, has identified the functional components of pharmacies which may agree to engage in the handling of prescriptions through a centralized model. These pharmacies are identified in the new rule as: an intake or originating pharmacy; a central processing pharmacy; a central fill pharmacy; and a dispensing pharmacy. In subsection (d) of the new rule, the Board sets out the requirements that the component pharmacies which wish to provide prescriptions through a centralized model must adhere to. Any or all of the pharmacies participating in central prescription handling must have a contractual agreement to provide such services or must have the same owner. Subsection (d) also provides that prior to engaging in central prescription handling, all pharmacies that are parties to central prescription handling must make a single application to the Board for prior authorization. In this application, the pharmacies must delineate the scope of practice of each pharmacy, as well as the specific Board rules with which each pharmacy will comply.
Subsection (d) also provides that all pharmacies that are engaged in central prescription handling must maintain an audit trail that records and documents the names of individuals and the component functions they perform for each step of the process. The audit trail must be maintained for five years from the date a prescription is filled or refilled. The oldest four years of information must be maintained in a manner that is retrievable and readable within two weeks, and the most recent one year of information must be immediately retrievable and readable.
Subsection (d) also provides that a prescription that is prepared and dispensed through a central model must contain a label with specific information as outlined in the rule. In addition, the patient to whom the prescription is dispensed must be provided information which directs the patient to the pharmacy to be contacted if the patient has any questions about the prescription. This information must be readily apparent and must include the pharmacy phone number and when the contact pharmacist is available. The telephone service must be provided at no cost to the patient. All pharmacies that engage in central prescription handling must maintain a common policies and procedures manual which identifies which pharmacy will be responsible for each of the component functions of handling the prescriptions and which pharmacy will be responsible for ensuring compliance with specific Board rules. The manual must also include how to maintain the required audit trail. The policies and procedures manual must be made available to the Board upon request. All of the pharmacies that engage in central prescription handling must share a common electronic file and are held responsible for ensuring that each prescription has been properly filled.
Subsection (e) provides direction for pharmacies engaging in central prescription handling of controlled substances. Prescriptions for controlled substances may be filled or refilled through a centralized process consistent with the Federal requirements outlined in 21 C.F.R. ß ß 1300 et seq. Recent amendments to Drug Enforcement Administration (DEA) regulations now permit the utilization of central fill pharmacies for the dispensing of controlled substances, subject to certain restrictions. These amendments will impose various requirements upon pharmacies which wish to process prescriptions for controlled substances in a centralized manner.
The Board notes that subsection (c) provides for the transmission of a prescription by a prescribing practitioner directly to a centralized pharmacy by facsimile and/or electronic means, consistent with the requirements set forth in N.J.A.C. 13:39-5.8A and 5.8B, which were proposed as new rules by the Board in the New Jersey Register at 34 N.J.R. 3064(a) on September 3, 2002. New rules N.J.A.C. 13:39-5.8A and 5.8B establish standards for pharmacies receiving, filling and dispensing prescriptions transmitted by practitioners by facsimile and/or electronic communication. The new rules became effective on September 15, 2003. See 35 N.J.R. 4290(a).
During its consideration of this new central prescription handling initiative, the Board reviewed the current requirements of the labeling rule at N.J.A.C. 13:39-5.9 and decided to amend the rule in order to make the labeling requirements for all pharmacies throughout the State more consistent with the labeling requirements that will be imposed upon pharmacies engaging in central prescription handling. To accomplish this, the Board is deleting the requirement that the label contain the name of the registered pharmacist-in- charge. The Board believes that requiring the name of the registered pharmacist-in-charge, who may or may not be the dispensing pharmacist, to appear on the label may confuse patients who have questions about their prescriptions and would like to contact the pharmacist who dispensed the medication. In light of this change, the Board is deleting paragraph (c)8 of N.J.A.C. 13:39-3.18, which imposes a duty upon the registered pharmacist-in- charge to ensure that all prescription labels contain his or her name. The subsequent paragraph of N.J.A.C. 13:39-3.18 will be recodified without change.
The Board is also amending the labeling rule to now require that the label state the strength of the medication and the quantity dispensed. In addition, the labeling rule is amended by substituting the words "use by date" and "expiration date" to clarify for the patient the latest time when the medication should be used. In new subsection (b) in N.J.A.C. 13:39-5.9, the Board will require that the patient's name, the name of the medication and the directions for use be in either larger type, in a different color or in bold in order to highlight this information from the rest of the information contained on the label.
The Board notes that the proposed amendments to the labeling requirements at N.J.A.C. 13:39-5.9, if adopted, would not be effective immediately. The Board recognizes that any changes to existing prescription labels would likely require pharmacies to change their current computer software and programs. The Board believes that it is necessary to provide pharmacists and pharmacies with sufficient time within which to complete such changes and, therefore, the Board intends to provide, on adoption, that all prescription labels must conform to the proposed amendments within six months, or 180 days, of the effective date of the changes.
The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
The proposed new rule which would establish procedures and permit the handling of prescriptions at a centralized pharmacy is expected to have a beneficial impact on pharmacists, pharmacies and consumers who frequent pharmacies to drop off and pick up prescriptions. Given the aging population and longer life expectancies, and the introduction of new medicines which promote a longer and healthier life, the number of prescriptions issued each year has been increasing steadily and will continue to increase for years to come. At the same time, there is a recognized need for additional pharmacists to handle the increase in prescriptions issued, but the number of individuals entering the pharmacy profession has been steadily declining. Hence, a pharmacist shortage exists and is expected to continue. The Board anticipates that a centralized prescription handling model, as contemplated by the proposed new rule, would shift the prescription filling function to a central pharmacy, thereby freeing up the pharmacies at the point where the prescription is dispensed to the patient/consumer. This benefits the pharmacist who has more time to counsel patients at the point of dispensing and benefits the patient/consumer through more direct contact with the dispensing pharmacist. The Board also anticipates that the time spent by consumers waiting for prescriptions may decrease while at the same time improving the pharmacist's work environment and job satisfaction. Pharmacies that enter into centralized prescription handling may achieve operational efficiencies, improve quality control and reduce prescription errors.
The proposed amendments to the labeling rule at N.J.A.C. 13:39-5.9 are also expected to have a positive impact on both pharmacists and consumers. Deleting the name of the registered pharmacist-in-charge from the label should eliminate consumer confusion because the name of the pharmacist on the label may not be the name of the person who actually filled the prescription. By labeling the strength of the medication and the quantity dispensed, the patient/consumer will know the potency of the medication being taken and how much medication has been dispensed. The proposed amendment changing "expiration date" to "use by date" will direct the patient/consumer to the date by when the medication may be taken. Lastly, the amendments requiring that the name of the patient, the name of the medication and the directions be in a larger type, a different color or in bold will assist the patient/consumer in identifying the medication and its proper use.
The proposed new rule does not impose any economic costs on pharmacies or pharmacists. Pharmacies which decide to handle prescriptions in a centralized manner may experience a reduction in inventory costs through the reduction and/or elimination of slow moving and/or expensive inventory. It may be possible that such economies of scale in centralized functions may reduce the cost of handling each prescription.
The proposed amendments to the labeling rule at N.J.A.C. 13:39-5.9 may impose some administrative costs on pharmacies by causing the pharmacies to reprogram computer equipment with the new information required to be on the label. Such one-time expense, if any, is not estimated, but the Board believes the benefits the new labeling requirements will achieve outweigh the conversion costs.
Federal Standards Statement
A Federal standards analysis is not required because the proposed new rule and amendments are governed by N.J.S.A 45:14-1 et seq., and, therefore, are not subject to any Federal requirements or standards. The Board notes, however, that pharmacies wishing to handle controlled substance prescriptions in a centralized manner must do so consistent with the Federal DEA standards articulated at 21 C.F.R. ß ß 1300 et seq.
The Board does not anticipate that the proposed new rule and amendments will result in the creation or loss of jobs in the State.
Agriculture Industry Impact
The proposed new rule and amendments will have no impact on the agriculture industry in the State.
Regulatory Flexibility Statement
The Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., requires the Board to provide a description of the types and an estimate of the number of small businesses to which the proposed new rule and amendments will apply. Currently, the Board licenses approximately 12,291 pharmacists. If Board licensees are considered "small businesses," within the meaning of the Act, then the following analysis applies.
The Act requires the Board to set forth the reporting, recordkeeping and other compliance requirements of the proposed new rule and amendments, including the kinds of professional services likely to be needed to comply with requirements. The Act further requires the Board to estimate the initial and annual compliance costs of the proposed new rule and amendments, to outline the manner in which it has designed the new rule and amendments to minimize any adverse economic impact upon small businesses, and to set forth whether the new rule and amendments establish differing compliance requirements for small businesses.
The proposed new rule will not impose any reporting requirements upon Board licensees. A recordkeeping requirement is proposed at N.J.A.C. 13:39-5.10(d) 3, where all pharmacies involved in central prescription handling must maintain, for five years, an audit trail of the individuals involved and the function performed by each during the prescription handling process.
The proposed new rule also imposes compliance requirements which are found in subsection (d) and (e) and are discussed above in the Summary. The proposed amendments to the labeling rule also impose new compliance requirements which are discussed above in the Summary.
It is not anticipated that any additional professional services will be needed to comply with the proposed new rule and amendments. In order to ensure that all pharmacies which intend to engage in central prescription handling adhere to the same standards, no differing compliance requirements are provided based upon the size of the pharmacy.
Smart Growth Impact
The Board does not believe that the proposed new rule and amendments will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.
Full text of the proposal follows :
<< NJ ADC 13:39-3.18 >>
13:39-3.18 Registered pharmacist-in-charge
(a)-(d) (No change.)
(e) A registered pharmacist-in-charge shall be physically present in the pharmacy or pharmacy department for that amount of time necessary to ensure the fulfilling of the following responsibilities:
1.-7. (No change.)
<<-8. Ensuring the use of prescription labels naming the registered pharmacist-in-charge;->>
Recodify existing 9.-14. as 8.-13. (No change in text.)
<< NJ ADC 13:39-5.9 >>
(a) The dispensed container for any product shall bear a permanently affixed label with at least the following information:
<<-1. The name of the registered pharmacist-in-charge;->>
Recodify existing 2.-3. as 1.-2. (No change in text.)
<<-4.->><<+3.+>> The brand name of generic name<<-;->> <<+ and+>>
<<-i. If->> <<+if+>> generic, the name of the manufacturer;
<<+4. The strength of medication, where applicable;+>>
<<+5. The quantity dispensed;+>>
<<-5.->><<+6.+>> (No change in text.)
<<-6.->><<+7.+>> A CDS cautionary label<<+, where applicable+>>;
<<-7.->><<+8.+>> (No change in text.)
<<-8.->><<+9. +>>Initials of the dispensing pharmacist;
<<-9.->><<+10.+>> The <<-prescriber's->><<+ prescriber+>> name;
<<-10.->><<+11.+>> (No change in text.)
<<-11.->><<+12.+>> Directions for use; and
<<-12.->><<+13.+>> The <<-expiration date->> <<+phrase "use by" followed by the product's use by date,+>> if dispensed in any packaging other than the manufacturer's original packaging.
i. For purposes of this paragraph, "<<-expiration->> <<+use by+>> date" means the earlier of one year from the date of dispensing or the expiration date on the manufacturer's container.
<<+(b) The patient name, the brand or generic name of the medication, and the directions for use shall appear in larger type, in a different color type, or in bolded type, in comparison to the other information required to appear on the label of the dispensed container pursuant to (a) above.+>>
<<-(b)->><<+(c)+>> In addition to the requirements set forth in (a) <<+and (b)+>> above, the dispense<<+d+>> container for any product shall bear all auxiliary labeling as recommended by the manufacturer and/or as deemed appropriate in the professional judgment of the dispensing pharmacist.
<< NJ ADC 13:39-5.10 >>
<<+13:39-5.10 Procedures for centralized prescription handling+>>
<<+(a) The four component functions of handling a prescription are intake, processing, fulfillment and dispensing.+>>
<<+(b) Central prescription handling entails two or more licensed pharmacies sharing responsibility for performing the four component functions of handling a prescription.+>>
<<+(c) The following pharmacies may engage in central prescription handling: an intake or originating pharmacy; a central processing pharmacy; a central fill pharmacy; and a dispensing pharmacy. The four component functions of handling a prescription shall be performed by the following pharmacies:+>>
<<+1. An intake or originating pharmacy, which is a licensed pharmacy that received the patient's or prescribing practitioner's request to fill or refill a prescription. A central processing pharmacy or a central fill pharmacy, as delineated in (c)2 and 3 below, may be considered the intake or originating pharmacy if the prescription was transmitted by the prescribing practitioner directly to the centralized pharmacy as provided in N.J.A.C. 13:39-5.8A and 5.8B or if the patient requested the refill from that pharmacy;+>>
<<+2. A central processing pharmacy, which is a licensed pharmacy that engages in prescription review by performing functions that may include, but are not limited to, data entry, prospective drug review, refill authorizations, interventions, patient counseling, claims submission, claims resolution and adjudication;+>>
<<+3. A central fill pharmacy, which is a licensed pharmacy engaging in central prescription handling by filling and/or refilling prescriptions which includes the preparation and packaging of the medication; and+>>
<<+4. A dispensing pharmacy, which is a licensed pharmacy that receives the processed prescription and/or the filled or refilled prescription for dispensing to the patient or to the patient's authorized representative.+>>
<<+(d) Two or more of the licensed pharmacies delineated in (c) above may engage in central prescription handling provided:+>>
<<+1. Any or all of the pharmacies participating in central prescription handling have a contractual agreement to provide such services or have the same owner;+>>
<<+2. Prior to engaging in central prescription handling, all pharmacies that are parties to the central prescription handling obtain Board approval. The pharmacies shall make a single application to the Board, delineating the scope of practice of each pharmacy and the specific rules in this chapter with which each pharmacy shall comply;+>>
<<+3. An audit trail is maintained that records and documents the name(s) of the individual(s) and the component function(s) performed by each, at the time the functions are performed, for each step of prescription handling. The audit trail shall be maintained for not less than five years from the date the prescription is filled or refilled. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be immediately retrievable and readable;+>>
<<+4. The dispensed prescription for any product bears a permanently affixed label with at least the following information:+>>
<<+i. The brand name or generic name, and if generic, the name of the manufacturer;+>>
<<+ii. The strength of medication, where applicable;+>>
<<+iii. The quantity dispensed;+>>
<<+iv. The date upon which prescription medication is dispensed;+>>
<<+v. A CDS cautionary label, where applicable and when permitted by law;+>>
<<+vi. The patient name;+>>
<<+vii. The prescriber name;+>>
<<+viii. The prescription number;+>>
<<+ix. Directions for use;+>>
<<+x. The phrase "use by" followed by the product's use by date, if dispensed in any packaging other than the manufacturer's original packaging. For purposes of this paragraph, "use by date" means the earlier of one year from the date of dispensing or the expiration date on the manufacturer's container;+>>
<<+xi. All auxiliary labeling as recommended by the manufacturer and/or as deemed appropriate in the professional judgment of the dispensing pharmacist; and+>>
<<+xii. The name, address and telephone number of any or all of the following:+>>
<<+(1) The intake pharmacy;+>>
<<+(2) The central processing pharmacy;+>>
<<+(3) The central fill pharmacy; and/or+>>
<<+(4) The dispensing pharmacy;+>>
<<+5. The patient name, the brand or generic name of the medication, and the directions for use appear in larger type, in a different color type, or in bolded type, in comparison to the other information required to appear on the label of the dispensed container pursuant to (d)4 above;+>>
<<+6. The patient is provided with written information, either on the prescription label or with the prescription container, that indicates which pharmacy to contact if the patient has any questions about the prescription or the medication. The written information provided to the patient shall be in bold print, easily read, and shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service shall be available at no cost to the pharmacy's primary patient population;+>>
<<+7. All pharmacies that are to engage in central prescription handling maintain a common policies and procedures manual which designates who shall be responsible for each of the component functions of handling the prescription and for ensuring compliance with the Board rules set forth in this chapter. The policies and procedures manual shall also include maintenance of the audit trail required by (d)3 above. The policies and procedures manual shall be made available to the Board upon request;+>>
<<+8. All pharmacies that are to engage in central prescription handling share a common electronic file; and+>>
<<+9. All pharmacies that are to engage in central prescription handling are responsible for ensuring that the prescription has been properly filled.+>>
<<+(e) A prescription for a controlled substance may be filled or refilled by pharmacies engaging in central prescription handling when permitted by law, consistent with Federal requirements set forth at 21 C.F.R. ß ß 1300 et seq.+>>