Pharmacy Services

Description of Federal Requirements  [TOP]

Under the Federal regulation 483.60, the facility must generally provide routine and emergency drugs and biological preparations to its residents, or obtain them under an agreement that meets the requirements for use of outside resources.  (Quality standards for contracted professionals are further specified under Administration, 483.75 (h), which requires that such contracted professionals hold required state licenses, meet accepted quality standards, and perform their duties under written contractual agreement.)    The pharmacy regulation specifically permits unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse.

To meet these general requirements, the regulation requires that the facility develop procedures for its pharmaceutical services to assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals, and employ a licensed consultant pharmacist to oversee these procedures.  The duties of the pharmacy consultant are briefly specified, including to: consult and advise on all aspects of pharmacy services, establish a record system on the receipt and disposition of all controlled drugs sufficient to accurately reconcile information on the drug supply, determine that drug records remain in order and accounts of controlled drugs are maintained and periodically reconciled; and establish drug regimen reviews for the individual residents.  A drug regimen review must be conducted for each resident at least monthly, the pharmacist must report any irregularities to the attending physician and director of nursing and these reports must be “acted upon.”   

The pharmacy consultant and the pharmacy service are responsible for assuring that drugs and biologicals are labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable. Also, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys. The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.

Medications are a key component of the management of health care, and are touched on, therefore, in several other regulations.  State regulations on medications are, therefore, reviewed in the context of other sections of this website.  The regulation 483.25 on Quality of Care, Section l, requires that each resident’s drug regimen be free of unnecessary drugs.  The duties of the consultant pharmacist in ensuring reviews of medication regimens clearly would extend to examining those regimens for unnecessary drug use.  An unnecessary drug is defined in Federal regulation as any drug used (i) in excessive dose (including duplicate drug therapy); (ii) for excessive duration; (iii) without adequate monitoring; (iv) without adequate indications for its use; (v) in the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (vi) any combinations of the reasons above. Unnecessary use of antipsychotic drugs is discussed separately; such drug use must be based on a comprehensive assessment and the facility must ensure that they are used only to treat specific conditions diagnosed and documented in the clinical record.  Further, residents who use antipsychotic drugs must receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.  Under Section (m), a specific standard is promulgated that the facility must ensure that it is free of medication error rates of 5% or greater, and that individual residents are free of significant medication errors. 

The regulation 483.13 on Resident Behavior and Facility Practices prohibits the use of chemical restraints imposed for the purposes of discipline or convenience and not required to treat resident’s medical symptoms.  Chemical restraints is not further defined in the federal regulation, but use of antipsychotic drugs, or other psychoactive drugs such as sedatives and mood-altering medications for behavior control without medical indications would fall clearly into the category of chemical restraint..  Under Physician Services 483.40 the physician must review the resident’s total program of care, including medications and treatments, at each visit, 2) write, sign, and date progress notes at each visit; and sign and date all orders.

As part of residents rights regulations, 483.10 (n), an individual resident may self-administer drugs if the interdisciplinary team has determined that this practice is safe.  Under another section of residents rights 483.10 (i), regarding the supplies facilities must offer Medicare or Medicaid residents without charge, over-the-counter drugs are included on a long list.

Finally the Resident Assessment regulation, 483.20, specifies that medications be included on the Assessment and the mandated Minimum Data Set contains a section on medications. 

Comparison of State Requirements  [TOP]

Every State has provided some additional specification of rules related to pharmacy requirements.  In some instances, the additions are very brief, perhaps adding detail to the requirements for reporting drug errors, or making small additions to the requirement for a consulting pharmacist or for the way that the facilities will interact with community pharmacies.   At the other end of spectrum, some States provide comprehensive detail, often organized under numerous subheadings related to securing and disposing of medications, administration of medications, individual regimen reviews, storage (especially for controlled substances), labeling, self-administration of medications, and reporting of errors or irregularities.  Often, a separate section is developed for interaction with pharmacies around unit dose systems.  Examples of States with extensive sections on pharmacy services that touch on many of these dimensions include Arkansas, Connecticut, Kentucky, Louisiana, Maine, Maryland, Massachusetts, North Carolina, New Jersey, Oklahoma, Rhode Island, and South Dakota.

Sometimes, the State pharmacy services rules emphasize the obvious. For example, some States stipulate that medications must only be given to the person for whom they are prescribed and that medications cannot be shared among residents.  North Carolina is somewhat exceptional because it includes the topic but allows for an exception.  The rule says that the administration of one patient's medications to another patient is prohibited except in the case of an emergency.  In the event of such emergency, steps shall be taken to ensure that the borrowed medications are replaced promptly and so documented.  [NHRegs Comments:  This proviso, so at odds with other States that simply prohibit using a drug for other than the person for whom is prescribed, may, in fact, allow staff to exercise responsibility in certain emergencies when the only solution on hand is part of another resident’s supply.  Safeguards are built into the rule in terms of keeping a record of the event.]  Other commonsense provisions often found in State rules related to medications:  for example, the person who sets up the drugs must be the person who administers the drugs (except for unit doses), drugs may not be set up in advance (unless they are unit doses set up by pharmacies); unused drugs may not be returned to containers; the resident must be clearly identified as the person for whom the drug is intended, and that staff may not bring medications home.  The Colorado rules say specifically that the facility shall protect each resident's drugs from use by other residents, visitors, and staff, and many of the other State’s provisions, especially around inventories and record-keeping, are directed at preventing staff misuse of drugs as well as errors affecting patients.

Variations on each of the above ideas appear in multiple States.  The very detailed rules on medication administration, labeling, and storage (none of which are not analyzed here as a category, but which are highlighted in the table at the end of this section) contain safeguards to ensure that medications not be given to the wrong person.  Illinois has a uniquely worded provision in that regard, which envisages consulting photographs.  The rule rads that the facility shall have medication records that shall be used and checked against the licensed prescriber's orders to assure proper administration of medicine to each resident.  Medication records shall include or be accompanied by recent photographs or other means of easy, accurate resident identification. Medication records shall contain the resident's name, diagnoses, known allergies, current medications, dosages, directions for use, and, if available , a history of prescription and non-prescription medications taken by the resident during the 30 days prior to admission to the facility. 

Other common State rules refer to drug reference resources that must be kept in the facility, or even at each nurse’s station, such as an up-to-date Drug Reference Manual.  Some States require their pharmaceutical committee or their quality assurance committee to maintain a formulary and make information available about the formulary to residents and family members.  In South Dakota, for example, each nursing facility must keep a list of the following in the drug storage area for reference: (1) Generic and trade names for drugs substituted within the facility; (2)  Drugs with unique requirements for administration, used within the facility, including enteric coatings, sublingual, buccal, and sustained release dosage forms; and (3)  Drugs controlled under SDCL 34-20B that are used within the facility.  Typically, too, States include detailed rules for residents taking medications with them when on leave or when being discharge.

Some State provide detailed rules for the training of individuals who administer medications or assist with self-administration of medications.   Iowa, Kansas and Maryland have training requirements, and in the case of the last two somewhat detailed description of curriculum and of competencies for administering medications.

Other sections of this Website deal with content related to pharmacy.  Specification on medication orders is also discussed under the Physicians Services (Signing of Orders).  In particular, many States have rules about automatic Stop-Order policies, which apply both to physician services and pharmacy services.  Also, although the federal Infection Control regulation makes no mention of pharmacy services, some States make that connection, specify a role for pharmacists in infection control, and specify immunization programs.   

Detailed regulations are frequently found related to labeling of medications, disposal of medications or return to pharmacy, safeguards for administration and recording at-point-of-use, and the medication reviews required under federal law.  Some States provide extensive definitions for classes of medication.  Some States discuss all routes of administration—topical, oral, suppositories, and injections.  Minnesota has an ambiguous provision related to administering in food: namely, “adding medication to a resident's food must be prescribed by the resident's physician and the resident, or the resident's legal guardian or designated representative, must consent to having medication added to food.  This subpart does not apply to adding medication to food if the sole purpose is for resident ease in swallowing.”  [NHRegsComments:  the ambiguity resides in the determination that the mashing is for the purpose of assisting with swallowing.  The probable genesis of this rule prohibiting medication in food has to do with prohibiting concealing medications in food, which side-steps resident consent and the possibility of refusal, but that explanation is not contained in the regulation.]

The Table at the end of this section indicates content by State, and Website users are urged to consult the particular States to identify their regulatory language on the topics listed.  Below we compare States on a few selected areas: self-administration of medications; choice of pharmacy; emergency medication stocks; and facilities for medications. [NHRegsComments: These detailed rules on medications suggest a paradox: although the rules are often extremely prescriptive—no pun intended, nonetheless, a well educated and oriented staff who understand the logic behind the rules is also needed.  This education and orientation includes not only nurses and medications aides, but housekeepers, dietary personnel, and the full range of individuals who come in contact with medications.  Oddly, despite their detail, many areas of judgment and discretion for staff are articulated in the medication regulations.  It is in keeping with the goals of culture change to envisage a well-educated, appropriately empowered staff at all levels.]

Self-Administration of Medications [TOP]

Most States make at least passing reference to self-administration of medications, including how the facilities shall judge whether a resident is capable of self administration, the way self-administration should be conducted and recorded, and storage in the resident’s room for self-administration.  [NHRegComments:  The connection between resident self-administration of medications and resident autonomy is obvious.  Little is known about the extent to which residents do administer their own medications in nursing homes, and the effect of that control on their well-being.]  State regulatory language varies in how it encourages or discourages self-administration.  Georgia, for example, states  that self-administration of medications by patients should be discouraged except for emergency drugs on special order of the patient's physician or in a pre-discharge program under the supervision of a licensed nurse.   Massachusetts explicitly gives the nursing home the last word over the physician, stating “notwithstanding a physician's order, a licensee shall not permit self-administration by any resident where, in his/her judgment, this practice would endanger another resident or other residents.”  In contrast, Nebraska rules states that the facility must allow residents of the facility to self-administer medication, with or without supervision, when resident assessment determines resident is capable of doing so.  

Some States clarify that self-administration extends to injectable medications (e.g. of diabetics) and to controlled substances.  State rules reflect some caution about what medications and how much of them to store in residents’ rooms.  Oklahoma, on the other hand, states that scheduled medications (e.g. morphine) shall not be authorized for self-administration, except when delivered by a patient controlled analgesia pump. [NHRegsComments: Given the literature on the advantages of managing morphine for residents with end-stage cancer to control their own pain, it is helpful that Oklahoma makes this kind of control possible.  Whether a cognitively intact resident in severe pain should also be permitted to manage oral medications as they might at home is an empirical question.]  Massachusetts requires that in the case of a resident with a history of mental illness, a self-administration order must be supported by written finding by the physician that the resident has the ability to manage the medication on this basis.  Oregon stipulates that the consulting pharmacist shall specify maximum quantities of medications to be stored at bedside to ensure prevention of poisoning by confused or suicidal residents.  

Most states envisage that a nurse will record the effect of the medication just as she would for facility-administered medication.  New Hampshire makes clear distinctions between facility administration, facility assistance with self-administration, and self-administration.  In Alabama and Texas, a nurse shall document a resident’s self-administration of medication.  Self-administration of medication is sometimes specified as to be included in the medication reviews performed by the pharmacist.  Kansas, in contrast, makes that review optional, stating that each resident who self-administers medications shall be offered the opportunity to have a drug review conducted by pharmacist at least quarterly.  If the resident refuses this service, the facility shall offer the service ach time the resident experiences a significant change in condition or at least annually.  Each facility shall maintain documentation of the resident's decision in the resident's clinical record. 

Most of the States commenting on self-administration also have stipulations of how medications be kept in the resident’s rooms, which basically is under lock and key.  Arkansas rules state that a locked container placed below food level in a home refrigerator is considered satisfactory storage space. [NhRegsComments:  This seems to set up the possibility for nursing homes with private rooms with kitchenettes or even self-contained private apartment to store medications in the residential refrigerator rather than at a distance, which would be helpful for both facility administration and self-administration.] South Dakota stipulates that if any patient or resident is permitted to self-administer medications, the facility's policies and procedures related to self-administered drugs must include a description of the responsibilities of the patient or resident, the patient's or resident's family members, and the facility staff. The facility must provide written educational material explaining to the patient or resident and the patient's or resident's family the patient's or resident's rights and responsibilities associated with self-administration.  Kansas specifies that a resident may request that the facility store a medication or medications when the resident is unable to provide proper storage as recommended by the manufacturer or pharmacy provider. [NHRegsComments:  In general, Kansas rules provide models for approaches beyond an either-or.  For example, residents may partly self-administer and partly request the facility to administer; they may store medications exclusively in their rooms or request the facility to store some medications.  Kansas rules also cross-reference nurse-practice act extensively, and allow family members and friends gratuitously to help residents with self-administration of medications.  The rules themselves blend material for assisted living and for nursing homes, but they generally combine permissive attitudes with a strong emphasis on training of personnel.]

Below are a few more complete examples.  Among them, Kansas provides rules in particular detail.

4In Arkansas, self-administration of medication is allowed only under the following conditions: If the physician orders, a patient may keep at the bedside the following nonprescription medications:

• Topical agents such as Vicks Salve, Mentholatum, etc.
• Eye drops such as Murine, Visine, etc.
• Cough drops, such as Ludens, Vicks, etc.
• Sublingual vasodilating agents such as Nitroglycerine tablets, Isordil Sublingual tablets.
• Metered dose aerosols for asthmatics such as primatene or bronkaid. Personal items such as toilet articles and cosmetic articles may be kept at the bedside.
[NHRegs Comments: The reference to toilet articles and cosmetics at the end of this list is noteworthy.  It suggests how much residents have been protected in their ordinary lives that their right to keep their own cosmetics and toiletries has to be asserted.]

4In Kansas, self-administration of medications is discussed in detail. The Kansas rules also contain detail about what is meant by medication reminders for residents who are self-administering medications. 
(1)  A resident may manage and self-administer that individual's own medications if an assessment by a licensed nurse or physician has determined that the resident can perform this function safely and accurately.  The assessment shall include the following information:
(A)  An evaluation of the resident's physical, cognitive, and functional ability to manage the individual's own medications; and
(B)  an entry in the resident's clinical record.
(2)  A resident who self-administers medications may select medications to be administered by a licensed nurse employed by the facility, a home health agency, or a hospice, or by a medication aide employed by the facility.  The negotiated service agreement shall reflect this service and shall identify who will be responsible for management of the selected medications. [NHRegs Comments:  This provision is noteworthy because it allows for residents to self-administer most of their medications but leave some to be administered by the staff.  Moreover, the use of the term “negotiated service agreement” is noteworthy.  A negotiated service agreement, a term rarely used in nursing homes, is an agreement reached between resident and facility in the interest of resident autonomy after risks have been explained to the resident,]
(3)  Medication reminding may be performed by staff if the medications are selected by the resident.  Medication reminding shall be limited to the following:
(A)  Inquiry as to whether the medication was taken; and
(B)  Verbal prompting to take medications.
(b)  Self-administration of medication with assistance.
(1)  A resident may self-administer medications with the use of prefilled medication reminder boxes or prefilled syringes, if an assessment has been performed by a licensed nurse and a determination has been made that the resident can safely and accurately administer the pre-selected medications, using medication reminder boxes or prefilled syringes, without further staff assistance.  The licensed nurse may be employed by the facility, a home health agency, a hospice, or the resident.
(A)  The assessment shall include an evaluation of the resident's physical, cognitive, and functional ability to safely and accurately administer medications using medication reminder boxes or prefilled syringes.
(B)  Assessment shall be performed when the resident is admitted and before the resident begins to self-administer medications with assistance; assessments shall also be performed following a significant change in condition and at least annually.  Each assessment shall be maintained in the resident's clinical record.
(C) The licensed nurse or pharmacist who prefills the resident's medication boxes or syringes shall ensure that all drugs are selected and prepared in accordance with a physician's written order.
(D)  The licensed nurse or pharmacist shall ensure that both of the following conditions are met:
(i)  Medication reminder boxes are labeled with the resident's name and date the box was prefilled.
(ii)  A label is placed on the medication box, or a medication administration record is provided to the resident, either of which includes the name and dosage of each drug and the time the drug will be self-administered by the resident.
(2)  A resident who self-administers with assistance may request that selected medications be managed by a licensed nurse employed by the facility, a home health agency, or a hospice, or by a medication aide employed by the facility, if the resident believes that individual to be unable to perform this function safely.
(3)  A licensed nurse employed by the facility, a home health agency, or the resident shall develop a health services plan that provides directions to unlicensed staff related to the resident's drug regimen when a pharmacist prefills the resident's medication reminder boxes or syringes.
(4)  Medication reminding by staff shall be permitted if all of the following conditions are met:
(A)  The medications are preselected for the resident by a licensed nurse, family member, or pharmacist.
(B)  The medication reminding is limited to the following:
(i)  Making inquiries as to whether or not medication was taken;
(ii)  Handling the appropriately labeled prefilled medication reminder box or syringe to the resident; and
(iii)  Opening the appropriately labeled prefilled medication reminder box, if the resident is unable to pen the container.
(C)  Medication reminding does not include taking the medication out of the medication reminder box.

4In New Jersey,   a resident may self-administer medications if the comprehensive resident assessment self-administration of drugs shall be permitted by qualified residents only as specified by the policy of the pharmacy and therapeutics committee and the assessment of the interdisciplinary team.  Self-administration procedures shall include, at a minimum, the following:
1.  The written order of the prescriber;
2.  Storage of medications in the resident’s room, based on resident assessments;
3.  Specifications for labeling, including directions for use;
4.  Methods for documentation in the medical record, based on resident assessment;
5.  Training of residents in self-administration by the nursing staff or the consultant pharmacist; and
6.  Policies for individual assessment of residents’ ability to self-administer medications.

Pharmacies and Choice of Pharmacy [TOP]

States sometimes differentiate between community pharmacies and institutional pharmacies in their regulations.  They sometimes require written contracts between the facilities and any community pharmacies used, and impose requirements on contracting pharmacies.  For example, methods of labeling or packaging can be specified.  Connecticut provides an example of a State that lists detailed requirements for community pharmacies that contract with nursing homes. Maryland requires that nursing homes arrange for pharmacies which provide medications for patients in the facility to agree, in a written agreement with the facility, to maintain at the pharmacy a patient profile record system for each resident.

Residents have the rights to choose their own pharmacy.  Some States reassert that right in their regulations and attempt to reconcile it with other State regulations designed to effect standards for community pharmacists.  Arkansas perceives that true unit does systems are incompatible with choice of pharmacy.  Other States appear to find unit dose systems and choice of pharmacy compatible as long as the pharmacy adheres to the standards laid out by the facility.  Below are examples of variations in the way States articulate expectations for community pharmacies that the residents might choose. [NHRegsComments:  The resident choice of pharmacy is clearly related to resident autonomy.  We are unaware of any studies of the extent to which this right is important to residents, or what criteria residents use beyond price and convenience (e.g. location and delivery policies) when choosing a pharmacy.  Perhaps, though this is conjecture, some residents in small communities like to support merchants in that community.  This is an area where quality standards or perceptions of quality protocols may interfere with resident autonomy, though the standards enunciated are largely those that would upgrade all pharmacies.]

4In Arkansas, to ensure that each patient admitted to a long term care facility is allowed freedom of choice in selecting a provider pharmacy, at the time of admission the patient or responsible party must specify in writing the pharmacy that they desire to use. The patient or responsible party must also sign the statement, or form, and the signed form should be filed with the signed Resident Rights’ statement. The patient must be allowed to change the provider pharmacy if he desires. If true unit dose system is used by the facility the patient will not be afforded the freedom of choice of pharmacy provider.  [NHRegsComments:  This last statement appears to be an example of a State failing to meet the stringency of a federal regulation—in this case the right to choice of pharmacy. We do not know if this rule has been tested.]

4In Florida, the right to freedom of choice in selecting a personal physician; to obtain pharmaceutical supplies and services from a pharmacy of the resident's choice, at the resident's own expense or through Title XIX of the Social Security Act; and to obtain information about, and to participate in, community-based activities programs, unless medically contraindicated as documented by a physician in the resident's medical record. If a resident chooses to use a community pharmacy and the facility in which the resident resides uses a unit-dose system, the pharmacy selected by the resident shall be one that provides a compatible unit-dose system, provides service delivery, and stocks the drugs normally used by long-term care residents. If a resident chooses to use a community pharmacy and the facility in which the resident resides does not use a unit-dose system, the pharmacy selected by the resident shall be one that provides service delivery and stocks the drugs normally used by long-term care residents.

4In Kansas, residents in adult homes have the right to choose the pharmacy where prescribed medications are purchased.  When the adult care home uses a unit dose or similar medication distribution system, the resident shall have the right to choose among pharmacies that offer or are willing to offer the same or a compatible system.  But in nursing homes, Kansas regulations state that residents who self-administer medications may request that the facility staff reorder the medications from the pharmacy of the resident's choice.  Staff who perform this function shall be authorized to administer medications. [NHRegsComments: It appears that right to choice of pharmacy in nursing homes in Kansas is limited to those who self-administer, but we have not verified this interpretation with the State.]

4In Maryland, policies and procedures developed by the pharmaceutical services committee may not prohibit or restrict a resident from receiving medications from the pharmacy of the resident's choice except that, when the cost of any medication obtained from the pharmacy selected by the resident exceeds the cost of the same or equivalent medication available through a pharmacy that the facility has contracted with to provide pharmaceutical services, the resident shall be responsible for the excess amount. The committee may not require the pharmacy to provide drugs by way of a specific drug.  Another part of Maryland regulations states that if a patient desires to designate a particular pharmacy to provide his drugs, he shall inform the pharmacist that he must conform with the facility's written policies concerning the provision of drugs. If the pharmacist agrees to comply with the facility's policies, the patient may request that the consenting pharmacist perform the service. If the pharmacist fails to comply with the policies, a representative of the facility shall discuss with the patient the policy infractions. If after being informed of the infractions the pharmacist then refuses to cooperate, the patient shall select another pharmacist who will agree to comply with the facility's policies. Providers of drugs, pharmacists, shall have access to a copy of the written patient care policies.

4In Ohio, the nursing home shall permit residents to use and continue to obtain medicines, drugs and biologicals dispensed to them from a pharmacy of choice provided the medicines, drugs and biologicals meet the standards of this rule. Each nursing home shall provide pharmacy services by employing a pharmacist on either a full-time, part-time, or consultant basis or by contracting with a pharmacy service. The pharmacist or pharmacy service shall be responsible for maintaining supervision and control of the stocking and dispensing of drugs and biologicals in the home in accordance with state pharmacy rules.

4In Pennsylvania, residents shall be permitted to purchase prescribed medications from the pharmacy of their choice. If the resident does not use the pharmacy that usually services the facility, the resident is responsible for securing the medications and for assuring that applicable pharmacy regulations and facility policies are met. The facility:
(1)  Shall notify the resident or the resident’s responsible person, at admission and as necessary throughout the resident’s stay in the facility, of the right to purchase medications from a pharmacy of the resident’s choice as well as the resident’s and pharmacy’s responsibility to comply with the facility’s policies and State and Federal laws regarding packaging and labeling requirements.
(2)  Shall have procedures for receipt of medications from outside pharmacies including requirements for ensuring accuracy and accountability. Procedures shall include the review of medications for labeling requirements, dosage and instructions for use by licensed individuals who are authorized to administer medications.
(3)  Shall ensure that the pharmacist or pharmacy consultant will receive a monthly resident medication profile from the selected pharmacy provider.
(4)  Shall have a policy regarding the procurement of medications in urgent situations. Facilities may order a 7-day supply from a contract pharmacy if the resident’s selected pharmacy is not able to comply with these provisions.

4In Texas, (a) Unless the facility is paying for the drugs and biologicals, the resident's choice of pharmacy provider and any changes in his choice must be recorded on appropriate forms maintained by the facility; (b) A Medicaid-certified facility must have written agreements with its provider pharmacies that define required services. These agreements will not be considered to abridge the resident's freedom of choice of pharmacy services when they require labeling, packaging, and a drug-distribution system according to facility policy. The drug-distribution system must be accessible to all pharmacies willing to meet the distribution system requirements. The agreements must require the following:
(1) that the resident's pharmacy services be provided by a pharmacy on a 24-hour basis for emergency medications; and
(2) that the resident's medications be delivered to the facility on a timely and reasonable basis.

4In Washington, the resident has the right to a choice of pharmacies when purchasing prescription and nonprescription drugs as long as the following conditions are met to ensure the resident is protected from medication errors:
(a) The medications are delivered in a unit of use compatible with the established system of the facility for dispensing drugs; and
(b) The medications are delivered in a timely manner to prevent interruption of dose schedule.

Emergency and bulk medication stocks [TOP]

State rules typically lay out details of storage of medications (both those that do and do not need to be refrigerated) and prohibit stockpiling of drugs except under specified circumstances.  They then allow for emergency stocks of medications, which are variously called emergency medication kits (Alabama, Florida, Massachusetts), emergency drug boxes (Arkansas, Maine), emergency tray (Iowa), contingency kit (New Hampshire), and other variations on the theme.  Some State rules are explicit about how many such emergency kits are needed and where they shall be located, the maximum number of doses of various types of medications that may be retained for emergency use, and/or the procedures and timing for refilling the emergency boxes.  Some States also allow for maintaining some stock of non-prescription medications or commonly used medications, and provide detail about that process.  [NHRegsComments:  This area is one where considerable prescriptive detail in regulations is combined with considerable discretion and judgment about the appropriate use of emergency medications.]  Some examples below show the level of detail that can be attached to these provisions.

4In Arkansas, a container which contains emergency stimulants and drugs for life saving measures must be maintained. This box should be located where it can be readily available to nursing personnel but kept in a secure place and should have a breakaway lock. There should be a list on the box of the drugs which are contained in the box. The drugs in the box should be checked periodically with the list to make sure that these drugs have been replaced after use and are not outdated. Only drugs which have been approved for this purpose by the Pharmaceutical Services Committee or Medical Director, as applicable, and/or the physician, can be place in this box. All controlled substances assigned to the box must be kept with the other controlled substances and labeled “Emergency Box”. All controlled substances assigned to the “Emergency Box” must be entered into the bound book. The location of these controlled substances should be noted on the list of drugs. The drug list should be signed by the physician member of the committee indicating his approval. The list and contents of the box shall be reviewed annually by the appropriate committee and/or physician and so noted on the emergency drug list.

4In New York, the contents of the emergency kit are more explicitly identified.  The facility shall ensure the provision of (an) emergency medication kit(s) as follows:
(1) The contents of each kit shall be approved by the medical director, pharmacist and director of nursing.
(2) Limited supplies of controlled substances for use in emergency situations may be stocked in sealed emergency medication kits.
(i) Each such kit may contain up to a 24 hour supply of a maximum of ten different controlled substances in unit dose packaging, three of which may be injectable drugs.
(ii) Controlled substances contained in emergency medication kits may be administered by authorized personnel pursuant to an order of an authorized practitioner to meet the immediate need of a resident. Personnel authorized to administer controlled substances shall include registered professional nurses, licensed practical nurses or other practitioners, licensed/registered under Title VIII of the Education Law and authorized to administer controlled substances.
(iii) The facility shall maintain all records of controlled substances furnished or transferred from the pharmacy and the disposition of all controlled substances in emergency kits, as required by article 33 of the Public Health Law and corresponding regulations. 3) For medications other than controlled substances the medication contents of each kit shall be limited to injectables except that the kit may also include:
(i) sublingual nitroglycerin; and
(ii) up to five noninjectable, prepackaged medications, not to exceed a 24-hour supply. The total number of noninjectables may not exceed 25 medications for the entire facility;
(4) Each kit shall be kept and secured within or near the nurses' station.

4In Florida, the Agency licensing nursing homes was empowered to adopt rules for emergency medication kits, and modify them as it deemed necessary.  The language state:  (1)  Other provisions of this chapter or of chapter 465, chapter 499, or chapter 893 to the contrary notwithstanding, each nursing home operating pursuant to a license issued by the agency may maintain an emergency medication kit for the purpose of storing medicinal drugs to be administered under emergency conditions to residents residing in such facility; (2)  The agency shall adopt such rules as it may deem appropriate to the effective implementation of this act, including, but not limited to, rules which: (a)  Define the term "emergency medication kit."
(b)  Describe the medicinal drugs eligible to be placed in emergency medication kits; (c)  Establish requirements for the storing of medicinal drugs in emergency medication kits and the maintenance of records with respect thereto; and (d)  establish requirements for the administration of medicinal drugs to residents under emergency conditions from emergency medication kits.

4In Idaho, certain emergency medications shall be available within the facility for occasional use where the pharmacy source is not immediately available; b. All medications included in the emergency supply shall be listed in an emergency medication formulary for the facility and reviewed and approved by the physician(s) responsible for the medical direction of the facility, director of nurses, and the administrator; c. All medication supplies of this category shall be stored apart from other prescription drugs in a separate, locked and convenient location near the nursing station. Control and access to these medications shall be limited to the nurse in charge of each shift and the pharmacist;. Medications shall be withdrawn and administered to patients/residents from this supply on direct physician, dentist or nurse practitioner order and shall be signed by the physician, dentist or nurse practitioner on the patient’s/resident’s medical record no later than seven (7) days from the withdrawal, and a copy of the order forwarded to the pharmacist. The pharmacist shall be responsible for replacing drugs which have been withdrawn.  All medication inventories contained within this emergency medication supply are the property and responsibility of the pharmacist, and he shall be responsible for maintenance of records for these medications.

4 In Illinois, the contents and number of emergency medication kits shall be approved by the facility's pharmaceutical advisory committee, and shall be available for immediate use at all times in locations determined by the pharmaceutical advisory committee.  1) Each emergency medication kit shall be sealed after it has been checked and refilled; 2) Emergency medication kits shall also contain all of the equipment needed to administer the medications; 3) the contents of emergency medication kits shall be labeled on the outside of each kit.  The kits shall be checked and refilled by the pharmacy after use and as otherwise needed.  The pharmaceutical advisory committee shall review the list of substances kept in emergency medication kits at least quarterly.  Written documentation of this review shall be maintained.  Further requirements need to be met when controlled substances are kept as part of the emergency medication kits: 

If an emergency medication kit is not stored in a locked room or cabinet, or if the kit contains controlled substances that require refrigeration, then the controlled substances portion of the kit shall be stored separately in a locked cabinet or room (or locked refrigerator or a locked container within a refrigerator, as appropriate) and labeled with a list of the substances and a statement that they are part of the emergency medication kit.  The label of the emergency medication kit shall list the substances and the specific location where they are stored. 

4North Carolina provides considerable specificity as well as information for obtaining more detail from the Board of Pharmacy and the Drug Regulatory Branch of the State Division of mental Health, Developmental Disabilities and Substance Abuse Services.  The rule reads that  the facility shall maintain a supply of emergency drugs in compliance with 21 NCAC 46 .1403 which is hereby incorporated by reference including subsequent amendments. Copies of the rule may be obtained from the North Carolina Board of Pharmacy, P.O. Box 459, Carrboro Plaza, Highway 54 Bypass, Carrboro, North Carolina 27510 at a cost of eight dollars and forty eight cents ($8.48).
(b) Emergency drugs shall be stored in a portable container sealed with an easily breakable closure which cannot be resealed or reused and shall be readily accessible for use.
(c) Emergency drug kits shall be stored in a secure area out of site of patients and the general public. If stored in a locked area the kits shall be immediately accessible to all licensed nursing personnel.
(d) All emergency drugs and quantity to be maintained shall be approved by the Quality Assurance Committee.
(e) If emergency drug items require refrigerated storage, they shall be stored in a separate sealed container within the medication refrigerator. The container shall be labeled to indicate the emergency status of the enclosed drug and sealed as indicated in Paragraph (b) of this Rule.
(f) An accurate inventory of emergency drugs and supplies shall be maintained with each emergency drug kit.
(g) The pharmacist shall personally examine the refrigerated and non-refrigerated emergency drug supply at least every 90 days and make any necessary changes at that time.
(h) The facility shall have written policies and procedures which are enforced to ensure that in the event the sealed emergency drug container is opened and contents utilized, immediate steps are taken to replace the items used.
(i) The availability of a controlled substance in an emergency kit shall be in compliance with the North Carolina Controlled Substances Act and Regulations (10A NCAC 26E) which is hereby incorporated by reference including subsequent amendments. Copies of the rules may be obtained from the Drug Regulatory Branch, Division of Mental Health, Developmental Disabilities and Substance Abuse Services, 3016 Mail Service Center, Raleigh, NC 27699-3016 at a cost of thirteen dollars ($13.00).

4In Oklahoma, there shall be an emergency tray or cart with the following items labeled and accessible to licensed personnel only: resuscitation bag; tongue depressors; and assorted airways; sterile hypodermic syringes in 2 cc, 5 cc, and 20 cc or larger sizes and appropriate needles. The content shall be limited to emergency medications and contain no scheduled medications. Only two single dose vials of the following medications may be on the tray or cart: 50% Dextrose, respiratory stimulant, a cardiac stimulant, injectable lasix, injectable dilantin and injectable benadryl.

Illinois distinguished clearly between emergency medication kits and “convenience boxes.”   A facility may stock drugs that are regularly available without prescription.  These shall be administered to a resident only upon the order of a licensed prescriber (see Section 300.1620).  Administration shall be from the original containers, and shall be recorded in the resident's clinical record.   A facility may keep convenience boxes containing medications to be used for initial doses. 
1) The contents and number of convenience boxes shall be determined by the pharmaceutical advisory committee.  The contents shall be listed on the outside of each box. 
2) Each convenience box shall be the property of and under the control of the pharmacy that supplies the contents of the box, and it shall be kept in a locked medicine room or cabinet.
3) No Schedule II controlled substances shall be kept in convenience boxes.

Facilities for Medications [TOP]

State regulations sometimes are specific about the spaces where medications are compounded and stored, refrigeration for medications that require it, the carts and other equipment used to dispense medications, and the sinks and lighting needed for medication handling. Sometimes the regulations also call for the separation of household toxins for cleaning from medications.  Sometimes, as in Maine, the stipulation is that the medicine cabinets be sufficiently roomy and uncrowded.   Temperature ranges for refrigerators or room temperature may be listed, and, if so, they differ somewhat from State to State.  A few examples are found below.  [NHRegsComments.  Some of the detailed environmental requirements related to medications may be more difficult to comply with in neighborhood environments.  Some of the specifications relate to nursing stations, which themselves may not be used in some newly designed smaller-scale nursing homes.]

4In Idaho, all medications in the facility shall be maintained in a locked cabinet located at, or convenient to, the nurses’ station. Such cabinet shall be of adequate size, and locked when not in use. The key for the lock of this cabinet shall be carried only by licensed nursing personnel and/or the pharmacist. (1-1-88)
m. An adequate lighting system shall be provided in the drug storage area. (1-1-88)
n. Poisons and toxic chemicals shall be stored in separate locked areas apart from medications. (1-1-88)
o. External-use-only medications shall be stored only in a separate, locked area apart from internal use medications. (1-1-88)
p. All bleaches, detergents, and disinfectants shall be kept in locked utility storage, separate and apart from medicines, drugs, and food. (1-1-88)
q. Biologicals and other medications requiring cold storage shall be refrigerated. A covered container in a home refrigerator is considered satisfactory storage space if the temperature is maintained at thirty-six degrees Fahrenheit (36F) to forty-five degrees Fahrenheit (45F). The temperature shall be monitored daily. (1-1-88)
r. An up-to-date medication reference index and sources of information such as the American Hospital Formulary Service of the American Society of Hospital Pharmacists, or other suitable and acceptable references, shall be provided in each unit. (1-1-88)
s. Hypodermic syringes and needles (except sterile disposables) shall be autoclaved before each use. (1-1-88)
t. Equipment for the administration of medications shall be thoroughly cleaned and suitably stored after each use. (1-1-88)

4In Kansas, the licensed pharmacist shall ensure that all drugs and biologicals are stored according to state and federal laws; the nursing facility shall store all drugs and biologicals in a locked medication room or a locked medication cart located at the nurses' station.  Only the administrator and persons authorized to administer medications shall have keys to the medication room or the medication cart; the nursing facility shall store drugs and biologicals under sanitary conditions; and the temperature of the medication room shall not exceed 85 degrees Fahrenheit. The nursing facility shall store drugs and biologicals at the temperatures recommended by the manufacturer.

4In Illinois, specifications for oxygen use are detailed. The oxygen supply shall be stored and handled in accordance with the National Fire Protection Association Standard No. 99:  Standard for Health Care Facilities (2002, no later amendments or editions included) for nonflammable medical gas systems.  The facility shall comply with directions for use of oxygen systems as established by the manufacturer and the applicable provisions of the NFPA Life Safety Code (see Section 300.340) and NFPA 99. 
1) Facilities shall store medical grade products separately from industrial grade products.  The storage area for medical grade products shall be well defined with one area for receiving full medical gas vessels and another for storing empty vessels.
2) All personnel who will be handling medical gases shall be trained to recognize the various medical gas labels.  Personnel shall be trained to examine all labels carefully.
3) If the facility's supplier uses 360-degree wrap-around labels to designate medical oxygen, personnel shall be specifically trained to make sure each vessel they connect to the oxygen system bears such a label.
4) All facility personnel responsible for changing or installing medical gas vessels shall be trained to connect medical gas vessels properly. Personnel shall understand how vessels are connected to the oxygen supply system  and shall be alerted to the serious consequences of changing connections.
5) If a medical gas vessel fitting does not seem to connect to the oxygen system fitting, the supplier shall be contacted immediately.  The vessel shall be returned to the supplier to determine the fitting or connection problem.
6) Once a medical gas vessel has been connected to the oxygen supply system, but prior to introducing the product into the system, a trained facility staff member shall ensure that the correct vessel has been connected properly.

4In Maine, a cabinet or medication cart shall be provided for individual prescriptions. The cabinet/cart shall be of sufficient size, properly lighted, and located where easily accessible and locked when not in use. The medicine cabinet/cart shall be equipped with separate cubicles, plainly labeled, or provided with other physical separation for the storage of each resident's prescriptions.  Also appropriate measuring devices for the accurate measure of liquid medications shall be provided. If not disposable, these medicine containers shall be returned to the institution's dishwashing unit for processing after each use.

4In Massachusetts, all facilities shall provide a locked medicine cabinet or closet of a type approved by the Department within the nurses' or attendants' station for the proper storage of all patients' or residents' drugs except those approved for self-administration.  Such cabinets or closets shall be used exclusively for the storage of medications and equipment required for the administration of medications; the locked medicine cabinet or closet shall be located within or close to the nurses' or attendants' station in a place that is removed from areas frequented by patients, residents or visitors; the medicine cabinet or closet shall be well-lighted, locked at all times with a suitable lock, and maintained in a clean and sanitary manner.  It shall be sufficient in size to permit storage without crowding and shall have running water accessible; there shall be a separately locked, securely fastened compartment within the locked medicine cabinet or closet for the proper storage of prescribed controlled substances under the federal Comprehensive Drug Abuse Prevention and Control Act; medications requiring refrigeration shall be properly refrigerated and kept in a separate, locked box within a refrigerator at or near the nurses' or attendants' station; poisons and medications for "external use only," including rubbing alcohol, shall be kept in a locked cabinet or compartment separate and apart from internal medications; medications shall not be stored in patient's or resident's rooms except drugs approved for self-administration; the custody of all keys to the medicine cabinets or closets shall at all times be assigned to a licensed nurse (or a responsible person in facilities that provide only Level IV care).

4In North Carolina, the pharmacist and director of nursing shall ensure that drug storage areas are clean, secure, well lighted and well ventilated; that room temperature is maintained between 59 degrees F. and 86 degrees F.; and that the following conditions are met:
(1) All drugs shall be maintained under locked security except when under the immediate or direct physical supervision of a nurse or pharmacist.
(2) Drugs requiring refrigeration shall be stored in a refrigerator containing a thermometer and capable of maintaining a temperature range of 2 degrees C. to 8 degrees C. (36 degrees F. to 46 degrees F.) Drugs shall not be stored in a refrigerator containing non-drugs and non-drug related items, except when stored in a separate container.
(3) Drugs intended for topical use, except for ophthalmic, optic and transdermal medications, shall be stored in a designated area separate from the drugs intended for oral and injectable use.

4In Oklahoma, the following storage rules are specified:
(1)  Medications shall be stored in a medication room, a locked cabinet, or a locked medication cart, that is convenient to the nursing station and used exclusively for medication storage.
(2)  The medication storage area temperature shall be maintained between 60° F. (15.5° C.) to 80° F.(26.6° C.)
(3) The medication room, the medication storage cabinet, and medication cart shall be locked when not in use.
(4) The key to the medication storage areas shall be in the possession of the person responsible for administering medications.
(5) Scheduled medications shall be in a locked box within the locked medication area or cart.
(6) Medications for external use shall be stored separately from medications for internal use.
(7) Medications requiring refrigeration shall be kept within a temperature range of 36° F. (2.2° C.) to 48° F. (8.8° C.) and separated from food and other items. There shall be a method for locking these medications.
(8) The medication areas shall have a work counter; the counter and cabinet shall be well lighted, clean and organized.
(9) Running water shall be in close proximity to the medication area.
(10) Powdered over-the-counter medication for topical use may be kept in the resident's room for administration by a nurse aide if:
(A) The facility submits its policies and procedures for safe and appropriate storage and application of the powder to the Department and receives written approval from the Department prior to implementation.

[Summarized: September, 2006]
 

Table Comparing States  [TOP]

Note: If the States in this table are not hyper-linked, their provisions do not appear to address the topic, and therefore, do not alter the Federal Regulatory scope.  The Table summarizes content on Administration by State (with a link to each State's specific language).  Link to a downloadable PDF document containing all State regulation on Pharmacy Services at the bottom of the Table.