Does Your Practice Store and Dispense Sample Prescriptions?

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Does your practice store and dispense sample prescriptions? Rules and regulations to consider before doing so.

As always, one should research your state’s pharmacy and medical licensing board’s regulations, concerning the storage, dispensing and labeling of prescription medications (such as drug samples), some other organizations have their own recommendations and policies concerning drug samples that you should follow to minimize your professional liability. A few of these organizations include;

  1. The Joint Commission (TJC)
  2. Institute for Safe Medication Practices (ISMP)
  3. The National Coordinating Council (member ship includes the FDA and TJC)

State licensing board’s rules are concerned with obvious things like the proper storage, tracking and labeling of prescription medications. Labeling typically requires that the patient name, drug name and strength, quantity provided, directions, date dispensed, and drug expiration date and lot number be affixed to the packaging. Everyone needs to follow these regulations to minimize their legal liability. Of the three organizations listed the TJC Medication Management Standards for hospital affiliated physician offices and clinics are the most important to follow. Everyone wants to avoid receiving Requirements for Improvements (RFIs) after a survey during your Exit Conference.

TJC recommendations for sample prescriptions can be found at the Joint Commission Website

Some of the Medication Management Standards for Sample Prescriptions are:

  • Medications are dispensed safely. Note:  This standard is applicable to all practices that dispense medications, including those practices that dispense sample prescriptions. Quantities of medications are dispensed and minimize diversion yet are still consistent with the patient’s needs. (Standard MM.4.40 B1)
  • Procedures supporting safe medication prescribing or ordering address the following: Ordering, procuring, storing, controlling, labeling, preparing, and dispensing medications according to law or regulation (Standard MM.5.30 B1)
  • Medication orders must be written clearly (MM.3.20)
  • Medication orders or prescriptions are clear and accurate (MM.04.01.01)
  • The patient record contains information that reflects the patients care, treatment or services (RC.02.01.01)
  • Medications are appropriately labeled, Element of Performance #3 at a minimum – this information is usually included on the container (MM.4.30)
  • The organization follows a process to retrieve recalled or discontinued medications (MM.0501.17).
  • Medications dispensed by the practice are retrieved when recalled or discontinued by the manufacturer or the Food and Drug Administration for safety reasons. (Standard MM.4.70) B 4. The practice has procedures for retrieving and safely disposing of recalled medications including the following:

1) Identifying each patient who is receiving or has received recalled medications

2) Identifying the source of the medication

3) Providing for the retrieval and safe disposal of medications subject to recall

4) Providing for external reporting of medication product defects

  • The organization responds to actual or potential adverse drug events, significant adverse drug reactions, and medication errors (MM.07.01.03).
  • If the patient is transferred to another Provider, setting, level of care, a complete list of current medications, must be communicated (National Patient Safety Goal 8B).
  • Look-alike/sound-alike drugs are identified (NPSG 3, Requirement 3C). I.e., Drug Sample uses tall man lettering.

MEDeRx Software Solutions for Dispensing Sample Prescriptions

One of the many benefits of using MEDeRx’s software is that the software provides immediate compliance with many of the above requirements. For example, inventory, labeling, recall information, external reporting, patient demographics, medication orders, etc., are provided and housed within our software.

If your practice does or is considering dispensing sample prescriptions, choose the right software, choose MEDeRx.

Features of Dispensing Software

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WHAT SPECIFICATIONS SHOULD I LOOK FOR WHEN CHOOSING A PHYSICIAN DISPENSING SOFTWARE/SYSTEM?

Learn more about physician dispensing software and compare MEDeRx to the other leading brands: Software Specifications

A client recently asked us to provide a MEDeRx-feature-comparison to help them select a physician dispensing system. After compiling the information, we felt that this was a good summary of what sets MEDeRx apart from the all the other dispensing systems: Software Specifications

E-Prescribing from your EMR to MEDeRx’s Dispensing Platform

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E-Prescribing to MEDeRx’s Dispensing Platform

A common question surrounds the issue of whether physicians can e-prescribe to MedeRx’s in-office dispensing platform. In most cases, the answer is a resounding “YES”. However, some minor steps are involved as discussed below.

Physicians can use their EMR system to e-prescribe to their own location for the purposes of getting patient and prescription information into the MEDeRx dispensing software. Since patient/prescription information is sent electronically, the chances of an error is greatly reduced. Not to mention the time saved in transcribing information.

In order to e-prescribe, a gatekeeper company called “SureScripts” controls the electronic exchange of prescription information between prescribers and pharmacies and/or in-office dispensing locations. The MEDeRx dispensing software is certified with SureScripts as a pharmacy software vendor.

For your office to transmit prescription claims from your EMR to the MEDeRx platform, the following steps are required. The first step is to get your practice a NCPDP Id. (If you already have one, you can skip this step.) Registering with NCPDP.org for an NCPDP Id takes about one day and a one time cost of $275.00. Step two is registering your practice with SureScripts. SureScripts registration takes about one day and a one time cost of $125. The total time is typically two days and total cost is $125 or $325 depending on whether you already have a NCPDP Id or not. Of course, our team of professionals can assist you with NCPDP and SureScripts registration.

Please contact us to get started today!!

Precautions for physicians when self-prescribing and dispensing medications

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ARE PHYSICIANS ALLOWED TO SELF PRESCRIBE OR PRESCRIBE TO FRIENDS AND FAMILY?

According to Opinion 8.19 of the AMA Code of Medical Ethics, “physicians generally should not treat themselves or members of their immediate families.” The AMA cites the following reasons against the practice of physician self-prescribing:

  • Professional objectivity may be compromised when an immediate family member or the physician is the patient; the physician’s personal feelings may unduly influence his or her professional medical judgment.
  • Physicians may fail to probe sensitive areas when taking the medical history or may fail to perform intimate parts of the physical examination. Similarly, patients may feel uncomfortable disclosing sensitive information or undergoing an intimate examination when the physician is an immediate family member.
  • When treating themselves or immediate family members, physicians may be inclined to treat problems that are beyond their expertise or training.
  • Family members may be reluctant to state their preference for another physician or decline a recommendation for fear of offending the physician. In particular, minor children will generally not feel free to refuse care from their parents. Likewise, physicians may feel obligated to provide care to immediate family members even if they feel uncomfortable providing care.

The AMA also cites certain examples of appropriate physician self-prescribing and prescribing to immediate family members.

This would include emergency settings or isolated settings where there is no other qualified physician available. The AMA sees no issue with a physician providing routine care for short-term, minor problems; however, except in emergencies, Self prescribing is not appropriate for physicians to write prescriptions for controlled substances (I, II, IV) for themselves or immediate family members.

Source: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion819.page?

Are there self-prescribing laws physicians should know about?

While the AMA’s guidelines address the ethical issues for physicians, state law must be followed in every instance. Some states have laws that discipline a physician for prescriptions written outside the course of his or her medical practice, which could include self-prescriptions and prescriptions for those that do not have a documented patient-physician relationship. Additionally, the same conduct may also violate pharmacy statutes in those states that prohibit the filling of prescriptions which were not obtained through a physician-patient relationship. Every physician should find out what is allowed in their state and guide their conduct accordingly.

Here is a link that provides a state by state analysis of self prescribing laws. Source: http://irishhealthcarerarediseasestarlovcyst.blogspot.com/2015/01/state-by-state-opioid-prescribing.html

What are the Federal requirements for physicians when storing or handling scheduled medications?

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SECURITY REQUIREMENTS FOR HEALTHCARE PRACTITIONERS

Practitioners include physicians, dentists, veterinarians, researchers, hospitals, pharmacies, or other persons registered to do research, to dispense, or to use in teaching or chemical analysis a controlled substance in the course of professional practice.

Minimum security standards for practitioners are set forth in the regulations (Title 21 CFR 1300 to end) and are to be used in evaluating security. They may not necessarily be acceptable for providing effective controls and operating procedures to prevent diversion or theft of controlled substances. For example, a hospital that keeps large quantities of controlled substances on hand may need a safe or vault similar to the requirements for a distributor. The same reasoning also applies to other practitioners.

A practitioner’s overall security controls will be evaluated to determine if they meet the intent of the law and regulations to prevent theft or diversion.

Minimum Standards for Practitioners’ Handling of Controlled Substances

Controlled substances must be stored in a securely locked cabinet of substantial construction. Pharmacies have the option of storing controlled substances as set forth above, or concealing them by dispersal throughout their stock of non-controlled substances.

Even though the Federal regulations do not specifically define locked cabinet construction, the intent of the law is that controlled substances must be adequately safeguarded. Therefore, depending on other security measures, a wooden cabinet may or may not be considered adequate. In an area with a high crime rate, a strong metal cabinet or safe may be required.

Some of the factors considered when evaluating a practitioner’s controlled substances security include:

  1. The number of employees, customers and/or patients who have access to the controlled substances.
  2. The location of the registrant (high or low crime area).
  3. Use of an effective alarm system.
  4. Quantity of controlled substances to be kept on hand.
  5. Prior history of theft or diversion.

Again, an overall evaluation of the practitioner’s security will be made by DEA using the general and minimum security requirements as outlined in this manual to assure that the controlled substances are stored securely.

Other Security Controls for Practitioners

In order to minimize the opportunities for theft or diversion of controlled substances, practitioners have an obligation not only to provide effective physical security, but also to initiate additional procedures to reduce access by unauthorized persons as well as to provide alarm system where necessary.

Employee or Agent

A practitioner must not employ an agent or individual who has had his application for registration with the Drug Enforcement Administration (DEA) denied or revoked at any time, and who, as a result of his employment, will have access to controlled substances.

Loss or Theft

A practitioner shall notify the nearest DEA Field Office of the theft or significant loss of any controlled substance upon discovery of such loss or theft. The practitioner shall promptly complete and submit DEA Form 106 regarding the theft or loss.

Blank prescriptions and DEA Order Forms

A practitioner should develop the practice of keeping blank prescription forms in locations which would preclude patients or casual visitors from stealing the forms for the purpose of falsification. Unused DEA Order Forms should also be kept in a secure location for the same reason.

Additional Security Measures

Although not specifically required by Federal law or regulation, the following additional security measures are recommended to enhance the overall security of non-practitioners as well as practitioners in some situations….Continue

American Medical Association (AMA) Code of Ethics on Physician Dispensing

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WHAT ARE THE CODE OF ETHICS ON PHYSICIAN DISPENSING?

The American Medical Association (AMA) Code of Medical Ethics sets forth ethical rules relating to the prescribing and dispensing of drugs. In particular, Opinion 8.06 provides, inter alia, that:

  • (i) physicians should prescribe drugs based solely upon medical consideration, patient need, and reasonable expectation of the drug’s effectiveness,
  • (ii) physicians may dispense drugs within their office practices so long as the dispensing primarily benefits the patient and complies with self-referral guidelines,
  • (iii) physicians must respect the patient’s freedom of choice in selecting who will fill their prescriptions, and
  • (iv) physicians must not discourage patients from requesting a written copy of a prescription.

Although AMA guidelines typically do not have the force of law, some states have incorporated AMA standards into state law. Moreover, these standards of clinical purpose and patient freedom of choice are underlying principles for in-office dispensing in most states, whether explicit or implicit.

http://journalofethics.ama-assn.org/2010/12/coet1-1012.html

What is a PDMP? Prescription Drug Monitoring Program

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What is a Prescription Drug Monitoring Program?

According to the National Alliance for Model State Drug Laws (NAMSDL), a Prescription Drug Monitoring Program, or PDMP, is a statewide electronic database which collects designated data on substances dispensed in the state. The PDMP is housed by a specified statewide regulatory, administrative or law enforcement agency. The housing agency distributes data from the database to individuals who are authorized under state law to receive the information for purposes of their profession.

For a list of States with Prescription Monitoring Programs, please visit the link http://www.namsdl.org/library/55EF159E-BEE2-D6D5-11D72729DF059351/. For a quick reference, most states have operational PDMP‘s that have the capacity to receive and distribute controlled substance prescription information to authorized users.

Each state designates a state agency to oversee its PDMP, which may include health departments, pharmacy boards, or state law enforcement. The Alliance of States with Prescription Monitoring Programs (www.pmpalliance.org) maintains a list of state contacts.

MEDeRX’s software electronically reports the required data to each state agency that has an operational PDMP program. As a result, compliance is assured and reporting is automated for your office, clinic or urgent care.

If you are interested in learning about your specific states rules and regulations as they pertain to PDMP reporting, the National Alliance for Model State Drug Laws (www.namsdl.org) provides links to each state’s statutes and regulations regarding PDMPs.

Can Ambulatory Surgical Centers dispense medications?

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What is an Ambulatory Surgery Center?

We are commonly asked whether or not a physician can dispense medications, for profit, to a patient at an Ambulatory Surgery Center owned or partially owned by the dispensing physician. It begs the question: what is an Ambulatory Surgery Center?

Ambulatory Surgery Centers—known as ASCs—are modern health care facilities focused on providing same-day surgical care, including diagnostic and preventive procedures. Generally, each state licenses ASC’s by their respective governing body. The Center for Medicare and Medicaid certify ASC’s for their programs.

Can an Ambulatory Surgery Center Dispense Medications?

By and large, states require a separate pharmacy license or permit to dispense medications at an Ambulatory Surgery Center. For example, California now allows physician-owned ASC’s to obtain a permit to purchase drugs at wholesale for administering or dispensing to their patients under the direction of a physician. When they dispense, they are limited to dispensing a 72-hour supply. As with licensed ASCs, the Pharmacy Board is authorized to inspect a physician-owned ASC that has a limited pharmacy license at any time.

A potential work around from obtaining a separate pharmacy license or permit is dispensing medication from a physician’s office. In most states a physician can dispense medications in the usual course of professional practice and for a legitimate medical purpose, for profit, to his or her patients from his or her office.

In the instance where a physician has an independent office located within the ASC or an office located nearby, medication can be dispensed from the physician’s office pre or post operatively in such states that allow this conduct. In some states, a doctor can share the same entrance with the ASC but must be separate entities and waiting rooms.

Ethics, Regulations and Benefits of In-Office Dispensing

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 Great article on Physician Dispensing found here: Physician Dispensing Article 

reader take-away:

  • Understand the regulatory, legal and ethical issues surrounding physician dispensing.
  • Learn the benefits of physician dispensing and the hidden costs of prescription writing.
  • Find out physician dispensing’s impact on an organization’s revenue.
  • Review the steps for implementation and execution.
  • Get pointers on selecting a dispensing vendor.