MEDICATION SAFETY

Meeting HFAP Accreditation Standards for Pharmacy Services and Medication Use Part Two: Procurement, Preparation and Dispensing

 HFAP Chapter 25 keeps you in compliance with the Medicare Conditions of Participation

Medication Safety Series

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Prescribing challenges Procurement in an era of drug shortages – keeping it safe Preparation and dispensing – includes sterile preparation Administration of medications – timing, unit dose, bedside medication verification Monitoring of therapy, Medication Use Evaluations

Procurement, Preparation, and Dispensing- Objectives

 Describe the supply chain for pharmaceuticals  Discuss the challenges posed by drug shortages  Describe the process of ensuring adequate compounding facilities  Discuss the role and challenges of automated dispensing systems

The Problem

    The Institute of Medicine Report revealed that errors in medical care are responsible for many deaths Many health care providers are not aware of their responsibilities Medication errors responsible for numerous adverse outcomes, including death This results in high cost (emotional and financial)

Responsibilities

Prescribing Preparation Dispensing Administration Monitoring Physicians Nurses X Pharmacists Respiratory Therapists X X X X X X X X X X X X X X X X X

Regulatory Standards

 HFAP – Chapter 25  CMS Conditions of Participation 482.25

PROCUREMENT

 Formulary maintenance process managed by the Pharmacy and Therapeutics Committee and is subject to approval by the Medical Executive Committee  Non-formulary drugs can be obtained if the patient’s needs cannot be met by medications currently on the formulary

DRUG SHORTAGES

Drug Shortages: a Serious and Widespread Problem

Annual New Drug Shortages

January 2003 to December 31, 2010 Tripled since 2006 University of Utah Drug Information Service

National Drug Shortages

January 2001 – June 2011 120 88 73 58 74 70

77% Injectables

129 149 166 211 156

Drug Information Services, University of Utah, 2010

Causes of Shortages

 Fewer suppliers  Manufacturer financial decisions  Enforcement of FDA standards/regulations  Leaner inventory levels  Gray market distributors  Stockpiling by end-users  Unexpected increases in demand  Quality/availability raw material

Reasons for Shortages (Injectables)

Clinical

Impact of Drug Shortages

 Adversely affect drug therapy  Compromise or delay medical treatment/procedures  Failure to treat /progression of disease  Medication errors/adverse patient outcomes

Near Misses, Errors and Adverse Outcomes

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Dosing

– EPINEPHrine 1:1,000 overdose in substitution for 1:10,000 – Wrong dose of levoleucovorin substituted for leucovorin – IV etoposide converted to oral dosing without doubling dose 

Concentration

– Cytarabine dosing error using 1000mg vial instead of 500mg vial 

Alternative Drug

– Thrombophlebitis from Phenytoin administration

Near Misses, Errors and Adverse Outcomes

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No Therapy/Delayed Therapy

– Treatment of PCP due to no IV Bactrim – Death from Untreated resistant pseudomonas: no amikacin   Clinically significant delay in treating a patient with PCP due to IV TMP/SMX shortage Death from resistant pseudomonas infection due to amikacin shortage

Drug Shortage Survey - Impact

98% 89% 80%

Guidelines for Managing Drug Shortages

– Assessment of duration of shortage – Analysis of threat to patient care and cost – Exploration of therapeutic alternatives – Effective/Timely communication – Patient prioritization – Ensure external relationships

What Hospitals Experience

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Communication

– Appropriate timing – Target audience – Method of communication 

Ethical dilemma

– Patient prioritization 

System Limitation

– Complexity of the system 

Increased costs

What Hospitals Experience

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Compromise of safety measures

– Look-Alike drugs – Standard concentrations – Preparation of products 

Increased workload

– Compounding and repackaging – Finding drug supply – Establishing guidelines or identifying alternatives

Shortages Summary

  Problems – Difficult to impossible to predict – Little to no information from manufacturers – Increased cost and emotions – No evidence of relief from shortages Solutions – Work together as a multidisciplinary team to create guidelines for use, when possible – Use cost-saving and resource-sparing measures when appropriate – ABOVE ALL, KEEP IT SAFE!

Preparation Issues

 Environment of drug preparation – Sterile areas – Equipment (is everyone competent to use it?) – Procedures for preparation – Storage conditions

Preparation Responsibilities

 Pharmacists  Nurses  Respiratory therapists

Problems

       Drug names that sound and look alike Use of brand names Multiple package sizes Outdated information Inappropriate storage Not reading the label Poor labeling

APPROPRIATE LABELING Actual vial contents are listed

APPROPRIATE LABELING Strength per milliliter and total per vial are listed

This can be misleading to indicate that each ampoule contains only 1 mg

This can be misleading to indicate that each vial contains only 400 mg

Why Compounding?

 Shortage of commercially available products  Custom concentrations

Compounding In-House or Outsourcing?

 In-house OK if small quantity needed and adequate resources are available  Cannot prepare bulk quantities in-house – that is manufacturing  USP 797 requirements

Risk Level Classifications of Compounded Sterile Products

 Risk level classifications are divided up into low, medium, and high depending on how much manipulation to the admixture is involved  Low-risk level: – Manually mixing no more than three products to compound drug admixtures – i.e. Morphine drip, Dopamine drip, KCl drip

Risk Level Classification, cont.

 Medium-risk level: – Multiple individual doses of sterile products are combined to prepare a product that will be administered to multiple patients or the same patients on multiple occasions – Compounding includes complex aseptic manipulations other than single volume transfer – i.e. TPN admixtures – Inpatient pharmacy normally practices at a medium-risk level

Risk Level Classification, cont.

 High-risk level: – Measuring or mixing sterile ingredients in non-sterile devices before sterilization is performed – Dissolving non-sterile bulk drug and nutrient powders to make solutions, which will be sterilized – i.e. Cardioplegia drips

Handwashing  Touching sterile products while compounding is the most common source of contamination of pharmacy prepared sterile products.

 Scrub your hands, nails, wrists, and forearms thoroughly for at least 30 seconds with a brush, warm water, and appropriate bactericidal soap before performing aseptic manipulations. Wash your hands frequently and every time you re-enter the sterile compounding area.

 Workers who have open sores on their hands or have an upper respiratory tract infection should inform their supervisor and/or consult the institutions quality assurance procedures. Wear sterile gloves and mask is needed.

Equipment and Supplies  Another important factor in aseptic preparation of sterile products is the correct use of appropriate sterile equipment and supplies, including syringes and needles.

 Syringes: - made of either glass or plastic - most drugs are more stable in glass, so glass syringes are most often used when medication is to be stored in the syringe for an extended period of time.

- Composed of a barrel and plunger. To maintain sterility of the product, do not touch the syringe tip or plunger. Many syringes have a locking mechanism at the tip: Leur-lock, which secures the needle within a threaded ring.

Preparation of Intravenous Admixtures  Before compounding – assemble all materials and visually inspect vials, ampules, and IV solution containers for signs of cloudiness, particulate matter, cracks and punctures, expiration dates, and anything else that may indicate that the product is defective.

Preparation continued…  Next, disinfect all injection surfaces and allow them to dry.

- Flexible plastic bag – made of polyvinyl chloride (PVC) are frequently used.

- Easier to store, less breakable than glass bottles, and eliminates the need to vent the container when removing fluid.

- The protective overwrap should not be removed from a PVC bag until it is ready to be used.

- To minimize air turbulence in the critical area, position the injection port of a PVC bag, which is covered by an outside latex tip diaphragm, toward the HEPA filter when preparing an IV admixture.

Automated Compounding  Three primary pieces of equipment are used, sometimes together and sometimes individually.

- An automated compounder prepares the base components dextrose, amino acids, and possibly fat emulsion & H20 - A second automated compounder adds most or all of the additives or other components - A computer with software maintains the orders of the ingredients and controls the two compounders.  Quality assurance programs

Quality Assurance for Sterile Compounding

 Sterility Testing – Product – Staff  Potency Testing  Random samples  Pyrogen testing

Outsourcing

 Numerous companies  Not all alike  Compounding vs. manufacturing  FDA role  Buyer beware – NECC

Outsourcing – choosing a company

 Review their latest inspection records  Review their record with the State Board of Pharmacy  Are they accredited? By whom?

 PCAB  Ask to visit their facility  Can they supply in a timely manner?

 Perform your own QA

Recent Examples

 Sodium Bicarbonate  50% Dextrose  Epinephrine  Atropine  Magnesium sulfate

Dispensing Issues

 Verification of allergies and potential drug interactions  Verification of drug dosage  Identification of the patient (i.e.,right name on the label)  Automated dispensing devices – Accuracy of filling – Accountability of controlled substances

Dispensing Responsibilities

 Pharmacists and technicians  Nurses  Physicians (i.e., anesthesiologists)  Respiratory therapists

Potential Problems

 Mathematical mistakes  Excessive floor stock  Lethal doses easily available (such as concentrated potassium chloride – no longer available outside the pharmacy)  Ability to bypass controls in automated systems (OVERRIDE medications in ADC)

Solutions

 Double-check calculations (two different people starting at opposite ends)  Use the ADC profile system  Limit floor stock and ADC override capability  Require pharmacist review of every order (even if no 24 hour pharmacy available)

Remote Verification of Orders

 Essential if pharmacist not available  Available from several companies  Verify competency and licensure status  Complements the onsite pharmacy staff  Helps limit overrides

Summary

 Many challenges in procurement  No immediate relief of the shortage situation in sight  Need careful attention to preparation technique  Compounding can be our friend  Pharmacist verification prior to dispensing can save lives

Next Time

 Administration of Medications  Use of technology  Direct observation