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CE: Pharmacy technicians and other support staff: Legal roles for R.Ph.s


 

CONTINUING EDUCATION

Wyeth
TRENDS IN PHARMACY AND PHARMACEUTICAL CARE

An ongoing CE program of The University of Florida College of Pharmacy and DRUG TOPICS

The University of Florida College of Pharmacy is accredited by the American Council on Pharmaceutical Education as a provider of continuing pharmaceutical education. Accredited in every state requiring CE. ® ACPE # 012-999-04-274-H04

This lesson is no longer valid for CE credit after 07/31/06.

CREDIT:

This lesson provides two hours of CE credit and requires a passing grade of 70%.*

*To receive credit you must complete the evaluation. Upon successful completion, the University of Florida College of Pharmacy will mail Statements of Credit for written quizzes within 10 working days. Participants completing the program on-line may print a Statement of Credit after successfully completing the program.

OBJECTIVES:

Upon completion of this article, the pharmacist should be able to:

  • Describe the traditional activities of pharmacy technicians
  • Explain the liability issues surrounding pharmacy technician practice
  • Understand the regulatory policies and positions of organizations advocating pharmacy technician certification
  • Discuss the importance of risk management in pharmacy practice and describe how pharmacy technicians may participate in risk management activities

GOAL:

To give pharmacists a better understanding of the laws and rules concerning pharmacy technicians

Pharmacy technicians and other support staff:
The legal roles for R.Ph.s

By Karen Cheung, Pharm.D., M.B.A. Community Pharmacist in West Palm Beach, Fla.

What is the legal role of pharmacy technicians and support staff in relation to the supervising pharmacist? Technicians assist and support licensed pharmacists in the delivery of medications and provision of pharmaceutical care to patients. The term pharmacy technician is a relatively new title. Over the years, pharmacy technicians have been given a variety of titles, including pharmacy helpers, pharmacy clerks, pharmacy assistants, pharmacy aides, pharmacy support personnel, qualified pharmacy employees, support staff, unlicensed personnel, unlicensed assistants, and even pharmacy technologists. Many of these terms are still in use today because they are still found in pharmacy practice acts of various states, which were passed long ago.

Relatively recently, several developments have led to state regulation of the continually expanding role of pharmacy technicians. In 1988, eight states still did not allow technicians to practice in a community setting. Now, there is a national effort to address these roles and review training requirements, certification, registration, and licensure of pharmacy technicians. The National Association of Boards of Pharmacy has formed a specific task force to examine the regulation of pharmacy technicians and the role they play in delivering pharmaceutical care.

NABP was founded in 1904 to assist in the protection of the public health by regulating the practice of pharmacy. The primary focus of the various state boards of pharmacy is also to protect the public health. In 1993, NABP formally recognized pharmacy technicians. The association reviewed the expansion of pharmacist services, the increased role of the technician, and the differences in hospital and community pharmacy practice. It called for the establishment of a national technician competency exam and required site-specific training. In 1999, NABP recognized two levels of pharmacy support personnel: pharmacy technician and certified pharmacy technician (CPhT).

Today, pharmacy technicians are performing more activities once performed exclusively by pharmacists. At the same time, pharmacists are assuming responsibility for supervising pharmacy technicians and are moving into clinically oriented services focused on the patient's drug therapy outcome.

Under the supervision of a licensed pharmacist, pharmacy technician activities have traditionally included accepting a written prescription; checking the prescription for pertinent information such as allergies, age, and other patient information; determining benefit plan information; creating patient profiles; retrieving patient profiles; entering prescription information on patient profiles; and manually filling prescriptions, including obtaining the product, counting the number of tablets, and placing the indicated quantity in an appropriate size container. Technicians must also choose the correct trade formulation or package for certain products, such as ophthalmic, otic, nasal, and topical preparations.

Technicians have also done traditional activities, including preparing the prescription label, affixing the label to the container along with auxiliary labels, compounding medications according to explicit directions or recipes and formulations, and preparing billing information and claim forms.

Technicians are also involved in coordinating inventory control, which may include controlled or scheduled drugs. These inventory activities include establishing inventory levels of prescription and over-the-counter drugs, establishing ordering procedures, checking in orders, monitoring price changes, and checking expiration dates.

In addition to the above activities, institutional practice may include packaging and labeling medications based on physician orders, assembling a 24-hour supply of medication for each patient (filling unit doses), preparing commercially unavailable medications, preparing sterile intravenous and other parenteral medications, delivering medications, repackaging unit-dose medications, maintaining nursing-unit medications, inspecting and maintaining emergency carts, and inspecting and maintaining medication storage areas.

With today's expanded role of pharmacy technicians, some advanced roles for the tech may include regularly scheduled quality assurance activities, coordinating the introduction of updated technology, managing automation and current technology such as computerized dispensing or robotic or electronic equipment, first-dose and stat-dose dispensing, preparing written communications, implementing or revising policies and procedures, and assisting clinical pharmacists with data collection activities.

Technicians may also train other technicians by providing in-service programs, outside training programs, and continuing education. Pharmacy techs may be trained for specialty positions such as system coordinator, supervisor, and pharmaceutical buyer, further increasing their responsibility and liability.

A recent expansion of permitted technician activities includes the ability to accept verbal refill authorizations and verbal orders for new prescriptions. Some jurisdictions permit only refill authorizations, while others permit technicians to take both new prescriptions and refill authorizations. A third group of jurisdictions permits technicians to take refills only when there is no change in strength or directions. If there is, the technician must refer the call to the pharmacist.

By definition, a pharmacy technician is a staff member registered with the state board of pharmacy who may, under the supervision of the pharmacist, assist in the dispensing process, process medical coverage claims, stock medication, and perform cashiering duties. When a pharmacy technician becomes certified, the role is expanded even further. A CPhT is a staff member registered with the pharmacy board who has completed a certification program that has been approved by the board. The CPhT may perform certain activities such as receiving new prescription drug orders, receiving transferred prescriptions, and compounding under the supervision of a pharmacist. However, no pharmacy technician may contact a prescriber concerning prescription drug order clarification or therapy modification, perform patient counseling and education, or receive an oral prescription order without a recording mechanism.

In 2002, NABP partnered with the Pharmacy Technician Certification Board (PTCB) to develop and manage a certification examination for pharmacy technicians. The PTCB exam was officially recognized in the NABP Model State Pharmacy Act and Model Rules. In the same year, the scope of practice for CPhTs was expanded to allow receipt of new prescription drug orders.

The box on the left contains a sample job description, as developed by the PTCB, for a pharmacy technician in the community pharmacy setting.

The box on page 40 contains a sample job description, as developed by the PTCB, for a pharmacy technician in the hospital or institutional pharmacy setting.

Liability issues

The law in all states requires the supervision of pharmacy technicians by a licensed pharmacist. The degree of technician supervision required, however, varies from state to state. Most states require that technicians work under the direct supervision of a licensed pharmacist. For example, some states require that the pharmacist responsible for a pharmacy technician must be on the premises at all times and that the pharmacy technician be within the pharmacist's view. Other states require that the technician must be under the direct supervision of a licensed pharmacist who is physically present and capable of observing the actions of the pharmacy technician. Still other states require only general supervision, meaning that the pharmacist must be accessible but not necessarily in the technician's presence.

The pharmacist who supervises the technician is liable for the negligence of a pharmacy technician. This is based on the doctrine of Respondeat Superior. The doctrine states that an employer is responsible for the negligent acts of his employee. This doctrine holds both the employer—or the company—and the employee liable.

Furthermore, several states have specific regulations that hold the pharmacist liable for the actions of the pharmacy technician. This raises another area of concern—legislated technician and pharmacist liability. For example, one regulation states "when direct supervision is required, a licensed pharmacist shall be jointly responsible and liable for the actions of a pharmacy technician" and "the pharmacist on duty shall be directly responsible for the conduct of a pharmacy technician."

Pharmacists who violate statutes or regulations concerning the distribution of pharmaceutical products may be liable under the doctrine of Negligence Per Se. This conduct is treated as negligence without the need for proof because it is a violation of a statute or regulation designed to protect the public. If the pharmacist has clearly violated the statute or regulation, the pharmacist has then breached the duty of care. At this point, the plaintiff need only prove causation and damages. Likewise, pharmacy technicians are also exposed to liability through this doctrine. A likely scenario for a pharmacy technician would be one in which the technician incorrectly takes a telephoned prescription from a prescriber, causing the patient to receive the wrong drug, which then harms the patient. In a jurisdiction that does not permit the technician to accept verbal prescriptions, the doctrine of Negligence Per Se would apply.

Malpractice actions

Malpractice actions have two main purposes. First, they provide compensation for the harm one party has caused to another. Second, these actions serve as deterrents against substandard and irresponsible conduct. They are constant reminders that the pharmacy technician is held accountable for his or her actions.

Approximately 75% to 80% of malpractice cases filed are due to what are called mechanical type errors, such as the wrong drug being dispensed, the wrong directions being placed on the label, or the wrong strength of the drug being dispensed. The remainder of cases (25% to 30%) are due to what are called intellectual errors. These are cases in which the pharmacist has made an error in judgment or has provided incorrect advice. As technicians take over more drug dispensing functions, they are more likely to be involved in mechanical type errors. This means that pharmacy technicians have become more actively engaged in the type of activities that, if performed incorrectly, may result in the greatest percentage of malpractice cases.

In addition to the liability exposure discussed above, technicians may also be involved in intellectual errors. Typical scenarios include not advising the pharmacist of known drug interactions, providing the wrong information to patients, and providing advice when not permitted by law.

A technician has a fiduciary responsibility and may also have to face a lawsuit by a pharmacist who is supervising him or her. Although the pharmacist shares liability for the negligence, the pharmacist may proceed against the technician to collect a portion of the plaintiff's award or settlement. The doctrine of Contribution allows recovery from other responsible parties in these situations.

Technicians can also face other liability and legal difficulties. A lawsuit was threatened against a pharmacy technician when she named one of the pharmacy patients and referred to the patient as a drug abuser while presenting a seminar for other technicians on confidentiality. The technician may have violated confidentiality laws and libeled or slandered the patient.

Pharmacy technicians have increasing access to confidential and sensitive medical information. If this confidential information is improperly released or divulged, a lawsuit may result. A risk management policy that stresses the need to protect the confidentiality of information as it relates to customers and patients is one way to guard against this situation. Typical procedures would permit no disclosure of patient information to anyone outside the pharmacy unless specifically authorized by the pharmacist. Records of patient information should not be copied or removed from the premises except as authorized. Individual patients may be permitted to review or have copies of their own records, but, again, such review or copying should be done after specific authorization is received. Release of such information should be made only pursuant to a signed release by the patient or his or her guardian or other legal representative. This is important for the individual involved because there is no employer liability insurance coverage for slander, libel, or the improper release of confidential information that occurs outside the scope of employment.

Risk management

The purpose of risk management policies is to prevent medication errors. The proper use of and adherence to risk management policies and procedures by all pharmacy personnel can prevent medication errors. For example, many pharmacies have instituted a policy that requires the pharmacy technician to automatically refer questions regarding medications to the supervising pharmacist. The written policy would be a guide for pharmacy technician behavior that would make sure that the pharmacy abides by existing state law, which does not permit pharmacy technicians to counsel patients.

Today, pharmacy technicians are performing more activities that were exclusively performed by pharmacists years ago. This trend will surely continue into the future of the profession. At the same time, pharmacists are assuming responsibility for supervising pharmacy technicians and are moving into clinically oriented services focused on the patient's drug therapy outcome. The changing and expanding roles of pharmacists and pharmacy technicians require the application of risk management procedures to maximize patient safety and minimize the liability potential for pharmacy technicians, pharmacists, and pharmacies.

Risk management, as it relates to pharmacy practice, involves the concept of drug use control. Drug use control encompasses all aspects of drug use, including preparation of the medication, dispensing of the medication, and the correct use of the medication by the patient. Although pharmaceutical manufacturers do most drug product preparation, pharmacists and pharmacy technicians are frequently involved in compounding, mixing, or otherwise preparing medications for administration. Dispensing activities include: accepting a written prescription; checking the prescription for pertinent information, such as allergies, age, and other patient information; determining benefit plan information; creating patient profiles; retrieving patient profiles; entering prescription information on patient profiles; and manually filling prescriptions, including obtaining the medication, counting the number of tablets, and placing the indicated quantity in an appropriate size container. Pharmacy technicians must also choose the correct trade formulation or package for certain products, such as ophthalmic, otic, nasal, and topical preparations. Other activities include preparing the prescription label and placing the label on the container along with auxiliary labels. Successful risk management policies will address all activities described above.

The correct usage of the medication by the patient depends on several factors such as: effectiveness (relief of symptoms or curing the condition), adverse reactions, ease of administration, frequency of administration, directions for use, and proper storage. The pharmacist and, in some cases, the pharmacy technician can address many of these factors. The pharmacist is responsible for counseling the patient regarding side effects, adverse effects, proper administration, and proper storage.

While pharmacy technicians should never attempt to counsel patients, they can, in limited circumstances, provide directions for use to the patient. For example, technicians may review, explain, or emphasize directions for use and auxiliary labels (those that appear on the prescription bottle) to geriatric patients. In this same regard, technicians who are fluent in foreign languages can also provide directions for use or assist the pharmacist in communicating with the patient. Under no circumstances, however, should a pharmacy technician attempt to provide any information that does not appear on the prescription container. Risk management plays a large role in patient behavior and the correct use of the drug. The first step in risk management is to determine the cause of an error.

Patients tend to have complete trust in the pharmacist. However, errors can be made unintentionally. For example, the pharmacist refills a prescription. The correct drug and other information is in the computer database from the original fill. The pharmacist may then pick the incorrect bottle from the shelf. Even though the pharmacist was sure to check the name of the drug many times, the error was still made. Risk management addresses the prescription verification procedures that would have allowed the pharmacist to catch this error.

Another example comes from the situation dealing with the substitution of generic drugs. While most pharmacies strive to dispense the same brand of generic drug, sometimes this is impossible due to supply and demand. This results in patients receiving different generic drugs that are different in color and shape. Generally, changing the supplier of generic drugs should be kept to a minimum, but sometimes it is simply unavoidable. As a precaution, patients can be notified that the color and appearance of their drug will not change unless they have been told so by the pharmacy. A written policy can be established that instructs pharmacy personnel to routinely tell all patients that the color and appearance of their drug will not change unless they have been notified by the pharmacy. Further, pharmacy technicians can be instructed that any questions concerning the appearance of the medication must be referred to the pharmacist.

Pharmacy technicians and other personnel who accept prescriptions should make sure that the patient's age or date of birth is clearly written on the prescription so that when it is entered into the computer, the pharmacist or technician knows whether the prescription is for a child or an adult. Additionally, all new prescriptions should be filled from the hard copy. If new prescriptions are dispensed and checked based on the printed label, there will be no opportunity to catch or identify a typing error or misinterpretation of the original prescription. No matter whether a pharmacist or technician enters the order in the computer, by filling a new prescription from the original hard copy, this type of error can be avoided. Furthermore, if a mistake is not caught on the original filling, it may be compounded by each additional refill with catastrophic effects.

Federal law requires the use of child-resistant containers on almost all prescriptions. The law provides an exception when the patient or physician requests that a child-resistant container not be used. A procedure can be established that requires some form of documentation to prove the patient did request easy-open containers. Even though law does not require this documentation, prudent risk management dictates that documentation should be used. The documentation can consist of a stamp on the back of each new prescription signed by the patient or person representing the patient. As an alternative, a log book can be set up that patients can sign indicating that new prescriptions and refills should not be dispensed in child-proof containers. If a log book is used, a new request should be required at least once every year.

Conclusion

National pharmacy organizations are now advocating uniform state laws and regulations regarding pharmacy technicians. ASHP advocates an "optimal approach to protecting public health and safety by the development and adoption of uniform state laws and regulations regarding pharmacy technicians, mandatory completion of a nationally accredited standardized program of education and training as a prerequisite to pharmacy technician certification, and mandatory certification by PTCB as a prerequisite to the state board of pharmacy's granting the technician permission to engage in the full scope of responsibilities authorized by the state." This position would further support the registration of pharmacy technicians by state boards of pharmacy and would hold licensed R.Ph.s accountable for the quality of pharmacy services and the activities of pharmacy technicians under their supervision.

In the future, it is likely that state governments will mandate that all pharmacy technicians attain certification by PTCB and that pharmacy technicians become registered by state boards of pharmacy. Uniform standards for the education and training of all pharmacy technicians will ensure competency and the protection of public health and safety. Most important, licensed pharmacists will be held directly accountable for the quality of pharmacy services, including the activities of their pharmacy technicians and support staff.

Pharmacists and pharmacy technicians alike must be keenly aware of the consequences associated with negligent practice and must place the welfare of the public first and foremost. Practicing sound risk management activities can reduce the potential for therapeutic errors, maximize patient safety, and promote favorable therapeutic outcomes. Risk management policies and procedures should be carefully developed, documented, and updated on a regular basis. Orientation of new pharmacy personnel should include a thorough presentation of all risk management policies. All pharmacy employees should review these policies regularly.

The threat of liability, both civil and criminal, is very real in pharmacy technician practice and will increase as technicians gain greater responsibilities. Therefore, a thorough understanding of state and federal pharmacy regulations is also required to ensure that no criminal liability occurs. Finally, practicing sensible risk management activities can decrease the potential for professional malpractice actions against pharmacists and pharmacy technicians.

References are available upon request.


Pharmacy technician job description—Community

General definition

The purpose of the pharmacy technician is to assist the pharmacist with the day-to-day activities in the pharmacy.

Responsibilities

• Help patients who are dropping off or picking up prescription orders

• Enter prescription orders into the computer

• Create a profile of the patient's health and insurance information in the computer or update the patient's profile

• Assist the pharmacist, under direct supervision, in the practice of pharmacy, in accordance with local, state, federal, and company regulations

• Communicate with insurance carriers to obtain payment for prescription claims

• Verify, at point of sale, that customer receives correct prescription(s)

• Complete weekly distribution center medication orders, place orders on shelves, and verify all associated paperwork

• Assist the pharmacist with filling and labeling prescriptions

• Prepare the pharmacy inventory

• Screen telephone calls for the pharmacist

• Communicate with prescribers and their agents to obtain refill authorization

• Compound oral solutions, ointments, and creams

• Prepackage bulk medications

• Maintain an awareness of developments in the community and pharmaceutical fields that relate to job responsibilities and integrate them into own practices

• Assist in training new employees

• Assist other pharmacy technicians

• Assist pharmacist in scheduling and maintaining workflow

• Maintain knowledge of loss prevention techniques

Qualifications

• National certification desirable or preferred

• Professional demeanor

• Ability to respect confidentiality of patient data

• Strong communication skills

• Courteous attitude

• Understanding of medical terminology and calculations

• Ability to type at least 35 words per minute

• Knowledge of computer operations

• Knowledge of medication brand and generic names

• Knowledge of insurance and third-party payment systems

• High school diploma or graduate equivalent degree


Pharmacy technician job description—Hospital

General definition

Under the direction of a pharmacist, the pharmacy technician performs pharmacy-related functions, in compliance with department policies and procedures that provide optimal pharmaceutical care.

Responsibilities

• Rotate through all work areas of the pharmacy

• Transport medications, drug delivery devices, and other pharmacy equipment from the pharmacy to nursing units and clinics

• Pick up copies of physician orders, automated medication administration records, and unused medications from the nursing units and return them to the pharmacy

• Fill patient medication cassettes

• Prepare medications and supplies for dispensing, including:

• prepacking bulk medications
• compounding ointments, creams, oral solutions, and other medications
• preparing chemotherapeutic agents
• compounding total parenteral nutrition solutions
• compounding large-volume intravenous mixtures
• packaging and preparing drugs being used in clinical investigations
• preparing prescriptions for outpatients
• checking continuous unit-dose medications

• Control and audit narcotics/stock substance

• Assist pharmacists in entering medication orders into the computer system

• Prepare inventories, order drugs and supplies from the storeroom, receive drugs and stock shelves in various pharmacy locations

• Screen telephone calls

• Perform monthly nursing unit inspections, maintain workload records, and collect quality assurance data

• Assist in training new employees

• Assist other pharmacy technicians

• Coordinate insurance billing, including third-party prescriptions

• Deliver unit doses to automated dispensing systems

• Triage telephone/window inquiries

Qualifications

• National certification desirable or preferred

• Valid state pharmacy technician registration (required in some states)

• High school diploma or graduate equivalent degree

Training and experience

• Must have one year of hospital pharmacy experience, have completed a pharmacy technician vocational course, or be a pharmacy student

Knowledge and skills

• Ability to work as a team member

• Good communication skills

• Knowledge of basic pharmacy practices and procedures

• Knowledge of medications and medical supplies

• Strong mathematical computation skills

• Knowledge of record-keeping techniques

• Attention to detail

• Accurate typing skills (minimum 35 words per minute)

• Basic understanding of computer technology


TEST QUESTIONS

Write your answers on the answer form below (photocopies of the answer form are acceptable) or on a separate sheet of paper. Mark the most appropriate answer.

1. In 1988, pharmacy technicians were not allowed to practice in a community setting in how many states?

a. One
b. Four
c. Eight
d. 20

2. The National Association of Boards of Pharmacy was founded in:

a. 1898
b. 1904
c. 1956
d. 1972

3. The primary focus of state pharmacy boards is to:

a. Protect the public health
b. Provide legal advice to pharmacists
c. Distribute medications
d. Develop clinical activities for pharmacists

4. A certified pharmacy technician may not:

a. Process medical coverage claims
b. Perform patient counseling
c. Perform cashiering duties
d. Assist in the dispensing process

5. The national examination for pharmacy technician certification was developed by:

a. NABP
b. PTCB
c. None of the above
d. Both a. and b.

6. Pharmacy technicians must be supervised by:

a. A licensed pharmacist
b. A certified pharmacy technician
c. Only a consultant pharmacist
d. Only the pharmacy director of the institution

7. Who is responsible for the negligence of a pharmacy technician?

a. The supervising pharmacist
b. All technicians present at the time of error
c. The nursing staff
d. The patient

8. In a state that does not allow the technician to accept verbal prescriptions, if the pharmacy technician incorrectly takes a telephoned prescription, which doctrine of law would apply?

a. Negligence Per Se
b. Respondeat Superior
c. Contribution
d. All of the above

9. The purpose of malpractice actions is to:

a. Provide compensation for the harm done
b. Deter against substandard and irresponsible conduct
c. Release technicians from any liability
d. Both a. and b.

10. What percentage of malpractice cases is due to mechanical type errors?

a. 25%
b. 50%
c. 75%
d. 99%

11. What percentage of malpractice cases is due to intellectual errors?

a. 25%
b. 50%
c. 75%
d. 99%

12. A technician may have to face a lawsuit by the supervising pharmacist based on the doctrine of:

a. Negligence Per Se
b. Respondeat Superior
c. Contribution
d. All of the above

13. The purpose of risk management is to:

a. Prevent medication errors
b. Provide compensation for the harm done
c. Deter against substandard and irresponsible conduct
d. Release technicians from any liability

14. Who should adhere to risk management policies?

a. Pharmacists only
b. Pharmacy technicians only
c. Other support staff only
d. All pharmacy personnel

15. The correct use of medication by the patient depends on:

a. Effectiveness
b. Ease of administration
c. Directions for use
d. All of the above

16. The use of child-resistant containers for prescription drugs is required by:

a. Federal law
b. State law
c. Local county law
d. Not required

17. Uniform state laws and regulations regarding pharmacy technicians are being advocated by:

a. DEA
b. National pharmacy organizations
c. The FDA
d. They are not being advocated

18. In the future, it is likely that mandatory technician certification will be done by:

a. PTCB
b. ASHP
c. NABP
d. Accredited colleges of pharmacy

19. A nationally accredited program for technician certification would include:

a. Education
b. Training
c. National examination
d. All of the above

20. In the future, it is likely that:

a. State laws will mandate all pharmacy technicians be certified by PTCB
b. Pharmacy technicians will become registered by state boards of pharmacy
c. Uniform standards for education and training of pharmacy technicians will be established
d. All of the above

 


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Karen Cheung. Pharmacy technicians and other support staff: Legal roles for R.Ph.s. Drug Topics Jul. 26, 2004;148:36.

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