DRUG THERAPY DRUG THERAPY DURING PREGNANCYDURING PREGNANCY

Developed By Developed By

D. Ann Currie , R.N.,M.S.N.D. Ann Currie , R.N.,M.S.N.

PHYSIOLOGICAL CHANGES DURING PHYSIOLOGICAL CHANGES DURING PREGNANCY AND THEIR IMPACT PREGNANCY AND THEIR IMPACT ON DRUG THERAPYON DRUG THERAPY

EVERY SYSTEM IN THE BODY IS EVERY SYSTEM IN THE BODY IS EFFECTED BY PREGNANCYEFFECTED BY PREGNANCY

PHARMACOKENETICS OF DRUGS IS PHARMACOKENETICS OF DRUGS IS EFFECTED BY PREGNANCYEFFECTED BY PREGNANCY

PHARMACOKENETICS PHARMACOKENETICS OF DRUGS DURING OF DRUGS DURING PREGNANCYPREGNANCY

ABSORPTION- DECREASED GI MOTILITY ABSORPTION- DECREASED GI MOTILITY CAUSES INCREASED DRUG CAUSES INCREASED DRUG ABSORPTION.ABSORPTION.

DISTURBUTION- PROTIEN BINDING IS DISTURBUTION- PROTIEN BINDING IS DECREASED CAUSES INCREASED FREE DECREASED CAUSES INCREASED FREE DRUG TO BE AVAILABLE.DRUG TO BE AVAILABLE.

METABOLISM-INCREASED HEPATIC METABOLISM-INCREASED HEPATIC METABOLISM OCCURS FOR SOME METABOLISM OCCURS FOR SOME DRUGSDRUGS

PHARMACOKENETICSPHARMACOKENETICS

EXCRETION- IN THE 3RD EXCRETION- IN THE 3RD TRIMESTER INCREASED RENAL TRIMESTER INCREASED RENAL BLOOD FLOW & GFR CAUSES BLOOD FLOW & GFR CAUSES SOME DRUGS TO CLEAR THE SOME DRUGS TO CLEAR THE BODY FASTER.BODY FASTER.

DRUG THERAPY IN THE DRUG THERAPY IN THE CHILDBEARING CLIENTCHILDBEARING CLIENT REQUIRES REQUIRES

SPECIAL SPECIAL CONSIDERATIONSCONSIDERATIONS

IS CHALLENGING IS CHALLENGING TO PROVIDE TO PROVIDE EFFECTIVE TX EFFECTIVE TX WHILE AVOIDING WHILE AVOIDING HARM TO HARM TO EMBRYO,FETUS EMBRYO,FETUS OR NEONATEOR NEONATE

CENTERED ON CENTERED ON RISK/BENEFIT RISK/BENEFIT RATIORATIO

EFFECTS OF EFFECTS OF DRUGS NOT DRUGS NOT ALWAYS KNOWNALWAYS KNOWN

ANY DRUG TAKEN BY ANY DRUG TAKEN BY THE PREGNANT OR THE PREGNANT OR BREASTFEEDING BREASTFEEDING CLIENT HAS THE CLIENT HAS THE POTENTIAL TO REACH POTENTIAL TO REACH THE FETUS BY WAY THE FETUS BY WAY OF MATERNAL OF MATERNAL CIRCULATION OR CIRCULATION OR NEONATE BY WAY OF NEONATE BY WAY OF BREASTMILKBREASTMILK

EFFECTS OF DRUGS ON EFFECTS OF DRUGS ON THE EMBRYO, FETUS, THE EMBRYO, FETUS, OR NEONATEOR NEONATE

MAY VARY---MAY VARY--- NO EFFECT.NO EFFECT. LITTLELITTLE SERIOUS- FETAL TOXICITYSERIOUS- FETAL TOXICITY SPONTANEOUS ABORTIONSPONTANEOUS ABORTION DEATHDEATH FETAL MALFUNCTIONFETAL MALFUNCTION FETAL MALFORMATIONS.FETAL MALFORMATIONS.

DRUG THERAPY DRUG THERAPY DURING PREGNACYDURING PREGNACY CENTERED ON RISK/BENEFIT RATIOCENTERED ON RISK/BENEFIT RATIO EFFECTS OF SOME MEDICATION EFFECTS OF SOME MEDICATION

ARE KNOWNARE KNOWN UNKNOWN- NEW MEDICATIONS, UNKNOWN- NEW MEDICATIONS,

DIFFERENT COMBINATIONS, DIFFERENT COMBINATIONS, DEFICIENCY IN MATERNAL DEFICIENCY IN MATERNAL METABOLISMMETABOLISM

NO DRUG IS ABSOLUTELY SAFE.NO DRUG IS ABSOLUTELY SAFE.

RECENT STUDIESRECENT STUDIES

75% OF PREGNANT CLIENTS USE 75% OF PREGNANT CLIENTS USE 3-10 DIFFERENT 3-10 DIFFERENT DRUGS(PRESCRIPTION OR OTC’S) DRUGS(PRESCRIPTION OR OTC’S) OTHER THAN VITAMINS/MINERAL OTHER THAN VITAMINS/MINERAL SUPPLEMENTS DURING THEIR SUPPLEMENTS DURING THEIR PREGNANCY.PREGNANCY.

OTC’S WERE USED 4 TIMES THAT OTC’S WERE USED 4 TIMES THAT OF PRESCRIPTION DRUGS.OF PRESCRIPTION DRUGS.

TYPES OF DRUGS USED TYPES OF DRUGS USED IN THE STUDY BY IN THE STUDY BY PREGNANT CLIENTSPREGNANT CLIENTS DIETARY DIETARY

SUPPLEMENTSSUPPLEMENTS ANTIEMETICSANTIEMETICS ANTACIDSANTACIDS TRANQUILIZERSTRANQUILIZERS HYPNOTICSHYPNOTICS ANTIBIOBIOTICSANTIBIOBIOTICS ANTIHISTAMINESANTIHISTAMINES

ANALGESICSANALGESICS DIURETICSDIURETICS ETOHETOH CNS CNS

DEPRESSANTSDEPRESSANTS CNS STIMULANTSCNS STIMULANTS

DRUG LEVELS IN THE DRUG LEVELS IN THE FETUS REACHED 50-FETUS REACHED 50-100% OF THE 100% OF THE MATERNAL BLOOD MATERNAL BLOOD LEVELSLEVELS

SELF TREATMENT SELF TREATMENT WITH DRUGS DURING WITH DRUGS DURING PREGNANCYPREGNANCY

SELF TX OF MINOR ILLNESSES OR SELF TX OF MINOR ILLNESSES OR DISCOMFORTS SHOULD BE DISCOMFORTS SHOULD BE DISCOURAGEDDISCOURAGED

*SELFTREATMENT OF ANY ILLNESSES *SELFTREATMENT OF ANY ILLNESSES SHOULD BE DISCOURAGEDSHOULD BE DISCOURAGED

WOMEN SHOULD BE INSTRUCTED TO WOMEN SHOULD BE INSTRUCTED TO KEEP A COMPLETE RECORD OF ALL KEEP A COMPLETE RECORD OF ALL MEDICATIONS TAKEN .MEDICATIONS TAKEN .

THE CHALLENGE OF THE CHALLENGE OF PROVIDING EFFECTIVE PROVIDING EFFECTIVE CARE/TX FOR THE CARE/TX FOR THE CHILDBEARING CLIENTCHILDBEARING CLIENT

AVOID HARM TO EMBRYO, FETUS, AVOID HARM TO EMBRYO, FETUS, NEONATE.NEONATE.

DILEMMA UNFORTUNATELY THE DILEMMA UNFORTUNATELY THE RISK OF MOST DRUGS HAVE NOT RISK OF MOST DRUGS HAVE NOT BEEN ESTABLISHED.BEEN ESTABLISHED.

DESPITE NOT KNOWING DRUG DESPITE NOT KNOWING DRUG THERAPY DURING PREGNANCYTHERAPY DURING PREGNANCY

CANNOT OR SHOULD NOT BE CANNOT OR SHOULD NOT BE AVOIDED BECAUSE THE HEALTH AVOIDED BECAUSE THE HEALTH OF THE FETUS DEPENDS ON THE OF THE FETUS DEPENDS ON THE HEALTH OF THE MOTHER.HEALTH OF THE MOTHER.

FOR EXAMPLE: SEIZURES ,DM, MG, FOR EXAMPLE: SEIZURES ,DM, MG, SLE,OR INFECTIONS.SLE,OR INFECTIONS.

BIRTH DEFECTSBIRTH DEFECTS

INCIDENCE OF MAJOR INCIDENCE OF MAJOR STRUCTURAL STRUCTURAL DEFECTS(ABNORMALITIES) IS DEFECTS(ABNORMALITIES) IS ABOUT 6% OF ALL PREGNANCIES.ABOUT 6% OF ALL PREGNANCIES.

3% ARE CAUSED BY DRUGS OR 3% ARE CAUSED BY DRUGS OR ENVIRONMENTAL ENVIRONMENTAL FACTORS/EXPOSUREFACTORS/EXPOSURE

3% HAVE A UNKNOWN CAUSES3% HAVE A UNKNOWN CAUSES

BIRTH DEFECTSBIRTH DEFECTS

1/2 OF THE BIRTH DEFECTS ARE 1/2 OF THE BIRTH DEFECTS ARE OBVIOUS AT BIRTH.OBVIOUS AT BIRTH.

1/2 OF THE BIRTH DEFECTS AREN’T 1/2 OF THE BIRTH DEFECTS AREN’T DISCOVERED UNTIL LATER IN LIFE DISCOVERED UNTIL LATER IN LIFE OR DISCOVERED DURING AN OR DISCOVERED DURING AN AUTOPSYAUTOPSY

INCIDENCE OF MINOR STRUCTURAL INCIDENCE OF MINOR STRUCTURAL ABNORMALIES IS NOT KNOWN.ABNORMALIES IS NOT KNOWN.

BIRTH DEFECTSBIRTH DEFECTS

INCIDENCE OF FUNCTIONAL INCIDENCE OF FUNCTIONAL ABNORMALITIES IS NOT KNOWN-ABNORMALITIES IS NOT KNOWN-GROWTH RESTRICTIONS, MENTAL GROWTH RESTRICTIONS, MENTAL RETARDATION, AND LEARNING RETARDATION, AND LEARNING DISABLITIESDISABLITIES

SOME ABNORMALITIES HAVE SOME ABNORMALITIES HAVE MULTIPLE CAUSES-GENETIC MULTIPLE CAUSES-GENETIC FACTORS, ENVIRONMENTAL FACTORS, ENVIRONMENTAL FACTORS, CHEMICALS OR DRUGS.FACTORS, CHEMICALS OR DRUGS.

TERATOGENICTERATOGENICTERATOGENESISTERATOGENESIS TERAS-”MONSTER”TERAS-”MONSTER” GENSIS-”PRODUCING”GENSIS-”PRODUCING” BIRTH DEFECTS/DISTORTION OF BIRTH DEFECTS/DISTORTION OF

GROSS ANATOMY.GROSS ANATOMY. EXAMPLES- CLEFT LIP/PALATE, EXAMPLES- CLEFT LIP/PALATE,

CLUBFOOT, NEURAL TUBAL CLUBFOOT, NEURAL TUBAL DEFECTS, MISSING OR DEFECTS, MISSING OR MALFORMED LIMBS/FINGERS.MALFORMED LIMBS/FINGERS.

TERATOGENICTERATOGENIC

ALSO-BEHAVORIAL AND/ OR ALSO-BEHAVORIAL AND/ OR BIOCHEMICAL ABNORMALITIES.BIOCHEMICAL ABNORMALITIES.

TERATOGENESIS MAYBE DIRECT-TERATOGENESIS MAYBE DIRECT-IE-MALFORMATIONS OF IE-MALFORMATIONS OF STRUCTURESSTRUCTURES

OR INDIRECT-SUCH AS OR INDIRECT-SUCH AS INTERFERING WITH O2 OR INTERFERING WITH O2 OR NUTRIENTS.NUTRIENTS.

TERATOGENICTERATOGENIC

EXAMPLE OF KNOWN TERATOGENIC EXAMPLE OF KNOWN TERATOGENIC AGENTS:AGENTS:

ONE TIME EXPOSURE IS ONE TIME EXPOSURE IS THALIDOMIDE-CAUSES MISSING THALIDOMIDE-CAUSES MISSING LIMBS.LIMBS.

CONT. OR PROLONG EXPOSURE IS CONT. OR PROLONG EXPOSURE IS ETOH-CAUSES FAS.ETOH-CAUSES FAS.

SEE HANDOUT FOR OTHER AGENTS.SEE HANDOUT FOR OTHER AGENTS.

FETAL EFFECTS FROM FETAL EFFECTS FROM DRUGS DEPEND ON DRUGS DEPEND ON SEVERAL FACTORSSEVERAL FACTORS

TIME- WHEN DRUG IS TAKEN IN TIME- WHEN DRUG IS TAKEN IN PREGNANCY.PREGNANCY.

PREIMPLANTATION/PRESOMITE PREIMPLANTATION/PRESOMITE PERIOD-CONCEPTION TO 2 WEEKPERIOD-CONCEPTION TO 2 WEEK

HIGH DOSE- MAYBE HIGH DOSE- MAYBE LETHAL/DEATH/ABORTIONS.LETHAL/DEATH/ABORTIONS.

LOW DOSE-MAYBE NOTHING.LOW DOSE-MAYBE NOTHING.

EMBRYONIC PERIOD-3-8 WEEKS EMBRYONIC PERIOD-3-8 WEEKS *FIRST TRIMESTER* *FIRST TRIMESTER*

GROSS MALFORMATIONSGROSS MALFORMATIONS FETAL PERIOD-9-40 WEEKS(TERM)FETAL PERIOD-9-40 WEEKS(TERM) FUNCTION PROBLEMS RATHER FUNCTION PROBLEMS RATHER

THAN GROSS ANATOMY- THAN GROSS ANATOMY- *LEARNING DEFICITS &/OR *LEARNING DEFICITS &/OR BEHAVORIAL ABNORMALIESBEHAVORIAL ABNORMALIES

WHY IS WHY IS IDENTIFICATION OF IDENTIFICATION OF TERATOGENIC AGENTS TERATOGENIC AGENTS SOMETIMES DIFFICULT SOMETIMES DIFFICULT TO IDENTIFY?TO IDENTIFY?

INCIDENCE OF CONGENITAL ANOMALIES IS INCIDENCE OF CONGENITAL ANOMALIES IS GENERALLY LOW.GENERALLY LOW.

ANIMAL TESTS MAY NOT BE RELIABLEANIMAL TESTS MAY NOT BE RELIABLE PROLONGED OR INCREASED EXPOSURE MAYBE PROLONGED OR INCREASED EXPOSURE MAYBE

REQUIRED.REQUIRED. EFFECTS MAYBE DELAYED OR NOT RECONIZED.EFFECTS MAYBE DELAYED OR NOT RECONIZED. BEHAVIORAL EFFECTS ARE DIFFICULT TO BEHAVIORAL EFFECTS ARE DIFFICULT TO

DOCUMENT.DOCUMENT. CONTOLLED EXPERIMENTS CANNOT BE DONE CONTOLLED EXPERIMENTS CANNOT BE DONE

ON HUMANS.ON HUMANS.

DOCUMENTATION IS INCOMPLETEDOCUMENTATION IS INCOMPLETE ONLY IN A LIMITED NUMBER OF DRUGS ONLY IN A LIMITED NUMBER OF DRUGS

IS THE TERATOGENIC EFFECTS KNOWN IS THE TERATOGENIC EFFECTS KNOWN OR PROVEN.OR PROVEN.

LACK OF PROOF OF TERATOGENICITY LACK OF PROOF OF TERATOGENICITY DOES NOT MEAN A DRUG IS SAFE IN DOES NOT MEAN A DRUG IS SAFE IN PREGNANCYPREGNANCY

MAY MEAN THERE IS A LACK OF MAY MEAN THERE IS A LACK OF RESEARCH OR INFORMATION.RESEARCH OR INFORMATION.

PROVING A DRUG IS A PROVING A DRUG IS A TERATOGENTERATOGEN 3 CITERIA MUST BR MET:3 CITERIA MUST BR MET: 1. DRUG MUST CAUSE A 1. DRUG MUST CAUSE A

CHARACTERISTIC SET OF CHARACTERISTIC SET OF MALFORMATIONS.MALFORMATIONS.

2. IT MUST ACT ONLY DURNIG A 2. IT MUST ACT ONLY DURNIG A SPECIFIC WINDOW OF SPECIFIC WINDOW OF VULNERABILITY-3-8 WEEKS OF VULNERABILITY-3-8 WEEKS OF GESTATIONGESTATION

3.THE INCIDENCE OF 3.THE INCIDENCE OF MALFORMATIONS SHOULD MALFORMATIONS SHOULD INCREASE WITH INCREASED INCREASE WITH INCREASED DOSAGE & DURATION OF DOSAGE & DURATION OF EXPOSURE.EXPOSURE.

PLACENTAL DRUG PLACENTAL DRUG TRANSFERTRANSFER THE PLACENTA IS NOT A THE PLACENTA IS NOT A

COMPLETE BARRIER.COMPLETE BARRIER. SOME DRUGS ARE STOPPED.SOME DRUGS ARE STOPPED. SOME DRUGS(IN FACT MOST) ARE SOME DRUGS(IN FACT MOST) ARE

NOT.NOT. WAYS DRUGS ARE TRANSFER WAYS DRUGS ARE TRANSFER

ACROSS- SIMPLE DIFFUSION-ACROSS- SIMPLE DIFFUSION-ACTIVE TRANSPORT.ACTIVE TRANSPORT.

TRANSFER DEPENDS TRANSFER DEPENDS ON SEVERAL FACTORSON SEVERAL FACTORS

CHEMICAL PROPERTY OF THE DRUGCHEMICAL PROPERTY OF THE DRUG MOLECULAR WEIGHT.MOLECULAR WEIGHT. PROTEIN BINDING CAPABILITIES.PROTEIN BINDING CAPABILITIES. CHEMICAL CONFIQURATION.CHEMICAL CONFIQURATION. LIPID SOLUBILITY.*LIPID SOLUBILITY.* PERIOD OF TIME DRUG REMAINS IN PERIOD OF TIME DRUG REMAINS IN

MATERNAL BLOODSTREAMMATERNAL BLOODSTREAM HALFLIFE OF THE DRUG.HALFLIFE OF THE DRUG.

TRANSFER DEPENDS TRANSFER DEPENDS ON SEVERAL FACTORSON SEVERAL FACTORS CONT.CONT. AMOUNT OF THE DRUG.AMOUNT OF THE DRUG. PATHOLOGICAL PROCESSES OF PATHOLOGICAL PROCESSES OF

THE PLACENTA.THE PLACENTA. WHEN IN THE PREGNANCY-WHEN IN THE PREGNANCY-

INCREASED BLOOD FLOW TO THE INCREASED BLOOD FLOW TO THE PLACENTA IN LAST PART OF PLACENTA IN LAST PART OF PREGNANCY.PREGNANCY.

MOST DRUGS MOST DRUGS TRANSFER AND ARE TRANSFER AND ARE AT 50-100% THAT OF AT 50-100% THAT OF THE MATERNAL THE MATERNAL LEVELS * SOME DRUG LEVELS * SOME DRUG LEVELS ARE MORE LEVELS ARE MORE THAN THE MATERNAL THAN THE MATERNAL LEVELSLEVELS

DRUGS THAT TRANSFER EASILY DRUGS THAT TRANSFER EASILY ARE LIPID SOLUBLE.ARE LIPID SOLUBLE.

DRUGS THAT ARE DIFFICULT/HARD DRUGS THAT ARE DIFFICULT/HARD TO TRANSFER ARE IONIZED TO TRANSFER ARE IONIZED DRUGS-HIGHLY POLAR-OR DRUGS-HIGHLY POLAR-OR PROTEIN BOUND.PROTEIN BOUND.

HOW IS DATA HOW IS DATA COLLECTED ON DRUGS COLLECTED ON DRUGS WHICH CAUSE WHICH CAUSE PROBLEMS IN PROBLEMS IN PREGNANCIES?PREGNANCIES? NO HUMAN EXPERIMENTATIONNO HUMAN EXPERIMENTATION

SYSTEMATIC COLLECTION AND SYSTEMATIC COLLECTION AND ANALYZING OF DATA ON DRUGS ANALYZING OF DATA ON DRUGS TAKEN BY PREGNANT CLIENTS.TAKEN BY PREGNANT CLIENTS.

REPORTING OF INFORMATION BY REPORTING OF INFORMATION BY HEALTH PROFESSIONALS.HEALTH PROFESSIONALS.

SEE FORM.SEE FORM.

THE NURSE’S ROLE THE NURSE’S ROLE AND RESPONSIBILITY AND RESPONSIBILITY IN DRUG THERAPY IN IN DRUG THERAPY IN THE CHILDBEARING THE CHILDBEARING CLIENTCLIENT KNOWLEDGE (CURRENT KNOWLEDGE (CURRENT &ACCURATE INFORMATION)-&ACCURATE INFORMATION)-

PREGNANCYPREGNANCY MEDICAL CONDITIONSMEDICAL CONDITIONS MEDICAL TREATMENTSMEDICAL TREATMENTS DRUGS AND CLIENTDRUGS AND CLIENT

EDUCATION OF EDUCATION OF PREGNANT/PREPREGNPREGNANT/PREPREGNANT CLIENTSANT CLIENTS

PROVIDE ACCURATE INFORMATION PROVIDE ACCURATE INFORMATION WITH RATIONALESWITH RATIONALES

INFORMATION SOULD BE CURRENT INFORMATION SOULD BE CURRENT AND BASED ON EVIDENCE.AND BASED ON EVIDENCE.

* ESTABLISH ENVIRONMENT * ESTABLISH ENVIRONMENT CONDUCIVE TO EXCHANCE OF CONDUCIVE TO EXCHANCE OF INFORMATION*- TRUST.INFORMATION*- TRUST.

POTENTIAL HARM/RISKS.POTENTIAL HARM/RISKS.

EDUCATIONEDUCATION

BENEFITSBENEFITS COMMON SUBSTANCES & OTC COMMON SUBSTANCES & OTC

DRUGS TO AVOID IN PREGNANCY- DRUGS TO AVOID IN PREGNANCY- ASA,ETOH,INCREASED DOSES OF ASA,ETOH,INCREASED DOSES OF MULTVITAMINS,CAFFIENE,CIGAREMULTVITAMINS,CAFFIENE,CIGARETTE SMOKING,ETC.TTE SMOKING,ETC.

AVOID SELF TX-OTC’S, DRUGS AVOID SELF TX-OTC’S, DRUGS FORM MEXICO.FORM MEXICO.

ADVOCATE FOR CLIENTS AND ADVOCATE FOR CLIENTS AND GENERAL PUBLIC.GENERAL PUBLIC.

* SUPPORT** SUPPORT* ASSIST WITH COPING IF CLIENT ASSIST WITH COPING IF CLIENT

HAS TAKEN A TERATOGENIC HAS TAKEN A TERATOGENIC AGENT..WITH GUILT OR FEAR…AGENT..WITH GUILT OR FEAR…ASSOCIATED WITH DRUGS TAKEN ASSOCIATED WITH DRUGS TAKEN IN PREGNANCY.IN PREGNANCY.

PREGNANT CLIENT’S PREGNANT CLIENT’S BILL OF RIGHTSBILL OF RIGHTS

““RIGHT TO KNOW”RIGHT TO KNOW”

For individual drugs For individual drugs see handout.see handout.