Drug use in lactating mothers.

In the women breast, the milk-producing glands are surrounded by fine blood vessels. Fine molecules for example drugs can enter into breast milk from the blood. Drugs that are soluble in fat may enter into breast milk more easily. This is how drugs can be passed to a breastfed baby through the mother’s breast milk.

When a breast-feeding mother takes a drug, it can either causes

• insignificant effects on the baby (because the amount of drug passed through the milk is too small) or
• adverse/unwanted effects on the infant or
• a reduction in the production of  breast milk

Lactating mothers should consult their doctors or pharmacists for further details.

What are the factors that a doctor considers before prescribing or administering a drug to a breast-feeding mother?

They include whether:

• the drug therapy is really needed.
• the drug is the least toxic drug and yet is effective.
• the dosing schedule can be timed/arranged to reduce the drug delivered to the baby.
• the drug can also be used for the baby.
• the baby suffered from any medical problem such as liver or renal failure that would affect the drug metabolism or excretion and cause drug accumulation in the baby.
• the drug amount delivered through the breast milk reaches a therapeutic dose in the baby.
• the idiosyncratic or adverse reactions affect the baby.
• the drug produce any side effects.

Note:

• Lactating mothers must avoid using drugs unnecessarily. Usually the doctor will assess the potential risk against the benefit of using the drug for both mother and infant.
• Breast-feeding mothers must avoid using drugs that are known to cause serious side effects in adults. Lactation should be discontinued if the treatment is necessary and there is no suitable alternative therapy available.
• Lactating mothers should breast-feed their baby first before administering the medication.
• Lactating mothers must avoid breast-feeding when drug levels in the breast milk are highest. Consult your doctor or pharmacist.
• Breast-feeding mothers should use the most appropriate route of administration.
• Before taking any over-the-counter drugs including herbal preparation, lactating mothers must consult their doctors first.
• Avoid excessive intake of alcohol and caffeine drinks.

Drug use in pregnant women.

During pregnancy, drug treatment may be needed in order to treat common complaints related to the pregnancy for example constipation or vomiting or even to treat pre-existing/chronic conditions. However, drugs taken by a pregnant mother may enter the baby’s blood stream through the placenta. Some of the drugs may cause harm to the developing baby or the mother or even both. Hence, it is vital to CONSULT your doctor before taking any medication including over-the-counter or herbal medicine if you are pregnant or trying to conceive. Your doctor will prescribe drug treatment only if the possible benefits of administering the drug outweigh any potential risks. It is also important to seek your doctor’s advice before you continue taking the long-term drug treatment for chronic conditions such as diabetes, high blood pressure or epilepsy. Modification in the drug therapy may be required in this case. During pregnancy, pregnant women must avoid using drugs of abuse such as marijuana and heroin as their newborn babies will have low birth weight and withdrawal symptoms (for example feeding and sleeping difficulties, trembling and seizures) and the babies may then die. Pregnant women who are intravenous drug abusers may infect their babies with HIV. You must also avoid smoking (nicotine) and drinking alcohol if you are pregnant. Smoking during pregnancy may lead to premature labour and low birth weight of babies. Drinking alcohol during pregnancy may affect the fetus by causing growth retardation, facial abnormalities and serious central nervous system problems.

Pregnancy period is categorized into 3-month stages that are usually called trimesters. If you administer drugs during:

• the first 3 months of pregnancy / first trimester :

some of the drugs may interfere with the fetal organ development leading to birth malformations /defects. Very severe defects may lead to miscarriage. Therefore, unless directed by your doctor, you must avoid taking any drugs during the first trimester.

         

• the next 3 months of pregnancy / 4^th –6^th month of pregnancy / second trimester : 

some of the drugs may retard/slow down fetal growth leading to low birth weight of the baby. Whereas, some drugs may cause specific fetal tissue damage.

• The end of pregnancy period / 6^th – 9^th month of pregnancy / third trimester or during labour / delivery :

Labour may be premature, delayed or prolonged by certain drugs. Additionally, some drugs may cause problems to the newborn baby. For example, newborn baby may experience breathing difficulty if the mother is administered with narcotic analgesic.

Note:

• Remember to always seek your doctor's advice before taking any medication including over-the-counter or herbal medicine if you are pregnant or trying to conceive.
• Drugs that have been usually used during pregnancy and usually safe are preferred compared to new drugs.
• Smallest effective dose of drug should always be used.
• Unless directed by your doctor, you must avoid self-medication with any drugs at any stages of pregnancy. If possible, you should try non-drug or alternative treatments first. For example, if you experience vomiting during pregnancy, you should take small, frequent meals. In addition, you should avoid foods, smells, or situation that induce vomiting. Then, take an effervescent glucose (However careful if you are diabetic).  If these are not effective, then only you seek your doctor advice on drug therapy. 
• If you have constipation during pregnancy, you should try proper diet, adequate fluid intake and exercise. If these are ineffective, you should seek your doctor’s advice on laxative preparations.
• Before taking any vitamins or health supplements, you should also consult your doctor first.
• If you are pregnant or suspect pregnant, you should avoid or reduce food or drugs containing caffeine.

Tips on documentation and record keeping

Good documentation is essential part of the quality assurance system.

• CLEARLY written documentation prevent errors from spoken communication and permits traceability.
• Documents should be designed, prepared, reviewed and distributed with CARE. They should comply with rules and regulations.
• Title, nature and purpose should be CLEARLY STATED. They should be laid out in an orderly fashion and be easy to check.
• Documents should be APPROVED, SIGN and DATED by appropriate and AUTHORIZED  person.
• ALL procedures being used within a company, are APPROVED by related experts are CONSISTENT with other documents and are in the most CURRENT or updated version. Authorized Quality Assurance personnel usually is the last person to sign on the document to verify and approve.
•  ALL documents: current, obsolete, superseded as well as all the history on creation and revision of the document are kept by Quality Assurance following the document retention period.
• Data may be recorded by electronic data processing systems, photographic or other reliable means or methods. However, detailed procedures relating to the system in use should be available. In addition, the accuracy of the records should be checked. 
• If documentation is handled by electronic data processing methods, only AUTHORIZED persons should be able to enter or modify data in the computer. A record of CHANGES and DELETIONS should be available. Access should be RESTRICTED by passwords or other means. The results of entry of CRITICAL DATA should be independently CHECKED. Back ups must be available. Data must be readily AVAILABLE throughout the retention period.
• Documents should be REGULARLY REVIEWED and kept UP-TO-DATE. When a document has been revised and approved, systems should be operated to PREVENT inadvertent use of superseded documents.
• Documents should not be hand written; although, where documents need the entry of data, these entries may be made in CLEAR, LEGIBLE and INDELIBLE handwriting. Sufficient space should be provided for such entries.
• Practice yourself to ALWAYS record ALL necessary information IMMEDIATELY upon completion of each task. This is to avoid from forgetting to record the details of the necessary information and to avoid any mistakes. Remember, no matter whether you are so busy or whether you don't have enough time, you have to do this. Never compromise. If you compromise, you'll be in trouble! .
• NEVER trust your memory. You will never remember everything in details.
• SIGN, DATED and write your NAME legibly in ink. Remember that by signing records, you are certifying that the record is correct and that you have performed the task as per the defined procedure. NEVER sign a document without reading the contents of the document.
• DRAW a SINGLE line through any mistakes, SIGN and DATE the alteration or correction. The alteration should PERMIT the reading of the original information. INCLUDE a REASON for the correction near the mistakes or note at the bottom of the page.
• Reproduced documents should be CLEAR and LEGIBLE. The reproduction of working documents from master documents must NOT allow any error or mistake to be introduced through the reproduction process.
• NEVER write any results or records or important details on loose pieces of paper. Because, you may lost it.
• DON'T document someone else's task/work unless you are designated and trained to do so.
• NEVER assume that undocumented work has been properly completed. If it is not written down, then it didn't happen! (although actually it has been completed). If something goes wrong, you can't proof that the work has been properly completed if it is not documented.
• NEVER lie or manipulate data/records. It is essential to keep ACCURATE records. During an audit, it helps convey that you are following procedures. It also demonstrates that processes are known and under control. Quality Assurance ensures that all documents are maintained and controlled.
• ALWAYS follow APPROVED procedures. Should a deviation occurs, all changes and deviations must be recorded.
• ALWAYS record details when you deviate from a procedure. ALWAYS ask your supervisor/superior or the Quality Department for advice should a deviation occurs.

 "Quality,
Quality,
Quality:
Never waver from it,
even when you don't see
how you can afford to keep it up.
When you compromise, 
you become a commodity, 
and then you die!"
~Gary Hirshberg