Med­i­ca­tion safety dur­ing se­vere weather, power out­ages

Jamaica Gleaner - - MESSAGE -

IN THE drug (medicine) world, the qual­ity of any medicine pretty much hinges on the acro­nym – SESA. What does this acro­nym rep­re­sent? The let­ter S rep­re­sents sta­bil­ity, the let­ter E rep­re­sents ef­fi­cacy, the Let­ter S rep­re­sents safety and last, the let­ter A rep­re­sents ac­cept­abil­ity.

A drug prod­uct must meet all es­tab­lished spec­i­fi­ca­tions that are em­bod­ied within this acro­nym be­fore it reaches the con­sumer. But most im­por­tant, af­ter the phar­ma­cist has dis­pensed the medicine to the con­sumer or care­giver, it is ex­pected that the drug prod­uct is han­dled, trans­ported, stored and used in such a man­ner that the ac­tive in­gre­di­ent con­tained in the prod­uct and the over­all prod­uct re­mains safe, sta­ble, ac­cept­able and have the re­quired po­tency to ex­ert its bi­o­log­i­cal ef­fect (ef­fi­cacy).

This ar­ti­cle will be fo­cus­ing on the sta­bil­ity and safety of medicines dur­ing se­vere weather con­di­tions.

SE­VERE WEATHER CON­DI­TIONS AND MED­I­CA­TION MAN­AGE­MENT

By know­ing what ac­tions to take be­fore, dur­ing and af­ter a hur­ri­cane or storm, you can in­crease your chance of sur­vival. This, of course, in­cludes proper med­i­ca­tion man­age­ment be­fore, dur­ing and af­ter a storm or hur­ri­cane has passed. Ex­tra care in stor­age con­di­tions is of par­tic­u­lar im­por­tance, espe­cially “if the power goes out.

A drug prod­uct (drug) must have both phys­i­cal sta­bil­ity (re­tains its phys­i­cal prop­er­ties, in­clud­ing ap­pear­ance, taste, uni­for­mity) and chem­i­cal sta­bil­ity (chem­i­cal in­tegrity and la­belled po­tency within spec­i­fied lim­its) to be of ac­cept­able qual­ity and deemed safe for use. Other ar­eas of in­ter­est are: mi­cro­bi­o­log­i­cal sta­bil­ity (steril­ity or re­sis­tance to mi­cro­bial growth ac­cord­ing to spec­i­fied lim­its); ther­a­peu­tic sta­bil­ity and tox­i­co­log­i­cal sta­bil­ity (no sig­nif­i­cant in­crease in tox­i­c­ity).

Dur­ing se­vere weather con­di­tions, the way medicines are stored is of­ten com­pro­mised due to pos­si­ble ex­po­sure to ex­ces­sive heat (fire), mois­ture (wa­ter and hu­mid­ity changes) and lack of re­frig­er­a­tion (power out­ages), all of which can speed up the rate at which a drug prod­uct breaks down.

YOUR DRUG SAFETY

The Cen­ter for Drug Eval­u­a­tion and Re­search at the US Food and Drug Ad­min­is­tra­tion pro­vides the fol­low­ing in­for­ma­tion on the use of drugs (medicines) that may be af­fected by fire, flood­ing or un­safe wa­ter, and on the use of the tem­per­a­ture-sen­si­tive drugs when re­frig­er­a­tion is tem­po­rar­ily un­avail­able.

Drugs ex­posed to ex­ces­sive

heat such as Fire: The ef­fec­tive­ness of drugs can be de­stroyed by high tem­per­a­tures from fire. If you think your medicine have been ex­posed to ex­ces­sive heat, con­sider re­plac­ing them.

Drugs ex­posed to un­safe

wa­ter: Drugs ex­posed to flood or un­safe mu­nic­i­pal wa­ter may be­come con­tam­i­nated, which may lead to se­ri­ous health ef­fects. If this oc­curs, then even those in their orig­i­nal con­tain­ers with screw-top caps, snap lids or drop­pers should be dis­carded if they came into contact with flood or con­tam­i­nated wa­ter. In ad­di­tion, medicines placed in other stor­age con­tain­ers should be dis­carded if the medicines came in contact

with flood or con­tam­i­nated wa­ter.

Life­sav­ing drugs ex­posed to

heat and un­safe wa­ter: Drugs ex­posed to fire or un­safe wa­ter should be re­placed as soon as pos­si­ble once a re­place­ment is avail­able. If the drug looks un­changed – for ex­am­ple, pills in a wet con­tainer ap­pear dry – the drugs can be used un­til a re­place­ment is avail­able. If the pills are wet, then they are con­tam­i­nated and need to be dis­carded.

Drugs that need to be re­con­sti­tuted (made into

liq­uid): Drugs that have to be re­con­sti­tuted (made into a liq­uid, us­ing wa­ter) should be mixed only with pu­ri­fied or bot­tled wa­ter. Liq­uids other than pu­ri­fied or bot­tled wa­ter should not be used to re­con­sti­tute these prod­ucts.

DRUGS THAT NEED RE­FRIG­ER­A­TION

Some drugs re­quire re­frig­er­a­tion (for ex­am­ple, in­sulin and cer­tain liq­uid an­tibi­otics). If elec­tri­cal power has been off for a long time, the drug should be dis­carded and re­placed. How­ever, if the drug is ab­so­lutely nec­es­sary to sus­tain life (for ex­am­ple, in­sulin), it may be used un­til a new sup­ply is avail­able.

Tem­per­a­ture-sen­si­tive drugs will lose po­tency if not re­frig­er­ated; there­fore they should be re­placed with a new sup­ply as soon as pos­si­ble. For ex­am­ple, in­sulin that is not re­frig­er­ated is ef­fec­tive for a shorter pe­riod of time than the la­belled ex­pi­ra­tion date given on the pack­ag­ing.

In­sulin and other prod­ucts in need of re­frig­er­a­tion (cold stor­age): Af­ter a dis­as­ter, pa­tients in the af­fected area may not have ac­cess to re­frig­er­a­tion.

IN­SULIN PROD­UCTS

Ideal stor­age tem­per­a­tures: Ac­cord­ing to the prod­uct la­bels from in­sulin man­u­fac­tur­ers, it is rec­om­mended that in­sulin be stored in a re­frig­er­a­tor at ap­prox­i­mately 36°F to 46°F (2 to 8°C). Un­opened and stored in this man­ner, these prod­ucts main­tain po­tency un­til the ex­pi­ra­tion date on the pack­age.

In­sulin prod­ucts con­tained in

vials or car­tridges: Opened or un­opened in­sulin may be left un­re­frig­er­ated at a tem­per­a­ture be­tween 59°F and 86°F (15° to 30°C) for up to 28 days and con­tinue to work.

ALL PROD­UCTS IN NEED OF RE­FRIG­ER­A­TION

It is rec­om­mended that you try to keep in­sulin and other medicines that re­quire re­frig­er­a­tion as cool as pos­si­ble. Cool means to store at tem­per­a­ture be­tween 8°C and 15°C (46°F and 59°F) If you are us­ing ice, avoid freez­ing the med­i­ca­tion. DO NOT USE the med­i­ca­tion, espe­cially in­sulin, if it has been frozen. Keep these medicines away from di­rect heat and out of di­rect sun­light. Freez­ing may result in loss of med­i­ca­tion strength or po­tency, or de­struc­tive al­ter­ations of prod­uct char­ac­ter­is­tics.

GEN­ERAL MED­I­CA­TION STOR­AGE CON­SID­ER­A­TIONS:

If you are con­cerned about the ef­fi­cacy or safety of a par­tic­u­lar prod­uct, contact your phar­ma­cist, health-care provider or the man­u­fac­turer’s cus­tomer ser­vice de­part­ment. Also, con­sult your drug prod­uct la­bel (pack­ag­ing in­sert) or the con­tainer, as well as the pa­tient pre­scrip­tions la­bels that the phar­ma­cist would place on the boxes or pill con­tain­ers (jars and en­velops) to see the rec­om­mended stor­age con­di­tions for your medicines.

REF­ER­ENCES

1. National Weather Ser­vice. Weather Safety. http://www.weather.gov/safety. Up­dated 2016. 2. US Food and Drug Ad­min­is­tra­tion. Hur­ri­canes: Health and Safety. 2014. 3. Allen LVJ, Popovich NG, Ansel HC. Ansel’s Phar­ma­ceu­ti­cal Dosage Forms and Drug De­liv­ery Sys­tems. 9th ed. Philadel­phia: Lip­pin­cott Wil­liams & Wilkins; 2011. 4. USP 33-NH 28. Gen­eral no­tices and re­quire­ments. n.d. 5. Udesky L.: Stor­ing your Medicine. Jan 20, 2016. https://con­sumer.health­day.com/e ncy­clo­pe­dia/drug-cen­ter-16/mis­c­drugs-news-218/stor­ing-yourmedicine-646535.html

TIECA HAR­RIS, MPHIL, RPH, BPHARM Regis­tered Phar­ma­cist and Lec­turer Phar­ma­ceu­tics De­part­ment School of Phar­macy, Col­lege of Health Sciences Univer­sity of Tech­nol­ogy, Ja­maica

TIECA HAR­RIS

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